Pharmaceutical Payouts
Boy wins £120,000 damages for narcolepsy caused by swine flu vaccine
Ruling comes after government claimed illness was not serious enough to merit payment, and opens door for up to 100 families to seek compensation
A 12-year-old boy has been awarded £120,000 by a court that agreed he had been left severely disabled by narcolepsy triggered by the swine flu vaccine, following a three-year battle in which the government had claimed that his illness was not serious enough to merit payment.
The ruling is expected to lead to as many as 100 other families of people affected by the sleeping disorder after receiving the vaccine bringing fresh compensation claims, in a dispute where the government’s initial hostility was described by the family’s legal team as offensive.
“They felt quite insulted to have their condition basically dismissed as something quite trivial. They are incredibly needy. Some have lost their jobs, dropped out of university or seen their marriages break down as a result [of narcolepsy],” said Peter Todd, the solicitor for the family of the 12-year-old, a partner with the London firm Hodge Jones & Allen.
The youngster, whose parents have asked he remain anonymous, has become disruptive at school due to extreme tiredness brought about by the illness, triggered after he took the vaccine in 2009, the court heard. He has only one friend because the sleep disorder makes socialising difficult.
The upper tribunal court that heard the case, also heard that the boy is unable to shower unattended or take a bus alone and needs to take several naps during the school day. He is unlikely to be allowed to drive as an adult.
To say that it’s not impactful just makes me mad. Narcolepsy affects everything that Ciara does and always will do.
Anthony O’MahonyOthers expected to bring fresh claims against the government, include the parents of a 17-year-old whose life was permanently altered by the condition, and an eight-year-old whose family relocated to California to seek better medical care.
The narcolepsy was triggered by the Pandemrix vaccine, made byGlaxoSmithKline, was given to around 6 million people in Britain as part of a national vaccination scheme rolled out during the 2009-10 swine flu pandemic. While the swine flu outbreak never reached the proportions that had been feared, scientists now believe the vaccine caused narcolepsy in a small number of patients.
The government now acknowledges the link, but had previously argued those affected by narcolepsy do not meet the threshold for the Department for Work and Pensions’s compensation scheme, which automatically awards a £120,000 lump sum to anyone with “severe” and permanent disabilities as a result of certain vaccines.
Anthony O’Mahony, whose 17-year-old daughter, Ciara, developed narcolepsy after being given the vaccine in 2009, said that the government’s suggestion that illness was not “severe” was offensive to victims. “To say that it’s not that impactful just makes me mad,” he said. “Narcolepsy affects everything that Ciara does and always will do.”
His daughter received the vaccine in 2009 and in the months afterwards began showing symptoms of the sleep disorder, such as lethargy and sudden loss of muscle control. Twice, her mother has found her asleep in the bath and on several occasions she has fallen suddenly after losing consciousness.
The family only became aware of the link with Pandemrix last year and O’Mahony stresses he is not “anti-vaccine”, despite what happened. “There’s always going to be someone who has some kind of reaction to vaccines,” he said. “We just want an acknowledgement.”
Ciara is one of 74 others represented by Todd who are seeking to challenge similar compensation rejections by the DWP, and the group is pursuing a separate civil action against GSK. The costs of any financial settlement are likely to be met by the taxpayer because of an indemnity agreed signed between the government and the pharmaceutical giant.
Narcolepsy is a rare but serious neurological disorder that affects about 31,000 people in Britain. It can cause sleep disruptions, including night terrors and hallucinations, and extreme drowsiness during the daytime. Some narcoleptics also suffer from cataplexy, where a sudden burst of emotion such as shock or happiness causes total loss of muscle control.
In 2013, a major study by the Health Protection Agency found that around one in every 55,000 swine flu jabs led to narcolepsy, but the exact biological causes for the link are not clear.
To qualify for the DWP’s Vaccine Damage Payment Scheme, a victim has to be classed as at least 60% disabled, which is described as equivalent to the loss of one hand.
Matt O’Neill, chairman of the charity Narcolepsy UK, said: “The problem is that it is often hidden condition, but there are so many things that people with narcolepsy can’t do that you would be able to do with a physical disability. To suggest that narcolepsy is not severe is absolutely ridiculous.”
The government now has 21 days to appeal the ruling. A spokesman for the Department of Work and Pensions said the government would not comment on individual cases, adding: “The Vaccine Damage Payments Scheme provides support in very rare cases where someone has become severely disabled as a result of immunisation against certain diseases. Decisions on claims take into account the individual circumstances of each case and the latest available medical evidence.”
A GSK spokesman said: “We are actively researching the observed association between Pandemrix and narcolepsy and the interaction this vaccine might have had with other risk factors in those affected.
“We’re also continuing to support ongoing work from other experts and organisations investigating reported cases of this condition and we hope these efforts will enable us to provide more answers in the future. We take the safety of patients who entrust their health in our vaccines and medicines very seriously.”
Source : The Guardian (June 2015)
Drugmaker Roche must pay more than $1.5 million in damages to a woman who developed bowel disease after using the company’s Accutane acne medicine, a jury ruled in her retrial.
Officials of Basel, Switzerland-based Roche failed to properly warn Kamie Kendall’s doctors that Accutane could cause ulcerative colitis and were liable for her injuries, jurors in state court in New Jersey concluded today.
It was the second trial of Kendall’s Accutane claims. A New Jersey appeals court overturned a $10.5 million verdict in 2010, ruling that a judge improperly barred Roche from using evidence about the medication’s use. Roche has lost 10 of 13 suits brought by former Accutane users that have gone to trial since April 2007, according to data compiled by Bloomberg.
“This is another in a long line of juries that have found Roche knew this drug caused bowel disease and wrongfully withheld that information from patients and their doctors,” Mike Hook, Kendall’s lawyer, said in a phone interview.
About 16 million people have taken Accutane, once Roche’s second-biggest selling drug, since it went on the market in 1982. Roche, which recently exited its shuttered its sprawling campus on the border of Nutley and Clifton, lost patent protection in 2002 and continued to sell the drug along with generic competitors. In addition to bowel disease, Accutane has been linked to birth defects and depression.
Roche, the world’s biggest maker of cancer drugs, pulled its brand-name Accutane off the market in 2009 after juries awarded millions of dollars in damages to former users over the bowel-disease claims.
In 2012, a New Jersey jury ordered Roche to pay a total of $18 million to two former Accutane users. The same jury rejected claims by two other patients who blamed their bowel ailments on the drug.
Source : NJ.com (March 2014)
Brain-Damaged UK Victims of Swine Flu Vaccine to Get £60 Million Compensation
Patients who suffered brain damage as a result of taking a swine flu vaccine are to receive multi-million-pound payouts from the UK government.
The government is expected to receive a bill of approximately £60 million, with each of the 60 victims expected to receive about £1 million each.
Peter Todd, a lawyer who represented many of the claimants, told the Sunday Times: "There has never been a case like this before. The victims of this vaccine have an incurable and lifelong condition and will require extensive medication."
Following the swine flu outbreak of 2009, about 60 million people, most of them children, received the vaccine.
It was subsequently revealed that the vaccine, Pandemrix, can cause narcolepsy and cataplexy in about one in 16,000 people, and many more are expected to come forward with the symptoms.
Across Europe, more than 800 children are so far known to have been made ill by the vaccine.
Narcolepsy affects a person's sleeping cycle, leaving them unable to sleep for more than 90 minutes at a time, and causing them to fall unconscious during the day. The condition damages mental function and memory, and can lead to hallucinations and mental illness.
Cataplexy causes a person to lose consciousness when they are experiencing heightened emotion, including when they are laughing.
The Pandemrix vaccine was manufactured by pharmaceuticals giant Glaxo Smith Kline, which refused to supply governments unless it was indemnified against any claim for damage caused. The company will pay the bill, and claim the money back from the government.
"There's no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries - and probably in most countries," Emmanuelle Mignot, a specialist in sleep disorder at Stanford University in the United States told Reuters.
Mignot has been paid by GSK to research the effects of the drug.
Among those affected are NHS medical staff, many of whom are now unable to do their jobs because of the symptoms brought on by the vaccine. They will be suing the government for millions in lost earnings.
However, the vast majority of patients affected - around 80% - are children.
Among them is Josh Hadfield, 8, from Somerset, who is on anti-narcolepsy drugs costing £15,000 a year to help him stay awake during the school day.
"If you make him laugh, he collapses. His memory is shot. There is no cure. He says he wishes he hadn't been born. I feel incredibly guilty about letting him have the vaccine," said his mother Caroline Hadfield, 43.
Despite a 2011 warning from the European Medicines Agency against using the vaccine on those under 20 and a study indicating a 13-fold heightened risk of narcolepsy in vaccinated children, GSK has refused to acknowledge a link.
"Further research is needed to confirm what role the vaccine may have played in the development of narcolepsy in those affected," the company said in a statement.
Source : IBTimes
Merck Said to Agree to $100 Million NuvaRing Settlement
Merck & Co. (MRK) agreed to pay $100 million to settle several thousand lawsuits alleging the drugmaker’s NuvaRing contraceptive device causes potentially fatal blood clots, two people familiar with the accord said.
The settlement, which resolves cases in federal and state courts in Missouri and New Jersey, will provide an average payout of more than $58,000 a case and will be announced today, said the people, who asked not to be identified because they weren’t authorized to speak publicly about it.
Women accused Whitehouse Station, New Jersey-based Merck of selling NuvaRing knowing it posed a higher risk of heart attack-inducing blood clots than competing products.
The settlement allows Merck, the second-biggest U.S. drugmaker by sales, to pay less than Bayer AG (BAYN) and other competing contraceptive makers did to resolve lawsuits over their products. Bayer said last year that it has paid more than $1.6 billion to settle claims over its Yasmin and Yaz lines of birth-control pills. Women said Yaz also caused blood clots that led to strokes and heart attacks.
“Merck may be getting out much more cheaply than its competitors because proving the liability case against the NuvaRing device appears to be more difficult than against the other contraceptives,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview.
Lainie Keller, a Merck spokeswoman, declined to comment on the settlement in an e-mail. Roger Denton, a plaintiffs’ lawyer in St. Louis who is leading the consolidated NuvaRing cases, didn’t return a call seeking comment.
FDA Report NuvaRing is a hormonal-vaginal contraceptive that combines both estrogen and progestin in a ring to prevent pregnancy. The product, which was linked in a 2011 U.S. Food and Drug Administration report to a higher risk for blood clots, has been sold in the U.S. since 2001.
Merck opened today down 5 cents to $53.72 at 9:36 a.m. in New York Stock Exchange trading.
Merck reported fourth-quarter earnings this week that fell short of estimates. Earnings excluding certain items were 88 cents a share, 1 cent below the average of 15 analysts’ estimates compiled by Bloomberg. The company also forecast 2014 profit of $3.35 to $3.53 a share, compared with $3.48 projected by analysts.
Dozen Studies Lawyers for women suing over the NuvaRing product contend in court filings there are almost a dozen studies showing the type of progestin used in the device is twice as likely to cause blood clots. Such clots can block veins and cause heart attacks or travel to the lungs and cause other health issues.
The family of a Nebraska mother who used a NuvaRing device sued Merck in 2010 after the woman was found dead with a blood clot in her lung. Ann Tompkins’ family alleged in their suit that Merck misled users about the device’s health risks.
Women contend in court filings that Merck failed to provide proper warnings about NuvaRing’s higher clot risks on the device’s label to protect sales. Suits have been filed against Merck and Organon USA Inc., a unit that sold the device.
More than 1,500 NuvaRing suits were consolidated before U.S. District Judge Rodney Sippel in St. Louis in 2008 for pre-trial information exchanges. Sippel had set the first trial over the blood-clot claims for April.
Case Consolidation More than 200 suits also have been consolidated in New Jersey state court before Judge Brian Martinotti in Hackensack. Those cases also will be part of the settlement, the people said.
Last year, Martinotti threw out seven NuvaRing cases set as the first suits to go to trial in New Jersey after finding women couldn’t show the device caused their injuries.
The judge said plaintiffs also couldn’t show doctors wouldn’t have prescribed the birth-control device if Merck had included information about higher clot risks on its warning label.
Source : Bloomberg
Pfizer loses its Supreme Court bid to squash $142M Neurontin verdict
It was March 2010 when Pfizer ($PFE) first lost its bid to escape a $142 million racketeering verdict, with a federal jury ruling the company's marketing of epilepsy treatment Neurontin violated both federal and state law. Now, nearly four years later, Pfizer's appeal process has come to the end of the line. The Supreme Court has refused to hear the drugmaker's appeal, leaving the verdict intact and the door open for similar claims to proceed.
Chalk up a win for Kaiser Foundation Health Plan, a health maintenance organization that claimed Pfizer's marketing damaged it and its affiliates, as it shelled out for scripts relating to conditions Neurontin was not cleared to--and did not effectively--treat. As Reuters notes, Aetna Inc. and Harden Manufacturing Corp. also are free to go forward with their own claims, which a lower court had previously dismissed.
Pfizer first faced penalties for Neurontin marketing in 2004, when it wrapped a $430 million settlement with the feds comprising both civil and criminal fines. A Massachusetts court found that Pfizer marketed the drug for unapproved uses like migraines and bipolar disorder; sales for those and other off-label uses accounted for 94% of the drug's $2.3 billion in 2002 sales, court documents attest.
As Reuters notes, considering the drug's haul and Pfizer's $50 billion in yearly sales, an extra $142 million is but a slap on the wrist for the company. Government settlements totaling in the billions haven't stopped some Big Pharma players from landing on the repeat offender list for their underhanded marketing practices.
Pfizer itself followed up its Neurontin agreement with a $2.3 billion settlement in 2009 involving Bextra and three other drugs; that settlement included a $1.2 billion criminal fine, the largest ever in an off-label case. And just this year, the company agreed to pay another $491 million to wrap up allegations that its subsidiary Wyeth, purchased in 2009, mismarketed the transplant drug Rapamune.
What's more worrisome for Pfizer and other drugmakers on the marketing-violations list is that this decision might embolden other insurers to sue. In the past, the Department of Justice has taken the lead on holding companies accountable for impure marketing tactics, but as Morningstar analyst Damien Conover told Reuters, that could begin to change with Kaiser's win. "I'm a little concerned these litigation trends could spread more widely to private entities," he said.
Source : FiercePharma
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists
WASHINGTON - Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.
“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” said Associate Attorney General Tony West. “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”
In addition to imposing substantial monetary sanctions, the resolution will subject J&J to stringent requirements under a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). This agreement is designed to increase accountability and transparency and prevent future fraud and abuse.
“As patients and consumers, we have a right to rely upon the claims drug companies make about their products,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery. “And, as taxpayers, we have a right to ensure that federal health care dollars are spent appropriately. That is why this Administration has continued to pursue aggressively – with all of our available law enforcement tools -- those companies that corrupt our health care system.”
J&J Subsidiary Janssen Pleads Guilty to Misbranding Antipsychotic Drug
In a criminal information filed today in the Eastern District of Pennsylvania, the government charged that, from March 3, 2002, through Dec. 31, 2003, Janssen Pharmaceuticals Inc., a J&J subsidiary, introduced the antipsychotic drug Risperdal into interstate commerce for an unapproved use, rendering the product misbranded. For most of this time period, Risperdal was approved only to treat schizophrenia. The information alleges that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. The information alleges that the company created written sales aids for use by Janssen’s ElderCare sales force that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of schizophrenia. The company also provided incentives for off-label promotion and intended use by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses.
In a plea agreement resolving these charges, Janssen admitted that it promoted Risperdal to health care providers for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients. Under the terms of the plea agreement, Janssen will pay a total of $400 million, including a criminal fine of $334 million and forfeiture of $66 million. Janssen’s guilty plea will not be final until accepted by the U.S. District Court.
The Federal Food, Drug, and Cosmetic Act (FDCA) protects the health and safety of the public by ensuring, among other things, that drugs intended for use in humans are safe and effective for their intended uses and that the labeling of such drugs bear true, complete and accurate information. Under the FDCA, a pharmaceutical company must specify the intended uses of a drug in its new drug application to the FDA. Before approval, the FDA must determine that the drug is safe and effective for those specified uses. Once the drug is approved, if the company intends a different use and then introduces the drug into interstate commerce for that new, unapproved use, the drug becomes misbranded. The unapproved use is also known as an “off-label” use because it is not included in the drug’s FDA-approved labeling.
“When pharmaceutical companies interfere with the FDA’s mission of ensuring that drugs are safe and effective for the American public, they undermine the doctor-patient relationship and put the health and safety of patients at risk,” said Director of the FDA’s Office of Criminal Investigations John Roth. “Today’s settlement demonstrates the government’s continued focus on pharmaceutical companies that put profits ahead of the public’s health. The FDA will continue to devote resources to criminal investigations targeting pharmaceutical companies that disregard the drug approval process and recklessly promote drugs for uses that have not been proven to be safe and effective.”
J&J and Janssen Settle Civil Allegations of Targeting Vulnerable Patients with the Drugs Risperdal and Invega for Off-Label Uses
In a related civil complaint filed today in the Eastern District of Pennsylvania, the United States alleges that Janssen marketed Risperdal to control the behaviors and conduct of the nation’s most vulnerable patients: elderly nursing home residents, children and individuals with mental disabilities. The government alleges that J&J and Janssen caused false claims to be submitted to federal health care programs by promoting Risperdal for off-label uses that federal health care programs did not cover, making false and misleading statements about the safety and efficacy of Risperdal and paying kickbacks to physicians to prescribe Risperdal.
“J&J’s promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society – children, the elderly and those with developmental disabilities,” said U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger. “This historic settlement sends the message that drug manufacturers who place profits over patient care will face severe criminal and civil penalties.”
In its complaint, the government alleges that the FDA repeatedly advised Janssen that marketing Risperdal as safe and effective for the elderly would be “misleading.” The FDA cautioned Janssen that behavioral disturbances in elderly dementia patients were not necessarily manifestations of psychotic disorders and might even be “appropriate responses to the deplorable conditions under which some demented patients are housed, thus raising an ethical question regarding the use of an antipsychotic medication for inappropriate behavioral control.”
The complaint further alleges that J&J and Janssen were aware that Risperdal posed serious health risks for the elderly, including an increased risk of strokes, but that the companies downplayed these risks. For example, when a J&J study of Risperdal showed a significant risk of strokes and other adverse events in elderly dementia patients, the complaint alleges that Janssen combined the study data with other studies to make it appear that there was a lower overall risk of adverse events. A year after J&J had received the results of a second study confirming the increased safety risk for elderly patients taking Risperdal, but had not published the data, one physician who worked on the study cautioned Janssen that “[a]t this point, so long after [the study] has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
The complaint also alleges that Janssen knew that patients taking Risperdal had an increased risk of developing diabetes, but nonetheless promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes).” When Janssen received the initial results of studies indicating that Risperdal posed the same diabetes risk as other antipsychotics, the complaint alleges that the company retained outside consultants to re-analyze the study results and ultimately published articles stating that Risperdal was actually associated with a lower risk of developing diabetes.
The complaint alleges that, despite the FDA warnings and increased health risks, from 1999 through 2005, Janssen aggressively marketed Risperdal to control behavioral disturbances in dementia patients through an “ElderCare sales force” designed to target nursing homes and doctors who treated the elderly. In business plans, Janssen’s goal was to “[m]aximize and grow RISPERDAL’s market leadership in geriatrics and long term care.” The company touted Risperdal as having “proven efficacy” and “an excellent safety and tolerability profile” in geriatric patients.
In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.
The government’s complaint also contains allegations that Janssen paid speaker fees to doctors to influence them to write prescriptions for Risperdal. Sales representatives allegedly told these doctors that if they wanted to receive payments for speaking, they needed to increase their Risperdal prescriptions.
In addition to allegations relating to Risperdal, today’s settlement also resolves allegations relating to Invega, a newer antipsychotic drug also sold by Janssen. Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.
As part of the global resolution, J&J and Janssen have agreed to pay a total of $1.391 billion to resolve the false claims allegedly resulting from their off-label marketing and kickbacks for Risperdal and Invega. This total includes $1.273 billion to be paid as part of the resolution announced today, as well as $118 million that J&J and Janssen paid to the state of Texas in March 2012 to resolve similar allegations relating to Risperdal. Because Medicaid is a joint federal-state program, J&J’s conduct caused losses to both the federal and state governments. The additional payment made by J&J as part of today’s settlement will be shared between the federal and state governments, with the federal government recovering $749 million, and the states recovering $524 million. The federal government and Texas each received $59 million from the Texas settlement.
Kickbacks to Nursing Home Pharmacies
The civil settlement also resolves allegations that, in furtherance of their efforts to target elderly dementia patients in nursing homes, J&J and Janssen paid kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients. In a complaint filed in the District of Massachusetts in January 2010, the United States alleged that J&J paid millions of dollars in kickbacks to Omnicare under the guise of market share rebate payments, data-purchase agreements, “grants” and “educational funding.” These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to engage in “active intervention programs” to promote the use of Risperdal and other J&J drugs in nursing homes. Omnicare’s consultant pharmacists regularly reviewed nursing home patients’ medical charts and made recommendations to physicians on what drugs should be prescribed for those patients. Although consultant pharmacists purported to provide “independent” recommendations based on their clinical judgment, J&J viewed the pharmacists as an “extension of [J&J’s] sales force.”
J&J and Janssen have agreed to pay $149 million to resolve the government’s contention that these kickbacks caused Omnicare to submit false claims to federal health care programs. The federal share of this settlement is $132 million, and the five participating states’ total share is $17 million. In 2009, Omnicare paid $98 million to resolve its civil liability for claims that it accepted kickbacks from J&J and Janssen, along with certain other conduct.
“Consultant pharmacists can play an important role in protecting nursing home residents from the use of antipsychotic drugs as chemical restraints,” said U.S. Attorney for the District of Massachusetts Carmen Ortiz. “This settlement is a reminder that the recommendations of consultant pharmacists should be based on their independent clinical judgment and should not be the product of money paid by drug companies.”
Off-Label Promotion of the Heart Failure Drug Natrecor
The civil settlement announced today also resolves allegations that J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. This approval was based on a study involving hospitalized patients experiencing severe heart failure who received infusions of Natrecor over an average 36-hour period.
In a civil complaint filed in 2009 in the Northern District of California, the government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. These infusions generally involved visits to an outpatient clinic or doctor’s office for four- to six-hour infusions one or two times per week for several weeks or months.
The government’s complaint alleged that Scios had no sound scientific evidence supporting the medical necessity of these outpatient infusions and misleadingly used a small pilot study to encourage the serial outpatient use of the drug. Among other things, Scios sponsored an extensive speaker program through which doctors were paid to tout the purported benefits of serial outpatient use of Natrecor. Scios also urged doctors and hospitals to set up outpatient clinics specifically to administer the serial outpatient infusions, in some cases providing funds to defray the costs of setting up the clinics, and supplied providers with extensive resources and support for billing Medicare for the outpatient infusions.
As part of today’s resolution, J&J and Scios have agreed to pay the federal government $184 million to resolve their civil liability for the alleged false claims to federal health care programs resulting from their off-label marketing of Natrecor. In October 2011, Scios pleaded guilty to a misdemeanor FDCA violation and paid a criminal fine of $85 million for introducing Natrecor into interstate commerce for an off-label use.
“This case is an example of a drug company encouraging doctors to use a drug in a way that was unsupported by valid scientific evidence,” said First Assistant U.S. Attorney for the Northern District of California Brian Stretch. “We are committed to ensuring that federal health care programs do not pay for such inappropriate uses, and that pharmaceutical companies market their drugs only for uses that have been proven safe and effective.”
Non-Monetary Provisions of the Global Resolution and Corporate Integrity Agreement
In addition to the criminal and civil resolutions, J&J has executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). The CIA includes provisions requiring J&J to implement major changes to the way its pharmaceutical affiliates do business. Among other things, the CIA requires J&J to change its executive compensation program to permit the company to recoup annual bonuses and other long-term incentives from covered executives if they, or their subordinates, engage in significant misconduct. J&J may recoup monies from executives who are current employees and from those who have left the company. The CIA also requires J&J’s pharmaceutical businesses to implement and maintain transparency regarding their research practices, publication policies and payments to physicians. On an annual basis, management employees, including senior executives and certain members of J&J’s independent board of directors, must certify compliance with provisions of the CIA. J&J must submit detailed annual reports to HHS-OIG about its compliance program and its business operations.
“OIG will work aggressively with our law enforcement partners to hold companies accountable for marketing and promotion that violate laws intended to protect the public,” said Inspector General of the U.S. Department of Health and Human Services Daniel R. Levinson. "Our compliance agreement with Johnson & Johnson increases individual accountability for board members, sales representatives, company executives and management. The agreement also contains strong monitoring and reporting provisions to help ensure that the public is protected from future unlawful and potentially harmful off-label marketing."
Coordinated Investigative Effort Spans Federal and State Law Enforcement
This resolution marks the culmination of an extensive, coordinated investigation by federal and state law enforcement partners that is the hallmark of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaborations to fight fraud. Announced in May 2009 by Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius, the HEAT initiative has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.
The criminal cases against Janssen and Scios were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania and the Northern District of California and the Civil Division’s Consumer Protection Branch. The civil settlements were handled by the U.S. Attorney’s Offices for the Eastern District of Pennsylvania, the Northern District of California and the District of Massachusetts and the Civil Division’s Commercial Litigation Branch. Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division, the FDA’s Office of Chief Counsel and the National Association of Medicaid Fraud Control Units.
This matter was investigated by HHS-OIG, the Department of Defense’s Defense Criminal Investigative Service, the FDA’s Office of Criminal Investigations, the Office of Personnel Management’s Office of Inspector General, the Department of Veterans Affairs, the Department of Labor, TRICARE Program Integrity, the U.S. Postal Inspection Service’s Office of the Inspector General and the FBI.
One of the most powerful tools in the fight against Medicare and Medicaid financial fraud is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $16.7 billion through False Claims Act cases, with more than $11.9 billion of that amount recovered in cases involving fraud against federal health care programs.
The department enforces the FDCA by prosecuting those who illegally distribute unapproved, misbranded and adulterated drugs and medical devices in violation of the Act. Since 2009, fines, penalties and forfeitures that have been imposed in connection with such FDCA violations have totaled more than $6 billion.
The civil settlements described above resolve multiple lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the government and to share in any recovery. From the federal government’s share of the civil settlements announced today, the whistleblowers in the Eastern District of Pennsylvania will receive $112 million, the whistleblowers in the District of Massachusetts will receive $27.7 million and the whistleblower in the Northern District of California will receive $28 million. Except to the extent that J&J subsidiaries have pleaded guilty or agreed to plead guilty to the criminal charges discussed above, the claims settled by the civil settlements are allegations only, and there has been no determination of liability.
Court documents related to today’s settlement can be viewed online at www.justice.gov/opa/jj-pc-docs.html.
Source US Department of Justice
Court Awards $969,474.91 for MMR Vaccine Causing Boy’s Autism
Do vaccines cause autism? Many parents think so – and the story is very familiar to many of us. Parents often report their child regressing into an “autistic-like state” shortly after being vaccinated. This term has become broadly known as Autism Spectrum Disorder.
Health organizations such as the Centers for Disease Control and the Food and Drug Administration staunchly deny any possible link to vaccines. However, they may want to pay attention to a recent and important court ruling.
According to a document filed on December 13, 2012, Chief Special Master Patricia E. Campbell-Smith awarded Ryan B. Mojabi $969,474.91 for injuries caused by the MMR vaccine. [1] You should also know the money awarded comes from a vaccine tax and not from taking the vaccine manufacturers to court.
Page two of the filing declares Ryan suffered, “a severe and debilitating injury to his brain, described as Autism Spectrum Disorder (‘ASD’).” It continues, he “suffered a Vaccine Table Injury, namely, an encephalopathy as a result of his receipt of the MMR vaccination on December 19, 2003.” [1] (emphasis mine)
Encephalopathy is a swelling of the brain due to infection. Is it possible that autism goes by a different name?
If this is the first time you have seen or heard of the term encephalopathy, it may surprise you to see it used in the same context as autism. The big question you may have now is, Can vaccines cause encephalitis, or swelling of the brain?
The answer is yes.
AUTISM HAS A DIFFERENT NAME
A study entitled Unanswered Questions from the Vaccine Injury Compensation Program: A Review of Compensated Cases of Vaccine-Induced Brain Injury found the National Vaccine Injury Compensation Program (NVICP) acknowledged 83 cases of vaccine-induced brain damage that include autism. [2] Many of these cases include encephalitis, or swelling of the brain.
One resource many doctors and health professionals use for research on health conditions is called The Merck Manual, published by Merck Pharmaceuticals.
The Merck Manual describes encephalitis as, “…inflammation of the brain that occurs when a virus directly infects the brain or when a virus or something else triggers inflammation.” [3]
The Merck Manual explains the causes of encephalitis as:
- “A virus directly infects the brain.
- A virus that caused an infection in the past becomes reactivated and directly damages the brain.
- A virus or vaccine triggers a reaction that makes the immune system attack brain tissue (an autoimmune reaction).” (emphasis mine) [3]
If encephalitis and autism are related, you can see the huge problem vaccine manufacturers would have on their hands.
Maybe the real reason the1986 National Childhood Vaccine Injury Act was passed was to protect pharmaceutical companies from the growing tide of vaccine-injured children.
Under this law, no parent can sue a vaccine manufacturer.
CONCLUSION
Parents consistently report having a typically healthy child prior to being vaccinated. The National Vaccine Injury Compensation Program (NVICP) has already recognized vaccine-induced brain damage, including autism, as a vaccine injury.
I’m glad Ryan Mojabi was awarded a large amount of money as his life and his family will never be the same. I suspect there are many other children suffering the same fate he did. The sad truth is that many more thousands of children who are injured by vaccines will never be compensated.
If you decide to vaccinate your children, you do so at your own risk. No vaccine manufacturer is liable for your child’s vaccine-related injury or death from a recommended vaccine.
Source : VacTruth
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Settlement reached in Boston lawsuit claiming mom's pregnancy drug caused 4 daughters' cancer
Eli Lilly and Co. has settled a lawsuit brought by four sisters who contended their breast cancer was caused by a drug their mother took during pregnancy in the 1950s, a move some believe could trigger financial settlements in scores of other claims brought by women around the country. A total of 51 women, including the Melnick sisters, filed lawsuits in Boston against more than a dozen companies that made or marketed a synthetic estrogen known as DES.
The Melnick sisters' case was the first to go to trial. The settlement was announced Wednesday on the second day of testimony.
DES, or diethylstilbestrol, was prescribed to millions of pregnant women over three decades to prevent miscarriages, premature births and other problems. It was taken off the market in the early 1970s after it was linked to a rare vaginal cancer in women whose mothers used it. Studies later showed the drug didn't prevent miscarriages.
Attorney Aaron Levine, representing the Melnick sisters, told the jury during opening statements that Eli Lilly failed to test the drug's effect on fetuses before promoting it as a way to prevent miscarriages.
Lawyer James Dillon, for Indianapolis-based Eli Lilly, told the jury that there was no evidence the drug causes breast cancer in the daughters of women who took it.
Dillon also said that no medical records show that the mother of the Melnick sisters took DES or that, if she did take it, it was made by Eli Lilly. Leading researchers at the time recommended that DES be used for pregnant women who had consecutive miscarriages, he said.
DES was not patented and was made by many companies.
Boston attorney Andrew Meyer, who's handled numerous medical malpractice cases, said the settlement in this case could signal settlements in other cases.
"When one settles a case, they recognize they can lose it," he said. "The reason they can lose it is because there's enough evidence for the plaintiffs to be able to win it. So it's not just optics, it isn't."
Columbus, Ohio, resident Irene Sawyer also is suing Eli Lilly, alleging that her prenatal exposure to DES caused her breast cancer. She called the settlement "a huge victory" for DES daughters.
"The bottom line is that this company put out a drug without testing, without knowing the consequences of this drug," she said.
It's wonderful, she said, that drug companies "are starting to realize this is not right, that there are consequences."
The Melnick sisters, who grew up in Tresckow, Pa., said they all developed breast cancer in their 40s.
Levine told the jury that their mother did not take DES while pregnant with a fifth sister and that sister has not developed breast cancer.
The four Melnick sisters also had miscarriages, fertility problems or other reproductive tract problems long suspected of being caused by prenatal exposure to DES. They were diagnosed with breast cancer between 1997 and 2003 and had treatments ranging from lump-removal surgery to a full mastectomy, radiation and chemotherapy.
Thousands of lawsuits have been filed alleging links between DES and vaginal cancer, cervical cancer and fertility problems. Many of those cases were settled.
Source : Star Tribune
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Johnson & Johnson - Risperdal, Invega, Natrecor, Levaquin, Procrit
Company: Johnson & Johnson
Settlement amount: Reportedly between $1.6 billion and $2.2 billion
Drugs: Risperdal, Invega, Natrecor, Levaquin, Procrit, according to press reports
Year: 2012 You might call Johnson and Johnson's ($JNJ) Risperdal settlement an omnibus deal. It is expected to cover federal probes about off-label Risperdal marketing, state claims of Medicaid fraud (also related to Risperdal), kickback allegations involving the nursing home pharmacy provider Omnicare and several other drugs besides Risperdal. It would also settle litigation over marketing practices involving Invega, another antipsychotic, and Natrecor, a congestive heart failure treatment. The company had already pleaded guilty to misbranding Natrecor and agreed to pay an $85 million fine.
What it doesn't cover, according to media sources: Lawsuits filed by several states that either have their own individual deals or jury verdicts, or are holding out for one or the other. Texas, for instance, which settled its off-label marketing claims against J&J for $158 million. Arkansas, where a jury found the company guilty of fraudulently marketing Risperdal--and a judge ordered the company to pay a $1.2 billion penalty. (That award is under appeal.)
J&J's settlement would wrap up some 8 years of government investigations and whistleblower lawsuits. From 2003 to 2010, Risperdal brought in more than $24 billion worldwide; in the U.S. alone, the drug ginned up $20 billion before it lost patent protection in 2007. Much of that revenue came from off-label sales, investigators have said.
Source : Fierce Pharma
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Abbott Laboratories - Depakote
Company: Abbott Laboratories
Settlement amount: $1.6 billion
Drug: Depakote
Year: 2012 Dementia patients were a target market for drugmakers in the late '90s and into the new millennium, if off-label marketing settlements are any indication. Like Eli Lilly ($LLY) and Johnson & Johnson ($JNJ), Abbott ($ABT) promoted a product--the seizure drug Depakote--for off-label use in elderly dementia patients who became agitated or aggressive. A specialized, specially trained Abbott sales force pushed Depakote in nursing homes to help control these patients, even though it had no credible evidence that the drug was safe or effective for that use. In fact, the company had to stop a clinical trial in elderly dementia patients because of adverse events.
Abbott also admitted that it pushed Depakote as a schizophrenia treatment. Though the drug was approved to treat mania in bipolar patients--and sometimes those patients display psychotic symptoms--clinical trials showed that Depakote added to antipsychotics didn't help schizophrenia patients any more than the antipsychotics alone. The company didn't tell Depakote sales reps about that data for two years.
To put the allegations to rest, Abbott agreed to pay a criminal fine of $500 million and plead guilty to a misdemeanor misbranding charge. It also agreed to forfeit $198.5 million in assets, and to 5 years of probation.
The civil side of the settlement--$800 million--wrapped up lawsuits alleging that its marketing tactics triggered false claims to government health programs, including Medicare and Medicaid. Abbott also agreed to pay $100 million to wrap up consumer-protection claims at the state level. And then there's the corporate integrity agreement, a 5-year pledge that Abbott's board and top executives will get involved in the company's compliance efforts.
Source : Fierce Pharma
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GlaxoSmithKline to pay $3bn in US drug fraud scandal
GlaxoSmithKline (GSK) is to pay $3bn (£1.9bn) in the largest healthcare fraud settlement in US history.
The drug giant is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).
The settlement will cover criminal fines as well as civil settlements with the federal and state governments.
The case concerns the drugs Paxil, Wellbutrin and Avandia.
Deputy US Attorney General James Cole told a news conference in Washington DC that the settlement was "unprecedented in both size and scope".
Doctors bribed GSK, one of the world's largest healthcare and pharmaceuticals companies, admitted to promoting antidepressants Paxil and Wellbutrin for unapproved uses, including treatment of children and adolescents.
Continue reading the main story “Start Quote We have learnt from the mistakes ”
Andrew Witty GlaxoSmithKline chief executive The illegal practice is known as off-label marketing.
The company also conceded charges that it held back data and made unsupported safety claims over its diabetes drug Avandia.
In addition, GSK has been found guilty of paying kickbacks to doctors.
"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.
As part of the settlement, GSK agreed to be monitored by government officials for five years.
GSK said in a statement it would pay the fines through existing cash resources.
Andrew Witty, the firm's chief executive, said procedures for compliance, marketing and selling had been changed at GSK's US unit.
"We have learnt from the mistakes that were made," Mr Witty said. "When necessary, we have removed employees who have engaged in misconduct."
Source BBC News
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J&J's Marketing of Risperdal Violated Law, Arkansas Jury rules
Johnson & Johnson (JNJ) officials misled Arkansas doctors and patients about the risks of the antipsychotic drug Risperdal, and the company’s marketing campaign violated consumer-protection laws, a jury ruled.
Jurors in state court in Little Rock, Arkansas, deliberated about three hours yesterday before finding J&J and its Janssen unit engaged in “false or deceptive acts” by sending a 2003 letter touting Risperdal as safer than competing drugs to more than 6,000 doctors across the state. The state is seeking more than $1.25 billion in penalties over the Risperdal marketing campaign, and a judge will decide later whether to fine J&J.
It’s the third jury verdict against J&J, the second-biggest maker of health products, in cases where states alleged the drugmaker hid Risperdal’s risks and tricked Medicaid regulators into paying more than they should have for the medicine. Louisiana and South Carolina juries also found the company’s Risperdal marketing violated consumer-protection laws.
“Three losses in a row means the company needs to become more realistic about its exposure and come up with an exit strategy in the form a settlement,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview.
Teresa Mueller, a spokeswoman for J&J’s Janssen unit, said the drugmaker was disappointed with the Arkansas jury’s ruling.
“It is our position that an individual state should not penalize a pharmaceutical company for using an FDA-approved package insert or decide for itself whether a company complies with FDA rules,” Mueller said in an e-mailed statement.
‘Lied To Patients’ Arkansas Attorney General Dustin McDaniel said in an e- mailed statement that he filed the suit because he believed Arkansas residents deserved to be protected from “fraud and deceptive practices.”
He said that jurors found “Johnson & Johnson and Janssen Pharmaceuticals lied to patients and doctors because they cared more about profits than people.”
Risperdal’s global sales peaked at $4.5 billion in 2007 and declined after the company lost patent protection. The drug generated $3.4 billion in sales in 2008, or 5.4 percent of New Brunswick, New Jersey-based J&J’s revenue, according to company filings. Sales of the drug fell to $527 million in 2010, according to earnings reports.
Safer, Better Along with contending that J&J and Janssen defrauded the Medicaid program by failing to properly outline the antipsychotic medicine’s risks, Arkansas officials alleged J&J officials deceptively marketed the drug as safer and better than competing medicines.
The state also argued the companies marketed the drug for “unapproved uses, including various symptoms in children and the elderly” after being warned by federal authorities to halt such sales.
The U.S. has been investigating Risperdal sales practices since 2004, including allegations that the company marketed the drug for unapproved uses, J&J executives said in a U.S. Securities and Exchange Commission filing last year.
The U.S. Justice Department is demanding that J&J pay about $1.8 billion to resolve the civil claims by federal regulators and some state attorneys general, people familiar with the settlement talks said this month.
Side Effects Arkansas officials asked jurors to find J&J’s Risperdal marketing campaign violated the state’s deceptive-trade practices law by making false and deceptive statements about the drug in the letter to doctors.
They also argued J&J and Janssen executives made false statements about the drug’s diabetes risks and other side effects in its warning label
The state will now ask Judge Tim Fox to fine J&J at least $5,000 for each prescription affected by the Risperdal marketing campaign. Arkansas said at least 250,000 prescriptions may have resulted from illegal marketing. That would amount to a fine of at least $1.25 billion.
The state said it also will seek damages over the misleading statements in the so-called “Dear Doctor” marketing letter the company sent to Arkansas doctors in 2003.
Arkansas officials also will also seek penalties for more than 19,000 sales calls in which J&J representatives allegedly used the letter or made other deceptive statements about the drug.
Public Funds Fox said he’d hear arguments today about the state’s requests for penalties, but didn’t say whether he’d issue his ruling at that time. “Let’s get this matter resolved,” he told lawyers for both sides after the jury verdict.
J&J and Janssen have been sued by 11 states seeking reimbursement for Medicaid or other public funds paid on Risperdal prescriptions. The lawsuits allege that J&J promoted the drug for dementia, mood and anxiety disorders and other unapproved uses, or downplayed risks.
In June 2010, a judge threw out Pennsylvania’s suit over the Risperdal marketing campaign in the middle of a trial. An appeal of that ruling is set to be heard next month.
Four months later, jurors in Louisiana ordered the drugmaker to pay almost $258 million to state officials for making misleading claims about the drug’s safety. J&J has appealed.
In June 2011 a South Carolina judge ordered J&J to pay $327 million in penalties for deceptively marketing the medicine. The company has appealed that ruling. J&J ended the most recent trial in Texas with a $158 million settlement in January.
The case is State of Arkansas v. Ortho-McNeil-Janssen Pharmaceuticals Inc., CV07-15345, Pulaski County Circuit Court (Little Rock) Arkansas.
Source : Bloomberg
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Merck & Co agrees $1bn Vioxx settlement in US
US drugs firm Merck & Co has agreed to pay almost $1bn (£640m) to settle criminal and civil charges arising from the marketing of one of its drugs, the US Department of Justice has said.
The company will pay a $322m criminal fine and $628m to settle civil charges regarding the promotion of the painkiller Vioxx.
The department said Merck & Co promoted the drug for rheumatoid arthritis before it was officially approved.
The drug was withdrawn in 2004.
Merck & Co said the civil settlement did not constitute an admission of liability or wrongdoing.
"We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx," said the company's Bruce Kuhlik.
In October last year, Merck & Co said it would be setting aside $950m to cover the cost of the settlement.
In 2007, the company paid $4.85bn to settle thousands of Vioxx-related lawsuits.
A study found the drug could increase the risk of heart attacks and strokes.
New Jersey-based Merck & Co should not be confused with its German chemicals and pharmaceuticals namesake, Merck KGaA.
Although the two firms share the same historic roots, they are separate companies.
Source : BBC News
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US lawsuit extends thalidomide's reach
Drug blamed for a broader range of harmful effects.
Meredith Wadman
In a new twist of a historic tragedy, 13 Americans who say they are survivors of thalidomide are suing four companies for producing and distributing the notorious drug. They say that the drug — used by pregnant women for morning sickness until it was discovered to cause severe birth defects — affected more people in the United States than thought, and caused a wider range of deformities. And, they say, the companies have done all they can to hide these facts.
Thalidomide's devastating effects first came to light 50 years ago this month in the German newspaper Welt am Sonntag. In Europe, the drug was implicated in thousands of cases of malformed newborns, but in the United States the damage was limited because the Food and Drug Administration (FDA) refused to approve it for market. Until now, most US cases were thought to originate from thalidomide obtained abroad.
The lawsuit, filed in a Philadelphia court on 25 October, asserts that before thalidomide was pulled from markets around the world, samples were doled out to more than 1,200 physicians in the United States by three companies whose legal liabilities are now the property of Sanofi-Aventis US, based in Bridgewater, New Jersey. Separately, it alleges, citing an FDA memorandum that only came to light earlier this year, the company Smith, Kline & French, now GlaxoSmithKline (GSK), ran a clinical trial of the drug in the US involving 875 people, including pregnant women, in 1956–57. The suit claims that at least one malformed baby was born to a trial participant in 1958. (The German firm Grünenthal, based in Aachen, and Avantor Performance Materials, based in Center Valley, Pennsylvania, are also named in the suit.)
Sanofi-Aventis and Grünenthal say that they cannot comment on ongoing litigation.
Mary Anne Rhyne, a spokeswoman for GSK, says that the company "intends to vigorously defend itself against this lawsuit". She notes that Smith Kline & French never manufactured or sold thalidomide and adds: "The Plaintiffs' complaint is replete with scientific inaccuracies and misstatements."
The company challenges the claim that thalidomide can cause limb defects that are confined to one side of the body, as seen in nine of the plaintiffs. Conventional wisdom has long held that thalidomide's signature defect — a shortened, seal-like 'flapper' arm, known as phocomelia — affects both sides of the body.
The plaintiffs' lawyers argue that this assumption is unproven. "There are no representative, controlled studies documenting the true spectrum of thalidomide injuries," they write in the lawsuit. "A universe of thalidomide related injuries has been thereby excluded from diagnosis." They further suggest that "recently available studies published in medical and scientific journals reveal the flaws in the orthodox medical opinion".
When asked by Nature for relevant studies, the plaintiffs' lawyers at Hagens Berman Sobol Shapiro in Seattle, Washington, pointed to work showing one-sided limb defects in chick embryos exposed to thalidomide and thalidomide analogues (C. Therapontos et al. Proc. Natl Acad. Sci. USA 106, 8573–8578; 2009). The paper's senior author, Neil Vargesson of the School of Medical Sciences at the University of Aberdeen, UK, says that the one-sidedness was due to the physical orientation of the developing chick when the medication was injected into the egg
Vargesson says his work does not confirm or deny that the plaintiffs' defects are the result of thalidomide. "The biggest issue facing the lawyers is persuading authorities that thalidomide gave rise to a range of other defects, including unilateral limb defects — or that it caused other damage without apparent limb defects at all." However, adds Vargesson, who has advised lawyers for potential plaintiffs in the United Kingdom who do not have apparent limb defects, "it's pretty clear that this drug did an awful lot of things and they don't always centre around limb defects".
Lewis Holmes, an expert in birth defects at Massachusetts General Hospital in Boston, says that the plaintiffs will have an uphill struggle to support their argument from the scientific literature because of the lack of systematic studies that follow up the offspring of women who took thalidomide during pregnancy. Holmes also notes that the relative paucity of thalidomide births in the United States means that few researchers there can speak with authority on the drug's effects. "None of us ever saw thalidomide-damaged children," he says.
Source : Nature News
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Pfizer pays compensation to families of four children after 15-year legal battle over controversial drug trial in state of Kano
The parents of four Nigerian children who died of meningitis have become the first winners of a 15-year legal battle against Pfizer over a fiercely controversial drug trial.
The world's biggest research-based pharmaceutical company announced on Thursday that it had made payments of $175,000 (£108,000) to each family. More such compensation settlements are expected to follow.
Pfizer was sued after 11 children died in a clinical trial when the northern state of Kano was hit by Africa's worst ever meningitis epidemic in 1996. A hundred children were given an experimental oral antibiotic called Trovan, while a further hundred received ceftriaxone, the "gold-standard" treatment of modern medicine.
Five children died on Trovan and six on ceftriaxone. But later it was claimed that Pfizer did not have proper consent from parents to use an experimental drug on their children and questions were raised over the documentation of the trial.
Legal action filed against the company alleged that some received a dose lower than recommended, leaving many children with brain damage, paralysis or slurred speech.
US-based Pfizer had argued that meningitis and not its antibiotic had led to the deaths of 11 children and harm to dozens of others. But in 2009 it reached a tentative out-of-court settlement with the Kano state government worth $75m.
The families of four of the children each collected cheques for $175,000 from a compensation trust fund, after submitting DNA samples to show that the dead were their offspring.
The compensation was the first given out by the Healthcare/Meningitis Trust Fund. The decision over who is compensated and for how much is being managed by an independent board of trustees in Kano, not by the government or Pfizer, the company has said. "We are pleased that these four individuals, the first group of qualified claimants of the Healthcare/Meningitis Trust Fund, have received compensation," said a spokesman.
"This is the first step in a multiphase review process by which the independent board of trustees that manages the funds will deliver payments to all other claimants.
"We thank them for their commitment and dedication to seeing this process through in the most timely and transparent way possible."
But one parent who lost a daughter said the process was still dogged by local factionalism and he had no idea when he would receive money.
"I talked to my attorney this week," said the man, who did not wish to be named for legal reasons. "They are still in contact with Pfizer as to when I will get paid. We are just crossing our fingers."
He added: "We are fed up with this case. Our children are dead and some are maimed. We want to end this matter now, but some people are being opportunist for riches."
Pfizer said in February it had settled all outstanding lawsuits involving accusations that it tested the experimental antibiotic Trovan on children.
The pharmaceutical giant also agreed to sponsor health projects in Kano as well as creating a fund of $35m to compensate those affected.
But last year a US diplomatic cable uncovered by WikiLeaks revealed that Pfizer hired investigators to look for evidence of corruption against the Nigerian attorney general in an effort to persuade him to drop the legal action.
The cable reported a meeting between Pfizer's country manager, Enrico Liggeri, and US officials at the Abuja embassy on 9 April 2009. It stated: "According to Liggeri, Pfizer had hired investigators to uncover corruption links to federal attorney general Michael Aondoakaa to expose him and put pressure on him to drop the federal cases.
He said Pfizer's investigators were passing this information to local media."
There is no suggestion that the attorney general was swayed by the pressure. Pfizer, for its part, issued a statement at the time saying it had acted properly while negotiating its 2009 settlement with the government. "Although Pfizer has not seen any documents from the US embassy in Nigeria regarding the federal government cases," it said, "any notion that the company hired investigators in connection to the former attorney general is simply preposterous."
Pfizer had planned to sell Trovan in the US and Europe after the trials on African children. However, its licence was withdrawn in Europe because of concern over liver toxicity.
Source : The Guardian (12 August 2011)
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Jury orders J&J to pay $10M in Motrin injury case
A Philadelphia jury levied a $10 million judgment against Johnson & Johnson in a liability lawsuit over its Motrin fever and pain reliever. After deliberating for 10 hours, the jury decided to hold J&J liable for the severe injuries of a 13-year-old girl who developed a reaction after taking Children's Motrin when she was three years old.
As Bloomberg reports, the issues in this trial were whether the J&J drug caused Brianna Maya's Stevens-Johnson Syndrome--and whether the company had adequately warned consumers about the
risk of that reaction. Maya developed burns over 84 percent of her body and was left blind in one eye after taking the drug in 2000; the companies later warned that Motrin's active ingredient could cause "a severe allergic reaction."
The Philadelphia jury panel found that McNeil was negligent for failing to properly warn about Children's Motrin's risks, saying that the failure was "a factual cause" of Maya's injuries, Bloomberg says. But the jury rejected the idea that the drug was defectively designed. It also refused to award punitive damages.
"J&J and McNeil will be called to task" for failing to warn parents, Maya's attorney Keith Jensen told the news service. For its part, a spokesman for J&J's McNeil Consumer Healthcare unit said the company "strongly disagrees with today's verdict and we are considering our legal options."
Source : Fierce Pharma (23/05/2011)
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Pfizer Will Pay $330M To Settle Prempro Cases
Pfizer has agreed to pay about $330 million to settle more than 2,200 lawsuits charging its Prempro hormone replacement therapy caused women to develop breast cancer, embracing a strategy used by several other drugmakers to cap the cost of growing product-liability litigation that can worry investors. The cases settled for an average of about $150,000, according to Bloomberg News, which first reported the settlement, although a Pfizer spokesman disputed the figures. The move came after a Pennsylvania appeals court reinstated $1.7 million in compensatory damages and $8.6 million in punitive damages against Pfizer in a lawsuit filed by an Arkansas woman, who alleged its Wyeth unit failed to warn that Prempro could cause her to develop breast cancer.
The settlement comes just weeks after Ian Read took over as Pfizer ceo, suggesting a desire to put aside an eight-year-long battle over Prempro. In recent months, GlaxoSmithKline has agreed to pay large sums to resolve lawsuits alleging harm from its Avandia diabetes pill and Paxil antidepressant (see here and here). Similarly, AstraZeneca has settled lawsuits over its Seroquel antipsychotic (read this).
The Superior Court of Pennsylvania issued the ruling Monday, reversing a 2007 trial court decision to grant Wyeth a new trial and throw out the compensatory damage award. The appellate panel concluded no “fraud on the court took place here and a new trial should not have been granted,” according to the Superior Court of Pennsylvania (here is the ruling).
The ruling means Pfizer must also pay anotherl $2.4 million in interest, Esther Berezofsky, the attorney for the plaintiff, Mary Daniels and her family, tells Bloomberg News. Pfizer is considering its options.
For those keeping score, Pfizer has now lost eight of 15 Prempro cases that were decided by juries since trials began five years ago. However, Pfizer has succeeded in having some verdicts tossed after a trial or had awards reduced. Some verdicts, meanwhile, were settled and some are on appeal. Pfizer also won dismissals of more than 3,000 cases before these went to trial.
Source : One Click Group via Pharmalot
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Pfizer Must Pay $1.6 Million Drug Damages, Judges Say
Pfizer Inc., the world’s largest drugmaker, must pay $1.68 million plus undisclosed punitive damages to a woman who blamed her breast cancer on the Prempro menopause drug, after an appeals court reinstated a verdict. In 2007, a trial jury in Philadelphia Court of Common Pleas awarded Mary Daniel and her family $1,681,650 from Pfizer’s Wyeth unit, plus punitive damages that the court kept secret. A judge later overturned the verdict. Daniel filed an appeal with the Superior Court of Pennsylvania.
The three-judge panel ruled yesterday that “contrary to Wyeth’s contentions,” no “fraud on the court took place here and a new trial should not have been granted” by the lower court.
“The company disputes the fairness of the previous trial and the appropriateness of the jury’s verdict. We are considering all our legal options,” Christopher Loder, a spokesman for New York-based Pfizer, said today in an e-mailed statement.
Annual sales of Wyeth’s hormone-replacement drugs once topped $2 billion before the Women’s Health Initiative study, sponsored by the U.S. National Institutes of Health, suggested that women on the therapy had a 24 percent higher risk of breast cancer.
Pfizer rose 4 cents to $19.08 at 2:07 p.m. in New York Stock Exchange composite trading.
The case is Daniel v. Wyeth, 040602368, Court of Common Pleas (Philadelphia).
Source : Bloomberg Business
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Glaxo Said to Pay $250 Million to Resolve Avandia Suits (Update1
GlaxoSmithKline Plc agreed to pay more than $250 million to resolve about 5,500 claims related to its Avandia diabetes drug and avoid the first trial over claims it can kill users, two people familiar with the accords said.
Glaxo, the U.K.’s biggest drugmaker, agreed to settle the lawsuits claiming the drug causes heart attacks and strokes for an average of at least $46,000 each, said the people, who declined to be identified because they weren’t authorized to speak publicly.
The accords included a previously reported settlement of an undisclosed amount for the family of James Burford, an Avandia user who died in 2006. The Burford family’s case, filed in federal court in Philadelphia, was set for trial last week.
“An average of $46,000 per case is a modest price to pay, in the grand scheme of things,” Gbola Amusa, an analyst at UBS AG in London, said in a telephone interview. “If Avandia definitively had caused heart attacks, Glaxo would have been forced to pay” as much as $1 million a case, he said.
The cases settled were filed by plaintiffs’ lawyers Joseph Zonies and Thomas Cartmell. Glaxo was facing about 2,000 suits alleging the drugmaker hid Avandia’s heart-attack and stroke risks prior to the settlements, lawyers for former users and the company said in court hearings. The company already agreed to pay about $460 million to resolve allegations it didn’t properly warn doctors and consumers about the medicine’s risks.
European Sales Halted
Mary Anne Rhyne, a U.S.-based spokeswoman for Glaxo, declined to comment on the settlements. Zonies, of Denver, and Cartmell, of Kansas City, Missouri, didn’t immediately return calls seeking comment.
The company said Sept. 23 it would stop promoting Avandia worldwide after regulators said the treatment would be withdrawn from the market in Europe and sales would be limited in the U.S. because of studies linking the drug to increased risks of heart attacks.
Avandia sales fell 43 percent to $710 million last year in the wake of the sales restrictions, the company said. Avandia was once the world’s best-selling diabetes pill, generating $3 billion in annual sales.
Glaxo said Jan. 17 it’s taking a $3.5 billion charge to cover expenses linked to investigations and suits over Avandia. The reserve brings to $6.4 billion the amount the drugmaker has set aside in the past year for legal costs tied to Avandia.
GlaxoSmithKline officials said today they’ve updated Avandia’s warning label to include safety restrictions ordered by federal regulators, who cited studies showing the drug poses an increased risk of heart attack and stroke for some users.
10,000 Cases
The label now warns users that the drug is only intended for consumers who can’t control their blood-sugar levels with other diabetes drugs, according to an e-mailed statement from the company.
Glaxo officials agreed in July to resolve about 10,000 Avandia cases, which they said was the majority of claims over the drug at the time.
Publicity about those accords brought in another wave of suits over the drug, said the people familiar with the settlement of the Zonies and Cartmell cases.
The lawyers were appointed by U.S. District Judge Cynthia Rufe in Philadelphia to lead a group steering the progress of more than 1,600 cases consolidated in that court. London-based Glaxo is facing another 400 claims in state courts across the country, according to a September court filing.
The Zonies and Cartmell settlement included some cases that haven’t yet been filed under an agreement with Glaxo, the people familiar said. Such pacts, known as “tolling agreements,” are common in mass-tort cases.
Shares Rise
Trial was slated to begin Jan. 31 in federal court in Philadelphia in the Burford family’s case.
Burford, an electrical-parts salesman, took Avandia for 15 months to treat diabetes before having a fatal heart attack in his North Carolina home, according to court filings. He was 49 at the time of his death.
Glaxo’s American depositary receipts, each representing two ordinary shares, rose 67 cents, or 1.8 percent, to $38.68 at 12:47 p.m. in New York Stock Exchange composite trading. The company rose 18 pence to 1,189 pence in London trading today.
The consolidated case is In re Avandia Marketing, Sales Practices and Products Liability Litigation, 07-01871, U.S. District Court, Eastern District of Pennsylvania (Philadelphia). The Burford case is Deborah Burford v. SmithklineBeecham Corp., 07-CV-05360, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).
Source : Bloomberg
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Merck KGaA Is Latest Pharma to Settle Justice Department Claims
German pharmaceutical and chemical company Merck KGaA will pay $280 million to settle a claim brought against a former subsidiary, Dey Pharma, regarding Medicare and Medicaid reimbursements, the U.S. Justice Department said. This is the fourth such settlement by a pharmaceutical company this month alone.
According to the Justice claim, Dey charged customers one price, then reported inflated prices to the lists that federal health care programs use to calculate payment rates, which resulted in much higher prices. This created an incentive to purchase the drugs because buyers could pocket the difference between the purchase price and the reimbursement price.
Dey Pharma is now owned by Pittsburgh-based drugmaker Mylan (MYL), but under the 2007 acquisition agreement, Merck is responsible for paying the full amount of this settlement. "The settlement agreement confirms that the resolution of the case does not constitute an admission, finding, or evidence of fault, liability or wrongdoing by Dey," the company said in a statement.
The other pharmaceutical settlements with Justice this month involve similar allegations against Abbott Laboratories (ABT), B. Braun Medical and Roxane Laboratories, which totaled $421.1 million in payments.
Top Defrauders of Uncle Sam
"With this settlement, the Department of Justice has now recovered over $2 billion dollars from pharmaceutical manufacturers arising from similar unlawful drug pricing schemes," said Tony West, assistant attorney general for Justice's Civil Division. "Taxpayer-funded kickback schemes like this not only cost federal health care programs millions of dollars, they threaten to undermine the integrity of the choices health care providers make for their patients."
The settlement comes days after a study found that pharmaceutical companies have become the biggest defrauders of the federal government, surpassing the defense industry.
The Health Research Group at Public Citizen, which looked at payments made for violations of the False Claims Act (FCA), found that pharmaceutical cases accounted for at least 25% of all federal FCA payouts over the past decade, compared with 11% by the defense industry.
"An Alarming Rate"
Indeed, Justice says that since January 2009, its total recoveries in FCA cases approach $6.8 billion, of which $5.3 billion are related to health care programs. This is also in line with findings from Taxpayers Against Fraud published in October (via Pharmalot).
Not only that, but the "frequency with which the pharmaceutical industry has allegedly violated federal and state laws has increased at an alarming rate." Of all the pharmaceutical industry settlements during the past 20 years, 73% of the settlements and 75% of the dollar amount have occurred during the past five years.
Off-label promotion of drugs -- when a company markets the medicine for an unapproved use -- was the single largest category of financial penalties. Another one was exactly what Dey has been charged with: purposely overcharging for drugs under various federal programs.
More than one-half of the industry's fines, $10.5 billion, were paid by just four companies -- GlaxoSmithKline (GSK), Pfizer (PFE), Eli Lilly (LLY) and Schering-Plough, which was bought by Merck (MRK). The world's largest pharmaceutical, Pfizer, also has the dubious honor of topping the list of fines with $1.2 billion in 2009.
"[S]everal recent prosecutions (and settlements) confirm that the government is now focusing on an industry that has long made significant profits, but has escaped close scrutiny. That is now changing," says Carlos Gonzalez, a partner at Diaz Reus & Targ in Miami, a firm that advises general counsels at major pharmaceutical companies, particularly outside the U.S., regarding FCPA [Foreign Corrupt Practices Act] and FCA issues. Drug companies must closely monitor operations both at home and abroad, he adds. "Either way, in this new era of government scrutiny, executives cannot be too careful."
The U.S. spending on prescription drugs increased from $40 billion in 1990 to $234 billion in 2008. "Given the relatively small size of current financial penalties when compared to the perpetrating companies' profits," Public Citizen calls not only for much steeper financial penalties but for criminal prosecutions of company leadership, including jail sentences, if merited.
Source: Daily Finance
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Novartis Whistleblower Speaks Out "we wasted money"
For six years, Jeremy Garrity worked for Novartis promoting various cardiovascular medicines, such as Diovan and Tekturna. But he was fired in 2008 and later filed a whistleblower lawsuit, one of four that prompted the federal government to launch an investigation into off-label marketing. Yesterday, the drugmaker agreed to pay $422.5 million to settle civil and criminal charges. Garrity, who no longer works in the pharmaceutical industry, revealed in his lawsuit several interesting practices: some doctors who served as speakers read from prepared scripts; some doctors were recruited as speakers even if their English was poor; both doctor and event attendees were paid honoraria, and doctors who did not prescribe did not get paid. We spoke with Garrity, who is 35 and lives in the Midwest, and asked him to reflect on his stint… Pharmalot: At what point did you feel uncomfortable with the way Novartis conducted business?
Garrity: We had a meeting in Las Vegas in 2006 and the president of sales stood on the stage and said one of our biggest goals was to have the most programs of anyone in the industry. Dinner programs, medical education programs. We’d gotten beaten out earlier by Benicar, it’s a (Daiichi) Sankyo drug. They had more events than we had. And they had a higher market share than Diovan, so it was presumed that if we had more events, we would have more market share. That was a turning point for me…The only true programs were few and far between. By that I mean where you would have a respected physician who knew the disease state very well and a lot about the drugs and the class of drugs, not a physician who would spew out a commercial. The reps saw this decision as the company cramming programs down our throats. You had to have a certain number each month. I was putting in extra hours. I was sick of it. The work was exhausting and I was burning out.
Pharmalot: And this was a change from what you experienced previously?
Garrity: When I started at Novartis, there wasn’t the push for programs. So you’d get a legitimate turn out. But that changed over time. You would have your bogus programs where no one would show up and you would still have to pay the honorarium. You would have two programs in the same small town in the same week. They pressured reps to get speakers and turn out these new drugs. It snowballed and continued to go in the wrong direction. One of the other irritating things was you had to buy a lunch for an entire office in order to see anyone. These are all the complaints of a drug rep. But things had started to get worse, probably in 2004.
One of the issues that really bothered me was the waste of money. That was a gradual thing. You just don’t notice it right away. Like how much honorariums were paid out for physicians. I knew how much the dinners cost and for what? So you could outdo other companies with dinners? At the time, there was no data at all to support switching a patient over to Tekturna. And you want to convince doctors to write prescriptions for Tekturna over a generic ace inhibitor that you can get for 10 bucks at Walmart? We wasted hundreds and hundreds of thousands of dollars that could have been spent on something better. It could have been spent on a program to give less fortunate patients access to medicine.
Pharmalot: What happened after the Vegas meeting?
Garrity: Around the same time of that meeting, I had interviewed for a spot that I was told would be more in medical science. Those folks would talk to key opinion leaders, but I ended up as an area scientific sales consultants, or ASSC. They work congruently with medical science liaisons. I had wanted to get away from the marketing stuff. My forte was the science. I started at Bristol-Myers Squibb in 1999 and by ‘06, I was tired of the marketing aspect. But this didn’t turn out to be the kind of job I had hoped. I ended up being a liaison for the speakers in my area. So I was in limbo. I wasn’t a rep but I wasn’t on the medical science team.
When I was a rep. I was isolated to a fairly small geographic area. When I took this job it was almost the third of a state, so I saw a lot more of what was going on. And I had to make sure these guys (the speakers) were trained, that they had their slide decks, and we were the ones who looked after the money, the budgets. How much guys got paid. That’s all I was doing. I thought it was a waste. I thought maybe it could change from the inside. It was not the job that I signed up for.
Pharmalot: What led you to become a whistleblower?
Garrity: I had an excel spreadshseet that had everybody’s payments – all these physicians across the US. It was a lot of money and I knew the quality of what had gone on at these medical education events. There would be a doctor who could barely speak English, but wrote a lot of Tekturna (prescriptions). He had a pretty high market share relative to another physician in the same practice who didn’t speak for Tekturna. So he would be a speaker and get paid. It’s not very hard to put together the numbers, especially when you launch a drug and track it…But management would say you couldn’t use someone (as a speaker) if they didn’t write a lot of Tekturna, even if the person was an authority.
Pharmalot: Did you approach anyone inside Novartis and talk about what you saw and whether it may have been illegal?
Garrity: That stuff came up in a discussion at a manager’s meeting at the regional office…I had the info. I just thought, ‘Hey, it’s worth a shot if they’ll stop this nonsense.’ These things we were doing were a colossal waste of time…No, I didn’t have discussions where there was mention about the law. I did have discussions saying that it wasn’t what I signed up to do. And what are we doing here? It wasn’t right. He said we work within the constraints we’re given. Maybe things will change in the future but this is the job we’re doing now.
Pharmalot: Some people say whistleblowers are only in it for the money. What’s your reaction to that?
Garrity: Not at all. I remember talking to (my lawyer) for the first time and she said a lot of times, this (type of lawsuit) goes nowhere. And I said that’s allright. I’m willing to do that because I honestly believe what they were doing was wrong. It’s wrong to pay doctors to write prescriptions for drugs that were proven no better than the generic. I mentioned I was selling Tekturna and there was no data to support switching a patient. But that’s the problem with industry…But I feel like justice has been served. I think Novartis should be punished for what they did because it was wrong…I’ll pay bills, give to charity. And save some for my family.
Pharmalot: What would you say to someone who wants to be a rep?
Garrity: I’d say don’t do it. This isn’t a sales job. I mean it’s changed a bit since I left the industry. There are supposed to be new rules in place. But it wasn’t a real sales job. You may be disappointed if what you’re looking for is a pure sales job. I call it marketeering.
SOURCE : Pharmalot 1/10/2010
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MMR Causes Autism – Another Win In US Federal Court
Julia a three year old US citizen has just won substantial compensation in the US Federal Court for autism caused by MMR vaccine – says her mother.
What is different about this case? They kept the “autism” word out of the case. Many parents in other US cases have been advised to do this:-
CBS News has found that since 1988, the vaccine court has awarded money judgments, often in the millions of dollars, to thirteen hundred and twenty two families whose children suffered brain damage from vaccines. In many … cases, the government paid out awards following a judicial finding that vaccine injury lead to the child’s autism spectrum disorder. In each of these cases, the plaintiffs’ attorneys made the same tactical decision made by Bailey Bank’s lawyer, electing to opt out of the highly charged Omnibus Autism Proceedings and argue their autism cases in the regular vaccine court. In many other successful cases, attorneys elected to steer clear of the hot button autism issue altogether and seek recovery instead for the underlying brain damage that caused their client’s autism.”: [Vaccine Court: Autism Debate Continues - Robert F. Kennedy, Jr. and David Kirby Huffington Post 24 Feb 2009]
Julia’s Mom emphasises Julia has no formal diagnosis of autism and says:-
after Julia’s last neuro appointment when her dr said she had signs of autism. I didn’t want that “word” in her records until Julia’s case was decided.
Julia’s diagnosis was “Encephalitis (inflammation of her brain) most likely attributed to the MMR-V (measles, mumps, reubella, chicken pox) vaccine she had received nine days previously.
I do not want this to be misunderstood. She was never formally diagnosed. Do I think that there is a link between vaccines and Autism, absolutely. Is Julia Autistic? I’m not sure.“
Data from formal peer refereed medical papers show vaccines caused autism in Japanese children. The number developing autism rose and fell in direct proportion to the number of children vaccinated each year: [click here for full details Japanese Data Show Vaccines Cause Autism]
[Click on graph to enlarge in new window]
Data from the UK’s General Practice Research Database supports the Japanese data and shows that with each major change in the UK childhood vaccination programme the rates of childhood autism has increased significantly: British & Japanese Data Show Vaccines Cause Autism
[Click on graph to enlarge in new window]
The current UK rate of children with autistic conditions is 1 in 64. The rate in boys is 1 in 40. Prior to 1988 which saw the first of several major changes to the UK childhood vaccination programmes the rate of childhood autism was running at between 1 and 4 in 10,000. Childhood autism is also known as “typical” or “Kanner” autism.
Research showing Autistic Spectrum Conditions can result from brain injury caused by encephalopathy (a degenerative disease of the brain) can be found HERE. Encephalopathies are normally caused by an infection (90% of the time), and most often we will expect a viral infection. MMR contains three live viruses. [See also Explaining Vaccines Autism & Mitochondrial Dysfunction/Disorder]
Julia’s Mom says she was:
accepting the loss of the world as i knew it before she got sick, before my divorce, before i lost my house.
This is such a huge, huge, huge help for Julia and my family”
If this is what compensation means for Julia’s Mom think of all the families and children who should never have got sick in the first place and will never get compensation just because they used the “autism” word.
Does it help to think your child is “just a little bit” autistic but still injured and in need of financial help with medical care for life? Autism Spectrum Conditions are a spectrum from very mild to incapacitating.
Not only does it not end like this for other families – some children die as this 2005 Federal Court decision in a case very similar to Julia’s shows [and which took 9 years to achieve a decision]:-
Eric Fernandez Cusati v Secretary for Health and Human Services
How many cases are like these ones? Who knows the exact number – the majority of decisions are never published – kept in secret. And then there are all the cases the US Secretary of Health and Human Services settles – also kept in secret. And how many cases are just not filed? No one publicly knows for sure.
Before drug companies came up with the triple MMR vaccine rubella vaccine was of no benefit to a child especially boys and especially compared to the risks. Mumps vaccine was expressly not recommended for children.
So why are we giving them? It is time all parents started asking the simple questions – like that one.
And who said so?
The British Medical Association, the Royal Pharmaceutical Society of Great Britain, the UK’s Joint Committee on Vaccination and Immunisation and the UK’s Ministry of Defence:
“Since mumps and its complications are very rarely serious there is little indication for the routine use of mumps vaccine”: British National Formulary (’BNF’) 1985 and 1986
The BNF is a joint publication of the BMA and RPSGB.
Freedom of Information documents show the UK’s Joint Committee on Vaccination and Immunisation and Ministry of Defence agreed as early as 1974 that:-
“there was no need to introduce routine vaccination against mumps” because “complications from the disease were rare” JCVI minutes 11 Dec 1974.
It is unethical to give a child unnecessary medical treatment and can be a criminal offence: Appleton v Garrett (1995) 34 BMLR 23.
And with 1 in 38 British boys with an autistic condition [and the problem is not just autism] the question must be asked – how many children who would otherwise have grown up healthy are going to continue to be sacrificed and claimed to be for the very few but in reality for drug company profits in their move to a new business model based on “vaccines for all”. [Autism Rates Rocket – 1 in 38 British Boys – Cambridge Study See also: Government Risks Male Sterility As Mumps Vaccine Fails]
Today it is your kid. Tomorrow it is you.
Julia’s Story [by her Mom] Julia was born a healthy baby on 12-28-05. She was a delight to her family and friends.
On January 5th, 2007, one week after her 1st birthday, our family’s lives changed forever. Julia (unknowingly to her family) had been seizing in her crib most of the night, was transported to the nearest ER for stabilization, and then airlifted to Miami Children’s hospital, where she stayed in PICU and the neurology ward for close to one month.
Her diagnosis? Encephalitis (inflammation of her brain) most likely attributed to the MMR-V (measles, mumps, reubella, chicken pox) vaccine she had received nine days previously. When Julia left the hospital, she was functioning at a two month level. She was (and in some respects still is) globally delayed and with significant left sided hemiplegia.
It has been over two years since her MMR-V induced encephalitis, and Julia has come a long way, but has a very long way to go. Julia lives with her brother, Jack who is six and so understanding of her. She also lives with her mom, Susan. Her father recently moved out of state following her parent’s divorce. Julia and her family are hanging in there and hope you enjoy her blog! Go Julia!
AMAZING DAY! A MIRACLE HAS HAPPENED!
[Posted by Julia's Mom - 12 June 2009]
JULIA WON HER LAWSUIT WITH THE VACCINE INJURY COMPENSATION PROGRAM! THE GOVERNMENT CONCEDED!
This means that they agreed that the MMR vaccine caused her encephalitis and resultant brain damage (I mean Marvelous Mind – right Howard!!).
This is such a huge, huge, huge help for Julia and my family. The government will reimburse all of her past medical expenses (to her, not to us, which I find a little odd, but OK!) and will pay for all future medical expenses that she incurs from her vaccine injury. I will update as I find out more.
Her attorney (Ron Homer and/or Kevin Conway) will be flying out here this summer to evaluate her and her needs with a “life planner” to try to determine what her needs will be. This is HUGE! HUGE! The VICP rarely concedes…..almost never……but they did for her! AMAZING!
Another funny thing to go along with this…..I had just the day before changed my ringtone on my phone to “Its the end of the world as we know it….and I feel fine” trying to find a positive ringtone – accepting the loss of the world as i knew it before she got sick, before my divorce, before i lost my house, and moving forward – and being fine with it….AND NOW – ITS THE END OF THE WORLD AS I KNOW IT – AND I REALLY FEEL FINE! SHE has HELP!!!!! Our struggle is going to be lessened!!!!
Source : Child Health Safety
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Family to Receive $1.5M+ in First-Ever Vaccine-Autism Court Award
The first court award in a vaccine-autism claim is a big one. CBS News has learned the family of Hannah Poling will receive more than $1.5 million dollars for her life care; lost earnings; and pain and suffering for the first year alone.
In addition to the first year, the family will receive more than $500,000 per year to pay for Hannah's care. Those familiar with the case believe the compensation could easily amount to $20 million over the child's lifetime.
Hannah was described as normal, happy and precocious in her first 18 months. Then, in July 2000, she was vaccinated against nine diseases in one doctor's visit: measles, mumps, rubella, polio, varicella, diphtheria, pertussis, tetanus, and Haemophilus influenzae.
Afterward, her health declined rapidly. She developed high fevers, stopped eating, didn't respond when spoken to, began showing signs of autism, and began having screaming fits. In 2002, Hannah's parents filed an autism claim in federal vaccine court. Five years later, the government settled the case before trial and had it sealed. It's taken more than two years for both sides to agree on how much Hannah will be compensated for her injuries.
Read Sharyl Attkisson's 2008 report on Hannah Poling
In acknowledging Hannah's injuries, the government said vaccines aggravated an unknown mitochondrial disorder Hannah had which didn't "cause" her autism, but "resulted" in it. It's unknown how many other children have similar undiagnosed mitochondrial disorder. All other autism "test cases" have been defeated at trial. Approximately 4,800 are awaiting disposition in federal vaccine court.
Time Magazine summed up the relevance of the Poling case in 2008: ...(T)here's no denying that the court's decision to award damages to the Poling family puts a chink -- a question mark -- in what had been an unqualified defense of vaccine safety with regard to autism. If Hannah Poling had an underlying condition that made her vulnerable to being harmed by vaccines, it stands to reason that other children might also have such vulnerabilities." Then-director of the Centers for Disease Control Julie Gerberding (who is now President of Merck Vaccines) stated: "The government has made absolutely no statement indicating that vaccines are a cause of autism. This does not represent anything other than a very specific situation and a very sad situation as far as the family of the affected child."
Read the newly-released decision on Hannah Poling's compensation.
SOURCE : CBSNEWS (Sept 2010)
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Drug firms hiding negative research are unfit to experiment on people
Another pharmaceutical giant has settled a big compensation claim. So why are they allowed to go on misleading the public?
This week the drug company AstraZeneca paid out £125m to settle a class action. More than 17,500 patients claim the company withheld information showing that schizophrenia drug quetiapine (tradename Seroquel) can cause diabetes. So why do companies pay out money before cases get to court?
An interesting feature of litigation is that various documents enter the public domain. This is how we know about the tobacco industry's evil plans to target children, the fake academic journal that Elsevier created for Merck's marketing department, and so on.
One of the most revealing documents ever to come out of a drug company emerged from an earlier quetiapine case: an email from John Tumas, publications manager at AstraZeneca. In it, he helpfully admits that they do everything I say drug companies do.
"Please allow me to join the fray," Tumas begins, in response to a colleague. "There has been a precedent set regarding 'cherry picking' of data." Cherry picking is where you report only flattering data, and ignore or bury data you don't like. The ears of lawyers prick up at any use of the word "bury" in relation to drug company data, as it implies something deliberate, and luckily John uses this word himself. The precedent, he explains, is "the recent … presentations of cognitive function data from trial 15 (one of the buried trials)".
In trial 15, commissioned by AstraZeneca, patients with schizophrenia who were in remission were randomly assigned to receive either AstraZeneca's quetiapine, or a cheap, old-fashioned drug called haloperidol. After a year, the patients on Seroquel were doing worse: they had more relapses and worse ratings on various symptom scales. These negative findings were left unpublished: to use Tumas's word, they were "buried".
But in among all these important negative findings, on a few measures of "cognitive functioning" – an attention task, a verbal memory test – Seroquel did better. This finding alone was published in a research paper in 2002. AstraZeneca kept quiet about the fact that patients on Seroquel had worse outcomes for schizophrenia. The research paper went on to become a highly influential piece of work, cited by more than 100 academic research papers. Many researchers can only dream of publishing such a well cited piece of work.
Trial 15 also found that patients on Seroquel gained, on average, 5kg in weight over a year. This put them at increased risk of diabetes, which is what AstraZeneca is now paying to settle on (and in any case, a 5kg weight gain is a serious side-effect in itself).
Psychiatric drugs can do more good than harm overall, but many have serious, common side-effects. It is especially important that doctors and patients know all the risks, so that sensible and informed trade-offs can be made.
Here is the opening of another email in that quetiapine case. Richard Lawrence writes in an internal memo to colleagues: "Lisa has done a great smoke and mirrors job" on trial 15.
The pharmaceutical industry's behaviour has collapsed into farce. Doctors and academics – who should feel optimism at working with the drug companies to develop new treatments – feel nausea instead, knowing that there are only informal systems to deal with buried data, and these have clearly failed.
In 2005 the International Committee of Medical Journal Editors put its foot down and said its journals would only publish trials that were fully registered before they started, which should make any that went missing much easier to spot. Several years later, as recorded in this column, fewer than half of all the trials that the editors published had been adequately registered, and more than a quarter were not registered at all.
After the New York attorney general sued GlaxoSmithKline over its "illegal and deceptive" reporting of the risks of its anti-depressant paroxetine (tradename Seroxat), GSK agreed to publish all trial data on a website. But, several years later, we saw last month that GSK and the Food and Drug Administration had sat on data showing that rosiglitazone (tradename Avandia) increased the risk of heart problems.
I can't see why any company withholding data should be allowed to conduct further experiments on people. I can't see why the state doesn't impose crippling fines. I hope it's because politicians don't understand the scale of the harm.
Source : The Guardian 14/8/2010
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Family win 18 year fight over MMR damage to son: £90,000 payout is first since concerns over vaccine surfaced
A mother whose son suffered severe brain damage after he was given the controversial MMR vaccine as a baby has been awarded £90,000 compensation.
The judgment is the first of its kind to be revealed since concerns were raised about the safety of the triple jab.
Robert Fletcher, 18, is unable to talk, stand unaided or feed himself.
He endures frequent epileptic fits and requires round-the-clock care from his parents Jackie and John, though he is not autistic.
He suffered the devastating effects after being given the combined measles, mumps and rubella vaccine when he was 13 months old.
The Department of Health had always denied that the jab was the cause of Robert’s disability.
But now, in a judgment which will give hope to hundreds of other parents whose children have been severely affected by routine vaccinations, a medical assessment panel consisting of two doctors and a barrister has concluded that MMR was to blame.
Robert’s mother Jackie said the money would help with his care, though she described the amount as ‘derisory’.
Her first application for compensation under the Government’s Vaccine Damage Payment Scheme was rejected in 1997 on the grounds that it was impossible to prove beyond reasonable doubt what had caused Robert’s illness.
But Mrs Fletcher appealed and in a ruling delivered last week, a new panel of experts came to a different conclusion.
In a six-page judgment, they said: ‘Robert was a more or less fit boy who, within the period usually considered relevant to immunisation, developed a severe convulsion... and he then went on to be epileptic and severely retarded.
‘The seizure occurred ten days after the vaccination. In our view, this cannot be put down to coincidence.
'It is this temporal association that provides the link. It is this that has shown on the balance of probabilities that the vaccination triggered the epilepsy.
'On this basis, we find that Robert is severely disabled as a result of vaccination and this is why we allowed the appeal.’
The ruling will reignite the debate over the safety of common childhood vaccines, although it makes clear that Robert’s case does not involve autism.
There is one other reported case of a family being given compensation as a result of an MMR jab.
But Mrs Fletcher said she believed the compensation award to Robert was the first to a surviving MMR-damaged person since controversy erupted in 1998 when the now discredited Dr Andrew Wakefield raised concerns about a possible link between the combined MMR injection and autism.
He has since been struck off the medical register.
The Government refuses to say how many awards have been directly attributed to this jab rather than other inoculations against illnesses such as diphtheria or whooping cough.
Details of successful claims involving vaccine-damaged children are seldom publicised because the Department of Health is thought to be anxious not to encourage a rush of applications.
Figures released in 2005 under the Freedom of Information Act revealed that tribunals had paid out £3.5 million over the previous eight years.
The Department for Work and Pensions, which administers the Vaccine Damage Payment Scheme, said: ‘We do not hold any information on how many awards have been MMR-related.
'It is not a requirement when a case is being assessed for the medical adviser to state which vaccine the damage has been attributed to.
'Nor is it a requirement to list the disabling condition that gave rise to the award.’
The controversy over a suggested link between MMR and autism erupted in 1998 when Dr Wakefield published a paper in The Lancet medical journal.
His work has since been discredited and earlier this year Dr Wakefield, who has moved to America, was struck off the medical register after the General Medical Council ruled that he had acted against the interests of patients and ‘failed in his duties as a responsible consultant’.
Robert Fletcher does not suffer from autism. But Mrs Fletcher, from Warrington, Cheshire, said the ruling would give hope to hundreds of other parents fighting to prove that their children’s disabilities were caused by the MMR injection.
Mrs Fletcher set up and runs pressure group JABS - Justice, Awareness and Basic
Support.
Around 2,000 families seeking compensation for their vaccine-damaged children are registered with the group, which provides advice and support.
‘My husband John and I have battled for 18 years for the cause of Robert’s disability to be officially recognised,’ she said.
‘We were told the vaccine was perfectly safe. Like most people, we trusted what the doctors and nurses were putting to us.
'Robert is nearly 19 but mentally he is like a 14-month-old toddler. He can’t stand unaided and he is doubly incontinent.
'He can’t speak except to say “Hi, Mum” or “Hi, Daddy”.
‘We chop up his food and have to anticipate all his needs. He is prone to various illnesses and last week suffered around 40 severe epileptic seizures.
'In April this year, we thought we’d lost him. He contracted a chest infection and had to go to hospital for several days.
‘He is such a lovely boy. When he’s not ill, he’s so cheerful and seems to take everything on the chin. In between seizures he says “Hi, Mum” and tries to kiss me.
‘The money is a derisory amount though it will help with making adaptations to the house for Robert’s benefit.
'What matters is the recognition that MMR was the reason this happened.’
The first doctor who assessed Robert under the compensation scheme in 1996 concluded that he had suffered a ‘simple febrile convulsion with no long-lasting consequences’.
Although he agreed that Robert had a degree of disability, he refused to accept that the MMR vaccine was to blame.
At this month’s appeal, evidence was given by a leading expert on vaccine-damaged children, paediatric neurologist Dr Marcel Kinsbourne. He explained the biological changes which had occurred in Robert’s brain following the vaccination.
The one-day hearing was chaired by a barrister sitting with two doctors, Professor Sundara Lingam, a former consultant at Great Ormond Street Hospital for Children, and Dr Adrian Allaway.
In a dissenting judgment, Professor Lingam said he believed Robert was ‘genetically predisposed to epilepsy and that the vaccination triggered it rather than caused it.
'Robert would have developed epilepsy in any event, even if he had not had the vaccination’.
But Professor Lingam was overruled by his two colleagues.
In their final judgment, they accepted that MMR had caused Robert’s illness but added: ‘We would stress that this decision is fact-specific and it should not be seen as a precedent for any other case.
'In particular, it has no relevance to the issue... as to whether there is a link between the MMR vaccine and autism.’
Last night, Tory MP Nadine Dorries, a member of the powerful Commons Health Committee, said: ‘If an independent panel has reached the conclusion that there has been a link between the MMR vaccine and the brain damage suffered by this boy in this case, then it is fair to assume that there could be as many as thousands of children and parents in the same position.
‘There should be full and easy access to all documentation relating to the judgment for any parent or professional to read and assess.’
Dr Michael Fitzpatrick, a London GP whose own son is autistic, said: ‘It is a very important principle that parents should be compensated in cases of this kind.
'But although a causal link has been established in law in this instance, exhaustive scientific research has failed to establish any link between MMR and brain damage.
'This case should not make parents feel any different about the safety of the vaccine.’
The Department of Health said: ‘This decision reflects the opinion of a tribunal on the specific facts of the case and they were clear that it should not be seen as a precedent for any other case.
'The safety of MMR has been endorsed through numerous studies in many countries.’
New hope for parents who claim MMR jab blighted their children
By SALLY BECK
For MMR campaigners, the Robert Fletcher ruling is a small but significant milestone in their efforts to prove that the vaccine is not safe for a few children, even though the Government insists it is and that serious reactions are rare.
The triple jab was introduced in 1988, and has been given to millions of children as part of their vaccination schedule, which includes inoculations for 12 diseases.
The vast majority of children suffer no more than redness and swelling around the injection site or a fever that can be easily treated.
But a small number suffer serious reactions. The official figure is one in a million, but campaigners believe that is an underestimate.
Up to 2,000 parents remain convinced their children have suffered significant harm from MMR but have been unable to prove it.
This new decision will give them hope, even though compensation panels do not officially recognise autism claims.
Campaigner Polly Tommey, who edits the magazine The Autism File and believes her son Billy is autistic because of MMR, says: ‘This is fantastic news. Now doctors can’t tell me that the MMR is safe.
'This payout is evidence that it is not safe. It’s interesting that they will look at epilepsy
and not autism, and you have to ask why.
'Is it because the compensation would be billions?’
Parents have tried to get the medical profession and the Government to investigate their claims that MMR damaged their children but have failed so far.
A group of parents brought a case in 1993 which was blocked after their legal aid was withdrawn in 2003.
They claimed for various injuries including autism, Guillain-Barre syndrome, epilepsy, sensorineural deafness, diabetes and arthritis.
Robert’s mother Jackie Fletcher, who set up the vaccine campaign group JABS, is one of a group of parents who continued to fight.
His compensation comes 12 years after the London-based paediatrician Andrew Wakefield claimed a link between MMR and autism.
He was struck off this year after the General Medical Council judged his research to be flawed.
Claiming compensation for any vaccine-related disability is notoriously difficult.
Mrs Fletcher said: ‘Only one in 200 parents who applies to the Vaccine Damage Payment Scheme is successful in receiving compensation.
'Claims for autism are not considered. There are 120 MMR cases waiting to be heard, but none is for autism.’
In America, 4,000 parents are claiming compensation for MMR damage, but again the courts will not officially look at cases where autism is mentioned.
However, cases involving autism do slip through the net.
Bailey Banks, who suffered seizures 16 days after receiving the MMR jab and was diagnosed with pervasive developmental disorder, an autistic condition, was paid compensation.
So was Ben Zeller, who suffered seizures, while Hannah Poling, who is autistic, was paid in secret.
Another 1,820 cases of brain damage caused by vaccines in the U.S., including MMR, have been settled in private.
Mrs Fletcher hopes that the 2,000 families registered with JABS will be awarded legal aid to continue their cases.
She says: ‘We plan to talk to our MP Andy Burnham about the anomalies in the Vaccine Damage Payments Act, the main one being that you can apply for compensation only if a child has died after the age of two.
'We have a number of children on our books who died younger after receiving MMR, but they are not eligible to claim.
'Most vaccines are given at two, three and four months old, so this rule makes no sense.
‘Robert was 13 months old when he had his seizure and, under the rules today, he wouldn’t be eligible to claim.’
Source : Mail online 28/8/2010
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MERCK TO PAY $8M, IN DAMAGES IN FOSAMAX TRIAL
In replay of a courtroom battle that ended in a mistrial last fall, a federal jury today voted unanimously that Merck’s Fosamax osteoporosis drug was responsible for causing jawbone deterioration suffered by a Florida woman, who was awarded $8 million in compensatory damages (here is the lawsuit). Merck, which argued 71-year-old Shirley Boles was at increased risk for dental and jaw problems if she was not taking Fosamax, quickly indicated it would appeal the decision. “We disagree with the jury’s verdict. We believe the jury verdict was a result of the plaintiff’s counsel’s gross mischaracteraization, and inflammatory and prejudicial remarks,” Paul Strain, an attorney representing Merck, tells us. “We believe the court, from his remarks, made it clear he shares those concerns about the improper closing argument by plaintiff’s counsel. That gives us a strong foundation moving forward.”
This was the second bellwether case over whether Merck failed to warn docs and patients that Fosamax may cause osteonecrosis, which is the painful death of jawbone tissue. Merck won the first trial last month (see here). As of March 31, the drugmaker faces 1,039 lawsuits in and federal and state courts that were feild by 1,417 plaintiffs.
Source:pharmalot.com
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Pfizer Settles Neurontin Suit Over Minister’s Death
Pfizer Inc. agreed to settle a wrongful-death lawsuit alleging its Neurontin epilepsy medicine caused a retired minister to commit suicide two months after he started taking the drug. Lawyers for New York-based Pfizer, the world’s biggest drugmaker, told a judge in Nashville, Tennessee, they resolved claims by the family of Richard Smith, which were set to go to trial today. It’s the second settlement of claims that officials of a Pfizer unit knew the epilepsy drug posed a suicide risk and failed to disclose it to patients and doctors.
“I’m very pleased the case has been resolved,” U.S. District Judge Aleta Trauger told lawyers for Smith’s family and the company today. The terms weren’t disclosed. Smith, 79, was a retired Church of Christ minister, according to court papers. He was taking the drug to deal with chronic pain, not epilepsy, the filings show.
Pfizer faces more than 1,000 lawsuits accusing it of illegally promoting Neurontin for unapproved uses and helping to cause some users’ suicides. In March, a Boston jury ordered Pfizer to pay more than $140 million in damages to an insurer over its marketing practices in connection with the drug. Pfizer has denied any wrongdoing in connection with its handling of Neurontin.
‘Great Sympathy’
Its Warner-Lambert subsidiary pleaded guilty in 2004 to criminal charges filed by the Justice Department in connection with allegations it illegally marketed Neurontin and paid a $430 million fine. Pfizer bought Warner-Lambert for $120 billion in 2000.
“We are pleased to have reached an agreement with the Smith family to resolve this case as it avoids the time and expense of a trial,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement. “We have great sympathy for the Smith family and respect their desire for privacy regarding the outcome of the case.”
By prescribing Neurontin as a painkiller, Smith’s doctor was recommending a so-called off-label use of the drug. While doctors may prescribe a medicine for uses not approved by the U.S. Food and Drug Administration, companies are barred from promoting products for off-label uses.
As part of the guilty plea, Warner-Lambert officials acknowledged the company engaged in “deceptive off-label marketing” of Neurontin, Maryland Attorney General J. Joseph Curran Jr. said in 2004.
‘Snake-Oil List’
A former Warner-Lambert medical liaison testified in an earlier Neurontin suit he was trained to market the drug to doctors for uses beyond those approved by regulators. Dr. David Franklin, who won a $25 million whistleblower suit against the drugmaker over the medicine, said he was given a “snake-oil list” of unapproved uses to help pump up Neurontin’s sales. Franklin had been set to testify in Smith’s case.
Smith, who worked part-time as a service manager at a Nashville office-machines store, began taking Neurontin in March 2004 to deal with chronic pain tied to back and neck surgeries, according to court filings. Lawyers for his family say in the filings that Warner-Lambert officials didn’t properly warn Smith’s doctors the drug had been found to cause depression and suicidal thoughts in some users.
‘Forgive Me’
In May, Smith killed himself with a gunshot to the head, according to the filings. In a note he left to his family, Smith indicated he was tired of being in pain.
“Forgive me; I cannot go on like this, I cannot have my body, the temple of the Holy Spirit, cut on anymore,” Smith said in the note. “I have talked to God all night and he understands.”
Lawyers for Smith’s family said he’d told relatives prior to his suicide that the Neurontin “was making him feel not himself,” according to court filings. “Mr. Smith’s death was inexplicable to family members because Mr. Smith was a godly man and he knew suicide was wrong,” they added in the filing.
Pfizer’s lawyers countered in their filings Smith suffered through “numerous surgeries” which left him dealing with “increasing pain.” The retired minister told his family he “wished he could die because of the pain and the depression,” the filing added.
The case is Ruby Smith v. Pfizer Inc., 05-cv-11515-PBS, U.S. District Court, Middle District of Tennessee (Nashville).
Source: Bloomberg Businessweek
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Pfizer Agrees to First Neurontin Lawsuit Settlement
Pfizer Inc. agreed to pay about $400,000 to settle a lawsuit mid-trial that blamed its Neurontin epilepsy medicine for helping cause a Massachusetts man’s suicide, two people familiar with the accord said. It’s the first settlement over a Neurontin-related suicide claim. Pfizer, the world’s largest drugmaker, agreed yesterday to resolve allegations by Hartley Shearer’s family in Boston federal court that its Warner-Lambert unit knew the drug posed a suicide risk and failed to disclose it to patients and doctors.
“Pfizer agreed to settle the case for less than its defense costs remaining in this case,” said Rob Haralson, a spokesman for New York-based Pfizer. “Pfizer maintains that it has strong defenses to each of plaintiff’s claims.”
Pfizer faces more than 1,000 lawsuits accusing it of illegally promoting Neurontin for unapproved uses and helping to cause some users’ suicides. The settlement comes a week after another Boston jury ordered Pfizer to pay more than $140 million in damages to an insurer over the drug. Pfizer has denied any wrongdoing in connection with its handling of Neurontin.
Its Warner-Lambert subsidiary pleaded guilty in 2004 to criminal charges filed by the Justice Department in connection with allegations it illegally marketed Neurontin and paid a $430 million fine. Pfizer acquired Warner-Lambert in 2000.
For 16 Months
The 57-year-old Shearer, a part-time lecturer at Williams College in Williamstown, Massachusetts, took Neurontin for 16 months before killing himself, according to court filings.
Shearer’s family contends his doctor wasn’t aware of Neurontin’s suicide risk when he prescribed the drug to help deal with pain generated by a 1999 stroke.
Pfizer argued Shearer battled depression for most of his life and was taking a dozen prescription drugs, including an anti-depressant, when he shot himself to death with a .357 Magnum handgun in 2002.
The drugmaker’s lawyers also noted Shearer argued with his wife the day he killed himself and left a suicide note saying it was the last time she would “leave me powerless.”
Ron Rosenkranz, a lawyer for the Shearers, declined to comment when contacted yesterday evening. Today, he told U.S. District Judge William G. Young at a hearing in Boston that the “amount of the settlement, while confidential, is substantially less than the amount reported.”
‘An Iffy Case’
“This is an iffy case,” Young told jurors after announcing the accord. “This is why they settled. Iffy on both sides.” The people who said the settlement was about $400,000 declined to be identified because the terms are confidential.
By prescribing Neurontin as a painkiller, Shearer’s doctor was recommending a so-called off-label use of the drug. While doctors may prescribe a medicine for uses not approved by the U.S. Food and Drug Administration, companies are barred from promoting products for off-label uses.
Dr. Charles King, a former Harvard University business professor, told jurors in the Shearer case yesterday that Warner-Lambert officials used illegal off-label marketing tactics to turn Neurontin into a “blockbuster drug.”
“They took a drug that was expected to generate $500 million over its lifetime and turned it into a drug that sold roughly $10 billion,” said King, an economist who testified for the Shearers as an expert on pharmaceutical- industry marketing practices.
The Shearer suit was the second product-liability case over Neurontin to go to trial.
In July 2009, a Peabody, Massachusetts, family dropped its suit over the suicide of a woman who was taking the drug. The family was in the second day of trial in federal court in Boston when it decided to dismiss the case.
Misleading Doctors
Another jury in Boston’s federal court March 25 said Pfizer must pay Kaiser Foundation Health Plan Inc. $47.4 million for misleading doctors on whether Neurontin was effective for illnesses such as migraines and bipolar disorder.
The jury found the drugmaker violated the federal Racketeer Influenced and Corrupt Organizations Act, or RICO, and California’s Unfair Competition Law.
The Oakland, California-based insurer is a unit of Kaiser Permanente, the largest U.S. nonprofit health maintenance organization. Under RICO, the amount of actual damages will be tripled to $142.1 million.
Pfizer bought Warner-Lambert for $120 billion in 2000 and Pharmacia for $54 billion three years later.
$430 Million Settlement
Along with the $430 million settlement of allegations over Neurontin, Pfizer also paid $2.3 billion in October 2009 to resolve U.S. Justice Department allegations it illegally marketed the painkiller Bextra and three other drugs.
“When you acquire Warner-Lambert you get Neurontin, and when you acquire Pharmacia you get Bextra, and some of these problems came with the acquisitions,” Jeffrey Kindler, Pfizer’s chief executive officer told the New York Times March 31. “It doesn’t change the facts or our responsibility for them.”
The Shearer case is Shearer v. Pfizer Inc., 07-cv-11428- PBS, U.S. District Court, District of Massachusetts (Boston).
Source:Bloomberg Businessweek
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Pfizer to pay $142M for drug fraud
- Neurontin
Sales of drug total $300M annually in Canada
Pharmaceutical giant Pfizer has been ordered to pay $142 million US in damages for fraudulently marketing gabapentin, an anti-seizure drug marketed under the name Neurontin.
A federal jury in Boston ruled Thursday that Pfizer fraudulently marketed the drug and promoted it for unapproved uses. The jury sided with California-based Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals, the first to try a gabapentin case against Pfizer.
Data revealed in a string of U.S. lawsuits indicates the drug was promoted by the drug company as a treatment for pain, migraines and bipolar disorder — even though it wasn't effective in treating these conditions and was actually toxic in certain cases, according to the Therapautics Initiative, an independent drug research group at the University of British Columbia.
The trials forced the company to release all of its studies on the drug, including the ones it kept hidden.
A new analysis of those unpublished trials by the Therapeutics Initiative suggests that gabapentin works for one out of every six or eight people who use it, at best. The review also concluded that one in eight people had an adverse reaction to the drug.
"The much larger majority of people will not get any benefit and many of them will have chronic neurotoxicity or poisoning of the brain," said Dr. Tom Perry of the Therapeutics Initiative.
Dr. Harry Pollett, a pain specialist in North Sydney, N.S., calls gabapentin a so-so drug with potentially serious side-effects for patients. These include drowsiness, balance problems, fogginess and edema, or swelling.
"Weight gain is a very common problem and I see that a lot," Pollett said.
The drugs represent a waste of money for Canada's health-care system, said Perry, who questioned why some doctors continue to encourage people to take the drug even though the patients are not benefiting.
"We have been using probably somewhere in the order of around $300 million a year in Canada recently and this drug has been overused since the late 1990s," Perry said. "So, do the math. It's probably well in excess of a billion dollars."
Pfizer defends its actions and its drug. The company has already been hit with $430 million in penalties and fines for fraudulently promoting gabapentin in the U.S.
SOURCE: CBS NEWS
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Pfizer to pay out $75 million over 1996 drug trial deaths
Pfizer has agreed to pay 75 million dollars compensation over a 1996 drug trial that caused the death of 11 children in northern Nigeria, a source close to negotiations said Friday.
"Pfizer has agreed to pay the sum of 75 million dollars in compensation and the Kano state government has agreed to the offer," said the source, who did not want to be identified.
The source said a separate 6.5-billion-dollar suit lodged against the US drug firm by the Nigerian federal government will be dropped under the terms of the settlement.
The Kano high court hearing the case has fixed May 25 for both the prosecution and defence lawyers to submit a detailed report on the out-of-court-settlement.
Kano state filed civil and criminal suits against Pfizer demanding 2.75 billion dollars in compensation, as well as the prosecution of staff, for what it said was an illegal test of the meningitis drug Trovan on 200 children in the state capital Kano.
The trial was carried out during a triple epidemic of measles, cholera and meningitis in which more than 12,000 people died.
Eleven children died after taking Trovan, which is also alleged to have caused deformities such as blindness, deafness, brain damange and paralysis in 189 others.
"Out of the money, 35 million dollars will go to the victims, 30 million will be used in rebuilding the Infectious Diseases Hospital where the drug trial was conducted", said the source.
The remaining 10 million will be used to settle legal costs incurred by the Kano state government, which is representing the victims.
The US pharmaceuticals giant has been locked in months of negotiations with Kano State. The talks were brokered by former US president Jimmy Carter and Nigeria’s former military leader Yakubu Gowon.
Pfizer has consistently denied any wrong-doing and insisted that the trial conformed to ethical practices and was carried out with the consent of the Nigerian government.
Source
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Pensioner wins £28,000 payout after being left ill by drugs trial
A pensioner has won an £28,000 payout from a pharmaceutical company after being left seriously ill during a drugs trial.
Leslie Thomas, 75, claimed he suffered a string of severe side effects including blood poisoning, fits and a collapsed colon after testing anti-inflammatory drug Vioxx .
Previously fit and healthy, he was left a "virtual invalid" by the drug, which left him anorexic, dangerously dehydrated and with an irregular heart beat, he alleged.
He was later diagnosed with an incurable and life-long intestinal disease.
Mr Thomas, a former college lecturer, has now been awarded £28,000 compensation after Merck Sharp and Dohme Ltd dropped their appeal against a County Count judgement in favour of the pensioner.
It has also agreed to pay his legal fees, including £50,000 he took out from his home insurance to pursue the case.
The ruling potentially leaves the door open for a further 450 UK claimants who wish to seek compensation on grounds of ill-health caused by taking Vioxx, although Merck insists that the payout sets no precedent.
Gerard Dervan, a partner at Liverpool-based law firm MSB, who is representing more than 100 people who have been affected, said: "This is a huge development. It removes a big barrier and I hope it will herald the start of more cases.
"Now we have seen that this massive firm roll over and drop the fight."
A study published in 2004 suggested that Vioxx doubles the risk of non-fatal heart attack or stroke and increases the risk of premature death by 31 per cent when taken for 18 months or more.
Merck withdrew the drug from the market and paid out billions of pounds in compensation to Americans who suffered heart attacks and strokes after taking the drug.
It had denied that Vioxx was capable of causing Mr Thomas' intestinal condition.
More than 80 million people were prescribed Vioxx - also known as Rofecoxib - for arthritis in 80 countries between 1999 and 2004.
Mr Thomas, from Ely, Cambs, took part in the trial in 2003. It was meant to establish whether the drug could decrease the risk of prostate cancer.
Last month he became the first British citizen to win a legal ruling to bring a compensation claim against the American firm, and has agreed the out of court settlement.
He said: "I'm not happy with the sum of money but I'm thrilled at the principal. Now I'm hoping that my victory will enable others to take their case to court."
A Merck spokeswoman said the payout was in line with guidelines set out by the Association of the British Pharmaceutical Industry (ABPI).
"This case is unique and has no significance for any other claim in the UK or elsewhere. Mr Thomas’s claim - an exacerbation of ulcerative colitis - is a gastrointestinal condition that is unrelated to the cardiovascular conditions that were the subject of the US resolution.
"In addition, Mr Thomas’s condition occurred during a clinical trial and was resolved pursuant to the ABPI guidelines, which are not applicable outside of the clinical trial context.
"The company’s position with respect to claims in the UK has not changed: the appropriate way to address them is individually and in the UK courts. The company has won the overwhelming majority of product liability lawsuits regarding Vioxx that have been decided around the world."
Source: Telegraph Jan 2009
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Thalidomiders win payout 50 years on
The government has agreed a historic deal to give annual payments of up to £8m to the surviving victims of the drug thalidomide while also publicly apologising for their suffering over the past 50 years.
The settlement, which is receiving its final clearance this weekend and is expected to be announced within days, comes after a successful campaign, backed by The Sunday Times, to secure vital state funding for the “thalidomiders”.
Under the terms of the deal the Department of Health (DoH) will pay a grant of £20m, spread over three years, to the Thalidomide Trust, which dispenses aid to the roughly 450 thalidomide victims living in the UK.
The £20m could be boosted by up to a further £5m if, as the DoH hopes, extra funds are procured from the devolved governments of Scotland, Wales and Northern Ireland.
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In an apology, which could be made by Gordon Brown, the prime minister, the government will express its “sincere regret and deep sympathy for the injuries and suffering” endured by thalidomide victims and their families.
The thalidomiders were born in the 1950s and 1960s with deformed and stunted limbs and even brain damage as a result of their mothers being prescribed the drug as a treatment for morning sickness or insomnia while pregnant.
After thalidomide was withdrawn from sale in 1961 the affected families fought a lengthy legal battle, backed by this newspaper, for compensation from its UK manufacturer, Distillers Biochemicals.
The money from Distillers — about £28m — was paid to the Thalidomide Trust in the 1970s, which handed out disbursements to its beneficiaries. Currently each victim receives an average of £18,000 a year from the trust. Many are unable to work and the money forms their only income.
However, as their contorted bodies have aged, the thalidomiders’ health problems — and the cost of treating them — have multiplied, leaving the victims financially pressed. They are forced to buy their own specialist wheelchairs and adapted cars, which can cost up to £60,000 each.
In 1958 a state agency, the Cohen committee, agreed that thalidomide, as a supposedly “proven remedy”, should be exempted from purchase tax, thereby in effect approving it for prescription on the NHS. Despite this, no British government has ever seen fit to offer a financial settlement to the victims or apologise for its role in the tragedy.
When The Sunday Times first announced the new campaign in February this year, the position of Alan Johnson, then the health secretary, was that he was “not persuaded” by their call for government compensation.
However, following the 10-month campaign, which saw one victim, Gary Skyner, go on hunger strike and a string of stories in The Sunday Times about the hardships being endured by other victims of the drug, the government has now met the campaigners’ demands in full.
Nick Dobrik, the leader of the campaign, expressed his satisfaction with the settlement and praised the role played by Mike O’Brien, the health minister, in agreeing it.
He said: “I was very impressed with the way Mike O’Brien handled the negotiations with the national advisory council of the trust.
“He was sympathetic and attentive to the difficulties facing our community and always acted in good faith and with integrity.”
Mikey Argy, chairwoman of the trust’s advisory council and a single mother of two girls, said the settlement would mean she would now be able to pay for £80,000-worth of life-enhancing alterations to her home.
Argy, who was born with drastically shortened arms, said: “I had architects draw up plans of how my house could be altered to make it more manageable for me, but until now I could never have afforded it. Now I may be able to secure a mortgage based on these new payments.”
Argy said that because her arms were unable to reach inside her overhead kitchen cupboards she has to climb up to use them.
New cupboards, however, would be fitted with sliding shelves, enabling her to use them safely.
Her bathroom would also be equipped with a walk-in shower, since at present she has to negotiate a normal bath in order to wash.
“Having short arms makes falling very dangerous and the last thing you want to be doing is stepping over a slippery- sided bath,” she said.
Argy added: “With this settlement the government is recognising its role and responsibility for the thalidomiders and this money will go some way to assisting us to get the adaptations we need to enable us to live as independently as possible and go towards getting the extra medical care we need.
“It’s not just about the money. I know quite a few thalidomiders who have said that all they ever wanted was an apology. It is a huge thing for us.”
Martin Johnson, the director of the trust, said he was pleased that the DoH would allow the trust to use its discretion as to how to distribute the money.
He said: “The money is set to be distributed on the basis of the trust now. We have jumped an awful lot of hurdles.”
Ministers tried to protect industry profits
The question of the state’s responsibility for part of the thalidomide tragedy has dogged governments since the 1960s.
Documents released by the National Archives show ministers and civil servants have repeatedly denied any official culpability and tried to protect drug industry profits.
In January 1973, in response to newspaper claims that the state had “moral responsibility” for the scandal, Sir George Godber, chief medical officer, wrote a memo for ministers in which he said the pharmaceutical industry should not be further burdened with checks in case profits were affected.
“There has to be some sort of a balance between the extent of the testing required and the possibility of recouping its loss from subsequent sales,” he wrote.
Source: Sunday Times Dec 2009
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Pfizer Pays $2.3 Billion to Settle Marketing Case
By GARDINER HARRIS Published: September 2, 2009
WASHINGTON — The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.
It was the largest health care fraud settlement and the largest criminal fine of any kind ever.
Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud.
“It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Kathleen Sebelius, secretary of health and human services.
Republicans and Democrats on Capitol Hill have accused the Obama administration of failing to crack down adequately on health care fraud, arguing that huge savings in government health programs could be found with better enforcement. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.
“Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism,” said Michael K. Loucks, acting United States attorney for the Massachusetts district.
Amy W. Schulman, Pfizer’s general counsel, said that Pfizer had reformed — again.
“The reasons to trust Pfizer are because, as I have walked the halls at Pfizer, you would see that the vast majority of our employees spend their lives dedicated to bringing truly important medications to patients and physicians in an appropriate manner,” she said.
The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.
Much of the activities cited Wednesday occurred while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, an epilepsy drug for which the company in 2004 paid a $430 million fine and signed a corporate integrity agreement — a companywide promise to behave.
John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government’s Bextra case, said that company managers told him and others to dismiss concerns about the Neurontin case while pushing them to undertake similar illegal efforts on behalf of Bextra.
“The whole culture of Pfizer is driven by sales, and if you didn’t sell drugs illegally, you were not seen as a team player,” said Mr. Kopchinski, whose personal share of the Pfizer settlement is expected to exceed $50 million. Mr. Kopchinski left Pfizer in 2003.
Altogether, six whistle-blowers will collect $102 million from the federal share of the settlement and more from states’ shares. Forty-nine states and the District of Columbia will collect $331 million, with New York State alone getting $66 million. Only South Carolina chose not to participate in the settlement.
As news of the riches earned by whistle-blowers spread through the industry in recent years, scores of fraud cases have been filed by former drug sales representatives using a Civil War-era law that pays a bounty for fraud alerts. The cases charge that illegal drug marketing cost the federal Medicare and Medicaid program millions.
Under the agreement with the Justice Department, Pfizer will pay a $1.3 billion criminal penalty related to Bextra and $1 billion in civil fines related to other medicines. In addition, a Pfizer subsidiary, Pharmacia and Upjohn, will plead guilty to violating the Food, Drug and Cosmetic Act for its promotion of Bextra. The company has agreed to sign another corporate integrity agreement that requires senior company executives to annually certify legal compliance and mandates that Pfizer post on its Web site many of its payments to doctors.
Consumer advocates heaped scorn on Pfizer and said that illegal marketing was still common in the drug industry.
“Consumers should ask their doctor whether the medication being prescribed is F.D.A.-approved for their condition,” advised Lisa Gill, editor of Consumer Reports Best Buy Drugs. If a drug is not approved for their condition, patients should press their doctors to explain their reasoning for the drug’s use.
Almost every major drug maker has been accused in recent years of giving kickbacks to doctors or shortchanging federal programs. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would more vigorously prosecute doctors as well.
Dr. Scott Gottlieb, a top F.D.A. official in the Bush administration who now consults for drug makers, said that government prosecutors were increasingly criminalizing “what reasonable people might argue is a reasonable exchange of important clinical information between drug companies and doctors.”
Bextra was approved in 2001 by the Food and Drug Administration to treat arthritis and menstrual cramps. The drug was not approved for the treatment of acute pain, nor was it shown to be any more powerful than ibuprofen. But Pfizer instructed its sales representatives to tell doctors that the drug could be used to treat acute and surgical pain and at doses well above those approved, even though the drug’s dangers — which included kidney, skin and heart risks — increased with the dose, the government charged. The drug was withdrawn in 2005 because of its risks to the heart and skin.
Mr. Loucks, the prosecutor, accused Pfizer of aggressive marketing tactics.
“Among other things, Pfizer did the following: Pfizer invited doctors to consultant meetings, many in resort locations. Attendees expenses were paid; they received a fee just for being there,” he said. Such weekend getaways for doctors are still common throughout the drug and medical device industries.
Top Republican officials rarely publicized drug marketing cases or appeared during news conferences about them. Eli Lilly agreed to pay $1.4 billion over its marketing of Zyprexa, an antipsychotic, in January, before President Obama took office. The announcement was made by prosecutors in Philadelphia.
Ms. Sebelius’s decision to make the Pfizer announcement in Washington suggests that the political environment for the pharmaceutical industry has become more treacherous despite the industry’s commitment to save the government $80 billion as part of efforts to change the health care system.
Source: New York Times
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