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News :: Social Welfare
Juries rules against Pfizer for biotech workers, victims
01 Apr 2010
Boston - A federal jury in Boston has found that Pfizer violated U.S. racketeering laws by illegally promoting off-label uses of its epilepsy drug Neurontin, and the drug maker may be forced to pay more than $142 million in damages in the case.

Hartford — Becky McClain, a Deep River [Conn.] scientist who claims to have been infected by an experimental virus while working at Pfizer Inc.'s Groton laboratories, was awarded $1.37 million today by a U.S. District Court jury.
Workers' rights organizations immediately hailed the verdict, in which Pfizer also was ordered to pay McClain's attorneys' fees. They said the outcome of the federal civil suit was a major milestone for biotech and nanotech workers everywhere.
Neurontin Lawsuit Results in $142M in Damages Against Pfizer

Published: March 29th, 2010 • One Comment
feature photo

A federal jury in Boston has found that Pfizer violated U.S. racketeering laws by illegally promoting off-label uses of its epilepsy drug Neurontin, and the drug maker may be forced to pay more than $142 million in damages in the case.

The Neurontin lawsuit, brought by Kaiser Foundation Health Plan, Inc. and Kaiser Foundation Hospitals, charged Pfizer with illegal promotion of Neurontin for migraines, bipolar disorder and other conditions. The plaintiffs alleged that they were forced to overpay $90 million for the medication, which did not perform as advertised.

The U.S. District Court jury in Boston deliberated for two days after a month-long trial, and awarded the plaintiffs $47.36 million in damages. However, since the charges include claims that Pfizer violated the federal Racketeer Influenced and Corrupt Organizations Act (RICO), the jury award is automatically tripled, meaning that if the ruling stands Pfizer would have to pay $142.1 million in total.

The case is just one of about 1,200 lawsuits over Neurontin that Pfizer is facing. Most of the lawsuits have been brought by individual plaintiffs who say that Neurontin side effects increase the risk of suicide. In 2008, the FDA required Neurontin and similar epilepsy drugs to begin carrying label warnings alerting users to the risk of suicidal thoughts.

While doctors are free to prescribe drugs for uses not approved by the FDA, manufacturers are prohibited from marketing the drugs for such uses that they have not established are safe and effective. In 2004, Parke-Davis, a division of Warner-Lambert that was acquired by Pfizer, paid $430 million to the U.S. Justice Department over claims that they were illegally promoting Neurontin for off-label uses, including control of mood swings. Last fall, Pfizer paid the Justice Department $2.3 billion to settle a number of off-label marketing claims which included its marketing of Neurontin.

Neurontin (gabapentin) is an epilepsy medication approved by the FDA in 1983, which generated $387 million in sales for Pfizer in 2008.

The first Neurontin lawsuit to go to trial, which involved a claim brought by the family of Susan Bolger, who committed suicide in 2004 after taking the drug, was dropped last summer before a verdict was ever returned.

All federal lawsuits involving Neurontin have been consolidated before U.S. District Judge Patti B. Saris, and the next Neurontin lawsuit trial is scheduled to begin next week in the same court.

Article published Apr 1, 2010
Ex-Pfizer scientist wins $1.37 million in federal lawsuit
Lee Howard
Hartford — Becky McClain, a Deep River [Conn.] scientist who claims to have been infected by an experimental virus while working at Pfizer Inc.'s Groton laboratories, was awarded $1.37 million today by a U.S. District Court jury.
Workers' rights organizations immediately hailed the verdict, in which Pfizer also was ordered to pay McClain's attorneys' fees. They said the outcome of the federal civil suit was a major milestone for biotech and nanotech workers everywhere.
"If this could happen at the biggest drug company in the world, it could happen in other plants," said Steve Zeltzer, chair of the California Coalition For Workers Memorial Day, a group that advocates for employees hurt on the job. "It's a vindication of the courage shown by Becky to confront the need to do a proper oversight of the biotech industry."
The suit, argued during a three-week trial before Judge Vanessa Bryant, has been closely followed by labor organizations, attorneys and members of the medical and research community because it is the first federal case involving a biotech worker who claims to have been harmed by a novel virus on the job.
Workers' rights groups have criticized Judge Bryant, however, for throwing out McClain's major claim shortly before the trial began. The claim was that Pfizer engaged in willful and wanton misconduct in exposing her to a dangerous work environment that led to health problems that included bouts of temporary paralysis.
McClain, a molecular biologist who filed her suit about three years ago in New London Superior Court, had claimed that Pfizer violated whistleblower laws. A former member of the company's safety committee, McClain also charged that Pfizer violated her freedom of speech by terminating her after she pressed complaints with the U.S. Occupational Safety and Health Administration.
McClain's attorney, Bruce E. Newman of Bristol, previously called the case precedent-setting because there are few government standards regulating the bioengineering field. Backers of McClain said they hoped the scientist's victory in court would send a notice to companies everywhere that a safe working environment is paramount to those who work in biotech specialties that deal with potentially lethal organisms.
Pfizer continues to deny all of the suit's charges and said today that the company is considering its options for appeal.
"We are disappointed with the verdict and do not believe the facts of this case warrant the conclusion reached by the jury," Pfizer said in an e-mailed statement.
"Pfizer is committed to protecting the health and safety of our colleagues and the communities in which we operate," the statement continued. "In addition to our commitment to full compliance with environmental, health, and safety laws and regulations, we have company-wide policies, standards, and programs combined with site-level management systems and initiatives tailored to the particular safety issues and needs at each location."
Pfizer previously said it had thoroughly investigated McClain's health and safety claims and found them to be untrue.
McClain, who worked at Pfizer for nearly a decade before being terminated in 2005, was employed in Groton's embryonic stem cells program when she said she became ill after being subjected to repeated noxious fumes coming from the hood of a device at Lab B313, according to her suit. She said her supervisor also became ill, but later conspired to cover up the incident, warning her that she "would lose her job if she made too big an issue out of lab safety," the suit said.
McClain said she asked for a transfer out of Lab B313 because of ongoing health concerns. Later, she developed chronic fatigue symptoms, according to the suit, and discovered that a co-worker had been working next to her with a "dangerous lentivirus material (similar to the AIDS virus) and embryonic stem cells on an open lab bench without biological containment."
McClain later went on medical leave, according to testimony, but continued to raise safety concerns until she received a termination notice during her absence.
Backers of McClain said OSHA denied her workplace complaints largely because federal worker-safety laws have not kept pace with the rising hazards in U.S. laboratories. They have called for OSHA to reopen its investigation of the McClain case, a cause that may have received a boost from the six jurors whose verdict was read in court today.
McClain's lawsuit claimed her continued exposure to genetically engineered viruses had led to a condition that leads to periodic paralysis, joint pain and fatigue. The attacks, which were particularly severe before the 52-year-old McClain started taking massive amounts of potassium, have dissipated in recent months, according to Mark McClain, the plaintiff's husband.
But McClain has said there is no known cure for the condition, and claims that Pfizer has refused to hand over exposure records that might help her identify the virus that infected her. She said Pfizer has claimed exemption from laws requiring health records to be handed over based on other laws that protect patent information.

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FOR MORE INFORMATION LISTEN TO KPFA - FLASHPOINTS, APRIL 1, 2010
01 Apr 2010
For more information listen to KPFA - Flashpoints, April 1, 2010. [Use archives]