Articles Tagged with drug

AstraZeneca is preparing for a products liability trial next week over claims that their antipsychotic medication Seroquel causes diabetes. About 26,000 lawsuits have been filed against the drugmaker, with one of many trials set for February 16th in New Jersey.  That trial will be the first of thousands filed in New Jersey alone.  Seroquel is the UK-based drugmaker’s second most popular drug after Nexium, the well known heartburn relief medication, and is used to treat bipolar disorder and depression. AstraZeneca claims that the plaintiffs’ evidence is insufficient to show that the drug was responsible for their alleged personal injuries.

In January, U.S. District Judge Anne Conway, who is overseeing all federal Seroquel litigation, ordered the parties to attend mediation.  The parties were unable to reach a settlement agreement after two days of talks.  The mediator, George Washington University Law Professor Stephen Saltzberg, said he expects further settlement negotiations to occur.  Judge Conway, who sits in Florida, has said that she will ask a panel of judges to return the 6,000 consolidated cases scheduled to come before her to their resident states, adding to the litigation headache.

Seroquel was introduced in 1997 and has long been linked to weight gain and diabetes.  The plaintiffs are claiming that AstraZeneca downplayed the risk of diabetes, cherry-picked positive trial results, and buried negative results.  Documents discovered in 2009 appear to substantiate the plaintiffs’ claims.  As early as 1997, emails between AstraZeneca officials reveal that the drugmaker hid negative trial results from US and Canadian investigators.  AstraZeneca is not the first antipsychotic drugmaker to be hit with claims that its medication causes diabetes.  In 2009, Zyprexra-maker Eli Lilly agreed to pay at least $1.2 billion to similar settle lawsuits filed by about 31,000 patients.

For more information on Seroquel side effects, see the Seroquel website.  The Alliance for Human Research Protection has a collection of articles on the Seroquel product liability litigation.
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In what is being called the largest prescription drug criminal fraud case in U.S. history, Pfizer will pay $2.3 billion in civil and criminal penalties to compensate taxpayers, patients and doctors across the United States for illegal drug marketing.

A government investigation revealed that Pfizer promoted the sale of Bextra – an anti-inflammatory drug that Pfizer pulled from the market in 2005 – for uses and dosages that the FDA specifically declined to approve due to safety concerns. Despite the lack of approval, Pfizer literally wined and dined physicians around the country to promote the “off-label” uses of its drug. As a result, Pfizer will pay a criminal fine of $1.3 billion.

In addition, Pfizer agreed to a $1 billion civil settlement to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications.

The U.S. Supreme Court’s decision in Wyeth v. Levine on March 4, 2009, represents a resounding triumph for all Americans who take prescription drugs. In short, the Court found by a 6-3 margin that the federal regulations of the Food and Drug Administration (FDA) do not prevent a consumer from bringing a state court product liability claim against a pharmaceutical company that negligently manufactures, distributes or labels a prescription drug. The case preserves the rights of Massachusetts consumers to obtain compensation for personal injuries resulting from defective drug products.

Details of the Case

Diane Levine brought suit against Wyeth Pharmaceuticals after being forced to amputate her right forearm nearly nine years ago. A professional musician, Deborah had suffered from persistent migraine headaches and visited a local clinic for treatment. She was prescribed Phenergan, an antihistamine used to treat nausea. A physician assistant administered the drug by “IV-push,” which caused the drug to come into contact with arterial blood. As a result, she developed gangrene, leaving her no choice but to amputate half of her right arm.

Levine sued Wyeth Pharmaceuticals, claiming that Wyeth failed to adequately warn medical professionals and consumers of the risks of IV administration. At trial, evidence indicated that since the approval of the drug in 1955, more than 20 other patients had suffered from similar amputations. A Vermont jury concluded that Phenergan was a defective product, and awarded Levine $6.7 million to compensate for her devastating injury.

Wyeth appealed the verdict, and argued that because the drug’s label had been approved by the FDA – a federal agency – a consumer such as Deborah could not sue the company in state court. The Supreme Court rejected Wyeth’s argument, and ruled that a drug manufacturer ultimately “bears responsibility for the content of its label at all times.” The FDA’s purpose is to regulate, not to compensate consumers for injuries caused by drugs. “State law remedies further consumer protection,” Justice Stevens wrote, “by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.”

What does this mean for Massachusetts consumers?

The Wyeth decision will make it much harder for drug manufacturers to hide behind a shield of compliance with federal regulations. FDA approval will not provide immunity for a drug company with a defective product. If you are injured by a negligently produced prescription drug, your right to bring a product liability action in state court against the drug company is preserved, and drug companies cannot hide behind a wall of federal preemption.

Another important effect of the decision is that pharmaceutical companies will likely pay closer attention to their labels and instructions, therefore improving consumer protection and safety in the prescription drug marketplace.

More Information

To read the entire decision, click here: Wyeth v. Levine

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