US Supreme Court To Decide On Drug Lawsuits

By Dianna Cooper
13:14, November 3rd 2008
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Unquestionably, there are thousands of suspended cases across the United States that hang on the decision of the Supreme Court. After hearing arguments, the high court will have to decide on Monday if patients who suffered serious drug adverse events could file a lawsuit if they consider manufacturers of the medicines hadn’t cautioned them adequately about the risks associated with the drugs.

"How else would an individual protect himself?" said 64-year-old Mike Seuferer, a diabetes sufferer who claims the drug called Avandia led to the heart failure which required hospitalization three years ago.

Both the Bush administration and the pharmaceutical industry insist patients are offered significant protection by the Food and Drug Administration, the agency of the Unites Stated Department of Health and Human Services responsible for the safety regulation of most types of drugs (and not only). So the agency initially assesses the benefits, as well as the health risks the drugs pose, and then it decides whether to approve the medicines or not.

In the case called Wyeth vs. Levine No. 06-1249, the Supreme Court was solicited to impose strict limits on suits against drugmakers. The case arose when Diana Levine, a professional guitarist, went to the hospital complaining about a nausea associated with strong headache. After being incorrectly injected with an anti-nausea drug called Phenergan, Levine lost a hand and forearm, despite the fact that the drug’s label received FDA approval.

"I never expected to sue anyone in my life," Levine stated at the beginning of the trial. It’s just "sometimes it takes something like this to make it known when a drug is not being used right," she added.

Claiming Phenergan’s labeling was unsafe, Levine filed a lawsuit against Wyeth, formerly known as American Home Products, one of the leading pharmaceutical companies worldwide. A Vermont jury awarded Levine $7 million in damages and ruled that Wyeth hadn’t warned consumers about the risks linked to IV push administration of Phenergan (the drug was injected to Diana Levine into an artery during a “push IV injection”).

The woman appealed and the Vermont Supreme Court decided that the state tort claim wasn’t preempted by the Food and Drug Administration approval of the medicine’s label. Wyeth could have given the FDA-approved label and extra warnings about IV push administration, Vermont’s high court said. Asking the company to do so wouldn’t have as consequence hindering any of the goals set by the 1938 federal Food, Drug and Cosmetic Act (FFDCA).

Wyeth, along with several other drug companies, maintain the fact that state juries analyzing and deciding on the experience of only one patient lack the know-how to establish whether a medication has or is deficient in accurate warnings.

According to the U.S. Chamber of Commerce, Wyeth vs. Levine is likely to also affect countless other businesses unrelated to the pharmaceutical industry that face liability claims, Reuters reported.



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