Supreme Court To Consider Whether To Bar Liability Lawsuits Against Pharmaceutical Companies

Main Category: Pharma Industry / Biotech Industry
Also Included In: Medical Malpractice / Litigation;  Regulatory Affairs / Drug Approvals
Article Date: 09 Sep 2008 - 8:00 PDT

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The U.S. Supreme Court in November will consider whether to shield the makers of prescription and over-the-counter drugs from liability lawsuits, the Los Angeles Times reports. According to the Times, "the right to a civil jury trial has been a historic protection for consumers," but a recent series of lawsuits "has limited lawsuits against businesses," including a Supreme Court ruling in February that shields the manufacturers of government-approved medical devices from liability claims. In the past, "FDA had maintained that regulatory laws passed by Congress did not bar such lawsuits," but the agency "changed course" under the Bush administration and said that its oversight of drugs and medical devices barred most lawsuits regarding those products, the Times reports.

According to the Times, the Bush administration and the pharmaceutical industry now "stand on the verge of shutting down tens of thousands of lawsuits that have cost the industry billions of dollars in jury verdicts and settlements." After the Bush administration failed to persuade states or Congress to limit liability suits, it had federal agencies "reinterpret" laws to conclude that jury verdicts "would conflict with federal policy," and "[n]owhere is this approach having more effect than in the area of drugs and medical devices," the Times reports. Georgetown University law professor David Vladeck, formerly of Public Citizen, said, "This is a radical restructuring of the American civil justice system."

The case before the Supreme Court in November involves Diana Levine, who was awarded $6.7 million in damages from Wyeth after an anti-nausea drug was improperly injected into an artery and caused gangrene, which resulted in the amputation of her lower right arm and hand. Although the warning label urges extreme caution when administering Phenergan via injection, Levine sued the drugmaker, claiming that the company should have warned against injecting the drug under any circumstance.

The U.S. solicitor general, representing FDA on Wyeth's side, along with a broad coalition of business groups, including the U.S. Chamber of Commerce and the pharmaceutical industry, say that FDA had approved the label for Phenergan and that the Vermont jury did not have the authority or the expertise to decide whether a stronger warning was needed. Meanwhile, consumer rights advocates say lawsuits can alert the public to dangers that FDA might have missed, as well as provide compensation for injured patients (Savage, Los Angeles Times, 9/8).

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