Editorial, Opinion Piece Address Whether FDA Approval Of Medications Should Exempt Companies From Liability Lawsuits

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Litigation / Medical Malpractice
Article Date: 28 Apr 2008 - 0:00 PDT

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USA Today on Friday published an editorial and an opinion piece that addressed whether FDA approval of medications should protect pharmaceutical companies from product liability lawsuits filed in state courts. The Supreme Court this year will hear a case that could decide the issue. Summaries of the editorial and opinion piece appear below.

• USA Today: "FDA's endorsement of a medicine or a warning label could be enough to bar" such product liability lawsuits in the event that pharmaceutical companies and the Bush administration "get their way" in the Supreme Court case, and, "in a perfect world, that's how it should be," a USA Today editorial states. According to the editorial, FDA "would be able to police the pharmaceutical companies, detect fraud or deceit, and monitor drugs effectively after they're released to the market." However, in the "real world," the "underfunded, understaffed FDA can be overmatched by pharmaceutical companies that withhold or manipulate information when seeking FDA approval, or are slow to report adverse results once drugs are in widespread use," the editorial states. "That's where the legal system comes in" because "litigation or fear of litigation plays important roles in backstopping the FDA and promoting pharmaceutical safety," the editorial states, adding, "Litigation can ferret out crucial information about drug company deception and risky drugs." The editorial recommends that the Supreme Court "let the suits proceed," with a requirement that plaintiffs "demonstrate that a company deliberately deceived the FDA or knowingly failed to warn about the risks of its medicines." The editorial concludes, "That should both protect the drug companies and help keep them honest" (USA Today, 4/25).
  
  
• Diane Bieri, USA Today: "For 70 years, Congress has charged FDA with ensuring that medicine labeling adequately warns about potential side effects," but today "lawyers are trying to second-guess FDA's expertise regarding the way to warn about potential drug risks," Bieri, senior vice president and general counsel for the Pharmaceutical Research and Manufacturers of America, writes in a USA Today opinion piece. According to Bieri, in the event that plaintiff attorneys "are successful" in the Supreme Court case, the "companies researching and developing medicines could face massive damages" in product liability lawsuits filed in state court -- "even after they discussed potential risks with FDA scientists and they required different warnings" -- which "would be unfair and would hinder the development of lifesaving treatments." Bieri writes that such lawsuits "would weaken FDA further because it no longer would have adequate authority to control safety warnings we all depend on" and "would effectively weaken FDA's power to protect patients." In addition, the "opinion of lawyers and juries would replace the judgment of FDA's scientists and doctors," she writes. Bieri writes, "Federal pre-emption is not about providing blanket immunity for pharmaceutical companies," adding, "Simply put -- pre-emption is about allowing FDA scientists to do their job and protect patients" (Bieri, USA Today, 4/25).
  

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