FDA stepping into liability lawsuits on side of drug makers

By Robert Cohen
Newhouse News Service

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His widow sued Pfizer, the drug's manufacturer, charging that the company should have warned doctors that Zoloft could cause some people to have suicidal thoughts.

But Flora Motus soon discovered the pharmaceutical giant wasn't her only adversary. The California woman was also fighting the U.S. government.

The Food and Drug Administration filed a legal brief on Pfizer's behalf in the fall of 2002, asserting that antidepressants don't increase the risk of suicide. "Had Pfizer given a warning as to a causal relation between Zoloft and suicide, the FDA would have disapproved the warning," the agency argued.

The Motus case ended up being dismissed by a federal appeals court in February on other grounds. But it is one of several legal cases the FDA has joined since 2002 on behalf of drug and medical-device makers sued for injuries allegedly caused by their products.

The FDA argues that as the federal agency that regulates drugs and medical devices, its determination that a product is safe pre-empts state lawsuits seeking damages for product defects and personal injury claims. The agency's legal strategy has been led by the FDA's general counsel, Daniel Troy, who represented Pfizer while in private practice.

Critics argue the Bush administration is working to undermine state laws allowing damages for injuries caused by negligence, defective designs or failures to warn.

"If the FDA position prevails, injured patients will have no legal remedies when the products harm them," said Allison Zieve of the Public Citizen Litigation Group, an affiliate of Ralph Nader's consumer advocacy organizations. "Cutting off the right of injured people to sue is an extreme thing to do."

Rep. Maurice Hinchey, D-N.Y., said the agency's legal strategy represents a departure from the past. He said personal-injury lawsuits have coexisted with the regulation of drugs for decades, serving as an added protection against companies that mislead the public or that have been negligent.

"The FDA was created by Congress to protect the public, but the FDA is now going out of its way to use its resources on behalf of drug companies and device manufacturers," said Hinchey, a member of the House Appropriations Committee.

Later this month, the FDA is expected to return to federal court to file a brief on behalf of the maker of an FDA-approved heart pump that allegedly malfunctioned and resulted in the death of a Pennsylvania man. The company argues that the lawsuit, brought by the man's widow, is pre-empted by the FDA's approval of the device, which followed a rigorous review.
 
The FDA's efforts on behalf of drug and medical device makers are part of a broader Bush administration effort to curb lawsuits arising from personal injuries.

The Bush White House supports immunizing gun manufacturers from lawsuits, ending asbestos litigation in favor of a national compensation fund, and capping damage awards in medical-malpractice and product-liability cases. It argues that there is a proliferation of frivolous lawsuits that are hurting business and stifling innovation.

In the case of drugs and medical devices, "product liability cases seem to be on the rise, and judges and juries seem more and more willing to make determinations about medical products that conflict with FDA scientists' expert determinations," said Peter Pitts, an associate FDA commissioner.

The FDA's efforts are not meant "to bar the courthouse door," Pitts said. "Plaintiffs can still seek relief in court, as long as no court or jury establishes a requirement for an FDA-regulated product that conflicts with one of FDA's requirements."

Courts traditionally have found that FDA-approved warnings about drugs constitute a minimum standard and do not preclude claims filed under state laws claiming negligence or that warnings were inadequate or misleading.

The Supreme Court has allowed lawsuits involving medical devices that received fast-track FDA approval without clinical testing on humans. This category represents most medical devices. But appeals courts are divided over whether devices that undergo premarket human trials are immune from product-liability and personal-injury lawsuits.

Peter Barton Hutt, the FDA's counsel in the Nixon and Ford administrations, said Troy is "acting to protect the FDA's jurisdiction" in the pre-emption cases just as others who held his job have done in the past.

"What Dan Troy is saying is we have to have one national authority," Hutt said. "When the FDA issues a rule or makes a decision, there has to be deference in states and in federal courts to the FDA's primary role in setting that policy. He doesn't care if it helps or hurts industry."

Zieve, of the Public Citizen Litigation Group, said that although there have been cases in which the FDA has asserted its jurisdiction to reconcile conflicts with state regulatory actions, the agency "has not supported pre-emption of personal-injury claims prior to this administration."