Legal Theory Seeks to Curtail Tort Cases

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In 2001, after years as a lawyer for pharmaceutical and tobacco companies, Daniel Troy was tapped as President George W. Bush’s general counsel of the Food and Drug Administration. Almost immediately, the FDA filed several friend of the court briefs on behalf of medical device and drug companies being sued in state courts. The briefs argued that it is not the place of state judges and juries to question the safety of a drug that FDA scientists have approved.

Troy was applying the preemption principle — which argues that federal regulations of a product preempt consumers from suing the maker of that product in state civil courts. Troy left the FDA in 2004, but the U.S. Supreme Court subscribed to his logic earlier this year in a ruling that preempted lawsuits against makers of medical device. It could do the same this fall, in a case about consumers’ right to sue drug companies. The Bush administration’s once obscure legal argument for curtailing lawsuits against industry has become the nation’s predominant opinion.

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But at a congressional hearing Wednesday, Democrats threw down the gauntlet. The House oversight committee said that it has had many disagreements with this administration, but this preemption principle is offensive. Rep. Henry A. Waxman (D-Calif.) and Rep. Bruce Braley (D-Ia.) spent most of the day arguing that for 100 years FDA regulations have coexisted, and benefited, from state civil suits. If the preemption principle prevails in the court this fall, the committee said Congress would write legislation saying that FDA regulations do not take away a consumer’s right to sue.

Waxman, the chairman of the House Committee on Oversight and Government Reform, called a parade of witnesses to make the case against preemption. David C. Vladeck, a Georgetown Law School professor, argued that not only had the Supreme Court gone against Congress, it had broken precedent with institutional history of the FDA, which, before the Bush administration, supported lawsuits.

“Since the FDA was created in 1908 there has been concurrent state liability actions,” Vladeck said. “Then, in 2002 the FDA took the position their ought to be broad preemption. What’s changed beyond the change in administrations? As far as I can tell — nothing.”

Braley built on Vladeck’s argument by citing a statement made in 1997 by Troy’s predecessor, Margaret Porter, that supported civil suits. “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct layer of consumer protection,” Porter had said.

Chris Shays (R-Conn.) was the lone Republican to stick around through the hearing to defend of the preemption principle. Shays made an argument similar to Troy’s — and the Supreme Court’s — that juries of laymen shouldn’t be usurping the rigorous decision-making process of federal scientists.

Shays, though, acknowledged that in arguing the preemption principle, Republicans were advocating for a stronger federal bureaucracy at the expense of states and individual rights. “The irony of this hearing,” Shays said, “is that Republicans are usually not great fans of the FDA.”

But for Republicans on the oversight committee, the real bogeymen are not federal bureaucrats but trial lawyers. Shays and Tom Davis (R-Va.), the ranking Republican on the committee, both argued that FDA regulators are protection enough. Civil claims, Davis insisted, foster a “litigious society.”

“The FDA, when left to its devices, does a good job of appropriately warning Americans about the drugs and devices they use,” said Davis.

But lawmakers from both parties have said for months that the FDA is not doing a good job. This argument was bolstered by a New York Times story Wednesday that FDA Commissioner Andrew von Eschenbach wrote to Sen. Arlen Specter (R-Penn.) saying that the agency needed an infusion of $275 million.

Von Eschenbach said that the $2.4 billion the president proposed for the agency’s budget can’t ensure the safety of food, drugs and medical devices. Congress has sharply criticized the FDA since November, when the agency’s own scientific advisory board determined they are slow to respond to product dangers.

At the hearing, David A. Kessler, the FDA’s commissioner between 1990-1997, testified that even if the FDA were doing its job of monitoring manufacturers, “the companies will always have better and more timely information on its products than the FDA will ever have.” Kessler urged Congress to write legislation explicitly giving consumers the right to sue both medical device and drug makers.

The hearing largely came about because of the two cases that reached the Supreme Court. First was Riegel vs. Medtronic, an 8-1 decision in February that said a consumer can’t sue the maker of a medical device if the FDA has tested and approved that device. The FDA tests all “life sustaining” medical devices, like implants and heart catheters, before they come onto the market.

The second case, expected this fall, looks at whether FDA-approved drug makers are also immune from lawsuits. In Wyeth vs. Levine, Diana Levine is suing the Wyeth company, that made an FDA-approved anti-nausea drug. The drug caused gangrene and Levine had to have her arm amputated. The case will look at whether the 1938 Food, Drug and Cosmetic Act should be read as pre-empting such lawsuits.

In the Reigel case, the court found that the 1976 Medical Device Amendments Act preempt claims made by consumers in state courts. The court’s interpretation was news to Sen. Edward M. Kennedy (D-Mass.), who had been the Senate sponsor of the 1976 law.

“In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,” Kennedy, who was hospitalized this weekend after a seizure, had said after the ruling. “Congress obviously needs to correct the court’s decision.”

Waxman’s oversight committee was probably the first step in that process.