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Democrats Fight to Stop Preemption

May 19, 2008 | Parker Waichman LLP

Almost immediately after being hired as President George W. Bush's general counsel of the Food and Drug Administration (FDA) in 2001, Daniel Troy began applying the preemption principle.  This principle argues that federal regulations of a product preempt consumers from suing the maker of that product in state civil courts.  Troy filed a variety of friend of the court briefs on behalf of medical device and drug companies which were being sued in state courts and 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 served for years as a lawyer for pharmaceutical and tobacco companies.

Troy left his appointed position with the FDA in 2004; however, the U.S. Supreme Court adopted his logic in a ruling this year that preempted lawsuits against makers of medical devices.  The courts could do the same this fall in a case about consumers' right to sue drug companies.  Meanwhile, at a congressional hearing Wednesday, Democrats in the House oversight committee said they have many disagreements with this administration, calling preemption offensive.  Representative Henry A. Waxman (Democrat-California) and Republican Bruce Braley (Democrat-Louisiana) spent the bulk of the day arguing that for 100 years FDA regulations have coexisted, and benefited, from state civil suits.

If preemption succeeds in court this fall, the Committee said Congress would write legislation saying 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 many 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 broke precedent with the institutional history of the FDA, which, prior to the Bush administration, supported lawsuits.  "Since the FDA was created in 1908 there has been concurrent state liability actions," Vladeck said.  Braley cited a statement made in 1997 by Troy's predecessor, Margaret Porter, which 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 (Republican-Connecticut) was the only Republican to remain through the hearing to defend preemption, but did admit that in arguing the preemption principle, Republicans were advocating for a stronger federal bureaucracy at the expense of states and individual rights.

For Republicans on the oversight committee, the concern is with trial lawyers.  Shays and Tom Davis (Republican-Virginia), the ranking Republican on the Committee, both argued that FDA regulators are sufficient protection.  Civil claims, Davis insisted, foster a "litigious society and, the FDA, when left to its devices, does a good job of appropriately warning Americans about the drugs and devices they use."  A strange observation given that lawmakers from both parties have long been arguing that the FDA is not doing a good job, some even calling for the removal of FDA Commissioner Andrew von Eschenbach.  Also, the FDA’s own scientific advisory board determined the agency is slow to respond to product dangers.

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