Waxman Launches Salvo Against FDA Pre-Emption Of State Tort Suits

House Oversight and Government Reform Committee Chairman Henry Waxman has lined up prominent physicians, a former FDA commissioner and a celebrity to make a case against pre-emption.

The group testified at a May 14 hearing on whether FDA regulation of drug and medical devices should bar state product-liability suits.

"Under a radical legal doctrine being advocated by the pharmaceutical and device industries" and FDA, "patients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries in state court," Waxman, D-Calif., said in his opening statement.

"The result is that one of the most powerful incentives for safety - the threat of liability - would vanish."

Eight of the 10 witnesses agreed with Waxman.

Gregory Curfman, executive editor of the New England Journal of Medicine, noted that the journal has published several articles about safety issues with drugs after their approval. He said in some instances, including an NEJM article about Vioxx , manufacturers knew of safety risks but failed to publish them.

"Drugs have placed millions at risk, but those harmed could seek redress" through the courts, Curfman stated. "Pre-emption would remove that right."

The Supreme Court ruled in February in Riegel v. Medtronic that the pre-emption clause in the Medical Device Amendments of 1976 bars suits that challenge the safety and efficacy of devices given pre-market approval by FDA (¹ (Also see "Supreme Court Ties On FDA Pre-Emption; Congress Seeks To Resolve Issue" - Pink Sheet, 10 Mar, 2008.), p. 8).

During its October term, in Wyeth v. Levine, the court will take up the question of whether FDA-approved drug labeling provides immunity from litigation.

Waxman and Rep. Frank Pallone Jr., D-N.J., have drafted legislation to block the Riegel decision by changing the Medical Device Amendments so the law does not preclude state actions for damages.

Dennis Quaid's Battle Against Baxter

Actor Dennis Quaid, the star witness at the hearing, related what happened to his infant twins when they were treated for a staph infection in November. A nurse mistakenly injected a 10,000-unit bottle of heparin into an IV bag instead of a 10-unit bottle of Hep-Lock . As a result, the twins received 1,000 times the normal dose of heparin two times and nearly died.

The bottles are similar in size and color, and previous mix-ups have occurred. Quaid noted that in 2006 three infants in Indianapolis died and three others were seriously injured after receiving the large unit of heparin. Baxter sent a warning letter to hospitals after the Indianapolis incident and in August 2007 changed the labeling of the higher-dose drug. But the company failed to recall the outstanding heparin product.

"This was a dangerous, potentially deadly decision," Quaid said. He and his wife filed a lawsuit against Baxter in November. The company has filed a motion to dismiss, citing FDA pre-emption as a defense.

FDA Regs Pre-Empt State Law

David Clark, Republican majority leader of the Utah House of Representatives, said federal agencies "have taken inappropriate liberties with the regulatory process" and gone so far as to pre-empt state law without enabling legislation from Congress.

Clark, representing the National Conference of State Legislatures, cited an FDA rule on Rx drug labeling finalized in 2006. He said NCSL did not submit comments on the proposed rule because the agency said the regulation would not pre-empt state law.

However, Clark said the group later learned that the final rule would pre-empt state product liability laws. NCSL asked FDA to re-open the comment period, but the agency refused, he said.

Unelected federal bureaucrats "should not have the authority to wipe laws out with a single swipe of a pen," Clark said.

FDA Shifts Position on Pre-Emption

Waxman and other members criticized the change in FDA's long-held position against pre-emption.

Rep. Bruce Braley, D-Iowa, noted that the change occurred in 2002 when FDA issued a final drug labeling rule, stating in the preamble that it favored agency pre-emption in state product-liability suits. The policy change came under then-FDA chief counsel Dan Troy.

Randall Lutter, FDA deputy commissioner for policy, responded that the agency has articulated this position in a number of amicus briefs over the years and in regulatory preambles.

However, Waxman said the Bush administration decided to insert pre-emption into the law without asking Congress to change the law.

"I'm offended all the time by the administration's view that you are the supreme branch," he said.

David Kessler, who was commissioner of FDA from 1990 to 1997, agreed that the agency's position on pre-emption has shifted. He quoted remarks Margaret Porter, who was FDA chief counsel during his tenure, made to the Food and Drug Law Institute in 1996.

"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 stated at the time. Pre-emption of product liability claims "would result in the loss of a significant layer of consumer protection, leaving consumers" harmed by defective medical devices without recourse.

Kessler, now a professor at the University of California, San Francisco, said he supports federal pre-emption in certain cases, such as when FDA has taken substantive and definitive action.

However, he said pre-emption proponents focus on a drug's life during the approval process and claim what is known about the approved labeling reflects the agency's definitive judgment. However, risk is not static, and after approval, companies have more information than FDA about their products.

"My greatest concern about pre-emption is that it would dramatically reduce the incentives for manufacturers to act quickly and responsibly to detect, analyze, investigate and take action on potentially serious and life-threatening adverse reactions once a drug is on the market," Kessler stated.

Lutter, however, said "state product-liability lawsuits challenging FDA's careful determination of safety, efficacy and appropriate labeling can have detrimental effects to public health," including limiting patient and doctor choices, decreasing patient access to beneficial products, and increasing confusion over warnings.

- Brenda Sandburg ([email protected])