Draft Bill Would Overrule Supreme Court’s Device Pre-emption Support

House Democrats plan to introduce a bill next month to reverse the impact of the recent Riegel v. Medtronic U.S. Supreme Court decision protecting PMA-approved devices in most cases from personal injury lawsuits.

The ¹ legislation, drafted by Reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif., would add a provision to the 1976 Medical Device Amendments of the Food Drug and Cosmetic Act entitled "No Effect On Liability Under State Law."

It reads, "Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State."

The language is designed to counter an 8-1 decision handed down by the Supreme Court Feb. 20 that is expected to cause a slow-down in product liability lawsuits against device manufacturers (² (Also see "In Victory For Device Industry, Supreme Court Favors PMA Pre-emption" - Medtech Insight, 25 Feb, 2008.), p. 3).

The majority of the court concluded that the device amendments expressly grant PMA approval pre-emptive authority over state court lawsuits. If a device is PMA approved and is being marketed within the constraints of FDA regulation, an injured patient can't sue the manufacturer for damages, the majority opinion, written by Justice Antonin Scalia, explained.

The justices cite the section of the amendments that precludes states from establishing a requirement "which is different from, or in addition to, any requirement" established by federal law and "which relates to the safety or effectiveness of the device."

Plaintiffs argued in the case that this provision was meant to support FDA pre-emption over specific state legislation seeking to regulate devices, but it was not meant to preclude lawsuits. The Pallone/Waxman language would codify that interpretation (³ (Also see "Democrats Seek To Overturn Supreme Court Device Liability Decision" - Medtech Insight, 25 Feb, 2008.), p. 5).

Pallone is chairman of the House Energy and Commerce Health Subcommittee and Waxman is chair of the House Committee on Oversight and Government Reform.

Sen. Edward Kennedy, D-Mass., the chair of the Senate Health, Education, Labor and Pensions Committee also criticized the Riegel decision as inconsistent with the original intent of the 1976 amendments, which he sponsored. His office says a Senate version of a bill to overturn Riegel v. Medtronic is being drafted.

Could Legislation Reanimate Old Lawsuits?

Pallone and Waxman's draft, as written, is intended to be retroactive, taking effect "as if included in the enactment of the Medical Device Amendments of 1976."

But lawyers on both sides of the FDA pre-emption issue say old cases will probably not be reopened even if the bill gets enacted.

"The legislation wouldn't help or affect, depending on your perspective, patients and cases [that have already been decided]," Public Citizen attorney Allison Zieve, who argued for the plaintiffs in Riegel v. Medtronic, said in an interview.

Most previous lawsuits could not be reopened because of expired causes of action and sunset provisions on personal injury claims. A case cannot be reopened if it has been dismissed or reached a final judgement, she explained.

However, Medmarc Insurance Group Chairman Jaxon White said a revision of the 1976 law could "energize the trial bar to do something" about suits that, pre-Riegel, "might not have been brought in the first place." Medmarc specializes in medical device and lifescience product liability. White was assistant general counsel for the Health Industry Manufacturers Association (now AdvaMed) during the 1976 passage of the device amendments.

"That mischief would be unreal because you would have so many presumptive plaintiffs thinking that they could bring an action against a Class III medical device and maybe even feeding that interest in doing that to test this law a little further," White told "The Gray Sheet."

"It might start a grassfire here that could become a much bigger event to see if there was a way to create new causes of action," he said.

Will The Bill Go Anywhere This Session?

Zieve says President Bush will likely veto the Pallone/Waxman legislation if it reaches his desk as a standalone bill. The administration has prioritized strengthening FDA pre-emption powers for both devices and drugs, submitting briefs supporting manufacturer defendants in lower courts and the Supreme Court.

"[The Bush] administration has been so aggressive about pushing to limit consumers' right to recover from companies that make consumer products," Zieve argued. "This administration's effort to block consumers from having any means of recovery is unprecedented."

However, Bush could sign the bill into law if it is attached to a larger bill, Zieve suggests. "It also just might depend on how many sponsors [it has], what the vote is in the House and the Senate and what else is going on at the time.

White disagrees that Riegel needs to be "corrected."

"Congress intended what they said. It is plain language to pre-empt inconsistent state or judge-made laws and simply this [draft bill] is a means of denying the intent of Congress in 1976 when the law was passed," he said.

White doubts the bill will make it through Congress this session.

"At the moment it has two presumed sponsors," he said. "I don't know how many sponsors it's likely to attract, but certainly it would have to have more for it to get momentum. I don't believe that it is realistic to imagine this to pass in the current Congress, which only has another six to eight months of potential activity."

- Ingrid Mezo ([email protected]) and David Filmore ([email protected])