March 2009 Regulatory Affairs Monthly Topic

Supreme Court Ruling Drives Legislators to Challenge Preemption for Medical Devices

The 1976 Medical Device Amendments (“MDA”), which created the framework for the current regulatory scheme for medical devices, included a provision that effectively replaced or “preempted” certain state regulation of medical devices and authorized the U.S. Food and Drug Administration (“FDA” or “the agency”) to issue regulations to implement the preemption provision.(1)(2)  The idea was that, under certain circumstances, federal requirements established for the regulation of medical devices would prevent state law claims against a medical device manufacturer for injury resulting from use of the device.  However, the scope of this preemption provision remained ambiguous until two key Supreme Court cases, Medtronic v. Lohr (1996) and Riegel v. Medtronic (2008), ruled that devices approved through the premarket approval (“PMA”) process were protected from state law suits tied to device-related injuries while devices cleared through the 510(k) process were not entitled to this protection.(3) 

Essentially, the Court in Riegel held that the MDA’s preemption clause bars state common law suits regarding the safety and effectiveness of a PMA-approved device.(4)  It was thought that the Court’s decision in Riegel decisively restricted the right of device users to sue medical device firms regarding products approved through the PMA process, to the extent that the device complies with its FDA-approved specifications.  However, a recent Supreme Court case and legislation introduced this month may lead Congress to overturn the Court’s ruling in Riegel.

On March 4, 2009, the Supreme Court decided Wyeth v. Levine, ruling that drug companies do not enjoy the same protection from state law-based injury lawsuits as medical device companies, because no federal drug law explicitly includes language barring such suits or preempting state law claims.(5)  In the closely watched case, Justice John Paul Stevens, writing for the majority, said that because Congress did not include a preemption provision in the relevant drug laws, the Court would uphold a $6.7 million jury verdict for a musician injured by Wyeth’s Phenergan anti-nausea drug.(6)  Stevens noted that, by contrast, the MDA includes an express provision preempting state law claims related to medical devices, which explains the opposite outcome in Riegel.(7)

The Wyeth ruling has led to what many lawmakers deem an untenable parallel universe for drugs and devices, such that a patient can sue a drug company for drug-related injury but could not sue a medical device firm for device-related injury.(8)  The seemingly different rules for drug and device firms led legislators to immediately reintroduce legislation aimed at overturning the Court’s decision in Riegel.(9)  On March 5, 2009, Representatives Frank Pallone, Jr. (D-NJ) and Henry Waxman (D-CA) introduced the Medical Device Safety Act of 2009, which if passed would amend the MDA to allow state lawsuits due to injury caused by medical devices.(10)  A companion bill was introduced in the Senate by Senators Patrick Leahy (D-VT) and Edward Kennedy (D-MA).(11)  The legislation was first introduced in 2008, after the Riegel decision, but the measure did not pass.(12)  This time around, however, the bill faces a potentially more friendly Democratic Congress and has been endorsed by 14 interest groups, including the National Conference of State Legislatures, AARP, the New England Journal of Medicine (“NEJM”), Public Citizen, and the American Bar Association.(13)  In a March 18, 2009 NEJM editorial, the journal’s editors called for Congress to pass the bill, saying that preemption will result in less safe medical devices remaining on the market.(14) 

Device industry groups strongly oppose the bill, saying it will chill innovation and lead to frivolous lawsuits, ultimately raising health care costs for all consumers.(15)  AdvaMed, a leading medical device industry trade association, recently released a statement that the bill would “effectively allow state courts to review medical devices,” leading to a “patchwork” of confusing rules that could ultimately limit the availability of devices entirely.(16)  And, while Representatives Pallone and Waxman claim that the Riegel decision misconstrued Congress’ intent in passing the MDA, an attorney who was involved in the drafting of the MDA says the law was intended to prevent state courts from second-guessing FDA decisions.(17)  Whether the bill will pass remains to be seen, but if it does, the device industry could once again be subject to state product liability lawsuits.