Product liability litigation has become an unfortunate cost of doing business in the medical device industry. Last March, in our inaugural edition of Medtech Legal Update, we provided a report and analysis of the United States Supreme Court's landmark decision of Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2009). See What's Legal After Riegel? As Courts Strike Claims, Congress Mulls Action.

In Riegel, the Court held that state tort law claims relating to Class III medical devices, generally described as those posing a significant risk of illness or injury, were expressly preempted by the Medical Device Amendments of 1976. In other words, many, but not all, state-law product liability lawsuits relating to the use of FDA-approved Class III devices were barred by federal law.

Riegel Does Not Mark End of Product Liability Litigation

Although this decision was justifiably welcomed by the industry, Riegel is limited in its scope in a number of ways.

First, it does not apply to nearly 90 percent of medical devices available on the market; namely, those approved through the FDA's 510(k) process. FDA review in such cases is not focused on the safety and efficacy of the device per se, but rather whether it is "substantially equivalent" to a device already cleared by the FDA or marketed before 1976.

Second, not all claims relating to devices approved through the intricate, highly involved PMA process are preempted. For example, if a plaintiff can show that a device was not manufactured in accordance with FDA-approved specifications or otherwise violated federal law, as opposed to state law, his or her claims are not barred. Claims such as these are routinely included in most complaints. So any hope—or perhaps, for critics, concern—that Riegel doomed medical device product liability litigation was misplaced.

Congress nonetheless began the process of overturning Riegel.

Congressional Bill Would End Medical Device Preemption

In June 2008, members in each house introduced identical bills styled "The Medical Device Safety Act of 2008." Neither house, then controlled by Republicans, passed the bill. On March 5, 2009, however, the bills, H.R. 1246 and S. 540, were reintroduced in each house, each of which now has a Democratic majority.

The proposed legislation focuses solely on state product liability claims. The text in its entirety consists of fewer than 200 words and essentially states:

Section 521 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by adding at the end the following:

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 amendment made by subsection shall

(1) take effect as if included in the enactment of the Medical Device Amendments of 1976 (Public Law 94-295); and

(2) apply to any civil action pending or filed on or after the date of enactment of this Act.

The bill, which would apply to pending and future court cases, thus purports to at least overturn Riegel and, if read sweepingly, could call into question entirely the continued vitality of preemption in the medical device context.

Proponents of the legislation generally consist of consumer groups, including Public Citizen, The New York Times, editors of The New England Journal of Medicine, bar associations and certain medical associations. They argue that preemption wrongly shifts liability for any defective devices from the manufacturer to injured consumers. On the other hand, opponents of the proposed legislation, which include industry and tort reform organizations, contend it would stifle innovation and strip the FDA of its regulatory authority, exposing it to second-guessing by state-court juries.

Bill Advances in Congress

At present, the bill is working its way through Congress. Representatives Frank Pallone (D-NJ) and Henry Waxman (D-CA) introduced the current bill in the House; Senators Patrick Leahy (D-VT) and the late Ted Kennedy (D-MA) introduced it in the Senate. If willingness to sign on as a sponsor is any indication of the likelihood of passage, proponents of preemption should be worried: as of August 31, more than 100 members of the House of Representatives and nearly a fourth of the Senate were identified as co-sponsors.

H.R. 1346 was referred to the House Energy and Commerce Committee, a committee chaired by Rep. Waxman, a key supporter of the bill. On May 12, the Subcommittee on Health held hearings. Similarly, S. 540 was referred to the Senate Committee on Health, Education, Labor, and Pensions, a committee then chaired by Sen. Kennedy (D-MA). On August 4, Sen. Tom Harkin (D-IA), in place of Sen. Kennedy, chaired a nearly two-hour hearing on the bill.

The tenor of the hearing bodes ill for industry.

Committee Hears Emotional Testimony

The purpose of the proposed legislation, as Sen. Harkin put it, is "to protect consumers against defective medical devices." The committee called a number of witnesses to testify, including a physician, law professor and injured consumers.

The consumer testimony was particularly emotional. For example, one consumer testified to being an arrythmia patient with a defibrillator. While he was driving, his defibrillator discharged, causing him pain and suffering, and he claimed to have lasting physical and emotional problems.

Nothing was said about whether he would be alive to testify without one. Little, if anything, was said about the people and families who have benefited from such devices. And, in general, no data was offered to show that medical devices would be any safer if companies were subject to personal injury litigation.

Product Liability Litigation Will Live On—With or Without Congressional Action

Predictions are always unreliable. But given the current political climate, passage of the bill seems likely. The more difficult questions are when and in what form.

Although it is short, simple, clear—and has not, to date, been amended—the bill may transform as it continues to work its way through Congress. Moreover, the issue of medical device preemption may get wrapped up in the larger national discussion about health care reform.

And while the debate on these issues continues, it seems clear that Riegel did not portend the end of products liability litigation for device manufacturers. On the contrary, companies will remain subject to such claims either by virtue of Riegel's limitations or legislative fiat.