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Medical Device Safety Act of 2009–Rebuilding the Status Quo

The Medical Device Safety Act (MDSA) was a bill introduced in the U.S. Congress in 2009 that sought to overturn the Supreme Court’s decision in Riegel v. Medtronic, which had limited the ability of patients to sue medical device manufacturers for injuries caused by their products.

Specifically, the MDSA would amend the Federal Food, Drug, and Cosmetic Act to allow state tort claims against medical device manufacturers, even if the device had been approved by the FDA. The bill would have essentially eliminated the preemption defense that medical device manufacturers have used to shield themselves from liability in lawsuits. The MDSA was introduced in response to growing concerns about the safety of medical devices and the ability of patients to seek compensation for injuries caused by these devices.

Many in Congress Support the Bill

The bill was introduced in Congress and has several sponsors and co-sponsors, mostly Democrats. Representative Frank Pallone Jr. of New Jersey, who is the Chairman of the Energy and Commerce Committee introduced the bill in the House of Representatives. It is co-sponsored by several other Representatives, including Henry Waxman of California, Rosa DeLauro of Connecticut, and Bart Stupak of Michigan.

In the Senate, the MDSA is introduced by Senator Edward Kennedy of Massachusetts, who is a strong advocate for patient safety and healthcare reform. The bill is co-sponsored by several other Senators, including Patrick Leahy of Vermont, Sheldon Whitehouse of Rhode Island, and Sherrod Brown of Ohio.

The MDSA also has support from several patient advocacy groups, including Public Citizen and the National Research Center for Women and Families, who argue that the bill is necessary to ensure that patients have the ability to hold medical device manufacturers accountable for injuries caused by their products.

Lobbying efforts, particularly by injured victims and their counsel (as well as manufacturers of medical devices), are continuing for the Medical Device Safety Act of 2009. It’s no surprise that each side takes the position it takes—the victims hoping to pass the legislation to prevent more blanket immunity for manufacturers of devices that hurt or kill patients, and manufacturers hoping to reap the benefits of zero liability for some of their devices that cause injury. However, it is interesting to note that one group, which has typically opposed the desires of victims, has also weighed in.

Doctors Support the Bill

Physicians are coming out to support the Medical Device Safety Act. Typically, they support tort reform and anything to prevent or limit lawsuits against healthcare providers. However, in a New England Journal of Medicine Editorial of April 9, 2009, three physicians took a stand behind the proposed legislation.

The argument of victims and doctors is essentially this—for many years, medical device manufacturers have been liable for injuries caused by their products. No surprise there. However, last year the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturers can’t be sued under state law for devices that received marketing approval from the FDA. Before Riegel, manufacturers had a clear incentive to warn about the possible dangers of their products. The result, of course, has been an untold dismissal of lawsuits, leaving many victims without any recompense.

In their editorial, the physicians clarify that patient safety is enhanced by accountability. Considering the recent case of Wyeth v. Levine, which holds pharmaceutical manufacturers responsible for their products, it is clearly unfair for medical device manufacturers to get off scot-free. In this post-Enron world, the public understands that safety is good, and corporate greed is not.

2023 Post Script

This bill did not ultimately pass into law. Despite gaining some bipartisan support, the bill faced opposition from medical device manufacturers and other industry groups who argued that it would lead to increased litigation and higher costs for medical device manufacturers.

In the years since the MDSA was introduced, there have been ongoing efforts to reform the medical device regulatory system and strengthen patient protections. While the MDSA did not become law, it contributed to a broader conversation about the need to balance the interests of medical device manufacturers with the need to ensure patient safety and access to justice.