The New England Journal of Medicine Supports the Medical Device Safety Act of 2009

Billy Cunningham

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An editorial of the April 9, 2009 issue of the prestigious New England Journal of Medicine encourages Congress to swiftly pass Medical Device Safety Act of 2009 and to allow lawsuits by injured patients to proceed in the courts. In doing so, the editors note that allowing lawsuits like this are an important part of the regulatory framework and very effective in keeping medical devices safe.

The Medical Device Safety Act of 2009 was introduced in response to the U.S. Supreme Court’s ruling in Riegel v. Medtronic, 552. U.S. 2 (2008) where the Court ruled that a medical device manufacturer cannot be sued under state law by patients who claim to have been harmed by the device that received marketing approval from the FDA. Since the ruling thousand of lawsuits have been dismissed and the editors express a concern that continued preemption will result in medical devices that are less safe for the American people.

The Medical Device Safety Act of 2009 as introduced along with a companion bill would nullify the Court’s ruling in Riegel by adding language to make explicit that the law does not preempt suits against device companies. The Court has allowed similar failure to warn suits against drug companies that had FDA approval. The inconsistency needs to be corrected and the proposed bill will do just that.

I believe the editors summed it all up rather well in their last sentence: “ The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation’s supply of medical devices and drugs should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides.”