From the desk of Hector Lombana

The recent U.S. Supreme Court ruling in the case of Riegel v. Medtronic has taken a significant toll on the rights of injured patients in cases involving defective medical devices. The Court ruled in favor of Medtronic, one of the largest makers of cardiovascular devices, and found that manufacturers of federally approved medical devices cannot be sued under state law if the device causes an injury.

Those who represent the victims of faulty medical devices are now preparing for a flurry of court filings from manufacturers such as Medtronic asking that lawsuits involving their products be dismissed.

In the Riegel case, the Supreme Court concluded that Congress intended that the FDA's pre-market approval (PMA) process would bar patients from filing lawsuits that second-guess regulators' judgments about the safety and effectiveness of approved devices. The Court also ruled that the labels that companies develop to warn of side effects and limitations are adequate because they, too, receive FDA review.

The lawyers of Gamba & Lombana as well as others who represent injured patients believe that there is a serious flaw with the Supreme Court's reasoning. The majority of the new medical devices that are covered under the ruling are actually variants of standard pacemakers and other products that were already on the market in 1976 when Congress enacted the law. The FDA does not require extensive safety and effectiveness testing for these products before approving them for use, yet they are now protected under the new ruling. For example, Medtronic's own Sprint Fidelis heart defibrillator lead, which the manufacturer recalled after reports that the wires were more prone to deadly fractures than the company's older model, was classified as a supplement to earlier leads and approved in less than 30 days despite a major change in how the wires were welded.

Two crucial figures in the passage of the original 1976 device law, Representative Henry Waxman of California and Senator Edward Kennedy of Massachusetts said in the days following the ruling that it was contrary to Congress's intent and they would introduce legislation to overturn it.

For the present, medical device injury lawsuits involving design flaws will be restricted. The focus will shift to whether a manufacturer failed to follow the safety processes set forth in the documents approved by the FDA.

The full implications of this ruling by the Supreme Court will become apparent in the months to come. These lawsuits may be barred even in cases where manufacturers deceived regulators by providing false or incomplete information regarding the safety and effectiveness of the product in order to secure FDA approval. Lawyers will be precluded from gaining access to this information through discovery to prove such violations of the product approval process took place.

Unfortunately for the victims of faulty medical devices, the Supreme Court decision will act to shield medical device companies from most product injury lawsuits. Prior to this decision, medical device manufacturers, even with the threat of lawsuits, were not able to effectively ensure product safety. Without the threat of lawsuits, medical product safety problems will become more prevalent.