On Wednesday, the United States Supreme Court issued a ruling in the case of Riegel v. Medtronic Inc., No. 06-179, holding that makers of medical devices can not be held liable for injuries caused by these devices if the Food and Drug Administration approved the device prior to its marketing and it meets the specifications set forth by the F.D.A.. The ruling in the Court was 8-1, with Justice Ginsberg as the sole dissenter.
Justice Scalia, writing for the majority, found that state laws allowing lawsuits for personal injury against these manufacturers conflict with federal law. Under the federal laws, the F.D.A. has the responsibility to ensure that benefits outweigh the risks and that the device is safe for use as intended. When such suits are brought in state court, Justice Scalia contends that the jury “is not concerned with its benefits” and “the patients who reaped those benefits are not represented in court.”
In her dissent, Justice Ginsberg stated that the preemption only goes to the states creating “their own premarket approval process on new medical devices.” She contends that Congress merely passed the law to “protect consumer safety”, not to prevent states from hearing cases based on injuries caused by these devices, a matter she asserts that has been “a domain historically occupied by state law.”
Edward M. Kennedy, the sole Senate sponsor of the 1976 legislation, agrees with Justice Ginsberg’s analysis. He states, “In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.” Mr. Kennedy and Representative Henry Waxman, who served on the House panel that approved the legislation, state that Congress will need to act in order to correct this ruling and implement the original intent of the 1976 law.
The ruling on Wednesday does not prevent lawsuits asserting that a device was manufactured contra to the F.D.A. specifications set forth. Also, suits may be brought under state law if they “mirror federal rules, as opposed to supplementing them.” For now, the ruling also does not cover the manufacturing of drugs; this is a issue that will be heard by the Supreme Court next term.
It is uncertain the exact number of lawsuits that will now have to be dismissed, but it is most certain that this ruling, until potentially corrected by Congress, will prevent many personal injury lawsuits merely because the F.D.A. granted previous approval of a device. While it is the job of the Supreme Court to determine the intent of Congress when no stated intent is obvious, it seems here that there were a number of potential witnesses for the government, such as Edward M. Kennedy, that could have provided an accurate view of what the 1976 legislation intended. Until Congress is able to act and correct this ruling, which will most likely not be anytime soon due to the process required, the original intent of the law seemingly will not be met. While Congress had intended to protect consumers while seemingly still providing the power to state courts to hear personal injury liability cases regarding these devices, this Supreme Court has instead taken the power from the states and placed it more fully in the hands of the federal government.
For more information you can read the entire New York Times article here, the Supreme Court decision here and obtain background information from the Supreme Court of the United States Wiki here.