Democrats Announce Bill To Allow Liability Suits Against Medical Device Makers

Congressional Democrats on Thursday introduced measures that would enable consumers harmed by a FDA-approved medical device to sue the device's manufacturer for liability in state courts, the Wall Street Journal reports (Rockoff, Wall Street Journal, 3/6).

The U.S. Supreme Court in 2008 in Riegel v. Medtronic ruled that FDA approval of medical devices pre-empts state courts from hearing liability suits against their makers. Justice Antonin Scalia wrote in the majority opinion that product liability lawsuits filed against medical device companies in state courts could undermine the balance between the benefits and risks of medications as determined by FDA. Scalia also wrote that states cannot implement safety requirements for the medical devices that differ from federal requirements (Kaiser Daily Health Policy Report, 2/21/08).

The court on Wednesday ruled in Wyeth v. Levine against pre-emption, allowing consumers harmed by an FDA-approved pharmaceutical product to sue drugmakers for liability in state courts. Democrats seized on the decision, introducing the new legislation, called the Medical Device Safety Act, which would allow similar lawsuits against device makers. Rep. Frank Pallone (D-N.J.) in a statement said, "Yesterday the Supreme Court rightfully upheld a patient's right to legal recourse after sustaining an injury from a pharmaceutical product. Today, we introduce legislation that gives patients that same right when injured by a medical device" (AP/New York Times, 3/6).

Stephen Ubl, president and CEO of the Advanced Medical Technical Association said rescinding the principle of pre-emption for medical devices would not improve patient safety. Rather, Ubl said it would "restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans" (Attias, CQ HealthBeat, 3/5). Analysts predict the measure will become law, the AP/New York Times reports (AP/New York Times, 3/5).

Editorials, Opinion Piece

• Boston Globe: The Wyeth verdict "tells the pharmaceutical industry that it bears final responsibility for the way its products are made and administered," a Globe editorial states. The editorial continues that drugmakers "cannot hide behind the approval of an FDA that has shown a weakness for approving drugs before they are sufficiently tested and then failing to monitor closely the drugs' often harmful side effects once they are on the market." According to the editorial, critics are concerned that the ruling "will cause pharmaceutical companies to steer away from innovative drugs in favor of modest improvements to existing medications." The editorial concludes that the ruling "need not have that effect" if firms "would test their new medications more thoroughly before bringing them to market, and then do a better job of monitoring adverse events and reacting to them decisively" (Boston Globe, 3/6).
  
  
• USA Today: The "welcome" ruling in Wyeth "took account of the real world, where the understaffed FDA ... is hard pressed to monitor the safety of 11,000 drugs on the market and ensure that makers are properly warning of the risks," a USA Today editorial states. It adds that while there is "a downside to too many lawsuits," litigation "can play an important role in backstopping the FDA and other federal regulators" because the "discovery process can expose damaging secrets and ferret out crucial information." However, "states should ... set a high burden of proof on the plaintiffs" in liability suits against drugmakers, by requiring that they "demonstrate that a manufacturer deceived regulators or otherwise acted negligently," the editorial continues. The editorial concludes, "That sort of balance should protect the interests of companies and consumers alike" (USA Today, 3/6).
  
  
• Bert Rein, USA Today: It "takes experts to consider the complexities and the risks and benefits of prescription drugs and medical devices," but "permitting lay juries to second-guess the FDA's decisions on what options doctors should have available in administering prescription drugs ... creates uncertainty for patients and doctors by placing the experience of a single patient above the public health interests of everyone," Rein, an attorney who is of counsel to Wyeth in the case, writes in a USA Today opinion piece. He adds that the decision in Wyeth "has the risk of not enhancing medical decisions but rather narrowing it and potentially limiting lifesaving options." According to Rein, "The question we must resolve is: Is it good public policy to shut down" the use of a drug proven effective and relatively safe by FDA "in reaction to an isolated tragic injury arising from a practitioner's failure to follow labeled instructions?" He concludes, "Federal regulators might not always get it right, but I would certainly prefer to ride with their expert judgment than to have my access to prescription drugs, or other federally regulated products, dictated by a process of lay jury trial" (Rein, USA Today, 3/6).