The Indianapolis Star (3/5) reported, In a case closely watched by drugmakers, the U.S. Supreme Court ruled that federal approval of a drug is no protection from lawsuits in state courts over safety issues that arise later — a decision that could have implications for Eli Lilly and Co. and other pharmaceutical makers.” Erik Gordon, an analyst and professor at University of Michigan’s Ross School of Business, said, “This is like blood in the water for plaintiff lawyer sharks.”
Opinions discuss Wyeth ruling, weigh in on likely effects. The Boston Globe (3/6) editorializes, “The 6-to-3 ruling sends two messages. It tells President Obama that he can waste no time fulfilling his pledge to strengthen the FDA” and “the ruling tells the pharmaceutical industry that it bears final responsibility for the way its products are made and administered.” Concluding, the Globe says, “Critics of the court’s Levine decision worry that it will cause pharmaceutical companies to steer away from innovative drugs in favor of modest improvements to existing medications.” However, that doesn’t have to be the effect “if companies 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.”
USA Today (3/6) editorializes, “Wyeth argued it was immune from liability because it had met the FDA’s requirements” but the “Supreme Court disagreed, ruling that state laws do not interfere with FDA rules but are meant to enhance them.” The ruling may have wide ranging effects as “many industries have spent millions on lobbying and campaign contributions to achieve this ‘federal pre-emption,’ often finding a sympathetic ear from Republicans who otherwise champion ‘states’ rights.'” Today says, “Now that the court has ruled, states should allow suits but set a high burden of proof on the plaintiffs. They shouldn’t be able to collect unless they can demonstrate that a manufacturer deceived regulators or otherwise acted negligently.” Concluding, the paper says, “That sort of balance should protect the interests of companies and consumers alike.”
In USA Today’s (3/6) opposing view blog, Bert Rein, partner at Wiley Rein and of counsel to Wyeth in the Levine case, writes, “Congress created federal public health agencies such as the Food and Drug Administration (FDA) because it takes experts to consider the complexities and the risks and benefits of prescription drugs and medical devices.” He says, “By permitting lay juries to second-guess the FDA’s decisions on what options doctors should have available in administering prescription drugs, the Supreme Court’s decision in Wyeth v. Levine creates uncertainty for patients and doctors by placing the experience of a single patient above the public health interests of everyone.” 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.”
In the Law Blog on the Wall Street Journal (3/5) posted, “A WSJ piece today looks at the conundrum of peremptory challenges. They are designed to help lawyers pick a fair jury, but judges are often loath to seriously probe whether lawyers are using peremptories to discriminate against jurors.” The Journal adds that there are “some critics” who believe that “states should abolish peremptory strikes, which typically allow lawyers to dismiss a limited number of jurors, no questions asked.” However, Texas prosecutor John Bradley said, “It would be strikingly more time-consuming to have to do all challenges for cause.”
