The U.S. Supreme Court issued a ruling in June 2013 affecting the permissibility of products liability lawsuits against generic drug makers, and this ruling has heavy implications on the American consumer. The ruling, in Mutual Pharmaceutical Co. v Bartlett, is the culmination of acts that began with the dispensation of the generic form of a brand-name drug. Millions of Americans take prescription drugs daily for a wide variety of ailments and illnesses. Over three-fourths of those prescriptions are issued in generic form largely due to the fact that generic drugs are much less expensive than their brand-name counterparts. That is where Mutual Pharmaceutical Co. v Bartlett got it’s start.
In 2004, Karen Bartlett received a prescription for the generic drug, Sulindac, a non-steroidal anti-inflammatory (NSAID). Within weeks, she began experiencing the symptoms of toxic epidermal necrolysis (TEN), a more severe form of Stevens-Johnson Syndrome (SJS). Karen’s skin was essentially burning off from the inside out on over 60% of her body. She is permanently disfigured, has undergone over a dozen eye surgeries, and is almost completely blind.
Karen sued Mutual Pharmaceutical Co., the maker of Sulindac, and her lawsuit focused on design defects and failure-to-warn (i.e., mislabeling), alleging that the generic drug was unreasonably dangerous and labeling did not include warnings about TEN being a potential side effect. The package insert for the drug did include a warning referencing TEN, but because Karen’s physician affirmed that he had not read the insert, the failure-to-warn portion of the products liability lawsuit was dismissed.
Karen was awarded $21 million and Mutual Pharmaceutical’s response was to remove the case to the Supreme Court. Mutual claimed there could be no products liability attached to their design and labeling of the generic drug because both were copies of the FDA-approved brand-name design and labeling. FDA regulations explicitly prohibit any changes to the design or label approval. The Supreme Court reversed the state court’s verdict, upholding Mutual’s argument that makers of generic drugs have no potential for products liability because of those regulatory prohibitions.
What effect will this have on products liability lawsuits and consumer protection in the future? Millions of Americans are prescribed a generic drug, believe in the it’s safety due to FDA approval, take it in good faith, and will have no legal recourse to make product liability claims when they suffer serious or life-threatening side effects. Aside from deterioration of health, this impacts a person’s ability to support themselves and their families when they are unable to work due to ailments, medical bills accrue and remain unpaid, and their families cannot make up the difference.
Supreme Court ruling will affect products liability lawsuits
Critics of the Supreme Court’s ruling state that one factor in the argument for more responsibility on the part of drug manufacturers is that some serious side effects from medications take years to develop, and the products liability statute of limitations will prevent litigation. In Philadelphia, PA, the time period is two years. The laws, regulations, and governance of the drug trade are conflicting and ambiguous and tend to lean heavily in favor of manufacturers rather than consumers, for obvious reasons – the government profits from drug sales, not lawsuits.
Bruce Ginsburg of Ginsburg & Associates, a Philadelphia PA personal injury firm, stated that the Supreme Court’s ruling on products liability “is another example of how the government is taking away the American people’s ability to defend themselves and protect their right to life and liberty.” Ginsburg also adds that many people cannot afford brand-name medications and quite a few insurance providers will only permit generic prescriptions, a situation that forces consumers into a corner where their only alternative is to choose a generic drug, cross their fingers, and hope for the best. With this ruling, even the best product liability attorney or firm will be have their hands tied, preventing them from giving the basic legal defense we expect in Philadelphia and America at large.