Supreme Court to Hear Defective Drug Case

To say that Ms. Bartlett’s injuries, which were caused by taking a mild pain pill, are devastating would be a gross understatement. What seemed like a harmless visit to the doctor’s office for shoulder pain quickly turned into a hellish experience when the woman developed a rare but severe reaction to the drug sulindac. Bartlett was awarded $21 million in a trial which took place at a Federal District Court in Concord, N.H. and her award was upheld later on by an appeals court. The manufacturer of the generic drug which caused the injuries, Mutual, is further contesting the rulings and succeeded in getting a writ of certiorari from the Supreme Court.

In 2004, Bartlett took sulindac, also known as Clinoril, a drug similar to ibuprophen, for her shoulder pain. Just weeks later, the woman’s skin began to slid off until nearly two-thirds of it was gone. She spent two months in a burn and months in a medically induced coma so that she could recover from the severe damage to her skin. The reaction also rendered her legally blind and permanently damaged her lungs and esophagus. The burn surgeon who treated her injuries described her experience as “hell on earth.”

Federal law prohibits generic companies from the deviation of the brand-name drug they are copying. The reason that this case is being so aggressively contested is because it falls under a category of product liability which has made a previous appearance in Supreme Court. In 2011, the Court placed strict conditions on cases brought by consumers of generic drugs against the manufacturers. In the case, Pliva v. Mensing 131 S. Ct. 2567, it was decided because such companies simply manufactured their product based on the original, brand name drug and therefore could not be held accountable for the content, or lack thereof, on the drug’s warning labels. Therefore, manufacturers of generic drugs cannot be sued for failing to alert patients of the risks of taking their drug.

The manufacturing drug in this specific instance, Mutual, is arguing that this case falls under this previously decided upon principle. Bartlett’s party, however, is contending that the issue is the design of the drug, which led to a detrimental reaction by the consumer. This, they claim is a different issue than what is on the warning label of the drug. Mutual responds by claiming that the rationale for that accusation is the same and falls under the case law of Pliva. The Supreme Court of the United States will ultimately hear the defective drug case and decide whether to extend their previous decision implications to include the design of the drug as well as the warning label. If the Supreme Court rules in favor of Mutual and generic drug companies in general, the plaintiff’s counsel wonders whether generic drugs can be sued or held accountable to anything at all. However, the defense and its advocates have stated that if the decision is for Bartlett, they fear that individual juries in civil cases can trump the authority of federal agencies such as the Food and Drug Administration. Implications for the decision looming will be significant whichever way the Supreme Court decides.

Drugs with bad design are only one example of possible defective products that can lead to the injury of consumers. While the law on this specific case of generic drugs is yet to be decided, in most cases the manufactures are held accountable for injuries sustained due to defects in the design or manufacturing of their product. Injured victims are often entitled to compensation to recover from their injuries and recompense for the damage. If you or someone you know has been injured due to damaged or defective products, contact an NYC personal injury attorney at Greenberg & Stein, P.C. to learn more about how we may be able to help you.