Another Skirmish in the Preemption War: Does FDA Approval Trump Strict Liability?

Next Tuesday, the Supreme Court will hear oral arguments in Mutual Pharmaceutical Co. v. Bartlett, a case that raises once again the troubling question of whether federal regulatory agencies should trump local juries in common law tort actions. The precise question at issue is whether the fact that the federal Food and Drug Administration (FDA) approved a name-brand drug many years ago precludes a state court jury from holding the manufacturer of the generic version of that drug strictly liable for damages to patients caused by marketing the drug. The plaintiff in this case, Karen Bartlett, visited her doctor in December 2004 complaining of shoulder pain. Her doctor prescribed Clinoril, one of many non-steroidal anti-inflammatory drugs (NSAID) that are commonly used to treat arthritis, bursitis, and other painful conditions. When Ms. Bartlett's pharmacist filled the prescription, however, it gave her the generic version of the drug sulindac, rather than the brand-name drug. Under federal law, the generic version of sulindac had to be chemically and biologically equivalent to the brand-name version that had been approved by the FDA. Not long thereafter, Ms. Bartlett developed a horrific disease called SJS/TEN, which caused massive burns over 60-65 percent of her body. For the next year, her life was, in the words of her surgeon, a "hell on earth" as she spent 100 days in five hospitals and several months in a medically induced coma. During this time she was fed by tube, suffered two septic shock episodes, endured twelve eye surgeries, and became legally blind. Although she survived, she is severely disfigured, cannot eat normally due to esophageal burns, cannot have sexual relations, and cannot engage in aerobic activities because of burns to her lungs.