In Massachusetts, sellers of products are subject to and required to uphold what is called the implied warranty of merchantability. This near-equivalent of strict liability helps ensure that buyers are protected against faulty and defective products. However, product liability concerns sometimes stem from less expected sources—sometimes the lack of a proper warning can be enough to constitute a violation of Massachusetts product liability law.
In Reckis v. Johnson & Johnson, a 7-year-old Massachusetts girl was given several doses of an over-the-counter ibuprofen. She developed a rash, which triggered severe dermatologic disease toxic epidermal necrolysis (“TEN”). TEN, also known as Lyell’s syndrome, is a rare, life-threatening skin condition that causes the top layer of skin to detach from the lower layers of the skin all over the body. Death usually occurs because of sepsis and subsequent organ failure.
The child’s parents sued the drug manufacturers in Massachusetts Superior Court for negligence, breach of the implied warranty of merchantability and violation of the Massachusetts unfair and deceptive practices statute (Mass. Gen. L. ch. 93A).
According to a Foley Hoag article, the parents alleged that the drug caused the TEN, and that the manufacturer failed to adequately warn consumers that rash symptoms could be signs of a “life-threatening” disease. A jury awarded the 7-year-old girl $50 million and the parents $13 million.
The Massachusetts Supreme Judicial Court, the Commonwealth’s highest court, granted the defendant-manufacturer direct appellate review but then affirmed the lower court decision. The defendants contended that the Federal Food, Drug, and Cosmetic Act preempted the parents’ failure-to-warn claim. However, the Supreme Judicial Court found that a claim would only be preempted if there was “clear evidence” that the United States Food and Drug Administration (“FDA”) would not have approved the warnings for which the parents advocated. Based on previous FDA rejections of citizen-group petitions, the SJC held that there was clear evidence that the FDA would have rejected the plaintiffs’ TEN-specific warning but not a more general “life-threatening” illness warning. The SJC, therefore, affirmed the compensatory damages awards.
If you or a loved one has suffered from the negligent actions of a manufacturing company, please email us at info@gilhoylaw.com or call 617-787-3700 now to speak with one of our Massachusetts product liability specialists.
