The Massachusetts Appeals Court recently assessed a summary judgment in favor of the defendant manufacturer in Niedner vs. Ortho-McNeil Pharmaceutical, Inc. (No. 15-P-1272). The estate filed suit against the makers of a birth control device that was prescribed and taken by a deceased college student. The woman was first prescribed an oral form of birth control in 2008, which she took but eventually discontinued. The young woman then looked for another form of birth control and was prescribed the Ortho Evra patch (patch), which transfers synthetic forms of estrogen and progestin through the skin. Rather than daily ingestion, this method only requires direct application to the skin once a week for three straight weeks, followed by a patch-free week. After taking this second round of hormonal birth control for three months, the young woman collapsed and died in her dorm room from a pulmonary embolism. The estate filed suit, alleging breach of warranty. The central focus of this breach of warranty claim was that the birth control manufacturer failed to adequately warn of the increased risks of suffering a blood clot.
By law, a manufacturer of a product with known dangers has a duty to warn consumers who will foreseeably come in contact with the product and be subjected to those dangers. (See H.P. Hood & Sons v. Ford Motor Co., 370 Mass. 69, 75 (1976). If communication with a consumer is unreasonable, the burden of this duty is alleviated. Specifically, this comes in the form of the “learned intermediary rule,” under which the manufacturer is not as responsible for passing the knowledge of risks to the consumer if those risks are communicated to the physicians and pharmacists handling the drug. However, case law has shifted part of this duty back to the manufacturer as patient participation has increased and the medical supervision over commonly used products, like birth control, has decreased.