On September 21, 2016, the Massachusetts Appeals Court upheld the grant of summary judgment to Johnson & Johnson (“J&J”), the manufacturer of the Ortho-Evra birth control patch at issue in the case of Niedner v. Ortho-McNeil Pharmaceutical, Inc., No. 15-P-1272, 2016 WL 5106479 (Mass. App. Ct. Sept. 21, 2016). In so doing, the Appeals Court held that J&J had a duty to warn the decedent, but that it adequately did so.
Neidner involved the death of 17-year-old Adrianna Duffy, which resulted from blood clots allegedly caused by the Ortho-Evra birth control patch worn by Ms. Duffy. Plaintiff claimed that she and Ms. Duffy had not been adequately warned about the increased risk of developing blood clots to those who use the patch.
In June, 2009, Ms. Duffy and her mother met with Ms. Duffy’s doctor to discuss birth control options. Ms. Duffy specifically asked her doctor about the Ortho-Evra patch, as she had previously taken an oral birth control pill but now wanted an easier birth control method. Id. at *1. Ms. Duffy’s doctor prescribed her the patch after this meeting and informed Ms. Duffy and her mother of the risks associated with using the patch, including that of blood clots. The prescription package filled by Ms. Duffy came with an insert from the manufacturer (J&J), as well as a leaflet from the pharmacy at which the prescription was filled, both setting forth the risks associated with the patch, including heart attack, stroke, and blood clots. After approximately three months of use, Ms. Duffy collapsed and died from a massive bilateral pulmonary embolus. Id. at *1.
Ms. Niedner filed suit in October, 2010, alleging, among other things, that her daughter’s death was caused by her use of the patch and that J&J was liable for breach of warranty under the theories of design defect, failure to warn, and manufacturing defect. Id. at *1. J&J filed a motion for summary judgment, arguing that the patch’s risks, including the increased risk of blood clots, were sufficiently disclosed. Id. at *1. A Superior Court judge agreed, allowing the motion, and plaintiff appealed.
Typically, a manufacturer has a duty to warn product users of dangers associated with the reasonably foreseeable use of its product. Manufacturers of prescription drugs and medical devices are, however, generally excepted from that rule based on the “learned intermediary” rule, which provides that the manufacturer fulfills its duty by providing physicians with an adequate warning about the risks associated with its product. In these instances, the physician acts as the “learned intermediary” between manufacturer and consumer to ensure the patient understands the potential risks and benefits. In MacDonald v. Ortho Pharmaceutical Corp., however, the Massachusetts Supreme Judicial Court created a narrow exception to this rule for the manufacturer of oral contraceptives, which it held has a duty to directly warn not only medical professionals, but also the consumer, about the risks associated with birth control medications. Id. at *2. The Neidner court held that this same exception to the “learned intermediary” rule applies to birth control patches, such as the Ortho-Evra patch, and as such, J&J had a duty to warn Ms. Duffy directly of the risks associated with the use of the patch. Id. at *2.
The Appeals Court also held, however, that J&J had satisfied that duty. It noted that the box of patches purchased by Ms. Duffy contained a pamphlet which explained the risks associated with its use and contained instructions to consult a physician concerning information contained in the pamphlet. Both Ms. Duffy and her mother read the insert, though neither then consulted with Ms. Duffy’s doctor. Among other topics, the pamphlet thoroughly discussed in multiple locations the risk of developing blood clots while using the patch, particularly in the lungs like those Ms. Duffy developed. Id. at *3. The Appeals Court found as a matter of law that the pamphlet adequately warned of the increased risk of developing blood clots that could result in death, and described these warnings as “plain, numerous, and comprehensive.” Id. at *4.