Massachusetts Appeals Court Upholds Ruling for Birth Control Manufacturer Following Teen’s Death

Leslie Nieder filed suit against Ortho-McNeil Pharmaceutical and Johnson & Johnson after her 17-year-old daughter, Adrianna Duffy, collapsed in her dorm room and died of a pulmonary embolism. The case alleged multiple causes of action related to Johnson & Johnson’s birth control patch, Ortho Evra. Following a hearing, the lower court judge upheld Johnson & Johnson’s motion for summary judgment and ordered the dismissal of the complaint. The Massachusetts Court of Appeals recently affirmed the lower court’s dismissal of the complaint.

birth control

In July 2008, Duffy and her mother met with Duffy’s pediatrician, Sara Nelson, at Massachusetts General Hospital’s Chelsea Clinic to discuss birth control options. Nelson recommended and prescribed an oral birth control. At some point thereafter, Duffy discontinued using birth control pills. In June 2009, Duffy decided she needed a new birth control method. Nieder and she met with Nelson to discuss options. Nelson prescribed the Ortho Evra patch after Duffy inquired about the patch as an easier method of birth control. (Unlike oral birth control pills, which must be taken at the same time each day, the patch is applied to the skin once per week for three weeks.)

Nelson informed Duffy and Niedner of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of suffering blood clots. When the prescription was filled, the package included an insert prepared by Johnson & Johnson, as well as a leaflet from the pharmacy, both of which set forth the risks associated with the use of the patch, including the risks of stroke, heart attack, and blood clots. Approximately three months after Duffy began using the patch, she died from a massive bilateral pulmonary embolus.

In October 2010, Niedner filed her first amended complaint, alleging that Duffy’s use of the patch had caused her death and that Johnson & Johnson was liable for breach of warranty (under theories of design defect, failure to warn, and manufacturing defect), breach of express warranty, negligence, fraudulent concealment, conscious pain and suffering, and violating the consumer protection act. The complaint centered on Niedner’s failure to warn claim, which was based on her allegation that Duffy and she were not told that the risk of suffering a blood clot is significantly increased with the use of the patch as compared to an oral contraceptive. That is, Niedner’s complaint was focused on the comparative risk of developing blood clots, rather than the risk of developing blood clots in and of itself. Johnson & Johnson moved for summary judgment, arguing that the risks of using the patch, including the increased risk of blood clots, were adequately disclosed, and that Niedner’s remaining causes of action failed as a matter of law for lack of evidence. The trial court judge agreed.

In rejecting Niedner’s first claim, the appeals court explained that normally a manufacturer of a product with known dangers has a duty to warn consumers who will foreseeably come in contact with and be endangered by the product. Thus, Johnson & Johnson had a duty to warn Duffy of the risks associated with the use of the patch. The box containing the patches purchased by Duffy contained an insert entitled “DETAILED PATIENT LABELING.” The insert explained how to use the patch and the risks associated with its use, and it informed consumers that they should consult their physician to discuss the information contained in the insert. Both Duffy and Niedner read the insert for the patches Duffy purchased.

Duffy developed blood clots in her lungs, a risk expressly set forth in the insert, where it is described in no fewer than four places. The greater dose of estrogen and the corresponding increased risk of adverse events, such as blood clots, also was clearly stated in plain language. The insert also cautioned that it is not a replacement for careful discussion between the patient and her health care professional and that these discussions should take place when the patient first uses the patch and during the patient’s revisits. Thus, the court held, the insert adequately warned both Niedner and Duffy as a matter of law of the increased risk of developing blood clots that could result in death, as compared to the risks associated with the birth control pill, in terms understandable to a layperson.

Niedner nevertheless claimed the law compelled a reversal of the summary judgment because the insert failed to warn that the patch “delivers a variable and unreasonably dangerous amount of estrogen, up to 56 micrograms, directly to the bloodstream, unlike any contraceptive on the market, and, as a result, it is twice as likely to cause a fatal blood clot.” The appeals court held that the insert was abundant in its warning of the possibility of blood clots in the lungs that could lead to death, including the outcome of one study that showed a doubling of the risk of serious blood clots as compared to oral contraceptives. The insert did not omit language that would have been more understandable to an average user. Instead, the warnings were plain, numerous, and comprehensive. Therefore, this argument also failed.

The court next addressed the plaintiff’s argument that the patch was defectively designed. For a product to be defective, it must be made according to an unreasonably dangerous design and must not meet a consumer’s reasonable expectation as to its safety. The focus of the claim must be on the design itself, rather than on the manufacturer’s conduct, and it requires proof of the existence of a safer alternative design. Niedner contended that oral contraceptives, which are taken daily, are a feasible and safer alternative design to the patch. For this argument to work, the law requires that the safer alternative be fundamentally the same. In a case in which the allegedly defective product is a cigarette, for example, the reasonable alternative design must also be a cigarette. Here, by contrast, the difference in the drug delivery method makes the pill fundamentally different from the patch. As a result, one cannot legally constitute a safer alternative for the other. Therefore, this argument also failed.

The court next rejected the appellant’s argument that there was a manufacturing defect in the patch. A manufacturer of a product that is dangerous due to a lack of reasonable care in its manufacture or inspection owes a legal duty to those who will foreseeably come into contact with it to use reasonable care to prevent injuries to those persons. The inquiry is whether the deviation from the design rendered the product unreasonably dangerous and therefore unfit for its ordinary purposes. The appeals court found, however, that the summary judgment record was devoid of any evidence that the patch used by Duffy was manufactured differently or deviated from its intended design.

The appeals court finally rejected Niedner’s remaining claims as unsupported by the record. No breach of express warranty occurred because the risks associated with the use of the patch were clearly explained in the insert, and Johnson & Johnson made no representations or specific promises to Niedner or Duffy other than those contained therein. Since Niedner failed to demonstrate that the insert was inaccurate, false, or deceptive, her negligent misrepresentation claim also failed.

Finally, the court explained that recovery for a decedent’s conscious pain and suffering requires “cognizable proof beyond mere surmise.” Since the summary judgment record contained no evidence to support this claim beyond Niedner’s unsupported contention that sudden death from blood clots would cause such suffering, this also failed.

For these reasons, the appeals court affirmed the lower court’s grant of summary judgment to defendant Johnson & Johnson.

If you have been harmed by a faulty product, you may need the assistance of a product liability lawyer to seek compensation. At the Neumann Law Group, our Massachusetts product liability attorneys provide trustworthy legal representation to accident victims all over the state. Contact us toll-free at 800-525-NEUMANN or use our online form to set up a free consultation.

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