By Susan Lasser, J.D.
Finding that a birth control patch manufacturer met its obligation under Massachusetts law to directly warn the user of the medication about the risks of taking the product in addition to providing warnings to medical professionals pursuant to the learned intermediary doctrine, the Massachusetts Appeals Court affirmed the dismissal of a complaint alleging that the patch caused a 17-year-old college student’s death by a pulmonary embolism. The warnings were "plain, numerous, and comprehensive," and expressly warned of higher estrogen levels and blood clots. In addition, an asserted design defect claim failed because contraceptive pills were "fundamentally different" from a patch, and could not serve as a safer alternative for the latter. Finally, because there was no evidence that the patch used by the decedent deviated from its intended design, the manufacturing defect claim also failed (Niedner v. Ortho-McNeil Pharmaceutical, Inc., September 21, 2016, Blake, A.).
The decedent was a 17 year-old college student when she collapsed in her dorm room and died of a pulmonary embolism. Her mother, as administratrix of her estate, filed a complaint against Ortho-McNeil Pharmaceutical, Inc.; Johnson & Johnson; and Johnson & Johnson Pharmaceutical Research and Development, LLC (manufacturers, and, collectively, J & J), alleging causes of action that included failure to warn, design defect, and manufacturing defect relating to J & J's birth control patch, Ortho Evra. The young woman’s pediatrician had originally recommended and prescribed an oral birth control pill. After the prescription was filled for three months, the young woman asked about the Ortho Evra patch for an easier and simpler method of birth control. Unlike 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, followed by a fourth patch-free week. The doctor prescribed the patch, and, as she had when she prescribed oral birth control pills, the doctor informed the young woman and her mother of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of blood clots. Further, the package for the patch included an insert prepared by J & J, as well as a leaflet from the pharmacy, both of which set forth the risks associated with use of the patch, including the risks of stroke, heart attack, and blood clots. The young woman died approximately three months after she began using the patch.
Complaint and dismissal. The decedent’s mother alleged that use of the patch caused her daughter’s death. Her complaint centered on a failure to warn claim, which was based on her allegation that she and her daughter were not told that the risk of a blood clot was significantly increased with use of the patch as compared to an oral contraceptive. As such, the complaint "focused on the comparative risk of developing blood clots, not the risk of developing blood clots in and of itself." J & J moved for summary judgment, arguing that the risks of using the patch, including the increased risk of blood clots, were adequately disclosed, and that the mother’s remaining causes of action failed as a matter of law for lack of evidence. The trial court agreed, and ordered the dismissal of the complaint in its entirety.
Learned intermediary rule and an exception. Under the learned intermediary rule, a drug manufacturer’s duty to warn generally is discharged by providing physicians with an adequate warning about any risks associated with the manufacturer’s prescription drug products. The Massachusetts Supreme Judicial Court created a narrow exception to the learned intermediary rule, holding that a manufacturer of oral contraceptives was "not justified in relying on warnings to the medical profession to satisfy its common law duty to warn," but it also had a duty to directly warn the consumer about the risks of taking birth control. Heightened participation by patients in decisions relating to use of birth control was given by the state high court as one of the factors setting birth control medication apart from other prescription drugs. Also, the court noted that federal regulations require manufacturers of oral contraceptives to warn consumers directly of their risks. The appellate court determined that because the patch is a hormonal birth control product like the birth control pills at issue in the Supreme Judicial Court case, the state high court decision was controlling in the current case. Thus, J & J had a duty to warn the young woman directly of the risks associated with use of the patch.
Adequacy of the warning. It was undisputed that the young woman developed blood clots in her lungs, and that this was a risk expressly set forth in the insert in the box containing the patches where the risk was described in four places. Also, the greater dose of estrogen, and the corresponding increased risk of adverse events, such as blood clots, was clearly stated in plain language. Thus, the appeals court held that, as a matter of law, the insert adequately warned both the young woman and her mother—both of whom read the insert—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 lay person.
The mother’s argument that the state high court’s decision compelled reversal of judgment for J & J because the patch insert failed to warn that the patch "delivers a variable and unreasonably dangerous amount of estrogen … directly to the bloodstream" unlike other contraceptives and, thus, was twice as likely to cause a fatal blood clot was rejected. The appellate court found that the insert’s warning of the possibility of blood clots in the lungs that could lead to death was "abundant," and included the outcome of a study showing a doubling of the risk of serious blood clots as compared to oral contraceptives. Unlike the state high court case, the insert in the current case did not omit language that would have been more understandable to an average user, the court of appeals said, finding the warnings were "plain, numerous, and comprehensive."
Design defect. The appellate court also agreed with dismissal of the design defect claim. Under Massachusetts law, for a product to be defective, it must be made according to an unreasonably dangerous design and not meet a consumer’s reasonable safety expectations. A design defect claim also requires proof of the existence of a safer alternative design. The mother argued that oral contraceptives, taken daily, are a feasible and safer alternative design to the patch, which is applied once per week for three weeks. Although both products are hormonal contraceptives that prevent pregnancy, the court held that the difference in the drug delivery method made the pill fundamentally different from the patch, and, therefore, one could not serve as a safer alternative for the other.
Manufacturing defect. The manufacturing defect claim also was dismissed because the record lacked any evidence that the specific patch used by the young woman was manufactured differently, or deviated in any respect from its intended design.
The case is No. 15-P-1272.
Attorneys: Roopal P. Luhana (Chaffin Luhana, LLP) for Leslie Niedner. Susan M. Sharko (Drinker Biddle & Reath LLP) for Ortho-McNeil Pharmaceutical, Inc., Johnson & Johnson and Johnson & Johnson Pharmaceutical Research and Development, LLC f/k/a R.W. Johnson Pharmaceutical Research Institute.
Companies: Ortho-McNeil Pharmaceutical, Inc.; Johnson & Johnson; Johnson & Johnson Pharmaceutical Research and Development, LLC f/k/a R.W. Johnson Pharmaceutical Research Institute
MainStory: TopStory WarningsNews DesignManufacturingNews DrugsNews MassachusettsNews
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