In a ruling significant to pharmaceutical manufactures, a New Jersey state court judge has dismissed a lawsuit brought by the husband of a woman who passed away from a blood clot to her lung allegedly caused by a birth control patch. The patch, called Ortho Evra, is manufactured by Ortho-McNeil Pharmaceutical, Inc. In this instance, the husband of the decedent, Djuna Hayes-Jones, brought suit alleging that the product’s warning was insufficient, and that Ortho-McNeil had a duty to warn consumers, in addition to physicians, about the risks of the product.
Judge Jessica Mayer granted summary judgment in favor of Ortho McNeil. Based upon the testimony of the prescribing nurse practitioners, Judge Mayer determined the product contained an adequate warning that the estrogen level in the patches exposed the user to a greater risk of blood clots than birth control pills. Judge Mayer explained that, “[w]arnings can always be made better, either by the FDA or the manufacturer. However, the relevant standard is not the best possible warning. The standard is a reasonably adequate warning.”
Additionally, Judge Mayer was not persuaded by the Plaintiff’s claim that the manufacturer had a duty to directly warn consumers, in addition to the medical community. In doing so, the court upheld New Jersey’s learned intermediary doctrine, which prevents pharmaceutical manufacturers from being held liable in failure-to-warn claims so long as the user’s physician had been properly advised of the risks associated with the drug at issue.