By Sheryl Allenson, J.D.
An infant and her mother’s claim asserting a manufacturer failed to warn the FDA survived the manufacturer’s motion to dismiss after a federal district court in New York found that the claim was neither expressly nor impliedly preempted. On the other hand, the child’s claims for fraud, design defect, and manufacturing defect were all dismissed (A.F. v. Sorin Group USA, Inc., September 28, 2018, Ramos, E.).
The child, who had a heart defect, received a prosthetic Mitroflow Aortic Pericardial Heart Valve, which failed after two years. The device is a Class III medical device that is regulated by the FDA, pursuant to the Medical Device Amendments of 1976 (MDA) of the Federal Food, Drug, and Cosmetic Act (FDC Act). The manufacturer submitted both an original and several amended applications for premarket approval of the valve. Among other things, the applications indicated that there were no contraindications to proposed indications for use. The applications also indicated that there was no one under the age of 27 in clinical studies of the valve.
The FDA granted conditional approval for the valve, setting out numerous requirements, including the reporting of adverse effects of the device in patients. In fact, after the valve was released, the were instances of valve deterioration and malfunction of one of the components of the device. Additionally, there was a report of a child dying after implantation of a valve, which was "severely obstructed and deteriorated due to excess calcification." The child and her mother claimed that, despite these issues, the manufacturer did not timely report these incidents to the FDA, but rather tried to conceal them.
Nonetheless, the Child alleged that these incidents led the manufacturer to alter the product and ultimately discontinue the first version from the market. Specifically, the manufacturer applied to the FDA to change the valve’s manufacturing process so that it could add an anticalcification treatment.
However, about a month after the manufacturer applied to the FDA to change the manufacturing process, but before it was approved, the child was implanted with the first version of the valve. This version did not have the anticalcification treatment. About two years later, the valve failed and the child had to have additional surgery, although at risk for complications. As a result of the second surgery, the child suffered complications and ultimately injury. After she filed suit, the manufacturer filed a motion to dismiss.
In reviewing the manufacturer’s motion, the court, citing various cases, explained that the MDA expressly preempts state law claims under certain circumstances and impliedly preempts state law under other circumstances. Specifically, the child had to sue for conduct violating the FDC Act but must not be suing because the specified conduct violates the act. If the child did not sue for conduct violating the FDC Act there would be express preemption under Sec. 360k(a) of the MDA. On the other hand, if she sued because the conduct violated the statute, the claim would be impliedly preempted. In other words, the court held, the state-law claim must parallel a federal duty under the MDA but also exist independently of the MDA.
Turning to the child’s state-law claims, the court granted the manufacturer’s motion to dismiss her fraud, design, and manufacture defect claims. However, the child’s failure to warn the FDA claim survived the manufacturer’s motion. The court carefully parsed out its analysis, noting that its decision was not based upon the inadequacy of the valve’s warning label, but rather upon the manufacturer’s failure to timely and properly report information to the FDA regarding adverse effects of the device, in violation of FDA requirements. State-law claims for violation of FDA reporting requirements are deemed parallel to the MDA and therefore not expressly preempted by the statute.
After concluding that a state-law claim for failure to warn the FDA is not preempted, the court analyzed the issue of whether, under New York law, the duty to warn extends to warning the FDA. Although decisions were split on the matter, the court held that "a manufacturer’s duty to take steps that are reasonably necessary to warn the medical community may include warning the FDA, as required by the MDA." Thus, the failure to warn the FDA was not expressly preempted, the court ruled. Similarly, the court held that the claim was also not impliedly preempted. Accordingly, the court found that the child plausibly pleaded a claim for failure to warn the FDA under state law.
The case is No. 1:17-cv-05903-ER.
Attorneys: Daniel John Woodard (Phillips & Paolicelli LLP) for A.F. and Yael Fogel. Katy Koski (Foley & Lardner, LLP) for Sorin Group USA, Inc., Carbomedics, Inc. and Sorin Group Canada, Inc.
Companies: Sorin Group USA, Inc.; Carbomedics, Inc.; Sorin Group Canada, Inc.
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