1st Circ. Asks Mass. Court To Weigh In On Heart Valve Suit


 The First Circuit is asking Massachusetts’ highest court to weigh in on whether state law requires medical device manufacturers to report adverse events to federal regulators in a suit by parents whose child died after she was implanted with a heart valve implant made by Sorin Group USA Inc.

The three-judge panel certified the question to the Supreme Judicial Court of Massachusetts to aid in deciding whether to revive claims by William Plourde and Freda Merrill, who are appealing the dismissal of their claims against Sorin over the death of their daughter, Allison.

Because there is no clear precedent on the “knotty and important question” at issue in the suit, the panel wrote that they do not wish to steer the state law into uncharted waters when the state’s high court is better positioned to interpret state law and act as its final decider.

As the appeal turns on whether Massachusetts state law creates a parallel duty for medical device manufacturers to report adverse events to the U.S. Food and Drug Administration, the circuit judges asked the state justices to weigh in and provide a definitive answer.

Physicians at Boston Children’s Hospital surgically implanted a Sorin Mitroflow Bovine Pericardial Bioprosthetic Aortic Heart Valve in Allison Plourde in June 2012, according to the complaint. About a year and a half later, an autopsy of a recently deceased 13-year-old girl who had received the same implant showed her valve was surprisingly calcified, and the doctors called William Plourde to alert him.

The day after receiving that phone call, Allison Plourde underwent heart surgery to remove the valve, and the doctors found the device had deteriorated.  Allison Plourde died following the procedure.

In the complaint, the Plourde family alleged that Sorin hid information from the U.S. Food and Drug Administration about the device, and in its April 2018 answer, the company said that it began working with federal regulators to reinforce its prosthetic heart valves six months before Allison Plourde’s death and denied it withheld information.

LAW360: https://www.law360.com/articles/1454659/1st-circ-asks-mass-court-to-weigh-in-on-heart-valve-suit

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