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Plourde v. Sorin Group USA, Inc.

United States District Court, D. Massachusetts

March 29, 2018

WILLIAM PLOURDE, Individually and as Administrator of the Estate of Allison Plourde, and FREDA MERRILL, Plaintiffs,
v.
SORIN GROUP USA, INC. and CARBOMEDICS, INC., Defendants.

          MEMORANDUM AND ORDER ON MOTION TO DISMISS

          ALLISON D. BURROUGHS U.S. DISTRICT JUDGE

         Plaintiffs William Plourde and Freda Merrill are the parents of Allison Plourde, who died in February 2014 after suffering complications during a surgery to remove an aortic bioprosthetic heart valve, the Sorin Mitroflow Aortic Pericardial Heart Valve (the “Valve”). Defendant Sorin Group USA, Inc. manufactures and sells the Valve.[1] Plaintiffs bring claims based on Massachusetts state law for breach of warranty, negligence, failure to warn, and a violation of the consumer protection statute, Mass. Gen. Laws ch. 93A. [ECF No. 1-1 at 17-30]. Now before the Court is Defendants' motion to dismiss for failure to state a claim [ECF No. 16], which asserts that all of Plaintiffs' claims are preempted by federal law. For the reasons set forth below, the motion is granted in part and denied in part.

         I. BACKGROUND

         The following facts are drawn from the complaint, the allegations of which are taken as true for purposes of evaluating the motion to dismiss. Ruivo v. Wells Fargo Bank, 766 F.3d 87, 90 (1st Cir. 2014).

         A. Allison Plourde

         Allison Plourde, a resident of Massena, New York, was born with DiGeorge syndrome and later diagnosed with aortic arch and ventricular septal defect. She received ongoing treatment for 21 years, and lived a normal life given her diagnosis. On June 19, 2012, Ms. Plourde underwent an aortic heart valve replacement surgery at Boston Children's Hospital (“BCH”) during which the Valve was implanted in her heart. The Valve contained bovine animal tissue and did not contain any anti-calcification reduction treatment. After the implant surgery, Ms. Plourde continued to meet with her doctor for regular follow-up treatment.

         In January 2014, physicians at BCH conducted an autopsy of a recently deceased 13-year-old girl who had also received an implanted Valve. The autopsy revealed that the girl's Valve had severely deteriorated, despite the fact that she had an echocardiogram seven months earlier which showed only mild stenosis and decreased leaflet mobility. This caused BCH physicians to become concerned that, given the deterioration, patients might not be receiving heart valve related check-ups frequently enough to detect deterioration before it became life-threatening. The BCH physicians concluded that the increased metabolism and blood flow common in patients under 30 years old caused a heightened risk of bovine tissue deterioration in the Valve, which necessitates a risky second surgery, and in some cases proves fatal.

         In mid-January, 2014, BCH physicians called BCH patients who had recently received a Valve implant and requested that they be immediately evaluated to determine whether their implants showed signs of premature rapid deterioration. Ms. Plourde received a phone call from a BCH physician on January 13, 2014 requesting that she immediately be examined to determine whether her Valve had experienced rapid deterioration. Ms. Plourde was admitted to BCH on January 14, 2014. Testing revealed that her Valve was so severely deteriorated that it required immediate removal and replacement with a valve from a different manufacturer. Ms. Plourde underwent valve replacement surgery on January 16, 2014. During the surgery, she experienced severe complications due to the calcification of the Valve leaflets. Upon removal of the Valve, the calcified heart valve leaflets broke off, leading to hemorrhaging and chest wall bleeding. Ms. Plourde was transferred to the Intensive Care Unit, where she remained in a coma until February 7, 2014, when she was taken off life support and pronounced dead.

         In April 2014, BCH physicians published a study in a scientific journal, Circulation, which concluded that patients under 30 who received the Valve were at heightened risk for rapid progression from mild to severe aortic stenosis over the course of months. The study determined that “heightened echocardiographic surveillance” was required, and suggested that the Valve should not be implanted in young patients. Ms. Plourde was one of the patients referenced in this study.

         B. The Valve

         The U.S. Food and Drug Administration (“FDA”) issued premarket approval allowing the Valve to be sold on the market on October 23, 2007.[2] The premarket approval required the Valve to be sold with a warning that it carried a heightened risk of deterioration in patients younger than 55.

         Plaintiffs assert that Defendants learned between October 23, 2007 and the date the Valve was installed in Ms. Plourde, June 19, 2012, that the Valve had a heightened propensity for valve calcification and deterioration in individuals younger than 30, above and beyond the risks disclosed to the FDA in its original premarket approval application. Plaintiffs claim that Defendants knew or should have known of studies conducted in several countries which indicated that the Valve experienced rapid premature deterioration and calcification in patients under 30 years old, necessitating check-ups more frequently than originally recommended. Plaintiffs further contend that Defendants did not update the FDA with information concerning the calcification problem or the rapid premature deterioration in recipients under 30 years old prior to June 19, 2012. They assert that, had Defendants kept the FDA informed of these issues, the FDA could have issued a more particularized warning describing the risks involved in installing the Valve in patients younger than 30, thus preventing Ms. Plourde's death.

         Following the 2014 publication of the study by the BCH physicians, Defendants addressed the Valve's rapid deterioration problem by implementing anti-calcification measures known as Phospholipid Reduction Treatment.

         II. DISCUSSION

         A. Standard of Review

         To withstand a motion to dismiss under Rule 12(b)(6), a complaint must allege a claim for relief that is “plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). Assessing the plausibility of a claim is a two-step process. “First, the court must sift through the averments in the complaint, separating conclusory legal allegations (which may be disregarded) from allegations of fact (which must be credited). Second, the court must consider whether the winnowed residue of factual allegations gives rise to a plausible claim to relief.” Rodriguez-Reyes v. Molina-Rodriguez, 711 F.3d 49, 53 (1st Cir. 2013) (citation omitted). Along with all well-pleaded facts, the Court must draw all logical inferences from a complaint in favor of the plaintiff. Frappier v. Countrywide Home Loans, Inc., 750 F.3d 91, 96 (1st Cir. 2014). “If the factual allegations in the complaint are too ...


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