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November 7, 2002


The opinion of the court was delivered by: Mcclure, United States District Judge



The issue in this case is whether the Medical Device Amendments to the Food, Drug, and Cosmetic Act (the MDA) preempts a plaintiff's common law tort claims.

Barbara E. Horn, as Executrix of the estate of her late husband, Daniel Ray Horn (Horn), is suing Thermo Cardiosystems, Inc. (TCI) for negligence, strict liability, and breach of warranty. The lawsuit focuses on the condition of a heart pump, which had been implanted inside Horn.

TCI asserts that plaintiff's common-law claims are preempted by the MDA's express preemption clause. Before being approved for sale, the heart pump underwent a rigorous safety review process known as premarket approval. TCI asserts that because the premarket approval represents a specific federal safety requirement with which plaintiff's state claims conflict, the state claims are preempted. The overwhelming weight of authority supports TCI's argument; as a result, we find that plaintiff's claims are expressly preempted.



Summary judgment is appropriate if the "pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c).

The moving party bears the initial responsibility of stating the basis for its motions and identifying those portions of the record which demonstrate the absence of a genuine issue of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). "It can discharge that burden by `showing' — that is, pointing out to the district court — that there is an absence of evidence to support the nonmoving party's case." Id. at 325.

Once the moving party points to evidence demonstrating that no issue of material fact exists, the non-moving party has the duty to set forth specific facts showing that a genuine issue of material fact exists and that a reasonable factfinder could rule in its favor. Ridgewood Bd. of Educ. v. N.E., 172 F.3d 238, 252 (3d Cir. 1999) (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986)). "Speculation and conclusory allegations do not satisfy this duty." Ridgewood, 172 F.3d at 252 (citing Groman v. Township of Manalapan, 47 F.3d 628, 637 (3d Cir. 1995)).


The Product

The HeartMate LVAD (HeartMate) is a pump that assists blood flow to and from the heart in patients with cardiac conditions. The HeartMate contains a "pump body" and two conduit assemblies. The tube-shaped conduit on one side of the pump is surgically attached to the heart; it is designated the "inlet side" because blood flows through it from the ventricle into the pump body. The conduit on the other side of the pump is surgically attached to the aorta; it is designated the "outlet side" because blood flows out to the aorta where it is dispersed into the body. Both conduits are attached to a circle-shaped pump housing, which contains a pump and related equipment. A tube attached to the pump housing exits the body and connects to a console containing an air compressor. The air compressor forces air through the tube into a pump, which assists the heart's natural pumping of blood from the ventricle to the aorta.

Plaintiff's claims focus on the connection between the pump housing and a certain part of the outlet, known as the "elbow." The elbow is a small tube that is located between the outlet conduit and the pump housing. The elbow is inserted into an adapter conduit, which in turn is screwed into the open port of the pump housing. A screw ring is tightened over the elbow to ensure that the elbow does not become disconnected from the pump. To provide added assurance that the screw ring will not rotate, a suture is tied over it and secured to the adaptor conduit. The HeartMate is manufactured with the adapter conduit, outlet elbow, screw ring and suture in place; thus, when the surgeon implants the HeartMate in a patient, he need not manipulate the screw ring or tie the suture.

The Complaint

On January 17, 1998, Mr. Horn was admitted to the Williamsport Hospital while suffering from an acute myocardial infarction. He was transferred to Hershey Medical Center, where doctors determined that a heart transplant was necessary. On January 22, 1998, Horn's condition deteriorated, and he was surgically implanted with the HeartMate to provide temporary circulatory support while a transplant donor was being sought. Horn was then transferred to an assisted-living facility.

On May 3, 1998, Horn began to bleed from the site where the tube exits the body. He was taken to Hershey Medical Center, where he underwent exploratory surgery. During the surgery, Dr. Benjamin Sun discovered two problems with the HeartMate: (1) the screw ring that connects the outlet elbow to the pump housing had become disconnected; and (2) the suture had worn through as a result of rubbing against the sternum, allowing the screw ring to disconnect. Sun reconnected the screw ring with metal wire, but he was not in time: the disconnection had allowed an air embolus to go to Horn's brain, and he suffered a brain hemorrhage.

Plaintiff brings claims for negligence, strict liability, and breach of warranty. The crux of her claim is that the outlet elbow was deficiently designed. The complaint alleges:

Had the screw ring been of an appropriate and feasible design which would not permit the screw ring to become unscrewed as a result of pump movement, or had something more durable than a suture been used to secure the tightened screw ring, or had the threaded sleeve with the eyelet been placed in such a way that the retaining suture did not run across the interior portion of the screw ring directly beneath the underside of the sternum, the disconnection which ultimately caused Mr. Horn's death would never have occurred.

(Complaint, Rec. Doc. No. 1, at ¶ 16.)

In addition to its principal focus on the design of the outlet elbow, the complaint contains other allegations relating to negligence, strict liability, and breach-of-warranty. The claims of negligence include: (1) failure to test and study adequately the HeartMate; (2) failure to provide adequate warnings regarding the possibility that the screw ring may disconnect; (3) failure to provide adequate instructions to physicians; and (4) failure to use proper suture material. The claims of strict liability include (1) failure to use "good manufacturing practices"; and (2) ...

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