Horn v. Thoratec Corp.

• Decision Date: 20 July 2004
• Docket Number: No. 02-4597.,02-4597.
• Citation: 376 F.3d 163
• Parties: Barbara E. HORN, Executrix of the Estate of Daniel Ray Horn, Deceased, Appellant v. THORATEC CORPORATION.
• Court: U.S. Court of Appeals — Third Circuit

Page 163

376 F.3d 163

Barbara E. HORN, Executrix of the Estate of Daniel Ray Horn, Deceased, Appellant v. THORATEC CORPORATION.

No. 02-4597.

United States Court of Appeals, Third Circuit.

Argued on December 11, 2003.

Filed July 20, 2004.

Appeal from the United States District Court for the Middle District of Pennsylvania, James F. McClure, Jr. Allison Zeive (Argued), Public Citizen Litigation Group, Washington, John M. Humphrey, Rieders, Travis, Mussina, Humphrey, Harris, Waters & Waffenschmidt, Williamsport, for Appellant Barbara E. Horn.

Gary A. Winters, Mayer, Brown, Rowe & Maw, Washington, Alan E. Untereiner (Argued), Robbins, Russell, Englert, Orseck & Untereiner LLP, Washington, Charles W. Rubendall, II, Keefer, Wood, Allen & Rahal, Harrisburg, Arnd N. von Waldow, Reed Smith, Pittsburgh, for Appellee Thoratec Corporation.

Douglas Letter, Appellate Litigation Counsel, Peter R. Maier, Attorney, Civil Division, Department of Justice, Washington, for Amicus Curiae United States of America.

Robert N. Weiner, Arnold & Porter, Washington, for Amicus Curiae Product Liability Advisory Council, Inc.

Daniel G. Jarcho, McKenna Long & Aldridge LLP, Washington, for Amicus Curiae Chamber of Commerce of the United States of America.

Before AMBRO, FUENTES, and GARTH, Circuit Judges.

GARTH, Circuit Judge.

Barbara Horn ("Horn") appeals from the District Court's grant of summary judgment to Thoratec Corp. (hereinafter "TCI"¹), based on its determination that Horn's claims against TCI are preempted by the express preemption provision in the Food Drug and Cosmetic Act (the "Act"), 21 U.S.C. § 360k(a).² We affirm.

I.

TCI manufactured and distributed the left ventricular assist device known as the HeartMate. The HeartMate is a pump that assists the blood flow between the heart's ventricle and the aorta in patients with cardiac conditions. The inlet side tube is surgically attached to the heart via the ventricle, and carries blood from the heart into the pump. The outlet side tube brings blood from the pump to the aorta, where it is dispersed to the body. There is a tube attached to the pump that exits the body and connects to an external console. The console contains an air compressor which powers the HeartMate.

The facts underlying this case pertain to the outlet side tube, which connects the pump to the aorta. The connection between the pump and the tube, called the "elbow," is inserted into an adapter conduit, which is screwed into the open port of the pump. A screw ring is secured over the elbow to ensure that it remains connected to the adapter conduit and the pump. A suture is tied over the screw ring and secured to the adapter conduit to ensure it will not rotate.³ The HeartMate was approved by the FDA pursuant to the Pre-Market Approval ("PMA") process set forth at 21 U.S.C. § 360e(c) (discussed in depth, infra).

On January 17, 1998, Horn's husband, Daniel Horn, was admitted to Williamsport Hospital suffering a heart attack. He was later transferred to Hershey Medical Center. Doctors there determined that Mr. Horn required a heart transplant, and they waited for a suitable donor heart to become available. On January 22, 1998, Mr. Horn's condition deteriorated and a HeartMate was implanted in him to provide circulatory support. He was then transferred to an assisted living facility.

On May 3, 1998, Mr. Horn began to bleed from the spot where the HeartMate tube exited his body. Thereupon, he underwent exploratory surgery at Hershey Medical Center, during which Dr. Benjamin Sun discovered that the suture on Mr. Horn's HeartMate had worn off and the screw ring linking the pump to the output side elbow had disconnected. The disconnection had allowed an air embolus to travel to Mr. Horn's brain. Although Dr. Sun reconnected the screw ring and once again linked the pump to the elbow, it was too late. Mr. Horn suffered a brain hemorrhage, and he was rendered brain dead. On May 8, 1998, his organs were donated for transplant and he was pronounced dead.

On April 28, 2000, Horn filed a Complaint against TCI in the United States District Court for the Middle District of Pennsylvania. The Complaint alleged defective design and manufacture of the HeartMate and failure to warn of the alleged defects; it was based on Horn's claim that the HeartMate's output side elbow was defectively designed. TCI moved for summary judgment, arguing that Horn's state law claims are expressly preempted by 21 U.S.C. § 360k(a).

The District Court granted TCI's motion on November 7, 2002, holding that Horn's state common law claims were preempted. The District Court applied a two-prong test endorsed by the Sixth and Eleventh Circuits,⁴ which instructs that a state claim attacking the safety of a medical device is preempted if (1) the FDA has established specific federal requirements that are applicable to that particular device, and (2) the state claim is different from, or in addition to, the specific federal requirements.

In granting TCI's motion for summary judgment on express preemption grounds, the District Court found that (1) the HeartMate's PMA approval process imposes a specific federal requirement applicable to the HeartMate, and (2) if Horn were successful on her state law claims, "any judgment that the HeartMate was unsafe or otherwise substandard would be in direct conflict [with]-i.e., different from-the FDA's determination that the product was suitable for use." Dist. Ct. Op. at 20. This timely appeal followed.

II.

We have jurisdiction to hear this appeal pursuant to 28 U.S.C. § 1291. Review of a district court's decision to grant a motion for summary judgment is plenary. Goodman v. Mead Johnson & Co., 534 F.2d 566, 573 (3d Cir.1976), cert. denied, 429 U.S. 1038, 97 S.Ct. 732, 50 L.Ed.2d 748 (1977); Hilfirty v. Shipman, 91 F.3d 573, 577 (3d Cir.1996).

Summary judgment is appropriate only when there is no genuine issue as to any material fact and the moving party is entitled to a judgment as a matter of law. See Fed.R.Civ.P. 56(c); see also Armbruster v. Unisys Corp., 32 F.3d 768, 777 (3d Cir.1994). In examining the record, the court gives the nonmoving party the benefit of all reasonable inferences from the record. Saldana v. Kmart Corp., 260 F.3d 228, 232 (3d Cir.2001); Gray v. York Newspapers, Inc., 957 F.2d 1070, 1078 (3d Cir.1992).

This Court also exercises plenary review over a district court's preemption determination, as it is a question of law. Travitz v. Northeast Dep't ILGWU Health & Welfare Fund, 13 F.3d 704, 708 (3d Cir.1994), cert. denied, 511 U.S. 1143, 114 S.Ct. 2165, 128 L.Ed.2d 888 (1994); Michael v. Shiley, Inc., 46 F.3d 1316, 1321-22 (3d Cir.1995).

III.

At issue is whether Horn's suit against TCI, alleging causes of action under Pennsylvania common law, is expressly preempted. We need not examine the doctrine of implied preemption, because the Act under which the FDA preempted the state causes of action contains an express preemption clause, which obviates any reference to the doctrine of implied preemption. The express preemption clause, 21 U.S.C. § 360k(a), provides:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement —

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

In this case, Horn contends that her state common law claims would impose generally applicable duties to use good care in manufacturing and to warn users of the product's attendant risks. They would not, she argues, impose specific requirements with respect to the HeartMate. Paragraphs 15 and 16 of Horn's Complaint set forth the gravamen of her action as follows:⁵

15.... The continual pumping action of the TCI HeartMate, together with natural body movements, caused the wearing away of the suture so placed, and once the suture was worn through, said movement of the pump caused the screw ring to become unscrewed.

16. 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.

TCI responds that Horn's state common law claims would impose state requirements that are specifically applicable to the HeartMate, and as such are expressly preempted.

Horn relies on Medtronic v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), a Supreme Court case which involved the FDA's approval of a pacemaker. In that case, which we discuss in more detail later, the FDA's approval of the device did not result in preemption of the plaintiff Lohr's state law claims because the approval process involved in that case was not the same detailed approval process that was employed by the FDA to approve the HeartMate. In Lohr, the FDA determined that the pacemaker was "substantially equivalent" to an existing FDA-approved device pursuant to § 510(k) of the Act, and therefore did not undergo the far more thorough and rigorous PMA approval process under § 360e(c) of the Act. It was this latter type of approval that the HeartMate received.

The FDA, in its Amicus Curiae Letter Brief to this Court, contrasted the § 510(k) "substantial equivalence" approval process with the § 360e(c) PMA process as follows:

A manufacturer can obtain an FDA finding of `substantial equivalence' by submitting a pre-market notification to the agency in accordance with Section 510(k) of the [Act]. 21...