451 F.3d 104 (2nd Cir. 2006), 04-0412, Riegel v. Medtronic, Inc.

Docket Nº:04-0412-CV.
Citation:451 F.3d 104
Party Name:Charles R. RIEGEL and Donna S. Riegel, Plaintiffs-Appellants, v. MEDTRONIC, INC., Defendant-Appellee.
Case Date:May 16, 2006
Court:United States Courts of Appeals, Court of Appeals for the Second Circuit

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451 F.3d 104 (2nd Cir. 2006)

Charles R. RIEGEL and Donna S. Riegel, Plaintiffs-Appellants,


MEDTRONIC, INC., Defendant-Appellee.

No. 04-0412-CV.

United States Court of Appeals, Second Circuit.

May 16, 2006

Argued: Dec. 15, 2005.

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Allison M. Zieve, Public Citizen Litigation Group, Washington, DC (Brian Wolfman,

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Public Citizen Litigation Group, Washington, DC; Wayne P. Smith, Schenectady, NY, of counsel) for Plaintiffs-Appellants.

Michael K. Brown, Reed Smith LLP, Los Angeles, CA (Richard Bakalor, Quirk and Bakalor, P.C., New York, NY, of counsel) for Defendant-Appellee.

Before: POOLER, KATZMANN, and B.D. PARKER, Circuit Judges.

KATZMANN, Circuit Judge.

This case calls upon us to determine, inter alia, the scope of the preemption provision set forth in Section 360k(a) of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et. seq. Specifically, we must decide whether Section 360k(a) preempts common law tort claims regarding medical devices that have entered the market pursuant to the Food and Drug Administration's ("FDA") rigorous premarket approval ("PMA") process. The Supreme Court left open this question in Medtronic v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), which held that tort claims as to medical devices that have entered the market pursuant to the far less intensive premarket notification process (often referred to as the "Section 510(k) process") are not preempted by Section 360(k)(a). Since Lohr, the majority of circuits addressing this question have held that claims regarding PMA-approved medical devices are, by contrast, preempted. See Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.2004); Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir.2001); Brooks v. Howmedica, Inc., 273 F.3d 785 (8th Cir.2001); Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir.2000); Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir.1997); but see Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir.1999).

We now join this growing consensus and hold that tort claims that allege liability as to a PMA-approved medical device, notwithstanding that device's adherence to the standards upon which it obtained premarket approval from the FDA, are preempted by Section 360(k)(a). We therefore affirm the district court's (Kahn, J.) summary judgment dismissal of the plaintiffs-appellants' strict liability, breach of implied warranty, and negligent design, testing, inspection, distribution, labeling, marketing, and sale claims as to the Evergreen Balloon Catheter, a PMA-approved medical device. With regard to the plaintiffs' remaining claim for negligent manufacturing--which premised liability on the theory that the particular Evergreen Balloon Catheter deployed during plaintiff-appellant Charles Riegel's angioplasty had not been manufactured in accordance with the PMA-approved standards--we agree with the district court that this claim was not preempted, but that no genuine issue of material fact existed, and thus affirm the district court's summary judgment dismissal of that claim as well.

We note that our preemption analysis is quite limited in scope, affecting the small universe of cases resting on claims alleging liability despite a PMA-approved device's adherence to the standards upon which it secured FDA premarket approval. We take care to explain that we do not hold that all state tort claims as to PMA-approved devices are preempted. Thus, tort claims that are based on a manufacturer's departure from the standards set forth in the device's approved PMA application--such as the Riegels' negligent manufacturing claim--are not preempted.



The Evergreen Balloon Catheter is a prescription medical device that defendant-

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appellee Medtronic, Inc. developed for patients with coronary disease. Physicians use it during angioplasties to open patients' clogged arteries, essentially by inserting the catheter into the clogged vessel, inflating the catheter like a balloon, and then deflating and removing the catheter. The Evergreen Balloon Catheter entered the market pursuant to the PMA process in the mid-1990s. Specifically, on August 30, 1994, the FDA approved Medtronic's PMA application for the Evergreen Balloon Catheter, and on April 27, 1995 and April 18, 1996, the FDA approved Medtronic's PMA supplements, which requested approval for revised labeling for the device. We discuss the PMA process in greater depth infra Part III.A.

On May 10, 1996, plaintiff-appellant Charles Riegel underwent a percutaneous transluminal coronary angioplasty, during which his surgeon used an Evergreen Balloon Catheter. The procedure was intended to dilate Riegel's right coronary artery, which had been found to be "diffusely diseased" and "heavily calcified." The device label for the Evergreen Balloon Catheter specifies that its use is contraindicated for patients who have "diffuse or calcified stenoses." During the procedure, Riegel's physician, Dr. Eric Roccario, first attempted to remove the calcium deposits in Riegel's artery with a rotoblator device, and then unsuccessfully inserted several different balloon catheters. Dr. Roccario ultimately inserted the Evergreen Balloon Catheter into Riegel's artery and inflated the device several times, up to a pressure of ten atmospheres. The device label for the Evergreen Balloon Catheter specifies that it should not be inflated beyond the "rated burst pressure" of eight atmospheres. On the final inflation, the Evergreen Balloon Catheter burst, and Riegel began to rapidly deteriorate. He developed a complete heart block, lost consciousness, was intubated and placed on advanced life support, and was rushed to the operating room for emergency coronary bypass surgery. Riegel survived, but according to his Complaint, he suffered "severe and permanent personal injuries and disabilities."


Riegel and his wife, Donna, subsequently filed suit against Medtronic in the Northern District of New York, alleging five state common law causes of action: (1) negligence in the design, testing, inspection, manufacture, distribution, labeling, marketing, and sale of the Evergreen Balloon Catheter; (2) strict liability; (3) breach of express warranty; (4) breach of implied warranty; and (5) loss of consortium. 1 In its amended answer, Medtronic raised the affirmative defense of federal preemption by Section 360k(a) of the 1976 Medical Device Amendments, 21 U.S.C. § 360(c)-(k), to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et. seq, and subsequently moved for summary judgment on its preemption defense.

In a March 14, 2002 opinion, the district court (Kahn, J.) ruled that the Riegels' strict liability claim, breach of implied warranty claim, and all of their negligence claims except for the negligent manufacturing claim were preempted by Section 360k(a), and therefore dismissed all of these claims. The court let stand the Riegels' breach of express warranty claim. Thus, discovery continued on the two remaining substantive claims: the negligent manufacturing claim and the breach of express warranty claim. 2

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Medtronic later moved for summary judgment on these two remaining claims, and on December 2, 2003, the district court granted that motion. The court dismissed the breach of express warranty claim because the Evergreen Balloon Catheter's instructions had clearly disclaimed any express warranty. It dismissed the negligent manufacturing claim on grounds that there was insufficient evidence upon which a reasonable fact-finder could conclude that the Evergreen Balloon Catheter had burst because of negligent manufacture, rather than because it had encountered a calcium spicule in Riegel's artery, had been inflated beyond the specified eight atmosphere limit, or some combination thereof.

The Riegels proceeded to file the instant appeal, in which they challenge both the March 14, 2002 and December 2, 2003 summary judgment rulings of the district court. With regard to the March 14, 2002 ruling, they argue that none of their claims was preempted. With regard to the December 2, 2003 ruling, they argue that there were genuine issues of material fact as to their negligent manufacturing claim. 3


Initially, we note the applicable standard of review. An order granting summary judgment will be affirmed only when no genuine issue of material fact exists and the movant is entitled to judgment as a matter of law. See Fed.R.Civ.P. 56(c); Island Software & Computer Serv. v. Microsoft Corp., 413 F.3d 257, 260 (2d Cir.2005). With regard to the March 14, 2002 dismissal of many of the Riegels' claims on preemption grounds, there are no disputed facts, and "our task is to determine whether the district court correctly applied the law." Pagan v. NYNEX Pension Plan, 52 F.3d 438, 441 (2d Cir.1995) (internal quotation marks omitted). With regard to the December 2, 2003 dismissal of the Riegels' negligent manufacturing claim, we must decide whether, "construing the evidence in the light most favorable to the non-moving party and drawing all reasonable inferences in its favor," there are any genuine issues of material fact. SCS Communications, Inc. v. The Herrick Co., Inc., 360 F.3d 329, 338 (2d Cir.2004).



We begin with the preemption issue, for which, at the outset, it is helpful to review the overarching regulatory structure. In 1976, Congress enacted the Medical Device Amendments ("MDA") to the 1938 Food, Drug, and Cosmetic Act, in order to "provide for the safety and effectiveness of medical devices intended for human use." 90 Stat. 539. The MDA established a regulatory structure pursuant to which the Department of Health and Human Services, through the FDA, would regulate medical devices.

Under the MDA, medical devices are categorized into three classes, based on the level of risk that they pose. 21 U.S.C. § 360c(a)(1). First, those devices that "present minimal potential...

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