Talbott v. C.R. Bard, Inc.

• Decision Date: 01 March 1995
• Docket Number: No. 94-1951,94-1951
• Citation: 63 F.3d 25
• Parties: , Prod.Liab.Rep. (CCH) P 14,300 Linda TALBOTT, etc., et al., Plaintiffs, Appellants, v. C.R. BARD, INC., et al., Defendants, Appellees. . Heard
• Court: U.S. Court of Appeals — First Circuit

Page 25

63 F.3d 25

64 USLW 2123, Prod.Liab.Rep. (CCH) P 14,300

Linda TALBOTT, etc., et al., Plaintiffs, Appellants, v. C.R. BARD, INC., et al., Defendants, Appellees.

No. 94-1951.

United States Court of Appeals, First Circuit.

Heard March 1, 1995.

Decided Aug. 14, 1995.

Jeffrey S. Beeler with whom Jeffrey A. Newman and Newman, Heineman & Itzkowitz, Boston, MA, were on brief, for appellants.

Francis C. Lynch with whom Daryl J. Lapp and Palmer & Dodge, Boston, MA, were on brief, for appellee C.R. Bard, Inc.

Robert D. Keefe with whom Hale and Dorr, Boston, MA, was on brief, for appellee David Prigmore.

William H. Kettlewell with whom Dwyer & Collora, Boston, MA, was on brief, for appellee John Cvinar.

Michael S. Raab, Atty., Civil Div., with whom Frank W. Hunger, Asst. Atty. Gen., Washington, DC, Donald K. Stern, U.S. Atty., Boston, MA, Douglas N. Letter, Appellate Litigation Counsel, U.S. Dept. of Justice, Washington, DC, and Margaret Jane Porter, Chief Counsel, and Beverly Rothstein, Atty., Food and Drug Admin., Rockville, MD, were on brief, for the U.S., amicus curiae.

Before STAHL, Circuit Judge, CAMPBELL, Senior Circuit Judge, and JOHN R. GIBSON, ^* Senior Circuit Judge.

LEVIN H. CAMPBELL, Senior Circuit Judge.

Section 360k(a) of the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetic Act ("FDCA") 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.

21 U.S.C. Sec. 360k(a) (1988). This appeal presents two questions: (1) whether the above provision applies to state tort law claims asserted against a medical device manufacturer; and (2) if so, whether there is an exception to the preemption clause where the manufacturer fails to comply with the MDA. We hold that the answers to the two questions are, respectively, yes and no. We therefore affirm the district court's dismissal of this case for failure to state a claim under Fed.R.Civ.P. 12(b)(6).

I.

It is unnecessary to set out the facts and procedural background at length as these are in the district court's comprehensive opinion. Talbott v. C.R. Bard, Inc., 865 F.Supp. 37, 39-52 (D.Mass.1994) (sections I and II.A). To orient the reader of this opinion, we provide only the following brief summary. On December 28, 1988, Eunice Beavers died on the operating table during an angioplasty procedure when a heart catheter failed to deflate while inserted in one of her coronary arteries. Her heirs, Linda Talbott et al., sued the manufacturer of the heart catheter C.R. Bard, Inc. ("Bard"), and two members of its management for wrongful death, alleging numerous state tort claims: negligence, breach of express and implied warranties, punitive damages, negligent infliction of emotional distress, fraudulent misrepresentation and concealment, negligent hiring, civil conspiracy, unfair trade practices. The district court dismissed the complaint under Fed.R.Civ.P. 12(b)(6), finding that all the claims were preempted by Sec. 360k(a) of the MDA. Plaintiffs now appeal.

II.

To determine whether federal law preempts state law, we look to the intent of Congress: congressional intent to displace state law must be "clear and manifest" before preemption is found. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947). Such intent may be expressed either explicitly, in the language of a statute, or implicitly, through passage of a statutory scheme that extensively occupies the field or where the purpose and objectives of federal law would be frustrated by state law. Here, Congress has manifested its intention an explicit preemption clause, Sec. 360k(a). Thus, absent any "general, inherent conflict" between state and federal law, we need only ascertain the preemption Congress intended. Freightliner Corp. v. Myrick, --- U.S. ----, ----, 115 S.Ct. 1483, 1488, 131 L.Ed.2d 385 (1995); Cipollone v. Liggett Group, 505 U.S. 504, 515-18, 112 S.Ct. 2608, 2617-18, 120 L.Ed.2d 407 (1992). We review the district court's reading of the clause de novo, taking all of plaintiffs' factual averments as true and indulging every reasonable inference in plaintiffs' favor. Garita Hotel Ltd. Partnership v. Ponce Federal Bank, 958 F.2d 15, 17 (1st Cir.1992).

A. State Tort Law Imposes Requirements

Plaintiffs insist that the district court erred in concluding that state tort law imposes a "requirement" as that term it used in Sec. 360k(a). Plaintiffs argue that Congress meant "requirement" to include only the state's positive enactments--such as statutes and regulations--and not common law causes of action. This issue, however, has been resolved against plaintiffs in this circuit in two decisions: King v. Collagen Corp., 983 F.2d 1130, 1135-36 (1st Cir.), cert. denied, --- U.S. ----, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993), and Mendes v. Medtronic, Inc., 18 F.3d 13, 16 (1st Cir.1994). In both, this court has ruled that Congress understood state tort law to impose a "requirement" such as to subject state tort law to the MDA's preemption clause. Where the requirement is "different from, or in addition to" the requirement imposed by the MDA, state tort law will be preempted. A like construction has been adopted by every other circuit court that has considered the issue. ¹ Plaintiffs argue that we should overrule King and Mendes as having been wrongly-decided. However, except in certain circumstances not present here, the prior decisions of panels of this court may be overruled only by the full court en banc. United States v. Newman, 49 F.3d 1, 11 (1st Cir.1995). We accordingly, we hold that state tort law falls within Sec. 360k(a).

B. No Exception For Non-Compliance

Plaintiffs next argue that, even assuming Sec. 360k(a) applies to state tort law generally, the district court erred in holding that it applies where a manufacturer has failed to comply with the provisions of the MDA by fraudulently obtaining approval from the Food and Drug Administration ("FDA"). Plaintiffs argue that, in enacting Sec. 360k(a), Congress intended to preempt only state laws that sought to impose liability on manufacturers who were already complying with the MDA. Congress did not, plaintiffs assert, intend to afford such protection to manufacturers who failed to comply with the provisions of the MDA. Such a result would conflict, in plaintiffs' view, with the MDA's basic purpose of protecting individuals from unreasonably dangerous and defective medical devices. Where a manufacturer has failed to comply with the MDA, state tort liability would merely impose additional state sanctions for noncompliance with the MDA. Here, plaintiffs argue, Bard clearly violated the provisions of the MDA by submitting false data to the FDA in order to obtain approval of its heart catheters.

As the district court explained, Talbott, 865 F.Supp. at 41-42, Bard pled guilty in an earlier proceeding to a criminal indictment charging it with conspiring to defraud the FDA in connection with applications for pre-market approval of its heart catheters. Bard was eventually forced to pay civil and criminal fines totaling $61 million. United States v. C.R. Bard, Inc., 848 F.Supp. 287, 289 (D.Mass.1994). There is some dispute between the parties as to whether Bard's guilty plea admitted wrongdoing with respect to the particular heart catheter used in Mrs. Beavers's angioplasty. As this is a motion to dismiss, however, we accept plaintiffs' version of the facts. Watterson v. Page, 987 F.2d 1, 3 (1st Cir.1993). Thus, for present purposes we shall assume that Bard fraudulently obtained approval for the heart catheter by submitting false information to the FDA. The question is whether Sec. 360k(a) applies despite such fraudulent activity.

The latter issue may already have been resolved in this circuit against plaintiffs. In King, the plaintiff contended that the manufacturer had fraudulently obtained FDA approval and that the MDA's preemption clause therefore did not apply. Judge (now Chief Judge) Torruella, in the opinion for the court, did not reach the question, construing the fraud claim as essentially a failure to warn claim preempted by the MDA. In what was titled a "concurrence," however, the two other judges on the panel expressed the opinion that there was no exception to the MDA's preemption clause for cases in which the manufacturer failed to comply with the MDA. As two judges of the panel took this view, it is arguably now stare decisis.

If so, however, a separate panel in Mendes overlooked the fact. The plaintiff in Mendes did not make the exception-for-noncompliance argument made by the plaintiff in King, arguing merely that the MDA did not apply to state tort law. However, at the end of the opinion, the panel wrote:

We express no opinion on whether products liability claims are preempted only if the manufacturer complied with applicable FDA regulations. The complaint contains no allegations regarding Medtronic's noncompliance with FDA regulations, and plaintiff has offered no evidence that Medtronic violated any FDA requirement. Our holding is limited to the facts and claims in this case.

Mendes, 18 F.3d at 19-20 (citations omitted). The dicta in Mendes can be read (and plaintiffs argue should be read) to indicate that the issue is still open in this circuit. Alternatively, it might mean only that the panel in Mendes did not pay close attention to the concurrence in King, since that issue was not before it. Given the uncertainty regarding the precedential status of the King concurrence, we shall address the arguments anew, as the district court did.

We hold that Congress did not intend to provide for an exception to...