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In re Medtronic

October 15, 2010


Appeal from the United States District Court for the District of Minnesota.

The opinion of the court was delivered by: Loken, Circuit Judge

Submitted: April 12, 2010

Before LOKEN, MELLOY, and SHEPHERD, Circuit Judges.

Defendant Medtronic, Inc., designed, manufactured, and sold the Sprint Fidelis Lead, a wire that delivers signals that allow an implantable cardiac defibrillator to detect an abnormal heart rhythm and deliver a shock to help the heart return to an appropriate rhythm. After Medtronic recalled the product in October 2007, Anna Bryant and other patients with implanted Sprint Fidelis Leads filed suits across the country against Medtronic and its affiliates (collectively, Medtronic) asserting tort and breach of warranty claims for injuries allegedly caused by the defective leads. The cases were transferred to the District of Minnesota for pretrial proceedings by the Judicial Panel on Multidistrict Litigation.

Plaintiffs filed a Master Consolidated Complaint seeking damages and equitable relief on behalf of "all Plaintiffs who had Sprint Fidelis Leads implanted," asserting some twenty distinct state law causes of action including failure to warn, defective design and manufacturing, breach of express warranty, and fraud. Applying the preemption principles of Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and the pleading principles of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), the district court*fn1 granted Medtronic's motion to dismiss and denied Plaintiffs' post-judgment motions for recusal and for leave to file an amended complaint. Plaintiffs appeal these rulings. We affirm.

I. Background

In the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act ("MDA"), Congress authorized the Food and Drug Administration ("FDA") to regulate the safety and effectiveness of medical devices. The Sprint Fidelis Lead was a Class III device, one that presents a potentially unreasonable risk of injuring patients or that is used to sustain life. See 21 U.S.C. § 360c(a)(1)(C); Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). Before a new Class III device may be marketed, the manufacturer must assure the FDA through a rigorous Pre-Market Approval ("PMA") process that the device is safe and effective. Once the product is approved, the manufacturer may not change its design, manufacturing process, labeling, or other attributes that would affect safety or effectiveness without filing a PMA Supplement.

21 C.F.R. § 814.39(a). The PMA Supplement is reviewed using the same standard as the original PMA. See generally Riegel, 552 U.S. at 315-19.

In December 1993, the FDA granted Medtronic premarket approval for the Transvene Lead System. Progressively smaller leads, such as the Sprint Quattro, were later approved in a series of PMA Supplements. In June 2004, the FDA approved a PMA Supplement for the Sprint Fidelis Lead. Patients with implanted Sprint Fidelis Leads began suffering unnecessary shocks. Dr. Robert G. Hauser of the Minneapolis Heart Institute and his colleagues investigated patient complaints, published a report finding that the Sprint Fidelis Lead was more likely to fracture than other types of leads, met with Medtronic to voice their concerns, and advised the FDA of those concerns. Despite knowing the leads were unsafe, Plaintiffs allege,*fn2 Medtronic undertook a vigorous defense of its product that included sending a "Dear Doctor" letter to practitioners asserting that failures may be the result of improper surgical technique and assuring doctors that the Sprint Fidelis Leads performed as well as other Medtronic leads.

In May 2007, Medtronic applied for a PMA Supplement approving design and manufacturing changes to the Sprint Fidelis Leads without, Plaintiffs allege, advising FDA of the high rate of failures. A PMA Supplement was approved in July. Medtronic continued to sell previously manufactured Sprint Fidelis Leads, "finally" filed 120 adverse event reports in September, and suspended sales in early October, but doctors continued to implant Sprint Fidelis Leads. Not until October 15, 2007, did Medtronic announce a world-wide recall of the Sprint Fidelis Lead. Soon after, the FDA announced a Class I recall, the most serious type of medical device recall. These product liability lawsuits followed.

The MDA contains an express preemption provision: no State "may establish or continue in effect with respect to a device . . . 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." 21 U.S.C. § 360k(a).*fn3 In Riegel, the Court held that, for § 360k(a) preemption purposes, (i) FDA pre-market approval is "federal safety review" that results in federal "requirements" specific to the approved device, and (ii) common law product liability claims result in "state requirements" that are preempted to the extent they relate to the safety and effectiveness of the device and are "different from, or in addition to," the federal requirements established by PMA approval. 552 U.S. at 322-24. However, the Court noted, § 360k "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." Id. at 330.

The MDA also provides that all actions to enforce FDA requirements "shall be by and in the name of the United States," 21 U.S.C. § 337(a). In Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 349 n.4 (2001), the Court construed § 337(a) as barring suits by private litigants "for noncompliance with the medical device provisions." Read together - Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).

Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009). The contours of the parallel claim exception were not addressed in Riegel and are as-yet ill-defined.

Medtronic moved to dismiss the Master Consolidated Complaint, arguing that the claims were preempted by § 360k(a). The district court granted the motion, holding all claims preempted. In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009) ("Medtronic Leads"). Plaintiffs' product liability claims (design defect, manufacturing defect, failure to warn, breach of warranty, and fraud, among others) unquestionably relate to the safety or effectiveness of the Sprint Fidelis Lead. Thus, the crucial question on appeal is whether these claims are parallel claims that avoid preemption because they would not impose state requirements "different from or in addition to" the federal requirements established by PMA approval of the Sprint Fidelis Lead.*fn4

II. Parallel Claim Issues

A. Failure to Warn and Related Claims

In the Master Consolidated Complaint, Plaintiffs alleged that Medtronic failed to adequately warn consumers of "known defects" and that the Sprint Fidelis Leads presented an unreasonably dangerous risk beyond what the ordinary consumer would reasonably expect. These claims are preempted by § 360k. The FDA's PMA approval includes specific language for Class III device labels and warnings. Plaintiffs did not allege that Medtronic modified or failed to include FDA-approved warnings. Rather, they alleged that, by reason of state law, Medtronic was required to give additional warnings, precisely the type of state requirement that is "different from or in addition to" the federal requirement and therefore preempted. See Riegel, 552 U.S. at 330.

Even if federal law allowed Medtronic to provide additional warnings, as Plaintiffs alleged, any state law imposing an additional requirement is preempted by § 360k. "Where a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is preempted." McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005), cert. denied, 547 U.S. 1003 (2006). Plaintiffs' reliance on Wyeth v. Levine, 129 S.Ct. 1187 (2009), for a contrary rule is unavailing. Wyeth turned on implied conflict ...

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