Laverty v. Smith & Nephew, Inc.

Decision Date23 June 2016
Docket NumberCase No. 15 C 9485
Citation197 F.Supp.3d 1026
Parties Terence LAVERTY and Sherry Laverty, Plaintiff, v. SMITH & NEPHEW, INC., Defendant.
CourtU.S. District Court — Northern District of Illinois

John C. Ellis, Ellis Legal P.C., Chicago, IL, for Plaintiff.

Anthony Joseph Monaco, Brittany Lynn Kaspar, Swanson, Martin & Bell, LLP, Chicago, IL, for Defendant.


MATTHEW F. KENNELLY, District Judge:

Terence and Sherry Laverty1 have sued Smith & Nephew, Inc., asserting tort claims under Illinois law for negligence, strict products liability, and loss of consortium. Smith & Nephew has moved for partial judgment on the pleadings under Federal Rule of Civil Procedure 12(c). For the reasons stated below, the Court denies Smith & Nephew's motion.


The Court takes the following facts from the Lavertys' complaint, accepting them as true for the purposes of the present motion. See Satkar Hosp., Inc. v. Fox Television Holdings , 767 F.3d 701, 703 (7th Cir.2014). The 1976 Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act of 1938 (FDCA) classifies medical devices in three categories based on their function and risk. Class III devices are the most heavily regulated, for they are devices that either "present[ ] a potential unreasonable risk of illness or injury" or are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health." 21 U.S.C. § 360c(a)(1)(C). The FDCA and MDA require that before a manufacturer may introduce a new Class III device to the market, the manufacturer must provide "reasonable assurance" to the Food and Drug Administration (FDA) that the device is safe and effective. See id. § 360e(d)(2). This "reasonable assurance" is given through what is known as "premarket approval," a rigorous process through which a manufacturer must submit detailed information concerning the safety and efficacy of the new device for the FDA to review and consider. If the FDA accepts the manufacturer's "reasonable assurance" of the product's safety and efficacy, it grants or conditionally grants premarket approval, whereupon the manufacturer can begin to introduce the product into the market. See id.

Smith & Nephew is the designer, manufacturer, and distributor of a Class III device known as the Birmingham Hip Resurfacing System (BHR). The BHR is a metal-on-metal hip resurfacing prosthesis composed of a stemmed femoral head and a hemispherical acetabular cup

. In May 2006, the FDA granted conditional premarket approval to Smith & Nephew for its BHR. The FDA's approval letter to Smith & Nephew imposed conditions on the commercial distribution of the BHR, including a requirement to make post-market reports to the FDA regarding the device's safety and efficacy. Failure to comply with these conditions, the letter said, would constitute a violation of the FDCA.

In March 2011, doctors implanted one of these devices into Terence Laverty's right hip during a full arthroplasty

surgery. After his surgery, Terence experienced severe pain that progressed over time, eventually becoming so severe that he could barely walk. Upon discovering that the BHR that had been implanted during his arthroplasty procedure had failed and was contributing to his pain, his doctors advised him to undergo revision surgery to replace the BHR. Terence underwent a right total hip revision arthroplasty in October 2015, during which physicians confirmed that the original BHR inserted in 2011 had failed.

Later that month, the Lavertys filed this lawsuit. In their complaint, they alleged that after the FDA granted conditional premarket approval but prior to Terence's surgery, Smith & Nephew became aware of defects in the BHR and the fact that those defects were causing serious harm. The Lavertys claimed that Smith & Nephew "received hundreds of adverse reports regarding the BHR but [ ] delayed its reporting to the FDA and, when Smith & Nephew did communicate adverse reports, it did not do so properly but in fact attempted to blame others for adverse events." Compl., dkt. no. 1, ¶ 12. They alleged that Smith & Nephew "only initiated follow up inquiry on a fraction of adverse events reported directly to the FDA by patients regarding the BHR" and that "[d]espite wide evidence of the BHR's wearing down more quickly and severely than anticipated, Smith & Nephew failed to take appropriate action to determine the cause and provide a solution." Id. ¶¶ 13, 14. And the Lavertys claimed that Smith & Nephew did not "appropriately advise the FDA, medical community or general public of the problems." Id. ¶ 14.

These failures, according to the Lavertys, constituted violations of FDA regulations promulgated under the FDCA and applicable to Smith & Nephew's BHR as a Class III device. Based on these alleged violations, the Lavertys asserted state tort claims for negligence (count 1) and strict products liability (count 2). They also asserted a claim of loss of consortium (count 3) on behalf of Sherry, who allegedly "suffered a loss of services, support, affection, society, companionship and consortium of her husband" as a result of Smith & Nephew's claimed misconduct. Id. ¶ 47. Smith & Nephew answered the Lavertys' complaint in November 2015, and discovery commenced. In April 2016, Smith & Nephew moved for partial judgment on the pleadings.


The parties appear to agree that the Lavertys' negligence and strict products liability claims are based on theories of manufacturing defect and failure to warn. Smith & Nephew denies these claims but does not dispute the propriety of bringing them insofar as they rely on a manufacturing defect theory. Smith & Nephew contends, however, that insofar as these claims are grounded in a theory of tortious failure to warn, they are either expressly preempted under the MDA or impliedly preempted under the FDCA.

"Preemption is an affirmative defense, and pleadings need not anticipate or attempt to circumvent affirmative defenses." Bausch v. Stryker Corp. , 630 F.3d 546, 561 (7th Cir.2010) (internal citation omitted). This is why a motion to dismiss for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6) is not the appropriate vehicle for a preemption challenge: affirmative defenses "typically turn on facts not before the court at [the dismissal] stage." Brownmark Films, LLC v. Comedy Partners , 682 F.3d 687, 690 (7th Cir.2012). However, "when all relevant facts are presented, the court may properly dismiss a case before discovery—typically through a Rule 12(c) Motion for Judgment on the Pleadings—on the basis of an affirmative defense." Id. "A motion for judgment on the pleadings under Rule 12(c) of the Federal Rules of Civil Procedure is governed by the same standards as a motion to dismiss for failure to state a claim under Rule 12(b)(6)." BBL, Inc. v. City of Angola , 809 F.3d 317, 325 (7th Cir.2015) (internal quotation marks omitted). Accordingly, a court may grant a Rule 12(c) motion only where it is clear from the pleadings that the plaintiffs will be unable to maintain their cause of action in light of the facts presented.

A. Express preemption

In addition to categorizing classes of medical devices and defining how those devices are to be regulated, the MDA includes an express preemption provision for products liability claims against Class III medical device manufacturers:

[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. § 360k(a). Smith & Nephew contends that this provision expressly preempts the Lavertys' failure-to-warn claims because they seek to hold Smith & Nephew to standards of safety or effectiveness that are "different from, or in addition to," the standards imposed under the MDA.

In support of this argument, Smith & Nephew relies upon McMullen v. Medtronic, Inc. , 421 F.3d 482 (7th Cir.2005), in which the Seventh Circuit found a plaintiff's failure-to-warn claims expressly preempted under the MDA. There, plaintiffs sued the manufacturer of a Class III medical device that had received premarket approval. They claimed that the manufacturer had learned of an anecdotal report that revealed that the device, a brain implant intended to suppress tremors in persons with Parkinson's disease

, could malfunction and cause death or serious injury in persons with the implant who underwent a dental procedure known as "diathermy." Id. at 485. The device manufacturer provided a warning about diathermy in its manuals for physicians and patients as required pursuant to the conditions the FDA imposed in granting premarket approval, but it did not modify the warning after learning of the anecdotal report until three months after the injured plaintiff underwent diathermy treatment and sustained injuries from his implant malfunctioning. Id. at 486. Plaintiffs asserted state-law failure-to-warn claims based on the manufacturer's failure to provide post-sale warnings prior to the injury. Id.

The Seventh Circuit observed that section 360k(a)"sets three conditions for preemption": (1) there must be a requirement a state establishes or continues with respect to a medical device; (2) there must be "a relevant federal requirement under the FDCA applicable to the device at issue"; and (3) the state requirement "must be ‘different from, or in addition to,’ the federal requirement." Id. at 487 (quoting 21 U.S.C. § 360k(a) ). The parties in McMullen agreed that the first two conditions were satisfied— state-law failure-to-warn claims created a state-established requirement with respect to the medical device, and premarket...

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