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From Products Liability Law Daily, October 7, 2014

New life infused into patient’s complaint against Medtronic

By Michelle L. Oxman, J.D., LL.M

A patient allegedly injured by the Infuse® bone graft device made by Medtronic, Inc. (Medtronic) will be allowed to proceed with his lawsuit because a Maryland appeals court reversed the trial court’s dismissal of his complaint. The trial court’s ruling that all of the patient’s claims were preempted under sec. 521 of the Medical Device Amendments (MDA) (21 USC sec. 360k) was incorrect with respect to the patient’s claims alleging that Medtronic made misleading statements in its promotion of the off-label uses of the Infuse device. The appellate court found that the MDA provisions of the Food, Drug, and Cosmetic Act (FDC Act) protected Medtronic only to the extent that its marketing activities complied with the terms of the Food and Drug Administration (FDA) approval of the device—it could not be sued for statements it made in the course of obtaining FDA approval or for statements that were consistent with the approved labeling. Nevertheless, the court held that Medtronic could be held liable for statements and failures to disclose information necessary to make its statements not misleading when those statements or nondisclosures concerned uses not approved by the FDA (McCormick v Medtronic, Inc., October 6, 2014, Arthur, K).

The product and the injury. Medtronic obtained FDA approval for the Infuse device in 2002. The device as approved consists of three parts: a genetically engineered protein that stimulates bone growth, a collagen sponge that holds the protein, and a metal cage or cylinder, which contains the implanted material, surrounds the vertebrae and directs the bone growth. The terms of the FDA approval were limited to an anterior approach, i.e., reaching the spine through the patient’s abdomen rather than the back. Medtronic knew from its clinical studies that use of the posterior approach led to excess bone growth.

Steven McCormick underwent surgery for back pain in 2007. His physician implanted the Infuse device using a posterior approach rather than the approved anterior approach, and he used a Medtronic cage other than the one approved for use with Infuse. The operation did not relieve his pain, and he went on permanent disability in October 2008. In 2010, McCormick’s physician discovered that he had developed excessive bone growth and a narrowing of the cervical disc space at the site of the implantation. Later that year, McCormick underwent revision surgery in which the surgeon chiseled off excessive bone growth and treated inflammation; both conditions allegedly resulted from the inappropriate use of the Infuse device. McCormick also alleged that he developed nodules in his lungs and that his exposure to the Infuse materials greatly increased his risk of cancer.

Alleged off-label promotion. McCormick alleged that Medtronic engaged in unlawful activities promoting the off-label use of the Infuse device. Specifically, he alleged that Medtronic: (1) paid physicians incentives to use the device; (2) paid “opinion leaders” in the profession millions of dollars to promote the device in professional journals in which their financial relationship was not disclosed; (3) failed to report adverse effects known to have occurred in clinical trials; and (4) placed sales representatives in the operating room during operations in which surgeons used the off-label approach. As a result of Medtronic’s promotional activities, 85 percent of Infuse devices were implanted in off-label procedures.

The pleadings. McCormick’s complaint alleged claims for fraud, negligent misrepresentation, negligence per se, breach of express and implied warranties, strict product liability, and violations of the state consumer protection law. Initially, McCormick also sued his surgeon. The trial court dismissed all claims against Medtronic on the grounds that they were preempted either expressly or by implication under MDA sec. 521 and that he failed to plead the misrepresentation counts with sufficient particularity. The action against the physician remained pending, but McCormick later dismissed it because the physician had no insurance coverage.

The appeal. First, the court determined that it could exercise jurisdiction under its procedural rules. Next, it considered the off-label use and promotion and use of Infuse. It is not unlawful for physicians to use FDA-approved devices in a manner that is inconsistent with the approval. Manufacturers’ promotion of off-label use may constitute misbranding if the label or advertising is false or misleading in any way, if the label does not contain adequate directions for safe use for its intended purpose.

Preemption. Section 521 provides that state law requirements that are additional to or different from the requirements of the federal FDC Act are preempted by the MDA. The U.S. Supreme Court held in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) that strict products liability, breach of implied warranty, and similar actions were preempted because they imposed additional or different requirements on manufacturers. In Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the Supreme Court held that private parties cannot bring tort claims based solely on a violation of the FDC Act or regulations because the FDA has exclusive authority to enforce the FDC Act—these private actions are impliedly preempted.

The court determined that there is a narrow area in which state law requirements that exist independently of the FDC Act but which impose parallel requirements are enforceable. The claims for misrepresentation were not preempted to the extent that they were based on statements made in off-label promotion activity that were misleading. To the extent that Medtronic’s representatives withheld information that was necessary to make its statements not misleading, the failures to disclose were also actionable.

Pleading fraud. The court ruled that McCormick pleaded that Medtronic knew that its statements were false or acted with reckless disregard of their falsity and that it intended to induce reliance. More detail was required, however, as to the “how, when and where” of the false statements and why they were false. The trial court was directed to allow McCormick to amend the complaint.

The case number is 670.

Attorneys: George Somerville Tolley, III (Dugan, Babij, Tolley & Spector LLC) for Steven L. McCormick. Lauren Schultz Colton (Hogan Lovells US LLP) and Andrew E. Tauber (Mayer & Brown, LLP) for Medtronic Inc. and Medtronic Sofamor Danek USA Inc.

Companies: Medtronic Inc.; Medtronic Sofamor Danek USA Inc.

MainStory: TopStory PreemptionNews WarningsNews MedicalDevicesNews MarylandNews

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