Dunn v. Genzyme Corp.

Citation486 Mass. 713,161 N.E.3d 390
Decision Date29 January 2021
Docket NumberSJC-12904
CourtUnited States State Supreme Judicial Court of Massachusetts

486 Mass. 713
161 N.E.3d 390

Patricia M. DUNN


Supreme Judicial Court of Massachusetts.

Argued September 11, 2020.
Decided January 29, 2021.

John C. Dougherty for the defendant.

Matthew J. Dunn for the plaintiff.

The following submitted briefs for amici curiae:

Lawrence G. Cetrulo, Kyle E. Bjornlund, & Jesse G. Ainlay, Boston, for Massachusetts Defense Lawyers Association.

Jaime A. Santos, Sarah K. Frederick, & Edwina B. Clarke, Boston, for Chamber of Commerce of the United States of America & another.

David R. Geiger, Michael Hoven, Boston, & Stephen Stich, for Washington Legal Foundation.

Present: Lenk, Gaziano, Lowy, Budd, Cypher, & Kafker, JJ.1


486 Mass. 713

We are asked in this case involving claims of personal injury and product liability against the manufacturer of

486 Mass. 714

a medical device to decide whether Federal law preempts the plaintiff's State law claims because the device is regulated under the Medical Device Amendments (MDA), 21 U.S.C. §§ 360c et seq., of the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. State law claims survive preemption under the MDA so long as these claims parallel, rather than supplement, Federal requirements. See Riegel v. Medtronic, Inc., 552 U.S. 312, 330, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). Under this standard, plaintiffs need not specify the precise defect in the medical device nor the specific Federal regulatory requirement allegedly violated in order to survive a motion to dismiss. No heightened pleading standard is required. Rather, we conclude that plaintiffs asserting parallel State law claims may do so with no greater degree of specificity than otherwise required under Iannacchino v. Ford Motor Co., 451 Mass. 623, 636, 888 N.E.2d 879 (2008).

161 N.E.3d 393

While all of the plaintiff's State law claims here properly parallel the Federal requirements, none of them is sufficiently pleaded under Iannacchino, supra, to survive the manufacturer's motion to dismiss. Accordingly, the Superior Court judge's decision denying the manufacturer's motion to dismiss must be reversed.

1. Statutory background. Congress adopted the MDA in 1976, in response to the perceived failure of the various States to provide for the adequate regulation of new medical devices. See generally Medtronic, Inc. v. Lohr, 518 U.S. 470, 475-477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ( Lohr ). In an effort to establish regulatory uniformity and enhance consumer protection, the MDA thus "swept back some state obligations and imposed a regime of detailed federal oversight." Riegel, 552 U.S. at 316, 128 S.Ct. 999.

The MDA establishes three classes of medical devices, and corresponding levels of oversight, depending on the risks they present to the public. Class III devices -- those "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," as well as those that "present[ ] a potential unreasonable risk of illness or injury" -- are subject to the most stringent oversight. 21 U.S.C. § 360c(a)(1)(C)(ii)(I), (II). Such devices generally are subject to a "rigorous" premarket approval process by the Food and Drug Administration (FDA). See Lohr, 518 U.S. at 477, 116 S.Ct. 2240. This process includes, among other precautions, a review of the device's proposed labeling to evaluate the safety and effectiveness of using the device under the conditions set forth on the label, 21 U.S.C. § 360c(a)(2)(B), and

486 Mass. 715

to ensure that the proposed labeling is neither false nor misleading, 21 U.S.C. § 360e(d)(1)(A).

Once a medical device has been approved, manufacturers of Class III devices also have continuing duties to comply with regulations and reporting requirements. See generally 21 U.S.C. §§ 360 et seq. The MDA, for example, prohibits the manufacturer from making changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness without FDA permission. See 21 U.S.C. § 360e(d)(5)(A)(i). More generally, the FDA's good manufacturing practice regulations impose comprehensive requirements concerning the device-manufacturing process, including a manufacturer's personnel qualifications,2 buildings,3 equipment,4 production and process controls,5 packaging and labeling,6 distribution,7 and recordkeeping.8 Additionally, manufacturers are required to inform the FDA of new clinical investigations or scientific studies concerning the device that the manufacturer is aware of or reasonably should be aware of, see 21 C.F.R. § 814.84(b)(2), and to report incidents in which the device may have caused or contributed to death or serious bodily injury, or malfunctioned in a manner that likely would cause or contribute to death or serious bodily injury if it recurred, see 21 C.F.R. § 803.50(a). The FDA "shall" withdraw approval if it determines that a device is unsafe or ineffective under the conditions of its labeling.

161 N.E.3d 394

21 U.S.C. § 360h(e). To facilitate this Federal regulatory scheme, the MDA expressly preempts certain State regulation of approved medical devices. Under its preemption clause,

"Except as provided in subsection (b), no 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
486 Mass. 716
or to any other matter included in a requirement applicable to the device under this chapter."

21 U.S.C. § 360k(a). An exception in subsection 21 U.S.C. § 360k(b), not relevant here, permits the FDA to exempt some State and local requirements.

2. Factual background. In an attempt to alleviate the symptoms of osteoarthritis in her knees, according to her complaint, the plaintiff, Patricia Dunn, received two injections of Synvisc-One on June 8, 2015, one in each knee. Synvisc-One is manufactured by Genzyme Corporation (Genzyme) and is a Class III medical device subject to premarket approval under the MDA. Synvisc-One was approved by the FDA in 2009 for the treatment of pain associated with osteoarthritis of the knee in patients who have failed to respond to other treatments.

Immediately after receiving the injections, Dunn experienced severe side effects, including "pain and swelling in her knees, difficulty walking, hip bursitis and systemic pseudoseptic acute arthritis." These side effects caused her to fall several times and ultimately resulted in serious injuries, including a tear to her meniscus and breaking her neck. As a result of these injuries, Dunn asserts that she "experienced significant physical pain and suffering, under[went] surgeries, and endured prolonged hospitalization and physical rehabilitation."

In June 2018, Dunn commenced an action against Genzyme in the Superior Court, asserting that Synvisc-One was "negligently manufactured, designed, distributed, and sold by [Genzyme], and ... failed to contain appropriate and significant warnings related to its use." Specifically, Dunn sought monetary damages based upon four State law claims: (1) failure to warn; (2) breach of warranty; (3) negligence; and (4) products liability. In a joint stipulation filed on June 22, 2018, and subsequently approved by the judge, both parties agreed to extend the time within which Dunn could file an amended pleading until August 17, 2018. Dunn, however, failed to meet this deadline. She filed an amended complaint on September 11, 2018, three days before the parties had stipulated that Genzyme was to file its response. In her amended complaint, Dunn added a fifth claim under the Massachusetts consumer protection act, G. L. c. 93A, asserting that Genzyme "undertook certain unfair and deceptive acts or practices."

In response to the amended complaint, Genzyme filed a motion to dismiss pursuant to Mass. R. Civ. P. 12 (b) (6),

486 Mass. 717

365 Mass. 754 (1974), on the grounds that the allegations of both the original complaint and the amended complaint were preempted by Federal regulation and failed to meet the applicable State law pleading standards.

Following a nonevidentiary hearing, the judge denied Genzyme's motion to dismiss, concluding that Dunn had supplied sufficient factual allegations in her complaint to "state a plausible claim for relief" and survive preemption under the MDA. The judge noted that courts, both nationally and in the Commonwealth, have disagreed about the required level of specificity with

161 N.E.3d 395

which a plaintiff must allege a violation of FDA regulations to properly plead State law claims; neither the United States Supreme Court nor the United States Court of Appeals for the First...

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