Gale v. Smith & Nephew, Inc.

• Decision Date: 13 February 2013
• Docket Number: No. 12 CV 3614 (VB).,12 CV 3614 (VB).
• Citation: 989 F.Supp.2d 243
• Parties: Howard GALE, Plaintiff, v. SMITH & NEPHEW, INC., Sound Shore Medical Center of Westchester, Specialty Orthopaedics, PLLC, Steven B. Zelicof, M.D., Vaishafee R. Shukla, M.D., Ognian I. Bouhlev, M.D., Michael S. Ackerman, M.D., Yigal Samocha, M.D., Ira Novich, M.D., Courtney Kuhn, P.A., Craig S. Steinberg, P.A., Michael J. Cicatelli, P.A., J. Delacruz, R.N., K. Miller, R.N., D. Brown, R.N., Vennetta L. Doles, R.N., and C.D., R.N., Defendants.
• Court: U.S. District Court — Southern District of New York

989 F.Supp.2d 243

Howard GALE, Plaintiff,

v.SMITH & NEPHEW, INC., Sound Shore Medical Center of Westchester, Specialty Orthopaedics, PLLC, Steven B. Zelicof, M.D., Vaishafee R. Shukla, M.D., Ognian I. Bouhlev, M.D., Michael S. Ackerman, M.D., Yigal Samocha, M.D., Ira Novich, M.D., Courtney Kuhn, P.A., Craig S. Steinberg, P.A., Michael J. Cicatelli, P.A., J. Delacruz, R.N., K. Miller, R.N., D. Brown, R.N., Vennetta L. Doles, R.N., and C.D., R.N., Defendants.

No. 12 CV 3614 (VB).

United States District Court,

S.D. New York.

Feb. 13, 2013.

Gary Todd. Certain, The Certain Law Firm, PLLC, New York, NY, Victor M. Serby, Woodmere, NY, for Plaintiff.

Glenn Stuart Kerner, Goodwin Procter, LLP, Laura Anne Delvecchio, Heidell, Pittoni, Murphy & Bach, LLP, New York, NY, Christopher A. Terzian, Bartlett, McDonough, Bastone & Monaghan, LLP, John J. Corgan, Schiavetti, Corgan, Soscia, Dieedwards and Nicholson, LLP, Glen Steven Feinberg, Wilson, Elser, Moskowitz, Edelman & Dicker, White Plains, NY, for Defendants.

MEMORANDUM DECISION

BRICCETTI, District Judge.

In this diversity action, plaintiff Howard Gale brings a variety of common-law tort claims arising from his hip replacement surgery on May 6, 2008. Specifically, plaintiff brings claims for medical malpractice, negligence, and breach of warranty against medical practice Specialty Orthopaedics, PLLC; public hospital Sound Shore Medical Center of Westchester (“SSMC”); physicians Michael S. Ackerman, Ognian I. Bouhlev, Ira Novich, Yigal Samocha, Vaishafee R. Shukla, and Stephen B. Zelicof (“Doctors”); physician's assistants Michael J. Cicatelli, Courtney Kuhn, and Craig S. Steinberg (“PAs”); and registered nurses D. Brown, C.D., J. Delacruz, Vennetta L. Doles, and K. Miller (“Nurses”).

Plaintiff also brings claims against Smith & Nephew, Inc. (“S & N”), the designer, manufacturer, and distributor of the Birmingham Hip Resurfacing System (“BHR System”), alleging negligence, products liability, failure to warn, and breach of warranty. Plaintiff's remaining claims are for deceptive trade practices, under New York General Business Law § 349, and for fraud committed against the United States Food and Drug Administration (“FDA”).

Defendants S & N and Samocha each move to dismiss plaintiff's first amended complaint for failure to state a claim.¹ (Docs.# 10, 27).

Both motions are GRANTED in part and DENIED in part.

The Court has jurisdiction under 28 U.S.C. § 1332.

BACKGROUND

For purposes of ruling on these motions to dismiss, the Court accepts as true all well-pleaded allegations in the amended complaint, as summarized below.

On May 6, 2008, plaintiff underwent a right total hip replacement surgery at SSMC. During the operation, the surgical team implanted four BHR System components and parts, for which the FDA had granted premarket approval two years earlier.²See21 U.S.C. 360e. Dr. Zelicof, SSMC's Chief of Orthopaedic Surgery and a member of Specialty Orthopaedics, performed the surgery. He was assisted in the surgery, and in the subsequent care of plaintiff, by the Doctors, PAs, and Nurses.

According to the amended complaint, between July 3, 2011, and April 30, 2012, plaintiff suffered five right total hip dislocations. Plaintiff also “went into acute renal failure because of chromium/cobalt poisoning caused by the implanted device.” After consulting Dr. Zelicof, plaintiff was told he needed to have the BHR System prostheses removed and replaced.

Plaintiff thereafter filed this action.

DISCUSSION

I. Standard of Review

The function of a motion to dismiss is “merely to assess the legal feasibility of the complaint, not to assay the weight of the evidence which might be offered in support thereof.” Ryder Energy Distrib. v. Merrill Lynch Commodities, Inc., 748 F.2d 774, 779 (2d Cir.1984) (internal quotation marks omitted). In deciding a motion to dismiss pursuant to Rule 12(b)(6), the Court evaluates the sufficiency of the amended complaint under the “two-pronged approach” suggested by the Supreme Court in Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009). First, plaintiff's legal conclusions and “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements,” are not entitled to the assumption of truth and are thus not sufficient to withstand a motion to dismiss. Id. at 678, 129 S.Ct. 1937;Hayden v. Paterson, 594 F.3d 150, 161 (2d Cir.2010). Second, “[w]hen there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief.” Ashcroft v. Iqbal, 556 U.S. at 679, 129 S.Ct. 1937.

To survive a Rule 12(b)(6) motion to dismiss, the allegations in the amended complaint must meet a standard of “plausibility.” Ashcroft v. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937;Bell Atl. Corp. v. Twombly, 550 U.S. 544, 564, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A claim is facially plausible “when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. “The plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Id. (quoting Bell Atl. Corp. v. Twombly, 550 U.S. at 556, 127 S.Ct. 1955).

II. S & N's Motion³A. The Medical Device Amendments of 1976

After perceiving the common-law tort system had failed to manage risks associated with medical devices, Congress passed the Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq., to “swe[ep] back some state obligations and impose[ ] a regime of detailed federal oversight.” Riegel v. Medtronic, Inc., 552 U.S. 312, 315–16, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The MDA included an express pre-emption provision, which states in pertinent part:

[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).

The MDA also established a three-tier regulatory framework whereby the FDA subjects new devices presenting the greatest risk—Class III devices—to “rigorous” premarket approval before they can be sold. Riegel v. Medtronic, Inc., 552 U.S. at 316–20, 128 S.Ct. 999 (describing MDA regime and noting on average FDA spent 1,200 hours reviewing each premarket approval application). ⁴ The FDA grants premarket approval only if it is reasonably assured the device is safe and effective, after reviewing, among other things, the product's principles of operation, ingredients, manufacture, and labeling, id. at 317–18, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(c)(1)), and weighing “any probable benefit to health from the use of the device against any probable risk of injury or illness from such use,” 21 U.S.C. § 360c(a)(2)(C). The FDA “may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.” Riegel v. Medtronic, Inc., 552 U.S. at 318, 128 S.Ct. 999.

A manufacturer's obligation does not end once the FDA grants premarket approval. For example, “the MDA forbids a manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.” Id. at 319, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). The manufacturer must also inform the FDA if it learns new information about the device, and must report when the device has caused or contributed to death or serious injury. Id. (citing 21 C.F.R. § 803.50(a)). If at any time the FDA determines a device is unsafe or ineffective under the terms of its labeling, it may withdraw premarket approval. Id. at 319–20, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(e)(1)).

B. Federal Pre–Emption Under the MDA

The Supreme Court has partly explained the contours of federal pre-emption under MDA Section 360k(a). In Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), the Supreme Court held federal law impliedly pre-empted state-law claims alleging fraud on the FDA, and held plaintiffs had no private right to sue for noncompliance with the MDA. Id. at 348, 349 n. 4, 121 S.Ct. 1012. Then, in Riegel v. Medtronic, Inc., the Supreme Court ruled on whether Section 360k(a) expressly pre-empted state tort law. First, the Court held FDA premarket approval was a federal requirement that triggered the MDA's express pre-emption clause. 552 U.S. at 322–24, 128 S.Ct. 999. Next, the Court held that common-law tort causes of action were pre-empted under Section 360k(a) to the extent they (1) imposed a requirement “different from, or in addition to” the FDA-imposed federal requirements, and (2) related to a device's safety or effectiveness. See552 U.S. at 322–24, 128 S.Ct. 999. The Court noted, however, that Section 360k(a) 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, 128 S.Ct. 999. But Riegel did not elaborate on this “parallel claim” exception, and did not address Buckman.

Courts have reconciled Riegel and Buckman to “create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption.” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010). To shoot this gap, the “plaintiff must be suing for conduct that violates [federal law, or Section 360k(a) pre-empts the claim,] ... but the plaintiff must not be suing...