Gelber v. Stryker Corp..

• Decision Date: 18 April 2011
• Docket Number: No. 09 Civ. 1322.,09 Civ. 1322.
• Parties: Jeanette GELBER & Hugh Gelber, Plaintiffs,v.STRYKER CORPORATION, Howmedica Osteonics, & Stryker Orthopedics, Inc., Defendants.
• Court: U.S. District Court — Southern District of New York

788 F.Supp.2d 145

Jeanette GELBER & Hugh Gelber, Plaintiffs,

v.STRYKER CORPORATION, Howmedica Osteonics, & Stryker Orthopedics, Inc., Defendants.

No. 09 Civ. 1322.

United States District Court, S.D. New York.

April 18, 2011.

Alan Bruce Brill, Alan B. Brill P.C., Suffern, NY, for Plaintiffs.Amy Terry Sheehan, Ronald Gustav Blum, Manatt, Phelps & Phillips, LLP, New York, NY, for Defendants.

MEMORANDUM AND ORDER

P. KEVIN CASTEL, District Judge:

In this action, plaintiff Jeanette Gelber asserts multiple medical device liability claims against Stryker Corporation, Howmedica Osteonics, and Stryker Orthopedics, Inc.,¹ (collectively “Stryker”) seeking to recover damages arising from the surgical implantation of an artificial hip prosthesis known as the Trident™ hip replacement system (“Trident System”). She alleges that because the Trident System was defective, she experienced pain and eventually required an additional surgical procedure to have a new hip prosthesis implanted. State law claims of negligence, breach of express and implied warranty, and strict products liability are asserted. Plaintiff Hugh Gelber seeks to recover for various derivative injuries he suffered as a result of the injury to his wife. Defendants move to dismiss the Amended Complaint on the grounds that plaintiffs' claims are preempted by federal law and fail to state a claim for relief pursuant to Rule 12(b)(6), Fed.R.Civ.P. For the reasons stated below, defendants' motion to dismiss is granted in part and denied in part.

BACKGROUNDI. Factual History

Mrs. Gelber underwent a total right hip arthroplasty on July 21, 2004 at Lenox Hill Hospital in New York, New York. (Am. Compl. ¶ 7.) The Trident System was the prosthetic device implanted into Mrs. Gelber during the surgical procedure. (Am. Compl. ¶ 19.) Plaintiffs allege that the Trident System components implanted during this procedure were manufactured either in defendants' Mahwah, New Jersey plant or its Cork, Ireland plant. (Am. Compl. ¶ 21.) In Spring 2007, Mrs. Gelber began to experience pain in her right hip and heard squeaking and/or creaking emanating from her right hip. (Am. Compl. ¶ 22.) Mrs. Gelber later experienced numbness and burning in her calf and loss of balance. (Am. Compl. ¶ 24.) Despite undergoing conservative treatment, Mrs. Gelber required hip revision surgery on January 26, 2009 to remove the Trident System and implant a different prosthetic device. (Am. Compl. ¶ 26.) Upon removal and inspection of the Trident System, Mrs. Gelber's surgeon noted a stripe on the ceramic head component, as well as wear on the ceramic insert. (Am. Compl. ¶ 27.)

The FDA approved the Trident System for sale in the United States on February 3, 2003. (Am Compl. ¶ 14.) The parties agree that the Trident System implanted into Mrs. Gelber was a Class III medical device; the significance of this classification is explained below. (Pls. Mem. 6; Defs. Mem. 12.) However, plaintiffs also allege that “[a]fter the conditional approval, but before implantation into [p]laintiff ..., [d]efendants modified the Trident System through submissions pursuant to the abbreviated review process under to [sic] 21 U.S.C. 510(k) on several occasions, including but not limited to May 25, 2004, by increasing wall thickness in the Trident “T” Acetabular Shells.” (Am. Compl. ¶ 65.) Plaintiffs further allege that this specific modification, approved under the abbreviated 510(k) review process, “was made in part to address the very defects in the Stryker Trident System that caused [p]laintiff's implant to fail.” (Am. Compl. ¶ 66.)

II. Procedural History

On January 22, 2009, plaintiffs commenced this action by filing the Summons and Verified Complaint with the Clerk of the Supreme Court of the State of New York, County of Rockland. (Docket # 1.) Defendants removed the case to this Court on February 13, 2009, alleging diversity of citizenship and an amount in controversy in excess of the jurisdictional threshold. 28 U.S.C. § 1332. Defendants then filed a motion to dismiss the Complaint on March 13, 2009. (Docket # 7.)

Chief Judge Loretta A. Preska, in a September 14, 2010 Order and Opinion, granted defendants' motion to dismiss, pursuant to Rule 12(b)(6), Fed.R.Civ.P. Gelber v. Stryker Corp., 752 F.Supp.2d 328, 330–31 (S.D.N.Y.2010). The Court concluded that plaintiffs' claims of negligence, strict liability, and breach of warranty were preempted under the under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (“MDA”). Id. at 335 (“The failure to allege state law claims that are parallel to federal requirements is the primary ground on which the Court grants Defendants' motion to dismiss.”) The Court also concluded that plaintiffs failed to plead properly the elements of their manufacturing defect claim and their breach of express warranty claim. Id.

In granting defendants' motion to dismiss, Chief Judge Preska concluded that plaintiffs “failed to allege that their claims are parallel to federal regulations so as to avoid preemption and failed to properly plead the elements of their claim.” Id. at 335. Plaintiffs initially asserted “claims based upon failure to warn, improper labeling, improper or misleading marketing and/or defective design,” but these claims were withdrawn. Id. at 333. The Court granted permission to amend the Complaint and the plaintiffs filed the Amended Complaint on September 30, 2010. (Docket # 18.) The Amended Complaint is starkly different from the initial Complaint; the Amended Complaint alleges that defendants violated multiple federal regulations, whereas the initial Complaint makes no similar allegations.

The Amended Complaint alleges five counts including: (1) strict products liability based on a defective manufacturing claim; (2) negligence; (3) breach of implied warranty of merchantability; (4) breach of express warranty; and (5) loss of consortium. These counts are alleged under individual headings setting forth the specific claim. Under a heading entitled “Facts,” plaintiffs also set forth multiple allegations that can be construed as alleging a cause of action for failure to warn, based on the defendants' alleged failure to take action to update the warning information on the Trident System's label, (Am. Compl. ¶¶ 29–37), and a cause of action for failure to report, based on defendants' alleged failure report to the FDA the true and accurate incidence of a squeaking noise emanating from the Trident System. (Am. Compl. ¶ 37.)

On October 27, 2010, defendants filed a motion to dismiss the Amended Complaint pursuant to Rule 12(b)(6), Fed.R.Civ.P. (Docket # 21.) The case was reassigned to the undersigned on November 15, 2010. (Docket # 24.) Defendants move to dismiss the Amended Complaint asserting the same grounds for dismissal as their first motion; specifically that plaintiffs' claims are preempted by federal law and, to the extent they are not preempted, they fail to state a claim for relief pursuant to Rule 12(b)(6), Fed.R.Civ.P. (Defs. Mem. 5.)

THE MEDICAL DEVICE AMENDMENTS

“The Federal, Food, Drug, and Cosmetic Act (FDCA) ..., as amended, 21 U.S.C. § 301 et seq., has long required FDA approval for the introduction of new drugs into the market. Until [Congress enacted the MDA], however, the introduction of new medical devices was left largely for the States to supervise as they saw fit.” Riegel v. Medtronic, Inc., 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The development of new medical technology and equipment, such as artificial heart valves and heart pacemakers, and the increasingly severe injuries individuals sustained from use of these devices prompted concern over the safety of medical devices. Medtronic, Inc. v. Lohr, 518 U.S. 470, 476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The Dalkon Shield, an intrauterine contraceptive device, was one specific medical device introduced in the 1970s that raised public concern because its use “resulted in a disturbingly high percentage of inadvertent pregnancies, serious infections, and even, in a few cases, death.” Lohr, 518 U.S. at 476, 116 S.Ct. 2240. Concern over these increasingly complex and invasive medical devices prompted some states, such as California, to enact law requiring premarket approval of medical devices. Riegel, 552 U.S. at 315, 128 S.Ct. 999. In 1976, Congress enacted the MDA, “which swept back some state obligations and imposed a regime of detailed federal oversight.” Id. at 316, 128 S.Ct. 999.

The MDA classifies medical devices into three categories based on the risk they pose to the public and provides greater oversight for devices in the highest risk classification level, Class III. Id. at 316–17, 128 S.Ct. 999. A medical device is “Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device is ‘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,’ or ‘presents a potential unreasonable risk of illness or injury.’ ” Id. at 317, 128 S.Ct. 999 (citing 21 U.S.C. § 360c(a)(1)(C)(ii)).

New Class III devices undergo a rigorous premarket approval process unless they are found to be “substantially equivalent” to another device that is exempt from premarket approval. Id. (citing 21 U.S.C. §§ 360c(f)(1)(A)). The approval process for devices that are “substantially equivalent,” referred to as the section 510(k) approval process, is much less demanding than the premarket approval process and is the process the majority of devices undergo in order to receive FDA approval. See id. (explaining that “[i]n 2005 ... the FDA authorized the marketing of 3,148 devices under § 510(k) and granted premarket approval to just 32 devices.”) The Supreme Court has described the premarket approval process as follows:

Premarket approval is a rigorous process. A manufacturer must...