Raab v. Smith & Nephew, Inc.

• Decision Date: 15 December 2015
• Docket Number: CIVIL ACTION NO. 2:14-cv-30279
• Citation: 150 F.Supp.3d 671
• Court: U.S. District Court — Southern District of West Virginia
• Parties: Anna Raab, et al., Plaintiffs, v. Smith & Nephew, Inc., Defendant.

150 F.Supp.3d 671

Anna Raab, et al., Plaintiffs,

v.Smith & Nephew, Inc., Defendant.

CIVIL ACTION NO. 2:14-cv-30279

United States District Court, S.D. West Virginia, Charleston Division .

Signed December 15, 2015

Deeann L. Germany, Derek K. Burch, Burch George & Germany, Oklahoma City, OK, Robert V. Berthold, III, Robert V. Berthold, Jr., Berthold Law Firm, Charleston, WV, for Plaintiffs.

David Wayne O'Quinn, Irwin Fritchie Urquhart & Moore, New Orleans, LA, Rebecca A. Betts, Kay Casto & Chaney, Susan M. Robinson, Thomas Combs & Spann, Charleston, WV, Michael J. Farrell, Tamela J. White, Farrell White & Legg, Huntington, WV, for Defendant.

MEMORANDUM OPINION AND ORDER

THOMAS E. JOHNSTON

, UNITED STATES DISTRICT JUDGE

Pending before the Court is Defendant's Motion to Dismiss the Amended Complaint (the “Motion to Dismiss”). (ECF No. 22.) For the reasons discussed herein, the Motion to Dismiss is GRANTED IN PART , and DENIED IN PART .

I. Background

In early 2010, Plaintiff Anna Raab underwent two hip surgeries

at St. Francis Hospital in Charleston, West Virginia, pursuant to which she was implanted with medical device components developed and manufactured by the defendant, Smith & Nephew, Inc. This is a lawsuit seeking redress, under various state law causes of action, for the severe and permanent injuries that Mrs. Raab and her husband allege resulted from the failure of the defendant's products.

The defendant is a developer and manufacturer of joint replacement systems. (ECF No. 21 (Plaintiff's Amended Complaint) ¶ 5.) As relevant to this case, the defendant manufactures the Birmingham Hip Resurfacing System (“BHR System”), a metal-on-metal hip resurfacing prosthesis that consists of two constituent components: (1) a Birmingham Resurfacing Femoral Head (the “femoral head”); and (2) a Birmingham Hip Resurfacing Acetabular Cup

(the “acetabular cup ”). (Id .) As will be fully discussed below, the BHR system is a Class III medical device and as such was required to receive premarket approval (“PMA”) pursuant to a rigorous review process administered by the Food and Drug Administration (“FDA”). This process was completed on May 9, 2006, on which day “the FDA conditionally approved the BHR for commercial distribution.” (Id . ¶ 6.)

On January 12, 2010, Mrs. Raab underwent the first of her surgeries, a right hip resurfacing performed by Dr. Jason Castle. (Id . ¶ 8.) During this surgery, “Dr. Castle utilized and implanted the Defendant's Birmingham resurfacing system.” (Id .) Accordingly, Mrs. Raab was implanted with both components, the femoral head and the acetabular cup

, of the BHR System. About a month later, on February 17, 2010, “it was discovered through diagnostic studies at St. Francis Hospital that Plaintiff suffered a right periprosthetic fracture of the femoral neck.” (Id . ¶ 9.) As a result, Mrs. Raab went forward with a second procedure, a revision surgery intended to convert her right hip resurfacing into a “right total hip arthroplasty.” (Id . ¶ 10.) Pursuant to this procedure, Dr. Castle left the acetabular cup in place but “revis[ed]” the femoral head. (Id .) Specifically, Dr. Castle implanted the following three components, all manufactured by the defendant, into Mrs. Raab's hip: (1) Synergy Porous High Offset Femoral Component; (2) Modular Head Sleeve; and (3) Modular Femoral Head. (Id .) These femoral components are not part of the BHR System approved by the FDA, and the defendant does not dispute that they were cleared by the FDA as Class II devices not subject to any PMA process. (See ECF No. 23 at 13.)

In the months following the revision surgery, Mrs. Raab began suffering complications. In response, she went to the University of Pittsburgh Medical Center for the purpose of undergoing a second right hip revision procedure. (ECF No. 21 ¶ 11.) Plaintiffs allege that it was pursuant to this surgery that they were notified, on May 8, 2014, that Defendant's metal-on-metal hip components “had failed.” (Id .) Plaintiffs further allege that this failure caused several medical complications, as well as the presence of metal debris “in the Plaintiff's surrounding bone and tissue of the right hip, including the presence of pseudotumors

.” (Id .) Ultimately, Mrs. Raab's Pittsburgh physician, Dr. Edwin McClain, III, replaced the BHR acetabular cup, as well as the Modular Femoral Head implanted in the first revision surgery. (Id .)

Based on these factual allegations, the plaintiffs filed a complaint in this Court on December 18, 2014. (ECF No. 1.) In response to the defendant's initial motion to dismiss, (ECF No. 15), Plaintiffs sought leave to file an amended complaint, (ECF No. 17). This Court granted that request by Order entered April 20, 2015, (ECF No. 20), and Plaintiff's Amended Complaint (the “Amended Complaint”) was filed the same day, (ECF No. 21).

The Amended Complaint asserts five claims for relief against the defendant manufacturer. The first four causes of action seek to assert “parallel state common law claims” based on the defendant's alleged violation of federal statutory and regulatory requirements. (Id . ¶¶ 16, 27, 40, 53.) The first two claims arise out of the original surgery on January 12, 2010. One asserts strict products liability and the other negligence, and both seek to impose liability on the premise that the BHR System, including both the femoral head and the acetabular cup, did not comply with the requirements imposed by the Federal Food, Drug and Cosmetic Act (“FDCA”) and the regulations promulgated pursuant thereto. (Id . ¶¶ 13–14, 24–25). To support the products liability claim, Plaintiffs allege that the BHR System was “designed and/or manufactured,” (id . ¶ 13), in violation of the Act and regulations, and that as a result was “unreasonably dangerous,” (id . ¶ 14). In support of the negligence claim, Plaintiffs again claim that the device was “designed and/or manufactured,” (id . ¶ 24), in violation of the Act and regulations, and that this violation breached Defendant's duty to comply with that Act and those regulations, (id . ¶ 25). In support of both claims, the Amended Complaint references an identical list of specific federal regulations that the defendant allegedly violated, all located within 21 C.F.R. § 820, a quality system regulation prescribing current good manufacturing practice for manufacturers of medical devices.

Plaintiffs' allegations with respect to their third and fourth claims follow a similar pattern. Again, state law strict products liability and negligence are asserted based on the defendant's alleged violation of federal statutes and regulations governing medical devices. These claims, however, are based exclusively on the revision surgery performed on February 17, 2010, and allege violations of a different, and smaller, set of statutory and regulatory requirements. Again, the plaintiffs support their claims for both strict products liability and negligence with reference to the same set of federal requirements. This time, though, the plaintiffs use identical language to support both claims. (Compare id . ¶¶ 34–46, with id . ¶¶ 47–59.) Plaintiffs' strict products liability claim does not allege that the defendant created an unreasonably dangerous product, as in the first claim for relief. Rather, it borrows the duty-based language of a negligence claim, alleging that the defendant should be liable because “[i]t was the duty of Defendant ... to comply with the Act, and the regulations promulgated pursuant to it, yet, notwithstanding this duty, Defendant ... violated the Act in one or more of the following ways ....” (Id . ¶ 38.) In support of both claims, Plaintiffs allege violations of 21 U.S.C. §§ 352

, 360h -360j, and 360l, as well as 21 C.F.R. § 814.39. (ECF No. 21 ¶¶ 38, 51.)

Pursuant to each of the first four claims, Plaintiff Anna Raab asserts the same measure of harm incurred:

As a direct result, Plaintiff, Anna Raab, endured pain and suffering, including, but not limited to pseudotumor

formation, recurrent dislocations and subluxations with swelling, proximal thigh enlargement, lumps in her groin, pain in her buttocks and has required additional and debilitating surgeries and has incurred significant medical expenses in the past and will incur additional medical expenses in the future; both past and future wage loss; physical pain and suffering, both past and future; mental anguish and emotional distress, both past and future, including, but not limited to, humiliation, embarrassment, annoyance and aggravation.

(Id . at ¶¶ 15, 26, 39, 52.)

The fifth claim for relief differs from the first four in that it is not based on violations of federal law. Rather, it asserts a variety of “state law and common law claims” based on the defendant's failures exclusively with respect to the Class II devices implanted in Mrs. Raab on February 17, 2010. (Id . at 17.) Specifically, the plaintiffs allege strict products liability under the doctrine of manufacturers' products liability, breach of implied and express warranties, including the implied warranties of merchantability and fitness for a particular purpose, and failure to warn. Mrs. Raab alleges the same measure of harm and damages for these claims as the other parallel claims. (Id . ¶ 63.) Pursuant to this overarching fifth claim for relief Plaintiff Terry Raab, Mrs. Raab's husband, asserts a claim for loss of consortium. (Id . ¶ 64.) Both Plaintiffs also seek punitive damages based on the “willful, wanton, intentional acts, reckless and/or the willful, wanton, intentional and reckless failures to act by Defendant.” (Id . ¶ 65.)

On May 4, 2015, the defendant filed the instant Motion to Dismiss, pursuant to Federal Rules of Civil Procedure 8

and 12(b)(6). (ECF No. 21.) Defendant asserts three bases for dismissal: (1) that claims one through four, seeking to impose liability based on alleged deficiencies in the BHR System, are expressly preempted pursuant to 21 U.S.C. § 360k(a)

; (2) that the same claims, to the extent th...