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Williams v. Smith & Nephew, Inc.

United States District Court, D. Maryland

August 18, 2015


Page 734

          For Lewis Williams, Jr., Angela Williams, Plaintiffs: Gregory Gene Hopper, Salsbury Clements Bekman Marder and Adkins LLC, Baltimore, MD.

         For Smith & Nephew Inc., Defendant: Terri Steinhaus Reiskin, LEAD ATTORNEY, Dykema Gossett PLLC, Washington, DC.

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         Catherine C. Blake, United States District Judge.

         Lewis Williams, Jr., and his wife, Angela Williams, filed this lawsuit against Smith &

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Nephew, Inc.--maker of the Birmingham Hip Resurfacing System (" BHR System" ) at the center of this lawsuit--alleging state law claims of negligence, strict liability, breach of warranty, and loss of consortium. The Williamses allege Smith & Nephew deviated, in several ways, from the requirements the Food and Drug Administration (" FDA" ) set in its order approving the BHR System for commercial distribution. In their view, these deviations ultimately caused Mr. Williams, the recipient of a BHR System implant, permanent and irreversible harm. Presently pending is Smith & Nephew's motion to dismiss for failure to state a claim, which invokes, as defenses, express preemption under 21 U.S.C. § 360k of the Medical Device Amendments of 1976 (" MDA" ), implied preemption under Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001), and Rule 8 insufficiency. For the reasons stated below, Smith & Nephew's motion will be granted in part and denied in part.


         In 1976, Congress passed the MDA " [i]n response to the mounting consumer and regulatory concern" over medical devices, which had not previously been subject to federal regulation. Medtronic, Inc. v. Lohr, 518 U.S. 470, 476, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The MDA changed that by imposing on medical devices " a regime of detailed federal oversight." Riegel v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008).

         The level of oversight established by the MDA regime varies according to a medical device's safety risks. Class I devices--such as elastic bandages and examination gloves--are least risky, and are therefore " subject to the lowest level of oversight: 'general controls,' such as labeling requirements." Id. (quoting 21 U.S.C. § 360c(a)(1)(A)). Class II devices--such as powered wheelchairs and surgical drapes--are subject to " heightened oversight mechanisms, such as 'performance standards [and] postmarket surveillance[.]'" Walker v. Medtronic, Inc., 670 F.3d 569, 572 (4th Cir. 2012) (quoting 21 U.S.C. § 360c(a)(1)(B)). Class III devices--such as replacement heart valves and pacemaker pulse generators--are the most risky, and are subject to " the highest level of federal oversight." Id. Accordingly, " [b]efore a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a 'reasonable assurance' that the device is both safe and effective" by completing the premarket approval (" PMA" ) process. Lohr, 518 U.S. at 477 (citing 21 U.S.C. § 360e(d)(2)).

         PMA is a " rigorous" process. Riegel, 552 U.S. at 317 (quoting Lohr, 518 U.S. at 477). It requires a device-maker to provide, among other things: information concerning a device's safety and effectiveness; " a full statement of [its] components, ingredients, and properties" ; the methods and facilities used to manufacture it; and examples of proposed labeling. 21 U.S.C. § 360e(c)(1). " This typically requires a 'multivolume application.'" Walker, 670 F.3d at 573 (quoting Riegel, 552 U.S. at 317). The FDA then reviews the device, and, after " 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), decides whether to grant premarket approval. Further, " the FDA may condition its grant of premarket approval upon certain requirements." Walker, 670 F.3d at 573. The PMA process takes, on average, 1,200 hours. Riegel, 552 U.S. at 318.

         After a device receives FDA approval, the MDA " forbids the manufacturer to

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make, without FDA permission, changes in design specifications, manufacturing process, labeling, or any other attribute, that would affect safety or effectiveness." Walker, 670 F.3d at 573 (quoting Riegel, 552 U.S. at 319). To make any such change, a manufacturer must submit a supplemental application that is " evaluated under largely the same criteria as an initial application." Riegel, 552 U.S. at 319; see also 21 U.S.C. § 360e(d)(6)(A)(i).

         PMA also imposes reporting requirements after a device has been approved. See Riegel, 552 U.S. at 319 (citing 21 U.S.C. § 360i). A device-maker has, for example,

the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the [device-maker] knows of or reasonably should know of, 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 injury, or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred, § 803.50(a).

Id. at 319. The FDA " has the power to withdraw premarket approval based on newly reported data or existing information and must [do so] if it determines that a device is unsafe or ineffective under the conditions in its labeling." Id. at 319-20 (citing 21 U.S.C. § 360e(e)(1)).

         As will be described further below, infra section I.A, the MDA also includes an " express pre-emption provision[,]" Riegel, 552 U.S. at 316, which is codified at 21 U.S.C. § 360k.

         * * *

         The Williamses' complaint alleges the following. Smith & Nephew designs, manufactures, and sells the BHR System, a " metal-on-metal hip resurfacing prosthesis" made from a cobalt chromium and molybdenum alloy. (Compl. ¶ 5, ECF No. 1.) The BHR System is a Class III device under the MDA. (Compl ¶ 6.) Accordingly, it is subject to the PMA process.

         In 2004, Smith & Nephew submitted an application to the FDA for premarket approval of the BHR System. (Compl. ¶ 7.) On May 9, 2006, the FDA " conditionally approv[ed]" the BHR System for commercial distribution. (Compl. ¶ 8; see also Pls.' Opp'n Ex. 1, Approval Order, ECF No. 11-1.) As a " condition for distribution," the FDA's Approval Order required Smith & Nephew to comply with specific regulations and provisions of the Food, Drug, and Cosmetic Act (" FDCA" ).[1] (Compl. ¶ ¶ 8a-8b.) The Approval Order also outlined other post-approval requirements for Smith & Nephew including, for example, studies of the longer-term safety and effectiveness of the BHR System for patients in the United Kingdom and United States; a training program for doctors using the BHR System; submission of adverse reaction and device defect reports to the FDA; and labeling and warning obligations. (Compl. ¶ ¶ 8c-8l.) The Approval Order warned that failure to comply with any of these conditions would be grounds for the withdrawal of FDA approval. (Compl. ¶ 9.) Upon receiving FDA approval, Smith & Nephew began distributing the BHR System. (Compl. ¶ 10.)

         On September 21, 2006, Mr. Williams received an implant of the BHR System. (Compl. ¶ 11.) Over half a decade later, in April 2013, he was admitted to a hospital with coughing, shortness of breath, fatigue,

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weakness, and other symptoms of cardiomyopathy. (Compl. ¶ 12.) His ejection fraction was 15-20%.[2] ( Id. ) In May 2013, Mr. Williams's cardiologist evaluated Mr. Williams and, after blood testing, confirmed that he had cobalt and chromium poisoning. (Compl. ¶ 13.) The cardiologist believed erosion of the BHR System had released metal ions into, and poisoned, Mr. Williams's bloodstream. ( Id. ) Accordingly, the decision was made to remove the BHR System as soon as possible. (Compl. ¶ 14.) By June 2013, Mr. Williams's ejection fraction was 8%. ( Id. ) On July 9, 2013, Mr. Williams's BHR System was removed and replaced with a ceramic hip replacement system. (Compl. ¶ 15.) The removed BHR System showed signs of wear and tear. (Compl. ¶ 16.) After removal, Mr. Williams's cobalt levels, cardiomyopathy, and ejection fraction immediately began to improve. (Compl. ¶ 17.) But the " long term toxic exposure" had caused " permanent, irreversible damage." ( Id. )

         On October 6, 2014, the Williamses filed their four-count complaint. Count I alleges negligence. The Williamses allege that, with respect to its development and distribution of the BHR System, Smith & Nephew had the " duty to comply with and not deviate from the PMA requirements contained in the BHR System's FDA approval order[,]" the conditions of approval attached to that order, and " other federal statutory and regulatory requirements" applicable to the BHR System. (Compl. ¶ ¶ 19-21.) These duties were ongoing--that is, they existed even after the FDA had issued its Approval Order. ( See Compl. ¶ ¶ 22-25.) " In parallel with" these duties, Maryland law imposed on Smith & Nephew " post-sale duties" : to monitor the sale and use of the BHR System; discover defects associated with the BHR System's use; and warn the government, doctors, and users about those defects. (Compl. ¶ 26.) Furthermore, " Maryland law treats violations of federal statutes and regulations as evidence of common law negligence . . . ." (Compl. ¶ 27.) Smith & Nephew allegedly " failed to comply with and not deviate from the[se] conditions . . . ." [3] (Compl. ¶ 28.) And those failures meant that " the FDA, doctors implanting BHR [S]ystems, and the public" did not know about the difficulties doctors and patients had with the BHR System, as well as the metal poisoning risks associated with the device. (Compl. ¶ 29.) Had the FDA or Mr. Williams's doctors known about these risks, Mr. Williams would not have experienced the " longstanding exposure to high levels of cobalt and other metals in [his] blood" that ultimately harmed him. ( Id. ) Moreover, had the FDA or Mr. Williams's doctors been " fully informed" of the metal

Page 739

poisoning risks associated with the BHR System, other preventive action could and would have been taken. (Compl. ¶ ¶ 30-31.) As a proximate result of Smith & Nephew's failures, Mr. Williams received a BHR System implant that " released high levels of cobalt and other metal ions into [his] bloodstream and caused him to develop metal poisoning, cardiomyopathy, heart damage, and other injuries." (Compl. ¶ 32.) The Williamses clarify that this count is " based solely on Smith & Nephew's failure to comply with the PMA approval order and the conditions and requirements set by federal regulatory and statutory law" and that they seek damages for violations of these duties " to the extent, and only to the extent, that they run parallel to the federal conditions and requirements." (Compl. ¶ 34.)

         Count II alleges strict liability on the theory that the BHR System was " defective and unreasonably dangerous," both when it entered the stream of commerce and when it was implanted into Mr. Williams's body, as a result of deviations from the FDA's requirements. (Compl. ¶ 36.)[4] As a result of these design and manufacturing defects, Mr. Williams suffered and continues to suffer harm. (Compl. ¶ ¶ 37-38.) The Williamses again clarify they allege strict liability only insofar as state requirements under that claim parallel federal ones. (Compl. ¶ 39.)

         Count III alleges breach of both express and implied warranty based on repeated assurances to Mr. Williams's doctors that the BHR System " was a safe medical device, free from known or unknown defects and hazards." (Compl. ¶ 41.) Smith & Nephew's sales materials allegedly referred to the BHR System's durability in relation to other hip replacement systems. ( Id. )

         Count IV alleges loss of consortium based on the " interfere[nce] with and injur[y] [to]" The Williamses' marital relationship. (Compl. ¶ 47.)

         On November 21, 2014, Smith & Nephew moved to dismiss for failure to state a claim.


         When ruling on a motion under Rule 12(b)(6), the court must " accept the well-pled allegations of the complaint as true," and " construe the facts and reasonable inferences derived therefrom in the light most favorable to the plaintiff." Ibarra v. United States, 120 F.3d 472, 474 (4th Cir. 1997). " Even though the requirements for pleading a proper complaint are substantially aimed at assuring that the defendant be given adequate notice of the nature of a claim being made against him, they also provide criteria for defining issues for trial and for early disposition of inappropriate complaints." Francis v. Giacomelli, 588 F.3d 186, 192 (4th Cir. 2009). " The mere recital of elements of a cause of action, supported only by conclusory statements, is not sufficient to survive a motion made pursuant to Rule 12(b)(6)." Walters v. McMahen, 684 F.3d 435, 439 (4th Cir. 2012) (citing Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009)). To survive a motion to dismiss, the factual allegations of a complaint " must be enough to raise a right to ...

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