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In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation

United States District Court, D. Maryland

March 26, 2018



          Catherine C. Blake, United States District Judge.

         Plaintiffs from 42 states and jurisdictions[1] have together filed more than 200 suits claiming that the defendant, Smith & Nephew, is liable under eight state common law theories of liability-strict products liability; negligence; strict liability for failure to warn; negligent failure to warn; negligent misrepresentation; negligence per se; breach of express warranty; and manufacturing defect-for, among other things, misrepresenting the safety of the defendant's Birmingham Hip Resurfacing device and failing to report adverse incidents to the FDA.[2] The plaintiffs also claim these facts support awarding punitive damages against Smith & Nephew.[3]Smith & Nephew has filed a motion to dismiss arguing that these claims are either preempted or insufficiently pleaded.

         The defendant's motion will be granted in part and denied in part. The plaintiffs' two strict liability claims are preempted because they require the court to impose requirements on Smith & Nephew that differ from or add to FDA requirements. All but one of the plaintiffs' six remaining claims survive the motion because they are traditional state law claims, may be established by conduct that also violates federal regulations, and have been sufficiently pleaded.

         Factual Overview

         This case concerns the Birmingham Hip Resurfacing Device (“BHR”), an artificial hip, developed, designed, manufactured, and sold by Smith & Nephew. The hip joint is formed by a ball and socket structure: the end of the femur closest to the hip, called the femoral head, is shaped like a ball and sits inside a socket in the hip called the acetabular cup. (Master Amended Consolidated Complaint (“MACC”) at ¶ 12). The BHR system replaces the hip joint with metal components-capping the femoral head with a metal covering and inserting a metal cup within the acetabular cup-to recreate the same ball and socket structure that occurs naturally. (Id. at ¶¶ 13-14). Unlike the naturally occurring structure, however, friction between the metal components of the BHR system, a consequence of movement within the joint, causes metal debris to accumulate within the joint and, eventually, the bloodstream. (Id. at ¶15).

         Far from benign, these shavings can cause significant medical complications such as swelling and pain, metallosis, immune reactions, pseudotumors, and premature loosening of the BHR device, that ultimately require serious corrective surgery. (Id.). Patients suffering from complications must undergo total hip replacements-surgeries to implant an entirely new ball and socket structure that are decidedly more complicated and invasive than those required to implant the BHR device. (Id. at ¶ 16).

         Smith & Nephew issued two recalls regarding the BHR device. First, several versions of the system were recalled in 2007 because of, among other things, labeling issues. (Id. at ¶ 18). And eight years later, after several of Smith & Nephew's competitors recalled or removed similar metal-on-metal devices from the U.S. market, Smith & Nephew voluntarily recalled some of the BHR devices because of “unreasonably high failure rates” for all women, all men over the age of sixty-five, and for “all men requiring femoral head sizes 46 mm or smaller.” (Id. at ¶¶ 19-21).

         A. Regulatory Background

         All this was in the future, however, when the device was approved by the Federal and Drug Administration in 2006. The Medical Device Amendments of 1976 (“MDA”) granted the FDA the authority to regulate medical devices. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 476 (1996). The FDA divides devices into three classes. Class I devices require minimal oversight and are least dangerous, while Class III devices are rigorously reviewed and represent the most dangerous devices. 21 U.S.C. § 360c. The BHR system is a Class III device. (MACC at ¶ 160).

         Class III medical devices must receive FDA approval before they may be marketed. 21 U.S.C. § 360e(a). The rigor of the premarket approval process has been well-documented, requiring nearly 1, 200 hours of review and substantial filings for each device, see, e.g., Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 344-45 (2001), including “a full statement of the components, ingredients, and properties and of the principle or principles of operation of such device, ” 21 U.S.C. § 360e(c)(1)(B), “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device, ” 21 U.S.C. § 360e(c)(1)(C), and “specimens of the labeling proposed to be used for such device, ” 21 U.S.C. § 360e(c)(1)(F).

         After the device-maker submits information regarding, among other things, the device's design, manufacture, and safety and effectiveness, 21 U.S.C. § 360e(c)(1), the FDA “weigh[s] 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). If a device receives approval, the manufacturer is forbidden “to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness” unless the manufacturer submits an additional application for FDA review. Riegel v. Medtronic, Inc., 552 U.S. 312, 319 (2008); see also 21 U.S.C. § 360e(d)(5)(A)(i). A manufacturer may, however, change its labeling without FDA approval through the discretionary Changes Being Effected (“CBE”) process to enhance “the safety of the device” with newly acquired information. 21 C.F.R. § 814.39(d)(1).The BHR device received conditional premarket approval from the FDA in 2006. (MACC at ¶¶ 197-200).

         As a condition of approval, the FDA required Smith & Nephew “to evaluate the learning curve, training program, and longer-term safety and effectiveness of the BHR System in the United States, ” to “implement a training program” and “to provide an analysis of adverse events and complaints . . . received regarding the BHR system.” (Def's Mot. Ex. A).[4] Smith & Nephew also was subject to reporting requirements: it was to report to the FDA if the BHR caused or contributed to death or serious injury, 21 U.S.C. § 360i(a)(1)(A), to report such adverse events to the FDA within 30 days after Smith & Nephew became aware of their occurrence, 21 C.F.R. § 803.50(a), and to provide all reasonable information Smith & Nephew possessed on any adverse event, 21 C.F.R. § 803.50(b)(1). Smith & Nephew also was obligated to investigate each adverse report, 21 C.F.R. § 803.50(b)(3), and, if it determined that remedial action was required to prevent substantial harm to public health, to report that information to the FDA within five business days. 21 C.F.R. § 803.53. The FDA may withdraw approval from a device if it determines, based on existing or new information, that “such device is unsafe or ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 360e(e)(1)(A)-(B).[5]

         B. The Birmingham Hip Replacement Device

         The plaintiffs claim Smith & Nephew violated the conditions of FDA approval by misrepresenting the safety of the BHR system “to the medical community, patients, and the FDA.” (MACC at ¶ 24). The plaintiffs allege that they viewed these misrepresentations and that Smith & Nephew was aware they would do so. (Id. at ¶¶ 53-54).

         The plaintiffs also claim that the BHR device was improperly manufactured. They cite evidence demonstrating that the linear wear rate-the degree of wear of the device components caused by the ball part of the artificial joint rubbing against the metal insert in the socket-of the BHR system exceeded the rate identified by Smith & Nephew's own studies and, as a result, failed “to meet manufacturing specifications for hardness, durability, composition, and finish” in violation of the FDA approved specifications. (Id. at ¶¶ 222-25).

         But the heart of the plaintiffs' complaint focuses on Smith & Nephew's unequivocal support for the BHR device's safety despite growing evidence of its risks and Smith & Nephew's failure to report adverse incidents to the FDA.

         Smith & Nephew insisted on the BHR's safety: the company (1) sent a letter in 2010 claiming, among other things, that the BHR system was not associated with an increased risk of disease, (id. at ¶ 64); (2) ran advertisements to reach members of the medical community and patients that claimed the BHR was safer than the average metal-on-metal device, (id. at ¶¶ 72-73); and (3) used Derek McMinn, one of the surgeon-inventors of the device, to claim that the BHR system does not cause metallosis, has a 96% survivorship rate, and, considering all of his surgeries, the device has a low risk of complications. (Id. at ¶ 156). On this last point, the plaintiffs claim that Smith & Nephew misrepresented the difficulty of BHR implant surgeries. The complaint cites a corroborated 2012 article that claimed the revision rate of a BHR surgery was three times higher for the general population than it was for the small number of patients operated on by the team that developed the device. ( ¶¶ 87-89). Neither this article, nor its corroborating study, was allegedly ever provided to the FDA. (Id. at ¶ 90).[6]

         The plaintiffs also claim that Smith & Nephew failed to adequately report adverse incidents involving the BHR device to the FDA. Smith & Nephew allegedly delayed reporting “hundreds of adverse reports and complaints regarding the BHR” system, failing to report entirely that the BHR system was “wearing down more quickly” than Smith & Nephew expected. (Id. at ¶ 201).When it did report adverse events, Smith & Nephew allegedly underreported or withheld information from the FDA “about the likelihood of [the device's] failure.” (Id.).

         C. Failure of Metal-on-Metal Devices and the BHR System

         The plaintiffs claim that because the risks associated with metal-on-metal devices were well-documented, Smith & Nephew knew or should have known of the danger associated with the BHR and, consequently, that the representations described above were false.

         An international consensus on the danger of metal-on-metal hip replacement systems, like the BHR, was formed shortly after Smith & Nephew began marketing its device. An Australian study published results indicating that the BHR revision rate was much higher for women in 2007 and 2008; a study by one of Smith & Nephew's paid researchers, Callum W. McBryde, showed that for every 4-mm reduction in femoral head size the risk of device failure increased four-fold; and another article, this one published in 2012, asserted that the BHR system fails in 26% of women after ten years. (Id. at ¶¶ 99-102).

         The plaintiffs also provide pages of studies detailing the risk associated with metal-on-metal devices more generally. As early as 2006, the United Kingdom's Medicines and Healthcare Products Regulatory Agency, (“MHRA”), warned of shavings caused by friction within metal-on-metal devices, (id. at ¶ 117); in 2008, an Australian warning described a three times higher risk of revision for women with femoral heads smaller than 50 mm, (id. at ¶ 121); and in 2010 the MHRA recommended blood tests for patients with metal-on-metal hip replacements, (id. at ¶ 124), which was supported by a report later that year that detailed the high failure rates in females and indicated that “soft tissue reactions occur[] ¶ 14.2% of revised metal-on-metal devices, ” and “an incident rate of 12.5% for the revised total hip resurfacings, ” (id. at ¶ 128). MHRA followed up on its earlier studies in 2012, recommending that patients with metal-on-metal devices receive annual follow-ups for at least five years. (Id. at ¶ 132). That year, a Canadian health organization also promulgated information encouraging follow-ups. (Id. at ¶ 133). And a year later, the FDA warned doctors and patients about the risks posed by metal shavings produced by metal-on-metal devices. (Id. at ¶ 139).

         The plaintiffs also note that Smith & Nephew employees attended an FDA advisory panel on the dangers of metal-on-metal devices in 2012. (Id. at ¶ 103). And although the defendant's reporting of complaints over about a 12-month period projected a more favorable outlook on the safety of the device, the report was missing thirty complaints, artificially increasing the survivorship rate of the device, according to the plaintiffs. (Id. at ¶ 105).

         In the face of this information, and the withdrawal of competing metal-on-metal systems-Zimmer in 2008, Johnson & Johnson in 2010, Depuy in 2010, and Stryker in 2012, (id. at ¶¶ 120, 122, 126, 136)-Smith & Nephew continued to sell the BHR device, partially removing it from the market only in 2015.


         This is the background of more than 200 separate law suits, consolidated as an MDL, arising out of 42 states and jurisdictions. The plaintiffs' lead counsel have filed a Master Amended Consolidated Complaint to represent the plaintiffs' claims, which alleges that Smith & Nephew committed eight common law violations by misrepresenting the safety of the BHR device, failing to supply adverse incident reports to the FDA, and manufacturing a defective product. (ECF No. 124). They argue that this conduct violated Smith & Nephew's obligations to report adverse incidents to the FDA, to disseminate only truthful and non-misleading information regarding the BHR device, and to manufacture the device as approved by the FDA.

         Smith & Nephew has moved to dismiss these claims, asserting that the plaintiffs' claims are preempted or insufficiently pleaded. (ECF No. 409). Oral argument was heard on January 24, 2018. For the reasons stated below, the motion will be denied in part and granted in part.

         Standard of Review

         To survive a motion to dismiss, the factual allegations of a complaint “must be enough to raise a right to relief above the speculative level on the assumption that all the allegations in the complaint are true (even if doubtful in fact).” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (internal citations omitted). “To satisfy this standard, a plaintiff need not ‘forecast' evidence sufficient to prove the elements of the claim. However, the complaint must allege sufficient facts to establish those elements.” Walters v. McMahen, 684 F.3d 435, 439 (4th Cir. 2012) (citation omitted). “Thus, while a plaintiff does not need to demonstrate in a complaint that the right to relief is ‘probable, ' the complaint must advance the plaintiff's claim ‘across the line from conceivable to plausible.'” Id. (quoting Twombly, 550 U.S. at 570). And the plaintiff typically must do so by relying solely on facts asserted within the four corners of his complaint. Zak v. Chelsea Therapeutics Intern., Ltd., 780 F.3d 597, 606-07 (4th Cir. 2015). The same standard applies to pleading a parallel claim under the Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) preemption standard. Bass v. Stryker Corp., 669 F.3d 501, 509 (5th Cir. 2012) (collecting cases).


         Smith & Nephew argues that the plaintiffs' claims should be dismissed for three reasons: (1) the claims are expressly preempted under the FDA's statutory framework; (2) if the claims are not expressly preempted, they are impliedly preempted; and (3) even if the claims are neither expressly nor impliedly preempted, they have not been sufficiently pleaded. The plaintiffs reject all three arguments, and further claim the court should abstain, for legal and prudential reasons, from considering Smith & Nephew's preemption arguments. The court will consider the plaintiffs' abstention arguments before discussing the parties' disputes over preemption and the sufficiency of the pleadings. The court will conclude that the briefing is sufficient to resolve the motion to dismiss; the plaintiffs' two strict liability claims are expressly preempted; the six remaining claims, at least facially, survive preemption; and all but one of the six surviving claims have been sufficiently pleaded.

         I. Preemption Analysis on Motion to Dismiss

         The plaintiffs insist that this court should leave the preemption analysis to transferor courts on remand, or at least for summary judgment or a jury, because preemption is a fact-specific issue and ...

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