Felger v. Smith & Nephew, Inc.

222 F. Supp. 3d 746, 2016 U.S. Dist. LEXIS 186112, 2016 WL 8673054
CourtDistrict Court, D. Alaska
DecidedMarch 4, 2016
DocketNo. 3:15-cv-0210-HRH
StatusPublished
Cited by1 cases

This text of 222 F. Supp. 3d 746 (Felger v. Smith & Nephew, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Alaska primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Felger v. Smith & Nephew, Inc., 222 F. Supp. 3d 746, 2016 U.S. Dist. LEXIS 186112, 2016 WL 8673054 (D. Alaska 2016).

Opinion

ORDER

H. Russel Holland, United States District Judge

Motion to Dismiss

Defendant moves to dismiss plaintiffs complaint.1 This motion is opposed.2 Oral argument was requested but is not deemed necessary.

Background

Plaintiff is Kimerly Dale Felger. Defendant is Smith & Nephew, Inc.

Defendant designed, manufactured, and marketed the Birmingham Hip Resurfacing (BHR) System, which is used in total hip replacements (THR). The BHR System is a Class III medical device. “A Class III device is subject to a pre-market approval [PMA] process of the” Food and Drug Administration (FDA). Stengel v. Medtronic Inc., 704 F.3d 1224, 1226 (9th Cir. 2013).

The FDA’s pre-market approval process of a Class III device is rigorous. The FDA performs a risk-benefit assessment of the device and determines the adequacy of the manufacturer’s proposed label. The FDA then denies, approves, or approves with conditions on distribution, marketing, or sale.

Id. (citations omitted). “The FDA spends an average of 1,200 hours reviewing each [PMA] application and grants premarket approval only if it finds there is a reasonable assurance of the device’s safety and effectiveness[.]” Riegel v. Medtronic, Inc., 552 U.S. 312, 318, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008) (internal citations omitted). The PMA application includes

among other things, full reports of all studies and investigations of the device’s safety and effectiveness that have been published or should reasonably be known to the applicant; a full statement of the device’s components, ingredients, and properties and of the principle or principles of operation; 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; samples or device components required by the FDA; and a specimen of the proposed labeling.

Id. (citations omitted).

Even after pre-market approval is granted, there are post-approval statutory and regulatory requirements the manufacturer must satisfy, in addition to any post-approval conditions the FDA imposes on the specific device subject to the PMA. In general, the manufacturer must refrain from manufacturing, packaging, storing, labeling, distributing or advertising the medical device “in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device.” 21 C.F.R. § 814.80. In addition, the manufacturer must report deaths and serious injuries that the device “has or may have caused or contributed to” and certain device malfunctions, and it “must establish and maintain adverse event files,” and “submit specified followup.” 21 C.F.R. §§ 814.84(a) (must comply with Part 803 reporting requirements); [750]*750803.1(a) (general statement of reporting requirements).

Herron v. Smith & Nephew, Inc., 7 F.Supp.3d 1043, 1048 (E.D. Cal. 2014).

The BHR was approved by the FDA on May 9, 2006, with conditions.3 Defendant was required to submit a PMA supplement “when unanticipated adverse effects, increases in the incidence of anticipated adverse effects, or device failures necessitate a labeling, manufacturing, or device modification.” 4 Defendant also agreed “to conduct a study to evaluate the learning curve, training program, and longer-term safety and effectiveness of the BHR System in the United States.”5 As part of the study, “cobalt and chromium ions concentration in the blood and renal function data ... w[ere to] be collected postoperatively and at the 1-, 4-, and 10-year follow-up timepoints.”6 Defendant also agreed “to provide an analysis of adverse events and complaints .., received, regarding the BHR system” and to “use this analysis to provide a justification for modifications to the training program, post-approval study, labeling, and/or device design.”7

Plaintiff alleges, however, that defendant

failed to timely report adverse events; failed to timely conduct ... investigations and analysis; failed to timely report any and all information concerning product failures and corrections; failed to timely and fully inform [the] FDA of unanticipated adverse events, increases in the incidence of adverse effects, or device failures necessitating a labeling, manufacturing or device modification; failed to conduct necessary design validation; and sold a misbranded and adulterated product.[8]

On October 30, 2008, plaintiff underwent a left total hip replacement during which a BHR System was implanted.9 Plaintiff alleges that

[t]he defective design and manufacture of the BHR allows fretting and corrosion to occur at the junction of the head of the Birmingham cup and the Acetabular lining. The fretting and corrosion allows metal ions, including cobalt and chromium, to be released into the surrounding tissues. The fretting and corrosion and release of ions also manifest in increased cobalt and chromium blood levels of the patient. These cobalt and chromium ions destroy surrounding tissue and bone often causing pseudo tumors and a condition called metallosis.[10]

Plaintiff alleges that “[a]fter the surgery, fretting and corrosion from the BHR THR caused large amounts of toxic metal ions and particles to be released from the [751]*751BHR into and throughout [plaintiffs blood stream, organs, and soft tissue.”11 Ultimately, it was recommended that plaintiff “have the BHR in her left hip removed through a painful, expensive, and risky hip revision surgery.”12 On October 19, 2013, plaintiff had the revision surgery, which “demonstrated that she had significant tissue necrosis, both chronic and acute tissue and joint inflamation in the area of the Smith and Nephew BHR THR, all symptoms of metallosis. In addition, her blood cobalt levels were found to be elevated at 47 ng/L.”13

Plaintiff alleges that her injuries “were caused by the defective design and construction, lack of adequate warnings, lack of adequate notice once problems with the BHR were known, and the unreasonably dangerous character of the BHR THR that was implanted,”14 She alleges that had defendant “not concealed the known defects, the early failure rate, the known complications and/or the unreasonable risks associated with the use of the BHR, [she] would have not consented to be implanted with the BHR.”15

On October 9, 2015, plaintiff commenced this action in state court. On'November 2, 2015, defendant removed the action to this court on the basis of diversity jurisdiction.

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222 F. Supp. 3d 746, 2016 U.S. Dist. LEXIS 186112, 2016 WL 8673054, Counsel Stack Legal Research, https://law.counselstack.com/opinion/felger-v-smith-nephew-inc-akd-2016.