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Lafountain v. Smith & Nephew Inc.

United States District Court, D. Connecticut

July 18, 2016

ROXANNE LAFOUNTAIN, Plaintiff,
v.
SMITH & NEPHEW, INC., Defendants.

          MEMORANDUM OF DECISION ON DEFENDANT’S MOTION TO DISMISS

          Warren W. Eginton, Senior U.S. District Judge.

         This case stems from two failed hip replacement surgeries that involved implant parts designed, constructed, manufactured and sold by Smith & Nephew, Inc. Plaintiff Roxanne LaFountain underwent two surgeries at St. Vincent’s Medical Center in Bridgeport, Connecticut, on August 25 and November 10, 2009, respectively.

         Plaintiff alleges that defendant Smith & Nephew is liable to her under the Connecticut Product Liability Act (“CPLA”). In her fourth amended complaint, plaintiff alleges theories of strict products liability; breach of express and implied warranty; negligence; and innocent and negligent misrepresentation. Plaintiff’s product liability claims relate to the defendant’s design, testing, warnings, marketing, distribution, and warranties associated with the hip replacement system and its component parts.

         Defendant has filed a motion to dismiss on the basis of preemption pursuant to the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act (“FDCA”). Defendant also argues that plaintiff has failed to state a claim.

         I. BACKGROUND

         The following factual background is reflected in the allegations of the complaint that are considered to be true for purposes of ruling on this motion to dismiss. The Court also includes facts that are reflected in official public documents of which the Court takes judicial notice. See Apotex Inc. v. Acorda Therapeutics, Inc., - F.3d -, 2016 WL 2848911, at *5 (2d Cir. May 16, 2016).

         Defendant was involved in the manufacture, design, and marketing of healthcare products, including the hip replacement system and component parts that were used for plaintiff’s hip replacement.

         Prior to plaintiff’s surgeries, defendant had received Section 510(k) approval from the United States Food and Drug Administration (“FDA”) for (1) the Class II Reflection Acetabular System (“R3 Acetabular System”), which is an implant used for total hip replacement procedures. The R3 Acetabular System consists of the Acetabular Cup (“R3 Acetabular Shell”) and one of several possible liners used for primary and revision hip replacement surgery; it is used with defendant’s Echelon Hip Stems, Modular Femoral Heads and Modular Head Sleeves manufactured from cobalt chrome materials.[1] Defendant had also received FDA Section 510(k) Class II approval for these components prior to plaintiff’s hip replacements.

         Prior to plaintiff’s surgeries, defendant had received FDA premarket approval for marketing the Birmingham Hip Resurfacing System (“BHR”), a Class III “metal on metal resurfacing artificial hip replacement system.” In 2008, the R3 Acetabular Liner became a Class III component to be used with the BHR System. As of February 2009, defendant marketed the R3 Acetabular Liner for use with the R3 Acetabular System.

         On August 25 and November 10, 2009, plaintiff underwent left and right hip replacements, respectively. Plaintiff’s doctor decided to use the R3 Acetabular Liner with a hip replacement system other than the BHR System for which it was approved (an off-label use of a Class III device).

         Plaintiff’s Claims

         Plaintiff alleges that the implanted devices, the R3 Acetabular Liners, Modular Femoral Heads, Modular Head Sleeves and Echelon Hip Stems caused the accelerated release of metal debris and ions into her body and blood stream, which resulted in her having to endure pain, difficulty walking and additional surgeries.

         In her strict liability count, plaintiff asserts, inter alia, that defendant defectively designed the R3 Acetabular Liner by using cobalt-chrome materials; sold it without adequate warnings about its associated risk of causing accelerated release of metal debris and ions and other complications such as pain and infection; improperly marketed it for use with the R3 Acetabular System; violated FDA standards for obtaining FDA approval; misrepresented information to the FDA; improperly misbranded its R3 Acetabular Liner to be used in applications other than the BHR System; and failed to comply with FDA monitoring and reporting requirements.

         Plaintiff alleges, inter alia, that defendant defectively designed and manufactured the Echelon Hip Stem, Modular Femoral Head and Modular Head Sleeve by using cobalt-chrome materials; improperly marketed them without adequate warnings about their associated risks including the accelerated release of metal debris and pain and infection; misrepresented information to the FDA; and failed to comply with FDA post-marketing surveillance requirements.

         In her breach of express and implied warranty claims, plaintiff alleges that defendant expressly warranted that the R3 Acetabular Liner, the Modular Femoral Head, Modular Head Sleeve, and Femoral Stem were safe for their intended uses despite having knowledge that these devices had a design flaw that could likely lead to plaintiff’s injuries. Defendant allegedly violated the express warranties of these device by “underplaying” the negative results associated with the use of the medical devices. Defendant impliedly warranted that these devices were of merchantable quality, and it breached this warranty when it delivered them to be used in plaintiff’s surgeries despite the inherent design flaw. Defendant knew that the devices had a likelihood of causing complications based on their intended uses and failed to disclose that information to plaintiff or her surgeon.

         In her negligence claim, plaintiff asserts that defendant knew or should have known that the R3 Acetabular Liners had not been subjected to appropriate FDA approval due to defendant’s manipulation of the premarket approval process; failed to test the Liner to determine whether it could be safely implanted into a patient’s body when used with a metal femoral head; failed to focus its testing of the R3 Acetabular System or the BHR System with use of the R3 Acetabular Liner; failed to provide proper warnings; designed, manufactured and fabricated the Liner in such a manner that it was subject to corrosion and failure when used in combination with its Femoral Heads; failed to comply with certain FDA requirements; and failed to subject the Liner to proper testing.

         Relevant to the Echelon Femoral Stem, Modular Femoral Head, and Modular Head Sleeve, plaintiff asserts that defendant failed to adequately test the devices; failed to provide proper warnings; designed and manufactured the devices in such a manner to cause an accelerated release of metal debris and ions; underreported and withheld information about the flaws in the devices; misrepresented information about the devices to the FDA; and failed to update the FDA with new information about the complications associated with the devices.

         Plaintiff also alleges that defendant delayed its voluntary recall of the Modular Femoral Head and Head Sleeve despite being aware of information demonstrating a decline in its performance.

         In her final count of innocent and negligent misrepresentation, plaintiff asserts that defendant should have known that its representation of the R3 Acetabular Liner’s safety and effectiveness was false because defendant could have discovered the inherent design defect; ignored test results demonstrating the inherent defect; failed to timely report the negative test results and adverse health events; failed to accurately report the increased risk of failure to plaintiff’s surgeon; promoted the use of the R3 Acetabular Liner prior to gaining appropriate FDA approval; and marketed the R3 Acetabular Liner for use in applications other than the BHR System.

         II. DISCUSSION

         The function of a motion to dismiss is “merely to assess the legal feasibility of the complaint, not to assay the weight of the evidence which might be offered in support thereof.” Ryder Energy Distrib. v. Merrill Lynch Commodities, Inc., 748 F.2d 774, 779 (2d Cir. 1984). When deciding a motion to dismiss, the Court must accept all well-pleaded allegations as true and draw all reasonable inferences in favor of the pleader. Hishon v. King, 467 U.S. 69, 73 (1984). The complaint must contain the grounds upon which the claim rests through factual allegations sufficient “to raise a right to relief above the speculative level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). A plaintiff is obliged to amplify a claim with some factual allegations to allow the court to draw the reasonable inference that the defendant is liable for the alleged conduct. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).

         A. ...


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