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Jana Goldin v. Smith & Nephew

April 24, 2013


The opinion of the court was delivered by: J. Paul Oetken, District Judge:


This is a products liability case brought by Plaintiff Jana Goldin against Defendant Smith & Nephew, Inc. with respect to the R3 Constrained Acetabular Liner. Defendant has filed a motion to dismiss the Complaint. For the reasons that follow, Defendant's motion is granted and Plaintiff is granted leave to file an amended complaint within the next 60 days.


Following a diagnosis of loss of joint space, Plaintiff underwent right total hip replacement in July 2009. Approximately four months later, Plaintiff developed right groin pain. Testing revealed that she had developed a mental sensitivity. On May 4, 2010, Plaintiff underwent revision and exchange of the metal components with metal and polyethylene components. After this revision surgery, Plaintiff experienced three episodes of recurrent instability, each consistent with anterior dislocation. As a result, her physician recommended that she undergo revision total hip replacement with conversion to a constrained liner.

On June 8, 2010, Plaintiff had revision surgery performed at New York University Hospital for Joint Diseases, utilizing the Smith & Nephew 56mm R3 acetabular component with screw fixation, 22mm inside diameter constrained polyethylene liner, and 22mm  modular femoral head. Smith & Nephew had marketed the R3 Constrained Liner for patients at high risk of dislocation due to a history of dislocation, and the R3 Constrainer Liner was recommended to Plaintiff by her surgeon, and accepted by Plaintiff, based on this representation. After the prosthesis was fully implanted, Plaintiff's surgeon placed Plaintiff's hip through a full range of motion and found the components to be secure with excellent stability. An x-ray taken the day of the surgery showed the components to be in good position and alignment, as did x-rays taken at a six-week follow-up visit. At that follow-up visit, Plaintiff was noted to be making good progress toward regaining her range of motion, ambulation, and overall function. She was advised to begin increasing her physical activities and was told that she could return to work on July 26, 2010.

On August 12, 2010, Plaintiff was taking a shower when she experienced excruciating pain in her right hip. She was taken by ambulance to the NYU Hospital for Joint Diseases, where x-rays revealed that the right femoral head had become dislodged from the polyethylene liner. The liner itself was not displaced, leading the surgeon to conclude that the problem was with the constrained liner. Because of this failure of the constrained liner, Plaintiff was advised to undergo another revision surgery. During that surgery, the surgeon checked the acetabular component and found the screws to be secure and in the proper position. A liner with a 20 degree offset was chosen to enhance stability, trial reductions were performed to find components with a good range of motion and stability, and a 40mm modular femoral head and  sleeve were selected and impacted into place. The femoral head was reduced onto the acetabular component, and the implant checked and found to provide good stability and range of motion. On August 13, 2010, Smith & Nephew issued a voluntary recall of R3 Constrained Acetabular Liners, warning of the risk of intra-operative and post-operative dislocation.

Plaintiff filed suit against Smith & Nephew on November 28, 2012 in the Supreme Court of the State of New York, County of Bronx. Her Complaint alleged causes of action for strict products liability under manufacturing defect, design defect, and failure to warn theories of liability, breach of implied warranty, breach of express warranty, negligence, and violations of New York's consumer protection statute. On December 18, 2010, Smith & Nephew filed a notice of removal to this Court. On January 25, 2013, it filed a motion to dismiss.

II.Standard of Review

To survive a motion to dismiss pursuant to Federal Rule 12(b)(6), a plaintiff must plead sufficient factual allegations "to state a claim to relief that is plausible on its face." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007). A claim is facially plausible "when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). In other words, the "[f]actual allegations must be enough to raise a right to relief above the speculative level." Twombly, 550 U.S. at 555. The Court must accept as true all well-pleaded factual allegations in the complaint, and "draw [ ] all inferences in the plaintiff's favor." Allaire Corp. v. Okumus, 433 F.3d 248, 249-50 (2d Cir. 2006) (internal quotations omitted). That said, "the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Iqbal, 556 U.S. at 678. In a recent summary of the plausibility standard, the Second Circuit explained that:

[Twombly] stated that a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, but mere labels and conclusions or formulaic recitations of the elements of a cause of action will not do; rather, the complaint's factual allegations must be enough to raise a right to relief above the speculative level, i.e., enough to make the claim plausible.

Arista Records, LLC v. Doe 3, 604 F.3d 110, 120 (2d Cir. 2010) (quoting Twombly, 550 U.S. at 555, 570) (quotation marks and internal citations omitted). The Circuit clarified that this rule "does not impose a probability requirement at the pleading stage; it simply calls for enough facts to raise a reasonable expectation that discovery will reveal evidence of illegality." Id. (citing Twombly, 550 U.S. at 556) (quotation marks omitted).


A.Strict Liability

1.Manufacturing ...

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