Tuesday, December 10, 2013

Hip Implant Litigation Part II – TwIqbal Plus Preemption



Yesterday we blogged about Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS (E.D.N.Y. July 15, 2013) – a hip implant case that was dismissed because the court found the complaint woefully deficient.  Keeping with the same subject matter, today we have another hip implant case, from a neighboring court, with another insufficient complaint, plus a positive preemption ruling.  Sort of a variation on a theme.

In Simon v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 170413 (S.D.N.Y. Dec. 3, 2013), plaintiff also alleged that she was injured by implantation of the R3 Acetabular System.  It’s important to the preemption discussion to know a little bit more about the device.  The R3 System includes a liner component made of cross-linked polyethylene (non-metal).  Id. at *6.  The R3 System, with its non-metal liner, received §510(k) approval (“substantial equivalence”) from the FDA.  Id.  Defendant also manufacturers the Birmingham Hip Resurfacing ("BHR") System -- a separate PMA-approved device.  The BHR System was designed to be used with a metal liner.  As part of the BHR System, the metal liner also received PMA approval.  Id. at *7.  Plaintiff’s surgeon opted to implant the R3 System with the metal liner from the BHR System.  Id.at *2.

Plaintiff alleged three causes of action:  negligence, strict liability design defect, and breach of implied warranty.  The court dismissed all three for roughly the same reasons.  If the crux of plaintiff’s allegations are that her injury was caused by the R3 System as a whole – her complaint fails to state a claim.  If she is alleging injury from the metal liner component alone – her claims are preempted.

First, it appears that plaintiff’s sole argument against preemption is that the R3 System was approved via the §510(k) process, not the PMA process.  Id. at *14-15.  While plaintiff is correct that the approval process impacts the preemption analysis, she was incorrect about which applied to her case.  A device’s approval applies equally to each of its components.  Therefore,

even if the Amended Complaint were fairly read to assert a claim of design defect based solely on the optional metal liner, any such claim would be preempted. That is because the optional metal liner received supplemental PMA approval in conjunction with the BHR System. As noted, design defect claims regarding a PMA-approved device are squarely preempted by the MDA.

Id. at *20.  Plaintiff’s other causes of action suffered the same preemption fate.  Since “claims of negligent manufacture with respect to PMA-approved devices are preempted . . . . to the extent that Simon means to claim negligence on the ground that the optional metal liner was defective, her negligence claim is preempted.”  Id. at *22-23.  See id. at *26-27 (implied warranty claim preempted if based on PMA-approved component).  

Plaintiff’s claims regarding the R3 System as a whole didn’t fare much better – because plaintiff mistakenly included the metal liner component as part of the R3 System.  Plaintiff alleged that she was injured by the R3 Acetabular System, including the optional metal liner component.  Id. at *15.  But, the R3 System, as approved by the FDA, nowhere mentions an “optional metal liner component.”  Therefore, the complaint “does not allege any facts that could plausibly indicate that a Smith & Nephew product, as designed, was defective and caused her injuries.”  Id. at *16-17. 

There are no concrete factual allegations to support the claim that the R3 Acetabular System was defective as designed. To the extent that the Amended Complaint implies that the inclusion of an optional metal liner in that system rendered it defective, that claim is defeated by the fact that the R3 Acetabular System, as reviewed and approved by the FDA, did not contain any such liner.

Id. at *26 (dismissing breach of implied warranty claim on same ground).

We are well aware that it is common for surgeons to substitute parts and components of devices as they see fit using their medical knowledge and judgment.  But that’s a surgeon’s choice.  Here, the defendant did not design the metal liner to be used in conjunction with the R3 System.  And,

Without concrete allegations tying Smith & Nephew to the decision to make such use of the optional metal liner component, however, this conduct does not state a claim for strict products liability, let alone on a design defect theory.

Id. at *17.  Like in yesterday’s case, the court was unpersuaded by allegations regarding defendant’s voluntary recall of the metal liner.  In this case, the court found that such allegations didn’t support a design defect claim with respect to the R3 System – because the R3 System didn’t include a metal liner.  Id.  

The court found that plaintiff’s negligence claim as to the overall R3 System failed for the same reasons.  Id. at *21-22.  But, the court also went on to detail how the negligence allegations were factually deficient under TwIqbal:

The Amended Complaint contains a long list of conclusory allegations as to the ways in which Smith & Nephew was purportedly negligent in designing the R3 Acetabular system. . . .But the Amended Complaint does not contain any concrete factual allegations to back up these legal conclusions. In short, there are not specific allegations plausibly indicating that the R3 Acetabular System was defective or that Smith & Nephew breached a duty of care; the Amended Complaint instead is limited to rote incantations of the elements of negligent manufacture.

Id. at *23-24.

Finally, we want to point out that the court took judicial notice of records on the FDA website.  Id. at *6 n.2.  Another great decision on hip implants.    

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