Photo of Michelle Yeary

This post is from the non-Reed Smith side of the blog.

Today’s case is no “mixed bag,” no cautionary tale. We don’t have to look for a silver lining or a rose among the thorns.  Rather, Shuker v. Smith & Nephew, PLC, 2015 U.S. Dist. LEXIS 43141 (E.D. Pa. Mar. 31, 2015) is one of those cases that just keeps giving and giving and giving.  We’ve got component parts, preemption, off-label use, failure to report, pleading deficiencies, and plenty of other small but delightful nuggets. So we’ll get straight to it.

In April 2009, plaintiff underwent a total hip replacement. Id. at *12.  Plaintiff eventually had to have multiple revision surgeries to correct and alleviate complications from the original hip replacement.  The lawsuit ensued alleging claims for  (1) negligence/negligence per
se, (2) negligence based on violations of FDA regulations and FDCA provisions, (3) strict products liability, (4) breach of express warranty, (5) breach of implied warranties of merchantability, (6) fraud, and (7) loss of consortium.  Id. at *39-40.

For the hip replacement, plaintiff’s surgeon opted to use components from defendant’s R3 System and a metal liner which is a component of defendant’s BHR System.  Id. The R3 System is a hip replacement system.  It is a Class II medical device that was cleared via the §510k process.  Id. at *4.  The BHR System is a hip resurfacing system.  It is a Class III medical device that received pre-market approval from the FDA.  Id. at *6.  The Supreme Court has held that PMA approved devices, having undergone a rigorous safety review, are subject to federal requirements that implicate the express preemption provision of the MDA.  Hence, any claims that seek to
impose requirements on PMA devices that are different form or in addition to federal requirements are preempted.  Only claims that parallel federal regulations can survive preemption (Riegel preemption).  Devices cleared via the §510k process have been held not to invoke the same preemption issues.  Id. at *21-24.

So, the first question for the court was whether PMA preemption applies in a situation where a surgeon opts to use a PMA approved component in conjunction with components from a § 510(k)-cleared device.  Id. at *24-25.  The answer is yes.  Plaintiff made two primary arguments in opposition.  First, because the majority of the components used in his surgery were from the §510k cleared device, that should control.  On this point, the court notes that plaintiff’s allegations almost exclusively focus on the safety and effectiveness of the metal liner itself. Therefore, the court’s legal analysis was similarly focused.  Because the metal liner was approved as part of the BHR System, it received PMA approval and was subject to PMA preemption.  Id. at *27-28.

Second, plaintiff argued that because his surgeon chose to use components from two different systems, the actual device implanted had not gone through either 510k clearance or PMA approval.  Here, the plaintiff attempted to rely on case law that has held that the preemption analysis must be applied to the device as a whole, not its component parts.  But, as the court notes, those cases didn’t involve off-label use.  In the cases cited by plaintiffs, physicians used PMA approved devices, certain components of which had separately received 510k clearance.

In that situation, courts have uniformly rejected the argument that the § 510(k)-cleared component was not subject to express preemption, holding the approval of a PMA supplement incorporating the § 510(k)-cleared component extended premarket approval to the entire device.

Id. at *30 (citations omitted).  Unlike in those cases, the only approval the metal liner used in plaintiff’s surgery has gone through is PMA-approval – and that is the standard to which the manufacturer is accountable.  The court correctly held that the surgeon’s choice to use the component off-label doesn’t alter the preemption analysis:

But while the FDA considers the intended use of a device in determining whether to grant premarket approval, the requirements such approval imposes on a device are not use-specific, as the FDA does not regulate the use of medical devices–or their components–by physicians, who remain free to use such devices in an off-label manner. In other words, by granting premarket approval, the FDA requires the manufacturer of an approved device to place the device on the market in the form–and accompanied by the warnings and indications for use– approved by the agency, but does not prevent physicians from using the device in a different manner.

Id. at *33-34.  On this, the court joins the many courts who have reached the same conclusion – off-label use does not negate PMA preemption.  (see our posts on the InFuse litigation).

So, if PMA preemption applies, what did that mean for plaintiff’s claims?  First the court had to try to determine what plaintiff’s claims actually were, finding the pleadings “broad-ranging and extremely general.” Id. at *40.  What the court was able to piece together was that to the extent plaintiff’s negligence, strict liability, and implied warranty claims relate to the safety of the metal liner, they are preempted.  Id. at *42.  Plaintiffs alleged that some of their claims concerned the R3 System, which would not be covered by PMA preemption.  But the court concluded that the only such claim was one for failure to warn – challenging the warnings that accompanied the R3 System as opposed to the metal liner.  The claim was that the R3 System should have included warnings about use of the metal liner with the R3 System, but that necessarily would have required the defendant to include warnings about the metal liner that the FDA did not require:

A warning against using the R3 metal liner with the R3 System in a hip replacement procedure is undoubtedly a warning that “relates to the safety or effectiveness” of the liner, regardless of whether the warning accompanies the liner or another component. Allowing Plaintiffs to pursue a claim that the components of the R3 System should have included such a warning would thus effectively impose a state-law requirement “with respect to” the liner that is “different from, or in addition to,” the warnings the FDA required. The Court therefore concludes such a claim is no different, for preemption purposes, than a claim challenging the warnings accompanying the liner itself.

Id. at *44-45.

That leaves plaintiff’s claims for breach of express warranty, fraud, and negligence based on violations of the FDCA still standing after preemption.  The express warranty claim was the first to be dismissed for pleading deficiencies.  The complaint did not adequately describe the source or the content of the warranty, nor did it allege how plaintiff or his surgeon became aware of the warranty. Id. at *46-47.

The fraud and negligence based on violations of federal regulations are the claims the court found could potentially survive as parallel claims.  But again, plaintiff’s pleadings were sub-par:

Although defendants devote twenty pages–approximately one-third of the Second Amended Complaint–to cataloging these alleged violations, they offer no legal support for, or explanation of, most of the theories they seek to advance in their briefing of S&N’s motion for summary judgment or their own motion for leave to amend. As a result, the Court is left to parse a lengthy laundry list of FDCA provisions and FDA regulations.

Id. at *50.  You never want the court to have to “parse” through your allegations or arguments – it usually means there’s not much there (or else you would have spelled it out).

True to that, the court found that the primary focus of plaintiff’s FDA violations and fraud claims was off-label promotion. Citing many of the InFuse rulings, the court acknowledged that “federal law has generally been interpreted to prohibit off-label promotion, at least when it is false and misleading.”  Id. at *51.  But the court determined that it did not need to decide the proper scope of a parallel off-label promotion claim because “[p]laintiffs have not pleaded facts supporting a plausible inference that Defendants engaged in off-label promotion of the [ ] metal liner that influenced the selection of the liner for use in [plaintiff’s] surgery.”  Id. at *53. While plaintiff cites to a press release about the liner being an option for the R3 System, he does not allege that he or his surgeon ever saw the release, or that it caused plaintiff’s surgeon to use the liner in this case.  Id. at *55.  These deficiencies in plaintiff’s pleadings led the court to dismiss both the fraud claim and the negligence claim to the extent it was premised on off-label promotion – but with leave to amend.

Finally, the last portion of plaintiff’s negligence based on FDCA violations claim (that the court could decipher) was failure to report adverse events.  Our old Stengel favorite.  While we believe Buckman implied preemption should be the start and end of this claim, the court here focused more on plausibility – demonstrating why even in those jurisdictions that allow this claim to survive preemption, causation remains a significant hurdle.  As the court notes, “there must be some factual basis from which it can plausibly be inferred that [adverse] events occurred and that Defendants failed to report them during the six-month window in question.” Id. at *60 (plaintiff’s surgery took place 6 months after the metal liner received PMA approval in the U.S.).  Further, even if plaintiff did have support for his contention that events went unreported, he failed to allege that “information about those events would have reached [plaintiff’s surgeon] in time to prevent [plaintiff’s] injuries.  Id. at *61.  Any allegation that the FDA would have taken corrective action is completely conclusory. So the failure to report claim was dismissed with prejudice.

All that plaintiff has left is the potential for an off-label promotion claim, but plaintiff has to plead allegations that meet that heightened standard for fraud – a significant hurdle as we’ve seen in InFuse. And we are hopeful that stripped of all the other claims alleged in the current complaint, the court will be able to focus more closely on the off-label promotion claim and render an equally well-considered opinion on that issue.