Source: https://www.druganddevicelawblog.com/2015/04/a-jam-packed-hip-implant-case-fro.html
Timestamp: 2019-08-21 14:00:10
Document Index: 778290866

Matched Legal Cases: ['§510', '§510', '§ 510', '§510', '§ 510', '§ 510']

A Jam Packed Hip Implant Case From the Eastern District of Pennsylvania | Drug & Device Law
Home » A Jam Packed Hip Implant Case From the Eastern District of Pennsylvania
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.
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).
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.
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.
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.