We were both frustrated and unsurprised with the decision in Dwyer v. Boston Scientific Corp., 2015 WL 3384894 (Mass. Sup. Ct. Apr. 2, 2015). 

Our frustration comes from the Court’s treatment of the ever-so-hard-to-pin-down concept of parallel violation claims.  The plaintiff was the surviving wife a man who died from head injuries suffered during a fall that happened after the failure of his implanted defibrillator.  Id. at *1.  The manufacturer, Boston Scientific, received PMA approval for the defibrillator.  That means that the plaintiff’s state law claims are preempted unless they parallel federal regulations.  And the court believed that they did.

But the court’s reasoning is a bit troubling, particularly because it relies on the Bausch case that we love to criticize.  The plaintiff alleged that the defendant violated a whole host of Current Good Manufacturing Practices (cGMPs) found in FDA regulations.  Even though these cGMPs are general in nature and not specific to the defibrillator (e.g., assign trained personnel, establish procedures to ensure components conform to requirements, maintain procedures for corrective action), the Court held that the plaintiff could sue for their violation:

This court agrees with the Seventh Circuit’s reasoning that there is no “sound legal basis ... to distinguish between general requirements [such as the CGMPs] and ‘concrete, device-specific’ requirements [such as those related to the PMA process]” given that 21 U.S.C. § 360k(a) uses the phrase “‘any requirement.’ And federal law is clear: for manufacture’s of Class III medical devices, the ... [CGMPs] adopted by the FDA ... are legally binding requirements ‘under [the FDCA].’”  Bausch, 630 F.3d at 555, quoting 21 U.S.C. § 360k(a).

Id. at *5.  

There are a number of problems with this reasoning, not the least of which is that the use of these general, non-product-specific regulations leaves a jury with wide discretion on what is or is not improper under the regulations.  Yet there is little reason to assume that every jury, faced with general language in a general regulation, would see it the same way as the FDA.  And that creates a great risk that the jury will apply a standard “in addition to” or “different from” that of the FDA – the very reason that such claims should be preempted in the first place.  

Moreover, as readers of this blog well know, there is no private right of action under the FDCA.  But this sure seems like one. The plaintiff simply took cGMPs and sought to enforce them through various state law claims, none of which say anything about cGMPs, FDA regulations or implanted defibrillators.  Turning state defect and warranty claims into methods for enforcing FDA regulations seems to vitiate the ban on private rights of action under the FDCA.  All the while, it gives juries the opportunity to interpret and apply general FDA regulations in myriad ways that differ from how the FDA would likely do it.  

That said, our pragmatic side accounts for our lack of surprise at this decision.  Why?  The manufacture sent a detailed letter to the husband’s cardiologist explaining why the defibrillator failed, mentioning things like damaged device circuitry and a lack of pacing output.  Id. at *1-2.  Frankly, with a letter like that, we were a bit surprised that the plaintiff couldn’t find a product-specific manufacturing regulation that may have been violated.  A complaint and decision mentioning such a product-specific PMA requirement would have made a lot more sense to us, maybe even enough for us to ignore the fact that plaintiff’s claims would still seem to be an effort to privately enforce the FDCA.