A federal court in Washington produced yet another preemption decision dismissing a complaint in the hip implant litigation.  Hernandez, v. Stryker Corp., 2014 U.S. Dist. LEXIS 171697 (W.D. Wa. Dec. 11, 2014).  The plaintiffs’ complaint referenced two FDA warning letters and a product recall but failed to allege facts connecting any of that to plaintiff’s injury.  Moreover, while the warning letters identified alleged failures to follow cGMPs, plaintiffs alleged nothing to suggest that the FDA specifically imposed those cGMPs on the hip implant device.  And, since parallel violation claims must mirror FDA requirements specific to the approved medical device, plaintiffs’ allegations failed to establish a basis for a parallel violation claim.  Plaintiffs’ express warranty claim had similar flaws.  And so the court dismissed the complaint in its entirely.

Given that this decision, while good, offers no groundbreaking law, and that, more importantly, it’s the holiday season, this is a perfect opportunity for a holiday jingle. Last week, Paul McCartney discussed his song Wonderful Christmas Time on the Tonight Show.  Perfect.  For those who need to rekindle the tune in their heads, here it is.

With that melody in mind, we present: Simply Suing One More P-M-A Device.

Approved device, by FDA
That’s very nice, sue anyway
Simply suing one more P-M-A device
Simply suing one more P-M-A device

A Warning Letter, product recall
That’s all we need, let’s file ‘em all
Simply suing one more P-M-A device
Simply suing one more P-M-A device

The choir of lawyers sings their song

They do it all year long
Ding-dong, ding-dong, ding-dong, ding
Ooh, ooh, ooh, ooh, ooh
Ooh, ooh, ooh, ooh, ooh

Simply suing one more P-M-A device
Simply suing one more P-M-A device

But word is out, the courts can hear
TwIqbal them out, there’s nothing here
Simply suing one more P-M-A device

The choir of lawyers sings their song
They do it all year long
Ding-dong, ding-dong, ding-dong, ding
Ooh, ooh, ooh, ooh, ooh
Ooh, ooh, ooh, ooh, ooh

Preemption’s on, the feeling’s here
Complaint is gone, it’s time for cheer
Simply suing one more P-M-A device
They’re simply suing one more P-M-A device
Simply suing one more P-M-A device