There are lots more cases recognizing broad preemption in product liability cases involving pre-market approved (PMA) medical devices than refusing to, but strange things happen in tort preemption cases, so we don’t view anything – especially in state court – as a sure thing.
Blog reader Alan Lazarus over at Drinker Biddle has just (and we do mean just) sent us a favorable PMA preemption opinion, Blanco v. Baxter Healthcare Corp., G038255 (Cal. App. 4th Dist. Jan. 11, 2008), for publication (that matters because in California you can’t even cite unpublished appellate cases). Here it is – hot off the presses (now reported at 70 Cal. Rptr.3d 566).
In Blanco, the PMA device is an artificial heart valve. It was subject to a Class 1 (the most serious) FDA recall. The plaintiff died from the complication that prompted the recall.
Even though these weren’t the greatest facts, preemption nevertheless prevailed, and the entire product liability case was dismissed. Blanco is thus a prime example of why we describe preemption as the most a powerful defense a drug or device manufacturer has at its disposal.
There are two prior California appellate PMA preemption decisions, Steele v. Collagen Corp., 54 Cal.App.4th 1474 (3d Dist. 1997), and Armstrong v. Optical Radiation Corp., 50 Cal.App.4th 580 (2d Dist. 1996). Steele found preemption, Armstrong didn’t. Neither was controlling on Blanco, since in California intermediate appellate courts from different districts may (and often do) disagree with each other.
Blanco’s rationale is: (1) PMA approval imposes preemptive, device specific federal requirements; (2) state common-law actions impose requirements that may be preempted; and (3) the plaintiffs’ claims – negligent manufacturing (no claim of FDCA violation was made), negligent warning, strict liability – would differ from or add to the requirements imposed by the FDA on the device by virtue of PMA approval. The most important specific argument is on page 20, explaining why the recall did not preclude preemption.
Oh yes, and by the way, implied warranty was barred by lack of privity, so preemption was not reached.
We’re happily updating the device preemption to add this one to the win column.
Way to go, Alan.