Thus, though it may have been time-consuming and expensive for [defendant] to change the design of its fentanyl patch, it was not impossible for [defendant] to change its design to [the alternative] design prior to FDA approval. As a result, it was not impossible for [defendant] to comply with both the FDCA and the state-law requirements.
It’s four days post Sandy and many of us are still without power (certainly true of our New Jersey bloggers and many of our New York colleagues) and none of us can escape the images of the devastation in the Mid-Atlantic states. In the face of what will likely be months and months of clean up and rebuilding, we had to take a moment to say thank you to all those who are doing so much for the victims of this massive storm. From the first responders rescuing people from flooded homes to neighbors offering hot coffee and warm showers to friends without power, we have to admit that collectively we are pretty good in a crisis. We pull together. So, for that we again extend a very heartfelt thanks.
With all of the problems still facing so many, we would prefer to be blogging about a defense-positive case – but since we can’t just ignore the decisions that don’t go our way, we’re bringing you Acree v. Watson Pharmaceuticals, Inc., 2012 WL 5306296 (N.D.Ill. Oct. 26, 2012). But we think we can give it a positive spin. And we’re going to keep it short because we are still working remotely (office still dark) and sheltering friends without electricity.
The facts are fairly straightforward and also fairly unique – which sets the stage for our positive spin. First, the product is a generic version of a fentanyl patch used for pain relief. Second, the only claims left in the case were negligent and strict liability design defect and manufacturing defect. And the only reason the design defect claim was hanging around is because patches like this are really a combination drug and device – the drug is the opioid fentanyl and the device is the delivery system that time releases the drug for absorption into the body. The delivery system, the device, is at issue here. Id. at *1. The delivery system for this particular FDA-approved generic patch was a reservoir system. Id. The FDA has also approved at least one other generic fentanyl patch that uses a different delivery system. Id. at *2.
By now, we are sure you are wondering when this post is going to get around to mentioning Mensing. Well, here it is. Of course the generic manufacturer defendant argued Mensing preemption. Acknowledging that Mensing had to do with failure to warn claims, defendant here argued that the Mensing rationale applied equally to design defect claims “because the FDCA similarly prohibits generic drug manufacturers from changing the design of their drug product.” Id. at *4. But the court found “unique circumstances” that made this case different.
Plaintiff pointed to the other FDA-approved patch with a different delivery system and said that patch was a feasible, safer, alternative design. For the court, that was enough to get around conflict preemption:
Id. at *6.
And here comes the positive. First, for drug products, design defect claims don’t usually get even this far. The ordinary constraint on design defect claims – that there be an alternative design – does not exist where the product is a chemical molecule, let alone one that would require FDA re-approval if it were changed in any way that affected its safety or efficacy. Second, the allegedly safer alternative design at issue here was approved by the FDA while this defendant’s ANDA was still pending. Indeed, the ANDA for the patch used by plaintiff was filed in 2003 and not finally approved by the FDA until 2007, during which time defendant amended the application at least twice. The fact that the defendant could have amended its ANDA to include the different delivery system design – rather than having to seek separate FDA approval – seems important to the court’s conclusion against preemption.
So, what we take from all this is a confirmation of just how difficult it is to escape preemption in the usual generic drug case – which this clearly was not. These aren’t the kinds of facts we expect to see often or maybe ever again. If plaintiffs cite this case against you – you should have a fairly easy time distinguishing it. Just look to the details.
Finally, we should also mention that this case is allowing plaintiff, who lost or discarded the patches, to proceed under a malfunction theory or res ipsa loquitur – relying on circumstantial evidence to create an inference of a defect. But that isn’t really all that surprising since the court relied on DiCosolo v. Janssen Pharm., Inc., 951 N.E.2d 1238, 1244 (2011) – the case we gave the distinction of being the worst drug/device product liability decision of 2011. Rather than re-hash, we’ll just point you our post on that case. Bottom line is that at least in Illinois, plaintiffs who throw away their products continue to have an advantage.
Here’s hoping for more positive news soon!