It is starting to feel like spring. For those with a poetic or philosophical bent, spring may bring thoughts of renewal and the cyclical rhythms of the planet, among other things. For those interested in more practical things, perhaps the need to do a spring cleaning or plan for some plantings outside. Clutter does have a way of accumulating throughout the year and it helps to, well, de-clutter if you can muster the energy and attention. Gardening is similar. Before you can put down your flowers, vegetables, or herbs, or just await the return of perennials, you probably will need to clear out an accumulated layer of gunk, turn over the soil, add some manure or other nutrients, and do other exhausting work.
With this lead-in, the reader can pick her own theme for the case we are about to discuss. One is that the bodies of law concerning the liability of generic drug manufacturers and pleading claims used to let quite a bit of junk get past the motion to dismiss stage. Morris v. Sun Pharma Global, No. CV-10441 PA (JPRx), 2021 WL 687247 (C.D. Cal. Feb. 19, 2021), shows us how things have changed for the better. Without pre-judging the merits in the least, we can say that the core claim plaintiff had to make in this case was for manufacturing defect, but he asserted several claims and paid little attention to what he alleged in support of manufacturing defect. The pertinent facts, based on allegations and judicial notice, are that the plaintiff was prescribed a generic testosterone with which he was supposed to inject himself every other week, he experienced pain soon after his first injection, and was ultimately diagnosed with paraspinal and epidural abscess, sepsis, liver and kidney damage, coagulopathy, and “bone infection.” About a year and a half later there was a recall of at least some lots of the medication apparently due to sterility issues. Plaintiff brought several claims under California law, each tied in some way to sterility. Defendants moved to dismiss on TwIqbal and preemption.
We will follow the issues in the order the court addressed them.
First, plaintiff asserted a strict liability design defect claim. The California Supreme Court disposed of that in the Brown case back in 1988, so this claim was dismissed with prejudice. Id. at *4.
Next, plaintiff’s negligent design and warnings claims against an ANDA-approved drug had to pass the preemption hurdle. This was no muss, no fuss. Mensing covered the warnings claims, which were predicated on the risks of injecting non-sterile drug. Id. Bartlett took care of the design claim, however it was framed. Id. These claims were also dismissed with prejudice.
Then plaintiff tried re-packaging his warnings claims as express warranty. Because “[t]he only representations Defendant might have made with respect to its testosterone cypionate injection were set forth in its label,” they were also preempted under Mensing. With prejudice for this one too.
Next up was whether plaintiff had offered facts in support of his manufacturing defect claim, which required that his “product differs from the manufacturer’s intended results” and “that any deviation from the intended design caused the harm at issue.” Id. (internal quotes and citations omitted). The complaint alleged that the product was not “sterile and free of any contamination” and that this defect “in manufacture of the [t]estosterone [c]ypionate caused injury and infection.” Id. at *5. This was too “vague and conclusory” to pass TwIqbal muster. Id. Although the plaintiff asserted that the contamination was Staphylococcus bacteria, that assertion was not in the complaint. Plaintiff would get another shot to re-plead this one, though.
The same was true for any other non-preempted negligence claim he could assert. This is one possible criticism we might offer. If the court could see that plaintiff was trying to plead a species of negligence not supported by California law, then it might have made sense to cut that off now rather than after another round of pleading and briefing.
We can extend that light criticism to the analysis of the implied warranty claim. If it was based on design defect or warnings, then it was preempted. Id. If it was based on manufacturing defect, then it was inadequately pleaded under TwIqbal and plaintiff would get another chance to fix it. Id. However, what is the point of an implied warranty claim that is based on the exact same alleged facts and theory as a manufacturing defect claim? If California does not allow that sort of double-dipping, then it might be best to say that now.
In any event, this was all pretty simple and civilized. After another round, we are guessing this might proceed on nothing more than a non-preempted manufacturing defect claim, which would be of the sort we have long said should be outside the scope of preemption for generic drugs and other classes of medical products. Plaintiffs often toss in a manufacturing defect claim that is just a design defect claim under a different heading, but, in the rare cases where there is really something suggesting the plaintiff was harmed by the product not meeting its design and manufacturing specifications, it should at least get to discovery.