Friday, August 3, 2012

Interesting Application of State of the Art Principles

There’s a lot going on in Wendell v. Johnson & Johnson, 2012 WL 3042302 (C.D. Cal. July 25, 2012), but much of it depends on very case-specific facts about a particular prescriber’s knowledge, and some of the rest was put off essentially as premature.  There is one aspect of the Wendell decision that merits our attention, however, and that’s the court’s application of state of the art principles in the context of a defendant’s sale of its proprietary rights to a drug.

That’s significant because, while the opinion doesn’t mention it, the identities of some of the defendants suggest that Wendell involves (at least partially) generic drugs and thus generic preemption.  With generic plaintiffs looking for other defendants after PLIVA v. Mensing, 131 S. Ct. 2567 (2011), this situation might come up again for our branded clients.

Here’s what went on in Wendell:  At various times the plaintiff’s decedent (who was chronically ill with inflammatory bowel disease) underwent treatment with different combinations of three drugs.  The decedent allegedly died from an adverse effect of one or all of these drugs.  2012 WL 3042302, at *1.  In Wendell the alleged injury was a type of cancer, but for purposes of this post, it could have been any newly discovered risk.

It’s not explicit, but the relevant defendant appears to be the original branded manufacturer of one of the drugs, but who left the market in July, 2003, after the onset of generic competition.  Id.  Plaintiff may well have used the branded drug at some point, since he started taking that product in 1999 (we’re not sure exactly when generics entered the market).  Id. at *2.  However, the first case report of the type of injury at issue in the litigation, in connection with the type of combination treatment the decedent received, was not published until February, 2005.  Id. at *3.  This risk led to the addition of a black box warning in May, 2006.  Id. at *4.

The branded manufacturer successfully raised the state of the art defense.  The risk for which it was being sued was not discovered until a year and a half after it left the market.  Wendell was decided under California law − meaning that the branded manufacturer was at least potentially subject to liability under Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008) − although as we have noted, Conte itself has probably been impliedly overruled by the California Supreme Court.  However, Conte aside, the law in almost every state is the same (at least as to prescription medical products) concerning the sort of after-discovered risk at issue in Wendell − “Drug manufacturers need only warn of risks that are actually known or reasonably scientifically knowable.”  2012 WL 3042302, at *12 (quoting Carlin v. Superior Court, 920 P.2d 1347, 1354 (Cal. 1996)) (emphasis original). Here’s another nice excerpt from Carlin on state of the art:

We reiterate that strict liability for failure to warn is not absolute liability. . . .  [D]drug manufacturers are not strictly liable for a risk that was not known or reasonably scientifically knowable.  In this context, it is significant that the FDA precludes drug manufacturers from warning about every conceivable adverse reaction; they may warn only if there exists significant medical evidence of a possible health hazard.

920 P.2d at 1352.

Apparently, the first known incidence of the risk in question actually occurred before the defendant’s withdrawal from the market, but critically nothing was either been published or reported to the manufacturer or to the FDA until the 2005 article appeared in the literature.  Wendell, 2012 WL 3042302, at *12.  Why it took so long to surface, we don’t know, but not even the plaintiff argued that this delay was the defendant’s fault.  So, as a practical matter, the risk was “unknowable” at the point when the defendant left the market.  Thus, summary judgment was appropriate:

Plaintiffs have not presented evidence that the risk was actually known or should have been known by the scientific or medical communities of which [defendant] is a part. . . .  [I]nformation concerning the occurrence of [the risk] in connection with [the defendant’s drug] was not reported to AERS or discussed in the medical literature until after [defendant] ceased to distribute the drug.  Furthermore, drug manufacturers are not required to warn of every conceivable adverse reaction.  Thus, [defendant] cannot be held strictly liable for failure to warn. . . .

Likewise, Plaintiffs’ negligence claim requires them to prove that [defendant] did not warn of a particular risk for reasons that fell below the acceptable standard of care; i.e., what a reasonably prudent manufacturer would have known and warned about.  Plaintiffs have presented no evidence, expert or otherwise, indicating that a reasonable manufacturer would have been in a position to discover the case that [was] reported, prior to [the date defendant left the market].  Thus, Plaintiffs cannot prevail on their negligence claim.

Id. at *12-13.

The situation in Wendell is not at all uncommon.  Branded manufacturers frequently sell their rights to drugs and exit the market after generic competition begins − and generic drugs enjoy the Mensing preemption defense.  So plaintiffs are going to be looking around for other entities to sue.  Conte liability is one example of that, and one of the many problems with that theory is its lack of any temporal limit.  So Conte claims are likely to arise well after branded defendants have left the market.  Besides Conte, branded manufacturers are likely to be sued no matter how remote actual use of their products is from onset of injury, as was the case in Wendell.  The state of the art defense is one weapon we have to defeat allegations of remotely related liability, and Wendell shows what the defense can do where the cut-off date is the defendant’s ceasing manufacture.