Without pulling back the curtain all the way on how we find out about new decisions worth a pithy post, we occasionally re-learn about decisions when they are published or added to an electronic reporting service a few months later. When there is a slow week, this dynamic may prompt us to talk about an older decision, even if has already been the subject of a breaking news post. The summary judgment decision in In re Accutane Litigation, No. 271 (MCL), 2015 N.J. Super. Unpub. LEXIS 1216 (N.J. Super. Law Div. Apr. 2, 2015) was the subject of a breaking news post two months ago, but deserves another look, more for the story it tells about drug litigation than for its direct precedential value.
We have posted through the years about the tortured course of Accutane litigation over the risk of inflammatory bowel disease ("IBD"). (There have also been cases about birth defect and suicidality, but we are not focusing on those here.) In general, the news out of the MDL proceeding has been good for years, both on expert issues and the substance of plaintiffs’ claims. For years, the news from the coordinated proceeding in New Jersey has been very bad, including a few large plaintiff verdicts. Issues with the judge who had overseen the New Jersey proceedings were highly publicized (but not by us), and it is easy to say that her assignment to a new post explained the sea change. We can guess that the new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. There has also, though, been development in the case law on the New Jersey Product Liability Act (NJPLA) that undercut the legal basis for old (bad) decisions. The persistence of the defendant and willingness of the new judge to consider broad issues late in the life of the litigation bring us to the decision finding the IBD warnings since April 2002 to be adequate as a matter of law under the NJPLA, which sets up a potential adoption for cases where other state law may control.
The history of Accutane’s IBD warnings from the approval of the drug in 1984 through the discontinuation of its sale in 2009 is so extensive that we wonder how warnings claims—the only claims we think should be typically available for a prescription drug—ever could have had legs. As discussed below, we also wonder about other reasons why warnings claims should not have been viable. The court provides detailed findings of fact about the warnings for IBD, which included mechanisms for providing warnings not seen with most prescription drugs. Id. at **15-26. We assume the extra measures were driven by concerns about suicidality in teenage patients and birth defects in their offspring, but IBD was also described in the warnings accompanying blister packs (the only means of distribution since 1990), a guide that physicians had to acknowledge receiving in order to prescribe the drug, a guide that pharmacists had to provide to patients while filling their prescriptions, and brochure that physicians were encouraged to give to patients. Combined with a paragraph in the Warnings section of the package insert, the information provided to physicians warned them up, down, and side to side about the risk of IBD. That sounds a lot like an adequate IBD warning as a matter of law under any state’s law on prescription drug warnings.
To get to that question—one that could have broad implications for the remaining cases—the court first had to deal with choice of law and the law of the case. Rather than simply brushing aside the latter issue by saying the old judge had got it wrong repeatedly, the court took a diplomatic approach and looked to the change in the case law on the NJPLA, specificallyDeBoard and Bailey, and that the present motion presented a later time frame than earlier motions. Id. at **7-9. The court also took a practical view on choice-of-law, deciding a key issue while requesting briefing to determine the extent of its application to pending cases.
[T]he court would be derelict in its duties were it to make no decision at this time . . . . No one’s interests would be served by [a case-by-case approach]. An estimated 800+ claims have been filed in the Accutane MCL wherein the post-April 2002 warnings are applicable. Both sides to this dispute are entitled to a ruling by the court on the adequacy of the warnings contained in literature distributed by Defendants to physicians prescribing Accutane.
Id. at **9-10.
The court’s analysis of the substantive issues likewise begins with an astute assessment of the relationship between the regulatory scheme and product liability litigation: ". . . once a label has been approved for marketing the drug to the public, anyone making a claim for injury purportedly arising from a medication has a significant burden of proof." Id. at *27. Even without the NJPLA’s rebuttable presumption of adequacy from FDA approval, the totality of warnings here were clearly adequate:
It is inconceivable to this court that the reasonable dermatologist (or any physician, generally) of ordinary education, training and experience could examine the materials comprising the warnings literature and not immediately conclude that Accutane has been associated with life-altering side effects, including IBD.
Id. at **36-37. That the presumption was unrebutted, based on the tight standards articulated in cases before and after the prior judge’s rulings, was icing on the cake. In addition to the evidence proffered in response to the motion, the court had the chance to look at the evidence offered at prior trials in finding a lack of proof of deliberate concealment of risks or manipulation of the post-approval regulatory process. Id. at *34-36. This approach allowed the court to make a ruling without, as plaintiffs urged, looking at the testimony of individual physicians. This makes sense, particularly with New Jersey’s standard.
Even if the IBD warnings were not adequate as a matter of law, then the plaintiffs would have needed to show proximate cause for failure to warn on a case-by-case basis to avoid summary judgment. This inquiry would have required a plaintiff to come forward with admissible expert testimony proposing what warning would have been adequate. There is no hint in this decision as to what plaintiffs’ experts proposed about the IBD warnings. It is hard to imagine an alternative warning that would have changed the prescribing decision of a physician aware of the panoply of warnings actually provided. It is also hard to see how a claim predicated on an alternative IBD warning would not be preempted, even under the Levine standard. The manufacturer could not have added a black box warning on its own and a Changes Being Effected submission could not have been used under the circumstances here—that is, to materially upgrade warnings for a risk that had been in the package insert for at least eighteen years and was incorporated in special forms of labeling that had been approved by FDA. Although a rarity, the regulatory history here—which included a 2012 approval of a drug in the same class with identical IBD warnings—looks to provide the "clear evidence" that whatever plaintiffs might have proposed as an alternative warning would never have been approved. So, it looks to us that the efficiency that the court noted in deciding the adequacy of the warning as a matter of law (within the parameters it specified) also does not shortchange plaintiffs who should have a hard time making out a non-preempted warning claim anyway. We also find it noteworthy that the new judge was willing not only to hit the "reset" button on prior rulings on the adequacy of the IBD warnings, but also ordered the parties to brief the applicability of his ruling to cases from other jurisdictions. This potential leveraging of his ruling to achieve a broader impact is a welcome development, and we hope it will promote a speedy end to a proceeding that has already gone on for far too long.
One thing we can advise out of this—other than having the persistence to last until new judge(s) enter the picture—is to push for a relatively early articulation of what the warnings should have said and when they should have said it in instances where the package insert already warned of the very thing about which the plaintiffs are suing. Going case-by-case through a large chunk of cases should not be necessary to see if the plaintiffs have an inadequate warning claim that might hold water. When it is clear that they do not, even if the first decision’s splash does not hit all cases directly, like here, the hope is it will have enough ripples to do the job.