If you read the decision in Rossitto v. Hoffmann-LaRoche Inc., 2016 N.J. Super. Unpub. LEXIS 1714 (N.J. App. Div. Jul 22, 2016), we think you’ll agree with our calling it “strong” criticism of two trial rulings that the appellate court firmly believed led to undue prejudice of the defendant.  The $18 million verdict awarded to two of four plaintiffs in a joint trial was vacated and the case is being remanded for a new trial.  This is not the first Accutane plaintiff’s verdict to be vacated by New Jersey’s appellate division, but rather another notch in the demise of this litigation which has seen a turn in favor of defendant since coming under new management.  Indeed, a quick search of the DDL blog for Accutane will show how the tide has turned.

The Accutane litigation is primarily comprised of claims alleging that the manufacturer failed to adequately warn about the risk of inflammatory bowel disease (“IBD”).  Therefore, the drug’s label takes center stage.  Here, the plaintiffs both used the drug with its 1984 label that included a warning that “Accutane has been temporally associated with IBD.”  Id. at *8.  In May 2000, after plaintiffs had stopped using Accutane, the label was revised to remove the word “temporally” and to add information about persistent IBD symptoms.  Id. at *18.

Although only one of the plaintiffs was a New Jersey resident, the parties agreed that New Jersey law would apply to both.  Id. at *34.  So, New Jersey’s “super-presumption” applies – that is if the warning given has been approved by the FDA, there is a rebuttable presumption of adequacy.  Id. at *37.  Called a “super-presumption” because it is “virtually dispositive” on failure to warn, it can be overcome with evidence of intentional concealment of a known risk or “substantial evidence of economically-driven manipulation of the post-market regulatory process.”  Id. at *37-38.  Plaintiffs got to trial in these cases because the New Jersey courts have found that as to the 1984 label plaintiffs have put forth enough evidence from which a reasonable jury could conclude they had rebutted the presumption.  Id.  at *55-56 (citing prior Accutane decisions addressing this issue).   But it’s a strong presumption so we decided to take the time to remind you about it.

With the 1984 label being the operative label, the question on appeal is whether the trial court erred in allowing into evidence the 2000 label change which defendant argued should have been excluded as a subsequent remedial measure.  The answer was a resounding yes; finding the trial court’s ruling “ill-advised” and an error “of such magnitude . . . to warrant relief.”  Id. at *47.

New Jersey Rule of Evidence 407, similar to the federal rule, provides that “[e]vidence of remedial measures taken after an event is not admissible to prove that the event was caused by negligence or culpable conduct.”  This rule is primarily based on the strong public policy encouraging remedial measures and for that reason if the action taken was mandated by the government as opposed to undertaken voluntarily, it is not barred by Rule 407.  In addition, subsequent remedial measures can be admitted for “other purposes” such as impeachment, if not unduly prejudicial.  Id. at *39-40.

In Rossitto, it appears the court first excluded the 2000 label change under Rule 407 as a non-mandated subsequent remedial measure.  Id. at *41.  During trial testimony by one of the manufacturer’s company witnesses on the strength of the 1984 label, the court “altered its course” and granted plaintiffs’ request to admit the 2000 label for purposes of impeaching the witness.  Id. at *42.  Ruling on defendant’s post-trial motion for JNOV, the trial court also concluded that the label change was not voluntary because the revision was “suggested” by the FDA and defendant “agreed.”  Id. at *40-41, 42.

The appellate division found this to be a “serious” error.  Id. at *42:

The court originally – and correctly – recognized before this trial began the substantial prejudice to [defendant] in allowing the subsequent post-ingestion labeling change to be considered by the jury. It should not have strayed from that correct determination.

Id. at *43.

As for whether the label change was FDA-mandated, the court noted that the FDA did not have authority to “mandate” such a change until 2007.  Nor was the court persuaded that proposing a change made the defendant’s decision to adopt the change involuntary.  Id.   So, the label change was a subsequent remedial measure within the scope of Rule 407.

That leaves whether the 2000 label was properly admitted for purposes of impeachment.  Plaintiffs argued and the trial court agreed that the defendant opened the door when its witness testified to the sufficiency of the 1984 label.  By that reasoning, the exception would swallow the rule.  “[S]uch a retrospective defensive posture is a natural aspect of a classic Rule 407 factual paradigm, in which defendants and their witnesses are tasked with justifying the sufficiency of past conduct or the benign quality of past conditions that preceded a subsequent remedial change.  Id. at *44.

Further, any impeachment value was substantially outweighed by the “strong prejudice” to defendant.  “[T]he 2000 label change could easily have been viewed by the jurors as ‘smoking gun’ evidence, signifying that the Accutane label that had preceded the 2000 version was deficient.”  Id. at *43-44.

Moreover, the limited admission for purposes of impeachment apparently flew out the window at the time of plaintiffs’ summation during which plaintiffs’ counsel spent “substantial” time focused on defendant’s conduct post-plaintiffs’ ingestion of the drug including the “stronger” 2000 label.  The appellate court found that “the 2000 label change was used within plaintiffs’ advocacy for its substantive evidential power.”  Id. at *46.  There was no legitimate basis for admission of the 2000 label change and the “improvident” decision to allow it was only compounded by allowing plaintiffs to use it substantively.

The label change wasn’t the only reversible error.  The trial court also limited the number of expert witnesses the defendant could present on particular subjects.  The appellate division addressed this issue in another case that came after the trial inRossittoMcLean v. Liberty Health System, 430 N.J. Super. 156 (App. Div. 2013).  The upshot is that in complex cases like medical malpractice and pharmaceutical products liability, trial courts should not limit experts to one per side per issue.  There is a difference between “duplicative” evidence and “needless . . . cumulative evidence.” Rossitto, 2016 N.J. Super Unpub. LEXIS 1714 at *49.  In this case, the court precluded defendant from offering testimony from its four experts on issues related to general causation while plaintiffs were permitted to elicit general cause testimony from two experts.  Id. at *50.  The inability to put in its expert case the way it wanted was certainly prejudicial to defendant and the appellate court agreed that the defense should have been given “freer rein” to overlap key causation opinions.  Id. at *51.

The appellate decision goes on to address some additional arguments raised by the defendants that the court did not believe gave rise to reversible error but most are fairly case specific, so we won’t get into them here.