This guest post is by Reed Smith‘s Devin Griffin. It deals with an important pending appeal in New Jersey’s version of Jarndyce v. Jarndyce – Accutane litigation. As always with our guest posts, the author is 100% responsible for what follows, deserving of all the credit, and any blame. Take it away Devin.
The court may have taken a relaxed approach, but its decision has done nothing but raise blood pressures over at that DDL blog. The course of the Accutane litigation in New Jersey has been labored and we’ve posted about the whole journey. For years, we were pretty riled up. The news from the coordinated proceeding…
The Supreme Court’s opinion on personal jurisdiction in BMS v. Superior Court has already made a substantial impact, despite being on the books for a mere three weeks. That’s probably because it’s the Supreme Court and also because personal jurisdiction is an issue in every lawsuit filed, whether in state or federal court. Another reason…
No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious. The rub is that the parties have very little to show for the effort. The…
When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that…
We’ve talked a fair amount about forum shopping on this blog. Forum shopping is largely in the control of plaintiffs’ counsel because they, within reason, get to choose where to file their clients’ lawsuits. And since they do need some reason, there are several frequently used methods by plaintiffs’ counsel when they’ve narrowed in on the court they’ve decided would be most favorable for their clients – typically state court. If a plaintiff wants to stay in state court where he/she resides, he/she sues a non-diverse party. In drug and device cases, that’s usually a pharmacy, a sales representative, a doctor. Sometimes the joinder of such a defendant is fraudulent and the case becomes removal, sometimes not. Another option is to sue a defendant in state court where the defendant resides, a court from which the defendant cannot remove the case. While venue in that scenario may be proper, where the only connection to the jurisdiction is the presence of the defendant, defendants have met with mixed success in arguing forum non conveniens. Just think, if plaintiff lives in Nebraska, ingested the drug in Nebraska, suffered her injury in Nebraska, but files suit in New Jersey – where is most of the discovery that is needed located? Especially discovery from third-parties who will require subpoenas. What state’s law is likely to apply to the bulk of the claims? Doesn’t make a lot of sense to be in New Jersey except for plaintiff’s preference to be in state court.
But what about when plaintiff’s choice of forum doesn’t turn out like he/she hoped? Should they get a do-over? A mulligan? A second chance? We don’t think so and neither did the court in Zarilli v. Johnson & Johnson, Docket No. ATL-L-1480-16, slip op. (N.J. Super. Law Div. Feb. 3, 2017). This case is one of several pending in New Jersey involving allegations of injury from the use of talc powder. The cases have been coordinated before a single judge for pre-trial proceedings. Plaintiff originally filed her suit in July 2016, and amended her complaint in September 2016. Defendants answered the complaint in October. Id. at 2.
Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving. The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super. Law. Div. Oct. 12, 2016), and In re Accutane Litigation, 2016 WL 5958375 (New Jersey Super. Law. Div. Oct. 12, 2016). Between these two orders, practically every permutation of causation under the learned intermediary rule is addressed, and the end result is the grant of summary judgment against an impressive 160 of 162 plaintiffs.
For obvious reasons, we’ll call the first (#374) “Accutane I” and the second (#375) “Accutane II” to tell them apart.
Eighty-six plaintiffs’ cases failed in Accutane I because they couldn’t even begin to satisfy their usual burden of proof. That was because, by the time they got around to bringing their lawsuits, their prescribing physicians had either died (44 plaintiffs) or else simply could not be located (42 plaintiffs). 2016 WL 5958374, at *1-2. As we’ve discussed before, in one of our “little lists” posts, there’s now quite a bit of law enforcing the burden of proof in dead/missing prescriber cases. We even feel somewhat paternal feelings in this area, because several of your merry bloggers (Eric A, Steve M, and Bexis), litigated this issue extensively a decade ago in Diet Drug cases at a time when there was practically no directly on-point precedent. In doing so, we increased the number of favorable decisions from one to seven.
Accutane I represents another giant step forward. The court held that, under the law of no fewer than 35 jurisdictions, a plaintiff who could not obtain any prescriber testimony at all could not meet his/her burden under the learned intermediary rule (now the law, as we’ve pointed out, of all fifty states) of establishing that the absent prescriber would have changed the relevant prescription had s/he received a supposedly “adequate” warning. The defendant’s causation argument was rather basic:
Defendants argue that without the testimony of the deceased or missing physicians, Plaintiffs cannot establish that [the drug] would not have been prescribed given a different warning and thus they cannot satisfy proximate cause. Absent physicians’ testimony, Defendants argue that the causal link to injury is broken. Even if the proximate cause standard were as Plaintiffs claim – that their prescriber might hypothetically have altered their risk discussion somehow if only [the manufacturer] had warned differently – Defendants assert that physician testimony is still needed.
2016 WL 5958374, at *3 (citation omitted). Plaintiffs fell back on that old canard, the “heeding presumption.” Id. at *4. The court, however, was having none of it.
[T]he Court is persuaded by Defendants’ arguments that the heeding presumption within a learned intermediary context does not equate with a decision by the physician to not prescribe the drug. If it did, medications would never be prescribed when accompanied by warnings because of the various risks associated with their use.
. . .Plaintiffs concede that their physicians are deceased or otherwise unavailable, and they have offered nothing by way of individual opposition papers. . . . Accordingly, the case-specific facts presented by Defendants are undisputed.
Plaintiffs’ reasoning is flawed, especially when one considers the slew of risks associated with and heeded by [prescription drug] users and prescribing physicians. Notably, application of the heeding presumption in the context of a pharmaceutical learned intermediary case where a manufacturer provided a warning and its adequacy remains in issue is not reflected within any of the cited case law.
Id. at 10-11 (citation omitted) (emphasis added). Regardless of any presumption, all plaintiffs “still have the burden of proof for every element of their claim.”
The decision in Carl v. Johnson & Johnson, 2016 WL 4580145 (N.J. Super. Law, Sep. 2, 2016) is masterful. It is a well-researched, well-vetted, and well-written decimation of plaintiffs’ expert case. It is the type of Daubert opinion that defendants long for. It is lengthy and there is so much in it that is good, to cover it all we’d simply have to re-print the decision here. Which we won’t do. However, we strongly encourage you to read this decision. If you aren’t embroiled in an expert battle right now, bookmark this case and come back to it. The thoroughness and attention to detail by the court in the face of an obvious lack of those things by plaintiffs and their experts makes this a real page-turner.
The decision actually was entered in two cases, both brought by women who were diagnosed with ovarian cancer who in these lawsuits allege their cancer was caused by their use of powder containing talc. Defendants filed motions challenging all five of plaintiffs’ experts and moved for summary judgment on the grounds that absent expert testimony, plaintiffs could not meet their burden of proof. Id. at *2. The court held a Daubert (in NJ Kemp) hearing and heard testimony from both plaintiffs’ and defense experts. In addition, the court requested that the parties provide the court with copies of “all reports, abstracts, epidemiology studies, and peer-reviewed articles” relied on by any of the experts in formulating their opinions. Id. (emphasis added). That resulted in the court receiving approximately 100 pieces of scientific literature – which the court apparently read and used in analyzing the expert evidence presented. Id. A serious undertaking. One which clearly inured to the benefit of the defense in this case, and frankly a deep dive on the science most often favors the defense. We welcome an informed and educated court. As this court stated at the outset: “Courts are experts in the law, not science.” Id. And juries are experts in neither. Which is why we greatly appreciate a court that takes seriously its role as the crossing guard at the intersection of science and law in the courtroom.
This post is not from the Dechert side of the blog.
The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”). So have federal courts of appeals.
If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.
Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).
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.