United States: Warning Causation Potpourri In New Jersey Mass Tort

Last Updated: October 21 2016
Article by James Beck

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."

Not only that, the heeding presumption is "rebuttable," id. at 11, and even in the absence of prescriber testimony, the defendants did so:

This Court does not find it reasonable to believe that a prescribing physician would cease to prescribe [this drug] when (1) the medical community issued statements urging continued use, (2) there is evidence that the learned intermediaries were otherwise aware of the risk [in question], and (3) no evidence has been provided supporting the notion that one additional risk factor would lead the prescribing physicians to avoid this drug.

Id. That settled the issue under New Jersey law.  Id. at *12.  In addition, the court pointed out that the following states have:

  • Never applied a heeding presumption at all – Idaho, Kentucky, Minnesota, New Mexico, Texas, Wisconsin.
  • Never applied a heeding presumption in a learned intermediary case – Arkansas, Maryland, Missouri, North Dakota, Utah.
  • Never applied a heeding presumption in a learned intermediary case where a warning (albeit allegedly inadequate) was given – Illinois, Indiana, Kansas, Louisiana, Massachusetts, New York, Ohio.

Id. at *12-16.  Finally, the Accutane plaintiffs "fail[ed] to proffer any case law for the remaining sixteen jurisdictions on proximate cause or the heeding presumption."  Id. at *16 (mentioning Alabama, Arizona, California, Connecticut, Colorado, Florida, Georgia, Mississippi, Nevada, North Carolina, Oregon, Pennsylvania, South Carolina, Tennessee, Virginia, and Washington).

Accutane II dispatched another 74 plaintiffs with a panoply of learned intermediary causation-defeating – and presumption-rebutting − testimony from their prescribing physicians.  In those situations, the prescribers' conduct was the dispositive issue under the learned intermediary rule:

[W]here the LID applies, the testimony of Plaintiffs or their medical decision makers is not a part of the proximate cause determination.  If it were, the LID would be rendered useless because a proximate cause determination would ultimately come down to what the patient would have done in response to a drug manufacturer's warning, the precise situation which the [doctrine] sought to avoid.

2016 WL 5958375, at *5 (applying New Jersey law).  Plaintiffs' claim that dictum in a recent, unpublished New Jersey decision made "revolutionary" changes to the rule was rejected.  Id. "[C]onflat[ing] the LID with the informed consent doctrine" is "simply not the law."  Id.  "When a prescribing physician comprehends the fact that a given medicine is associated with certain potential risks, and exercises his/her medical judgment in deciding whether and how to address those risks with his/her patient, the manufacturer cannot be held responsible for the prescriber's decision."  Id.

To make the multiple rulings meaningful for counsel in future cases, first, we'll break down the rulings by state, and then we'll organize the dispositive physician causation testimony in Accutane II by the categories that Bexis uses in his book.  See Beck & Vale, "Drug & Medical Device Product Liability Deskbook" §2.05[1].  Those are:  (1) prescriber already knew; (2) prescriber did not read; (3) prescriber did not think risk severe enough; (4) prescriber decided not to warn; and (5) prescriber would not change anything.  Most states involved multiple plaintiffs, so we'll also indicate the number of different plaintiffs who lost by each type of testimony (some prescribers gave more than one type of testimony).

So here is our summary of all the summary judgment rulings in Accutane II:

Alabama:  Not change anything (x6).  2016 WL 5958375, at *8-11.

Arizona:  Already knew; risk not severe enough, not change anything (x3).  Id. at *11-13.

Colorado:  Already knew (x2), did not read, not change anything (x4).  Id. at *14-17.

Georgia:  Already knew, risk not severe enough, not change anything (x4).  Id. at *17-20.

Illinois:  Already knew (x2), not change anything (x3).  Id. at *21-22.

Mississippi:  Already knew (x2), not change anything (x3).  Id. at *23-24.

Missouri:  Already knew (x2), decided not to warn, not change anything (x5).  Id. at *25-28.

Nebraska:  Already knew, risk not severe enough (x2), not change anything (x4).  Id. at *28-31.

New York:  Already knew (x5), risk not severe enough, not change anything (x6).  Id. at *32-35.

North Dakota:  Already knew (x2), not change anything (x6).  Id. at *36-39.

Ohio:  Already knew (x3), did not read, not change anything (x6).  Id. at *40-43.

Oklahoma:  Already knew, not change anything (x2).  Id. at *44.

South Carolina:  Already knew (x2), not change anything (x2).  Id. at *45-46.

Virginia:  Not change anything.  Id. at *46.

Wisconsin:  Already knew, risk not severe enough, not change anything (x3).  Id. at *47-48.

As mentioned at the outset, only two of the plaintiffs in Accutane II survived summary judgment on grounds of warning causation.  One was under Colorado law, where the court found the prescriber's testimony "demonstrate[d] substantial uncertainty" about what the prescriber would have done with a different warning.  Id. at *14.  The other denial was under Indiana law, where the doctor repeatedly testified that he was "not sure" what he would have done with a different warning.  Id. at *23.  That was it.  As to the other 74 plaintiffs, diligent defense questioning during prescriber depositions removed any possibility of causation.

While the learned intermediary rule is not as "strong" a defense as preemption or Daubert, because causation must be examined on a plaintiff-by-plaintiff basis, Accutane I and II demonstrate why the rule matters, even in a mass tort setting.  Any way one looks at it, 160 out of 162 is a great batting average.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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