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TRENTON, N.J. — (Mealey’s) A New Jersey appeals panel on Aug. 4 vacated a $2,125,617 Accutane bowel injury verdict and affirmed defense verdicts in two other cases tried at the same time (Gillian Gaghan v. Hoffman-La Roche Inc., et al., Nos. A-2717-11T2, A-3211-11T2 and A-3217-11T2, N.J. Super., App. Div. [enhanced opinion available to lexis.com subscribers]).
The New Jersey Superior Court Appellate Division vacated the verdict in favor of Gillian Gaghan because it said her failure-to-warn claims are barred by the learned intermediary doctrine and her claim was barred by the two-year statute of limitations.
As to the other two plaintiffs, James D. Greenblatt, also known as actor James D. Marshall, and Kelly Andrews, the panel said there was evidence the first could have had inflammatory bowel disease (IBD) before he took Accutane and there was no evidence that an IBD warning would have prevented the second plaintiffs from being prescribed the drug and taking it.
Each of the plaintiffs were prescribed Accutane-brand isotretinoin to treat severe acne and each claimed that the drug caused IBD or a related gastrointestinal condition such as Crohn’s disease. Each plaintiff sued then-Accutane manufacturer Hoffman-La Roche Inc., and their cases were centralized in New Jersey’s Accutane multicounty litigation in the Atlantic County Superior Court.
Learned Intermediary Doctrine
After a seven-week trial, the jury found that Accutane was a substantial factor in Gaghan developing IBD, that Roche’s warning was inadequate and that the inadequate warning was a substantial factor in Gaghan developing IBD. The jury awarded Gaghan $2 million in compensatory damages and $125,617 for past medical expenses.
Applying the law of California, of which Gaghan was a resident, the appeals court panel concluded that California law focuses on the prescribing decision of the doctor as the learned intermediary. In its per curiam ruling, it said Gaghan failed to prove that her prescribing dermatologist, Dr. Paul Hartman, would have altered his decision to prescribe Accutane to Gaghan.
The panel rejected Gaghan’s argument that California law focused on the decision of the patient to use a drug rather than the decision of the doctor to prescribe it. “Thus, even if California law did focus on the decision of the patient rather than the decision of the doctor, there was insufficient evidence in the record from which the jury could rationally conclude that stronger warnings would have altered Dr. Hartman's treatment of Gaghan in the sense of conveying the stronger warnings,” the panel wrote.
“Gaghan did not establish that stronger warnings would have changed Dr. Hartman's conduct,” the panel continued. “In sum, the evidence was not sufficient for the jury to conclude that Roche's allegedly inadequate warnings were the proximate cause of Gaghan's taking Accutane and her development of IBD.”
Plaintiff Should Have Known
Roche also argued that Gaghan’s claim was barred by the applicable two-year statute of limitations. It argued that Gaghan developed IBE in 1991 but did not file her complaint until 2004.
Gaghan argued that she did not discover the alleged link between her condition and Accutane until 2004 when her mother saw a lawyer’s advertisement for Accutane plaintiffs.
The appeals panel said that Gaghan testified that she read the patient brochure and blister pack warnings when she started taking Accutane and that sometime before 2002, she read the Accutane warning in the Physicians’ Desk Reference. Both warned of severe stomach pain, diarrhea, rectal bleeding and IBD.
The panel said Gaghan worked in the medical field and, if she thought that the “temporal” association with IBE in the warnings meant a “temporary” side effect, she would have known that it was not temporary when symptoms returned. In addition, the panel said Gaghan in 2000 got her medical record from Hartman and should have read his reference to Accutane and IBD.
High Court Kendall Ruling
Citing the 2012 New Jersey Supreme Court’s ruling in another Accutane case, Kendall v. Hoffman-La Roche, Inc. (209 N.J. 173  [enhanced opinion]), the panel said “we conclude that Gaghan had reason to know her IBD may have been caused by Accutane substantially earlier than in October 2002.”
“The jury's finding that the warning was inadequate before Gaghan took Accutane and experienced IBD symptoms does not eliminate the question of whether the warning was nevertheless adequate to prompt Gaghan to investigate the cause of her IBD condition after she had been diagnosed,” the panel held. “The fact that the FDA [Food and Drug Administration] found Roche's warning label to be adequate to warn of the potential side effect of the drug in connection with IBD is relevant on that issue — specifically, whether an ordinarily diligent patient would have been alerted to sufficient facts to learn that her IBD might be connected to her use of Accutane.”
“Viewing the same uncontradicted evidence that was before the trial court, and deferring to the court's mixed credibility determination with respect to Gaghan's testimony and that of her mother, we conclude that Gaghan knew or should have reasonably known before October 2002 that her IBD symptoms may have been caused by her use of Accutane,” the panel said.
Inadvertent Clip Played
In the case of Greenblatt/Marshall, the jury said Accutane was not a substantial factor in the plaintiff developing IBD. The plaintiff argued that his verdict was tainted by improper argument by Roche that stress caused his IBD.
Specifically, Greenblatt/Marshall argued that he was prejudiced when Roche played recorded testimony that the court had excluded. The panel said the inadvertent playing of the clip followed by a curative instruction by the judge for the jury to disregard the testimony did not produce an unjust result.
The panel also said there was ample evidence for the jury to conclude that the plaintiff’s IBD symptoms predated his use of Accutane and that the drug was not a substantial factor in his developing the disease.
As an actor, Greenblatt/Marshall is known for his role as a Marine private on trial for murder in the movie “A Few Good Men.”
Stronger Warning Inconsequential
In the case of Kelly Andrews, the jury found that Accutane was a substantial factor in the plaintiff developing IBD and that Roche failed to adequately warn of that risk. However, the jury found that the failure to warn was not a substantial factor in Andrews’ decision to take Accutane.
On appeal, Andrews argued that the jury’s decision on the third question was against the weight of evidence.
“There was substantial evidence from which the jury could have found that Andrews would have taken Accutane even if Dr. [Laura] Tenner had received and passed on to her and her mother a stronger warning in the form recommended by plaintiffs' expert witnesses,” the panel said. “We conclude there was no abuse of discretion in the trial court's denial of Kelley Andrews' motion for a new trial.”
Accutane is an oral drug prescribed to treat severe forms of acne. In the case of Greenblatt/Marshall and Andrews, both plaintiffs underwent bowel resections with ostomies. Gaghan was treated with Remicade, an immunosuppressant drug, but allegedly developed lupus as a result of the Remicade.
The panel consisted of Judges Victor Ashrafi, Jerome M. St. John and George S. Leone.
Roche is represented by Paul Schmidt and Michael X. Imbroscio of Covington & Burling in Washington, D.C., and Michelle M. Bufano of Gibbons in Newark, N.J. The plaintiffs are represented by David R. Buchanan of Seeger Weiss in New York and Michael D. Hook of Hook & Bolton, Mary Jane Bass of Beggs & Lane and William F. Cash III of Levin Papantonio Thomas Mitchell Rafferty & Proctor, all in Pensacola, Fla.
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