Court Tosses 2d Verdict in Accutane Case Because of Expert Testimony Mistakes

For the second time, an Alabama man had a jury award in his favor thrown out by New Jersey appellate courts in a case involving Accutane, which caused him to be surgically disemboweled.

The Appellate Division of New Jersey Superior Court reversed and remanded a 2010 jury award of $25.2 million, saying that it was error for the trial judge to prohibit duplicative defense expert testimony. Andrew McCarrell v. Hoffmann-La Roche, Inc. and Roche Laboratories, Case No. A-4481-12T1 (NJ Appellate Division, May 2, 2017).

The plaintiff, an Alabama resident, was prescribed by his dermatologist the acne medication Accutane, a drug manufactured by defendants. After his course of treatment with the drug, plaintiff developed inflammatory bowel disease (“IBD”) and other gastrointestinal disorders.

Eventually, his colon and rectum were surgically removed, and he underwent years of treatment.

Defective product

McCarrell filed suit in New Jersey state court against the defendants, alleging that Accutane is a defective product and that the defect proximately caused his injuries. In particular, the plaintiff claimed that defendants’ labeling and marketing of the drug was inadequate and failed to warn sufficiently of the risks of a patient contracting IBD.

The case was tried in 2007 and McCarrel recovered $2.6 million for in damages, but that verdict was overturned on an evidentiary issue,

Regarding the 2010 retrial, the appellate court said it was error for the trial judge, now deceased, to disallow duplicative expert testimony, limiting the parties to a general causation expert and a specific causation expert. This meant that two defense experts could not testify.

“[t]he trial court’s decision to disallow overlapping expert testimony about the scientific studies relating to causation was an error. The significance of those studies was a “central issue” in this hard-fought case,” the appeals court said.

Second error

The court reversed based on a second issue concerning the plaintiff’s prescribing dermatologist, Dr. Ann Gerald. Her deposition was taped in 2007 but no attorney asked her whether the doctor’s decision to prescribe Accutane would have been different if the drug had come with a stronger warning.

“Given this important factual gap in the record made significant by ensuing Alabama precedent, this matter should be remanded to enable the record to be appropriately developed on this critical issue,” the appeals court said.

“Assuming Dr. Gerald is still available, the parties should have the opportunity to re-depose her and obtain her sworn responses on the central prescribing question.”

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NJ Judge Dismisses 160 Cases in Accutane Litigation — 4,000 Remain

accutaneNew Jersey Superior Court Judge Nelson Johnson issued two orders dismissing a total of 160 cases from 20 states against Hoffman-LaRoche Ltd. in Accutane product liability litigation that alleges the acne drug caused inflammatory bowel disease. At least 4,000 cases remain in the consolidated litigation, Case No. 271. The court:

  • Granted summary judgment for the defendants in 86 cases from 35 jurisdictions because the plaintiff’s prescribing physicians are deceased on unable to be located.
  • Similarly dismissed 74 cases from 16 jurisdictions for failure to show proximate cause.

The rulings turned on a doctrine in product liability law known as the “heeding presumption.” This is a rebuttable presumption that the recipient of an adequate warning in a failure-to-warn case would have heeded the warning. It holds that a physician would not have prescribed a drug if its warning had been adequate, and places the burden on the drug maker to prove that the doctor would have heeded a different warning.

Proximate cause

The plaintiffs argued that the testimony of the missing physicians was not required to establish proximate cause because of the heeding presumption. They asserted that this presumption has been upheld in pharmaceutical failure to warn cases in 20 states. The plaintiffs argued that because the defendants did not present evidence to rebut the presumption, that the prescribing physicians would have heeded a stronger warning.

The defendants argued successfully that in a pharmaceutical products liability action alleging failure to warn, a plaintiff must show that a different warning would have altered their physician’s decision to prescribe the medication to satisfy proximate cause. However, there is no physician testimony.

“First, the heeding presumption does not eliminate Plaintiffs’ burden of proving a prima facie case,” the court stated.

The heeding presumption was rebutted because The American Academy of Dermatology (“AAD”) and The American Academy of Pediatrics (“AAP”) both issued statements approving the continued use of Accutane or isotrentinoin for the treatment of acne. The AAD’s statement confirmed the lack of association between isotrentinoin and inflammatory bowel disease and states that physicians should continue to prescribe the medicine while being aware of the risk, the court  said.

“Accordingly, the Court finds that under New Jersey law, a heeding presumption does not apply in cases such as these, and even if it did, Defendants’ FDA approved warning carries a presumption of adequacy until rebutted by Plaintiffs.”

See also Learned Intermediary Doctrine Causes Dismissal of New Jersey Accutane Suits

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