TRENTON, N.J. - (Mealey's) New Jersey's discovery rule is not foreclosed by a presumption in the state's product liability law that Food and Drug Administration-approved warnings are adequate, the state Supreme Court ruled 5-1 on Feb. 27 in an Accutane case now headed for retrial (Kamie S. Kendall v. Hoffman-La Roche, Inc., et al., No. A-73 September Term 2010 066802, N.J. Sup.; 2012 N.J. LEXIS 160).
A plaintiff attorney told Mealey Publications that defendant Hoffman-La Roche Inc. "tried to knock out pharma litigation in New Jersey" by appealing the Superior Court Appellate Division's statute of limitations decision in the case of Kamie Kendall. The Supreme Court appeal attracted amicus briefs from the New Jersey Lawsuit Reform Alliance, the New Jersey Business and Industry Association, the state Chamber of Commerce, the state Medical Society and the state Association for Justice.
In 2008, a jury in the Atlantic County Superior Court found that Accutane, a prescription acne drug, caused Kendall's inflammatory bowel disease. With interest, the judgment totaled $13.5 million.
Roche appealed, and in 2010 the Appellate Division reversed the verdict after finding that the trial court disallowed defense evidence about the number of patients who took Accutane. However, the appeals court rejected Roche's argument that Kendall's claim was barred by the statute of limitations.
Roche appealed the statute of limitations issue. It argued that the New Jersey Product Liability Act (PLA) (New Jersey Statutes Annotated 2A:58C-1 to -11), which presumes that drug warnings approved by the FDA are adequate, affected the state's discovery rule.
"Although that presumption is not a perfect fit for a statute of limitations analysis, we have concluded, as did the Appellate Division, that it cannot be totally ignored where the question is what a reasonable person knew or should have known about the risks of a product for discovery rule purposes," the majority wrote. "However, in the discovery rule setting, the presumption is not dispositive but may be overcome by evidence that tends to disprove the presumed fact."
"With that consideration in place, we are satisfied, as were the trial judge and the Appellate Division, that Kendall reasonably did not appreciate by December 21, 2003, that Accutane had caused or exacerbated her condition and that, therefore, her filing on December 21, 2005, was timely," the majority said.
The majority said a "middle-of-the-road" approach to the statute of limitations and discovery is justified. "That approach permits the judge at a Lopez [Lopez v. Swyer, 62 N.J. 267, 275-76 (1973)] hearing to consider the presumption of adequacy. However, we see no warrant for viewing the presumption, in the Lopez setting, as a 'virtually dispositive' super-presumption," it wrote.
"Rather, it should be treated, as would any presumption in the ordinary course, as capable of being overcome by evidence which '"tends to" disprove the presumed fact, thereby raising a debatable question regarding the existence of the presumed
fact,'" it continued, citing case law. "If, in the face of the evidence, reasonable people would differ regarding the presumed fact, the presumption will be overcome."
"Ultimately, the burden remains on the plaintiff seeking application of the discovery rule to show that a reasonable person in her circumstances would not have been aware, within the prescribed statutory period, that she had been injured by defendants' product," the majority said.
Kendall's evidence, the majority said, "not only overcame the presumption, but established that under all the circumstances, Kendall reasonably was unaware that defendants caused her injury until after December 21, 2003."
"Although we can conceive of circumstances in which the 2003 warning might have been sufficient to alert a plaintiff of the
connection between Accutane and her disease, it was certainly not sufficient, in these circumstances, to cause Kendall to
doubt her physicians or to disregard the advice and information that had been imparted to her by them for the prior six years," the panel said. "That is particularly so in light of the lack of a discernable link between Kendall's symptoms and the ingestion of the drug."
The majority said it took no position on whether lawyer advertisements about Accutane injuries in January and April 2004 should have spurred Kendall to take action. "If they had, the December 2005 filing would be timely," it said.
"Our conclusion is, like that of the Appellate Division - that a reasonable person in Kendall's circumstances would not have known by December 2003 of the relationship between Accutane and her condition," the majority said. "As such, her December 2005 filing was timely."
The majority opinion was written by Justice Virginia Long. She was joined by Chief Justice Stuart Rabner and Justices Jaynee LaVecchia, Barry T. Albin and Helen E. Hoens. Judge Dorothea O'C. Wefing of the Appellate Division, sitting as a temporary justice, dissented.
Justice Anne M. Patterson did not participate.
Judge Wefing said Kendall had adequate notice of the risks of Accutane, based on a patient brochure, the pill blister package and a package insert. She said that the 2003 warnings explained risks in plain language and that since Kendall experienced symptoms, she should have been aware of the potential risk.
The PLA's statutory presumption about FDA warnings cannot be overcome by "plaintiff's election not to review the material in which the warnings are set forth," Judge Wefing said. She also said she cannot find any justification for giving the presumption "different weight when the issue is timeliness of the filing of the complaint as opposed to the merits of the claim."
Judge Wefing said the purpose of the PLA was to "re-balance the law 'in favor of the manufacturer.'" She said the majority's approach does not further the law's legislative objectives.
The judge concluded that Kendall knew or should have known no later than her August 2003 prescription for Accutane of the potential link between the drug and her continuing gastrointestinal problems. "In my judgment, plaintiff's complaint was untimely and should have been dismissed."
Roche is represented by Paul W. Schmidt and Michael X. Imbroscio of Covington & Burling in Washington, D.C., Russell L. Hewit of Dughi & Hewit in Cranford, N.J., and Michelle M. Bufano and Natalie H. Mantell of Gibbons in Newark, N.J.
Kendall was represented by David R. Buchanan of Seeger Weiss in New York and Michael D. Hook of Hook & Bolton in Pensacola, Fla.
Amicus Medical Society of New Jersey was represented by John Zen Jackson of McElroy, Deutsch, Mulvaney & Carpenter in Morristown, N.J. Amicus New Jersey Association for Justice was represented by Michael A. Galpern and Jonathan W. Miller of the Locks Law Firm in Cherry Hill, N.J.
Amici New Jersey Business and Industry Association, New Jersey State Chamber of Commerce and Commerce and Industry Association of New Jersey were represented by Stephen C. Matthews and Brian P. Sharkey of Porzio, Bromberg & Newman in Morristown. Amici New Jersey Lawsuit Reform Alliance and Healthcare Institute of New Jersey were represented by Edward J. Fanning Jr., David R. Kott and Maritza Braswell of McCarter & English in Morristown.
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