The New Jersey Supreme Court on Wednesday said more than 500 lawsuits filed against pharmaceutical giant Hoffmann-La Roche by users of the acne drug Accutane—who allege the drug caused them to develop inflammatory bowel disease—should be dismissed because of the state’s strong public policy toward protecting drugmakers who follow federal Food and Drug Administration rules.
In a unanimous ruling, the court said an appeals court erred when it overturned a trial judge’s decision to dismiss the lawsuits.
The court’s latest decision in the Accutane mass tort litigation comes two months after it dismissed another 2,100 lawsuits, saying the Atlantic County judge assigned to oversee the litigation was correct in finding that those plaintiffs’ expert testimony should be rejected because of scientific unreliability.
The case decided on Wednesday involved 532 cases—18 involving New Jersey residents and another 514 from 44 other jurisdictions. The cases were primarily filed in New Jersey because that is where the company’s former North American headquarters were located. The lawsuits were declared a mass tort and consolidated before Superior Court Judge Nelson Johnson.
The court on Wednesday said the appeals court erred when it reversed summary judgment and said every case not involving a New Jersey plaintiff would have to be analyzed to determine whether the state law governing each individual plaintiff applied.
Justice Barry Albin, writing for the court, said New Jersey law should apply because of this state’s inherent interest in the matters and that it would be unreasonable for a judge to analyze more than 40 other jurisdictions’ laws regarding the right of pharmaceutical companies to rely on FDA approval of their package warning labels.
“We now reverse in all those cases in which the Appellate Division reinstated plaintiffs’ claims against Roche,” Albin said. “[W]e hold that New Jersey has the most significant interests, given the consolidation of the 532 cases … in Atlantic County.”
And, Albin said, New Jersey’s Products Liability Act says companies who use warning labels approved by the FDA should be afforded deference.
“The FDA’s presumption of adequacy for medication warnings approved by the FDA gives a reasonable measure of protection to pharmaceutical companies, which are researching and developing medications to combat diseases and maladies that afflict people around the world,” he said.
The plaintiffs, Albin said, failed to provide clear and convincing evidence that Roche failed to provide the FDA with internal research that purportedly showed a causation between the use of Accutane and irritable bowel disease.
The appeals court had overturned grants of summary judgment to Roche in cases where plaintiffs began taking the drug after April 2002, when the package insert was amended to say the drug was “associated with inflammatory bowel disease.” The appeals court said plaintiffs presented evidence that Hoffmann-La Roche’s knowledge of the drug’s harmful effects was sufficient to present a jury question as to the adequacy of the warning. A finder of fact could conclude that the company concluded internally that there was a causal effect between Accutane and bowel disease, but did not disclose that in its warning.
In the August ruling involving the thousands of other pending cases, the court adopted a new standard for the use of expert testimony.
“Our analysis of the record leads to a clear result: The trial court properly excluded plaintiffs’ expert testimony,” Justice Jaynee LaVecchia wrote for the court in that case.
“In this matter, the trial court did not abuse its discretion in its evidentiary ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts,” she said.
In the ruling, the court adopted the standard set by the U.S. Supreme Court’s 1993 decision, Daubert v. Merrell Dow Pharmaceuticals, which sets a high standard for the use of experts in products liability cases—more stringent than New Jersey’s Rule of Evidence 702. New Jersey currently follows the more relaxed standard set in the 2002 interpretation of evidence rule 702 in Kemp ex rel. Wright v. State of New Jersey.
Amanda Fallon, a spokeswoman for Roche, issued a statement in response to the ruling on behalf of the company.
“Because Accutane has for decades been such an important medicine for patients, Roche is gratified that New Jersey’s highest court has confirmed that Roche provided complete and accurate information about the medicine’s risks and benefits,” Fallon said.
The plaintiffs’ lead attorney, David Buchanan, of New York’s Seeger Weiss, did not return a telephone call.