The New Jersey Supreme Court clarified and toughened the standards for mass tort actions against drug companies and other manufacturers in a decision Wednesday involving the acne medication Accutane.
Its decision, praised by business groups and lawyers representing pharmaceutical and medical-device companies, requires courts to use the same methods federal and most states courts use in determining whether expert testimony is reliable; that is, whether the testimony is considered to be scientifically valid. In summary, Justice Jaynee LaVecchia wrote for the court, “An expert must demonstrate the validity of his or her reasoning.”
Lawyers defending pharmaceutical companies said clarifying and tightening the state’s standard for expert testimony should go a long way toward thwarting the filing of class-action suits and mass-tort cases in New Jersey, as lawyers tend to engage in “forum shopping” to find the state where they think they have the greatest chance of winning. New Jersey is or has been home to many pharmaceutical companies, and the state Supreme Court had relaxed its reliance on a “general acceptance” standard for judging evidence: whether the testimony is generally accepted as reliable by scientific standards.
“The vast majority of other states have already adopted the federal standard, putting New Jersey businesses at a growing disadvantage, as less rigorous gatekeeping invited out-of-state claims based on unreliable expert testimony,” said Alida Kass, president and chief counsel of the New Jersey Civil Justice Institute, an organization working to curb lawsuit abuse that had filed a friend-of-the-court brief in the case. “This new decision will go a long way to keeping such meritless cases out of New Jersey courtrooms.”
Making a case against Hoffmann-La Roche
Dating back to 2005, the case involves 2,079 plaintiffs in a mass-tort action who contended their use of Accutane led to Crohn’s Disease. The drug was made by Hoffmann-La Roche, which had operated a facility on the border of Nutley and Clifton for decades, and first gained federal approval for use to treat acne in 1982. The company took it off the market in 2009, losing cases worth millions of dollars in damages to former Accutane users who contended it had caused inflammatory bowel disease. It is currently available in its generic form, isotretinoin.
In 2014, Hoffmann-La Roche sought a hearing on the association between Accutane and Crohn’s, following the publication of several epidemiological studies that disproved the notion that the drug caused the disease. A Superior Court judge disallowed testimony from the plaintiffs’ experts as a “conclusion-driven” attempt to present only evidence supporting their opinions while disregarding better evidence that was contrary to their case.
An appeals panel overturned that ruling and the state Supreme Court took the case, not only to settle the specific Accutane suits, but also to evaluate the court’s standard for assessing the reliability of expert testimony and determine whether it needed clarification. The court ruling that the expert testimony was properly excluded by the initial judge revises the court’s rules regarding testimony.
“Our view of proper gatekeeping in a methodology-based approach to reliability for expert scientific testimony requires the proponent to demonstrate that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology,” the decision states. “When a proponent does not demonstrate the soundness of a methodology, both in terms of its approach to reasoning and to its use of data, from the perspective of others within the relevant scientific community, the gatekeeper should exclude the proposed expert testimony on the basis that it is unreliable.”
Expert testimony must meet scientific norms
In this specific case, the two plaintiff witnesses had discounted eight of nine epidemiological studies, each involving thousands of people, that stated there was no causal relationship between Accutane and Crohn’s disease. Instead, the witnesses based their contentions that the drug did cause the disease on case reports, animal studies, and other assessments. The Superior Court judge found, and the Supreme Court agreed, that the testimony did not adhere to scientific norms and should not be allowed.
LaVecchia wrote that the Supreme Court had in the past adopted “a more relaxed approach for causation expert testimony … for all medical cause-effect expert testimony,” rather than using a strict interpretation of the federal standard. That was because “it envisioned the trial court’s function as that of a gatekeeper — deciding what is reliable enough to be admitted and what is to be excluded.” But the court was changing that standard to a more rigorous one.
“The trial court is responsible for advancing the truth-seeking function of our system of justice, while still allowing for new or developing opinions on medical causation that may not yet have gained general acceptance,” she wrote. “Properly exercised, the gatekeeping function prevents the jury’s exposure to unsound science through the compelling voice of an expert … Difficult as it may be, the gatekeeping role must be rigorous.”
The court’s rules on expert testimony did need clarification, said Paul Schmidt, one of the lead counsels representing Hoffmann-La Roche. He said he believes this to be the first instance of excluding expert testimony in a mass-tort case in New Jersey.
‘More robust guidance’ for gatekeepers
Kass praised the court’s decision to embrace the federal standard for scientific testimony as providing “trial courts with more robust guidance in performing that gatekeeping role.”
“It’s clear the Supreme Court expects the trial courts to perform a rigorous review of expert testimony,” said Colleen Hennessey, the other lead counsel for Hoffmann-La Roche. “Obviously, it’s a very impactful decision … It should prevent juries from being exposed in the future to unsound science expounded by experts for hire.”
Schmidt said this decision will impact other pending cases that were stayed waiting the release of this ruling. These include suits alleging Accutane caused ulcerative colitis and that talcum powder caused ovarian cancer, the latter case against New Brunswick-based Johnson & Johnson.
“It’s not good enough just to have qualified experts,” he said. “The defense has an interest in only being taken to court on scientifically legitimate claims.”
Michele Siekerka, president and CEO of the New Jersey Business & Industry Association, said that while the organization is still reviewing the decision, its significance should benefit businesses in the state. NJBIA also filed an amicus brief in the case.
“Having a standard that ensures only reliable and scientifically valid testimony in the courts is critically important to our innovators and businesses,” she said.
An attorney for the plaintiffs in the case did not return a request for comment.