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Palazzolo v. Hoffman La Roche

February 3, 2010

VIRGINIA PALAZZOLO, ADMINISTRATOR AD PROSEQUENDUM OF THE ESTATE OF CHRISTOPHER TREMAIN, VIRGINA PALAZZOLO, INDIVIDUALLY, AND JAMES PALAZZOLO, PLAINTIFFS-APPELLANTS, AND ELENOR WRIGHT, AMANDA CALLAIS BY HER GUARDIAN AD LITEM, LORI CALLAIS, AND LORI CALLAIS AND ALVIN CALLAIS, INDIVIDUALLY, AND JESSICA BOERS, ARIE BOERS, AND JANE BOERS, PLAINTIFFS,
v.
HOFFMAN LA ROCHE, INC., AND ROCHE LABORATORIES, A MEMBER OF THE ROCHE GROUP, DEFENDANTS-RESPONDENTS.



On appeal from the Superior Court of New Jersey, Law Division, Essex County, L-5498-99.

Per curiam.

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION

Argued December 14, 2009

Before Judges Rodríguez, Reisner and Chambers.

Plaintiffs, Virginia Palazzolo, individually and as administrator ad prosequendum of her son's estate, and James Palazzolo, appeal from a trial court order dated January 16, 2008, precluding their general causation expert from testifying, and from a March 11, 2008 order dismissing their complaint on summary judgment. We affirm in part and remand this matter to the trial court.

I.

Much of the relevant evidence will be discussed later in this opinion. However, in summary, plaintiffs filed a product liability and consumer fraud complaint against defendants Hoffman La Roche, Inc. and Roche Laboratories, claiming that Accutane, a drug used to treat acne, caused their family member Christopher Tremaine, to develop depression which led to his suicide. They contended that at the time of Christopher's death in 1997, Accutane should have carried a warning label concerning the possibility that the drug could cause depression and suicide.

As one element of their product liability cause of action, plaintiffs needed to establish "general causation," by showing that Accutane can cause depression and suicide.*fn1 See Kemp v. State, 174 N.J. 412, 417 (2002); Coffman v. Keene Corp., 133 N.J. 581, 594 (1993). On that issue, plaintiffs retained Dr. James Bremner, an expert in psychiatry and nuclear medicine. Bremner had already done some research on the connection between Accutane (isotretinoin) and depression. Plaintiffs paid Bremner to undertake a further study. There is no dispute that the study was commissioned specifically for use in this litigation.

In the study at issue, Bremner and a team of other scientists used positron emission tomography (PET) technology to compare changes in brain metabolism between two groups of subjects being treated for acne. One group was receiving antibiotic treatment and the other group was being treated with Accutane. In brief, before and after they underwent the acne treatment, the subjects were injected with a radioactive glucose, and their brains were scanned with a PET machine. The PET machine took images of "slices" of designated portions of the brain, and allowed scientists to measure brain metabolism by detecting the glucose, which is used in brain activity.

According to Bremner, the PET study demonstrated that the subjects treated with Accutane showed decreased metabolism in the orbital frontal cortex, a portion of the brain associated with depression. He published a peer-reviewed article about the study in a scientific journal, describing his methodology and his conclusions. J. Douglas Bremner, M.D., et. al., Functional Brain Imaging Alterations in Acne Patients Treated With Isotretinoin, 162 Am. J. Psychiatry 983 (May 2005). Based on the PET study as well as other scientific evidence, Bremner issued an expert report opining that Accutane can cause depression and suicide.

Defendant challenged the admissibility of Bremner's expert report, and the trial judge determined to hold a pre-trial hearing under N.J.R.E. 104. Prior to holding the Rule 104 hearing, the judge made clear to counsel that one of the primary purposes of the hearing was to allow Bremner to explain to the court what he believed the PET scan established. In particular, the judge questioned how the PET scan study, which all parties agreed did not diagnose depression, nonetheless allowed Bremner to reach the conclusion that Accutane caused depression. The judge expressed the need to have Bremner explain his methodology and his conclusions, and the relationship between the two.

During the lengthy Rule 104 hearing, which spanned several months, Bremner was repeatedly confronted with problems in the PET study, including missing data, inaccurate data, and deviations from the methodology he claimed to have followed. As a result, in the middle of the Rule 104 hearing, the court permitted Bremner to re-work his study data and issue a supplemental expert report and allowed defendant to re-depose him. When the hearing resumed, Bremner admitted that certain underlying data, known as "Bmax numbers" which had been used to make critical calculations in the study, was not retrievable from its computerized format, and some of the data concerning individual study subjects was still inaccurate.

In a lengthy oral opinion placed on the record on November 8, 2007, the trial judge explained her conclusion that Dr. Bremner would not be permitted to testify as an expert witness on general causation. Key to her decision was her conclusion that the PET study was the linchpin of Dr. Bremner's expert opinion that Accutane "is capable of causing depression." The PET study was specifically designed to show that "Accutane has an effect on the brain" and specifically on the orbital frontal cortex. Because the judge determined that Dr. Bremner's opinion would stand or fall on the PET study, her opinion focused entirely on that study.

After reviewing in great detail the contradictions in Dr. Bremner's testimony about how he undertook the PET study, what data he relied on, and the lack of documentation to support his conclusions, she concluded that

Dr. Bremner did not follow his own methodology and has failed to persuade this Court that his conclusion in the case that Accutane causes depression was reached after following his own methodology and/or following any methodology that the Court could view as a scientific methodology. . . . it's not the uniqueness of the conclusion but rather, the lack of methodology in reaching it that has led the Court to . . . this ruling.

II.

Our review of the trial court's summary judgment decision is de novo, using the same standard employed by the trial judge. See Atl. Mut. Ins. Co. v. Hillside Bottling Co., 387 N.J. Super. 224, 230 (App. Div.), certif. denied, 189 N.J. 104 (2006); Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520, 540 (1995). However, we review the trial judge's decision to exclude expert testimony for abuse of discretion. Hisenaj v. Kuehner, 194 N.J. 6, 12 (2008).

We begin our review by considering the law as it relates to the admissibility of expert testimony in a case of this type.

[I]n toxic-tort litigation, a scientific theory of causation that has not yet reached general acceptance may be found to be sufficiently reliable if it is based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field. The evidence of such scientific knowledge must be proffered by an expert who is ...


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