New Developments in Pharmaceutical Lawsuits – Attorneys Studies for Hire: The Accutane Case

A new development in the continuing trend of pharmaceutical company lawsuits occurred last week, when a “New Jersey appeals court decided that a trial court should reconsider whether an expert should be allowed to testify in a lawsuit alleging the Accutane acne drug causes depression.” The issue involves whether an expert should be allowed to offer testimony on a study—that was considered flawed—which was funded by plaintiffs and lawyers involved in the litigation. The article based on the study was published in a peer-reviewed article in the American Journal of Psychiatry in 2005.

The trial court in New Jersey, “where hundreds of lawsuits allege Accutane is tied to depression, had ruled that Emory University professor Doug Bremner should not be allowed to offer expert testimony” regarding his “flawed study.” Now, Palazzolo v. Hoffman La Roche, Inc., A-3789, has been remanded to the trial court "to consider whether Bremner should be allowed to testify on causation, without reference to the study”, according to The New Jersey Law Journal.

Bremner’s study used “positron emission tomography (PET) scans to find metabolic changes in the brains of acne patients treated with Accutane that were not present in those given antibiotics.” The problem with this study protocol was that “all parties agreed that that the (PET) scans could not diagnose depression.” So the “judge questioned how the PET scan study nonetheless allowed Bremner to reach the conclusion that Accutane caused depression.”

The Drug & Device Law blog further quoted the court, which stated that “there was no dispute that the study was commissioned specifically for use in the litigation. Slip op. at 3, and that the study was bought and paid for by plaintiffs’ counsel, and was nevertheless published.” In fact, Bremner even writes on his own blog that the study “was largely funded by a parent not directly connected with the litigation (although the parent’s son committed suicide while on Accutane) and attempts to explain problems with the reported data which, he notes led to a single-line correction, not a retraction.”

The Drug & Device Law blog post also lists many of the mistakes Bremner made, such as “not actually using the methodology he claimed to have used, and not following the steps described in the article.” Slip op. at 10. In fact, “Roche, which sold the drug, challenged the report and a subsequent hearing found missing and inaccurate data. From this challenge, the “trial judge decided his study was central to his opinion and dismissed the case.”

Conclusion

While having medical experts testify in court is essential for due process, paying for testimony and research to artificially create a flawed study is unethical. As patients, we are all well aware of the risks and benefits associated with treating diseases—whether cancer or acne—and the other more invasive options, and of course, doing nothing. It is certainly a tragedy that risks can cause such harm in the lives of patients and result in such outcomes, but falsifying research as an attempt to get paid is not the way to achieve justice. 

With the Lancet scandal over Andrew Wakefield and his autism research last week, many people are calling this recent decision “litigation-inspired trash” and labeling the study “junk science.” Consequently, we agree with the Drug & Device Blog that academic journals should ask authors whether they’ve been retained as experts in litigation concerning any drug/device/vaccine they are studying.  The pay scale for physicians participating in legal cases is significant and can run in the hundreds of thousands for just one case.   One chief of medicine at a university hospital told me that he stopped working with pharmaceutical companies because the pay was too low, he could do much better working from home reviewing medical information for legal cases.

While numerous organizations, media and Congress are busy with potential conflicts between industry and academia, it seems like they should begin to focus on plaintiffs lawyers, who are building up their own.