Home -> Law Blog Directory -> Personal Injury Law Blogs -> Drug and Device Law

OR PHONE (866) 635-1838 for Bankruptcy Help, (866) 635-6190 for Divorce,
(866) 635-2689 for Personal Injury or (866) 635-9402 for Criminal Defense

Find a Local Lawyer

Bankruptcy (866) 635-1838
Divorce (866) 635-6190
Personal Injury (866) 635-2689
Criminal Defense (866) 635-9402

Personal Injury Law

: Drug and Device Law

Plaintiffs? Experts And Peer Review Don?t Mix

By James M. Beck and Mark Herrmann

Just the other day we brought you news that the British medical journal Lancet issued a full retraction of an purported scientific article by a plaintiffs? expert in autism litigation. The author, who was at the time also serving as a plaintiff-side expert, described parts of his research in a manner that ?have been proven to be false.?

Something similar seems to be happening in the Accutane litigation. There?s a new opinion, Palazzolo v. Hoffman-La Roche Inc., No. A-3789-07T3, slip op. (N.J. Super. App. Div. Feb. 3, 2010), in which another plaintiff?s expert has gotten called out for essentially the same thing ? publishing an article in a medical journal that failed to accurately describe what was actually done.

Be ready to hold your nose, here's what went down, and it ain't pretty:

In Palazzolo the plaintiff?s expert, James Bremner, was hired to offer an opinion that Accutane caused depression and suicide. The sticky situation began when, in the words of the Court, ?Plaintiffs paid Bremner to undertake a further study. There is no dispute that the study was commissioned specifically for use in this litigation.? Slip op. at 3. That study ? bought and paid for by plaintiffs? counsel ? was nevertheless published at J. Douglas Bremner, M.D., et. al., ?Functional Brain Imaging Alterations in Acne Patients Treated With Isotretinoin,? 162 Am. J. Psychiatry 983 (May 2005). Slip op. at 4. You can read the whole thing on line here.

According to the opinion, the study protocol (we use the term advisedly) injected some patients with ?radioactive glucose? and then ?sliced? their brains with something called a ?PET scan? ? ?PET? being short for "positron emission tomography.? Slip op. at 3. However, there didn't seem to be much dispute that PET scans can?t diagnose depression, therefore, the court held a hearing. Id. at 4 (?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?).

That hearing was beginning of the end for Dr. Bremner?s study, because the court ordered him deposed, and cross-examination brought out what four judges (the trial judge and the unanimous three-judge panel) all agree happened:

?Bremner did not actually use the methodology he claimed to have used. Although his PET scan article was peer-reviewed, he admitted that he did not in fact follow the steps described in the article.? Slip op. at 10.
?[C]ontrary to representations made in the article, he did not get before-and-after. . .questionnaires from many of the subjects.? Id. at 10-11.
"Bremner also could not document much of the data on which his published results were based." Id. at 11.
?[H]e admitted that some of the statistical analysis was inaccurate. For example. . .Bremner admitted that, for each study participant, comparing the activity in the orbital frontal cortex with the activity in the whole brain revealed no difference between the subjects who took Accutane and those who took antibiotics.? Id.
?[H]e testified. . .that the ?absolute metabolic rates? for the two groups was significantly different, and contended that was the key finding of the PET study. However, Bremner. . .could not produce the source data for that analysis because [it] was on an optical computer drive that could not be opened.? Id.
?[H]e admitted that some of the [data] he used in his calculations were inaccurate, [but] could not check the accuracy of the remaining numbers because the original data could not be retrieved.? Id. at 12.

Thus the court affirmed throwing the study out even under New Jersey?s relatively liberal standard for admissibility of expert evidence. ?An expert's scientific peers cannot fairly judge the expert?s written work. . .if his article does not accurately represent either the underlying data or what the author did to produce his results.? Slip op. at 12. Four judges unanimously agree that ?Bremner?s study was not soundly and reliably generated.? Id.

But just when we're getting ready to cheer the panel for calling out Dr. Bremner's faked article, we nearly swallow our tongues. The trial court's order excluded Bremner altogether, probably (we haven't seen it) reasoning along the lines of the old legal maxim, "falsus in uno, falsus in omnibus." State v. Wesler, 59 A.2d 834, 837 (N.J. 1948); see, e.g., Howard v. Fortuna, 2009 WL 2031060, at *7 (N.J. Super. A.D. July 15, 2009) (unpublished, affirming trial judge's decision on basis of "false in one, false in all" doctrine).

The appellate court reversed the total exclusion and ? despite all the findings about how the article had been faked ? remanded at plaintiff's insistence to determine if, "without reference to the PET study," Dr. Bremner could nonetheless give a causation opinion. Slip op. at 20. Our own words fail us, so we rely upon Joseph Welch's retort to Sen. Joseph McCarthy: "Have you no sense of decency, sir, at long last? Have you left no sense of decency?"

Thus, even after holding that Dr. Bremner's main basis for his testimony was an "article [that] does not accurately represent either the underlying data or what the author did," the court was nevertheless willing to allow him to offer an opinion in the same matter. Amazing.
On a more general level, we are, frankly, sick and tired of hearing the academic types and the popular press moan and wring their hands about the fact that our clients fund a lot of published studies in the medical literature. If they didn?t, there wouldn?t be very much literature, and the journals would have to print more junk science along the lines of the Lancet and the American Journal of Psychiatry articles.

Compared to that kind of litigation-inspired trash, the safeguards built into FDA-regulated clinical trials are ... well, there's no comparison, really. A drug manufacturer?s studies have to meet rigorous FDA standards. These studies are subject to written, detailed protocols, those protocols have to be followed or there?s Hell to pay (and a great deal of money down the drain), every step of the way has to be documented, and after that, everything is submitted for review by independent FDA scientists who can require submission of any additional data that they want.

Those are a lot of reasonable guarantees of genuineness ? to steal a phrase from hearsay evidence cases. They?re not perfect, of course, but FDA-regulated clinical trials are already subject to pretty stringent standards.

What?s really appalling is what happened twice this week ? exposure of the kind of shenanigans that turn up all too often when studies are actually paid for by litigants for litigation purposes. Where's the outrage (other than here)? We think that if academic journals don?t already ask authors whether they?ve been retained as experts in litigation concerning any drug/device/vaccine they are studying, they damn well should.

And mere disclosure's not enough. The ordinary peer review process doesn't seem to be robust enough to ferret out litigation-driven academic fraud. So we think that if the answer to the disclosure question is ?yes,? more needs to be done. If there?s a litigation expert seeking to publish about anything litigation related, we think academic journals ? to safeguard their own integrity ? should include at least one opposing-side litigation expert in the peer review process.

Note that we?re not limiting our proposal just to plaintiff-side experts, although that seems to be from where most of the ?smoke? is now rising. That's because: (1) we trust our experts more than we trust the other side?s, so we?re comfortable with increased scrutiny across the board, and (2) if we?ve got a bad apple with a rotten study, we?d like to know about that sooner rather than later.

If special scrutiny is not paid to studies being pushed by litigation experts, there are only going to be more embarrassments on the order of what we?ve seen this week. Junk science doesn?t stop being junk science just because some academic journal is bamboozled into publishing it.

Full post as published by Drug and Device Law on February 04, 2010 (boomark / email).

Lawsuits and Settlements

Job Site Fatalities Increase
Safety Experts Concerned

Nationwide Mutual
305,000 Potential Plaintiffs in Class Action

Tulsa County Natural Gas Royalties
Plaintiffs Awarded $126 Million

Kia Motors America, Inc.
Kia Class Action Ends in $6 Million Verdict for Plaintiffs in NJ

$47.5 Million Settlement Approved for September 11 Plaintiffs
$47.5 Million Settlement Approved for September 11 Plaintiffs

FDA Issues Update on Safety Review Orlistat
Orlistat FDA Issues Update on Safety Review