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Time and time again, we have opposed efforts by one side of a scientific dispute – typically involving a prescription medical product – to attempt to sue the other side of that dispute into silence.  We came to that position through the crucible of litigation, since plaintiffs in the Bone Screw litigation sought to sue a variety of medical societies because they supported the (at the time) off-label use of bone screws for pedicle fixation.  We have tried to be consistent.Continue Reading Agree To Disagree – Don’t  Sue the Other Side of a Scientific Dispute into Silence

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We have decried several times plaintiffs’ tendency in prescription medical product litigation, particularly mass torts, to try to sue into submission their opponents in scientific debates.  This often takes the form of lawsuits alleging that journal articles, continuing medical education, and other forms of scientific discussion are actionable “misrepresentations.” We said some time ago:

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We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes for scientific journals – and what can be done about it.  Dr. Frank has just written a law review article about this problem.  F. Woodside & M. Gray, “Researchers’ Privilege:  Full Disclosure,” 32 Cooley L.R 1 (2015), which is available online here.  Here’s the abstract:

An ever-growing chorus of academicians report that with the expanding number of academic journals there is a concomitant increase in the number of articles based on questionable methodology.  Many published studies contain improper statistical conclusions, flawed methodology, and results that cannot be replicated.  The recent controversy concerning the failure of parents to vaccinate their children because of the recommendations of flawed research exemplifies this crisis. This epidemic of faulty research has been exacerbated recently by the spread of low-quality academic journals and “pay-to-publish” journals, which will publish virtually anything for a fee.  This Article provides an analysis of a growing crisis of reliability in scientific research and how the so-called “researchers’ privilege” allows faulty research to go undetected.  This Article delineates the reasons why it is difficult, if not impossible, to evaluate published research findings without access to the underlying information that researchers have in their possession.  The Article then analyzes the state of the law regarding the ability of researchers to withhold records and data based on the so-called “researchers’ privilege.”  Finally, the Article explains why courts should favor the disclosure of research data and that confidentiality concerns should be addressed by a confidentiality order.

Id. at 1-2.  Here are the articles subheadings, which describe the material in it in more detail:

  • Misunderstanding and Misuse of Statistics and Research Methods
  • An Ever-Growing Number of Journals and “Pay to Play”
  • Fraud and Questionable Research Practices
  • Pre- and Post-Publication Peer Review Does Not Work

Continue Reading What To Do About Junk Science That’s Published?

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The Fourth of July is the time to celebrate everything American – baseball, apple pie, almost anything that’s red, white and blue (ironically so are the Russian, French, and British flags), the Declaration of Independence, the Constitution, and the Supreme Court making decisions that infuriate us one day and exhilarate us the next.  And regardless what decisions we love or we hate, we can get up on our soap box (literal or cyber) and disclaim our reasons.

That’s free speech.

And free speech is one of the linchpins of preserving everything else that makes America what we hope America can be.

So we thought we’d devote today’s post about an interesting free speech case, ONY Corp. v. Cornerstone Therapeutics, Inc., 2013 WL 3198153 (2d Cir. June 26, 2013) (also available here in slip).  No, this is not another screed about off-label use, although it’s related. ONY has nothing to do with the FDA, or even the federal government.  It’s a Lanham Act (and related state-law torts) case in which the plaintiff manufacturer accused a competing manufacturer of making inaccurate statements about the comparative effectiveness of their respective products.Continue Reading Celebrating Free Speech on the Forth of July

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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:

Continue Reading Plaintiffs’ Experts And Peer Review Don’t Mix

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J.C. McElveen, of Jones Day, wrote the following guest post, for which we thank him. As is always true of guest posts, the two of us had nothing to do with what follows; JC gets all the credit. (We alone, however, are to blame for not knowing how to create subscripts in blog posts.

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As you well know, this blog doesn’t pretend to be a newspaper.

If you want news, read the Times.

If you want — well, defense-side rants interspersed with legal citations and weak attempts at humor– visit Beck and Herrmann.

But there’s one pharmaceutical news story — the proposed suicidality warnings on anti-seizure medications —

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We’ve watched from a distance as the FDA has considered whether certain drugs indicated for epilepsy are associated with increased suicidality.
Please don’t confuse us with biostatisticians; we don’t even play ’em on TV.
But we looked at the evidence that epilepsy drugs are associated with suicidality, and we’re scratching our heads.
First, the FDA

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Today we’re boldly going where lawyers usually fear to tread (at least alone) – into the realm of epidemiology, albeit perhaps loosely defined. Why? Well, we do have to come up with things to write about, and there’s only so much preemption theorizing that even we can do before it sounds like we’re babbling.