Just so you know who to blame, this post is by Bexis only. Herrmann’s staying well away due to his representation of Wyeth.

The much-touted/much-reviled (depending upon which side of the “v” one resides) $27.12 million punitive damage award in the In re Prempro hormone replacement ltherapy litigation has been vacated. The judge admitted that he made a mistake in allowing multiple lines of testimony by the plaintiffs’ so-called “FDA Expert” Suzanne Parisian. Here’s a copy of the Scroggin v. Wyeth opinion. It’s since been reported at In re Prempro Products Liability Litigation, 554 F. Supp.2d 871 (E.D. Ark. 2008).

Although ostensibly qualified as an “FDA expert” – we’ve already expressed our opposition generally to experts testifying on legal subjects – Dr. Parisian, in fact ranged far and wide, offering an abundance (14 separate instances of error) of unqualified, prejudicial fact and non-regulatory opinion testimony, specifically:

  • Simply reading inflammatory docments into the record and commenting on the defendant’s “attitude.” Slip op. at 6-7.
  • “Regurgitati[ng]” exhibits. Id. at 7. See also id. at 9-10.
  • Taking turns with plaintiff’s counsel reading a company memo into evidence, with no point but to highlight something the witness never claimed was improper. Id. at 7-8.
  • Offering summaries that required no expertise. Id. at 8-9.
  • Opining on the merits of defendant’s marketing plan. Id. at 9.
  • Testifying beyond the scope of her report, after the court excluded another expert. Id. at 10-11 (“If a court strikes one expert, a party may not use another expert to give the same
    testimony if it is beyond the expert’s expertise and designation.”).
  • Testifying about exhibits that had nothing to do with the FDA. Id. at 11-13, 16.
  • Offering incompetent epidemiological testimony. Id. at 13-14.
  • Testifying about continuing medical education after admitting that it was not something the FDA could restrict. Id. at 14-15.
  • Testifying about defendant’s unrestricted grants after admitting that they were not something the FDA could restrict. Id. at 15.
  • Testifying about ghostwriting after admitting that it was not something the FDA was even aware of. Id. at 15.
  • Offering “more argument than expert testimony” about the contents of a Dear Doctor letter. Id. at 16.

The court went on to hold, generally, that it was improper to use experts just to “read selected
portions of documents in evidence, without further comment.” Id. at 18.

If an expert does nothing more than read exhibits, is there really any point in her testifying as an expert? As was seen during the punitive damages stage, the use of the “regulatory expert” to deal with large volumes of documents is subject to abuse. The expert did not explain the documents, provide summaries, or tie them in to her proposed regulatory testimony. Dr. Parisian did not provide analysis, opinion, or expertise.

Id.It was also improper to allow an expert just to give “bottom line” opinions that echoed the plaintiff’s legal arguments:

When Dr. Parisian actually elaborated on documents, her testimony did no more than counsel for plaintiff did in argument, i.e., propound a particular interpretation of defendant’s conduct. Having an expert witness simply summarize a document (which is just as easily summarized by a jury) with a tilt favoring a litigant, without more, does not amount to expert testimony. Because Dr. Parisian’s testimony – or reading – invaded areas that required no expert assistance, it was inappropriate “expert” testimony.Since Dr. Parisian testified as to the bottom line without any explanation, failed to
provide expert analysis, testified beyond limitations established by pretrial orders, testified in areas beyond her expertise, and invaded areas that required no expert testimony, most of Dr. Parisian’s punitive damages testimony should have been excluded.

Id. at 20 (footnotes and quotation marks omitted).With all of Dr. Parisian’s improper and prejudicial testimony excluded, the court held that the plaintiff had failed to establish a “clear and convincing” case of malice required for punitive damages. Id. at 51. Rather, what was left was “weaker than a $2.00 suitcase – it is not enough standing alone or with the other admissible evidence to create a submissible issue on punitive damages.” Id. at 36. Indeed, as to “ghostwriting,” there was no evidence even of negligence:

Plaintiff focused heavily on the fact that Wyeth … collaborated with authors to have articles written about HRT in a process called “ghostwriting.” … However, there is no evidence that this practice is inappropriate or that Wyeth supported articles that it knew were false or misrepresented the science. Rather, the articles supported Wyeth’s position on the state of the science. Additionally, there was evidence that ghostwriting was a common practice in the industry.

Id. at 36-37. The court’s opinion of ghostwriting isn’t very far from ours.In the end the punitive damages award was vacated in its entirety and judgment as a matter of law entered for Wyeth. Id. at 52This opinion should be provided, as a cautionary tale, to every judge at every trial at which Dr. Parisian is offered as a witness – so courts will have some idea what they’re likely to encounter if they allow her to testify.