Every time we think about addressing ghostwriting as a recurrent plaintiff-side jury distraction in drug/device product liability litigation, we get earwormed by “Ghost Riders in the Sky.” Whether one prefers the Johnny Cash or Outlaws version of the song – or one of who knows how many other covers of the song (originally written by Stan Jones in 1948), it’s hard to stop thinking about it once you start.
The most inveterate ghostwriters are, of course, lawyers themselves. Give us a chance (and a fee) and we’ll ghostwrite anything: opinions for judges, reports for expert witnesses (e.g., McClellan v. I-Flow Corp., 710 F. Supp.2d 1092, 1118 (D. Or. 2010)), and (most annoyingly) pleadings for supposedly “pro se” parties. But let a drug/device company provide authorship assistance to a busy doctor or a scientist, and the same plaintiffs’ lawyers who routinely massage (if not outright create) their experts’ opinions start screaming and yelling that something terrible is happening. And yet, there’s no proof (and often not even an allegation) that any of the actual science in the “ghostwritten” article was misstated.
So-called “ghostwriting” is “a fairly common, but little known practice, with a pejorative name would distract the jury and needlessly consume time.” Okuda v. Wyeth, 2012 WL 12337860, at *1 (D. Utah July 24, 2012). Plaintiffs regularly attempt to convince juries that routine “ghostwriting” is something nefarious. Defendants, just as often, try to keep this smoke-and-mirrors type evidence out. We haven’t blogged about this issue before, so we thought we’d take a look at decisions excluding ghostwriting allegations.
Perhaps the most notorious ghostwriting testimony was the inflammatory rhetoric initially admitted in In re Prempro Products Liability Litigation, 554 F. Supp.2d 871, 885 (E.D. Ark. 2008), to support punitive damages. There aren’t many judges – especially MDL judges in bellwether cases – willing to admit they were wrong and reverse a verdict, but this was one. In Prempro “Dr. Parisian testified that the FDA would not be aware of ghostwriting” but “provided no testimony linking FDA regulations and ghostwriting.” Id. at 885. Plaintiffs used these (and other) allegations to bamboozle a jury into awarding punitive damages. Id. at 889, 893, 897 (“Plaintiff asserted that ghostwriting is ‘exactly the type of conduct that necessitates punitive damages.’”) (footnote omitted). Holding that ghostwriting testimony should never have been admitted, the court granted a new trial:
[T]here is no evidence that this practice is inappropriate or that [defendant] supported articles that it knew were false or misrepresented the science. Rather, the articles supported [defendant’s] position on the state of the science. Additionally, there was evidence that ghostwriting was a common practice in the industry.
Id. at 888 (footnotes omitted). On appeal, the Court of Appeals affirmed. In re Prempro Products Liability Litigation, 586 F.3d 547, 571 (8th Cir. 2009) (“we cannot say that the district court abused its discretion”).
The same fact pattern was addressed in Cross v. Wyeth Pharmaceuticals, Inc., 2011 WL 2517211 (M.D. Fla. June 23, 2011). Cross “exclude[d] as irrelevant evidence of ‘ghostwritten’ articles” because “neither [plaintiff] nor her physician relied on a ‘ghostwritten’ article.” Id. at *4. Further, “evidence of “ghostwriting’ carries a substantial risk of misleading the jury.” Id. See Okuda, 2012 WL 12337860, at *1 (plaintiff could “not produce sufficient evidence that she or her prescribing physicians relied on any ghostwritten article in taking or prescribing the . . . drugs at issue or that the information in the articles is false”); Skibniewski v. American Home Products Corp., 2004 WL 5628157, at *1 (W.D. Mo. April 1, 2004) (evidence of ghostwriting also excluded).
Ghostwriting allegations similarly bit the dust in Bailey v. Wyeth Inc., 37 A.3d 549, 574-75 (N.J. Super. L.D. July 11, 2008). That wasn’t really surprising, since plaintiffs’ own expert “admit[ted] the beneficial contribution of the information contained in at least one article” that was allegedly ghostwritten, characterizing the information “provided to the doctor [a]s essential.” Id. at 574. Bailey therefore held:
There is no dispute that the articles were subject to a rigorous peer review process and were factually and medically sound. The identified articles were published after 1994 and would not have “polluted” the information regarding [the drug] already available to the FDA. There is no proof that these corporate-initiated articles in any way delayed the implementation of what the FDA requested be in the [drug] labeling or diluted the warnings on these drugs.
Id. at 574-75 (granting summary judgment). Bailey was affirmed on appeal “substantially on the basis of the well-considered and exhaustive opinion . . . in the Bailey matter, which we have determined to be well supported by the evidence and legally unassailable.” DeBoard v. Wyeth, Inc., 28 A.3d 1245, 1246 (N.J. Super. A.D. 2011).
Allegations that “ghostwriting” was a form of academic impropriety were raised, and rejected, in United States ex rel. King v. Solvay S.A., 2015 WL 8732010 (S.D. Tex. Dec. 14, 2015), a False Claims Act case. The court determined that “evidence that [defendant] directed progress and revised the final manuscript [of an article] is not probative.” Id. at *6. The ghostwriting allegations were simply a prejudicial sideshow:
Relators additionally contend that as part of [defendant’s] publication strategy it commissioned smaller “investigator initiated” studies and then found “thought leaders” willing to lend their names to articles actually written by the writers who worked for [defendant], known as ghostwriters. . . . This testimony is not an admission that [an author] merely “lent his name” to an article wholly written by [defendant’s] medical writers. Moreover, even if it were, [plaintiffs] do not link [the] allegedly ghost-written article to any DrugDex [a compendium of off-label research] entries. While the court understands [plaintiffs’] theory that [defendant] had a strategy to publish articles on small studies with positive outcomes and even had its own staff members write the articles and that these non-authoritative studies ended up supporting off-label use in DrugDex and other compendia, at this stage [plaintiffs] must have evidence specifically linking [defendant’s] conduct to . . . off-label use. Innuendo related to small articles that may have been partially ghost-written but did not even end up in DrugDex is not sufficient.
Id. at *6-7 (footnote omitted). Ghostwriting allegations in the air – not relating to anything that influenced an prescriber’s treatment of the plaintiff – also failed in Romero v. Wyeth Pharmaceuticals, Inc., 2012 WL 13036355, at *4 (E.D. Tex. April 25, 2012) (“[f]or these reasons, . . . marketing practices testimony, including . . . ghostwriting, are excluded”).
Other decisions excluding evidence of ghostwriting allegations are: Hill v. Novartis Pharmaceuticals Corp., 944 F. Supp.2d 943, 952 (E.D. Cal. 2013) (“[Defendant] moves to preclude [plaintiff] from ‘introduc[ing] testimony or evidence that some or many of the articles . . . were actually ghostwritten by drug companies. . . .’ Having reviewed . . . all competent and admissible evidence submitted, the Court agrees such evidence should be excluded.”); Mahaney v. Novartis Pharmaceuticals Corp., 835 F. Supp.2d 299, 318 (W.D. Ky. 2011) (granting in limine motion to exclude “[t]estimony or evidence that articles were ghostwritten by drug companies”), reconsideration granted on other grounds, 2012 WL 12996015 (W.D. Ky. Jan. 4, 2012).
Finally, accusations of ghostwriting have also been a stock-in-trade of notorious plaintiffs’ “expert” Suzanne Parisian, even though she has no relevant expertise in such matters. Ironically, in at least one deposition, “Dr. Parisian conceded that she had done ghostwriting on behalf of [a major drug company].” Prempro, 554 F. Supp.2d at 897. Parisian’s ghostwriting charges were excluded in a lot of Aredia/Zometa cases. For instance, in Deutsch v. Novartis Pharmaceuticals Corp., 768 F. Supp. 2d 420, 468 (E.D.N.Y. 2011).
[T]he Court grants [defendant’s] motion to exclude Dr. Parisian’s opinions on the use of ghostwriters. . . . The Plaintiffs argues [sic] that this testimony is relevant because it goes to [defendant’s] “communication of [relevant] risks to health care providers and the public,” which are required to be “fair and balanced” under 21 C.F.R. § 202.1. . . . Dr. Parisian does not provided [sic] any foundation beyond her personal opinion that the use of ghostwriters . . . does not provide “fair and balanced” information.
Id. at 468. Accord Kruszka v. Novartis Pharmaceuticals Corp., 28 F. Supp.3d 920, 935 (D. Minn. 2014) (“opinions that [defendant] convinced doctors to write publications favoring [its drugs] under the guise of independent reporting, or ‘ghostwriting,’ are outside the realm of Dr. Parisian’s expertise”); Lemons v. Novartis Pharmaceuticals Corp., 849 F. Supp.2d 608, 615 (W.D.N.C. 2012) (“the Court is not allowing Dr. Parisian to offer testimony regarding . . . ghostwriting”); In re Fosamax Products Liability Litigation, 645 F. Supp.2d 164, 191 (S.D.N.Y. 2009) (Parisian ghostwriting testimony excluded after “she could not name any standard that prohibits such a practice, as long as the information presented is accurate”); Bartoli v. Novartis Pharmaceuticals Corp., 2014 WL 1515870, at *6 (M.D. Pa. April 17, 2014) (“her testimony regarding ghostwriting . . . is inadmissible because she opines, without foundation, that employing such practices does not provide ‘fair and balanced’ information and that it must be disclosed); Earp v. Novartis Pharmaceuticals Corp., 2013 WL 4854488, at *4 (E.D.N.C. Sept. 11, 2013) (“[t]o the extent she also seeks to opine on . . . industry ghostwriting . . . that would unduly prejudicial, irrelevant, or outside the scope of her expertise, [and] the court will not allow her to do so”); Hill v. Novartis Pharmaceuticals Corp., 2012 WL 5451809, at *2 (E.D. Cal. Nov. 7, 2012) (“Defendant’s motion to exclude Dr. Parisian’s testimony regarding ghostwriting . . . is GRANTED”); Georges v. Novartis Pharmaceuticals Corp., 2012 WL 9064768, at *14 (C.D. Cal. Nov. 2, 2012) (“exclud[ing] Dr. Parisian’s testimony regarding ghostwriting”); Zimmerman v. Novartis Pharmaceuticals Corp., 2012 WL 13009101, at *1 (D. Md. Sept. 25, 2012) (“Dr. Parisian may not offer opinion testimony on . . . Ghostwriting”); Winter v. Novartis Pharmaceuticals Corp., 2012 WL 827245, at *3 (W.D. Mo. March 8, 2012) (“Motion to exclude evidence that articles concerning [the class of drugs] in medical journals were actually ‘ghostwritten’ by companies, including [defendant], is granted consistent with prior rulings”); Mahaney v. Novartis Pharmaceuticals Corp., 2011 WL 13209814, at *2 (W.D. Ky. Nov. 15, 2011) (“exclud[ing] Parisian’s testimony on ghostwriting”).
Sharp-eyed readers will note that all of these decisions, except for the King False Claims Act ruling, were issued in the decade between 2004 and 2014 – which we are wont to call the “coprolitic age” of ghostwriting allegations, powered mainly by the aforementioned Suzanne Parisian. We hope that the other side drew back a nub enough times on this issue that it’s no longer worth the candle to develop. After all, who knows how many of those expert opinions were ghostwritten by plaintiffs’ counsel? We’d like the issue to stay dead, so for the good of the order we have compiled all of the favorable precedent here.