United States: Ghostwriters In Disguise

Last Updated: March 28 2019
Article by James Beck

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.

This article is presented for informational purposes only and is not intended to constitute legal advice.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions