Vol 22, 2013 Annals of Health Law 439
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
relied on any Pfizer misrepresentation promoting an off-label use, as
opposed to relying on the professional’s own judgment and expertise, when
prescribing the drugs.”214 Although the motion to dismiss was granted, it
happened only after two years of litigation and multiple motions to
However, not all courts are as stringent in requiring this more
particularized evidence of reliance and causation, and third party payor
claims do have potential to continue past the pleading phase. In In re Actiq
Sales and Marketing Practices Litigation,216 two third party payors alleged
that Cephalon promoted Actiq, a drug approved for pain treatment in late
stage cancer patients, for off-label use with patients with less severe
conditions. As a result, the plaintiffs alleged that they had overpaid for
Actiq because it had been prescribed for beneficiaries with less severe
conditions who could have been treated with less expensive alternatives.217
The court did not require evidence of direct reliance by a particular
physician on Cephalon’s off-label marketing statements, and the plaintiffs’
claims under Indiana and Pennsylvania consumer protection statutes
survived summary judgment.218
3. Suits by Shareholders
Shareholder suits arising from settlements that resolve allegations of
FDCA violations are nothing new. Over a decade ago, in In re Abbott
Laboratories Derivative Shareholder Litigation,219 shareholders alleged that
Abbott’s directors breached their fiduciary duties and were liable for harm
resulting from an FDA consent decree that required the company to pay a
$100 million civil fine and take a number of corrective actions. Noting that
the directors were aware of the violations of the law and took no steps to
prevent or remedy the situation, the Seventh Circuit reversed the lower
court’s dismissal and allowed the action to move forward.220
However, the recent growth of DOJ-led investigations and high-dollar
settlements has spurred the development of a cottage industry in
214. See infra note 186.
215. Report and Recommendation of the United States Magistrate Judge, Home Health
Care Service Corp. v. Pfizer, Inc. et al., No. 2:10-cv-221, 2012 WL 2505555 (E.D. Tex.
April 23, 2012); Order Adopting the Report and Recommendation of the United States
Magistrate Judge, Home Health Care Service Corp. v. Pfizer, Inc. et al., No. 2:10-cv-221
(E.D. Tex. June 28, 2012).
216. In re Actiq Sales and Marketing Practices Litigation, Nos. 07-2292, 09-431, 2012
WL 2135560 (E.D. Pa. June 13, 2012).
217. See id.
218. Id. at *4-5.
219. In re Abbott Laboratories Derivative Shareholder Litigation, 325 F.3d 795 (7th