Vol 22, 2013 Annals of Health Law 435
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
who were prescribed the drug for an off-label purpose, by the third-party
payors who paid for the drug, and by its own shareholders.
1. Suits by Consumers
Consumer fraud cases may be brought on either an individual or a class
basis. Class actions typically include patients who were prescribed and
purchased the pharmaceutical for an off-label purpose, but they also can
include all purchasers of the drug, who allegedly paid more for it than they
would have if the price had not been driven up by the off-label marketing
efforts. Third party payors, as the parties who paid for the medication, may
be part of the class definition in a consumer fraud class action, but they
often opt out of the case to pursue claims on their own behalf.188 Related
causes of action that may accompany a statutory consumer fraud claim
include common law claims like negligence, negligent misrepresentation,
fraud, civil conspiracy, and unjust enrichment.
Whether brought as an individual action or on a class basis, these
claims face a number of hurdles and are often rejected at the motion to
dismiss phase. First, in some jurisdictions, the “learned intermediary”
doctrine bars consumer fraud claims by patients.189 Second, as a claim
rooted in fraud, the allegations must be pleaded with particularity. As a
result, the complaint must contain plaintiff-specific information and allege
facts that demonstrate that either the plaintiff or his physician relied on the
purported misrepresentations.190 It is not sufficient to rely on generic
allegations about off-label marketing efforts from the criminal complaint,
settlement, or other litigation, without facts showing a connection between
specific illicit marketing efforts that the prescribing doctor was exposed to
and the decision to prescribe the drug.191 Third, even when plaintiffs
188. See infra section V. B.2.
189. For example, in Smith v. Bristol-Myers Squibb Co., No. 3:06-cv-6053, 2009 WL
5216982 (D. N.J. Dec. 30, 2009), the plaintiff took Plavix in combination with aspirin as a
dual therapy, an off-label use that was allegedly promoted by the defendant manufacturers
and rebuffed in several letters from the FDA. After he lost sight in one eye, allegedly a
result of the drug that would not have occurred if he had been taking the equally effective
and less expensive aspirin-only regimen, he sued for violations of Pennsylvania’s Unfair
Trade Practices and Consumer Protection Law (“UTPCPL”), 73 PA Cons. Stat. §§ 201-1, et.
seq, negligence, and negligent misrepresentation. The court held that the learned
intermediary operates to bar his UTPCPL claim and granted the manufacturers’ motion to
dismiss. Id. at *6.
190. See, e.g., id. at *6-7 (dismissing UTPCPL claim in part because, “in the absence
of specific facts in the [complaint] that Plaintiff or his prescribing physician relied upon the
promotional materials that the FDA demanded Defendants discontinue disseminating four to
six years prior to Plaintiff’s prescription, the Court simply cannot find that the particularity
requirements have been met”).
191. See In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678
F.3d 235, 250-253 (3d Cir. 2012) (requiring plaintiff to show a connection between the