Vol 22, 2013 Annals of Health Law 437
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
(a) failing to disclose that the FDA had declined to approve Bextra
for the off-label uses; (b) paying physicians to attend presentations
to induce them to promote and prescribe Bextra; (c) training
physicians identified as “advocates” to “serve as public relations
spokespersons” for Bextra and paying them to make presentations
on the drug; (d) drafting and circulating “written protocols, pain
management pathways, and standing orders for Bextra“ for off-
label uses and dosages; (e) sending unsolicited Medical Inquiry
Letters to high-volume prescribers for competitor brands; (f)
distributing samples in unapproved doses to medical prescribers
who had no FDA-approved use for the samples; (g) funding
continuing medical education programs that were used to promote
Bextra for off-label uses; and (h) sponsoring articles that promoted
Proving these activities actually caused the third party payor financial
damage is the challenge that most cannot overcome. To have standing to
assert a claim, the third party payor “must allege facts showing a causal
relationship between the alleged injury – payments for [the drug] that was
ineffective or unsafe for the use for which it was prescribed – and [the
pharmaceutical company’s] alleged wrongful conduct.”198 Like consumers,
third party payors must allege injury in fact and causation with specificity,
and a court will evaluate claim based on the specific facts.
In Bextra, the court rejected the third party payor’s attempt to establish
causation through generic theories.199 There, the plaintiff payor offered two
theories to skirt the court’s insistence on specific allegations of causation:
(1) a forseeability theory; and (2) a “quantity effect” theory.200 The
foreseeability theory posited that it was the foreseeable and intended
consequence of the off-label marketing efforts that doctors would prescribe
Bextra for unsafe, ineffective, or unapproved uses.201 This argument was
insufficient to establish causation because it did not address the required
relationship between the conduct and the harm.202 The “quantity effect”
theory attempted to use statistics showing the extent to which sales were
impacted by the off-label scheme to create an inference of causation. The
third party payor reasoned that the defendants admitted that approximately
sixty-five percent of Bextra sales were the result of the fraudulent off-label
marketing efforts, and it had paid millions of dollars for Bextra
197. Id. at *1.
198. In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d
235, 247 (3d Cir. 2012).
199. In re Bextra, 2012 WL 3154957, at *9.
200. Id. at *4.
201. Id. at *4-7.