Vol 22, 2013 Annals of Health Law 426
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
prosecute pharmaceutical manufacturers and their representatives under the
FDCA for speech promoting the lawful, off-label use of an FDA-approved
drug.”133 Whether this rejection of the government’s ability to prosecute
pharmaceutical manufacturers and their representatives for truthful speech
about off-label uses will be followed in other Circuits remains to be seen.
IV. ILLUSTRATIVE FACTUAL SCENARIOS
INVOLVING OFF-LABEL PROMOTION EVIDENCE
Undoubtedly, pharmaceutical company representatives sometimes
“oversell” products for off-label uses, pushing profit before safety. As
Kesselheim describes:
Detailing can lead to overuse of drugs with dangerous side effect
profiles. [Vioxx] is a good example for this analysis. The drug was
an analgesic, and thus the manufacturer could legally engage in
promotion of its use to control certain types of pain....
However, the manufacturer’s multi-billion dollar promotional
effort led to its widespread adoption outside of this narrow
context. This became a public health disaster when rofecoxib was
later publicly linked to cardiovascular complications.134
If everything in the government’s many complaints against
manufacturers is true, it would seem that there is an epidemic of this type of
activity. But as discussed earlier, in light of the lack of clarity in the
regulations regarding what is and is not lawful promotion, along with the
fatal sanction of exclusion from participation in federal health care
programs, the cases actually decided on the merits are few and far between.
When cases settle, we are left without conclusive information about the true
facts of the company’s conduct. Furthermore, as is so often seen in the
context of mass tort litigation, judges and juries across the country reach
conflicting decisions about the scientific merits of product liability cases
every day. In the context of silicone breast implant litigation in the 1990s,
for example, tens of thousands of cases were pending, and many were tried
in front of a jury with conflicting results. In New Orleans, Louisiana135 and
Reno, Nevada,136 spectacular jury verdicts against the silicone
manufacturers were achieved by women with implants. Yet, in cases
133. Id. at 169.
134. Kesselheim, supra note 90, at 249.
135. Spitzfaden v. Dow Corning Corp., 833 So.2d 512, 515 (La. Ct. App. 2002) (noting
finding of liability in statewide class action).
136. Dow Chemical Co. v. Mahlum, 970 P.2d 98, 106 (Nev. 1998) (reporting award of
over $4 million in actual damages and $10 million punitive damages award to an implant
recipient and her spouse).
