Vol 22, 2013 Annals of Health Law 427
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
involving the same product in Denver, Colorado137 and Portland, Oregon,138
the defense won. Indeed, when Federal Judge Sam Pointer held Rule 706
hearings before an independent panel of experts, it was concluded that
implants did not, in fact, cause any disease.139 As time played out and more
epidemiology studies were conducted, the legal community finally caught
up with the scientific community, and it became widely accepted that
implants did not lead to disease in women.140 This ultimate resolution
would have been unimaginable to most, who had heard only about
thousands of legal complaints and inflammatory news headlines.141
Despite the difficulty in gaining a true understanding of the facts in off-label promotion matters brought by the DOJ, several cases have been
described in literature or case law that illuminate the questions about the
nature of the impact on public health from these cases.
The first criminal prosecution brought by the DOJ was against
Genentech Inc. for the company’s violation of the FDA rules against
promoting a drug for unapproved uses.142 The company’s product,
Protropin, was a human growth hormone approved for use to treat
undersized children who suffered from lack of adequate growth hormone.143
It was alleged that the company was marketing Protropin for “treatment of
children who were undersized [due to] a rare form of juvenile obesity and
[for] the treatment of burn patients.”144 The DOJ suggested that it could see
patterns in the marketing practices of Genentech that led it to suspect that
the company was marketing for off-label purposes.145 The company settled
for fifty million dollars.146 Several years later, the same company was faced
137. Jurors Absolve Maker of Implant, N.Y. TIMES, June 12, 1993, available at
verdict in favor of manufacturer Dow Corning).
138. Jennings v. Baxter Healthcare Corp., 14 P.3d 596, 597 (Or. 2000) (appeal from a
139. Silicone Breast Implants in Relation to Connective Tissue Diseases and
Immunologic Dysfunction: A Report by a National Science Panel to the Honorable Sam C.
Pointer Jr., Coordinating Judge for the Federal Breast Implant Multi-District Litigation, In re
Silicone Gel Breast Implant Prods. Liability Litig., Master File No. CV 92-P-10000-S (N.D.
Ala. 1998), available at http://www.fjc.gov/BREIMLIT/SCIENCE/report.htm.
140. See, e.g., COMMITTEE ON THE SAFETY OF SILICONE BREAST IMPLANTS, INSTITUTE OF
MEDICINE, SAFETY OF SILICONE BREAST IMPLANTS 225-226 (Stuart Bondurant et al. eds.
1999) (discussing very substantial body of evidence that found no elevated risk of
connective tissue disease in women with implants and concluding that there is no association
between implants and connective tissue disease).
141. See, e.g., MARCIA ANGELL, SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE
AND THE LAW IN THE BREAST IMPLAN T CASE 26 (1997).
142. Girard, supra note 10, at 126.
143. See id.