When we were still (relatively) young lawyers, we defended Bendectin cases. There was nothing wrong with Bendectin – the litigation produced Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court’s landmark decision on excluding bogus expert testimony, and numerous other decisions, state and federal, excluding “junk science.” Nonetheless, Bendectin’s primary use was as a treatment for morning sickness, and morning sickness occurs at the same time as do many fetal birth defects. The incessant litigation drove Bendectin off the market – the FDA did not remove it.
For example, according to [one] defendant . . ., Bendectin, the only antinauseant drug available for pregnant women, was withdrawn from sale in 1983 because the cost of insurance almost equalled the entire income from sale of the drug. Before it was withdrawn, the price of Bendectin increased by over 300 percent.
Brown v. Superior Court, 751 P.2d 470, 479 (Cal. 1988). The destructive power of Bendectin litigation also brought into currency the terms “tortogen” and “litigen,” both meaning products that generated litigation, but didn’t actually cause anything. See R.L. Brent, “Bendectin: Review of the Medical Literature of a Comprehensively Studied Human Nonteratogen & the Most Prevalent Tortogen-Litigen,” 9(4) Reprod. Toxicol. 337 (July-Aug. 1995) (available here for $$$). Because Bendectin was the only medication approved to treat this morning sickness, pregnant women with morning sickness were left with no FDA-approved therapeutic alternative.
We also worked on vaccine cases, mostly DPT, and but for Congress stepping in with the Vaccine Act – successful preempting just about all product liability litigation against essential vaccines – plaintiffs were on the verge of driving those products off the market as well:
But in the 1970’s and 1980’s vaccines became, one might say, victims of their own success. They had been so effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases, and much more concerned with the risk of injury from the vaccines themselves.
. . . This led to a massive increase in vaccine-related tort litigation. Whereas between 1978 and 1981 only nine products-liability suits were filed against DTP manufacturers, by the mid-1980’s the suits numbered more than 200 each year. This destabilized the DTP vaccine market, causing two of the three domestic manufacturers to withdraw; and the remaining manufacturer . . . estimated that its potential tort liability exceeded its annual sales by a factor of 200. Vaccine shortages arose when [it] had production problems in 1984.
Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226-27 (2011) (footnotes omitted).
But we haven’t looked at this issue recently – and never on the blog − so we thought we’d see what all this litigation, particularly the explosion of attorney-solicited MDL litigation, has affected targeted products. Put the emphasis on “recently,” because we’re not citing any material prior to 2000 for the rest of this post. For some older examples (other than those above). See Paula Jacobi, “Pharmaceutical Tort Liability: A Justifiable Nemesis to Drug Innovation and Access?,” 38 J. Marshall L. Rev. 987, 991-93 (2005) (the “other casualties” section).
We’ve already discussed the impact of product liability litigation on reproductive choice, since seemingly every contraceptive that’s come on the market has been the target of one mass tort or another. We’re not the only ones either.
[P]laintiff attorneys − perhaps inspired by the litigation surrounding silicone breast implants − targeted [the] contraceptive Norplant, a hormonal preparation encapsulated in a silicone elastomer. This was despite the FDA having no concerns over the drug’s safety. During more than five years in court, the manufacturer won three jury verdicts, 20 pretrial judgments and dismissal of some 14,000...
