Yeary takes a look at what happened in Holley v. Gilead Science, Inc., 2019 WL 2077845 (N.D. Cal. May 10, 2019). The case involves two of the main active ingredients in AIDS drugs: TDF and TAF. The plaintiff alleges that the defendant should be responsible for allegedly knowingly using TDF over TAF (allegedly a safer alternative). TDF was FDA approved first and TAF second. Unfortunately, Yeary wrote, hindsight “can be used to demand perfection,” allowing plaintiffs to “proceed on what is essentially a stop-selling theory,” that first-generation drugs should not be submitted to the FDA because, in hindsight, “later approved treatments were safer.” That’s what happened in Holley, she said.
Read the complete post by Michelle Yeary on the Drug and Device Law Blog here.