This winter we discussed new regulatory guidelines intended to increase transparency in Direct-to-Consumer (DTC) advertising including a proposed rule from the Centers for Medicare and Medicaid Services (CMS) that would require pharmaceutical manufacturers to list prices in DTC advertising for drugs costing $35 for a 30-day supply.
Much has been said about the eye-popping verdict and the post-trial rulings in the Roundup case tried in San Francisco earlier this year. Johnson v. Monsanto Co., 2018 WL 5246323 (S.F. Super. Ct. Oct. 22, 2018). The court sustained the jury’s award of ~$39 million in compensatory damages, including $37 million in non-economic damages, and its finding that Monsanto was liable for punitive damages. The court reduced the punitive award on due process grounds to a one-to-one ratio, slashing it from $250 million to approximately $39 million. Monsanto recently filed its notice of appeal, and as we await the briefing and argument, a few issues and takeaways merit further discussion, particularly several disturbing issues surrounding the award of punitive damages. We will save for another day (or post) other significant liability and damages issues.
The Central District of California recently issued an opinion that breathes new life into the argument that the § 510(k) substantial equivalence process for Class II medical devices involves an FDA finding of safety and effectiveness. It is part of a trend of recent federal cases giving credence to the § 510(k) process, which could have significant implications for punitive damages claims brought against manufacturers of Class II devices.