Third-party payor (TPP) claims against pharmaceutical companies are nothing new. The arguments are common – TPP insurers claim financial injury arising out of payments made for alleged medically unnecessary prescriptions written for numerous insureds/ beneficiaries. In some instances, the TPP plaintiffs point to evidence or allegations of off-label promotional activity to support the claims of lack of medical necessity; and sometimes the TPP plaintiffs attempt to bolster their allegations of “medically unnecessary” prescriptions by advancing a variation of the garden variety failure-to-warn narrative:
Alternatives to traditional food products have increased in availability, number, variety and popularity over the last decade. So where does this leave consumers and the regulators who are tasked with ensuring food safety? The Ninth Circuit has held that the reasonable consumer can digest the differences between almonds and cows.
In a world where consumers are more health-conscious and eco-friendly than ever, products containing artificial ingredients have become less attractive. Consumers are looking for natural alternatives, and the cosmetics industry is no exception. The recent boom of all-natural products has coincided with a rise in litigation. Like the food industry, cosmetic companies are learning that marketing products as “natural” comes with a price.
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.