Last week we posted about the Daubert decision in Lowery v. Sanofi-Aventis LLC, that tossed out both plaintiff’s medical causation expert and FDA expert. As promised, that was just the first blow. The knockout came in its companion decision granting summary judgement not just on medical causation but also on the grounds of preemption.
Perhaps the biggest conflict among the circuits in PMA preemption cases involves the extent to which plaintiffs can get away with pleading essentially nothing to support supposed “parallel” violation claims, on the one hand, or on the other must plead a particularized violation of an FDA regulation (usually a “Current Good Manufacturing Practice” or “CGMP”)
A great woman once said “When they go low, we go high.” Apropos of nothing in particular these days, we have been thinking about the issue of tone recently. For instance, what is the exact line between a negative political advertisement and a positive one? Are there circumstances where a candidate might suspend negative ads
Not long ago, an EPL (evil plaintiff lawyer) relayed to us that, based on reading our posts, another EPL had assumed we had a particular political view. As we laughed at the notion, we pondered the issues of assumption and incomplete information. Much like the old quip about what happens when you assume, many assumptions
If you have read more than a few posts on this Blog, then there is a good chance that you realize we have strong views on preemption. You might have also picked up that we think the way an issue is analyzed, not just the ruling after the analysis, matters. We have talked about the
As we approach the end of the year, we turn to reflecting on the events of the passing year. We do it here on the DDL blog with our best of and worst of posts. It is often a time to consider just how much (or how little) was accomplished in the course of a
Did you ever read something and think – I couldn’t have said it better myself. Sometimes we read opinions that give us just that feeling. A decision that ticks all of the boxes and leaves us wondering why everybody doesn’t see how easy it is to reach the right conclusion. Brooks v. Mentor Worldwide, LLC
Offhand, we cannot think of opinions we have blogged on that pleased us more than today’s cases, Jacob v. Mentor Worldwide, LLC, et al., 2019 WL 3500325 (C.D. Cal. Aug. 1, 2019) and Vieira v. Mentor Worldwide, LLC, et al., 2019 WL 3500331 (Aug. 1, 2019). The two decisions are virtually identical and
Our days of the week are mostly named based on Norse mythology, but our months are firmly Roman. May is named after the deity Maia, whose Roman version was honored for her role in the growth of plants. Her cousin Juno, the queen of the Roman gods, gave us the name for June. In their
The decision in Riera v. Somatics, LLC, 2018 WL 6242154 (C.D. Cal. Sept. 14, 2108), comes from California, a place in which private plaintiffs bring claims against medical device companies for violations of the FDCA all the time, despite the fact that the FDCA prohibits that very kind of thing. We won’t—yet again—get into