Drug & Device Law

The definitive source for intelligent commentary on the law that matters for drug and device cases

This post comes from the Cozen O’Connor side of the blog.   Today’s story is about a class action, one in which the defendant was sued for labeling its product “No Sugar Added” even though everyone involved, including the plaintiff, understood from the very start that no sugar had been added to the defendant’s product. You can probably already see where this is going. The named plaintiff in Perez v. The Kroger Co. 2018 WL…
Today’s guest post was is a group effort of Betsy Chance, Diana Comes, and Mac Plosser, all at the Butler Snow firm.  A little while ago they circulated (we don’t remember exactly how) an earlier version of a 50-state survey they had put together on state tolling statutes that preserve lawsuits that have been dismissed for non-merits reasons.  We had encountered this type of tolling before, in mass tort litigation – to see more, particularly…
There was a time when we paid quite a bit of attention to the circumstances under which a participant in a clinical trial could impose liability on the sponsor of the clinical trial. We even tried a case to a defense verdict for the sponsor of a clinical trial in a case where the plaintiff claimed, as to our client and the investigator defendant, that his HIV misdiagnosis should have been reversed during the clinical…
In a classic case of overreaching, plaintiffs in the In re Abilify MDL, sought sanctions against the defendant for not preserving emails dating between 2002 and 2006 – more than a decade before the start of the litigation. We have a hard time even contemplating what a duty to preserve that covered those emails would begin to look like. Fortunately, so did the court. Not for lack of argument by plaintiffs. They tried everything from…
We’re blogging today because of an annoyance – another of these nuisance motions filed by plaintiffs that should be skirting the border of Rule 11, but unfortunately isn’t.  Our particular gripe is a motion to strike a defendant’s pleaded defenses (please don’t call them “affirmative” defenses unless they really are) because they supposedly don’t meet the pleading requirements of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662…
Did you know that October is National Cybersecurity Awareness Month?  Neither did we, until we started poking around the FDA’s recent press release announcing that it intends to update its guidance on medical device cybersecurity within the next few weeks.  We also learned that National Cybersecurity Awareness Month has been observed each October since its inception in 2004.  Observed by whom?  We’re not exactly sure.  We picture our IT consultants walking office to office handing…
It would seem to go without saying that for a defendant to be liable for the purported “common-law” claim of failure to report adverse events to the FDA, there must actually be some adverse events that needed to be reported.  One would think so, but certain California breast implant plaintiffs (yes, some still exist) would beg to differ – at least they did before the recent decision in Mize v. Mentor Worldwide LLC, No. BC649083,…
If a court acknowledges that no state or federal appellate courts in the jurisdiction have addressed the question before it, we think at a minimum there also should be an acknowledgement of the Erie doctrine. Yet, in the case of Fogel v. Sorin Group USA, Inc., 2018 WL 4680022 (S.D.N.Y. Sep. 28, 2018) you get the former without the latter. Fogel is one of our least favorite types of decisions, one that claims to be…
We would be hard pressed to think of a recent judicial decision we have blasted as hard or often as the Third Circuit’s Fosamax opinion.  We deemed it the worst case of 2017.  It was bad enough that our hometown federal appellate court held that it was up to a jury whether the FDA would have rejected a stronger drug warning.  It was worse that the court held that a defendant had to prove…
Not too long ago we read a non-drug/device decision, Hale v. State Farm Mutual Automobile Insurance Co., 2018 WL 3241971 (S.D. Ill. July 3, 2018), which left us shaking our heads.  How this suit could not be a blatant First Amendment violation is beyond us. But that’s not really the point of this post. The alleged “facts” are downright bizarre:  The plaintiffs were sore losers in previous litigation against the same defendant.  They had managed,…