If drugs and medical devices undergo a product life cycle, so do drug and medical device litigations. We are currently laboring in the relatively early stage of a Multidistrict Litigation, where the court seems terrified of making any substantive decisions. We get no rulings. Rather, the parties are forced to listen to lectures about the

A long time ago in a law school relatively far away, we took torts as a first year law student.  Many of the cases about which we learned (or were supposed to have learned) were from even longer ago and we had no idea how much some of those old cases would inform our practice. 

When it comes to medical device preemption, having Pre-Market Approval (“PMA”) is like being dealt pocket aces in Texas Hold’Em Poker.  It’s the strongest starting hand you can have; a 4:1 favorite over any other two card combo.  It means you’re starting in the power position.  Since the Supreme Court’s decision in Riegel v. Medtronic

We’ve all had cases where plaintiffs try to use their prescribers and treaters as their experts on everything from failure to warn and causation to design defect and company conduct. Even on the medical aspects of the case, a treater needs to offer more than just an unsupported general conclusion in order to withstand scrutiny

This post does not come from the Reed Smith side of the blog.

Some of us here at the DDL Blog aren’t fans of typical New Year’s resolutions.  You never follow through, and you end up with an unused ab cruncher, a juicer of some sort that stays in the box, and a refrigerator full of rotting fruits.  We prefer atypical resolutions, ones that are more like affirmations.  For instance, I resolve to re-subscribe to Netflix.  I resolve to sleep even later on Sundays.  I resolve to deepen my relationship with chocolate.  I definitely resolve to continue to drink scotch.  Those are viable resolutions, ones that we’ll follow through on.  They remind us what we like to do and that we should do them.  No guilt.  You only feel good.

Along these lines, we hope that some plaintiffs’ counsel have resolved this New Year to miss deadlines.  Courts don’t always enforce missed deadlines.  But when they do the defense usually benefits.  In Thorn v. Medtronic, Inc., 2015 U.S. App. LEXIS 22582 (6th Cir. Dec. 15, 2015), an infuse case, the trial court granted defendant’s motion to dismiss based, for the most part, on preemption.  Id. at *3.  The court entered judgment.  Mr. Thorn, the plaintiff, did not appeal.

Thereafter, he sought leave to amend his complaint and add a fraud count.  Id.  He made the ordinary FRCP 15 amendment arguments—the defendant would not be prejudiced and an amended complaint would be in the interests of justice.  Id.


Continue Reading Plaintiff Tries To Amend Under Fed. R. Civ. P. 15 But Is Denied Under Fed. R. Civ. P. 59 & 60

The Pope came to Philadelphia this past weekend.  That’s not the first time this has happened (JPII stopped by in 1979), but the level of paranoia this time around led to four days of street shutdowns, parking prohibitions, and all-around dystopian security that closed roads all the way from Conshohocken to City Line Avenue to the Ben Franklin Bridge.  Commercial strangulation by the unprecedented security caused Bexis’ firm shut down its Philly office for two days.

Bexis, not being a Catholic, decided that the better part of valor was simply to get out of Dodge.  So he went to New York where instead he could follow the Devil’s Path instead.  It was good, very good – some parts considerably more perpendicular than horizontal.  The Devil’s Path and nearby areas beat the literal “hell” out of anything in Pennsylvania.  The only downside is the New York State Thruway, which in its southerly direction is prone to traffic jams for no discernable reason (of course, so is the Schuylkill Expressway in Philly, except when closed entirely for Papal visits).

While walking the Devil’s Path has its benefits, so does walking the path of compliance.  In an early blogpost on the subject of punitive damages, we collected all of the caselaw we could find where compliance with government regulatory standards precluded punitive damages.  Of all the cases we found, only a couple were from state supreme courts.  Now we have another one.  While the Pope was visiting Washington, DC, the Kentucky Supreme Court reversed a multi-million dollar punitive damages award in Nissan Motor Co., Ltd v. Maddox, ___ S.W.3d ___, 2015 WL 5626432 (Ky. Sept. 24, 2015), holding that the defendant’s undisputed compliance with (and in some ways exceeding) federal regulatory standards for automobiles precluded a finding of “gross negligence” or “reckless disregard,” which is the Kentucky standard, id. at *2, to support punitive damages.  That compliance precluded punitive damages as a matter of law even under a “slight care”/gross negligence standard is particularly notable, since many states set the bar higher for punitive damages than merely gross negligence.


Continue Reading Walking the Regulatory Compliance Path Defeats Punitive Damages