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

We walked into the Drug and Device Law Rock Climber’s room last night to find her packing for her return to college while the ignored TV blared in the background.  Onscreen was a popular cable reality franchise involving wealthy denizens of a gated community in Southern California.  The heated argument du jour involved one resident’s decision to speak privately to another about a third, during which exchange B-to-C confidences may or may not have been disclosed to A.  The original confider was adamant that the information was hers alone to control, insisting that the private conversation should not have occurred.  Much perfectly-coiffed shrieking ensued.

We were reminded of this spectacle as we read the decision of the Kentucky Supreme Court in Caldwell v. Chauvin, — S.W. 3d. –, 2015 WL 3653447 (Ky. June 11, 2015).  In Caldwell,  the underlying medical malpractice action involved plaintiff’s claim that her spinal surgery was unnecessary and negligently performed and caused her permanent injuries.  In the course of discovery, defendant moved for a qualified protective order permitting him to make ex parte contacts with plaintiff’s healthcare providers.   The court entered an order permitting such contacts but expressly declining to authorize disclosure of plaintiff’s health information. The order “also explicitly stated it was [not] requiring any physician to speak with [defendant] . . . , noting [that] the treating physicians [were] free to accept of decline counsel’s request as they [saw] fit.”  Id. at *2 (internal punctuation omitted).  Plaintiff sought a writ of prohibition from the Court of Appeals.  The Court of Appeals declined to issue the writ, holding: 1) no Kentucky law prohibits the trial court from authorizing ex parte communications with non-expert treating physicians; and 2) the order did not violate any privacy right plaintiff might have because it did not compel the disclosure of any information.  Id.

Continue Reading Ask But Don’t Tell: Kentucky Allows Defendant to Seek Ex Parte Interviews of Plaintiff’s Treating Physicians

This post is from the non-Reed Smith side of the blog only.

That’s an admonition that plaintiffs in Cales v. Medtronic, Inc. should have heeded. Last November, they became another of the many InFuse plaintiffs to have the bulk of their claims dismissed with prejudice on the grounds of preemption, with non-preempted claims dismissed without prejudice for failure to plead with sufficient particularity. See Cales v. Medtronic, Inc., 2014 WL 6600018 (Ky. Cir. Ct. Nov. 21, 2014).  Rather than spending their time drafting a well-pleaded amended complaint for their remaining causes of action, plaintiffs moved for reconsideration.  Cales v. Medtronic, Inc., No. 14-CI-1774, slip op. (Ky. Cir. Ct. Jul. 1, 2015).  Not only was their motion denied — the court found a few other things that had slipped through the cracks that should have been dismissed as well.  In other words, plaintiffs aren’t any better off for their motion; in fact, their worse.

The crux of plaintiffs’ motion for reconsideration is that the court applied the federal TwIqbal standard of pleading rather than Kentucky’s “notice” pleading standard. It turns out that plaintiffs’ complaint was so poorly crafted that the error was harmless – plaintiffs’ complaint failed even the less-demanding requirements.

But plaintiffs’ complaint wasn’t the only thing poorly crafted.  So too were plaintiffs’ arguments on reconsideration.  The court spends pages of its decision admonishing plaintiffs for “selectively cherry-pick[ing] quotes from a number of unpublished appellate decisions and out-of-context dictum to support their argument that merely pleading bald, legal conclusions satisfies Kentucky’s liberal pleading standard.”  Cales, slip op. at 5.  Challenging plaintiffs’ “Frankenstein-esque construction of notice pleading,” id. at 7, the court is clear that notice pleading does not “relieve [plaintiffs] of a responsibility to produce some factual basis to support the elements of their various claims.”  Id.

Continue Reading Be Careful What You Ask For