We confess that among the many benefits of being a DDL blogger, one of our favorites is our ability to have a little fun.  Let’s face it, legal writing can sometimes be a bit boring.  Try as we might, it tends toward being dry.  Even when railing against grave injustices, we need to be organized and strategic; we need to include often mundane facts and details; we need to discuss dense, arcane legal precedent.  But here, we can compare a legal decision to the most recent episode of the Walking Dead.  We can interweave sports loyalties with discussions of local court trends.  And we’ve never had to hide our bias – if we don’t like something, we tell you.

We imagine judges sometimes get bored too.  And that leads to opinions such as Justice Scalia’s glib dissent in PGA Tour, Inc. v. Martin, 532 U.S. 661 (2001) – funny even for those who don’t like golf.  Another classic is Noble v. Bradford Marine, Inc., 789 F. Supp. 395 (S.D. Fla. 1992) in which the judge peppered his decision with lines from the movie “Wayne’s World” — holding that defendant’s “most bogus” attempt at removal is “not worthy” and finding that the defendant must “party on” in state court. Sections of the opinion are labeled “Hurling Chunks” and “A Schwing and a Miss.”  And there is any number of examples of decisions written in verse.

So, when we were reading the case for today’s post – granting a plaintiff’s motion to remand and rejecting defendants’ fraudulent joinder argument – we knew we wouldn’t be celebrating the result.  But we can tip our caps to the prose.  Not often do you find this smattering of words and phrases in a single decision:  “checkered history,” “potential hitch,” “time bomb,” “hangover,” and “tyranny of labels.” It’s not a poem and it doesn’t read like a mystery novel, but it made the read a little more enjoyable.  And that’s about the only thing that made it enjoyable.


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Do we say often enough how much we dislike off-label promotion theories of liability?  It has its own section on the blog and on a quick skim through you will find traditional products liability cases, qui tam False Claims Act cases (and the subsidiary First Amendment litigation), securities fraud litigation, criminal actions, and third-party payer suits.  There are probably others, but we stopped scrolling.  The point is that just about everyone who wants to sue anyone in the pharmaceutical and medical device world has at some time tried to use off-label use and promotion to get the job done.

The fact that what is and is not permissible off-label promotion remains a question doesn’t help matters.  Really, it is what drives the vast scope of off-label litigation. And one of the primary problems is the confusion between truthful and untruthful off-label promotion. When courts, in our opinion, get it wrong is when they refuse to recognize that distinction. Simply because something is considered off-label promotion (addresses a use or indication not on the product’s approved labeling) doesn’t make it false, misleading or untruthful.  This is where we think the court got tripped up in Hricik v. Stryker Biotech LLC, 2015 U.S. Dist LEXIS 11714 (E.D. Pa. Jan. 30, 2015).

Plaintiff brought products liability claims against the manufacturer of a spinal fusion device and two of the manufacturer’s sales representatives.  The reps are residents of Pennsylvania and therefore, their presence in the suit defeats diversity jurisdiction unless they were fraudulently joined.  The defendant manufacturer made that very argument.


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If anyone gave out prizes for the most incomprehensibly named multi-district litigation, the one currently proceeding as “In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation” would be right up there.  Rarely have we encountered a case name with four words in a row that, without a dictionary, we didn’t know what they meant.  Basically, this is product liability litigation about two dialysis solutions (Granuflo and Naturalyte) over alleged serious adverse reactions related to effects on blood chemistry.

This MDL is currently pending in the District of Massachusetts.  Just after the new year the Fresenius MDL (that’s all the designation really needed) made some news with a quartet of decisions.  We’ll describe them for you briefly.

First Decision

In In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 44589, at *1 (D. Mass. Jan. 2, 2015), the court denied remand to a batch of California plaintiffs.  As is so often the case in removal/remand, there was a lot of gamesmanship going on.  The defendant proved, to the court’s satisfaction, that the principal place of business of the target defendant, Fresenius, USA, had been its Massachusetts for almost a decade, since a merger.  Id. at *2.  It satisfied the relevant “nerve center” test (see here for more on that) for personal jurisdiction.


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Here’s another guest post by Reed Smith’s own Kevin Hara, this time about a recent Texas case holding that health care providers involved in clinical trials are still protected by a state medical malpractice statute, and thus were fraudulently joined.  While we are of two minds about such statutes (making it harder to sue HCPs increases litigation against our clients), since HCPs are our clients’ clients, and thus the heart of their businesses – and we’re defense lawyers by temperament – in the end we come out in favor of less liability generally.  This is an interesting use of fraudulent joinder that could well apply to the definition of “health care provider” under similar statutes in other states.

As always, our guest posters deserve all the credit and any blame for the contents of their posts.

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When it comes to Texas, one might never know based on its jurisprudence that the state motto, and indeed the state’s moniker, is derived from “Tejas,” a Native American term for Friendship.  At least from a defense perspective, the Lone Star State at times seemed mighty inhospitable; after all, Texas invented that awful “heeding presumption” back in 1972, touching off a Reign of Fire, as states followed suit, adopting a variety of feeding presumptions.  It also allowed personal injury recovery under its consumer protection statute, made a big deal of Restatement Second §402B, and was the last of the large states to adopt the learned intermediary rule.  While we’re at it, let’s not forget the decision that would never die, the Murthy case, making the worst decisions list in consecutive years in 2011 and 2012, giving us not just one opinion to lament, but Two for the Money.

But we’re forgiving, and won’t “mess with Texas” too much.  Although it took until 2012, with some help from Bexis, for the Texas Supreme Court to finally adopt the learned intermediary doctrine, deciding that it was A Time to Kill an awful decision from 2010 whose name should have been Mud.  Texas adopted the Third Restatement, which should kill the heeding presumption, and even if it doesn’t, that presumption now excludes prescription drugs and medical devices, at least forcing it into Submission.  The Legislature amended the DTPA to eliminate personal injury damages, and we haven’t heard a peep from §402B in a while, and this section’s Failure To Launch into widespread acceptance is a good thing.  Texas Daubert decisions have been outstanding.  Not only that, a lot of excellent Reed Smith practitioners are based in our Houston office.

Texas has other positive attributes as well, including being the birthplace and home of Matthew McConaughey, and of baseball standout Nolan Ryan, who we believe, despite numerous accolades, remains underrated because of his somewhat pedestrian won loss record (which for pitchers reveals more about the team and much less about the individual).  Seriously, seven no-hitters?  Ryan pitched in an era where starters routinely went the distance, and they were their own closers; we urge you to check out his career innings pitched, hits allowed, complete games, and well, the strikeouts speak for themselves. No disrespect to Madison Bumgarner, who was otherworldly in the 2014 World Series, but who has 6 complete games in his career.  Ryan had an incredible 222, including several years where he had more than 20.  We realize that people smarter and more knowledgeable than we are will correctly we might add, mention that Ryan also walked many hitters and never won the Cy Young. That’s the beauty of sports.

And then there’s ZZ Top and Janis Joplin and Beyonce.

But we digress.  Back to the legal issues.  It would be remiss not to note that Texas also has some very favorable statutes, including Civil Practice and Remedies Code 82.007, which provides a rebuttable presumption of nonliability for manufacturers and prescribers in pharmaceutical product liability actions involving failure to warn for FDA approved warnings, and 82.008, which provides a presumption of nonliability for compliance with government standards.  See Tex. Civ. Prac. & Rem. Code §§ 82.007(a)(1) and 82.008.  We were concerned that a recent Southern District of Texas decision would a la Murthy, run roughshod over state law like the TCU Horned Frogs in an 82-27 rout of Texas Tech this year or UCLA in a 66-3 drubbing of Texas in 1997 (the Longhorns’ worst loss ever).  Fortunately, we were pleasantly surprised.


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What the deuce is it about today?  The date is made up of two 2’s.  Today is the 76th birthday of two of our favorite, though couldn’t-be-more-different, actors:  Derek Jacobi (I, Claudius/Last Tango in Halifax) and Christopher Lloyd (Back to the Future/Taxi).  This day in 1978 saw the papal inauguration of John Paul II.  And, after much hand-wringing and soul-searching, today we have decided to drop two TV shows from our viewing rotation:  Homeland and Masters of Sex.  Sorry, Showtime, but those programs jumped a shark swimming in a pool of implausibility. (Boozy, sexy, sometimes thrilling implausibility, to be sure, but implausibility nonetheless.)

It’s only fitting that today we address a pair of stinkpot cases. Fronczak v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. LEXIS 146347 (M.D. Fla. October 14, 2014) and Wier v. DePuy Orthopaedics, Inc., 2014 U.S. Dist. LEXIS 146353 (M.D. Fla. October 14, 2014) were decided on the same day by the same judge, involve the same issues, and offer the same lame fraudulent joinder analysis.

The plaintiffs in both cases (represented by the same attorneys) alleged injuries from the implantation of artificial hip prostheses manufactured by DePuy and distributed by Bayside Orthopaedics.  The plaintiffs asserted claims for negligence, negligent failure to warn, strict liability failure to warn, strict liability, and breach of warranty.  The cases were filed in state court in Sarasota, Florida.  The inclusion of Bayside as a local defendant wrecked diversity. Nevertheless, DePuy removed the cases to federal court and argued that Bayside had been fraudulently joined.


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We don’t particularly like starting our week with an adverse decision; certainly not after a holiday weekend.  But, we seem to have stumbled upon a variety of negative decisions to report on this week, so we’ll just dive in and get it over with. Fittingly for the day after Labor Day (we think), we decided to start with a case that centers on employee liability – specifically whether plaintiff had sufficiently pleaded his claims against the non-diverse sales representative so as warrant remand to state court.  The court said yes.

The case is Hutchens v. Smith & Nephew, Inc., 2104 U.S. Dist. LEXIS 116839 (N.D. Tex. Aug. 22, 2014).  Plaintiff sued the manufacturer and one of its sales reps over an allegedly defective hip implant, including a claim for violations of the Texas Deceptive Trade Practices Act (“DTPA”).  Id. at *6.  Defendants removed the case to federal court alleging that the sales rep had been fraudulently joined.  On plaintiff’s motion to remand, the question before the court was whether the claims against the sales rep survived a Rule 12(b)(6) dismissal-type analysis. Although pending in federal court, the court opted to apply Texas’ more lenient “fair notice” pleading requirement finding that the “standard applicable at the time the initial lawsuit was filed in state court should govern.”  Id. at *10.  First strike – no TwIqbal.

Moving to the substantive analysis, the court only examined plaintiff’s DTPA claim – only one claim against the sales rep needed to survive to remand the entire case.  The DTPA claim allegations as to the sales rep were that he:

exercised substantial control over the provision of warnings and . . . provided inadequate warnings, instructions, or representations to Plaintiffs that were incorrect, violated the . . . [DTPA] and induced Plaintiffs to implant the identified devices, causing Plaintiffs’ harm.


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The court in Turner v. DePuy Orthopedics, Inc., 2014 U.S. Dist. LEXIS (C.D. Calif. July 29, 2014), ordered the remand of a removed case after rejecting the defense’s argument that Mensing preemption (or at least its reasoning) should be extended to failure to warn claims brought against a doctor involved in the design of a medical device.  The defense’s argument was aggressive, even inventive, but it wasn’t bad.  Its argument was that the doctor-designer, much like a generic drug manufacturer, had no control over the warning label.  Rather, the manufacturer controls the ultimate content of the label, just as the brand manufacturer, not the generic manufacturer, controls the ultimate content of generic drug’s label.  The court saw things differently, though.  Taking plaintiff’s allegations as true, the court found a “possib[ility]” that the doctor “had a substantial ability to influence the manufacturing or distribution” of the device.  Id. at *10.

Maybe, but we’re not sure that any of that gave the doctor the power to control or influence the content of the label.  Nor did we find such support in plaintiff’s allegations.  According to the court, plaintiff alleged that the doctor “designed the hip implant,” received royalties (millions) from it, and participated in its marketing. Id. at *8-9.  We agree that, from these allegations, it’s “possible” that the doctor-designer could have influenced labeling of the device.  But did plaintiff allege enough to make it “plausible”?  It doesn’t seem so.  Only guesswork allows one to conclude that this particular individual had that type of influence.  Drugs and devices are generally developed and designed by multiple doctors and scientists.  This is reflected in the defense’s opposition, which included a declaration from the doctor-designer stating that he was only one of “eight physicians who acted as consultants in the design process.”  Id. at *9.  One of eight consultants certainly doesn’t sound like someone with influence over final labeling.  There needed to be more factual allegations suggesting, plausibly, that this doctor could have exerted such control or influence.


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Not to over-generalize, but older people have been known to break their hips.  Based on anecdotal evidence, broken hips hurt more than stepping on a broken bottle or a sea urchin during a tropical vacation.  Based on more than anecdotal evidence, product liability plaintiff lawyers prefer state courts over federal courts.  This is because of various factors that, they think, make the state courts more likely to impose pain, and impose a lot of pain, on the defendants.  We have posted on many cases discussing the strategies used by product liability plaintiffs to stay out of federal court.   These cases often come up in the posture of a motion to remand by the plaintiff after the defendant has removed under 28 U.S.C. § 1446.  If the case can be transferred to an MDL court—potentially well-versed in the anti-removal strategies—before a ruling on the motion to remand, then the chance of the case staying put tends to go up.

In Millman v. Biomet Ortho., Inc., No. 3:13-CV-77 RLM-CAN (N.D. Ind. Dec. 10, 2013), and Akin v. Stryker Corp., Civ. No. 13-1811 (DWF/FLN) (D. Minn. Dec. 12, 2013), we have decisions on motions to remand from two different MDL courts on two different cases involving two different hip replacement implantable medical devices.  We also have two different results, although both are good.


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This is from the Dechert side of the blog only.

Last week we gave you a lot of Medtronic decisions to mull over and to mostly be happy about.  And, like we mentioned, Medtronic is no stranger to preemption issues.  So, when we found yet another new Medtronic favorable device preemption case, at first we thought we might add it to one of our scorecards or cheat sheets and call it a day.  But, this is a win in a Ninth Circuit court and after Stengel, that can’t go overlooked. But, we’ll keep it short and simple nonetheless.

The case is Suckow v. Medtronic, Inc., No. 2:12-cv-01870-GMN-CWH, slip op. (D. Nev. Sept. 20, 2013) and it involves a pacemaker manufactured by Medtronic that was implanted in plaintiff in 2006.  Plaintiff had to have the device removed on an emergent basis in December 2010 and alleges she suffered injuries as a result of the removal surgery.  In addition to strict liability and breach of express warranty claims against Medtronic, plaintiff also brought negligence and misrepresentation claims against a Medtronic sales representative alleging that a few months before the removal, he evaluated the device and found it was operating normally and was fit and safe for continued use.  Slip op. at 2.Medtronic removed the case to federal court and argued that the sales representative was improperly joined.

Medtronic challenged the plaintiff’s claims against the sales representative on two grounds.  First, the sales rep had no contact with the plaintiff before December 2010.  Second, if the sales rep evaluated the device, it was at the request of the physician and it is the physician who “interprets any data and makes decisions.”  Id.  at 6.  While plaintiff argued that her claims against the sales rep weren’t preempted, she apparently neglected to address any of the arguments on fraudulent joinder.  Id.  So, it really was a no-brainer for the court to uphold removal and move on to decide Medtronic’s preemption motion.

But, we just want to take a minute to remind our readers that there are more substantive decisions out there about the risks of liability from the involvement of sales reps in the care and treatment of patients.  See our post here.  In Suckow, while the court didn’t have to reach it, it looks like defendants had a strong learned intermediary defense because the sales rep’s role was limited to the evaluation of the performance of the device, not in rendering advice, opinions, or direct care to the plaintiff.

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