April 2015

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We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws.  We have been remiss, however, in not mentioning the industry’s 2014 counter-proposal that’s was jointly proposed by GPhA (for the generic industry) and PhRMA (for the branded/innovator drug manufacturers). Given how intensely the generic and branded wings of the pharmaceutical industry compete with (and sue) one another, that they could join together in opposition to the FDA’s proposal says something in and of itself like how bad the FDA’s proposal really is.

Anyway, to start, here is a link to the joint GPhA/PhARMA letter that details the industry’s solution to the problem of label-update delay in general.  That’s the key.  The industry proposal ends the disparity (identified by the Supreme Court in Mensing, among other places) between how the FDA treats generic and branded/innovator drugs.  The industry proposal thus stands in stark contrast to the FDA’s, which would both perpetuate and worsen the divergence between the processes affecting the two types of prescription drug manufacturers.Continue Reading The FDA Gets an EARful on Label Changes

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This post is not from the RS side of the blog.

Medtronic removed today’s case, Cole v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 48095 (W.D. Ky. Apr. 13, 2015, to federal court in the Western District of Kentucky.  Three and a half months later, plaintiff asked the court to remand it back to state court because a second defendant, a hospital, was a citizen of the forum state, thus triggering the forum-defendant rule and blocking removal.  We think Glen Fry can best take it from here:Continue Reading You Want to Remand? I’m Already Gone

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Two days ago, we posted on a West Virginia Supreme Court decision that told non-resident plaintiffs the closing time refrain “you don’t have to go home, but you can’t stay here.”  OK, we took some liberties there, but the non-resident plaintiffs who had gone shopping in a non conveniens forum could not stay even after poking around for two years.  We commented that the same result seemed dictated by last year’s Bauman decision on personal jurisdiction, which has been the subject of a few other posts, like this, this, and this.  Last week, another Wild and Wonderful court took the Bauman route to send 141 plaintiffs packing, although they will probably be back.

Starting in Texas state court with the sort of CAFA-defying, misjoindering gamesmanship that we often see in serial product liability and mass tort litigation, two cases presenting virtually identical motions to dismiss were eventually heard by the pelvic mesh MDL court in Huston v. Johnson & Johnson, No. 2:15-cv-01519, 2015 WL 1565648 (S.D.W. Va. Apr. 8, 2015), and Kraft v. Johnson & Johnson, No. 2:15-cv-01517, 2015 WL 1546814 (S.D.W. Va. Apr. 8, 2015).  Separated only to help the effort to stay out of federal court, one case had ninety-four plaintiffs with only three allegedly from Texas (or connected to Texas by their medical care), and the other had fifty-two plaintiffs with only two allegedly from Texas (or connected to Texas by their medical care).  Of course, each case had the obligatory one plaintiff from the defendant manufacturer’s home state.  The plaintiffs were linked together in that they were suing over the same or similar products and injuries, although with nothing suggesting it was appropriate for these plaintiffs to be together.  On the same schedule, with the fairly predictable procedural steps, these cases made their way to the MDL court to address the basic—and appropriately first addressed—issue of whether all these non-Texans could drag a non-Texas company into Texas state court without offending due process requirements of general personal jurisdiction.

If they could, then trials through the MDL court sitting by designation or after remand back from the MDL would be in the United States District Court for the Northern District for Texas.  If they could not, then each forum shopping plaintiff faced the choice of 1) not re-filing, 2) re-filing in her home jurisdiction (where there would be probably specific personal jurisdiction over the defendant), or 3) coming up with some other way to avoid removal.  The second option eventually gets the plaintiff back to the MDL court, but in a single plaintiff case and with any eventual trial in the federal district court whose boundaries cover where she lives.  The “but” part of the preceding sentence makes a difference to defendants, but there is also the larger issue of striking a blow against forum shopping in its various forms.  A manufacturer of drugs or medical devices (principal among potential defendants, at least here) is entitled to expect to face individual product liability lawsuits in its home state’s (state) courts or in the federal court in plaintiff’s home state (as of the relevant events) after a successful removal. Setting aside MDLs or state coordinated proceedings, other options typically mean some jurisdictional games have been played.Continue Reading More Plaintiffs Go Home (Eventually And Based on Bauman)

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We’ve been thinking a lot about class actions lately.  One reason is that the Rule 23 Subcommittee of the (federal) Advisory Committee on Civil Rules just came out with a “sketch” of possible amendments – and from the defense perspective they’re frankly horrible. Bexis has been working with the Lawyers for Civil Justice to respond to a proposal that would:  (1) allow classes where most members aren’t injured at all; (2) allow free reign for non-predominance “issue classes”; (3) legitimize “cy pres” donations of class funds to charities that foment litigation; and (4) allow settlement classes that ignore the rest of Rule 23, among other things.  We’ll certainly have more to say on this if these “Frankenclass” amendments move forward, but for now, we just caution our pro-defense friends to remain alert and support LCJ.

The reason for such proposals is that, under the current rules, we on the defense side are generally not doing so badly, at least in prescription medical product third-party payor (“TPP”) cases.  The latest win is in In re Actiq Sales & Marketing Practices Litigation, ___ F.R.D. ___, 2015 WL 1312015 (E.D. Pa. March 23, 2015), in which the plaintiffs (including, of all entities, the Pennsylvania Turnpike Commission) had their class bounced out on its ear.

So, what happened?  First, plaintiffs proposed a nationwide class alleging the usual – off-label promotion of a drug that (this time a heavy-duty pain reliever approved under even more restrictive marketing scheme authorized by 21 C.F.R. §314.520 (so-called “Subpart H”), because of the drug’s known risks) that they never alleged was either ineffective or injurious to any of those prescribed.  Rather, “[f]or many patients, Actiq proved effective for alleviating their pain.”  Actiq, 2015 WL 1312015 at *6 (footnote omitted).  In short, Actiq was another TPP strike suit, an attempt to gin up “damages,” or should we say “unjust enrichment,” that didn’t exist in fact.Continue Reading Some Plaintiffs Just Have No Class

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Last weekend, we saw the surprisingly effective “Danny Collins,” a new movie starring Al Pacino as an aging rock star wondering how the focus of his life would have changed if he’d known contemporaneously about an admiring letter from John Lennon that was not given to him until decades later.

The focus of today’s post might have changed if, instead of celebrating a correct appellate decision, we were blogging about the underlying order.  Those of us who practice in the mass tort arena are all too familiar with the forum-shopping propensities of plaintiffs’ lawyers and the inevitably-resulting dockets filled with plaintiffs who bear no relation to the states in which their cases are pending.  In State of West Virginia ex rel. J.C. v. Mazzone, 2015 W.Va. LEXIS 259 (W. Va.  Apr. 10, 2015), the West Virginia Supreme Court entertained a Motion for Writ of Prohibition seeking to prevent West Virginia’s Mass Litigation Panel from enforcing its October 2014 order dismissing petitioners –  20 Zoloft plaintiffs from numerous other states – on forum non conveniens grounds.  (The named plaintiffs were infants who had allegedly sustained birth defects; hence, the Court referred to them by their initials). Had we blogged about the Panel’s order, we would have pointed out that the Panel did not need to consider the convenience of the forum.  Under SCOTUS’s April 2014 decision in Daimler AG v. Bauman, 134 S. Ct. 746 (2014), which we discussed here,  the fact that Pfizer was registered to do business in West Virginia did not confer general jurisdiction over it on West Virginia’s courts.  But forum non was the route the Panel chose and was the subject of the Court’s consideration.

The Court explained that “disputes over venue, such as a dismissal for forum non conveniens,” are exceptions to the “general proposition that prohibition does not lie to review discretionary rulings. . . .”  J.C., 2015 W.Va. LEXIS 259 at *14.  In considering a Motion for Writ of Prohibition, a court is to consider five factors, but “the third, the existence of clear error as a matter of law, should be given substantial weight.  Id. at *13.Continue Reading Plaintiffs Go Home: West Virginia Supreme Court Affirms Forum Non Dismissals of Non-Resident Zoloft Plaintiffs

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

We’ve been reporting on individual InFuse cases that have been chopped down by defendant swinging a preemption axe of sorts.  One by one, the cases have toppled. Occasionally, a branch or two hangs on, but they’re often too weak or flimsy to survive for long.  But yesterday, the Western District of Tennessee took a bulldozer to 141 InFuse cases.  The decision strikes a decisive blow to plaintiffs’ off-label promotion theories, while reinforcing the predominance of preemption in PMA medical device cases.

The decision was entered in Hafer v. Medtronic, Inc., No. 2:13-cv-02340-JTF-dkv, slip op. (W.D. Tenn. Apr. 13, 2015), but applies to the entire group of InFuse cases that were consolidated before a single judge in that jurisdiction.  The allegations are essentially the same as we’ve seen in other InFuse cases, discussed here.   Namely, that plaintiffs’ surgeons opted use the InFuse device, a multi-component spinal fusion medical device, in an off-label manner.  In so doing, say plaintiffs, they were not implanted with a PMA approved device and so preemption should not apply.Continue Reading Breaking News: 141 InFuse Plaintiffs Have Their Cases Clipped by Preemption

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This post comes from only the Cozen O’Connor side of the blog.

The plaintiffs in the Whitener v. Pliva case danced through the Mensing raindrops for quite some time, using off-label promotion allegations to avoid preemption.  But, no matter however inventively they articulated their claim, it was still a claim that the manufacturer didn’t warn about risks of the drug, in this instance, off-label risks.  And a claim that the manufacturer should have warned about those risks triggers Mensing implied conflict preemption.  Yet the Whitener plaintiffs had a history of surviving Mensing preemption, even if just barely.

Their off-label allegations survived the defense’s first motion to dismiss because the court handed them the opportunity to fix their pleadings.  Whitener, v. PLIVA, Inc., 2011 WL 6056546 (E.D. La. Dec. 6, 2011).  The next time around, the court found their off-label allegations to be sufficient to survive a motion to dismiss.  The court was concerned about the defense’s argument, particularly with “permitting a generic defendant to violate federal law by actively and aggressively promising a drug for a purpose not contemplated by the label approved by the FDA while also hiding behind an inability to provide warnings connected to that off-label use because it cannot change the approved label.”  Whitener v. PLIVA, Inc., 2012 WL 3948797, at *4 (E.D. La. Sept. 10, 2012).  While the court may have been concerned with the defense’s argument, Bexis became uber-concerned with the court’s ruling, particularly its conflation of the express-preemption concept of a “parallel violation” and the implied-preemption basis for Mensing.  Finally, everything – well, everything but that particular piece of reasoning – got fixed at summary judgment, when the court granted judgment against the off-label claim for lack of proximate causation.  The alleged off-label promotion hadn’t influenced the doctor.  Whitener v. Pliva, Inc., 2014 U.S. Dist. LEXIS 41121(E.D. La. March 27, 2014).  We were at least satisfied with the outcome, if not all of the reasoning.  While avoiding the Mensing raindrops, plaintiffs couldn’t avoid the reality of the prescribing doctor independently exercising his own medical judgment.

Plaintiffs tried their luck with the Fifth Circuit and just recently lost there too.  On Thursday, the Fifth Circuit affirmed summary judgment against plaintiff.  It did so in all respects, which is to say that it was still a little unsatisfying. The court did not invoke Mensing preemption.  But that may have been a little too much to expect given that the court had such an easy basis on which to affirm – the prescribing doctor’s testimony and proximate causation. So we won’t lament a good decision for not being great.Continue Reading The Next Best Thing to Mensing Preemption: Winning for Lack of Connection between Marketing and the Prescriber

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We knew that the Supreme Court’s opinion in Daimler AG v. Bauman, 134 S. Ct. 746 (2014), was a game changer the first time we read it. Gone is the concept of general personal jurisdiction that we learned in law school, where a defendant’s “continuous and systematic” contacts with a forum could allow a plaintiff to bring any and all causes of action against that defendant in that forum. Personal injury claims, business disputes, consumer claims, claims that the day is too long, that the night is too dark, or that Zane should never have left One Direction. Whatever. General jurisdiction means that a defendant can be held to respond without regard to the subject matter of the lawsuit.

In its place we have the properly recalibrated principle that a defendant can be subject to general personal jurisdiction only in forums where it is “at home”—which for a corporation means the place of incorporation and the principal place of business. This rule places no undue burden on plaintiffs: A plaintiff can still proceed in the defendant’s home forum, and we still have specific personal jurisdiction, under which a plaintiff can proceed against a defendant in a forum where the dispute arises from the defendant’s forum contacts. The Supreme Court merely reestablished that the Constitution will not permit importing disputes into forums where they absolutely do not belong. We are on board with that.

Our fear when Bauman came out in 2014 was that it would take an entire generation for the rule to catch on. But to our modest surprise, the Bauman track record is shaping up nicely. We reported to you last August on Bristol-Myers Squibb Co. v. Superior Court, 175 Cal.Rptr.3d 412 (Cal. Ct. App. 2014), a wrongly decided case in the California Court of Appeal, where the court paid lip service to Bauman and rejected general personal jurisdiction. But then it reached out to find specific personal jurisdiction based on “substantial, continuous economic activity” within the state, which sounds a lot like the old test for general jurisdiction. This wolf in sheep’s clothing lasted less than four months on the books before the California Supreme Court wiped it away.Continue Reading We’re Not in Kansas: No General Jurisdiction After Bauman

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We’ve already discussed the peculiar decision in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015), once, here.  This time, we don’t care much about the peculiar facts, but rather we’re directing ourselves to the court’s odd reasoning that somehow there’s a conflict between the learned intermediary rule (adopted at some level now in every American jurisdiction – see our “headcount” post here − and the Uniform Contribution Among Tortfeasors Act (“UCATA”).  Among the cases following the learned intermediary rule are four prior Arizona appellate decisions.  Davis v. Cessna Aircraft Corp., 893 P.2d 26, 38 (Ariz. App. 1994) (non-medical product), review denied (Ariz. April 25, 1995); Piper v. Bear Medical Systems, Inc., 883 P.2d 407, 415 (Ariz. App. 1993), review denied (Ariz. Nov. 1, 1994); Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978), review denied (Ariz. Nov. 21, 1978); Dyer v. Best Pharmacal, 577 P.2d 1084, 1087 (Ariz. App. 1978), review denied (Ariz. May 2, 1978).  In all four of these cases, the Arizona Supreme Court had the opportunity to evaluate the learned intermediary rule; all four times it passed and denied review.

Don’t be fooled by the 2007 date on our “headcount” post.  We’ve kept updating it.  Since we originally wrote that post in mid-2007, prompted by the terrible decision in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), two more state supreme courts have adopted the learned intermediary rule for the first time:  Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 154-59 (Tex. 2012); Rohde v. Smiths Medical, 165 P.3d 433, 438 (Wyo. 2007).  Two other state supreme courts have reaffirmed the learned intermediary rule since then, Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813, at *19-20 (Ala. Aug. 15, 2014) (the only good thing about an otherwise awful opinion); Klasch v. Walgreen Co., 264 P.3d 1155, 1159 (Nev. 2011), as have two state intermediate courts of appeal.  O’Connell v. Biomet, Inc., 250 P.3d 1278, 1281-82 (Colo. App. 2010), cert. denied, 2010 WL 4851480 (Colo. Nov. 30, 2010); Silva v. SmithKlineBeecham Corp., 2013 WL 4516160, at *2-3 (N.M. App. Feb. 7, 2013).  In addition, federal courts have predicted the rule’s adoption in Rhode Island, where there used to be no law.  Greaves v. Eli Lilly & Co., 503 F. Appx. 70, 71-72 (2d Cir. 2012); Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9-10 (E.D.N.Y. April 23, 2011), and in South Dakota, reconfirming earlier predictions.  Schilf v. Eli Lilly & Co., 2010 WL 4024922 (D.S.D. Oct. 13, 2010).  Finally, as we’ve blogged about before, West Virginia federal courts have recently cut back Karl to drug DTC advertising cases.  See O’Bryan v. Synthes, Inc., 2015 WL 1220973, at *6-7 (S.D.W. Va. March 17, 2015); Wise v. C.R. Bard, Inc., 2015 WL 502010, at *4 (S.D.W. Va. Feb. 5, 2015); Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993, at *5-6 (S.D.W. Va. Oct. 23, 2014).

So even since Karl, the learned intermediary rule has been doing quite well for itself.Continue Reading Low Wattage Reasoning

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TOP TEN REASONS to Attend the DRI Drug & Medical Device Seminar in San Francisco – the cultural, commercial, and financial center of Northern California – on May 14-15, 2015:

10. Earn up to 12 hours of CLE credit, including 1 hour of ethics credit.
9. Hear from Federal and State Court Judges about their views concerning the management of mass tort litigation.
8. Observe a mock closing argument and learn strategies for effective advocacy and how to close with passion as well as meaning.
7. Enjoy the delectable seafood at Fisherman’s Wharf, the shopping at Union Square, the tourist spots like the Golden Gate Bridge and Alcatraz, and all of the beautiful sights the elegant city San Francisco has to offer.
6. In-House Counsel can attend the Seminar for FREE!  You must be a DRI member and member of DRI’s Corporate Counsel Committee to take advantage of this incentive.  (Simply contact DRI Customer Service at 312.795.1101 or use this link to register.)

Continue Reading Annual Shameless Plug for DRI’s Drug and Device Conference

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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