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The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  A couple of anonymous, obviously plaintiff-side, comments to our “breaking news” Amarin post suggested that the Amarin First Amendment victory for truthful off-label promotion might have a downside.  Both comments raised the same issue:  what happens to “impossibility” preemption in the drug warning context once First Amendment protection is extended to truthful pharmaceutical promotion?

One response would be that, if such speech is fully protected, as the Supreme Court indicated in Sorrell v. IMS Health, Inc. – “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment” − 131 S. Ct. 2653, 2660 (2011), then it’s game over.  The same First Amendment protection equally precludes private suits under New York Times Co. v. Sullivan, 376 U.S. 254 (1964).  “What a State may not constitutionally bring about by means of a criminal statute is likewise beyond the reach of its civil law.”  Id. at 277.  See also In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994) (First Amendment precluded product liability action).  Sullivan also roundly rejected the “commercial” overtones of otherwise fully protected speech as a basis for suppressing it through tort litigation:

The publication here was not a ‘commercial’ advertisement. . . .  That the [defendant] was paid for publishing the advertisement is as immaterial in this connection as is the fact that newspapers and books are sold. . . .  To avoid placing such a handicap upon the freedoms of expression, we hold that if the allegedly [tortious] statements would otherwise be constitutionally protected from the present judgment, they do not forfeit that protection because they were published in the form of a paid advertisement.

376 U.S. at 266 (citations and quotation marks omitted).Continue Reading When They Don’t Have Anything, They’ll Try Anything

We have posted many times about cases where a manufacturer of a regulated product is sued over alleged violations of a state consumer protection or deceptive trade practices act because of something allegedly amiss in the product’s name, labeling, advertising, or sales practices.  We know that drug and device manufacturers like the ones we represent can spend resources dealing with state attorneys general over the threat that such suits will be brought.  We cannot recall seeing, let alone posting on, a case where the manufacturer sued the state attorney general because its threat of suit—relayed to major retailers, who stopped selling the product—allegedly hurt its business and constitutional rights.  There would seem to be lots of reasons why an action like this might not be taken by a company that wants to keep doing business in the particular state for other products it manufacturers.  But if you are a one product, dietary supplement company and your presumably large market in Texas disappeared after letters went out based on a determination by the Texas AG’s office, not by a court, then you might be the one to bring suit preemptively.  That is what happened in NiGen Biotech, L.L.C., v. Paxton, No. 14-10923, 2015 U.S. App. LEXIS 17223 (5th Cir. Sept. 30, 2015).

The unusual posture of the case—in comparison to those we usually handle or read—means that it delves into constitutional issues that we knew better back when we clerked and the docket was sprinkled with cases against state actors.  The ones brought by prisoners are remembered more for their unique fact patterns and brand of advocacy than for the constitutional principles they implicated.  NiGen, likewise, holds our interest not because its treatment of sovereign immunity, federal question jurisdiction, and standing has direct implications for the sort of cases that normally fill our posts.  Rather, it shows that a manufacturer can go on the offensive against a state AG who probably thought it could do just about whatever it wanted prior to bringing its own suit.  It is not that we think the manufacturer NiGen is right on the underlying issue of whether the product’s label was deceptive, which touches on some complex constitutional issues, especially since Amarin has come down since this case started.Continue Reading Going on Offense against State Deceptive Trade Practices AG Actions

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion.  Both of them raised the same suggestion:  “Does the logic of this opinion permit a generic manufacturer to include truthful warnings about the risks of a drug on its labeling when such truthful warnings do not appear on the labeling of the branded drug?”

Not much later, we saw the same point raised by a plaintiff-side lawyer in this story in 360:

“I think this decision has huge implications for the preemption doctrine,” Lou Bograd of the Center for Constitutional Litigation PC said.

“If it’s the case that drug companies have the First Amendment right to make truthful statements about off-label uses, and the FDA cannot prohibit them, then it follows that they would have the First Amendment right to truthfully communicate the risks of their products even if that information isn’t on the label of the brand-name products,” he said.

Needless to say, we don’t think that’s true.  Moreover, if plaintiffs try for what amounts to an Amarin-based Hail Mary pass, it may even create a jurisdictional advantage for our side.Continue Reading Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

Federal preemption in the drug and medical device world is a game of categories.  Express preemption versus implied.  Conflict preemption versus field preemption.  Drugs versus devices, generic versus branded, premarket approved versus not.  These categories make a difference, and if you can place your controversy into the correct boxes, you can usually determine how to analyze whether federal law preempts state-law claims.  Sometimes you can even predict the result, or at least predict what the correct result should be.  We say “should” because there is discretion involved, and also some ambiguity in the applicable law. Moreover, preemption is like hockey: Many Americans can discuss it with some familiarity, but a much smaller number have studied all the nuances of the game.

From time to time a preemption order thinks outside the box, and that is what happened in Williams v. Zimmer US, Inc., No. 5:14-cv-468, 2015 U.S. Dist. LEXIS 91238 (E.D.N.C. July 14, 2015).  The case involved a bizarre situation where a surgeon took a medical device home, and “in his own garage, [he] used nonmedical tools purchased from a home improvement store to bend a 5.5 mm chrome rod into a ‘U’ shape.” Id. at *4.  Facts like these make us scratch our heads, but putting the weird facts aside, the device was cleared through the 510k premarket notification process.  As our readers know, under Lohr and Riegel, there generally is no express preemption under the Medical Device Amendments for 510k-cleared devices, so our knee-jerk reaction when a 510k device is involved is to put that case into a “no preemption” box.

But don’t forget about implied preemption, which is where  this district judge went with this case. Our do-it-yourself doctor used his Home Depot version of the device to treat a patient, who later sued alleging injuries.  But she couched her complaint entirely in terms of violations of the FDCA.

That had two dramatic consequences.  First, the defendants removed the case to federal court, and the district court ruled that it had subject matter jurisdiction because the case arose under federal law, i.e., the court had federal question jurisdiction.  Id. at **6-7.  This is exceptional because the vast majority of drug and medical device cases in federal court are there under diversity jurisdiction, even though the industry is subject to intense federal regulation.  An opinion finding federal question jurisdiction in a medical device case is a welcome development, and this plaintiff seems to have pleaded straight into it.Continue Reading Inside the Implied Conflict Preemption Box

We will never forget our first removal under the Class Action Fairness Act.  It was circa 2006, shortly after President Bush signed CAFA into law, when we received word of a complaint against our client filed in California state court with more than 100 plaintiffs claiming injuries from the same prescription drug.  Aha!  A removable mass action, we thought.  And before we knew it, we had the case in federal court under CAFA jurisdiction, poised to be transferred into a distant MDL.  After all, the plaintiffs were almost all litigation tourists with no connection whatsoever to the Golden State.

Careful readers have already discerned the end to this story.  Mass actions removed under CAFA may not be transferred to an MDL under the MDL statute (28 U.S.C. § 1407) unless a majority of the plaintiffs request the transfer.  See 28 U.S.C. § 1332(d)(11)(C)(i).  No such a request was forthcoming in our case.  In the words of our favorite post-modern philosopher, Homer J. Simpson, “D’oh!”  We and our more-than-100 adversaries remained in California, a beautiful place to be for many reasons, but not the proper forum for these non-California plaintiffs and their lawyers.

Since those early days, we have come across two ways to transfer a CAFA mass action to an MDL, notwithstanding CAFA’s prohibition on section 1407 transfers.  The first is to state an alternate basis for removal jurisdiction, such as federal question jurisdiction or diversity jurisdiction based on fraudulent joinder or misjoinder.  The JPML has permitted transfer of CAFA mass actions to multidistrict litigation, so long as CAFA is not the only basis for removal jurisdiction.  The most-cited example comes from the Darvocet MDL.  See In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig., 939 F. Supp. 2d 1376 (J.P.M.L 2013) (“Section 1332(d)(11)(C)(i) does not prohibit Section 1407 transfer of an action removed pursuant to CAFA’s mass action provision so long as another ground for removal is asserted.”).

The second method is to seek transfer not under section 1407, but instead under 28 U.S.C § 1404, the general venue transfer statute.  This strategy also comes out of the Darvocet litigation, Romo v. McKesson Corp., No. ED 12-2036, 2015 WL 3622620 (C.D. Cal. June 9, 2015), and all we can say is that we wish we had thought of it ourselves.  We have written before
on Romo in connection with the Ninth Circuit’s opinion holding that hundreds of claims related to one prescription drug constituted a CAFA mass action, even though counsel tried strategically to evade federal jurisdiction by dividing the plaintiffs into multiple civil actions of slightly under 100 plaintiffs each.
Continue Reading How to Transfer a CAFA Mass Action to an MDL

Like pharmaceutical and medical device manufacturers, it is not surprising that compounding pharmacies facing personal injury/products liability litigation prefer the typically more defense-friendly federal arena over the often more challenging (to put it mildly) state court system.  But as today’s case demonstrates, that may not be the easiest path for compounders to follow.

The case…

Don’t get too excited.  When we say a twitch, we mean it in its smallest sense.  A shudder, a tremor.  One blip followed by a long flat line.  We aren’t talking about resuscitation at this point.  But, just maybe West Virginia hasn’t signed a DNR order quite yet.

Ever since the West Virginia Supreme Court of Appeals refused to adopt the learned intermediary doctrine in State of West Virginia ex rel. Johnson & Johnson Corp. v. Hon. Mark A Karl, 220 W. Va. 463 (W. Va. 2007), we haven’t been shy about telling you all the ways that decision simply got it wrong (see here and here). But, ever the optimists, we sift and pan through West Virginia decisions like 19th century gold miners – looking for those little nuggets we can use to breathe life back into the learned intermediary doctrine.

We got one of those nuggets back in 2010 when the West Virginia Supreme Court of Appeals decided that there is no private cause of action under the West Virginia Consumer Credit and Protection Act (“CCPA”) for prescription drugs.  White v. Wyeth, 705 S.E. 2d 828 (W. Va. 2010). Nowhere in that decision will you find the words “learned intermediary.”  However, what that court did say was that when a plaintiff alleges affirmative misrepresentations, he must prove reliance and because for prescription drugs “the consumer cannot and does not decide what product to purchase”, id. at 838, plaintiffs can’t establish a causal connection.  If we were playing charades, we’d be making the “sounds like” gesture.  The court even went so far as to say that it is the physician who must “exercise[] judgment whether or not to prescribe a particular medication.”  Id.   So close.Continue Reading A Twitch of Life for Learned Intermediary Doctrine in West Virginia

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

We embrace all defense wins on this blog.  From the small and routine to the precedent-setting.  From discovery violations to appeals and everything in between.  And we are certainly no strangers to talking about removal issues.  So, of course we want to share with our readers H.R. ex rel. Reuter v. Medtronic, Inc., 2014 WL 554454 (S.D. Ohio Feb. 13, 2014), and more specifically, the court’s decision that defendant properly removed the case in light of “substantial federal issues” within the meaning of Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005).  But, don’t go filing your removal papers quite yet.  Anything involving Grable is hardly a one size fits all argument, and we caution everyone to look closely at all aspects of your case (especially the jurisdiction) before attempting to squeeze anything into this slender and contorted federal question category.

The Grable argument isn’t new.  We’ve pondered it before because the restriction of theories via PMA preemption to “parallel” claims involving FDA violations does seem to push that type of case towards Grable.  But frankly, our idea hasn’t had much success.  Which also isn’t surprising.  The general principle is to use the presence of an issue implicating federal law – but something less than a federal cause of action – as a basis of obtaining subject matter jurisdiction in federal court.  Removal is appropriate where a state court claim “necessarily raise[s] a stated federal issue [that is] actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities.”  Grable, 545 U.S. at 312.  That last part, about “balance,” means that by definition Grable doesn’t apply to anything involving large numbers of cases.  So look elsewhere for jurisdictional panaceas.

H.R. is an InFuse case.  If you haven’t been following our other InFuse posts, InFuse is a PMA, Class III medical device.  In almost all of the InFuse cases, including H.R., plaintiffs’ claims are based on alleged off-label promotion of the device which they claim violates the FDCA.  The combination of a PMA device and plaintiff’s extensive, and nearly exclusive, reliance on detailed FDCA-related allegations involving off-label promotion are what made H.R. a particularly strong vehicle for advancing the Grable substantial federal question argument.Continue Reading A Removal Win With a Word of Caution

A few months ago, we told you that the Supreme Court granted certiorari in a case to decide whether a state’s parens patriae action is removable as a “mass action” under the Class Action Fairness Act (“CAFA”) when the state is the sole plaintiff and the claims arise under state law.  The decision on appeal is the Fifth Circuit’s Mississippi v. AU Optronics Corp., 701 F.3d 796, 800 (5th Cir. 2012).   The Fifth Circuit answered the question in the affirmative and as that remains the controlling law for the circuit, the Northern District of Mississippi recently followed suit in Hood v. Bristol-Myers Squibb Co., 2013 U.S. Dist. LEXIS 90540 (N.D. Miss. Jun. 27, 2013).  Since  Hood is a pharmaceutical case, we thought we’d use it as an opportunity to explore the issue a little more, and there is a also a good diversity ruling.

This AG action was brought in state court solely under the Mississippi Consumer Protection Act (“MCPA”) seeking civil penalties, disgorgement and injunctive relief.  Id. at *3.  Defendants removed the case to federal court.  In opposing plaintiff’s motion to remand, defendants asserted diversity jurisdiction, federal question jurisdiction and jurisdiction under CAFA.  The court agreed with defendants on both diversity and CAFA.

As a quick but important side note, plaintiffs filed an amended complaint on the same day they filed their motion to remand – presumably attempting to address the jurisdictional issues.  The court, however, found that the question of removal should be determined based on the original complaint that was in effect at the time of the removal.  Id. at *6-7.  Good practical reminder if you are faced with amended pleadings in the midst of a motion to remand.

On to diversity.  Here the question is who are the real parties in interest?  If the State of Mississippi is the sole party in interest, there cannot be complete diversity because a State is not considered a “citizen” for purposes of diversity.  Id. at *9-10.  That is precisely what the Mississippi AG argued – that he was bringing a ”parens patriae suit on behalf of the State of Mississippi under the MCPA, not a suit on behalf of the individual users of [defendant’s product].”  Id. at *9.  In opposition, defendants argued that the real parties in interest were the citizens of Mississippi who are completely diverse from the defendants.  Id.Continue Reading Diversity and CAFA Jurisdiction in Mississippi AG Action

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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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