June 2016

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Back when we were first getting into the drug and device practice, a senior partner we know and trust told us that the JPML was “in the MDL business.” What did he mean by that?  Well, that unique panel of federal judges never saw an MDL motion it did not like, making it a near certainty that if you found yourself before the JPML, your next step was likely to be multidistrict litigation in some forum of the Panel’s choosing.

The JPML still grants the vast majority of the MDL motions that it hears, but multidistrict litigation is not the foregone conclusion that it once was. We think that is partly due to plaintiffs’ attorneys who overreach by filing consolidation motions that stretch the JPML’s limits.  Take for example the JPML’s rejection of multidistrict litigation in cases involving Cymbalta, where the JPML found that the few cases at issue were at varied stages of litigation and that multidistrict litigation would offer little benefit.  It is telling that the plaintiffs’ attorneys pushing Cymbalta cases tried not once, but twice to persuade the JPML to create an MDL.  The cases had little to no arguable merit, so perhaps they needed an artificially created “mass” proceeding to attract more cases.  They failed, and when we looked at one of their websites a few minutes ago, it said they were “no longer taking these cases.”  Go figure.

That brings us to an order that the JPML entered a couple of weeks ago denying an MDL motion in cases alleging off-label promotion of amiodarone, a heart rhythm medicine. In re Cordarone (Amiodarone Hydrochloride) Marketing, Sales Practices, and Prods. Liab. Litig., MDL No. 2706, 2016 U.S. Dist. LEXIS 71769 (J.P.M.L. June 2, 2016).  Amiodarone is an old drug, used outside the U.S. for decades and approved in the U.S. in 1985.  Multiple generic manufacturers have distributed it since the late 1990s.  Amiodarone has several known risks, which are described in its exceptionally strong labeling and in a Medication Guide that accompanies prescriptions.  The FDA published a Drug Safety Communication last year about adverse events reported when amiodarone was prescribed with certain antivirals.  That may have piqued the interest of plaintiffs’ lawyers, but we don’t really know.  Whatever the motivation for pursuing the cases, there are not that many, which may itself be the motivation for seeking an MDL, i.e., to drum up more cases (see, e.g., Cymbalta).Continue Reading It’s Not The Same Old JPML

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Two of our bloggers, McConnell and Bexis, will be presenting a free, hour-long webinar on “Personal Jurisdiction: What Bauman Does and Doesn’t Mean, The Other Side’s Response, and Why Corporations Should Care” this coming Tuesday, June 14 at 12 p.m. ET.

As our readers know, post Bauman, plaintiffs’ lawyers are revising their strategies, looking…

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In a rare harkening to our past and discussion of specific judges, we recall that our first gig after law school was clerking for Judge Jon P. McCalla of the United States District Court for the Western District of Tennessee.  Downtown Memphis had not yet undergone “gentrification,” so a short walk in any direction from the Federal Building had to be undertaken with some caution.  In addition to barbecue and blues, a federal litigant’s visit to Memphis held the prospect of appearing before any one of an interesting assemblage of district judges.  Judge Odell Horton had taken senior status after a long stint as chief judge of the district; he was a Carter appointee and exceedingly nice to everyone.  He was also the first African American federal judge in Tennessee since Reconstruction.  Judge Julia Smith Gibbons had taken over as the chief judge after starting on the federal bench at 33—a Reagan appointee—and everyone knew she would be heading up to the Sixth Circuit at some point.  Judge Jerome Turner was another Reagan appointee, who we recall mostly for taking his clerks to lunch regularly and for an untimely death a few years later.  Judge Bernice Donald assumed the bench while we were there, having been tapped to jump up from the bankruptcy court by the first President Clinton.  (The actor/Senator who was in Die Hard 2: Die Harder showed up for the swearing in ceremony.)  Judge McCalla had been appointed by the first President Bush and clerked (for Judge Bailey Brown, before he went up to the Sixth Circuit) in the same chambers some years earlier.  He had the military bearing you would expect from his pre-law background as an office in Vietnam and a well-deserved reputation for being “by the book” and “no nonsense.”  (The softer side that attorneys appearing before him missed was evident when he was with his family, including the puppy we helped train while housesitting.)

Twenty years later, we discuss Judge McCalla’s decision in Fleming v. Janssen Pharms., Inc., No. 2:15-cv-02799-JPM-dkv, 2016 WL 3180299 (W.D. Tenn. June 6, 2016), which follows the memorable Yates decision authored by Judge Gibbons, who did, indeed, head up to the Sixth Circuit.  Hence why we recounted the iudicis personae of the Western District from our relative youth. Fleming involves asserted state law claims in connection with plaintiff’s alleged kidney injuries from a branded prescription diabetes drug.  Defendants moved to dismiss on various grounds, which we will discuss in the order of importance to us.

First, of course, was the argument that plaintiff’s design defect claim was preempted as pleaded. This angle of attack is noteworthy because winning any kind of preemption for a branded prescription drug at the motion to dismiss phase is rare and because the progression from Bartlett to Yates (decided on summary judgment) to such motions being viable was something we forecast/urged. As discussed more later, plaintiff had pretty barebones design defect allegations that suggested that all drugs within this class of anti-diabetic agents was too risky and that there were “several safer alternative products”—not alternative designs for this product. Id. at *1.  In response to defendant’s argument for impossibility preemption, plaintiff contended that its claim was based on a “duty to design the drug differently before FDA approval,” which could have been characterized as “never start selling theory.” Id. at *5.  “The Sixth Circuit, however, found this type of argument to be ‘too attenuated’ and ‘speculat[ive]’ because it requires several assumptions as to FDA approval and a patient’s selections of and medical reaction to the alternative design.” Id. (quoting Yates, 808 F.3d 281, 199-300).  While a case with the same drug in the Eleventh Circuit had rejected Yates impossibility preemption while granting a motion to dismiss, the analysis in Fleming was straightforward.  “The Court finds that Plaintiffs’ design defect claims are preempted by federal law because preemption can apply to both generic and branded drugs and because it would have been impossible for Defendants to comply with both state and federal law.” Id. Like we said, this is a “by the book” judge.  Other judges taking a similar approach could provide the advantage of getting obviously preempted design defect claims out early, narrowing the scope of fact and expert discovery.Continue Reading Dismissing Drug Design Defect Based on Preemption

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We blogged a couple of years ago about the beginnings of what has become a wave of state “Right to Try laws” – laws that purport to give terminal patients with no other medical options the right to seek investigational drugs for their conditions from manufacturers who have yet to obtain full FDA approval.  Mostly, these laws are motivated by the unwieldy nature of the FDA’s “compassionate use” regulations, which are directed at the same problems.  Given that these laws originated with a “states’ rights group” called the Goldwater Institute, we strongly suspect that a second motive of gratuitously poking the FDA in the eye was also at work.

Whatever their provenance, we were deeply skeptical of their practicality. Three large obstacles loomed.  Number one:

For one thing, there’s the FDA. States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen.

Number two:

The reason, as is the case for so many things these days, is the threat of liability. . . . You won’t induce a manufacturer to participate in a voluntary program by painting a target on its back.

Number three:

There’s no upside. These statutes are for use by very ill people, and if (as is unfortunately likely) the statutory participant died, then there’s an adverse event that must be reported to the FDA.  Companies investigate drugs in the hope of obtaining approval.  Adverse events definitely don’t help get approval.

Indeed, despite a couple dozen Right to Try statutes enacted over the last few years, we are unaware of even a single instance in which anybody successfully obtained treatment with an investigational drug under any of these state laws.Continue Reading Developments in Compassionate Use and Right To Try Laws

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Back in October, all of the Philadelphia Reed Smith bloggers participated in an in-house CLE presentation attended by colleagues and clients.  Our portion of the presentation dealt with third party litigation funding.  There are several different funding models, but all are united by a common theme: funding companies, aided by plaintiffs’ lawyers, identify vulnerable litigants…

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Is there a more misused statute than RICO?  Or one that more convincingly shows the weakness of the textualist position, which wads up any evidence of legislative intent and tosses it into the trash bin?  RICO was clearly intended to address organized crime, but its broad and vague language has been held to reach all sorts of commercial disputes and garden variety litigations where no hit-men, shake-down schemes, or cement shoes are in sight.  It’s easy to see why plaintiff lawyers love to lob RICO claims into their complaints – getting treble damages for labeling your opponent a racketeer is a good business model.  We’ve said all this before, of course.

The godfather of RICO was Notre Dame Law Professor G. Robert Blakey.  While in law school, Blakey authored a law review note about the inability of prosecutors to affix criminal liability to the attendees of the notorious Apalachin organized crime meeting in 1957.  Later, he worked on a bill that would take care of that problem.  President Nixon signed RICO into law in 1970 and, like a lot of what Nixon did, it created more problems than it solved.  Another law came into play – the law of unintended consequences.  The malleability of RICO didn’t merely suit plaintiff lawyers down to the ground; Blakey also seemed to enjoy the surprising scope and relevance of his baby.

When we were a young litigator we attended an all-day CLE conference in NYC on business litigation.  The moderator was a sharp litigator from the Mudge Rose firm named Jed Rakoff.  He is now one of the two or three smartest and scariest judges in the country.  The star speaker was Blakey, who held forth on how RICO was the cure for whatever ailed any wannabe plaintiff.  He probably never envisioned that RICO would result in his occupation of a Waldorf Astoria podium in front of 300 white-shoed lawyers.  But there he was.  The audience peppered Blakey with questions about the reach of RICO.  Would X fall within RICO’s grasp?  Yup.  Would Y?  Of course.  We went up to Blakey after the talk and poured into his ear a complex fact scenario we were defending.  Is that a RICO violation?  Sure.

Yikes.

Blakey must have been ecstatic about what happened in the District of Massachusetts Neurontin litigation, where allegations of off-label promotion and other marketing malfeasances supported RICO claims and, consequently, huge settlements.  RICO had been stretched up to (we would say past) its breaking point on issues such as causation, injury, and damages.  It was, in our judgment, one of this country’s enormous wrong turns in drug and device litigation.  D. Mass. prosecutors showed up at CLE conferences, crowing about their success and ominously hinting at more to come.  But their legal theories rang hollow and the showmanship looked cheesy.  Having prosecuted federal cases ourselves, we have a knee jerk reflex to assume the good faith and validity of USAO actions and policies.  Not so here.  It smelled like overreaching. We think history will vindicate our position.  It is not as if the history of Mass. litigation is a history of getting things right.  Ever heard of the Salem Witch trials?  Lizzy Borden?  Roberts v. Boston (which invented the separate but equal doctrine later embraced in Plessy v. Ferguson)? Sacco and Vanzetti?   A Civil Action? Reckis v. Johnson & Johnson (a Mass. Supreme Court decision that we listed as the single worst drug/device decision of 2015)? Anyway, maybe even the folks in Boston are starting to rethink the use of RICO to police the marketing of medicines.Continue Reading D. Mass. (!) Refuses to Certify Celexa/Lexapro RICO Class Action

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This post comes from the non Reed Smith side of the blog.

Minnesota is one of our most beautiful states and the setting for much of the terrific TV anthology series Fargo. But Minnesota is also home to a significant number of well-reasoned preemption decisions. While we’ll concede that beautiful lakes and Fargo are (way) more interesting and entertaining than preemption law, this is a drug and device law blog. So today’s visit to Minnesota will offer you the wonderful opportunity to review a well-reasoned preemption decision, not to enjoy a lazy, scenic day on a lake or a mesmerizing, voyeuristic view of fake true-crime drama. You can visit Minnesota and its lakes on your own time. And we’ll certainly talk about Fargo once season three starts next year. But, for now, you get Lutz Cummings v. Medtronic, Inc., 2016 WL 3082314 (Minn. D. Ct. May 31, 2016) and preemption.

In Lutz, one of the plaintiffs had complications from a pain-pump implant and filed a complaint in Minnesota state court alleging a host of state-law claims. Since the pain pump is a PMA device, plaintiffs’ state-law claims are preempted unless they can properly state parallel violation claims. The court effectively described how express and implied preemption work together to create a near air-tight seal that leaves plaintiffs only a “narrow gap” into which try to fit such claims. Their claims must be premised on conduct that violates FDA regulations but cannot seek to directly enforce those regulations. Rather, their state-law claims must be such that they would give rise to a recovery even if the FDA regulations didn’t exist:

Narrow Gap Between Express and Implied Preemption. State law claims involving an FDA-approved medical device are expressly and impliedly preempted by federal laws and regulations. A plaintiff may pursue state law claims involving an FDA-approved medical device only to the extent plaintiff can show that such claims escape express and implied federal preemption as contemplated by existing federal regulations and case law. In evaluating an allowable claim, the Minnesota federal district court in Riley v. Cordis Corp., states:

…Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by section 360 k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). For a state-law claim to survive, then, the claim must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.

625 F. Supp.2d 769, 777 (D. Minn. 2009).

Lutz, 2016 WL 3082314, at *4 (all emphasis in original). Not only did plaintiffs have to deal with the limited availability of parallel violation claims, they also had to allege facts that made those claims plausible under the pleading requirements of TwIqbal. With this construct in place, the court set about dismissing plaintiffs’ attempted parallel violation claims one at a time.Continue Reading Minnesota Gives Us Another Excellent Preemption Decision

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

It’s been a bit of a slow news week in the drug and device litigation world. We are coming off a short work week and like the rest of us, judges may be looking to enjoy a few extra hours outdoors during these late spring days. We don’t blame them. While we prefer bringing you hot of the presses news or interesting new takes on old standards, sometimes all we have to report is that good law continues to be good law.

That’s today’s case – another blow to innovator liability. As you’ll see from our innovator liability scorecard,  Rafferty v. Merck & Co., 2016 Mass. Super. Lexis 48 (Mass. Super. May 23, 2016) isn’t the first time a Massachusetts court has rejected this concept. But now that it has done so twice, we hope Massachusetts can be added to the list of states where innovator liability is now dead (we won’t say “and buried” since there is no state supreme court ruling yet). The case contains a thoughtful analysis of the issue and is certainly worthy of including if you are briefing this topic.

Plaintiff ingested finasteride, the generic version of Merck’s Proscar. After experiencing complications, plaintiff brought suit against his prescribing physician and Merck. Id. at 1. Plaintiff alleges that even though he didn’t ingest Merck’s product, as the brand manufacturer, Merck “had a duty to maintain the accuracy of the labels for those individuals who would rely on those labels,” including individuals who would ingest generic product. Id. at *8.

The court starts its analysis with the framework for how a generic drug gets FDA approval and following approval how the labeling requirements for brand and generic manufacturers differ. Id. at *3-6. This regulatory framework serves as the cornerstone for the Supreme Court’s Mensing and Bartlett decisions which largely insulate generic drug manufacturers from product liability lawsuits. The Rafferty court, like most others to have considered the issue, recognized the “unfortunate” result of barring generic users from recovery but also like most other courts, it was unwilling to bend or expand existing law to extend product liability to a company that did not manufacture the product at issue.Continue Reading Another Rejection of Innovator Liability

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Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit.  Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how drug labels, FDA, and cockamamie theories about off-label marketing should fit together.  We would like to see more of the judges handling product liability cases with similar issues follow the lead of the judges handling FCA cases and dismiss complaints premised on nonsensical interpretations of labels and regulations.”  In discussing U.S. ex rel. Polansky v. Pfizer, Inc., No. 14-4774,  2016 U.S. App. Lexis 8974 (2d Cir. May 17, 2016), we could be lazy and swap in “a panel” for “a judge” in the preceding quote.  That would be true, but it would be incomplete.  A few weeks after the district court’s decision in Polansky, the Second Circuit decided U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), where it vacated the conviction (conspiracy to sell a misbranded drug under 21 U.S.C. §§ 331(a) and 333(a)(1)) of a sales representative for promoting a prescription drug for off-label use.  Then, a few months before the Polansky appeal was argued, the Southern District of New York enjoined the FDA from prohibiting a manufacturer’s truthful off-label promotion concerning a (generic) prescription drug.  Next, a few months later, FDA reached a well-publicized settlement with that manufacturer, preserving that “Amarin may engage in truthful and non-misleading speech promoting the off-label use” of its drug without risking prosecution for misbranding.  While there are still decisions like Neurontin out there and many cases still seek to impose liability under the FCA or other statutes for truthful off-label promotion, the off-label landscape has clearly changed.

With that in mind, we turn back to Polansky.  For eight years and through multiple amended complaints, the plaintiff pursued a FCA claim that Pfizer’s promotion of Lipitor for use within the approved indications was actually off-label—and therefore allegedly led to false claims for Medicare and Medicaid reimbursement—because of references in the label to the National Cholesterol Education Program Guidelines.  We will be blunt—shocking to our readers, we know—this was always a dubious claim because any common sense reading of the label does not come close to supporting the contention that the Guidelines narrowed what was “on-label” compared to the five indications that were approved and described in the label.

The NCEP Guidelines, which came out of NIH and were expressly not intended to trump clinical judgment, set out an algorithm for  recommendations for the general type of treatment (e.g., just lifestyle modifications) depending on risk categories derived from lab results and clinical history.  2016 U.S. App. Lexis 8974, **7-9.  The Indications section in the pre-Physician Labeling Rule label referenced the Guidelines in conjunction with stating that lipid-altering agents should be used only when response to diet and other lifestyle modifications “has been inadequate” and included a summary of the Guidelines. Id. at **10-11.  When PLR changes went into effect in 2009, the reference and summary were omitted, which suggested something about the relative importance of these references. Id. at *9.  Both before and after PLR, the Dosage section of the label had a cite to the Guidelines when stating, for one subcategory of patients, that “The starting does and maintenance doses of Lipitor should be individualized according to patient characteristics such as goal of therapy and response.” Id. at *11.Continue Reading A Blow Against False Claims Act Liability For Off-Label Promotion

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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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