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We’ve generally been skeptical of state “Right To Try” statutes, for several reasons.  First, to the extent that they try to circumvent the FDCA, they’re likely to be preempted.  Second, drugmakers aren’t likely to distribute experimental drugs due to liability concerns, and these statutes don’t go far enough in removing that threat.  Third, such statutes…

Inferior vena cava filters resemble what we used to call “daddy long legs.” You know what we mean:  the spider-like creatures with small centers, from which long, bent legs emanate in all directions.  That is sort of what IVC filters look like, although any resemblance ends there.  Manufactured from thin flexible metal, IVC filters can be implanted in the big vein that returns deoxygenated blood to your heart—the vena cava—to trap clots (or anything else) and prevent them from traveling to your heart and lungs, where they can cause serious mischief.  They are potentially life-saving devices.  They last came to our attention the other day when we received a robotic phone call asking us if we knew anyone with an IVC filter who might want to sue.  Ye gods.

An order granting a motion to dismiss in an IVC filter case crossed our desks this week, and its discipline and thoroughness caught our eye. The case is Dunson v. Cordis Corp., No. 16-06-03076, 2016 U.S. Dist. LEXIS 94873 (N.D. Cal. July 20, 2016).  The complaint in Dunson included the claims of six different plaintiffs whose claims appear to be unrelated, except that they have the same lawyers and were treated with similar filters made by the same manufacturer. Id. at **3-4.  They all alleged complications from filter implantation, and they alleged the full range of product liability claims.  Only the express warranty claim survived, and here is why:

Strict liability for design defect:  Guess what.  The plaintiffs sued in California, and California does not permit strict liability design defect claims in prescription medical device cases.  Plaintiffs tried to get around this by asserting in their opposition, for the first time, that some of them had their filters implanted in Arizona and Pennsylvania and that those states’ laws therefore should apply. Id. at **9-12.  This position raises so many questions:  If they were treated outside California, do they also reside outside California?  If so, why are Pennsylvania and Arizona residents suing a Florida corporation with an Ohio headquarters in California’s courts?  If they are from out of state, why did they conceal those facts and wait until opposing a motion to dismiss to admit them?  The answers are that these are forum-shopping plaintiffs who are importing their claims along with hundreds of others into California for no legitimate purpose.  Their choice-of-law argument did not work this time around.  The district court still dismissed their design defect claim, and it admonished the out-of-state plaintiffs to allege facts in their amended complaint to support their choice of law. Id. at **12-13.  The court was “skeptical.”Continue Reading California Federal Court Dismisses Inferior Complaint

There is a lawyer we worked with at another firm who had a standard move, kind of the way that Jerry Seinfeld had a standard “move” – and, come to think of it, with a similar intention. (“The Move” shows up in “Fusilli Jerry,” the 107th episode of Seinfeld.)   In the face or fear of a hostile action against our client, this lawyer would file a declaratory judgment action in a friendly federal court.  The concept, of course, was to seize the initiative and do some forum-shopping.  Sometimes the action would be preemptive and sometimes it would be reactive. One would think that the timing would make a difference.  But as today’s case, Monster Beverage Corp., v. Herrera, 2016 U.S. App. LEXIS 9012 (9th Cir. May 17, 2016), demonstrates, that ain’t necessarily so.  We discussed the Monster case a couple of days after Labor Day in 2013, when Monster survived an attack on its preemptive preemption position.  Here it is just a couple of days after Memorial Day in 2016, and the Ninth Circuit has ended the case on grounds of Younger abstention and the Anti-Injunction Act.  That’s a long passage of time.  The judicial process, especially the appellate phase (doubly so in the Ninth Circuit), can take a while. What happened in the interim?

First, please enjoy this reminder of what the Monster case was about.   The San Francisco City Attorney wrote a letter to Monster informing it of an investigation into whether Monster’s marketing of its energy drinks was deceptive and bad in various other ways.  Needless to say, the City Attorney’s beef was really with the federal regulatory regime that already governed what Monster could and could not say about its products.  But San Francisco has been known to try to conduct its own foreign policy, so why should federal regulations stand in the way of its persistent effort to impose a nanny-state on its benighted citizens?   Monster filed a preemptive declaratory judgment action in C.D. Cal. (good idea to drag the San Francisco City Attorney down to SoCal), seeking to shut down the investigation because it was preempted by federal law.  Then the San Francisco City Attorney filed a complaint in San Francisco Superior Court, which Monster removed to federal court on grounds of federal question (preemption again), which the federal court remanded after rejecting the preemption argument. For those of you keeping score at home, that means there was a federal case in Dodger-land and a state case in Giant-land.

The San Francisco (honestly, by this point we are tired of writing the city name out in full, but Boranian warned us that we’d be jeered if we abbreviated the city’s name in any way) City Attorney, as is the case with all Bay Area denizens forced to contemplate anything south of Big Sur, must have seen the C.D. Cal. case as a vast annoyance.  That was certainly the idea behind Monster’s maneuver.  Not surprisingly, then, the City Attorney filed a motion to dismiss the declaratory judgment action in C.D. Cal., arguing that the preemption argument stood no chance. The federal court denied that motion to dismiss.  That is the ruling we applauded back in September 2013.Continue Reading San Francisco vs. The Monster (aka Federal Regulation)

Fifty-seven years ago the Music Died.  On Feb 3, 1959, a small aircraft carrying rock and roll legends Buddy Holly (“Everyday,” ”It’s So Easy,” “Peggy Sue,” and a whole lot of other, crucial early rock and roll tunes), Ritchie Valens (“La Bamba,” “Come On, Let’s Go”), and J.P. Richardson, aka the Big Bopper (“Chantilly Lace”) crashed in Clear Lake, Iowa.  It is the precipitating event in Don McLean’s eight and a half minute 1971 pop hit “American Pie.”  (Hence, “But February made me shiver/with every paper I’d deliver/bad news on the doorstep/I couldn’t take one more step.”) The plane was a four-seater, so only three passengers could join the pilot for the short flight to the next stop, which was  Moorhead, Minnesota – through a blizzard.  One of Holly’s backing musicians, Waylon Jennings, was also supposed to be on the plane, but he gave up his seat to the Big Bopper, who was suffering from the flu.  In some versions of the story, Jennings lost a coin toss.  But that is not the story on the official Waylon Jennings website.  In any event, Jennings rode the bus.  As a result, he lived another 43 years.  Fate gave Jennings a second chance.  He didn’t waste it.  Jennings had a fine career as an outlaw C&W star. His catalogue is impressive:  “Luckenbach, Texas,” “Are You Sure Hank Done it this Way, “ “Mamas, Don’t Let Your Babies Grow Up to be Cowboys,” and many more.  Jennings was also the balladeer/narrator on the Dukes of Hazzard tv show.

Jennings was also for a while part of a supergroup called The Highwaymen, which included a few other fellas you might have heard of:  Johnny Cash, Willie Nelson, and Kris Kristofferson.  And now our little account must take a legal detour.  There was an earlier musical group called The Highwaymen.  Some Wesleyan students got together to perform folk music.  Turns out they were pretty good.  They had a hit record in 1961 with their version of “Michael, Row the Boat Ashore.”  Those original Highwaymen were an impressive lot.  Several went on to graduate school.  Stephen Trott was one of the Highwaymen.  He attended Harvard Law School, became a prosecutor, and later became a Ninth Circuit Judge.  So maybe it’s not much of a surprise that these original, collegiate Highwaymen filed a lawsuit against Waylon, Willie, et al. for appropriating their group’s name.  Like most cases, it settled.  Unlike most cases, the settlement included a provision permitting the original Highwaymen to share the stage with the more famous folks during a 1990 concert in Hollywood.

Back to the main branch of our story.  Maybe Jennings never quite entered the pantheon alongside Holly.  Or maybe he did.  Either way, he did okay.  He used his second chance well.

Holly, of course, was a genuine musical genius and had attained stardom by 1959.  Jennings back then was a sometime dj and sometime musician who had been given a big break when Holly invited him along on the Winter Dance Party tour.  As the musicians gathered outside that little plane on that cold, blustery Iowa night, Holly jokingly told Jennings he hoped the bus would break down and that Jennings would freeze.  Just as jokingly, Jennings said, “I hope your ol’ plane crashes.”  Understandably, Waylon was always haunted by that near miss back in 1959.  You can see a video of Jennings telling the story here.

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Today’s case is about a second chance.

We are talking about the dismal topic of document confidentiality.  Many — definitely too many — documents are produced in mass tort litigations.  Almost all those documents are produced by the corporate defendants.  Most end up having nothing to do with the case.  If two million documents are produced in an MDL, fewer than 200 are likely ever to be marked as exhibits at trial.  But producing all those documents is wickedly expensive for the company, a lot say things that no company would want to become public, so what the hey, why shouldn’t the plaintiff lawyers have a little fun?  A lot of those documents involve proprietary information about marketing, pricing, new avenues of scientific research, etc. – all things that a competitor would enjoy reading.  (We remember a professor in law school suggesting that companies wishing to engage in joint-pricing arrangements would be smart to file bogus law suits against each other occasionally and then use document discovery as a way of learning, and then coordinating, pricing strategies.  Yes, our law school had as many cynics
as scholars.)Continue Reading New Jersey Federal Judge Says It’s Not So Easy to Preserve Confidentiality of Discovery Documents

A pharmacy case from Florida caught our eye this week.  We still have fresh in our minds the survey that Bexis posted a few days ago of state laws limiting the liability of non-manufacturing sellers of prescription medical products.  It was an impressive collection, as Bexis-prepared surveys tend to be, and it covered the potential liability (or lack thereof) of distributors, suppliers, pharmacies, etc.  You know, anyone in the chain who did not manufacture the drug or device and who typically would have no role in developing the product or its warnings. It comes up a lot for us in the context of removal jurisdiction, where plaintiffs fraudulently join local or non-diverse defendants in an attempt to prevent removal to federal court.  The plaintiffs never—and we mean never—actually pursue claims against the local defendants, and we routinely resist their motions to remand cases to state court with arguments that there are no viable claims against mere pass-through sellers of pharmaceutical products and medical devices.

In this regard, the result in Oleckna v. Daytona Discount Pharmacy, No. 5D13-3057, 2015 WL 477841 (Fla. Dist. Ct. App. Feb. 6, 2015), is not helpful because it allows negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written.  In Oleckna, the patient was being treated for stress, and his doctor prescribed Xanax and narcotic pain medication over a period of two years.  Id. at *1.  The patient, sadly, died allegedly “due to combined drug intoxication” of the prescribed medications, and his estate sued the physician who wrote the prescriptions and a pharmacy who filled many of them—allegedly more than 30 prescriptions.  Id. Continue Reading Florida Court Races to Questionable Conclusion on Pharmacy Liability

In 2012, the Third Circuit considered whether companies who provide insurance under Medicare Part C, known as Medicare Advance Organizations (“MAOs”), can seek reimbursement of medical expenses from pharmaceutical companies who settled with their insureds on litigation claims related to use of the pharmaceutical company’s drug.  That’s a mouthful, but essentially the question was whether MAOs can create a whole other litigation related to a mass tort in which they seek reimbursement for covering the mass-tort plaintiffs’ injuries. The answer from the Third Circuit was that they can.  See In re Avandia Marketing, Sales Practices and Products Liability Litig., 685 F.3d 353 (3d Cir. 2012).  Not great. But then last month the district court in that same case considered whether those MAOs do this in a class action. If so, that could foster a lot of this litigation.  This time, however, the answer was no.  See In re Avandia Marketing, Sales Practices and Products Liability Litig., 2014 U.S. Dist. LEXIS 164510 (Nov. 24, 2014 E.D. Pa.).  And given the factual background of this case, that answer is no surprise.

The underlying litigation was the Avandia mass tort.  GlaxoSmithKline, the manufacturer, settled with thousands of plaintiffs and thereby became obligated under Medicare law to reimburse certain MAOs that had initially paid the medical costs of plaintiffs.  That resulted, when applicable, in a lien on the settlement funds by MAOs.  GSK set aside a percentage of the settlement funds to account for those liens.  Id. at *14.  GSK also agreed with many MAOs to enter into Private Lien Resolution Programs (“PLRPs”), which satisfied the MAO liens.  Id. at *14.  GSK did this with 56 MAOs, which covered the vast majority of Avandia plaintiffs.  Id. at *5.  It sought to enter into PLRPs with other MAOs, but had not done so with 94 others at the time the court was considering plaintiffs’ class certification motion.  These other 94 MAOs covered only a small share of the Avandia plaintiffs.  Id.  There was some evidence that many, not all, of those MAOs were not interested in PLRPs or collecting on liens.Continue Reading Federal District Court in Pennsylvania Denies Class Treatment of Medicare Claims against Pharmaceutical Company That Settled Mass Tort Claims

Any defendant that has litigated – and lost − remand motions has encountered plaintiffs with very flexible facts, particular in opposition to fraudulent joinder arguments.  By that we mean:  dates that change after remand, non-diverse defendants that suddenly had nothing to do with anything, damages shrinking below the jurisdictional minimum, product exposures that disappear, “yes” that becomes “no” (and vice versa) in plaintiff testimony.  That kind of thing.

But there’s nothing anybody can do about it, right?  After all, a federal statute, 28 U.S.C. §1447(d), bars federal review of remand orders, so no matter how outrageous a plaintiff’s fraud on the court during the remand process is, they skate, and the defendants are stuck in state court, right?

Wrong.  At least not now.  At least in the Fourth Circuit.  See Barlow v. Colgate Palmolive Co., ___ F.3d ___, 2014 WL 6661086 (4th Cir. Nov. 25, 2014).

In the first precedential decision to address this issue, last week the en banc Fourth Circuit held in Barlow that, when a plaintiff’s remand-related misrepresentations are bad enough, a remand order can be vacated under Fed. R. Civ. P. 60(b)(3), with the result being that the case retroactively returns to federal court.  It’s a matter of first impression (prior adverse appellate decisions were all non-precedential), so all defendants should study Barlow closely.Continue Reading Fraud on a Federal Court Allows Vacation of Remand Orders

A federal court recently placed Colorado amongst the states that apply Restatement (Third) of Torts §6(c) in design defect cases.  That’s a good place to be when you’re defending a medical device company.  Section 6(c) creates a tougher burden for design defect plaintiffs than does Restatement (Second) of Torts.  Showing a safer alternative design isn’t enough.  And that’s important, because there are often alternative designs for medical devices.  Section §6(c) instead focuses on prescribing doctors and their risk-benefit analysis:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Restatement (Third) of Torts § 6(c).  In short, if a reasonable doctor would choose to use the device for any class of patients, knowing the risks, it is not defectively designed – regardless of whether there might be an alternative design.

The facts of the Colorado case, Haffner v. Stryker Corp., No 2014 U.S. Dist. LEXIS 137214 (D. Col. Sep. 29, 2014), show how this can work.  The plaintiff had knee replacement surgery, but later needed revision surgery.  He was allergic to the cobalt and nickel contained in the knee replacement system.  So he sued, claiming, amongst other things, that the system was defectively designed.  Id. at *1, 2, 7.Continue Reading A Colorado Federal Court Adopts Restatement (Third) of Torts Section 6(c)

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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