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It feels like we have been talking about Weeks for years.  Two slightly different versions of the same decision have allowed the “innovator liability” theory of recovery to survive in Alabama against manufacturers of drugs that the plaintiff did not take.  Each appeared on our bottom ten list over the last two years.

Too many posts to link have discussed how Weeks is on the wrong side of the weight of authority on what started with Conte years ago.  In the first five months after its feeble re-do, we did not see cases considering whether to extend Weeks. We now have, with Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073 (N.D. Ala. Jan. 14, 2015).  And that led us to find an older Weeks case that took a while to appear in “print,” Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014).  So, we present an end-of-the-week two-fer on Weeks from the federal judges in the northern part of this southern state.

Both cases involve plaintiffs who died sometime after taking generic amiodarone, a prescription anti-arrhythmia drug, and who sued various manufacturers, including the company that brought the branded drug to market long before the plaintiff got the generic.  Both cases also involve other issues we often discuss, like TwIqbal, preemption, and the learned intermediary doctrine, but we are not discussing those issues here.  Instead, we are limiting ourselves to how these cases limit Weeks and do not allow the plaintiffs to proceed against the branded manufacturer on the allegation that it owed a duty to each plaintiff to provide him with the Medication Guide that would have made clear that his physician was prescribing the drug off-label and that it had various risks.  (If we were talking about the risk of these cases, we might talk about how little apparent connection there seems to be between the information gap alleged with each brief prescription and the remote injuries.)  Amiodarone was originally approved as a “special needs” drug to be used as “a last resort,” and has a regulatory history with a fair amount of back-and-forth on discouraging (and not encouraging) physicians from prescribing it as first or second line therapy.  Plaintiffs apparently did not contend that the Medication Guide hid the ball on the drug’s indication or risks.

Continue Reading Not The End Of Weeks But A Start

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We are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.

We adopted a Drug and Device Rescue Cat this week.  Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago.   We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted.   And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwhacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.

In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case.   Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.

Continue Reading Opt-out Out of Court: Northern District of West Virginia Dispatches Lexapro Warnings Case

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

Having to report on a negative InFuse decision happens about as often as meteorologists correctly predict snowstorms.  Boy did they get it wrong for New Jersey and Pennsylvania this week.  Talk about deflated snowfall expectations.  Speaking personally for a minute, this non-skiing, non-snowboarding, warm-weather-loving blogger was not disappointed at this turn of events. And, we actually feel a little sorry for weather forecasters whose sole job it is to predict the often unpredictable, but who are held to exacting standards.  Next time a blizzard is predicted, people will mock the forecast, go to work, get stuck in ten inches of snow, slip and slide the whole way home, and then complain that the warning wasn’t strong enough.  Meteorologists really can’t win.

Defendants in the InFuse litigation, however, usually do. But like meteorologists who occasionally hit it right on, sometimes an InFuse judge gets it wrong.  When that judge is confined by having to apply Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010), the result isn’t completely shocking. Disappointing, but not shocking.

The basic allegations in Garross v. Medtronic, Inc., 2015 U.S. Dist LEXIS 6675 (E.D. Wis. Jan. 21, 2015) are like those in all of the other InFuse cases.  The InFuse bone fusion system is a Class III, pre-market approved medical device.  As such, plaintiff’s claims should only survive if they can squeeze through the “narrow gap” left after application of express and implied preemption.  Notably, the Garross court called it only “a gap,” id. at *7, suggesting a more spacious opening then we believe is supported by the case law.

Continue Reading Deflated PMA Preemption: Off-label Promotion and Failure to Report Keep InFuse Case Alive

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Any time you find yourself drawing an analogy to asbestos lawsuits, you know you’re in trouble.   We have too often heard plaintiff lawyers or, worse, judges advocate for borrowing procedures from asbestos litigation.  Almost always those procedures would make it easier for plaintiffs to ‘prove’ little things like product identification, and would abridge defendants’ rights to seek certain discovery or file motions.  If the symbol for the legal system is a scale, the symbol for the asbestos docket should be a meat-grinder.  We had the experience earlier in our career of representing a tertiary asbestos defendant that really and truly had nothing to do with any harm inflicted on any asbestos plaintiff.  It should never have been sued.  But after the actual asbestos manufacturers went bankrupt, enterprising plaintiff lawyers sued any and every entity in sight so as to keep the asbestos gravy train rolling.  Instead of winding down to extinction or at least to something with narrowly circumscribed limits, asbestos litigation entered second and third waves of opportunistic litigation. It is like what Hannah Arendt said about totalitarian regimes, how they constantly need to find new enemies and scapegoats.  Asbestos litigation became a bizarre, parallel legal system, more characterized by (bad) social engineering than coherent rules and procedures.  Our encounter with the asbestos maw was relatively brief.  We represented a company that made components for automobile brakes.  Mind you, the company did not use or touch asbestos at all.  After the products entirely left our clients’ hands, somebody else would add the asbestos.  When we pointed out that fact to the plaintiff lawyers, they still insisted that we must pay a nuisance exit fee.  When we sought to file a motion with the court, we were advised that the asbestos docket permitted no such motions until the eve of trial.   Good system, huh?

We do not know a whole lot of the facts behind the New England Compounding Pharmacy MDL, but the first opinion we have seen from it (there will doubtless be many more) gave us an ugly asbestos flashback.  The MDL stems from allegations that the New England Compounding Center (NECC) produced a contaminated medicine that caused people to suffer from fungal meningitis.  NECC recalled the medicine.  It then surrendered its pharmacy license, ceased production of all medical products, and filed for bankruptcy.  The plaintiffs steering committee filed actions against NECC, naturally enough, and also filed actions against affiliated entities and individuals.  The plaintiffs also filed complaints against not-so-affiliated entities and persons, including hospitals, clinics, and doctors.  This is where we started thinking about asbestos cases.  If there must be a remedy for every wrong, does that mean the remedy can be collected from someone who did nothing wrong?   The NECC opinion we are looking at today, In re New England Compounding Pharmacy, Inc. Products Liability Litigation, MDL No. 13-02419-RWZ (D. Mass. Jan. 13, 2015), provides an interesting snapshot.  This particular opinion relates to actions where plaintiffs alleged that Illinois medical providers played a role in administering the contaminated NECC medicine, thereby causing injuries.  The claims were for medical negligence, violation of the Illinois Consumer Fraud and Deceptive Business Practices Act, failure to warn, strict product liability, and punitive damages.  

The good news for the defendants was that the court dismissed the strict liability claim, because that theory could apply only if the defendants were predominantly providing a product rather than a service.  The court, quite sensibly, concluded that the medical providers were predominantly providing a service rather than a product.  But the rest of the opinion was bad news for the defendants.  The defendants made an argument that rings true to our admittedly biased ears: that physicians have no duty to regulate pharmacies and drug manufacturers.  But the court concluded that the master complaint passed muster because it alleged that the defendants had a duty to exercise reasonable care to ensure that the drugs they administered  to patients were procured from drug companies that complied with pharmaceutical laws, made safe and effective drugs, and utilized proper quality control, safety, and sterility measures.  Wow.  The plaintiffs also alleged that physicians must take care that the drugs administered were not contaminated, and must inform plaintiffs of the sources of drugs (especially if there was “an unaccredited, mass producing, out of state, compounding pharmacy, unregulated by the FDA … and the dangers associated therewith”).  That is a fairly breathtaking litany of duties for doctors.  The complaint also alleged that the defendants “deceptively concealed” information about the source of the medicine and failed to inform patients that they were being administered “an unsafe, unreasonably dangerous drug compounded by NECC.”    Those allegations were deemed enough to make out claims for negligence, consumer fraud, and failure to warn.  Moreover, because the complaint said that the defendants went beyond mere inadvertence and, instead, demonstrated such utter disregard for the rights of others as to amount to “complete neglect for the safety of patients,” and that the defendants “willfully and knowingly failed to abide by consumer safety regulations and withheld important safety information from patients,” the claims for punitive damages could go forward.

The court did cite TwIqbal, but certainly did not appear to apply the standard with any rigor.  As a result, the plaintiffs have gotten away with very vague, very broad allegations that rip large holes in the duty envelope.  It will be interesting to see what sort of proof the plaintiffs have that the doctors actually knew what was going on at the compounder.  Are these defendants now on the hook because they really were negligent, or merely because they were next?

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This past week you probably heard the low monotone sound that emanates from Patriot head coach Bill Belichick’s mouth whenever he’s explaining deflate-gate and trying to muster up the energy to drool out words that ultimately reveal only that he’s not interested in saying them. His barely operating mouth doesn’t tell you what his eyes so clearly communicate: “This is stupid.  It was a blowout.  It’s stupid, stupid, stupid.  Really stupid.”  His eyes make a better point than his mouth.  It was a blowout and was always going to be.

The same is true of Becker v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 6853 (D.N.J. Jan. 20, 2015).  Like most blowouts, you knew it early on.  Before the court even began analyzing the defendant’s motion to dismiss, it said this, which we describe as foreshadowing with a mallet:

Plaintiffs did not timely respond to the motion.  On December 3, 2014, after their response to the motion was due, Plaintiffs mailed the Court a short letter asking the Court to deny the motion.  Citing no case or other authority, the letter attached what it alleged were medical records of Deborah Becker and an earlier letter from Plaintiffs’ counsel to Defendant’s counsel describing those records.  Plaintiffs later filed the letter and attachments on ECF.

Id. at *3.  Uh-oh.  This was a mismatch from the start.  On one side, we have no cases, no authority, an almost fact-less complaint, and a letter to the opponent that attaches some medical records that was later filed with the court in lieu of a brief, amended complaint or something legal sounding like that.  On the other side, we have TwIqbal and New Jersey product liability law.  If you deflated defendant’s brief by removing half the authorities, you’d still get a blowout.

Continue Reading Deflate-Gate Wasn’t the Only Blowout Last Week

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Following the completion of its overhaul of Rules 26(b)(1) and 37(e) (see our most recent post here), the federal Advisory Committee on Civil Rules is set to take up Fed. R. Civ. P. 23, concerning class actions.  Sadly, our preferred outcome abolishing Rule 23 altogether and allowing Congress and state legislatures to determine the availability of class actions on a subject-by-subject basis – is not on the table. One thing that is on the agenda (in addition to cy pres, which we’ve discussed a lot lately) is ascertainability.

Ascertainability is the subject of this post.

“Ascertainability” is the radical proposition that the definition of the class in a class action ought actually to specify who is in the class. After all, no individual action would be allowed to proceed without the defendant knowing who was suing s/he/it. First, Rule 23 is not supposed to change substantive legal requirements.  Second, the federal rules do not (except in rare cases involving threats or humiliation) allow John Doe pleadings.  Third, any certification order “must define the class.”  Fed. R. Civ. P. 23(c)(1)(B).  A class action has no business being certified if nobody can tell who will be bound by a judgment or who the defendant will have to pay.

Unfortunately, all too many class action plaintiffs fail to follow this seemingly simple principle, and sue on behalf of classes similar to “everybody who was uncomfortable while riding the Broad Street Line during” some particular time.  Particularly where the claim purports to seek damages, that’s ridiculous.  How can membership be proven, other than by each would-be class member’s bald, ipse dixit say-so?  This combination of need for individualized proof of class membership and lack of any conceivable kind of documentary proof comes up all the time.

And gets shot down most of the time.  Hence, the “implicit” ascertainability requirement under Rule 23.

Continue Reading Putting Ascertainability into Rule 23

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It’s difficult to draw concrete conclusions in the world of homeopathic drugs.  It seems that we don’t know exactly what they are, why they work or whether they even do work.  We’re not exactly sure why we take them, but our friend at the yoga studio said they worked and so did Dr. Oz.  So we take them, hoping that they’re more fix than fairy dust.

In the preemption and FDA world, it’s even more difficult to draw concrete conclusions when homeopathic drugs are involved.  The FDA recognizes these drugs and has in fact devoted a section of its Compliance Policy Guide (“CPG”) to them.  CPG § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed.”  But after reading it, it’s not entirely clear how much the FDA is regulating these drugs. For OTC homeopathic drugs, it’s even less clear.  For the most part, these drugs must comply with labeling requirements, meaning that their labels must include directions for use, ingredients, the dilution and the indication.  Id.; see also 21 C.F.R. §§ 201.5, 201.10, 201.61, 201.62.  Depending on certain particulars, homeopathic drugs must also be recognized by and comply with requirements of the Homeopathic Pharmacopeia of the United States, the United States Pharmacopeia, or the National Formulary.  But none of that means that the drugs will perform as indicated or are not misbranded. CPG § 400.400.

Given this almost half-hearted regulation, it’s not all that surprising that certain courts see a way around preemption when it comes to state-law claims against homeopathic drugs.  In Forcellati v. Hyland’s, Inc., 2015 U.S. Dist. LEXIS 3867 (C.D. Cal Jan. 12, 2015), a putative class sued the manufacturer of homeopathic cold medicines, seeking financial damages under the usual trio of claims based on the California Legal Remedies Act, False Advertising Law and Unfair Competition Law, as well as warranty claims and a claim for violation of the Magnusson-Moss Act.  The FDCA has an express preemption clause for OTC homeopathic drugs that applies if the claims touch upon the same subject matter as FDA regulations and seek to impose a requirement that is “different from or in addition to, or that is otherwise not identical with” FDA regulations.  21 U.SC. §379r(d)(1).  It’s similar to the FDCA preemption clause that applies to medical devices.  While there is an exception to preemption for product liability claims, that preemption exception doesn’t apply to claims like these seeking only financial damages.

Continue Reading Homeopathic Drugs – Eh, We Don’t Know

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We normally prefer to trumpet birthday wishes rather than deathday anniversaries. But the guillotining of King Louis XVI was such a huge moment in Western history, not just French history, that we cannot let the event of January 21, 1793, go unremarked.  It is only a series of tiny conceptual steps to go from the French Revolution to nationalism, to total war, to the Napoleonic Code, to the metric system, and then to a weird overestimation of the films of Jerry Lewis.

Today is also National Hug Day in the United States.  Surely, Louis and Marie Antoinette could have used a hug as they rode toward the Place de la Revolution, which is now called the Place de la Concorde.  (In the Star Trek universe, the President of the United Federation of Planets is officed in the Place de la Concorde.  What other legal blog supplies that sort of crucial context?)   If we were discussing an especially lousy case today, we might say that we could use a hug, too.  But that turns out not to be necessary, because we are today reporting on a perfectly sensible case that rejected the Conte infamy.  It comes from the land of magnolias and Faulkner, of Robert Johnson and the International Ballet Competition, of Blind Melon and Viking Ranges. It comes from Mississippi.

The case is Truddle v. Wyeth,LLC, 2015 U.S. Dist. Lexis 4563 (N.D. Miss. Jan. 12, 2015).  Being long-time blues lovers, we cannot resist mentioning that the Truddle case resided in the Delta Division of N.D. Mississippi.  None of the courts in our burg has a title nearly so colorful.  (We could see Philly courts conducting proceedings in a Schuylkill Division, Hoagie Division, Mummers Division, and, in honor of the Sixers basketball team, Tankers Division.) Truddle was a pro se case and, as with so many of the cases we discuss, it arose from very sad circumstances.  A young man suffering from gastritis and related conditions was prescribed Reglan/metoclopramide.  He subsequently committed suicide.  That is not the typical injury alleged in Reglan/metoclopramide cases.  His relatives sued both the manufacturers of brand name Reglan as well as the manufacturers of generic metoclopramide.  Earlier in the proceedings, the court had dismissed the claims against the generic manufacturers based on Mensing preemption. Then the brand name manufacturers moved for summary judgment on the ground that there was no evidence that the decedent had ever taken brand name Reglan.  Thus we have the ‘one-two punch’ we have written about several times before, including here and here and here, among others.  The Truddle court followed the analysis of almost every other court in deciding that a brand name manufacturer cannot be held liable for injuries suffered by someone who never ingested the brand name product.  Put another way, the Truddle court rejected the Conte craziness that came out of California and that has been rejected by every right-thinking court (though, sadly, incoherently, maddeningly, it has been embraced by Mississippi’s neighbor to the immediate east).

Continue Reading One Mississippi, Two Mississippi: Dismissal of Claims against Brand Name Reglan and Generic Metoclopramide Manufacturers

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Way back in 2007 we said this:  “We really don’t see the purpose in a separate cause of action for breach of implied warranty in a case involving a prescription medical product. Warranty claims are for ham sandwiches and lawn chairs, where the term “merchantable” has some coherent meaning. . . . Except in unusual situations, where there’s physical contamination or a counterfeit product, an implied warranty of merchantability makes no sense and adds nothing except a different statute of limitations.”  We still feel the same way.  Fortunately, so do a lot of courts.

In some states breach of implied warranty claims have been merged with other warning-based theories of liability (like in New Jersey where all products claims other than breach of express warranty have been subsumed under the Products Liability Act).  In states where a breach of implied warranty claim remains as an independent cause of action, some courts have ruled that such claims are not allowed in the context of prescription drugs and devices.  The reasons vary but most often include application of the learned intermediary doctrine (see post here) or the unavoidably unsafe product doctrine.

And while at a quick glance, Alabama appears to be one of the states that generally doesn’t recognize a cause of action for breach of implied warranty of merchantability for inherently dangerous products – the law on the issue has become muddled over time.  So, in Collins v. Novartis Pharma. Corp., slip op., No. 2:08-cv-438-MHT-PWG (M.D. Ala. Jan. 14, 2015), the court tried to sort it all out.

Continue Reading Risks Don’t Make Drugs Un-Merchantable in Alabama

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This is a guest post prepared by Rachel Weil of Reed Smith, who has graced us with guest posts before and, we hope, will do so again.  This post concerns the latest of several recent appellate decisions that have imposed limits on the questionable practice of cy pres distributions in class action settlements.  As always, Rachel deserves all the credit, and whatever blame accrues from her post.

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Readers of this blog are familiar with our antipathy toward the remedy – or non-remedy – known as cy pres. If not, recollections can be refreshed here.  “Cy pres” is a French term that roughly translates to “next best” or “as near as possible.”  When class counsel can’t or won’t identify all class members to whom damages are owed, cy pres purports to allow the court to award remaining settlement funds to third parties – usually charities.  These funds are commonly included in the “lodestar” used in the calculation of class counsel’s fee.  “Next best” means, in theory, that non-class member recipients of settlement funds have some logical nexus to the litigation.  In practice, nothing in Rule 23 governs cy pres distributions and there is no institutional mechanism for vetting proposed recipients or ferreting out conflicts of interest.  As a result, class counsel and judges have been known to steer cy pres funds to charities they support or that provide benefits to them (or bestow honors on them), notwithstanding the charities’ lack of any relationship to the settled litigation.

In recent years, real pundits – actual judges − have chimed in to question cy pres awards and related practices.  See Marek v. Lane , 134 S. Ct. 8 (2013) (Justice Roberts, in a concurrence in a denial of certiorari, commenting that a differently-postured petition might have afforded the Court the opportunity to address “fundamental concerns” about the use of cy pres remedies in class action litigation); Holtzman v. Turza, 728 F.3d 682 (7th Cir. 2013) (Judge Easterbrook rejecting trial judge’s unilateral decision to seize residue of a settlement and award it to Legal Aid as “cy pres”); Cf Redman v. Radio Shack, 768 F.3d 622 (7th Cir. 2014) (non-“cy pres” decision condemning inflation of denominator used in calculation of attorneys’ fees by including funds not actually received by class members) (Judge Posner, this time).

Continue Reading Guest Post – Sayonara, Cy Pres

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