The beast part may be a bit of an exaggeration, but it serves the purpose of depicting what at least on the surface are two very opposite things. But if you delve more deeply, you find a lot of similarities. So many similarities that the two things shouldn’t really be opposites at all. That’s what happens in the fairy tale. The beast is really a prince. But life’s not a fairy tale. And neither is pharmaceutical litigation. And if it were, it wouldn’t be a Disney version, it would be one of those original Grimm Brothers’ stories – the dark and twisty ones. And that’s what we have today. Two cases that come to opposite conclusions but based on the same allegations about the same failure to warn about the same drug. We should be talking about a beauty and a prince. Instead we have a beauty and a beast . . . or at least maybe a frog.

Within two days of each other, two decisions were handed down in cases involving the generic prescription drug amiodarone manufactured by the same company – Hernandez v. Sandoz Inc.,  2017 U.S. Dist. LEXIS 120938 (N.D. Ill. Aug 1, 2017) and Tutwiler v. Sandoz Inc., 2017 WL 3315381 (N.D. Ala. Aug. 3, 2017). Both were second bites of the apple. In Hernandez, defendants moved for reconsideration of the court’s prior ruling rejecting preemption and allowing a failure to warn claim premised on defendants’ failure to provide medication guides per federal regulations. We blogged about that earlier decision here. In Tutwiler, the court had previously dismissed that same claim but plaintiff included it in her amended complaint. Defendants moved to dismiss again. Both courts stuck to their prior decisions.

Our prior post on Hernandez explains how we think the court got preemption wrong – notably by applying the Seventh Circuit’s awful PMA, medical device express preemption decision in Bausch v. Stryker to a pharmaceutical drug case and finding a parallel violation claim. On reconsideration, defendants argued that the court misapplied Bausch. In response, the court cited other district courts within the Seventh Circuit to also have applied Bausch to pharmaceutical cases, including another amiodarone case that we blogged about here. Hernandez, at *5-7. The old adage two wrongs don’t make a right comes to mind.

Unable to make the court see that this is really an implied preemption case – plaintiff was seeking to enforce an FDCA requirement regarding distribution of medication guides – defendants were left to argue that the claim isn’t really parallel to a state law duty to warn. There is no Illinois state law duty to warn pharmacists so they can in turn warn consumers. In fact, in prescription drug cases, the manufacturer’s duty is to warn the prescribing physician – not the consumer. Id. at *9n.4. From the court’s description of plaintiff’s allegations, plaintiff alleges both traditional failure to warn the prescriber and failure to warn the consumer by failing to provide medication guides. Id. at *9. The court then seems to conflate all those allegations into one plausible failure to warn claim. See id. (“The court remains convinced that plaintiff has sufficiently alleged each of the elements necessary to establish a failure to warn claim under Illinois law despite focusing much of his complaint on his allegations that defendant’s actions violated the FDCA.”). By alleging both failure to comply with the FDCA and failure to warn the prescriber plaintiff got to dodge both preemption and learned intermediary. But those are two separate claims and they should both fail.

And that’s how you turn the beast/frog into a prince. You apply both preemption and learned intermediary like in Tutwiler. First, in this case the court already dismissed plaintiff’s traditional failure to warn claim – the failure to warn plaintiff’s prescriber – under Mensing. These are after all generic prescription drugs and the Supreme Court has said they don’t survive conflict preemption. Which is presumably why plaintiffs in these cases are focused on the medication guide allegation. In Tutwiler, plaintiffs argued that failure to provide the medication violated the “duty of sameness” on which Mensing rests making Mensing inapplicable. Id. at *2. As we noted above, failure to warn based on failing to adhere to an FDCA requirement should also be impliedly preempted under Buckman or the prohibition of private causes of action to enforce the FDCA.

But the Tutwiler court said it didn’t need to consider preemption because the claim is barred by the learned intermediary doctrine. In Alabama, like in Illinois, in a prescription drug the case the duty to warn runs to the physician. Id.

[I]t does not follow . . . that if the manufacturer inadequately warns the physician, it owes an independent duty to warn the patient directly. This is the reason why this Court previously stated that “it appears unlikely that Plaintiff can state a failure-to-warn claim based on Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the application of both the learned-intermediary doctrine and Mensing.”

Id. And there’s the beauty.

There is one thing that both Hernandez and Tutwiler agree on – plaintiffs’ off-label promotion claims are fraud claims that must be pleaded to the heightened standard required by Federal Rule of Civil Procedure 9(b). Both plaintiffs tried to argue that these were negligent marketing claims. Hernandez, at *3; Tutwiler, at *2. But both courts were unpersuaded by those labels given the context of the allegations. Hernandez, at *4 (“Plaintiff’s complaint is a sprawling and, at times, confusing collection of largely unnecessary allegations that, for the most part, seem to attempt to assert a fraudulent misrepresentation claim as it relates to off-label promotion.”; Tutwiler, at *2 (Plaintiff “claims that Defendant engaged in a ‘concerted and systemic effort to persuade physicians’ . . . that the drug was safe and efficacious for off-label uses). Plaintiff Hernandez is getting another chance to re-plead his fraud claims with specificity. Since this was Plaintiff Tutwiler’s second attempt, and her complaint still failed “to identify a single statement in any promotional material to support [Plaintiff’s] contention that Defendant unlawfully promoted amiodarone for [an off-label use],” her claim is dismissed.

They say beauty is fleeting – and so too is a beautiful case. The beast/frog on the other hand lives to see another day.

As the calendar turns from August to September, it is time once again to concede the strength of the Southeastern Conference.  You probably think we are referring to college football or basketball, in which teams from Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, Missouri, South Carolina, Tennessee, and Texas prevail with grinding monotony.  [We have a feeling that OJ’s old college squad, USC, will have an ugly time of it against Alabama in the ostensibly neutral site of Jerry World this weekend.]  But, no, we are talking about product liability law.  [For the moment, we are pretending that the Weeks innovator liability abomination in Alabama never happened.  Moreover, the Alabama legislature eventually cleaned up that mess.]  Today we are focusing on the safer alternative requirement in design defect cases.  It occurs to us that some very good cases on this issue come out of the SEC.  In the beginning of the year, we discussed a Mississippi case, Mealer v. 3M, where the court dismissed a case on the ground that an elastomeric respirator was not a safer alternative to a cheap paper respirator mask.  They were two entirely different products, fundamentally different in terms of operation, longevity, and expense.   Consumers might have all sorts of important reasons, aside from safety, to choose one over the other.

[Readers who are especially nerdy or possess especially good memories might point out that in July we bemoaned a Louisiana opinion permitting a plaintiff to suggest that other drugs could constitute a safer alternative to the drug at issue.  To our mind, different drugs, which consist of different molecules with entirely different risk-benefit profiles, are separate products and cannot be treated as a safer alternative that can shame other drugs out of existence.  Under the plaintiff’s (and, unfortunately, the Louisiana court’s) theory, jury verdicts might drive all drugs that treat, say, diabetes, out of the market except one.  And even that one would not be safe from attack.  Or, to veer away from drugs and devices, we might as well shut down Harley-Davidson, since motorcycles are less safe than other modes of motorized transportation.   Live to ride, ride to live?  Not anymore.  But don’t worry too much.  You can still sing “Born to be Wild” on your Hydra Glide.  The recent Louisiana error stands as an aberration.  As Bexis pointed out in a magnum opus blogpost that strolled down bone screw memory lane back in 2013, Louisiana has quite a lot of good safer alternative decisions.]

Today’s case, Hosford v. BRK Brands, Inc., 2016 Ala. LEXIS 91 (Ala. August 19, 2016), sees the Alabama Supreme Court apply an even stricter test in pouring out a plaintiffs’ case on the ground that the proposed safer alternative was a separate product altogether.  The facts of Hosford are grim.  A four-year-old girl died in a fire that destroyed her family’s mobile home in May 2011.  The fire began in a faulty electrical outlet in the girl’s bedroom.  Her family sued the manufacturer of the smoke alarms in their mobile home.  The theory was that the smoke alarms were defectively designed because they relied solely on ionization technology which, the plaintiffs alleged, failed to give adequate warning to allow an escape in the event of a slow smoldering fire.  There are dual sensor smoke alarms on the market that employ both ionization and photoelectric technology.  According to the plaintiffs, such alarms would have roused the family in time to save the little girl.  After the plaintiffs presented their case at trial, the defendant moved for judgment as a matter of law.  The trial court mostly granted that motion, and only one claim went to the jury.  The jury ultimately returned a verdict in favor of the defendant.

Continue Reading Alabama Supreme Court Imposes Tough Standard on Safer Alternative Design

Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and superseded), and Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (en banc)—which kept alive a version of the innovator liability that had been rejected almost everywhere else.  The Alabama Supreme Court—in 2013 and again in 2014—deviated from the well-established principle of product liability that liability for an injury allegedly produced by a particular product may run to the manufacturer of that product but not to the manufacturer of some other product that did not allegedly injure the plaintiff.  Recognizing the weakness of Weeks, in 2015, the Alabama legislature re-affirmed the need for any product liability plaintiff to prove an injury from the defendant’s product, not just “a similar or equivalent product.”  Because Alabama’s law is not retroactive, there is a gap for plaintiffs in pending cases to try to impose liability on manufacturers of drugs they did not take.

Before we knew the days of Weeks were numbered, we highlighted how the Northern District of Alabama had distinguished the Weeks theory that “a brand-name-drug company may be held liable for fraud or misrepresentation . . . based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company” from the plaintiff’s theory that the innovator should be liable for “failing to ensure that [plaintiff] received the Medication Guide,” which plaintiff conceded provided adequate information on risks and indications for the drug.  Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073. *12 (N.D. Ala. Jan. 14, 2015).  Without support from Weeks, no putative breach of a duty by the innovator could give rise to liability.  Id. at *13.  We characterized the holding in another case from the same district, Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014), as “If Weeks does not allow innovators to be tagged for [run-of-the-mill product liability] claims, absent fraud allegations that will need to be pleaded in detail and eventually supported by lots of evidence, then the effect of Weeks may end up being pretty narrow.”

Continue Reading The Elephant in the Room in Alabama

That didn’t take long.  Yesterday the Alabama House of Representatives passed SB-80, which abolishes the innovator liability theory created in the execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014 (discussed here and here, and named #1 worst decision of 2014 here).  Here is a copy of the enrolled bill.  The online legislative history indicates that SB-80 passed the Alabama Senate 32-0 and the House 86-14.

The relevant statutory language, imposing a product identification requirement in all cases seeking damages caused by a product, states:

Section 1. In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product.  Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury.  A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.

Continue Reading Alabama Legislature Abolishes Weeks Innovator Liability Theory

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

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

The Alabama Supreme Court redecided Weeks v. Wyeth, Inc., No. 1101397, slip op. (Ala. Aug. 15, 2014), today.  It’s not all that much different than the original “Weeks Reasoning” decision that we excoriated here.  In fact, the first 54 pages of Weeks II (out of a “pithy” 145 pages, one observer noted) are almost verbatim identical to Weeks I.  So we simply reiterate here everything we said in our original post about what we’ll now call “Weeks I.”  Weeks II made only the following changes to Weeks I:

  • Changing “Wyeth Defendants” to “Wyeth” (causing a lot of spacing differences).
  • Adding footnote 2, trying to deny the magnitude of what the court has done – claiming not to “plow new ground.”  Positively Freudian, that.  This footnote would sound less defensive if it could cite some prior Alabama case doing even remotely the same thing.  It doesn’t, because no such opinion exists.
  • Spending a couple of pages distinguishing Pfizer, Inc. v. Farsian, 682 So. 2d 405 (Ala. 1996), a case in which it had equated fraud and product liability claims, essentially because, Farsian involved cognizable injury and Weeks involves, not a “defect,” but “what [defendant] said or did not say about [the drug].”  Weeks II, at 12.  Funny, that’s one spot on way of describing what’s otherwise known as a “warning defect.”
  • New footnote 6 admitting – contrary to new footnote 2 – that “this is the first time the highest court of a state has addressed the issue.”  Except they then admit that’s not so either, because of Huck v. Wyeth, Inc., ___ N.W.2d ___, 2014 WL 3377071 (Iowa July 11, 2014).  In an exhibition of sheer profundity, Weeks II distinguishes Huck because “Iowa law differs from Alabama law” in precisely the way they are changing Alabama law to become.
  • A non-substantive new paragraph break (the opinion could use a lot more) on page 46.

Continue Reading Breaking News: Weeks II – Lipstick (and Not All That Much) on a Pig

We do not hide the fact that we like the TwIqbal twins, Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009). Dismissals, even with leave to amend, are nice, but there is something more fundamental about requiring that pleadings provide meaningful information to the opposing party and the court about what the case is about.  As product liability defense lawyers, we tend to focus on how the difference between an uninformative boilerplate complaint and a complaint that spells out the pertinent facts and claims matters to the defendant.

We and our clients find it easier to do things like answer, move to dismiss, and map out a strategy for the case when the complaint includes information like the product at issue, when it was used, what injury it allegedly caused, where and when that injury happened, and what acts or omissions allegedly create liability.  If the complaint labels the causes of action being asserted, says what jurisdiction’s law is supposed to be implicated,and/or matches up the acts and omissions to the particular causes of actions, well, then that is just a bonus in our experience.

Not only do we use complaints to categorize cases by products, injuries, time of use in relation to events like label changes, lag from injury to filing, etc., but we have somewhere in our mind that at some point in the future we will be filing something with the court that includes a sentence like “plaintiff asserts causes of action for a, b, and c”and asks for something.  It is helpful at that point, whether it be on a motion to dismiss not based on TwIqbal, a summary judgment motion, proposed jury instructions, or something else, to not have to argue about the plaintiff has asserted something different than the a, b, and c we listed.  It is certainly helpful throughout the course of discovery, motions practice, and pretrial proceedings to have in mind the right a, b, and c so you are not wasting your efforts on α, β, and γ if א, ב, and ג are being asserted. Continue Reading Inherent TwIqbal Authority

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

The Alabama Supreme Court’s horrendous, but so far outlier, opinion in Weeks v. Wyeth (we discussed it here) will be reconsidered by that court sometime in September, according to a minute order issued on June 13.  Innovator liability is a novel theory that turns the traditional justification for product liability – that a manufacturer should be responsible for injuries caused by defects in its product – on its head.  Instead innovator manufacturers would be liable for their competitors’ generic products.  In the drug context it would also portent making the 30% of the market made up of new, innovative products bear the burden of injuries suffered by the 70% of the market represented by generic products.  For that reason, if widely adopted (which thankfully it is not) it would inevitably make the prices of innovator drugs skyrocket.  This theory hardly existed at all until the Mensing generic preemption decision made recovery against actual manufacturers problematic, so it’s emergence(?) has nothing to do with the proper workings of state law and everything to do with a desperate search for a deep pocket, no matter how bizarre the logic, in generic drug cases.

In Weeks the Alabama Supreme Court had acted precipitously, without oral argument discussing the above policy issues.  Fortunately, it seems to have realized that there is more to this theory than liability uber alles.

This post is by the Reed Smith part of the blog only.  The Decherts are too involved in this litigation to comment publicly.

There aren’t many research-oriented pharmaceutical companies based in Alabama, and after last week’s execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2013 WL 135753, slip op. (Ala. Jan. 11, 2013), that’s not likely to change any time soon.  We don’t know why that started; Huntsville, at least, has a distinguished scientific background (and there’s a statue of a Vulcan in Birmingham – wait a minute, the ears don’t match Spock’s), but it’s certainly true now.  Unfortunately it appears that, instead of (or perhaps in addition to, given the recent election results) the Ten Commandments, there’s another commandment that the Alabama Supreme Court is following:  Thou Shalt (if you’re an Alabamian) Recover From An Out-Of-State Drug Company.

While the Alabama Supreme Court certainly has the power to abandon the notion of manufacturer liability for defects in its products (unlike a federal court sitting in diversity), having the power to do something doesn’t make it right.  And if there’s one thing that’s not right, it’s having the liability of a defendant non-manufacturer turn on what its competitors did (or didn’t do).  And if there’s another thing that’s not right, it’s imposing liability on a product manufacturer that didn’t make a cent (and probably was driven out of the market by) from the product that actually caused the injury in question.

Nor is it very likely that this novel theory of “fraud/misrepresentation” liability can be limited to prescription drugs, whatever its intended scope.  There are lots of situations in which products bear similar warnings.

Sometimes, as with prescription drugs, such similarity is mandated by the government (cars, for example, or chemicals); sometimes similarity is simply a function of similar products having similar risks, and thus requiring similar warnings.  One such example could be asbestos.  There were lots of different asbestos products, and the same kinds of asbestos products do (or, at least, plaintiffs allege they do) have similar risks.  We have to think that asbestos plaintiffs are going to have a field day with Weeks – more, perhaps, than even generic plaintiffs, since the learned intermediary rule still applies to prescription drug cases.

Anyway, we could go through each of these policy considerations at length, but we’re not going to.  We already did that in connection with the original decision in Conte v. Wyeth, 168 Cal. App. 4th 89 (Cal. Ct. App. 2008).  So we’ll rely on our discussions there:

First, this kind of liability is contrary to the fundamental legal tenet that manufacturers’ are supposed to be liable because they made money putting the injurious product on the market:

Well, [branded liability] is an end run around the heart of modern product liability, which was created . . . some fifty years ago.  [Courts] recognized a core principle of social responsibility that justified what was then a new form of liability:  The purpose of this [product] liability is to ensure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market.  In other words, because manufacturers profit from the sale of their products, it is appropriate for them to answer for injuries caused by defects in those products.  Time after time, . . . liability for injuries caused by allegedly defective products has been justified by reference to this paramount policy.

DDLaw, Closing The Arguments On Conte (1/22/2009) (citations and quotation marks omitted).

Continue Reading Weeks Reasoning – No Sweet Home In Alabama For Research Pharma