November 2014

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There is no express federal preemption for drugs, right?

Wrong!  Today we expound on a flavor of preemption that we don’t often get around to—express preemption for claims related to non-prescription, over-the-counter drugs.  Under section 379r of the FDCA, no state may establish any requirement that relates to a non-prescription drug and “that is different from or in addition to, or that is otherwise not identical with” a federal requirement.  28 U.S.C. § 379r(a).  The “different from or in addition to” language rings familiar from medical device express preemption that we write on multiple times each month (such as here), and as if that were not clear enough, Congress drove the point home with the “otherwise not identical with” language.

So there you have it.  Express preemption in connection with drugs, albeit not the prescription drugs that usually occupy us, and not without significant exceptions.  The FDA can grant exemptions to the preemption rule under certain circumstances, and the provision does not preempt (1) state regulation of pharmacies or (2) any state requirement that a drug be dispensed only upon by an authorized prescription.  Id. § 379r(b), (c).  The really big exception is that the provision does not preempt product liability claims, Id. § 379r(e), so if we’re faced with claims alleging personal injury attributed to use of an allegedly defective non-prescription drug, express preemption will probably not come into play.

But that does not mean that OTC express preemption does not have teeth.  In Bowling v. Johnson & Johnson, No. 14-cv-3727, 2014 U.S. Dist. LEXIS 155899 (S.D.N.Y. Nov. 4, 2014), the plaintiffs alleged that the label on a popular brand of mouthwash falsely claimed that use would “Restore Enamel.”  Id. at *2.  According to the plaintiffs, loss of tooth enamel is permanent, making it “physically impossible” to restore enamel.  Id.  Based on this allegation, the plaintiffs alleged violations of multiple state statutes (the order does not say which statutes, but we presume they were statutes of the consumer fraud type) and the federal Magnuson-Moss Warranty Act, which governs warranties on consumer products.  Id. at *1.Continue Reading Express Preemption OTC

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Courtesy of Mike Imbroscio of Covington (who was on the winning team) today’s post is about a very satisfying Cymbalta win – not only did warning causation fail under the learned intermediary rule, but the warning for the drug was held adequate as a matter of law.  The case is McDowell v. Eli Lilly & Co., ___ F. Supp.3d ___, 2014 WL 5801604 (S.D.N.Y. Nov. 7, 2014).  It involved injuries (such as “brain zaps,” whatever those might be) allegedly suffered by the plaintiff when she was weaned from the drug too quickly.

We’ll briefly touch on the causation part first.  Under New York’s learned intermediary rule, a prescriber’s “independent knowledge” of a supposedly unwarned-of risk breaks any causal connection between the warning’s inadequacy and the plaintiff’s injuries.  2014 WL 5801604, at *15.  The prescriber (a nurse practitioner – we think McDowell is the first nurse-as-learned-intermediary decision under New York law) “testified that, based on her clinical experience and training, she was aware of the risk of discontinuation symptoms with abrupt cessation of [drug] treatment.”  Id. (there’s a lot more than just that statement).  Because the alleged understatement of the risk wouldn’t have changed the prescribing decision, plaintiff lost.  Id. at *17-18.  Plaintiff’s attempt to mislead the prescriber at her deposition with statements about the drug that had no basis in fact couldn’t create a disputed issue of fact.  Id. at *18 (pointing out “the absence in the record of any support for the claim”).  We also like the causation standard employed in McDowell:

[U]nder New York’s proximate cause standard, a plaintiff must demonstrate that had a different, more accurate warning been given, his physician would not have prescribed the drug in the same manner.  Summary judgment is appropriate where a plaintiff fails to establish that a prescribing physician’s decision to prescribe a particular medication would have changed had a different warning been given

Id. at *16 (citations and quotation marks omitted).  We’ve discussed as some length recently the muddle in New York law concerning the heeding presumption, with some federal courts ignoring state-court precedent that there’s no such animal.  No such laxity appears in McDowell.Continue Reading Statistics Not Necessary For Adequacy as a Matter Of Law

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A week or so ago Grantland tv critic Andy Greenwald penned a “can we talk” letter to Sunday night, asking how it managed to fall so far from greatness.  Just last Spring we could plop down on our couch at the end of the weekend to watch Game of Thrones, Mad Men, Veep, and Silicon Valley. Even if some time-shifting was required, it was worth it.  Now with the departure of the criminally underrated Boardwalk Empire, Sunday evening has morphed into a drama wasteland.  (Sunday Night Football certainly has not supplied any drama.  Did you see the dumpster fire that calls itself the Chicago Bears?) The sheer craziness of Homeland has driven us away, with a lead character who calls in drone strikes as she boinks her way into fresh intel.  And then we get the competing stories of The Affair, a show that hasn’t attained Rashomon heights of greatness (“Look, the guy from The Wire and the girl from Luther are remembering different wallpaper designs!” “Why is the cop telling them completely different stories about his home life?”).

Let’s pour out some hooch in honor of Boardwalk Empire and remember its well-drawn characters, some of them plucked from the pages of history, and their poetic recitations of despair.  The show has one of those historical characters, the gambler/gangster Arnold Rothstein (some say he fixed the 1919 World Series), sharing this bit of wisdom:  “All of man’s troubles come from his inability to sit in a quiet room by himself.”  As we plunge toward dotage, that sentiment seems very true.  Ex-federal agent Van Alden (played by the great Michael Shannon, the same actor who declaimed the insane sorority letter) realized, on the doorstep of his personal doom, that “[w]e haven’t thought this through.”

We are feeling a bit of despair this week  after reading an opinion that we do not think was thought through.  Last week we identified some things we liked and some things we did not like so much in the Daubert rulings in the Drake case pending in Vermont federal court, where the plaintiff claimed injuries from Botox injections.   This week we will look at the summary judgment rulings in that same case.  We harbor no mixed feelings at all about the opinion;  it is a complete stinker. Drake v. Allergan, Inc., 2014 U.S. Dist. LEXIS 154979 (D. Vermont October 31, 2014).  The opinion was appropriately issued on Halloween.  It is scary bad.  It mucks up the learned intermediary rule, whilst pretending to steer clear of saying anything about it.

In one courtroom scene in Boardwalk Empire, a judge says this to a prosecutor:  “I sympathize with your desire to bring purpose to your life, however this courtroom is not the place to do it.”  That is a hard-headed judge.  We like that judge.

But now let’s go to Vermont.  In Drake, the plaintiffs brought an action on behalf of their son, J.D., alleging that he was injured after receiving an “overdose” Botox injection for treatment of lower-limb spasticity.  They brought claims of strict liability/failure to warn, negligence, and violations of the Vermont Consumer Fraud Act, all premised on an alleged failure to warn about proper dosages.  Here is an additional wrinkle in this Botox case:  because the FDA has not approved Botox as a treatment for pediatric spasticity, the administration at issue was off-label.  Off label or not, the treating doctor testified that Botox has been one of the standards of care for treating pediatric spasticity for over 20 years.Continue Reading Hard Cheese: D. Vermont Avoids/Dilutes Learned Intermediary Rule

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This just happened yesterday down in Texas.  The defendant in this 77-plaintiff action raised fraudulent joinder/misjoinder and lack of personal jurisdiction in removing the case. Locke v. Ethicon, C.A. No. 4:14-CV-2648, slip op. (S.D. Tex. Nov. 10, 2014).  The defendant won, as the out-of-state (and non-diverse) plaintiffs were dismissed due to lack of personal jurisdiction under Daimler AG v. Bauman, 134 S. Ct. 746 (2014).  No other remand-related grounds (such as fraudulent (mis)joinder) had to be reached.

Of even greater importance is the “how to” aspect of Locke.  Can a court determining a remand petition decide a question of personal jurisdiction (the Bauman issue) prior to a question of subject matter jurisdiction (fraudulent (mis)joinder)?  The Locke court said “yes,” relying on Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574, 586-87 (1999).  Slip op. at 3-4 & n.3.  That’s critical, because unless a court can reach the Bauman issue first, it would have to find some basis to dismiss the non-diverse plaintiffs under fraudulent (mis)joinder standards – and those standards are much more difficult to satisfy.  The Supreme Court, however, had resolved this issue in Ruhrgas.

[T]he Court notes that the two motions present the Court with a procedural dilemma.  If the Court addresses the question of subject matter jurisdiction first, then [one of the plaintiffs’] New Jersey citizenship destroys diversity, thereby justifying remand for the Texas state court to resolve the personal jurisdiction issue.  Alternatively, if the Court addresses the question of personal jurisdiction first and finds for the defendants, dismissal would simultaneously reduce the number of plaintiffs to one and permit the Court to retain jurisdiction over the case.  It is well settled that a district court has discretion to dispose of jurisdictional questions in a manner that promotes judicial economy.

Locke, slip op. at 3 (citing Ruhrgas and other cases following it).  This is the first time (we ran a search) that Ruhrgas has been invoked in a fraudulent (mis)joinder remand where the basis for fraudulent joinder is inability of nondiverse plaintiffs to obtain personal jurisdiction over the defendant under Bauman.Continue Reading Breaking News: Win On Post-Bauman Personal Jurisdiction Avoids Fraudulent (Mis)Joinder Pitfalls

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It has taken us a few weeks to get around to posting on the recent string of favorable Daubert decisions coming out of the Boston Scientific Pelvic Mesh MDL.  That’s mostly because they are very long.  Very long.  But procrastination hasn’t made the opinions get any shorter, so we decided to finally dive in.  A decision that discusses opinions offered by biomedical engineer, a surgeon, a pathologist, a chemist and polymer science engineer, a gynecologist, and two regulatory consultants is going to be heavy and detailed.  A lot of those details are of course specific to pelvic mesh.  And, while that is enormously helpful to other defendants in that litigation – for the rest of our readers, we thought we’d try to distill the decision down to some of the core rulings that are the most significant and we think generally helpful in going after plaintiffs’ experts.  So, if you want all the details, you can find the decisions at:  Sanchez v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 137189 (S.D. W.Va. Sep. 29, 2014); Tyree v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 148312 (S.D. W.Va. Oct. 17, 2014); and Eghnayhem v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 152457 (S.D. W.Va. Oct. 27, 2014).   Since the decisions have overwhelming similarities, this post discusses Sanchez only.

Plaintiffs Can’t Dump in Company Documents via their Experts:  We see this all the time.  Plaintiffs give their experts hundreds, if not thousands, of pages of internal company documents.  The type of documents the experts would never see, never utilize in their field of study, and certainly never rely on.  Then plaintiffs try to get all these documents in at trial via that expert who purportedly is going to testify about what the company knew or didn’t know, what the company should or shouldn’t have done, or simply how bad the company is.

Well, not this time.  Plaintiffs were not allowed to use their experts to “usurp the jury’s fact-finding function by allowing an expert to testify as to a party’s state of mind or on whether a party acted reasonably.”  Sanchez, 2014 U.S. Dist. LEXIS 137189 at *9. Topics like corporate conduct, knowledge and state of mind are not appropriate subjects of expert testimony. Furthermore, an expert’s report that is nothing more than a “narrative review of corporate documents . . . riddled with improper testimony regarding [defendant’s] state of mind and legal conclusions” should be excluded.  Id. at *81.  So, for instance, testimony that the manufacturer acted “inconsistent with appropriate medical device design principles” goes to state of mind and is inadmissible.  Id. at *25.Continue Reading Strong Rule 702 Rulings in Pelvic Mesh MDL

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There are times that you can tell that a witness at a deposition just isn’t committed to his or her answers.  They get long-winded, creeping toward the ultimate answer, circling it, poking it, testing it, before ultimately offering it and then cautiously backing away.  It’s the reddest of red flags.  And, if it comes from a causation expert, you could be on the verge of hobbling or ending the plaintiff’s case.  Here is just that type of testimony:

Q: So, Doctor, would you be willing to testify to a jury Nexium [sic] can cause fractures?

A: You know, it would depend on the question posed to me in front of a jury. I would be honest in my interpretation of the data.  It would [sic] not take it any more than it is or less than it is.

I don’t think—if this is a question asked before a jury, I’ll be honest with them.  I don’t think that looking at all of this data any reasonable physician or scientist or even a person of the lay public reading this can say there’s absolutely no relationship between Nexium use and risk of fracture, absolutely none.

The weight of the evidence suggests otherwise,that there is a relationship, a causal relationship, can be inferred because of a number of studies that seem to point the same way.  And the evolution of those studies and that’s what I would testify that, yes, it seems from the weight of the scientific evidence we have that the long-term use of Nexium seems to be related to the risk of fractures.

In re Nexium (Esomeprazole) Prods. Liab. Litig., 2014 WL 5313871, at *2 (C.D. Cal. Sep. 30, 2014).  That answer is from a real expert in the Nexium litigation.  It’s loaded with just the type of hedging you get from an uncomfortable and uncertain witness: “it depends”; “I’ll be honest”; and “it seems from the weight of the evidence.”  That testimony would never convince a jury.Continue Reading Anatomy of a Rule 702 Win

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One or more of its variants appears in the vast majority of expert reports and transcripts for expert testimony on medical causation:  “reasonable degree of medical/scientific certainty/probability.”  Sometimes, it is attached as a seeming exclamation point at the end of direct testimony of an expert at trial with an exchange like “Were all of your opinions here held to a reasonable degree of medical certainty?” and “Yes, they certainly were.”  What does “reasonable degree of medical certainty” mean?  Does it mean something different than “reasonable degree of medical probability”?  If “certainty” means 100% and “probable” means more than 50%, then why are the words “reasonable degree” included in these phrases?  We leave the surveys and exposition of research dating to the 1907 Esso v. Teric case to Bexis and will simply offer that most experts, lawyers, and judges use these phrases reflexively, without pondering their meaning.  Clearly, “reasonable degree of medical certainty” plays some role in distinguishing guesswork from something on which a jury can place weight when deciding cases.  These words also come from substantive law and operate independent of the familiar procedural requirements of things like Fed. R. Evid. 401-403 & 701-03 and Daubert.  Independence means that expert opinion on medical causation could pass the “certainty” requirement and still not be sufficiently probative and reliable to be admitted, which happens all the time.  The flip side is rarer, where expert testimony that passes Daubert
might still fail because it is not sufficiently certain for state law.

Rare defines the situation in Valido-Shade v. Wyeth LLC, MDL No. 1203, Civ. No. 12-20003 (E.D. Pa. Nov. 3, 2014), slip op., in a number of respects.  The case is part of the diet drug litigation, which is heading toward its third decade, a rarity among single target litigations.  The injury claimed is pulmonary arterial hypertension, which occurs rarely in the general population–at least actual PAH does.  The particular plaintiff claimed to have been diagnosed with PAH in 2010 after using the drugs in 1996 and 1997.  Although not really explained in the opinion, the reference to “such a long latency period” means that the plaintiff was apparently asymptomatic for the vast majority of the 13 years from last use to diagnosis.  If she had been otherwise, given the ruling in Mingus v. Wyeth, MDL 1203, No. 04-23744, 2006 WL 1050289, *3 (E.D.Pa. Apr. 20 2006), then the plaintiff may have been required to establish her eligibility to sue under a defined exclusion from the Nationwide Class Action Settlement Agreement while her statute of limitations clock ran.  That also would have required her to contend that the drugs she took for “a number of months” produced a disease that was asymptomatic for perhaps a decade by relying on studies that showed a statistically significant increased risk for non-latent disease and no statistically significant risk of latent disease according to the time frames studied.  This same MDL court had previously denied a Daubert challenge to the general causation opinion that the drugs can cause PAH that was asymptomatic for eleven years, In Re: Diet Drugs (Phentermine/ Fenfluramine/Dexfenfluramine) Prods. Liab. Litig, 890 F. Supp. 2d 552 (E.D. Pa. 2012), itself an extension of another court’s denial of a Daubert challenge to general causation opinions for cases with initial symptoms arising more than a year after last use.  Smith v. Wyeth-Ayerst Laboratories Co., 278 F. Supp. 2d 684 (W.D.N.C. 2003).  Given our past involvement with this litigation, these issues, and some of these experts, we are feigning detachment and trying to present it with a modicum of neutrality.  Regardless, this is all quite rare in the world of drug litigation.Continue Reading When Magic Words Are Not

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We’ve made no secret of our distaste for the so called “heeding presumption” – that juries may presume that any alternative “adequate” warning would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber).  We have a topic header on this subject with multiple posts decrying such presumptions, both generally and in the particular context of prescription medical products.

The biggest conceptual problem is that there are two fundamentally different kinds of warnings.  Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t.  Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you).  Most step-by-step directions also fall in this category.

While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about.  Rather, with prescription-only products, most of the relevant risks arise whenever the product is used.  A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.

With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product.  The only way to avoid the risk is not to use the product at all.  All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place.  For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (applying Mississippi law), which you can find later in this post.Continue Reading Who Heeds The Heeding Presumption?

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Perhaps no case in the 8+ year history of the blog (well, maybe Wyeth v. Levine, 555 U.S. 555 (2009)), invoked greater ire from us than the atrocity in State ex rel. Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), making West Virginia the only state in the nation (still) not to apply the learned intermediary rule.  We excoriated Karl, of course, but even more, the decision prompted two of our early research-heavy posts, “In Defense of the Learned Intermediary Rule” (going over the rule’s justifications) and “Headcount: Who’s Adopted the Learned Intermediary Rule?” (one of our first 50-state surveys).  Needless to say, Karl also led our inaugural list as the worst drug/device decision of 2007.

In the wake of Karl, we followed a federal court’s attempt to assert Karl as West Virginia “public policy” and refuse to apply the learned intermediary rule to non-West Virginia plaintiffs who brought suit in West Virginia courts.  See Woodcock v. Mylan, Inc., 661 F. Supp.2d 602 (S.D.W. Va. 2009).  The West Virginia legislature squelched that initiative by passing W. Va. Code, §55-8-16, which explicitly provided otherwise.

We also pointed out that the West Virginia Supreme Court seemed to be having second thoughts about this whole learned intermediary thing in White v. Wyeth, 705 S.E.2d 828 (W. Va. 2010), since it cited learned intermediary principles as one reason for precluding actions under the state’s consumer protection statute against manufacturers of prescription medical products.

The intervention by a physician in the decision-making process necessitated by his or her exercise of judgment whether or not to prescribe a particular medication protects consumers in ways respecting efficacy that are lacking in advertising campaigns for other products.

Id. at 141 (citation and quotation marks omitted).Continue Reading A Learned Intermediary Comeback in West Virginia

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If all Vermont had given us was fantastic cheese and Ben & Jerry’s ice cream, that would have been plenty.  But the 14th state has also given us some interesting politicians (Calvin Coolidge, Howard Dean, Bernie Sanders), some riveting fictional characters (Simon LeGree, Pollyanna, Hawkeye Pierce), the setting for the sitcom that stuck the landing better than any other, Newhart, and, of course, perfect Autumn foliage.  Vermont has been called home by one of our greatest playwrights, David Mamet, and one of our finest character actors, Luis Guzman (Out of Sight, Carlito’s Way, etc.).  We hear that Guzman does ads for Cabot Creamery.  We’d love to see those ads.  Wait a minute – maybe through this internet thing we can do just that.  Hold on a second.  Okay, here you go.  Please please please, do yourself a favor and see Out of Sight if you haven’t already.  It might be Soderbergh’s and Clooney’s best movie.  It is certainly J Lo’s best.  It has a wonderful array of character actors: Ving Rhames, Steve Zahn, Dennis Farina, Don Cheadle, Albert Brooks, and the aforementioned Mr. Guzman.  The romance scene between Clooney and J Lo is perfect, melding expectation and experience into a sensory now-now-now.  See it!  Now back to the law biz.  By the way, the lawyer we most admire graduated from U. Vermont’s law school.

For the moment, let’s put aside the fact that Vermont gave us Wyeth v. Levine.  (Sigh.)

The opinion we are cheddaring about today, Drake v. Allegan, Inc., 2014 U.S. Dist. LEXIS 151830 (D. Vermont October 23, 2014), comes from Vermont and it isn’t half bad. But it might be close to that.  The plaintiff sued the defendant, alleging that its Botox product injured him. Both parties filed Daubert motions to exclude the other side’s experts. The court ended up entirely denying the plaintiff’s motion to exclude the defendant’s medical causation expert and partly granting the defendant’s motions to exclude the plaintiff’s regulatory and medical experts.  If we were defense counsel in the Drake case, we’d call that a good day and reward ourselves with a dish of Vermont’s state pie (apple) drizzled with maple syrup, with a side of Vermont’s state beverage (milk, of course).  And there would be fromage.Continue Reading D. Vermont Rule 702 Rulings: Some are Gouda; Some are So Grating We Camembert Them

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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