Learned Intermediary

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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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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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The MDL court in West Virginia in the pelvic mesh litigation is continuing to issue pre-trial opinions.  Amongst those issued last week was an opinion addressing 24 motions in limine filed by plaintiffs and defendant, Boston Scientific Corporation (“BSC”).  Eghnayem v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 153284 (S.D.W. Va. Oct. 28, 2014).  We won’t address all the court’s rulings.  A number of them, as is almost always the case, were denied without prejudice to re-raising them at trial.  But some are either interesting or address issues frequently raised in mass tort trials.  So we discuss them here.

Exclusion of Material Safety Data Sheets (“MSDS”).  Admissibility of MSDS is often an issue in drug and device law litigation.  BSC sought to exclude the MSDS for polyethylene because it was not used in BSC’s mesh product.  They won – for obvious reasons.  The loophole that plaintiffs apparently tried to exploit was that certain BSC employees answered questions at their depositions about the polyethylene MSDS, incorrectly believing that it was the MSDS for a different substance – polypropylene – that is contained in BSC’s mesh product.  The court figured that out and excluded the polyethylene MSDS.

BSC also tried to exclude the MSDS for polypropylene, a material that is in its product.  No luck. BSC argued that a representative from the chemical company that made the polypropylene testified that the MSDS cautionary language was not placed there for scientific concerns.  The court found that testimony to be unclear and that the witness had actually testified that he didn’t know who drafted the MSDS or why it was written.  The court denied BSC’s motion, so BSC went one for two on its attempts to exclude the MSDS.  Id. at *5-8.Continue Reading The West Virginia Pelvic Mesh Court Issues in Limine Rulings

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The key to appreciating the latest order granting summary judgment for the defense in the Ortho-Evra birth control patch MDL is to start with the order’s last paragraph:

The Court has found that the Defendants provided adequate warnings sufficient to discharge their duty to warn.  Because the Defendants exercised reasonable care by communicating the risks involved with the Ortho Evra® patch to [the plaintiff’s] physician, and those warnings were not faulty, [the plaintiff] has not established a claim of negligent misrepresentation under Tennessee law.

Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 145415 (N.D. Ohio Oct. 10, 2014).  Ah, the familiar ring of the learned intermediary doctrine, the beat to which the Drug and Device Law Blog most often marches.  But what’s this?  The doctrine applied to negligent misrepresentation?  Some background is in order:  The plaintiff in Brown alleged that her use of hormonal contraceptives caused blood clots, which is one of the most widely known drug risks ever known to medical science.  As we said when we first reported on this case, every doctor and medical student knows about the risk—so do most women—and the labeling for hormonal contraceptives has fully disclosed the risk of clots for decades.

The defendants therefore moved for judgment on the pleadings, which the district court granted on the failure-to-warn claims back in April 2014.  See Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 57319 (N.D. Ohio Apr. 24, 2014).  This was absolutely the correct result as far as it went, but there were still several claims left over—manufacturing defect, negligence, and fraud.Continue Reading Without Failure To Warn, Other Claims Collapse

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The overarching background of this case obviously involves highly complex medical issues as well as a real human tragedy.  Nevertheless, the outcome is ultimately determined by a relatively straightforward application of Virginia law.

That’s how the court in Higgins v. Forest Labs., 2014 U.S. Dist. LEXIS 124745 (W.D. Va. Sep. 8, 2014), concluded its…

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You’ve no doubt heard that hard cases make bad law. But sometimes hard cases make no law.  That is, the judge decides not to decide, because deciding seems too difficult.  We would have thought that ‘deciding stuff’ would have been way up there in the job description of judges, certainly above “managing litigation,” strong-arming settlements,…

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While we are often critical of federal courts that reach out to make new state law, today we commend a far-away judge for bringing California’s learned intermediary doctrine law back to its basics.  The case is Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 U.S. Dist. LEXIS 114122 (S.D. W. Va. Aug. 18, 2014),…

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Happy birthday to Al Roker, who makes even a rainy day forecast seem jolly.  Happy birthday to Amy Adams, who enchanted audiences in movies as diverse as Drop Dead Gorgeous, The Fighter, and American Hustle.  Happy birthday to the late Jacqueline Susann, who authored one of the key documents of the Mad Men era, Valley of the Dolls (1966).  That novel is what the English majors call a roman a clef – literally, a novel/romance with a ‘key.’  The key is the correspondence to real life.  Valley of the Dolls chronicled show biz women and their adventures in Hollywood, in bed, and in the medicine cabinet.  Some of the characters allegedly are based on real starlets, such as Judy Garland and Ethel Merman.  Most readers of this post are too young to remember what a big deal Valley of the Dolls was in the late 1960’s.  It was a huge success and a huge scandal.  Almost every adult of a certain age read it. Almost every one of them denied reading it.  Both Susann and her book were subjected to scathing reviews from the literati.  More than one critic said, “That’s not writing, that’s typing.”  If it was typing, it was typing on a cash register.  It rained money all over Ms. Susann.

The film version of Valley of the Dolls came out only a year later.  The plaintiff lawyers would probably call it a rush-to-market.  It starred Patty Duke, Barbara Perkins, and Susan Hayward.  Hayward played a part originally slated for Judy Garland, but Garland turned out to be more of a method actress than was expected, as her dissipations prevented her from doing little things like showing up on the set.  If you haven’t yet had your daily dose of trash, take a peek at the movie’s trailer.  Sharon Tate was another lead in the movie.  Only a couple of years later, she would become, at the hands of the Manson Family, perhaps the single most iconic victim of 1960’s craziness.

Valley of the Dolls is not wholly extraneous to this blog.  The “Dolls” in the title referred both to the female protagonists and the pills that … helped them.  However much you might sniff about the literary deficiencies of Valley of the Dolls, it still reads better than some of the judicial opinions we’ve discussed this month.

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And now for a little case analysis.  (At least one of you will send us a rejoinder along the lines of, “That’s not analysis, that’s typing.”)

Thomas v. Abbott Laboratories, 2014 U.S. Dist. LEXIS 109905 (C.D. Cal. July 29, 2014) is about causation – both warning causation and medical causation.  The plaintiff sued two companies that made the anti-cholesterol medications Trilipix and Zetia. The plaintiff claimed that he developed pancreatitis as a result of ingesting those drugs.  More specifically, the plaintiff alleged that the defendants failed to warn him and his primary care physician that Trilipix and Zetia, when taken together or alone: (1) would not reduce the risk of having heart problems or a stroke; (2) could cause gallstones; and (3) could cause the blockage of common bile duct, severe acute pancreatitis, diabetes, and other ailments.  The defendants filed for summary judgment.Continue Reading A Cause for Celebration

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August signals different things to different people.  When it comes to football, two August events come to mind:  1) NFL preseason games and 2) high school “two-a-day” practices.  The former are not like real NFL games, but they are better than nothing, particularly if you like to see how rookies are doing, guess at final rosters, or look for insight into compiling fantasy teams.  The latter have lost some of their mysticism due to school restrictions driven by safety concerns.  Long gone are the days of no water during practices (see Bear Bryant at Texas A&M in 1954) and the tradition of two practices per day in full pads seems to be disappearing.  There are still vomit-inducing gassers and thigh-burning hills.  There are also still numerous drills focused on the most basic of football plays, the run up the middle.  Good offenses need to be able to get the crucial yard with a dive on third and 1 and good defenses need to be able to stop the offense cold in such situations.  This has not changed.  There was a time, however, when an end run, a run to the outside, was considered a bit sneaky, particularly if there was an accompanying fake dive.  The “end run” has lived on in our vernacular as a less than straightforward way to accomplish a goal.

When it comes to prescription drug product liability cases, the most direct—and we would maintain, appropriate—way to establish liability cases is with a failure to warn claim.  The vast majority of jurisdictions recognize that the duty to warn in such cases runs to the prescribing physician (or other health care provider).  We have gone on many times about what the learned intermediary doctrine really means.  One thing most courts to come down clearly on the issue of proximate cause in prescription drug failure to warn claims have recognized is that a plaintiff bears the burden of establishing that a different warning (at the time, as to the condition plaintiff claims to have developed) would have changed the prescriber’s behavior such that the injury would not have happened.  Overwhelmingly, proximate cause in such cases turns on the testimony of the prescribing physician that she likely would or would not have still prescribed the same drug to the plaintiff even if the drug’s label (and other labeling like Dear Doctor Letters) had been changed to what plaintiff contends it should have.  We think this is appropriate.Continue Reading Allowing An End Run on Proximate Cause for Failure to Warn

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This post is from Bexis:

In a decision reflective of how attorney solicitation dredges up bad cases that should never have been filed, a New Jersey appellate court has handed the defense three wins in its Accutane litigation involving inflammatory bowel disease (“IBD”).  Gaghan v. Hoffman-La Roche, Inc.,Nos. A-2717-11T2, et al., slip op. (New Jersey Super. A.D. Aug. 4, 2014).  Gaghan involved three appeals, two from defense verdicts and one from a plaintiff’s verdict, affirming the defense wins and reversing the one adverse verdict.  The trial had been something of a circus – three unrelated Accutane plaintiffs’ cases tried together.  All three plaintiffs were litigation tourists from California, so that state’s law applied, which is probably why the decision is unpublished.  It certainly is detailed enough to be published, had it not been one state’s courts opining on the law of another state.Continue Reading Accutane Triple Win in Jersey

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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