Being that it was the Sixth Circuit that allowed a failure-to-update claim to proceed against a generic manufacturer, when we got the recent decision in McDaniel v. Upsher-Smith Labs, 2018 U.S. App. LEXIS 17884 (6th Cir. June 29, 2018), knowing it was about whether a claim for failure to distribute a medication guide was preempted, we flipped straight to the end looking for “affirmed” or “reversed.” We wanted to get into the proper frame of mind for reading the opinion. Were we going to be disheartened like we were by Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013). Or pleased by the court’s distancing itself from its prior ruling. Fortunately, it’s the latter.

While failure to distribute medication guide claims have been previously ruled on by district courts, it was a matter of first impression on appeal. The Eleventh Circuit had the issue before it just a couple of months ago, but decided the case on learned intermediary rather than preemption grounds. See our post on that case here. And while we’re at it, here is where you can find our discussion of Fulgenzi. The Sixth Circuit took just the opposite approach deciding not to reach the learned intermediary question but instead to focus all of its attentions squarely on preemption.

At issue was plaintiff’s husband’s use of a generic form of amiodarone. Plaintiff alleged that her husband did not receive the Medication Guide for the drug when he filled his prescriptions because the manufacturer failed to make sure they were available. McDaniel, at *3. This failure to provide the Medication Guide was the sole basis for plaintiff’s strict liability and negligence failure to warn claims.

So, to be clear, nowhere in plaintiff’s complaint does she allege that the warning that was provided with the drug (in its accompanying labeling) was insufficient or inadequate. Her only allegation is that the Medication Guide, the substance of which she also does not take issue with, was not provided to her husband as required by the FDCA. Which the Sixth Circuit determined was the pleading of a federal duty without any Tennessee state court parallel duty. “Said differently, the claims would not exist in the absence of the FDCA.” Id. at *4. And, that’s Buckman implied preemption territory.

The court starts by directly citing Buckman for the ruling that there is no private cause of action for enforcing the FDCA. Id. at *5. The court then quotes quite heavily from plaintiff’s complaint to demonstrate that she has not pleaded a traditional state law failure to warn to claim – indeed neither plaintiff’s complaint nor briefing even mentions the Tennessee Products Liability Act. Id. at *8-9. Instead, her allegations talk about the defendant’s failure to provide the guide “as required by the FDA.Id. at *6-7 (emphasis added). As if that wasn’t enough, in her briefing, plaintiff explicitly disclaimed any inadequate content basis for her failure to warn claims:

The allegation is not one of adequacy or “content” failure to warn, (i.e., the verbiage or even the format fails), but an actual and physical negligent failure of [defendant] to fulfill its federally mandated responsibility to ensure Medication Guides are available for distribution directly to patients with each prescription.

Id. at *8 (quoting plaintiff’s brief). So, we think the basis for the claim is quite clear. Failure to distribute the Medication Guide as required by the FDCA. Nothing more.

The court next moves to the decisions by various district courts finding failure to distribute claims preempted. See id. at *10-11. To which plaintiff responded by relying on Fulgenzi. Like we mentioned above, Fulgenzi was a failure to update case. Plaintiff alleged that the generic manufacturer defendant failed to update its labeling to include new warnings added by the brand manufacturer thereby violating both the federal duty of sameness required of generic labeling and Ohio state law requiring adequate warnings. The Fulgenzi court found that because it was the adequacy of the warning that was at issue – a traditional state law claim – rather than the failure to update, the claim wasn’t preempted. In other words, the allegation of the violation of the federal duty of sameness was not a “critical element” of the claim in Fulgenzi. It was pleaded by plaintiff to demonstrate that her state law failure to warn claim was not preempted because it paralleled a federal requirement. Plaintiff in McDaniel, tried to argue that she too only pleaded the federal-law violation to avoid impossibility preemption. In fact, the only element of her failure to warn claim was failure to comply with a federal duty. Id. at *11-12. The court was not willing to “ignore the language of [plaintiff’s] allegations simply so that [it could] shoehorn her claims into Fulgenzi’s realm.´ Id. at *14.

While we disagree with where Fulgenzi came out, we agree that even if you found Fulgenzi’s reasoning sound, it doesn’t apply to McDaniel. In this case, the court correctly concluded that the FDA requirements regarding distribution of Medication Guides was a “critical element” – actually only element — of plaintiff’s case, and therefore the claim was impliedly preempted.

Note that there is a dissenting opinion that argues the McDaniel case does fit within the Fulgenzi framework by finding that Plaintiff McDaniel also pleaded a failure to warn claim alleging inadequacy of the warning. We certainly think the language cited by the majority demonstrates that’s not the case, but we aren’t going to spend time quibbling over it because we don’t think adequacy should be outcome determinative. As we said back when we posted on Fulgenzi, there is no question that the duty at issue (to update or to distribute) is federal. Only the federal government may enforce it. Whether the updated warning and/or Medication Guide is, or is not, also “adequate” under state law amounts to nothing more than coincidence. At least that’s how we saw it then and still see it now.

And it’s the start of another season of too much eating, drinking, shopping, and socializing. Sometimes it feels like a year’s worth cramped into a little over a month. And, for some of us (OK, me), we’re entering this week still a little groggy and foggy. So, we’ll admit to looking for something fairly straightforward and on the shorter side to post about as we clear our heads and shake off the haze. That’s not to say Mitchell v. Boehringer Ingelheim Pharma, Inc., 2017 U.S. Dist. LEXIS 192498 (W.D. Tenn. Nov. 21, 2017) isn’t noteworthy, it’s just not overly complicated. Sometimes that’s what you need to get the ball rolling again.

Plaintiff in Mitchell alleged that she suffered diabetic ketoacidosis (“DKA”) as a result of using the prescription drug Jardiance to treat her type-2 diabetes. Id. at *3. The drug, one of a class of drugs known as SGLT-2 inhibitors, was approved by the FDA in August 2014 and plaintiff began using it in February 2015. In May 2015, the FDA issued a safety alert warning about the risk of DKA with this class of drugs. The alert was based on a review of adverse event reports collected from March 2013 to June 2014 – before Jardiance was approved. Id. at *3-4.

Products liability claims in Tennessee are governed by the Tennessee Products Liability Act. Under the TPLA, drug manufacturers have a duty to minimize the risk or dangers from their products and they can discharge that duty by providing adequate warnings and instructions. Id. at *7. Plaintiff in Mitchell alleged defendant failed to satisfy that duty because it did not warn about DKA at the time the drug was approved and did not amend the warning via the FDA’s Changes Being Effected (“CBE”) process at any time before plaintiff was injured. Id. at *4.

We see CBE and we immediately start looking for a preemption discussion. Sure enough, there is one. As discussed here many times before, the CBE process allows a manufacturer to add or strengthen a warning based on “newly acquired information” without first obtaining FDA approval. Id. at *9-10. Where a CBE label change is an option for a manufacturer, the Supreme Court has held that failure to warn claims are not preempted. See Wyeth v. Levine, 555 U.S. 555 (2009).

But what about when a CBE is not an option? In Mitchell, the court broke the plaintiff’s failure to warn claim into two pieces – a challenge to the original labeling and a challenge to warning as it was at the time plaintiff used the drug. The court found the former preempted because defendant could not have changed the original FDA approved labeling. The data plaintiff relied on to support her allegation on this claim was pre-launch data. In other words, data that was known to the FDA at the time they approved the drug’s warnings – not newly acquired. “[T]he FDA is the exclusive judge of safety and efficacy based on information available at the commencement of marketing.” Id. at *11 (citing  In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015).

Similarly, plaintiff cannot base her failure to warn claim challenging defendant’s failure to amend the warning after the drug was introduced on the market on information that existed pre-FDA approval. Id. at *13. So plaintiff cannot rely on the adverse events collected before June 2014. Plaintiff’s allegations must be based on information that was not known by the FDA at the time of approval. In her complaint, plaintiff alleged that additional DKA adverse events were reported in 2015. Defendant, citing federal regulations, argued that while later in time, the additional reports did not provide any “new” information that would support a CBE. The court determined that was an issue better suited to a motion for summary judgment and that plaintiff had done enough to withstand a motion to dismiss. Id. at *15. Not a win yet, but the door is certainly still open.

The court made a few other rulings as well. Based on the learned intermediary doctrine, plaintiff cannot bring a failure to warn claim premised on failing to warn plaintiff directly. She is limited to a claim for failure to warn her prescriber. Id. at *17-18. And plaintiff must plead warning inadequacies with specificity. The court determined her allegations as to DKA were sufficient. But, plaintiff failed to state a claim to the extent she was looking to recover for “other related health complications.” Id. at *22. Plaintiff’s complaint neither specified the alleged complications nor how the drug’s warnings were inadequate as to those complications. So, as to unspecified complications, the failure to warn claim was dismissed.

In the end, plaintiff is left with a narrow failure to warn claim and the hurdle of proving proximate cause.


In the annals of history, June 6 gets prime billing.  That’s understandable, because the successful Normandy landings on D-Day (June 6, 1944), probably saved Western Civilization.  (Or maybe that heroic endeavor simply preserved liberal democracy for another 75 years, now that we seem encircled by fanatics both home and abroad who view the Enlightenment with disdain.)  But June 7 is no slacker.  On June 7, 1776, Richard Henry Lee introduced the Lee Resolution, which later became the Declaration of Independence. 364 days before D-Day, the American Navy decisively won the Battle of Midway, which turned the tide of the Pacific War.  On June 7, 1892, Homer Ferguson refused to leave the whites-only part of a train.  He later lost his Supreme Court case, Plessy v. Ferguson.  That opinion upheld “separate but equal,” a nasty judicial stain that would not be scrubbed away until 1954.  (SCOTUS Lesson #1: Horrible Supreme Court precedents can be overturned, but it can take a terribly long time – almost as long as the interval between NBA Finals games.)  One year later, on June 7, 1893, an Indian barrister offered a very similar refusal in South Africa.  That refusal is usually counted as Gandhi’s first act of civil disobedience.  And on June 7, 1965, the Supreme Court issued its decision in Griswold v. Connecticut, holding that married couples have a constitutional right to contraception.  Maybe there are people in 2017 who regret that decision (see our overly political parenthetical above) but we’d be surprised to meet such people, just as we’d be surprised to meet people who regret Brown v. Board of Education.  Still, the High Court arrived at that sensible result via a fuzzy analysis (e.g., “penumbras” and “emanations”) that could justify just about anything.  (SCOTUS Lesson #2: Good results and good reasoning do not always operate in tandem.)

In the passage of time, whether viewed as a Hegelian movement of ideas or as merely One Damned Thing After Another, June 7 is a significant date.  Now here comes the inevitable strained segue: today’s case, In re Cook Medical, Inc. IVC Filters Marketing, Sales Practices and Product Litigation, 2017 U.S. Dist. LEXIS 82761 (S.D. Indiana May 31, 2017), is about the passage of time.  More specifically, it is about how statutes of repose apply in drug and device litigation.

We do not often get a chance to write about statutes of repose.  We get more opportunities to discuss statutes of limitations, though we infrequently seize those opportunities, because the issues are usually fact-specific and obvious.  By contrast, statutes of repose present interesting legal issues, and their force can be devastating to tardy claims.  In the In re Cook Medical case, the defendant made a motion on the pleadings to dismiss claims on the ground that they were precluded by statutes of repose.  The court wrestled with three different statutes of repose:  Georgia, Tennessee, and Texas.  The differences among those statutes resulted in different dispositions of the claims by the various IVC Filter plaintiffs’ claims.


The Peach State bars claims for strict liability, negligence, or breach of warranty if the suit is not brought within ten years from the date of the first sale.  The Georgia plaintiffs’ claims in this case were filed more than ten years after the sale.  Buh-bye, right?  Not so fast.  Georgia’s statute of repose contains an exception if the defendant manufacturer engaged in conduct manifesting “willful, reckless, or wanton disregard for life or property.”  The plaintiffs argued that they had alleged such conduct.  How? it is not clear from the opinion.  Please excuse a slight rant.  It seems far too easy for drug and device plaintiffs to allege that any failure to warn equals reckless or wanton conduct.  Courts need to clamp down on this all-too-easy way to maintain settlement leverage or exploit jury anger.  Not adding a warning in the face of controversial or mixed studies should not be the stuff of punitive damages.  Maybe someday courts will wake up to this nonsensical hole in product liability law.  End of rant.  The In re Cook court was not such a court.  But it did limit the damage. It held that that the willful/reckless/wanton exception applied only to negligence claims, but not to strict liability and warranty claims.  Thus, the court dismissed the strict liability and warranty claims per the statute of repose.  The negligence claims remained.  So did the consumer fraud claim, which the court held was not subject to the statute of repose.


Tennessee also has a ten year statute of repose, though apparently not the willful/reckless/wanton exception.  At least no such exception was raised in this case.  The Tennessee plaintiffs conceded that the strict liability claims were doomed, but they tried to keep their negligence and warranty claims alive.  Nice try, said the court, but Tennessee’s Product Liability Act defines “product liability action” to include all of the plaintiffs’ claims.  That did not quite end the debate. The plaintiffs pointed out that Tennessee extended the statute of repose to 25 years for asbestos and silicone gel implant claims.  Why should those claims get such special treatment?  Never you mind, said the court, which applied the rational basis test and concluded that the Tennessee legislature was allowed to make such distinctions.  Sure, IVC Filters might pose risks of latency, but the constitution does not compel legislators to treat all latent defects the same.  Put another way, “[i]t is no requirement of equal protection that all evils of the same genus be eradicated or none at all.”  In re Cook Medical, IVC Filters Prods. Litig., 2017 U.S. Dist. LEXIS 82761 at *14, quoting other cases.  The court dismissed all of the Tennessee claims.


“T for Texas, T for Tennessee.”  Those two states go together musically (see Guy Clark, Willie & Waylon, Lynyrd Skynyrd, etc.).  Here, they also go together legally, as the defendant prevailed on the statutes of repose from both states.  The Texas statute of repose is for 15 years.  (Of course it is bigger.  This is Texas.)  But there is an exception if the manufacturer/seller explicitly warrants that the product has a useful life longer than 15 years. The Texas plaintiff attempted to save her claims by filing an affidavit, wherein she said she was told that the device was permanent, and the Patient Guide, which stated that the IVC Filter was “safe and effective as either a permanent or temporary device.”  But this was a motion on the pleadings.  Outside materials are not allowed.  Looking just at the complaint, there was no allegation that the IVC filters were marketed as permanent devices.  That is very, very bad for the plaintiff:  “As this is a motion for judgment on the pleadings, the omission of her specific warranty allegations is fatal.”  Id. at *18.  You might think that is an extraordinarily severe result.  No matter. The court observed that even if the allegations of permanence were included in the complaint, the claims would still not fly, because the plaintiff nowhere alleged any specific person who warranted permanence, and nowhere alleged any reliance on such warranty of permanence. As for the Patient Guide, the plaintiff did not allege in either her complaint or her affidavit that “she read the Guide before her surgery, much less that she relied on the Guide rather than her own doctor’s recommendation.”  Id. at *20.  Accordingly, the exception to Texas’s statute of repose did not apply, the statute of repose did apply, the claims were timed-out, and they had to be dismissed.

In a rare harkening to our past and discussion of specific judges, we recall that our first gig after law school was clerking for Judge Jon P. McCalla of the United States District Court for the Western District of Tennessee.  Downtown Memphis had not yet undergone “gentrification,” so a short walk in any direction from the Federal Building had to be undertaken with some caution.  In addition to barbecue and blues, a federal litigant’s visit to Memphis held the prospect of appearing before any one of an interesting assemblage of district judges.  Judge Odell Horton had taken senior status after a long stint as chief judge of the district; he was a Carter appointee and exceedingly nice to everyone.  He was also the first African American federal judge in Tennessee since Reconstruction.  Judge Julia Smith Gibbons had taken over as the chief judge after starting on the federal bench at 33—a Reagan appointee—and everyone knew she would be heading up to the Sixth Circuit at some point.  Judge Jerome Turner was another Reagan appointee, who we recall mostly for taking his clerks to lunch regularly and for an untimely death a few years later.  Judge Bernice Donald assumed the bench while we were there, having been tapped to jump up from the bankruptcy court by the first President Clinton.  (The actor/Senator who was in Die Hard 2: Die Harder showed up for the swearing in ceremony.)  Judge McCalla had been appointed by the first President Bush and clerked (for Judge Bailey Brown, before he went up to the Sixth Circuit) in the same chambers some years earlier.  He had the military bearing you would expect from his pre-law background as an office in Vietnam and a well-deserved reputation for being “by the book” and “no nonsense.”  (The softer side that attorneys appearing before him missed was evident when he was with his family, including the puppy we helped train while housesitting.)

Twenty years later, we discuss Judge McCalla’s decision in Fleming v. Janssen Pharms., Inc., No. 2:15-cv-02799-JPM-dkv, 2016 WL 3180299 (W.D. Tenn. June 6, 2016), which follows the memorable Yates decision authored by Judge Gibbons, who did, indeed, head up to the Sixth Circuit.  Hence why we recounted the iudicis personae of the Western District from our relative youth. Fleming involves asserted state law claims in connection with plaintiff’s alleged kidney injuries from a branded prescription diabetes drug.  Defendants moved to dismiss on various grounds, which we will discuss in the order of importance to us.

First, of course, was the argument that plaintiff’s design defect claim was preempted as pleaded. This angle of attack is noteworthy because winning any kind of preemption for a branded prescription drug at the motion to dismiss phase is rare and because the progression from Bartlett to Yates (decided on summary judgment) to such motions being viable was something we forecast/urged. As discussed more later, plaintiff had pretty barebones design defect allegations that suggested that all drugs within this class of anti-diabetic agents was too risky and that there were “several safer alternative products”—not alternative designs for this product. Id. at *1.  In response to defendant’s argument for impossibility preemption, plaintiff contended that its claim was based on a “duty to design the drug differently before FDA approval,” which could have been characterized as “never start selling theory.” Id. at *5.  “The Sixth Circuit, however, found this type of argument to be ‘too attenuated’ and ‘speculat[ive]’ because it requires several assumptions as to FDA approval and a patient’s selections of and medical reaction to the alternative design.” Id. (quoting Yates, 808 F.3d 281, 199-300).  While a case with the same drug in the Eleventh Circuit had rejected Yates impossibility preemption while granting a motion to dismiss, the analysis in Fleming was straightforward.  “The Court finds that Plaintiffs’ design defect claims are preempted by federal law because preemption can apply to both generic and branded drugs and because it would have been impossible for Defendants to comply with both state and federal law.” Id. Like we said, this is a “by the book” judge.  Other judges taking a similar approach could provide the advantage of getting obviously preempted design defect claims out early, narrowing the scope of fact and expert discovery.

Continue Reading Dismissing Drug Design Defect Based on Preemption

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

Would you have bet on the Red Sox to win the 1986 World Series?  Would you have booked passage on the Titanic?  Would you have bought a ticket to see the movie Ishtar?  If someone asked us these questions today, we all would answer in the negative because we already know the outcomes.  The 1986 Red Sox won 95 games that year and were riding the arms of their two young stars, Bruce Hurst and Roger Clemens.  They may have been a good bet at the time, but Bostonians can still see that ground ball wiggling its way between the legs of a certain first baseman.  The Titanic was a modern marvel and highly sought after ticket, but that voyage ended in tragedy (a real tragedy, not a faux tragedy like losing a baseball game).  We actually did buy a ticket to the movie Ishtar when it debuted in 1987 (forgive us, we were young).  It was a big-budget vehicle for two A-list movie stars, Dustin Hoffman and Warren Beatty, but the film was an epic flop.

We know now how these events in history turned out, yet millions of people placed that bet, booked that passage, or bought that ticket—and they all had good reasons to do so. Hindsight is 20/20, and if those people said today that they would not have acted that way “if they had known,” they would be met with a smirk and a raised eyebrow.  If you add in a profit motive—such as when a plaintiff stands to recover damages in a lawsuit—a convenient change in position would be more than just irrational, it would be a farce.  When you further add a dire downside—such as leaving cancer untreated (you can see now where we are going with this)—a post hoc claim of different behavior becomes an obvious counterfactual construct aimed at recovering dollars and entitled to no consideration.

That is why the district court was correct and the Sixth Circuit is wrong in Payne v. Novartis Pharmaceuticals Corp., No. 13-6266, 2014 WL 4056889 (6th Cir. Aug. 18, 2014).  The case is an Aredia and Zometa case in which the plaintiff alleged that the drug manufacturer’s failure to warn regarding the risk of osteonecrosis of the jaw (“ONJ”) resulted in onset of ONJ several years after she first used one of the drugs.  Id. at *2.  The prescribing physician testified that he was not aware of the risk of ONJ when he first prescribed one of the drugs for breast cancer in 1999, but by the time the plaintiff shows jaw-related symptoms in 2005, he was aware of the risk and suspended treatment.  Id.  The plaintiff was later diagnosed with ONJ.  Id.

The district court granted summary judgment on the plaintiff’s failure to warn claims because the plaintiff produced no substantial evidence that a warning regarding ONJ in 1999 would have changed the physician’s decision to prescribe the drug.  Id. at *3.  This of course is a textbook application of the learned intermediary doctrine, under which the manufacturer’s duty to warn runs only to the prescribing physician and under which proximate causation is judged by the impact that a stronger warning would have had on the prescriber’s treatment decisions.

In Payne, there was no evidence that a warning regarding ONJ would have changed anything for this plaintiff, at least no evidence that would justify sending the case to a jury.  The prescribing physician testified that he now warns patients about the risk of ONJ and recommends that they see a dentist before taking bisphosphonates.  Id. at *5.  Fair enough, but there was no evidence that a dental exam would have shown anything noteworthy for this plaintiff, let alone anything that might have prevented the plaintiff’s injury, either in 1999 when the plaintiff started one drug or in 2001 when she switched to the other.

In other words, nothing would have changed in the prescribing physician’s decision making process, which is why the district court was correct to grant summary judgment on the warnings.

So why did the Sixth Circuit reverse?  It reversed because the doctor said he now instructs patients re ONJ and because the plaintiff filed an affidavit stating that she would not have taken the products if she had been warned.  Id. at *3.  The Sixth Circuit found this to be a “straightforward” argument, under which the plaintiffs had raised a jury issue on whether the lack of a warning on ONJ in 1999 or 2001 caused her injury.

We have two problems with the Sixth Circuit’s analysis.  First, we do not agree with the Sixth Circuit’s gloss on learned intermediary doctrine under the applicable Tennessee law.  According the Sixth Circuit, the learned intermediary rule is a liability-shifting doctrine that can place a duty to warn on the prescribing physician.  As the court explained, “At base, the doctrine can shift liability from drug companies to doctors:  If the drug company adequately warned and instructed the doctor but the doctor did not adequately warn the patient, the patient’s quarrel is with the doctor rather than the drug company.”  Id. at *4.

This statement misapprehends the law, which probably explains why the Sixth Circuit cited no real support.  (The Sixth Circuit cited only a concurring opinion and a law review article.)  The learned intermediary doctrine imposes no duty on prescribing physicians, nor does it provide patients any basis upon which to “shift liability to” or “quarrel” with doctors.  A healthcare provider’s potential liability to a patient is governed by state law on medical malpractice, which generally requires proof of a breach of a standard of care.  That standard may encompass a duty to provide patients with certain treatment-related information—or it might not.  The learned intermediary doctrine says nothing on that score.  It defines a drug or medical device manufacturer’s duty to warn and the manufacturer’s potential liability, and nothing further.

Our second problem with the Sixth Circuit’s analysis is more profound.  The district court was absolutely correct in ruling that the plaintiff’s affidavit stating that she would not have used the products if she had been warned of ONJ was not evidence sufficient to defeat summary judgment.  It was very easy for the plaintiff to say that she would not have used the drug after she already knew the outcome, i.e., that she experienced the exact condition about which she claims she should have been warned.  When bearing in mind that this plaintiff was being treated for a potentially fatal disease (breast cancer) and that she now stands to gain financially by saying that she would have refused cancer treatment, her statement is entitled to no weight, even if admissible.  We have commented on plaintiffs’ attempts to do an “end run” on warnings causation before, including within the last few days, and we consider such attempts to be idle conjecture based on “evidence” that does not prove anything.

States define the sufficiency of the evidence differently, but the law typically requires substantial evidence, something more than a mere scintilla or speculation.  The Sixth Circuit glossed past this point too, first by stating that there was no authority “that supports the proposition that this testimony is insufficient to forestall summary judgment.”  Id. at *6.  The problem with this conclusion is that there is no authority supporting the Sixth Circuit’s position either.  The Sixth Circuit therefore again inappropriately blended medical malpractice and product liability and analogized to cases involving informed consent, observing that “we can find no indication that the Tennessee Supreme Court would adopt a different standard.”  Id. at *6.  This is problematic too, because a patient’s consent—or lack thereof—is not an element of a product defect claim, even one based on allegedly inadequate warnings. The Sixth Circuit again could find no legal support for this extension of Tennessee law, citing another law review article, this time with the telltale “cf.” signal, code for “here’s something that is not totally off the wall.”

We have thought long and hard about whether a plaintiff’s retrospective change of heart can ever be substantial evidence sufficient to reach a jury.  If there is a scenario under which this can be true, we can’t think of it.  We understand that juries hear this sort of evidence somewhat regularly, and maybe there is corroborating evidence from time to time.  But that was not the case in Payne, which came to wrong result.  Now if only we can get a refund for our ticket to Ishtar.  Does anyone know a lawyer?

We knew what the correct result ought to be in Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 57319 (N.D. Ohio Apr. 24, 2014), as soon as we read the following statement in the second paragraph of the district court’s order:

The record reflects that at the time [the plaintiff’s physician] prescribed the [birth control patch], he was aware that [the birth control patch] exposes users to increased levels of estrogen, and that such increased exposure increases the risk of blood clots.  Moreover, [the plaintiff’s physician] testified that notwithstanding these risks, he believed the [birth control patch] was a reasonably safe method of birth control for Plaintiff, and further believed that the risks to Plaintiff were outweighed by the drug’s benefits.

Id. at **1-2.  Case closed.  Full stop. As our faithful readers know, there are generally three paths to defeating warnings-based claims for lack of causation.  The drug labeling fully disclosed the risk that allegedly befell the plaintiff; the prescribing physician did not read the labeling; or the prescribing physician was already aware of the risk through his or her medical training and experience. Sometimes, it is all three.  The upshot is that if the prescribing physician knew and understood the risks and decided that the benefits of the drug therapy outweighed those risks for that patient, then the plaintiff’s alleged injury did not result from any material failure to warn.

That is what happened in Brown, where the plaintiff used the Ortho Evra contraceptive patch, a contraception product that delivers estrogen and progestin hormones through a transdermal patch delivery system.  The patient experienced blood clots in her lungs, which is a serious condition.  Id. at *2.  But doctors have been well aware of the risk of blood clotting in connection with combination hormone contraceptives for more than 50 years. Ask any doctor (and we have), and he or she will tell you exactly that.  It is also true that labeling for combination hormone contraceptives has included comprehensive and prominent warnings against the risk of blood clots for almost as long as combination products have been prescribed—again for something like 50 years.  As medical science has developed over the years, those warnings have become even more comprehensive and robust.

The prescribing physician’s testimony in Brown resulted in summary judgment on the warnings-based claims, as it well should have.  Under Tennessee law, a warning can be adequate as a matter of law where the instructions are accurate and unambiguous, and the Ortho Evra package insert “provided specific warnings of the exact adverse events suffered by Plaintiff; namely, the package insert warned that . . . increased levels of estrogen can increase the risk of developing blood clots that may travel to the lungs.”  Id. at *8.  Moreover, in light of the prescribing physician’s testimony that he was aware of the increased risk of blood clots and that he nevertheless believed the benefits of the drug outweighed the risks, the warnings claims failed on causation as well.  As the district court concluded, “the learned intermediary doctrine bars Plaintiff’s failure to warn claims.”  Id. at **8-9.  Sometimes we call this a double whammy:  Summary judgment granted because (1) the warnings were adequate as a matter of law and (2) also because of a lack of causation.

This is the correct result, and it makes us wonder why substantial litigation over combination hormone contraceptives even exists.  (For our commentary on previous, similar orders involving the same product, see here and here.)  We are not insensitive to women who experience complications with contraceptive drugs.  But the risks of unintended pregnancy and postpartum care (including the risk of blood clots) are much worse.  In this day and age, it simply is not possible that any physician prescribing combination hormone contraceptives is not fully aware of the risk of blood clots, and it is equally implausible that any prescribing physicians failed to take that risk into account when making his or her prescribing decisions.  Under those circumstances, there is no way that any inadequacy in the warnings caused the patient harm.  What is more, it should not take years of litigation with all the trappings of multidistrict and coordinated proceedings to come to that conclusion.

There is more to the Brown order than just warnings.  The defendants also moved for judgment on the pleadings on the plaintiff’s claims for manufacturing defect, negligence, breach of warranty, and fraud claims.  Their success was limited:  Because the plaintiff did not allege privity of contract between herself and the defendant, the district court granted judgment as a matter of law on the warranty claim.  Id. at **11-12.  Otherwise the motion was denied.

Moving for judgment on the pleadings was an unconventional choice.  It is not entirely clear from the order whether the motion for summary judgment took aim at all of the plaintiff’s claims, but it would not surprise us if it did.  An argument that “warnings cover everything” recognizes that claims arising from the use of prescription drugs almost always come down to the warnings, and the defendants would have been more than justified in asserting their warnings arguments as broadly as they could.  Unfortunately, the district court ruled that the defendants raised their omnibus warnings argument improperly in reply, which allowed the court to brush it off as an “unsupported, passing assertion.”  Id. at **9-10.

In the end we don’t think the denial of judgment on the pleadings will matter much.  The core failure-to-warn claims are gone, and a plaintiff left with manufacturing defect, negligence, and fraud does not have much to work with going forward.  Manufacturing defects are extremely rare in pharmaceutical cases, and fraud is usually disposed of with one question posed to the plaintiff in written discovery or a deposition.  Question: “Have you ever had any contact or communication with the drug manufacturer? Answer:  “No.”  Of course, negligence can raise a host of issues, but we would not be surprised if further exploration of negligence beats a path straight back to the adequacy of the warnings, which leads straight back to the physician’s testimony cited at the outset of this post.  It does not get any better than that.

This post is written by our Reed Smith colleague, Adam Masin, who is solely responsible for its content.  He gets all the credit and all the blame.


This blog has previously written about Tennessee’s unusual statute of repose, herehere, and here, which bars claims “within one (1) year after the expiration date of the anticipated life of the product.”  Tenn. Code Ann. Sec. 29-28-103.  “Anticipated life” is a curious term.  For example, the season finale of Homeland had many of its main characters wondering what their own “anticipated life” might be like given their circumstances.  But we are not here to discuss the rather unrealistic-yet-compelling Homeland universe in which a bipolar CIA agent who never follows orders and is carrying the baby of the brainwashed former almost-terrorist who may not have bombed the CIA but still pretty much murdered the Vice-President can somehow find herself sent to Iran on purpose to oversee an impossible mission that involves trying to save her magically detoxed boyfriend (no spoilers here!).  That’s a different blog post we’d like to write.  We are here now to talk about “anticipated life” as it refers to products in Tennessee, the state that shares a border with the state where Homeland is filmed.

In Tennessee, “anticipated life of the product” is the “expiration date placed on the product by the manufacturer when required by law but shall not commence until the date the product was first purchased for use or consumption.” Id. at Sec. 29-28-102.  In Wahl v. General Electric Company, 2013 U.S. Dist. LEXIS 162320 at *19 (M.D. Tenn. Nov. 14, 2013), that meant that the plaintiff’s claims were barred by the statue of repose well before the plaintiff knew she had developed the condition she based her lawsuit on.  The same was true in Montgomery v. Wyeth, and Spence v. Miles Lab.  Other states have carved out latency or similar exceptions to their statues of repose that might apply to prescription medical products for various reasons, but Tennessee has not chosen that path.

Perhaps the only thing more unusual than Tennessee’s “anticipated life” statute of repose, however, is how courts have reacted to it.  In Montgomery, the trial court began its opinion by questioning the propriety of the law:

Rarely does this Court suggest that a legislative body reconsider one of its enactments. The Court believes its role is simply to apply the law applicable to the case before it and not concern itself with the merits of the case. However, because of the result in this case, this is one of those rare cases where the Court believes it is appropriate to urge the Tennessee legislature to look closely at the law governing this case.

The court in Wahl ended its own opinion doing the same thing:

the court views the result in this case as manifestly unjust. Through no fault of her own, Wahl is left with an essentially incurable degenerative condition for which she has no recourse, because Tennessee extinguished her claims against GE before she could have discovered them. The time period here between the procedures at issue and Wahl’s NSF diagnosis was only about four years, which is not a time period that shocks the conscience. This court, as did Judge Collier in Montgomery, 540 F. Supp. 2d at 936 and 945, urges the Tennessee General Assembly to revisit the TPLA and its effect on Tennessee citizens injured by pharmaceutical products.

Continue Reading Guest Post – Homeland and Anticipated Life (under Tennessee law): Being On the Wrong Side of Policy Isn’t Always Unjust

This post is not from the Dechert side of the blog, since they are involved in Reglan litigation.

Last evening, just before quitting time on the East Coast, we found the Sixth Circuit’s affirmance of the Rule 12 dismissal (that means no expensive discovery necessary) of seven Reglan cases under Tennessee Law.  See Strayhorn v. Wyeth Pharmaceuticals, Nos. 12-6195, et al.slip op. (6th Cir. Dec. 2, 2013).  The court also affirmed summary judgment against another set of defendants – affiliated with the original innovator manufacturer.

Because of that, we call this type of result a “onetwo punch” case.  That means that the plaintiffs – who took the generic version of the drug only – are:  (1) knocked out of the box against the generic manufacturer by preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013); and (2) barred from suing the original innovator manufacturer of the drug by the very simple and basic fact that the plaintiff never used that defendant’s product.

First, the generic side:

Plaintiffs had filed the usual kitchen-sink type complaint alleging everything from design defect to consumer fraud.  Plaintiffs abandoned consumer and unjust enrichment claims, but appealed dismissal of everything else.  Strayhorn, slip op. at 7.

They lost.

Continue Reading Lucky Seven − Strayhorn Affirmed

It’s late and we want to go home, but we just learned that the “one-two punch” dismissal of the plaintiffs’ claims in Strayhorn v. Wyeth (that is, generic preemption plus no innovator liability in a generic case) has been affirmed by the Sixth Circuit applying Tennessee law.  More about it tomorrow, when we’ve had more time to review it.  Here’s a link to the Sixth Circuit’s opinion if you can’t wait until then.