The district judge in the In re Zimmer Nexgen Knee Implant Products Liability Litigation MDL issued a summary judgment order in October 2016 that we called “the best Wisconsin law decision we have ever seen.”  What was the reason for our unusually unbridled enthusiasm?  The district judge debunked the idea that the learned intermediary rule does not apply in Wisconsin.  We have often heard that refrain, but we have always been skeptical.  The truth is that Wisconsin’s appellate courts have not addressed the issue, and the In re Zimmer Nexgen judge predicted that Wisconsin’s Supreme Court would adopt the learned intermediary rule if given the opportunity.

The Seventh Circuit has affirmed that order, so its opinion now inherits the mantle of “Best Wisconsin Law Decision We’ve Ever Seen.” That title is cemented not only by the adoption of the learned intermediary doctrine, but also the rejection of a heeding presumption, which is also very helpful.  We note that the three judges who issued this opinion have spent a combined 83 years on the Court of Appeals and that the author of the opinion spent five years on the Wisconsin Supreme Court.  Maybe the latter fact was considered when assigning the opinion; maybe it was not.  Regardless, it is a clear-minded and well-reasoned opinion that we commend to anyone who has grappled with warnings claims in Wisconsin.

Here is what happened. The plaintiff sued a knee implant manufacturer alleging design, manufacturing, and failure-to-warn claims after his prosthetic knee replacement loosened, which is a known complication of all joint replacement procedures. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., No. 16-3957, — F.3d –, 2018 WL 1193431, at *1 (7th Cir. Mar. 8, 2018).  Following summary judgment, the plaintiff raised only the warnings claims on appeal and argued that the manufacturer failed adequately to warn both the plaintiff and his surgeon.

Of course, an alleged failure to warn the plaintiff raises the application of the learned intermediary rule, which “holds that the manufacturer of a prescription drug or medical device fulfills its duty to warn of the product’s risk by informing the prescribing physician.” Id. at *2.  Because neither the Wisconsin Supreme Court nor the state’s intermediate appellate courts have addressed the rule, the Seventh Circuit undertook an Erie analysis. Id. at *3.

Although we would like to believe that the Seventh Circuit reviewed our frequently updated 50-state survey on the learned intermediary rule, it is more likely the court did its own research or relied on that provided by the manufacturer.  What it found was one Wisconsin trial court opinion applying the doctrine and noting its widespread acceptance. Id. at *3 (citing Staub v. Berg, No. 00-cv-0117, 2003 WL 26468454 (Wis. Cir. Ct. Jan. 6, 2003)).  The Court also found three federal district court opinions invoking the learned intermediary doctrine under Wisconsin law, and one case called Maynard v. Abbott Labs observing that “Wisconsin does not apply the learned intermediary doctrine.” Id. On this last point, the Seventh Circuit was particularly blunt:  “That statement is incorrect—the Wisconsin Supreme Court has never weighed in on the topic [and] Maynard itself is bereft of any analysis on the point.” Id.

The Seventh Circuit also relied on the learned intermediary doctrine’s “broad support in other jurisdictions,” including 48 states where the highest court or the intermediate appellate courts have adopted the doctrine in some form. Id. Finally, the rationale for the learned intermediary rule applies even more forcefully in cases involving surgical implants because “it is not reasonably conceivable that an individual could obtain and implant a device that requires a trained surgeon without the intervention of a physician.” Id. Amen.

The following holding and the reasoning upon which it is based are what make In re Zimmer Nexgen the Best Wisconsin Law Opinion We’ve Ever Seen:

In short, there is good reason to think that given the opportunity, the Wisconsin Supreme Court would join the vast majority of state supreme courts and adopt the learned-intermediary doctrine for use in defective-warning cases like this one involving a surgical implant. We predict the state high court would do so.  Accordingly, to the extent that [the plaintiff’s] defective-warnings claim is based on [the manufacturer’s] duty to warn him, it is foreclosed by the learned-intermediary doctrine.

Id. at *4.  For good measure, the Seventh Circuit held that the plaintiff’s direct warnings claim failed also because the plaintiff did not identify any danger about which that the manufacturer should have warned him and because he had no evidence of causation.  Even if the plaintiff would have heeded a different warning, “[he] didn’t select the NexGen Flex implant.”  His surgeon did.  Id.

The Seventh Circuit likewise rejected the plaintiffs’ argument that the manufacturer failed adequately to warn the surgeon.  The plaintiff cited the defense expert’s testimony that he would have used more cement to place the implant and argued that the manufacturer failed to warn about the amount of cement needed. Id. at *4.  But that was not sufficient because “no evidence supports [the plaintiff’s] contention that it was [the manufacturer’s] responsibility to instruct surgeons about the amount of cement they should use.” Id. at *5.  This surgeon relied exclusively on his education and training, not on any materials from the manufacturer, and the plaintiff offered no expert opinion that the warnings were inadequate in any event. Id.

Finally, the Seventh Circuit rejected the warnings claims on causation. The surgeon did not read the instructions for use and could not been affected by a different warning. Id. at **5-6.  The plaintiff urged the Seventh Circuit to apply a “heeding presumption,” i.e., a presumption in the absence of proof that the surgeon would have read and heeded a proper warning. Id. at *5.  But Wisconsin law squarely places the burden of proving causation on the plaintiff.  As the Seventh Circuit held,

Here again, the state appellate courts have not addressed this doctrine [the heeding presumption]. We seriously doubt that they would adopt it in this context.  [¶]  To the contrary, as we’ve already noted, the state court of appeals has recently held that “[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury.”

Id. (citing Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. Ct. App. 2004)).  In other words, since Wisconsin law already places the burden of proving causation on the plaintiff, the Seventh Circuit would not alter that law by creating a presumption.

The plaintiff’s last request was to certify questions to the Wisconsin Supreme Court, which the Seventh Circuit rejected because “[n]o genuine uncertainty exists here.” We could not agree more and would not be surprised to see this opinion on our Ten Best list at year end.

We don’t often get to discuss decisions from Maine. In fact, a quick spin through the blog and you’ll see Maine really only comes up in various canvases or surveys of state law. We don’t dislike the state. We love the lobster — that they take very seriously. We can’t say we love the winters there (at least this blogger doesn’t), but the coastline is beautiful in summer. And perhaps our vision of Maine is just ever so slightly skewed by Stephen King having set so many of his horror novels there. While King’s frightening tales are set in fictional towns, avid readers and explorers have suggested that you can visit several real places in Maine that seem to have inspired King’s work. For instance, if you’re looking for Derry, you want to stop in Dexter, Maine (mind the sewers). If you are more of a Cujo or Needful Things fan, Castle Rock is supposedly based on Woodstock, ME. You won’t find a giant dome in Rumford, but you’ll probably notice its otherwise close resemblance to Chester’s Mill (Under the Dome). And finally, there is King’s hometown of Bangor which is rumored to be the inspiration for the town of Haven from The Tommyknockers.

So, we were quite pleased when Dustin Rawlin and Bill Berglund of Tucker Ellis sent us their recent, far from creepy, win from the 23rd state. The case is Novak v. Mentor Worldwide LLC, 2018 WL 893914 (D. Maine Feb. 14, 2018) and the primary issue is statute of limitations. Statute of limitations cases are also not something we spend too much time on here, but this one has a notable ruling specific to prescription medical products liability cases – the discovery rule does not apply.

In 2004, plaintiff underwent surgery during which defendant’s product, a vaginal sling, was implanted to treat stress urinary incontinence. Id. at *1. Around 8 months to 1 year after the surgery, plaintiff started to experience pain during intercourse and by the end of 2006 was experiencing vaginal leaking and bleeding. Id. at *2. Before the end of 2006, plaintiff informed her surgeon of her problems. He ordered tests, the first round of which were inconclusive and plaintiff failed to undergo furthering testing. Id. In 2013, plaintiff attributed her problems to defendant’s product which was partially removed in another surgery in 2014. Id. Plaintiff filed suit in 2016. Id. at *1.

Maine’s statute of limitations for all civil actions is 6 years from when the cause of action accrues. Id. at *3. Further, Maine follows the date-of-injury rule when it comes to accrual. “[M]ere ignorance of a cause of action does not prevent the statute of limitations from running.” Id. In other words, generally Maine does not apply the “discovery rule” to determine when the statute starts to run (in states that do, a claim does not accrue until the plaintiff discovers or should have discovered the wrongdoing or misconduct). There are, however, exceptions where Maine has expressly applied the discovery rule: legal malpractice, foreign object and negligent diagnosis medical malpractice; and asbestosis. Id. General products liability claims not included.

Maine has also acknowledged the continuing tort doctrine where the alleged tort occurs over a series or chain of incidents. In such cases, the claim would not accrue until the last act in the chain – such as cases of pollution or contamination. Id. at *4. The continuing tort doctrine does not apply in cases where plaintiff’s alleged injuries, while occurring or perhaps worsening over time, are allegedly caused by a single act of negligence. Id.

Because plaintiff filed suit in 2016, her claims are time-barred if they accrued before 2010. As we noted above, her surgery was in 2004 and her complications appear to have started within the first year thereafter. So, unless the court applied the discovery rule, her claims would be barred.

Plaintiff’s first argument was that the presence of the defendant’s medical device in her body constituted a continuing tort that didn’t end until the product was removed in 2014. Id. at *5. But the continuing tort doctrine isn’t about continuing harm. What plaintiff here, or in almost any drug or device products liability case is alleging is a “finite act or set of acts (manufacture, design, inadequate warning, or misrepresentation) that led to her injuries.” Id. Once the device was implanted, the alleged wrongful act was over.

[Plaintiff] underwent only one, readily-identifiable exposure to the [device] (her surgery), and all of [defendant’s] allegedly tortious conduct took place before that point. . . . [defendant’s] wrongful conduct may have caused the [device] to deteriorate, which in turn may have caused injuries over time. However, once those injuries had manifested, the fact that their full scope remained unknown did not stop the statute of limitations from running.

Id. at *9, n.6.

Plaintiff’s second argument was that there was a genuine dispute regarding whether her earlier symptoms, pre-2006, were caused by the defendant’s medical device. Perhaps plaintiff should have thought of that argument before submitting an expert report tying those early symptoms to the medical device. Id. at *6. Nor could plaintiff rely on her surgeon not identifying a connection between the device and her symptoms when his tests were only inconclusive and plaintiff opted not to do further testing. Id. For a jury to conclude that plaintiff’s early injuries were not caused by defendant’s product would require “complete speculation.” Id. The statute started to run when plaintiff first experienced symptoms, regardless of how minor those symptoms were. Id. at *9, n.7.

While the statute of limitations did away with almost all of plaintiff’s claims, her fraud based claims remained. On those, as well as any other claim based on a failure to warn, defendant argued plaintiff failed to meet her burden to prove causation – plaintiff had no evidence that a different warning or information would have changed her surgeon’s decision to implant the device. Id. at *7. First, it is noteworthy that the court applied the learned intermediary doctrine. Id. at *8. Maine’s high court has never discussed the rule. The court relied on other federal courts interpreting Maine law on the issue.

So, applying the learned intermediary, the court’s focus correctly shifted to plaintiff’s surgeon. Plaintiff did not dispute that her doctor was aware of various risks, including those experienced by plaintiff. Id. Instead, plaintiff’s tried to meet their causation burden by arguing that the doctor “may very well have decided” not to implant the device if he had been provided different warnings. Id. But, that is either an unsupported fact or mere speculation and neither are evidence. Id. Plaintiff next showed the court some medical literature concerning the risks of the medical device and the doctor’s deposition transcript. But offered no connection between the two.

[The doctor’s] deposition transcript reflects that [plaintiff’s] counsel failed to ask him whether additional information would have altered his decision to go ahead with [plaintiff’s medical device] surgery.

Id. at *9. While not discussed directly in the opinion, requiring affirmative evidence that the doctor would have changed his use of the product for plaintiff to survive summary judgment is certainly an implicit rejection of the heeding presumption. Nor was it defendant’s obligation to ask these questions at the doctor’s deposition. Id. at *9, n.14.

So, while Maine may more quickly bring to mind images of butter poached crustaceans or mysterious floating red balloons, it’s not a bad place for prescription medical products cases either.

This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out of love stories involving semi-animate objects) and scouring recipe blogs for perfect Oscar party buffet items.  We have also reminisced, with amusement, about the climactic moments of last year’s show, during which the presenters announced the wrong Best Picture winner before an Academy official shoved them out of the way and corrected the error.  As we recall, it turned out (not surprisingly) that the mistake was caused by sloppiness.  The Academy’s accountant handed the presenters a duplicate envelope for an award that had already been presented, starting the embarrassing domino cascade.  We recall that heads rolled in the ensuing days.

Today’s case also involves the consequences of sloppiness, along with a couple of interesting legal rulings. In its unpublished decision in Small v. Amgen, Inc., et al., 2018 WL 501354 (11th Cir. Jan 22, 2018), the Eleventh Circuit considered the plaintiff’s appeal of two summary judgment orders:  a grant of partial summary judgment for the defendants, and a later grant of summary judgment on all of the remaining claims.

The plaintiff was prescribed the defendants’ drug to treat her rheumatoid arthritis. She took the drug for nearly six years then suffered a perforated bowel and a diverticulitis infection, for which she underwent multiple surgeries.  She sued the drug’s manufacturers, asserting all of the usual claims. In 2014, the district court granted summary judgment on the plaintiff’s failure-to-warn claims, holding that Florida’s learned intermediary doctrine precluded the claims.  Later, when the plaintiff’s expert disclosures revealed her sloppy omissions — although she identified five treating physicians she intended to use as non-retained experts, she had no expert to testify to general or specific causation — the defendants moved for summary judgment on the plaintiff’s remaining claims.  In 2017, the district court granted the defendants’ motion.

On appeal, the plaintiff did not dispute or even address the 2017 summary judgment order. Instead, she argued that the 2014 dismissal of her warnings claims was improper because there were factual issues “regarding the district court’s treatment of [her prescriber] as a learned intermediary.” Small, 2018 WL 501354 at *2.  She also argued that “the district court incorrectly decided that the direct ‘patient labeling requirement’ in the FDA medication guidelines did not preempt Florida’s learned intermediary doctrine.” Id.

With respect to the prescriber-as-learned-intermediary argument, the court explained that the plaintiff’s prescribing physician had 22 years of experience in rheumatology and “intentionally selected [the drug] for [the plaintiff], despite the risk of possible infections, because other forms of rheumatoid arthritis therapy had failed.” Id. What’s more, the prescriber was involved in clinical trials with the drug, and the plaintiff was a participant, giving the prescriber “more reason to know of and discuss possible side-effects or concerns” associated with the drug.” Id. The prescriber “knew that infections were possible but prescribed the drug anyway . . . because the benefits outweighed the risks.” Id. As such, because “the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer should have communicated,” the plaintiff could not prove warnings causation and her warnings claims failed as a matter of law. Id. (internal punctuation and citation omitted).   In other words, “the failure of the manufacturer to provide the physician with an adequate warning . . . is not the proximate cause of a patient’s injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated.” Id. (citation omitted).

Next, the plaintiff argued that Florida’s learned intermediary doctrine was preempted by the FDA’s requirement that the manufacturers provide patients with a “medication guide” for the drug. The court emphasized that “the historic police powers of the State [were] not superseded unless that was the clear and manifest purpose of Congress.” Id. at *3 (internal punctuation and citation omitted).   To discern such “clear and manifest purpose” in cases of implied preemption, the court explained that it considered “the promulgating agency’s contemporaneous explanation of its objectives as well as the agency’s current views of the regulation’s preemptive effect.” Id. (internal punctuation and citation omitted).

In the case of the medication guide regulation, the FDA had specifically addressed concerns that the regulation would alter the framework for manufacturers’ liability by abrogating the learned intermediary doctrine.  In response, the agency stated that “the written patient medication information provided did not alter the duty, or set the standard of care for, manufacturers [or] physicians . . . .” Id. (citation omitted).   Given this “contemporaneous explanation” from the FDA, coupled with the reality that “courts have not recognized an exception to the learned intermediary defense in situations where the FDA has required patient labeling . . . ,” the court held that there was no preemption.  We love this holding, and we believe this is the first time that an appellate court has so held.

No preemption, no warnings causation – summary judgment on warnings claims affirmed. And, because the plaintiff did not address her inexplicable failure to identify causation experts, the court held that she had waived any appeal of the 2017 summary judgment order.   Case (tidily) dismissed, in a no-nonsense decision we like very much.  We’ll let you know if we are similarly pleased by this year’s Oscars.

We’re now into the New Year but aren’t completely done with the old one.  The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways.  (We say “conventionally” because some sources report that January is actually named after its tutelary deity, Juno.) Janus, like some of our opponents, is two-faced.  Janus looks both forward and backward.  Bexis last month took a couple of long looks backward at 2017’s best and worst cases.  We’re still scrolling through the various Ten Best of 2017 culture lists for ideas, confirmations, and occasional outrages.  An in-house lawyer we endlessly respect pointed us to The New Yorker’s  list of top tv programs.  It’s hard to quarrel with Emily Nussbaum’s choice of The Leftovers, a fever-dream about love and loss (and a lion sex boat) as the best drama.  She was also right to praise American Vandal, the show that made us laugh out loud the most.  (The Good Place came in second on that score.)  Nussbaum also gave honorable mention to Halt and Catch Fire, an AMC show that really did seem to catch fire after its first, flawed season.  HACF stopped acting like a Mad Men, difficult-guy retread, shifted focus to the female protagonists,  and successfully steered us through the digital revolution – from PC clones to gaming to community chat boards to security to the web to PayPal to Yahoo to something even sexier than a lion sex boat: the Next Idea.  In seasons 2-4, HACF managed to show us (rather than merely tell us) how “computers aren’t the thing; they are the thing that gets us to the thing.”  That ‘thing’ is human connection. But you already knew that, right? There is an episode after the death of a major character that is the best depiction of grief and its clumsy toggling between the transcendent and the quotidian that we’ve seen.  The dead leave a lot behind.  Some of it goes to Goodwill.  Some of it survives in silly stories.  Some of it gets caught in our throats and some of it squeezes our tear ducts hard.  If you are looking for something to binge, consider The Leftovers, American Vandal, and Halt and Catch Fire (and maybe Patriot, The Americans, and Mindhunter).  You might also want to set aside an hour to take in episode 8 of Twin Peaks: The Return because you need to relive your college experience of attending a midnight showing of something arresting and supremely weird. 

Today’s post takes us back to 2017 for a case that is neither particularly arresting nor even a little bit weird.  Rather, the result seems inevitable.  In Siddoway v. GlaxoSmithKline LLC (In re Avandia Mktg., Sales Practices & Prods. Liab. Litig.), 2017 U.S. Dist. LEXIS 203885 (E.D. Pa. December 12, 2007), the plaintiff alleged that he sustained a heart attack from taking Avandia, and that the label did not warn him adequately.  The facts here, both regarding the plaintiff’s use and the regulatory backdrop, lead ineluctably to the defendant’s victory on summary judgment.   The plaintiff was initially prescribed Avandia from 2001 through 2002. In 2003, the plaintiff suffered two heart attacks, and ultimately underwent a successful heart transplant operation. He blamed Avandia for those heart attacks.  Following the heart transplant, a different doctor prescribed Avandia to the plaintiff. The plaintiff continued to take Avandia from December 2003 through June 2007, and did not experience any other adverse cardiovascular condition.

Let’s go backward for a moment.  When Avandia was initially approved by the FDA in 1999 to treat Type II diabetes, the drug’s label contained no warning of an increased risk of heart attack. But in 2007 – four years after the plaintiff’s heart transplant — the FDA issued a safety alert for Avandia, notifying consumers that “data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”  The FDA directed that a boxed cardio warning be added to the Avandia label.  So there’s your lawsuit, right?

Not quite.  Now let’s go forward.  After the label change and after the plaintiff filed his lawsuit, the manufacturer and the FDA conducted extensive research on Avandia’s safety. In 2013, the FDA ultimately concluded that there was no increased risk of heart attack associated with Avandia use compared to alternative diabetes medications. Thus, in 2014, the FDA approved an updated Avandia label that removed the boxed warning for a potential increased risk of heart attack.  Good science led to good news for patients, but not such good news for this particular patient’s lawsuit.  All of the plaintiff’s nine causes of actions essentially boiled down to failure to warn theories, and the facts on the ground had removed all support for that theory.  Even putting aside the question of whether the original label was inadequate because it lacked a warning that had now been repudiated by the FDA, the plaintiff’s case failed for inability to show that the alleged failure to warn was the proximate cause of the plaintiff’s injuries.  To the extent that specific claims bumped against the learned intermediary doctrine (Utah law governed, so the learned intermediary doctrine was alive and well), the plaintiff faced a huge problem when it came to posing the usual question to the prescriber:  knowing what you know today, would you still have prescribed this medicine to the plaintiff?  From his deposition testimony, it is clear that the prescriber’s “understanding of Avandia’s risk profile today is the same as it was when he prescribed Avandia to [the plaintiff]—that Avandia is not associated with an increased cardiovascular risk compared to other diabetes drugs.  He also testified that, if the current package insert were in place when he was prescribing Avandia to [the plaintiff], he still would have prescribed it.”  That is pretty inescapable logic.  John Adams once said that “facts are stubborn things.”  So is science.  So are label changes. 

But the plaintiff did try to escape the facts, the science, and the label changes.  He pointed to the prescriber’s testimony that he “quit using” Avandia for patients after 2007.  But that same prescriber’s testimony made clear that even when the 2007 data on which the plaintiff based his claims is considered along with the other Avandia risk data available today, he would still prescribe Avandia to the plaintiff, just as he had in 2001 and 2002, when there was no heart attack risk warning in the Avandia label. It is as if the plaintiff tried to preserve his case by seizing upon one favorable moment in time and excluding any other, subsequent facts that might prove inconvenient.  Don’t look forward, and don’t look backward.  Just look at the evidence in that nanosecond that might support a claim.  But no decent doctor would do that.  Nor would any sensible court.  Hence, the Siddoway court held that the plaintiff had failed to establish a genuine issue of material fact as to whether the prayed-for warning would have deterred the doctor from prescribing Avandia to the plaintiff before he suffered the 2003 heart attacks.  The court looked at all the evidence, forward and backward, and saw its way clearly towards complete dismissal of the case.   


In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own games.  Today’s case has both.  In Thompson v. Janssen Pharm., Inc., 2017 WL 5135548 (C.D. Cal. Oct. 23, 2017), the court considered simultaneous motions:  the plaintiffs’ motion for voluntary dismissal without prejudice and the defendants’ motion for summary judgment.

The plaintiff began taking Risperdal in 2001 after he was diagnosed with tics and other disorders, and he alleged that the drug caused him to develop gynecomastia (breast enlargement). Nevertheless, he continued – and continues – to take Risperdal (sixteen years, five doctors, and counting) because it effectively controls his tics, notwithstanding his alleged gynecomastia, his lawsuit, and his doctor’s recommendation that he stop taking the drug.

The Plaintiffs’ Motion for Voluntary Dismissal without Prejudice

The plaintiffs sued in the Central District of California, asserting the usual litany of claims. One day before the defendant moved for summary judgment, the plaintiffs moved for voluntary dismissal without prejudice so they could re-file their case in state court and park it in the already-existing JCCP, California’s version of an MDL.  They claimed that, though they had “been diligently seeking discovery” to prove their case, they were “unable to do so effectively” in federal court. Thompson, 2017 WL 5135548 at *4.

The court explained that factors relevant to its decision included: 1) the opposing party’s effort and expense in preparing for trial; 2) excessive delay and lack of diligence by the moving party in prosecuting the action; 3) insufficient explanation of the need for dismissal; and 4) the fact that the opposing party has moved for summary judgment. Id. at *5 (citations omitted).  Naturally, the plaintiff argued that all of these factors weighed in favor of granting the motion, but the court disagreed.

The court pointed out that, though the plaintiffs argued that they had been diligent in prosecuting his case, they had “failed to serve expert disclosure or expert reports.” Id. at *6.  Moreover, through the plaintiffs’ motion was “purportedly premised on their intention to join the pending state court [Risperdal litigation],” they gave “no explanation as to why they waited until . . . mere days before the summary judgment deadline” when they had notice of the state court litigation for more than a year. Id. The court concluded that this was “an insufficient explanation of the need for dismissal,” one of the factors to be considered. Id. (internal punctuation omitted).

In addition, though the defendants’ motion for summary judgment was not pending when the plaintiffs filed their motion (it was filed the next day), the defendants had notified the plaintiffs that they would be filing for summary judgment before the plaintiffs moved for dismissal. The court held that “the proximity of the two motions raise[d] the inference that that Plaintiffs’ motion might have been motivated by a desire to . . . avoid an imminent adverse ruling by way of Defendants’ summary judgment motion and also avoid the consequence of their failure to serve expert disclosures.” Id. (internal punctuation and citation omitted).

Simply put, as the court correctly perceived, the plaintiffs’ tactic was a transparent attempt to hide their meritless case in another mass proceeding on the chance that an inventory settlement would line their pockets at some point down the road.  The court concluded, “. . . Plaintiffs have not provided sufficient justification for voluntary dismissal given the untimeliness of the request and the proximity to Defendants’ motion for summary judgment.” Id.  Motion denied.

The Defendants’ Motion for Summary Judgment

It was undisputed that all of the plaintiffs’ claims were premised on the defendants’ alleged failure to warn about the rate of gynecomastia. As such, the defendants argued that all of the plaintiff’s claims failed because, inter alia: 1) the plaintiff assumed the risk by continuing to take the drug once he was aware of the alleged risk; and 2) the plaintiff could not prove “warnings causation;” in other words, he could not satisfy his burden of proving that that a different warning would have changed his doctors’ decisions to prescribe the drug for him. Id.

As to assumption of the risk, the defendants argued that the plaintiff was aware of the risk of gynecomastia but “continues to use Risperdal because he believes the benefits of the medicine in treating his condition outweigh the very risks that he has sued upon.” Id. at *7 (citation omitted).  The court disagreed, holding that the record did not clearly indicate that the plaintiff’s treating physicians discussed the risk of gynecomastia with the plaintiff.

But it was clear, on the record, that all of the plaintiff’s prescribing physicians were themselves aware of the risk of gynecomastia. And the plaintiff “provided no evidence that a different warning would have altered the physicians’ decisions to prescribe Risperdal.”  Therefore, the plaintiff could not “demonstrate the [warnings] causation required to survive summary judgment under California’s learned intermediary doctrine.” Id. at *8.

Nor were the plaintiffs’ claims saved by California’s “overpromotion exception.” As the court explained, “California courts have in the past recognized that the learned intermediary doctrine may not apply where a medication has been overpromoted to the extent that any warnings would have been nullified.” Id. at *9 (citation omitted).  But the overpromotion exception applies only in “unusual cases” (our California colleagues tell us that it is very rarely applied), and not “where a plaintiff’s prescribing physician did not rely on promotional statements when choosing treatment options.” Id. (citation omitted).  In this case, there was no evidence that any of the plaintiff’s prescribers relied on the defendant’s promotional activities, and the exception did not apply.

And so, in the absence of evidence of warnings causation, the court granted summary judgment for the defendants. The correct result, and a nice cautionary tale for plaintiffs thinking they can game the system, ignore both rules and law, and await the filling of their outstretched hands.  Does our defense heart good.

In one respect, Chaiken v. Bristol-Myers Squibb, 2017 U.S. Dist. 177588 (D.N.J. 2017), is just another example of a court granting a defendant drug manufacturer summary judgment on a failure to warn claim because the prescriber testified at her deposition that a different warning would not have changed her prescribing decision. On closer inspection, the decision also reveals a district judge unwilling to credit a prescriber declaration that was produced after a summary judgment motion was filed and, more important, obtained through ex parte discussions with the plaintiff’s attorney.

As background, this is a Plavix case. The plaintiff was admitted to the hospital in September 2011 with a TIA and prescribed Plavix. The prescriber in the hospital was a Dr. Bahreman. After her discharge, another doctor, a Dr. Leonard, prescribed plaintiff Plavix on an ongoing basis. In November 2011, while using Plavix prescribed by Dr. Leonard, plaintiff suffered a GI bleed, the basis of her lawsuit. Id. at *6-7.

During discovery, the deposition testimony of both prescribing doctors seemed to doom plaintiff’s failure to warn claim. The doctors testified to understanding the risk of bleeding associated with Plavix, and yet they still stood by their prescribing decisions:

Here, there is no dispute that both Drs. Bahreman and Leonard testified—at their deposition—that even considering the bleeding risks and the additional warnings, they would have prescribed Plavix to Plaintiff in light of various medical factors in connection with Plaintiff’s condition, particularly the fact that Plaintiff might have been intolerant of aspirin.

Id. at *19. That reads very much like “Miller time.”

But that’s when the ex parte declaration shows up. After the depositions, and indeed after defendants filed their summary judgment motion, plaintiff’s attorneys made a trip back to see the prescribing doctor in the hospital, Dr. Bahreman, held ex parte discussions during which they showed him a clinical study, and walked away with a declaration in which the doctor said that he would have shared the additional clinical information and plaintiff would not have been prescribed Plavix. Id. at *25.

While the content of this declaration appears, at first blush, to present problems, the procedure under which it was obtained had more problems. The court was uncomfortable with it. In a lengthy footnote, the court examined the history of the Plavix MDL’s restrictions on ex parte communications with doctors, including the court’s ultimate prohibition of such contact during discovery:

. . . After the deposition of Dr. Bahreman, Plaintiff’s counsel engaged in ex parte conversations with the doctor for the purposes of opposing Defendants’ summary judgment motion. . . . As Defendants pointed out, a previous Order, entered by the Magistrate Judge early in this litigation, disallowed counsel to have any ex parte communications regarding liability issues with the treating physicians of any of the plaintiffs in the MDL, with no exception for post-deposition communications. . . . I held that counsel may not have ex parte communications with plaintiffs’ treating physicians, including post deposition, except that counsel may contact a treating physician at the close of discovery and after the resolution of a summary judgment motion. . . .

Id. at *11, n. 2.

While clearly uncomfortable with the declaration, and faced with a request by defendants to apply the sham affidavit doctrine, the court was able to sidestep these issues by finding the declaration lacking in the necessary substance: “Because I find that even considering Dr. Bahreman’s declaration, summary judgment is appropriate, I need not address those arguments.” Id.

In particular, the court noted that Dr. Bahreman was not the prescribing physician at the time that the GI bleeding occurred. It was Dr. Leonard. Dr. Bahreman’s declaration did not matter. Separately, the court interpreted language in the declaration—that Dr. Bahreman would have “shared” information from the clinical study he’d reviewed with the plaintiff’s lawyers and Plaintiff “would not have been prescribed Plavix”—to mean that Dr. Bahreman would have shared the information with Dr. Leonard, the subsequent prescriber who treated plaintiff at the time of the GI bleed. But Dr. Leonard quite clearly testified that she would nonetheless have prescribed Plavix to plaintiff. As such, the court disposed of the failure to warn claim without addressing the potential impropriety of the ex parte declaration:

Dr. Leonard was the final decision-maker, or the prescribing physician, who ultimately determined that the benefits of placing Plaintiff on Plavix far out-weighed the bleeding risks that she posed. Thus, for the purposes of applying the learned intermediary doctrine, the relevant inquiry should be focused on whether Dr. Leonard was sufficiently warned by Defendants regarding the risks of Plavix, and whether Dr. Leonard would, in any event, have prescribed Plavix to Plaintiff in light of additional warnings proposed by Plaintiff. Indeed, as to both of these questions, Dr. Leonard testified in the affirmative.

Id. at *22.

We suspect that any future ex parte communications in the Plavix MDL with prescribers during discovery, and particularly after the filing of a motion for summary judgment, will be treated more directly and harshly by the court. This decision sends that signal. Justice is simply not served by presenting a “clarified” ex parte declaration after a deposition already resulted in testimony that had been vetted under adversarial questioning.



Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense and jeering a decision for the plaintiff, we do see some cases as having an obvious right result, no matter how long it takes to get there. However, just because a case is from a “bad” jurisdiction does not mean that all the decisions will be bad. In Johnson & Johnson v. Fortenberry, No. 2015-CA-01369-SCT, 2017 Miss. LEXIS 421 (Miss. Oct. 19, 2017), the geriatric plaintiff was prescribed defendant’s antipsychotic medication for about two years before developing a mild oral tardive dyskinesia (something that had appeared with the second medication plaintiff had been on). This was the third medication that plaintiff took for her severe psychosis and it apparently worked well for her. Her prescribing physician was well aware of the risk of tardive dyskinesia with every antipsychotic at the time, considering that the medication had a lower risk of tardive dyskinesia and other extrapyramidal symptoms according to both the medical literature and defendant’s marketing materials. After pending for twelve years, the case went to trial in a notorious plaintiff-friendly jurisdiction before a similarly known judge. Plaintiff proceeded at trial on failure to warn and negligent misrepresentation theories and won a sizable compensatory verdict, although punitive damages did not go to the jury. An appeal and cross-appeal followed.

As we often do, we will focus on the parts of the decision that seem more relevant to us. First, the warnings claim. You may have already guessed that we think this should have been a slam dunk for the defense. You would be right. In addition to what we noted above about the prescriber’s knowledge and plaintiff’s medical course, the prescriber testified that specifically warned plaintiff and her daughter-caregiver (who later pursued the suit for plaintiff’s estate) of the risk of tardive dyskinesia and other extrapyramidal symptoms. Id. at *8. His awareness of the risk was consistent with the thorough warnings for tardive dyskinesia in the FDA-mandate class labeling for all antipsychotics, which he considered to be consistent with his understanding of the risk from other sources. Id. at **9-11. For plaintiff, the prescriber stood by his decision to prescribe the drug, noting “the psychotic symptoms which are terrible and unremitting and lead to very bad outcomes. And those are much more certain than the risks of possible side effects.” Id. at *19. Plaintiff attacked the class labeling as “cookie cutter” and the prescriber’s self-professed understanding of the risk as influenced by the marketing for the drug. Id. at **20-21.

The first question on appeal was whether the label itself was sufficient to warn of the risk of tardive dyskinesia. This was not a close call, as the “label unequivocally communicated the risk of tardive dyskinesia associated with the use of all antipsychotic drugs, including Risperdal.” Id. at *18. In addition, the prescriber “specifically testified that he considered the language of the Risperdal label adequate to warn him of the risk of tardive dyskinesia in Risperdal users at the time he prescribed it to Taylor.” Id. at **18-19. It does not appear that the plaintiff, despite an array of willing expert, had much to say about the adequacy of the label itself. This may have never featured in the trial court, but there would have been an obvious problem with saying that the defendant needed to change the class labeling to avoid liability—implied preemption. In this situation, the drug’s manufacturer could not have taken an independent action to change the already robust class labeling. That did not come up on appeal because the plaintiff argued that marketing undercut the actual content of the label. However, the Mississippi Products Liability Act limits the inquiry to the label itself and the Mississippi Supreme Court was unwilling to allow marketing evidence to be considered. Id. at **21-23. Thus, after fifteen years, an obviously flawed warnings claim—we have not even mentioned the obvious lack of proximate cause—went away.

The negligent misrepresentation claim was another matter, as marketing evidence counted. As an initial matter, the parties agreed that the focus on such a claim for a prescription drug was on the representations to the prescribing physician. From the summary of the evidence at trial, it does not appear that there was a specific representation ever made to the plaintiff’s prescriber that was proven to be false and relied upon in connection with plaintiff’s care. Instead, generic evidence purportedly showing that the manufacturer marketed the drug as having less of risk of tardive dyskinesia and other extrapyramidal symptoms than other drugs was not tied to the prescriber’s decisions with plaintiff. Id. at **26-32. There was no evidence that he saw any of the marketing pieces that plaintiff contended were misleading or acknowledged a specific representation that misled him.

Instead, plaintiff offered a less direct chain of purported proximate cause: 1) prescriber testimony that “I just remember the information about it, and I assume marketing as well as reading about it – I can’t always differentiate because I read journals and things, too – but all the information identified it as atypical and having fewer EPS side effects”; 2) his view from all sources was that the risk of tardive dyskinesia was lower with Risperdal than lower than with older antipsychotics; 3) that he probably would have prescribed another, unspecified medication if he believed the risk of tardive dyskinesia with Risperdal was actually equal to an older antipsychotic; and 4) expert testimony that plaintiff would not have developed tardive dyskinesia if she had been prescribed one of two other antipsychotic medications instead of switching to Risperdal. Id. at **26 & 33-37. For the court, this was enough to raise a jury question as to whether the marketing materials provided to the prescriber misrepresented “that the tardive dyskinesia risk was low and materially lower than the tardive dyskinesia risk from Haldol”—the drug plaintiff was initially prescribed, but not one of the drugs plaintiff’s expert said would have avoided her injury—whether the prescriber relied on such a misrepresentation, and whether it proximately caused plaintiff’s injury. Id. at **38-39.

Here are some problems with that analysis. For the same reason that an adequate pleading of a misrepresentation claim needs to include the who, what, where, and when of the representation, it is hard to see how a plaintiff can establish a misrepresentation without something more specific than what plaintiff offered here. Moreover, where the general representations to the prescriber were perceived as being consistent with what he understood from the medical literature and other sources, there does not seem to have been reliance on any misrepresentation. Any reliance also did not seem to result in the prescription to plaintiff, as the prescriber’s impression from medical literature also would have needed to have been different to affect the prescribing decision. Plaintiff’s evidence on proximate cause also did not seem to match up because the prescriber did not say he would have prescribed one of the two medications that plaintiff’s expert testified would have avoided her injury. That all does not sound like plaintiff established enough to get to a jury on a negligent misrepresentation claim, but, like we said, we might be a bit biased.

Part of why plaintiffs like misrepresentation claims is that they tend to be a better vehicle for punitive damages than failure to warn claims. Here, despite the broad evidence admitted on marketing, which plaintiff contended showed intent to justify punitive damages, the trial court did not let punitives go to the jury. Along the way, the court excluded the defendant’s guilty plea to allegations of improper marketing after plaintiff’s last prescription. Id. at *64. That is a correct decision, but still deserves some recognition. In Mississippi, the trial is supposed to evaluate all the evidence to see if a punitive damages claim should go to the jury. Id. at **65-66. Because the trial judge did that, the Mississippi Supreme Court affirmed. That deserves a little credit too.


We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket (thank you medmal damage cap statutes).  We’ve said before (e.g., that both Levine and Riegel were really med-mal cases.   That search for a deeper pocket is undertaken by the lawyer, not the client.  We say this because we can use up all the fingers on one hand counting cases over the last year or so where it became clear that the product liability plaintiffs were certain that it was actually their doctors who erred.  The plaintiffs said so themselves.  They said so in their testimony.  They said so in contemporaneous diaries.  This evidence was hard to align with the lawyers’ strategy of making the case all about the manufacturer and its documents.  But why let reality get in the way of a game plan?  The plaintiffs’ discovery, motions, and rhetoric pretty much ignored whether the doctor met the standard of care.  Indeed, the doctors often got dropped just before trial.  Sometimes, we are sorry to say, our cynical eyes espied a shady quid pro quo, as the same doctors show up as witnesses for the plaintiffs



Why does a med-mal case turn into a product liability case?  Perhaps we should add a qualifier here.  It is product liability lawyers, not all lawyers, who contrive to turn med-mal cases into product liability cases.  There are plenty of superb med-mal plaintiff lawyers out there who are perfectly happy to practice their craft, and would sooner set their hair on fire before steering a case into comment K, the learned intermediary doctrine, or an MDL.  But product liability lawyers are at home with these lovely little bits of business.  It’s like that old saw about how a hammer sees nails everywhere.  We had lunch earlier this week with a friend who formerly worked with us at a defense firm, but who has now become a plaintiff med-mal lawyer and is doing terrifically well.  He wracks up big verdicts all the time.  His name on a complaint must up the settlement value of a case by 20%.  But he acknowledges that suing doctors isn’t easy.  He estimated that 90-95% of med-mal trials in Pennsylvania end with a defense verdict.  Of course he files his cases in Philadelphia whenever possible, but even in that benighted jurisdiction the defense win rate hovers in the 80s.  We were astonished to hear this.  We were less astonished after our friend explained that the slam-dunk med-mal cases invariably settle.  The ones that go to trial tend to be a bit on the flimsy side, or at least there is a yawning weakness somewhere in the case.  And then there is the fact that most people are willing to give the benefit of the doubt to doctors.  Unless you get the kind of stunning insider testimony that dealt Paul Newman a winning hand in The Verdict, doctors win most med-mal cases.  In addition, there are often procedural hurdles or damages caps unique to med-mal cases.  It is a different playing field from a mass torts case.  Doctors get treated like the home team.  Drug or device companies get treated like a criminal syndicate – even when the trial really is on their home turf.   


How does a med-mal case morph into a product liability case?  Failure to warn and failure to train are usually the operative theories.  Mind you, we don’t think failure to train is a legitimate theory at all. We have a whole topic thread devoted to that issue.  If there isn’t some specific law that requires such training, or that such training be carried out in a particular way, and if the company is going above and beyond what is legally required, it seems stupid and unfair to pin additional liability on a company for a voluntary undertaking or through some other specious legal theory.  In any event, at the doctor’s deposition the plaintiff’s lawyer will play the game of “wouldn’t you have liked to know x,” and whatever the x is, such as adverse event data, a footnote in a study, or the surprise ending of the new Harry Potter play, the doctor will likely say yes, because … well, because nobody with an advanced degree wants to come across as stubbornly ignorant.  Moreover, a plaintiff’s product liability case acquires enhanced sex appeal if it turns out that a company sales representative was in the operating room.  The plaintiff attorney will argue that the sales rep’s action or inaction was somehow a huge factor as to why the patient sustained the alleged injury.  Once or twice we have met sales reps who bragged about how they would use a laser pointer during an operation to ‘help’ the doctor, but most acknowledge that they would never render such ‘advice.’ Sales reps cannot and do not practice medicine.  More importantly, we have never met a doctor who said that a sales rep superseded seven-plus years of medical education.  Turning a med-mal case into a product liability case presupposes a willing suspension of disbelief, but upon that suspension of disbelief rests a huge chunk of the American tort industry. 


But here is a nifty New York County (that’s Manhattan) decision upholding the proposition that medical device manufacturers, even if they have representatives in attendance during the use of their products, are not liable for how the physician chooses to use them.  Gregory v. Tehrani, et al., 2017 N.Y. Misc. LEXIS 3491, 2017 N.Y. Slip. Op. 31963(U) (Supreme Ct. N.Y. County Sept. 15, 2017).  The Gregory case sheds light on the med-mal vs. product liability distinctions in an odd and unexpected way:  the plaintiff tried to make the manufacturer a defendant in a med-mal case.  The case wasn’t restyled as a product liability case – it was still travelling under a med-mal theory.  And therein lies the problem for the plaintiff. 


The plaintiff had undergone plastic surgery on his face.  The doctor used a facial filler during the procedure.  Representatives of the facial filler manufacturer were allegedly present during some of the treatments rendered by the doctor to the plaintiff.  Something apparently went wrong and the plaintiff sued the doctor, the facility, and the manufacturer of the facial filler for medical malpractice and lack of informed consent.  The manufacturer filed a motion to dismiss the claims against it.  The manufacturer won.


The medical malpractice claims simply did not fit against the manufacturer.  The court considered the second theory (lack of informed consent) first.  The plaintiff’s claim that the facial filler manufacturer failed to inform the patient was foreclosed by the learned intermediary rule.  The manufacturer had a duty to warn the doctor, not the manufacturer.  Put simply, informed consent is not a theory that lies against a manufacturer.  The medical malpractice claim made even less sense.  Rather than allege the classic product defect claim against the manufacturer, the plaintiff alleged that the manufacturer failed to ensure that the doctor used the device in “a safe, indicated manner … and according to their own product guidelines and the guidelines of administrative agencies and bodies including but not limited to the Food and Drug Administration.”   Gregory, 2017 N.Y. Misc. LEXIS 3491 at *5.  It sounds almost as if the plaintiff was complaining that the manufacturer had failed to practice medicine.  That is a weird theory.  It is also rare.  (Though it was alleged all the time in Bone Screw litigation.)  We have blogged about something like this before:  see  There’s a reason why the theory is rarely seen: it is fundamentally wrong.  It conflates product liability and med-mal law.  The Gregory court proceeds to un-conflate them:  “[W]hile the manufacturer of a medical device has a duty to warn a patient’s physician of the risks associated with the device, the manufacturer is not responsible for how the physician uses the device and renders the medical care.”  Id.  Further, the plaintiff didn’t allege anything wrong with the warnings themselves.  Further further, the plaintiff’s allegations did not connect any of the manufacturer’s actions or omissions to the alleged injuries.  In short, there was no reason for the manufacturer to be a defendant in this med-mal case, and after the court granted the motion to dismiss, it wasn’t.   




We all know how important a prescriber’s testimony is in a drug or device case. In many jurisdictions, the testimony of the prescriber is a mandatory requirement if a plaintiff is going to meet his/her burden of proof on a failure to warn claim. That’s because under an ordinary burden of proof, warning claims are dismissed on causation grounds where there is simply no evidence in the record about the prescribing physician’s actions. In other words, without evidence that a different warning would have altered the prescribing physician’s decision to prescribe, plaintiff hasn’t supported his claim.

Of course, this isn’t the case in jurisdictions where a “heeding presumption” puts the onus on the defendant to come up with affirmative proof of lack of causation. So, there are also, unfortunately, several jurisdictions where defendants are quite motivated to secure the prescriber’s testimony as well. We just posted last week about a case where the prescriber testified that he was fully informed of the risks and even if he had received the additional information plaintiff claimed he should have, he would have prescribed anyway. Under the learned intermediary doctrine, that testimony broke the causal chain on a failure to warn claim.

This means in every case, one side or the other (maybe even both) is looking to depose the prescriber. Sometimes that isn’t possible because he/she has died or can’t be found. And sometimes, the federal government simply says no. That happens when the prescriber is an employee of the U.S. Department of Veterans Affairs (the “VA”) and the plaintiff, a veteran, received his treatment, including prescription of the drug or device at issue at a VA hospital/clinic.

Generally, government employees are immune from discovery in private litigation under rules first set out in United States ex rel. Touhy v. Ragen, 340 U.S. 462 (1952). Pursuant to Touhy, a governmental agency can validly issue regulations restricting the availability of its personnel to participate (voluntarily or involuntarily) in private litigation. Id. at 468. Such discovery, the Court held, could easily become unduly burdensome to government operations. The “variety of information” that government employees possess” and “the possibilities of harm from unrestricted disclosure in court,” warrant “centralizing determination” concerning compliance with civil process. Id.

The VA has established its own set of Touhy regulations which can be found at 38 C.F.R. §14.800 et seq. And, if you’ve ever sent a Touhy letter to the VA requesting the deposition of a VA doctor, you’ve most likely received a courteous letter back denying your request and citing those regulations. Sometimes, further discussion can lead to an agreement to conduct a short deposition on a pre-determined set of topics. But, where a compromise with the VA cannot be reached, the issue may need to be litigated in federal court. Which brings us to today’s decision in Brown v. United States Department of Veterans Affairs, 2017 U.S. Dist. LEXIS 134556 (N.D. Ala. Aug. 22, 2017).

In this case, plaintiff was seeking to depose the doctor who had prescribed him Risperdal in connection with his products liability lawsuit pending in California state court. Id. at *1. His efforts to secure this testimony included multiple subpoenas issued by courts in California and Alabama, multiple emails with the Office of General Counsel for the VA, and a formal request for authorization of the deposition to the VA. Id. at *3-4. In its response to plaintiff’s request, the VA offered the following justifications for denying his request: conserving the time of VA employees to perform their official duties; the VA’s non-involvement in the state court case; that pertinent information can be obtained from production of the medical records; and that no advance authorization was sought per VA regulations. Id. at *5.

The court found none of these reasons persuasive. First, the court made clear that Touhy is not a locked door to the discovery of government information:

Application of Touhy regulations . . . is intended only to provide an orderly process by which a government agency may determine whether a demand for information from it is valid and lawful. Such regulations by themselves do not create a privilege or otherwise authorize the withholding of information.

Id. at *6; see also id. at *16-17 (Touhy does not “broadly exempt” the government from providing evidence). In the case of the VA, that process is a list of 15 factors to be considered in determining whether to allow a VA employee to testify. See 38 C.F.R. §14.804. But a list of factors isn’t enough. “There must be a good reason for an agency to withhold its evidence, and absent such a good reason, doing so is arbitrary, capricious, and an abuse of discretion.” Id. at *17. In this case, the court found the reasons the VA provided for withholding evidence simply didn’t make sense in light of the public’s right to obtain “every man’s evidence.” Id.

The VA’s first argument was burden/inconvenience. Section 14.804(a) provides that one consideration is “to conserve the time of VA personnel for conducting their official duties concerning servicing the Nation’s veteran population.” Certainly an honorable and essential service that nobody should be looking to undercut. But the court was perplexed at the VA’s assertion of this factor given that the deposition was limited to three hours, which even with prep time would likely mean no more than 8 hours total for the prescriber. Id. at *11.

[E]ight hours . . . is not a heavy burden of time compared to the need the plaintiff has for the testimony. It is ironic, indeed, that the VA does not consider supplying necessary information to veterans in need of it part of its “servicing of the Nation’s veteran population.”


The court also disagreed that plaintiff had not made a sufficient request for the testimony. He sent a letter summarizing the testimony that was sought and its importance. Plaintiff sought testimony about the doctor’s prescription of Risperdal to plaintiff and what the doctor knew about the drug when he prescribed it. Id. at *13. As the court acknowledged, what the prescriber knew concerning the risks of the drug is essential evidence for plaintiff’s case. “Only . . . the plaintiff’s treating physician, could provide this factual evidence.” Id. at *14-15. The VA’s argument that the necessary evidence can be obtained from the medical records fails for the same reason:

As mentioned already, under the Learned Intermediary Doctrine, necessary warnings related to drugs and medical devices are made to the treating physician, not the patient. This means that the plaintiff must explore, as a fact, whether [his prescriber] received any warnings or advisories regarding Risperdal, and their contents. Only [his prescriber] can supply this evidence concerning what he was told or read and what he knew about Risperdal when he prescribed it. That information is not likely reflected in medical records.

Id. at *20n.12.

The VA’s final argument was that it had “no direct or substantial interest in the private litigation between the plaintiff and the [drug] manufacturer.” Id. at *15. This lack of interest isn’t explicitly one of the 15 decision factors in §14.804, but could be related to the conservation of resources (already discussed above) or “that his testimony may create the appearance that the VA favors one litigant over another.” Id. On this point, the court repeatedly pointed out that the prescriber is being asked to provide factual testimony only. He is not being asked to serve as an expert or asked for his opinion on medical causation. Id. Moreover, a lack of interest in the litigation doesn’t “absolve” a witness of providing evidence. If it did, we’re sure private practitioners would turn down requests to testify all the time. The VA prescriber is no different than any other neutral, disinterested witness and his testimony is required only to comply with a general duty to provide evidence. Id. at *19-20.

The court’s reasoning would seem to apply to almost any prescribing testimony sought from a VA employee. If appropriately limited in scope to only factual evidence concerning the treatment of the plaintiff, the prescription of the drug, and the doctor’s knowledge of its risks and benefits, the factors for disallowing the deposition do not seem to apply – or are certainly heavily outweighed by the need for the evidence which cannot be obtained from any other source. We haven’t done a search for other Touhy decisions related to prescribers (maybe we will), but we certainly intend to add a cite to this decision to the next Touhy request we send to the VA.


We’ve posted a lot about Plavix recently but all in the context of the Supreme Court’s decision in BMS v. Superior Court on personal jurisdiction. So, we don’t blame you if you forgot that the product at issue in that case was Plavix. The product wasn’t really at the heart of the analysis. Neither the plaintiff nor the defendant having any contacts with or relation to the jurisdiction was where all the action was. But that’s state court. There is also a federal MDL concerning Plavix where the claims of plaintiffs who weren’t trying to be “litigation tourists” are moving forward on the substance. But it doesn’t look like they are moving very far if the recent decision in Armantrout v. Bristol-Myers Squibb, 2017 U.S. Dist. LEXIS 131334 (D.N.J. Aug. 17, 2017) is any indication.

Plavix is an anticoagulant which is approved for prescription alone or in conjunction with aspirin. Because the purpose of an anticoagulant is to prevent the formation of blood clots, it is well known that Plavix carries an increased risk of bleeding. Information about the risk of bleeding has been in the Plavix label since it entered the market. Id. at *4-5. While most of that is probably common knowledge, we thought it warranted repeating given that the crux of the claims in this litigation are for failure to warn. Failure to warn of a risk known by practitioners and most lay persons and that was disclosed in the product’s labeling. If this isn’t an uphill battle for plaintiffs, we don’t know what is.

Plaintiff alleged that he was prescribed and used Plavix in combo-therapy with aspirin following implantation of a stent to treat his acute coronary syndrome. Plaintiff used Plavix and aspirin for 8 years before he was hospitalized with gastrointestinal bleeding. Id. at *7-8. His prescriber testified at his deposition that:

  • He was aware of the risk of bleeding the entire time he prescribed Plavix, id. at *9;
  • He was aware of the increased risk of bleeding when prescribed in combination therapy with aspirin, another anticoagulant, id.;
  • He believed that combo-therapy was medically necessary for the type of stent implanted in plaintiff, id. at *10;
  • In his medical assessment, the benefits of combination therapy outweighed the risks for this plaintiff, id.;
  • “having reviewed all the relevant studies regarding Plavix, he believes – even now – that prescribing Plavix to [plaintiff] was the most appropriate medical therapy.” Id. at *21.

We’ve seen testimony like this before and it simply makes us giddy. It means that there is no causal nexus between any alleged inadequate warning and plaintiff’s injuries. If the prescriber was aware of the risk and prescribed anyway – no causation. If the prescriber, knowing the current state of the scientific information, would still prescribe – no causation. No causation, no causation, no causation. We just love the way that sounds.

But plaintiff wasn’t going down without at least some fight. He proffered an expert opinion on the adequacy of the warning. His expert opined that defendant failed to warn about the lack of studies evaluating the use of Plavix for greater than one year. Id. at *19. But the court found that was sort of like bringing a knife to a gunfight. Defendant wasn’t arguing the sufficiency of the warning but rather whether the prescriber would have prescribed even when provided with the most current research and labeling. Id. at *19-20. So, at oral argument, plaintiff tried to change weapons by arguing that his expert’s report called into question the prescriber’s credibility.

To make this argument, plaintiff relied on an old New York case that held that prescriber testimony similar to the testimony here was insufficient for resolving the issue of proximate cause because the doctor had a been a defendant in the case and since the testimony was not “self-disserving” the doctor’s credibility was in doubt and therefore was an issue for the jury. Id. at *24. But as the court pointed out – the prescriber here wasn’t a defendant. “[W]hen the treating physician is not a defendant, but rather a disinterested witness, the same concern regarding credibility is not present.” Id. at *25. Unfortunately, there are two decisions from the Southern District of New York and the Second Circuit that without explanation extend the concept of “self-disserving” to testimony of treaters who were not defendants. See id. at *22-25. Fortunately, this judge was more thoughtful in her analysis and, like a federal-judge sitting in diversity should be – was unwilling to enlarge state law. The court found no New York cases endorsing the Second Circuit’s decision but found decisions by New York’s highest court granting summary judgment relying on unrebutted doctor testimony. Id. at *27. The court also offered an important observation about the cases relied on by plaintiff:

Importantly, if I were to follow [the Second Circuit], summary judgment would never be granted in these types of cases, because a third-party prescriber’s testimony would always be subject to doubt, unless the prescriber testified he or she would not have prescribed the drug. Such a one-sided result for a disinterested physician’s testimony cannot be correct.

Id. at *25. We agree wholeheartedly.

So, the doctor’s credibility isn’t in question simply because his testimony isn’t “self-disserving.” That left plaintiff to argue that the prescriber wasn’t credible because he didn’t agree with plaintiff’s expert. Plaintiff’s expert opined that defendant should have warned about the lack of long-term safety and efficacy studies and because the prescriber didn’t have such studies while he was prescribing, his testimony wasn’t credible. The court found the argument “wholly without merit.” Id. at *28-29. Most importantly, plaintiff never questioned the prescriber at this deposition on this issue. Id. at *29. Probably because he didn’t think he’d like the answer. The doctor did testify about various studies he read and relied on and each of those studies reported on the duration. So he was both aware of the length of those studies and the lack of any longer studies and that did not change his prescribing decision. Id. at *30.

The bottom line is that plaintiff didn’t refute any of the prescriber’s testimony. In other words, plaintiff did not meet his burden of proving that a different warning would have altered the doctor’s decision to prescribe. In fact, the only evidence in the case is that the doctor was fully aware of the risk when he prescribed and prescribed anyway. Under New York law, the prescriber’s independent knowledge of the risk is an intervening event that precludes manufacturer liability regardless of the adequacy of the warning. Id. at *30-31.

Plaintiff also brought a design defect claim, but the court found it was no different than his failure to warn claim and in addition to failing for all the same reasons, also ruled that under New York law a design defect claim can’t be based on failure to warn alone. Id. at *36.

Summary judgment wins in Plavix cases are hardly anything new. Take a look at our prior posts here and here. But, it’s been a few years since the last wave and maybe Armantrout is the start of another round of dismissals. Given the well-known risk at issue, we wouldn’t be surprised to see more Plavix cases fail under the learned intermediary doctrine based on very similar testimony.