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., https://www.druganddevicelawblog.com/2008/10/everything-you-need-to-know-about-wyeth.html) 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.  https://www.druganddevicelawblog.com/tag/duty-to-train/  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 https://www.druganddevicelawblog.com/2013/12/drugdevice-labels-are-not-required-to.html.  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.”

Id.

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.

We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts).  Last week, we saw the wonderful new musical Come From Away.   It is a true story, and it begins in the tiny town of Gander, Newfoundland on September 11, 2001.  On that infamous day, Gander opened its doors, and its collective heart, to many thousands of U.S.A.-bound airline passengers whose planes were forced to land when U.S. airspace was closed in the wake of the 9-11 attacks.  Despite the tragedy in the background – and in the foreground for some characters unable to confirm whether relatives were victims of the attacks – the play is an exquisitely energetic and joyful celebration of the openness of the human heart and the resilience of the human spirit.  On the last note of the last song, the cheering audience rose in unison in a manner we have rarely seen.

As in Come From Away, tragic facts are common in our line of work, but they can sometimes provide the framework for a silver lining. In the hands of a rigorous judge committed to correct application of the law despite the pull of sympathy, difficult facts can produce laudable precedent.   Such is not the case in today’s decision out of the Depakote litigation in the Southern District of Illinois.

In E.R.G. v. Abbott Laboratories, Inc., 2017 WL 3055520 (S.D. Ill. July 19, 2017), the plaintiff was a child who was conceived while his mother was taking Depakote and who was born with spina bifida and other birth defects.  At trial, the jury found for the plaintiff on his claim of negligent failure to warn and awarded fifteen million dollars in compensatory damages.  (The jury found that the evidence did not support an award of punitive damages.)  The defendant filed a post-verdict motion for judgment as a matter of law, arguing that: 1) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of the risk of spina bifida; 2) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of other birth defects; and 3) the plaintiff failed to prove warnings causation because no doctor testified that a stronger warning would have altered his prescribing decision.  In the alternative, the defendant moved for a new trial, citing evidentiary issues and improper comments during closing argument.

  1.  Motion for Judgment as a Matter of Law

                        Adequacy of Label Warnings

The defendant argued that the label warnings were adequate as a matter of law because the label contained a black-boxed warning of the (correct) 1-2% incidence of spina bifida when the drug was taken during pregnancy. This portion of the decision – like much of the rest – is confusing, but the judge seems to say that, notwithstanding the accurate spina bifida warning, it might have been the case that other portions of the label were inadequate and that the plaintiff’s mother might be saying that other proper warnings would have resulted in a decision to stop taking the drug when she was pregnant.  It’s not clear where the judge is getting any of this, because none of this hypothetical testimony is cited in the decision.  The judge also states that the plaintiff did not “concede” that the spina bifida warning was adequate.  Instead, according to the judge, the jury could adopt the plaintiff’s expert’s theory that the spina bifida labeling was not adequate because it did not state that the drug should be used by pregnant women “only as a last resort.”  In an opinion rife with wrong, we found this “last resort” argument to be the furthest from the mark.  We know of nothing in law or regulation that invites a judge to deem that only specific semantics would have rendered a warning adequate, when the label warned of the precise risk that befell the plaintiff and included an accurate statement of the incidence of that risk.

Finally, the judge held that the jury could reasonably infer that the label was “materially misleading” when it stated that all antiepileptic drugs carried a risk of birth defects, based on evidence that the defendant’s drug carried a higher risk of spina bifida than other drugs in the class. As such, the judge held, the jury could conclude that the defendant “watered down” the spina bifida risk when it lumped the drug in with others that carried a “much lower risk of spina bifida.” E.R.G., 2017 WL 3055520 at *3.  The judge concluded, “Ultimately, there was more than enough evidence presented in Plaintiff’s case in chief to support an argument that the label, including the spina bifida waning was inadequate.” Id. 

            Warnings Causation 

Because the plaintiff’s mother’s physicians testified that they were aware of Depakote’s teratogenic effects when they prescribed the drug, the defendant argued that the plaintiff had not established that any inadequacy of the drug’s warnings was a proximate cause of the plaintiff’s injuries. The plaintiff countered that the issue was not whether the defendant “failed to warn generally of ‘teratogenic effects’” but whether the defendant “provided full, accurate, and complete information about Depakote’s total teratogenic risks and instructions on the safe use of Depakote in women of childbearing age . . . .” Id. Forgive us, but we fail to see the distinction here.  One of the last two physicians to prescribe the drug before the plaintiff was conceived testified that he would have advised the plaintiff’s mother to stop taking the drug if he had been advised to use it as a “last resort” (the chosen language of the plaintiff’s expert and the judge), but he later testified that he would not have “taken away” the drug if the plaintiff’s mother had insisted on taking it.  The judge concluded, “. . . [A] reasonable jury could find that . . . a stronger warning would have caused [the last prescriber] (who was already on the fence about the efficacy of Depakote for [the plaintiff’s mother], to stop prescribing the drug.” Id. at *4.   We think this is a stretch, given the testimony.

The judge may have thought so, too, because she made a confusing attempt to justify her conclusion.   She postulated, “If the jury believed that [the doctor] would have discontinued [plaintiff’s mother’s] prescription in favor of a different [drug], then the jury could reasonably infer that she would still have been off of Depakote when she went to see [the other doctor] for her final visit” to the doctors’ clinic. Id. “Nothing in the testimony of [the second doctor] indicates that if [the plaintiff’s mother] had shown up for her appointment on [a different drug], he would have independently restarted the Depakote prescription.  [The second doctor] that, while he did make an independent assessment of [the plaintiff’s mother] at her last visit, he repeatedly asserted that he was ‘refilling’ her medication.” Id. (citation omitted).   Have trouble following that?  Can’t figure out what it has to do with warnings causation?  Neither can we.  Bottom line is that the prescribers knew that the drug could cause spina bifida and prescribed it anyway.  And, even if the imaginary “last resort” language had been included, the doctor would not have taken the drug away from the plaintiff’s mother if she wanted to keep taking it.  We fail to see how any of this adds up to warnings causation, except in the mind of a judge who didn’t want to grant the defendant’s motion.

  1.  Motion for New Trial 

Predictably, the judge also denied the defendant’s motion for a new trial. Some highlights of that decision:

Mother’s Testimony

In this case, unlike what we are used to seeing in the prescription drug context, the patient – the plaintiff’s mother – was apparently warned about birth defects while the plaintiff alleged that the prescribers weren’t. This led to an upside-down trial in which plaintiff didn’t call his mother in his case in chief while the prescribers testified live.   When the defendant learned that plaintiff’s mother was not being called, it filed a motion to compel her to sit for a de bene esse deposition.  The judge denied the motion, and this denial was one of the bases of the defendant’s motion for a new trial.  The judge held that her denial of the defendant’s motion was proper because the defendant had not adequately explained why the mother’s fact deposition (which was not videotaped) “did not accurately capture her testimony.” Id. (This in spite of the fact that, in our experience, plaintiffs routinely win motions like these.)

“Top 3” Opinion 

The defendant challenged the admission of one of the plaintiff’s expert’s opinions that Depakote was one of the “top three” teratogenic drugs in the PDR, arguing that the opinion was not the product of a reliable methodology. The court disagreed, holding, “While a different expert may come to a different conclusion or may even use a different methodology to determine what the three worst drugs are in terms of teratology, that is not the test for excluding an opinion under Daubert.” Id. at *6.

Improper Comments in Plaintiff’s Closing Argument 

The defendant argued that prejudicial comments in the plaintiff’s closing argument entitled it to a new trial.   These included the comment that the defendant was “guilty as hell” (the judge had to explain to the jury that this was not a criminal trial), as well as comments suggesting that compensatory damages should be based on the defendant’s alleged “bad behavior” (the judge halted this line of argument after the defendant objected that it was an argument for punitive damages, not compensatories) and that the jury, through its award “had a chance to make a decision about the kind of world [it] wanted to live in.” Id. at *7 (citation omitted).  The judge, predictably, held that none of the comments was “overly prejudicial.” Id.  

And so the verdict was allowed to stand. While we reiterate that we were not always able to follow the judge’s reasoning, our takeaway was that she started with her desired result and worked backwards.   As for us, our next foray onto the Great White Way occurs next week, when we accede to a request from the Drug and Device Law Rock Climber that we accompany her to the production of 1984 currently playing at the Hudson Theatre.  This production is notable for the proliferation of audience members fainting and vomiting during the torture scene, so we suspect that cheerfulness may not permeate our description.  And we will have to find a case that makes us queasy so we can easily tie it in.  Based on today’s decision, we suspect this will not be too difficult.  We’ll keep you posted.

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

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

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

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

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

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

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

Id. And there’s the beauty.

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

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

We’ve heard more about the constitutional “emoluments clause,” Art 1 §9, clause 8, this year than during the entire rest of our legal careers.  But while it’s illegal for anybody working for the U.S. government to accept anything of value from a “foreign state,” that doesn’t make it illegal, unethical, or even particularly noteworthy for a “learned intermediary” to accept things of value from prescription medical product manufacturers – provided, of course, that doing so doesn’t adversely affect patient care.

For example, the FDA knows and accepts that not only patients/subjects in clinical trials, but also physicians/investigators are routinely paid for their trouble. The FDA’s longstanding Guidance for Industry Financial Disclosure by Clinical Investigators does not require disclosure of “normal reimbursable expenditures” that compensate investigators for routine costs, as long as payments do not “exceed reasonable expectations.”  2001 WL 34768176, at *11.  Such expenses aren’t seen as having a “potential for bias.” Id. at *1.  Even interests that could potentially be a source of bias aren’t prohibited, or limited – they must only be disclosed:

  • Compensation the “value of which could be affected by study outcome.”
  • “A proprietary interest in the tested product”
  • An “equity interest in the [study] sponsor.”
  • “Any equity interest in a publicly held company that exceeds $50,000”
  • “Other sorts” of payments with “a cumulative monetary value of $25,000 or more made by the [study] sponsor.”

Id. at *1-2.

Thus, we don’t have much good to say about a couple of Texas district court opinions that would create an exception to the learned intermediary rule whenever the plaintiff’s prescriber has received any sort of compensation.  Not only is creating exceptions to state common-law rules none of a federal court’s business, but such a broad exception is contrary to precedent and totally unnecessary.

Anyway, the first of these cases was Murthy v. Abbott Laboratories, 847 F. Supp.2d 958 (S.D. Tex. 2011).  The plaintiff was a participant in the defendant’s clinical trial, and signed the standard informed consent documents to participate. Id. at 964.  Murthy refused to apply the learned intermediary rule, “first” because the defendant “arguably directly marketed” the drug to the plaintiff “by creating a promotional video,” and “second” because the prescriber – plaintiff’s doctor – “was compensated by [defendant].” Id. at 967.

Murthy then launched into an extended discussion of the “foundations” of the learned intermediary rule under Texas law.  Id. at 967-70.  This exegesis was not necessary.  The Fifth Circuit, whose law Texas district courts are bound to follow, has repeatedly recognized that Texas applies the learned intermediary rule to all prescription medical products.  Pustejovsky v. PLIVA, Inc., 623 F.3d 271, 276 (5th Cir. 2010) (generic drug); Ebel v. Eli Lilly & Co., 321 Fed. Appx. 350, 355-56 (5th Cir. 2009) (branded drug); Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203, 207-08 (5th Cir. 2008) (same); McNeil v. Wyeth, 462 F.3d 364, 368 (5th Cir. 2006) (same); Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir. 1999) (medical device); Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 (5th Cir. 1992) (contrast medium); Hurley v. Lederle Laboratories, 863 F.2d 1173, 1178 (5th Cir. 1988) (vaccine).  The only loophole to the learned intermediary rule ever recognized under Texas law is the so-called “mass vaccination” exception – where a nominally prescription product was dispensed with no doctor, and thus no physician-patient relationship, actually present.  See Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1277-78 (5th Cir. 1974).

However, Murthy was bound and determined to change Texas law.  Rather than follow binding Fifth Circuit precedent, the decision latched onto a “recent[]” decision by a “Texas state appellate court [that] recognized an exception to the learned intermediary doctrine.”  Id. at 970.  That was the so-called “direct-to-consumer” (“DTC”) exception where, according to Murthy, “a drug manufacturer practices consumer marketing that fraudulently touts the drug’s efficacy while failing to warn of the risks.”  Id.  After a long paragraph describing the DTC exception, Murthy pointed out (accurately) that the Texas Supreme Court had yet to pass on any learned intermediary rule exception.  Id.

At this point Murthy imitated Captain Kirk – boldly going where no federal court had gone before.  In the absence of on-point Texas precedent, Murthy elected to “consider, among other sources, treatises, law review commentaries, [and] decisions from other jurisdictions.” Id. at 971 (citation and quotation marks omitted).  What followed were several pages (and long footnotes) that resembled what we saw in Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1257-59 (N.J. 1999), or State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 472-75 (W. Va. 2007) – both of which were cited in Murthy – long on rhetoric and citations to law reviews, but notably lacking in precedent that actually did what Murthy was proposing.

What did Murthy propose?

First it jumped on the DTC exception bandwagon.  Id. at 971 (“the Court believes that the Texas Supreme Court will likely agree with the Court of Appeals’ reasoning”).  “By creating and disseminating a promotional video . . ., [defendant] may have circumvented the doctor-patient relationship.” Id.

Then Murthy turned to the “gifts or compensation” that the prescriber-investigator had received for participating in the clinical trial in which plaintiff had been enrolled:

Studies have documented, however, that gifts or compensation from drug companies influence medical professionals’ treatment decisions.  Conflicts of interest also arise when clinicians stand to gain from enrolling their own patients as subjects in clinical trials. Indeed, a doctor who receives gifts or compensation from a drug company may no longer, as the prescriber, stand between the drug and the ultimate consumer, as the doctor has an incentive to prescribe a particular drug or, in this case, enroll a patient in a clinical trial. . . .  Under certain circumstances, when a physician receives compensation or gifts from drug companies, his or her role as the neutral decision-maker may be diminished.  As such, dismissal of [plaintiff’s] failure to warn claim on learned intermediary grounds would not be appropriate at this time.  Rather, the Court would have to examine the factual circumstances surrounding the compensation of [plaintiff’s] physician in order to evaluate whether application of the learned intermediary doctrine is appropriate.

Id. at 971-73 (citations, quotation marks and two gigantic footnotes to “studies” omitted).  In the end, however, all this discussion in Murthy was merely an extended exercise in obiter dictum – a judicial hit and run − as the warning claims in that case had to be dismissed for another reason.  See Id. at 975-76 (all warning claims fail under Texas statutory presumption of adequacy in FDA-approved warnings).

The second case, In re Depuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016) (“DOPHI”), purported to turn Murthy’s case-by-case evaluation into a blanket compensation exception:

Moreover, the learned intermediary doctrine does not apply when a manufacturer compensates a physician or incentivizes him or her to use its product.   Murthy v. Abbott Labs, 847 F. Supp. 2d 958, 971-73 (S.D. Texas 2012).   Because of the relationship between [defendant] and [the prescribers], a fact question exists regarding the legitimacy and objectiveness of [these prescribers] that precludes application of the learned intermediary doctrine as a basis for summary judgment.

Id. at *6.

There are a number of problems with this nascent emoluments exception to the learned intermediary rule.  First, its meager support in Texas precedent was blown away when the Texas Supreme Court unanimously reversed the “appellate court” decision that Murthy had followed and just an unanimously adopted the learned intermediary rule:

[W]e hold that a prescription drug manufacturer fulfills its duty to warn end users of its product’s risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly. . . .  Our decision to apply the learned intermediary doctrine in the context of prescription drugs, prescribed through a physician-patient relationship, not only comports with our prior references to the doctrine and many years of Texas case law, but it places us alongside the vast majority of other jurisdictions that have considered the issue. . . .  The underlying rationale for the validity of the learned intermediary doctrine remains just as viable today as stated by Judge Wisdom in 1974.

Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 157-58 (Tex. 2012) (long string-cite footnote and quotation from Reyes, supra omitted).

As for exceptions to the learned intermediary rule, the Texas Supreme Court declined to recognize any.  Id. at 160 n.18 (“we need not determine whether Texas law should recognize exceptions to the learned intermediary doctrine”).  Particularly with respect to the DTC exception Centocor held:

We acknowledge that some situations may require exceptions to the learned intermediary doctrine, but without deciding whether Texas law should recognize a DTC advertising exception when a prescription drug manufacturer distributes intentionally misleading information directly to patients or prospective patients, we hold that, based on the facts of this case, no exception applies.

Id. at 162 (footnote omitted)  (emphasis added).  In the omitted footnote the Texas Supreme Court further criticized the decision that Murthy had blithely predicted it would follow, stating “[t]he court of appeals’ reasoning . . . relegates physicians to a mere dispensary role of prescriptions [and] fails to consider the important professional and ethical standards the law requires of physicians.”  Id. at n.24 (citing Texas statutes governing physician conduct).

After the Centocor reversal, the putative emoluments exception to the learned intermediary rule in Texas rests on precisely zero precedent, only the law journal articles and other studies that Murthy used to justify its prediction.

That brings us to the second point.  Perez and Karl, however wrong we believe them to be (and Karl has since been legislatively overturned), were decided by state high courts.  Those courts have the authority to change state law, even changes based entirely on academic musings, if they so decide.  Murthy and DOPHI, being federal district courts exercising diversity jurisdiction, do not have such authority.  We’ve been over this many times before on the blog.  In the words of the Supreme Court:

A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975).  The Fifth Circuit, which as we mentioned includes Texas, agrees:

No Texas court has interpreted [the law] that way.  And we see no other sufficiently strong indication to make an Erie guess that the Supreme Court of Texas would do so.  [I]t is not for us to adopt innovative theories of Texas law, but simply to apply that law as it currently exists.

Barnett v. DynCorp International, LLC, 831 F.3d 296, 307 (5th Cir. 2016) (citations and quotation marks omitted).

[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it.  The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.

Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008) (citations omitted).  Accord, e.g., Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 616 (5th Cir. 2014); Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 184 (5th Cir. 2012); Holden v. Connex-Metalna Management Consulting GmbH, 302 F.3d 358, 365 (5th Cir. 2002); Batts v. Tow-Motor Forklift Co., 66 F.3d 743, 749 (5th Cir. 1995); Solomon v. Walgreen Co., 975 F.2d 1086, 1089 (5th Cir. 1992); Dean v. Dean, 837 F.2d 1267, 1268 (5th Cir. 1988); United Parcel Service, Inc. v. Weben Industries, Inc., 794 F.2d 1005, 1008 (5th Cir. 1986); Galindo v. Precision American Corp., 754 F.2d 1212, 1217 (5th Cir. 1985).

Finally, our third point is that no other state in the union has adopted any sort of emoluments exception to the learned intermediary rule.  Rather, such claims have been occasionally made, and always rejected, in other states.  That’s quite logical.  Unlike the mass vaccination exception, less accepted exceptions involving consumer choice products (contraceptives) or FDA-mandated DTC warnings – or even the New Jersey-only DTC advertisement “exception” – every other purported exception to the learned intermediary rule has at its justification some kind of communication that avoids the physician-patient relationship.  Claims about financial relationships with prescribers don’t do that.  Rather, they seek to attack an existing relationship using emoluments to claim the physician wasn’t “independent” of the drug/device company.  That’s not a proper “exception” to the learned intermediary rule; that’s a causation issue, if anything other than a smoke screen.  To the extent there is ever any evidence of actual influence over a particular patient’s prescription decision, that is more logically dealt with as tending to defeat a causation defense, but it is not a basis to require direct manufacturer-to-patient warnings where a physician/patient relationship has already been established, which is what exceptions to the learned intermediary rule require.

The first cases to assert financial relationships in opposition to the learned intermediary rule were in Ohio.  In Blatt v. Hamilton, 1986 WL 2925 (Ohio App. March 6, 1986), the plaintiff claimed that his prescriber’s receipt of free drug samples meant that the prescriber should be viewed as the defendant’s agent.  The court disagreed:

The mere fact that a salesman of the manufacturing company gives samples to a doctor and the doctor distributes these samples to a patient, without more, does not prove an agency relationship. . . .  There was no evidence that . . . the manufacturer, had control as to whom, when, in what doses, and in what form, topical or oral, the [drug] was prescribed or distributed by [the prescriber].

Id. at *3 (citation omitted).  Then, in Tracy v. Merrell Dow Pharmaceuticals, Inc., 569 N.E.2d 875 (Ohio 1991), the Ohio Supreme Court considered facts quite like Murthy – the prescriber had treated the patient under an investigational research protocol and received a per patient payment from the manufacturer.  Id. at 879.  The receipt of routine research-related compensation did not, Tracy ruled, compromise the prescriber’s independence:

Although [defendant] paid [the prescriber] for each participant in the . . . study program, the evidence does not support a finding that [the prescriber] was an employee of [defendant] or that [the prescriber] was acting under the control of [defendant] rather than as a physician exercising his independent judgment. . . .  [Defendant] did not control [the prescriber’s] judgment, duties and responsibilities as he used [the drug] in the treatment of patients.  Accordingly, we find that [the prescriber] was acting as an independent physician in dispensing [the drug] to [plaintiff], that he was a learned intermediary and that the trial court correctly instructed the jury on the learned intermediary doctrine.

Id.

Participation in clinical trials similarly did not affect the learned intermediary rule in Little v. Depuy Motech, Inc., 2000 WL 1519962 (S.D. Cal. June 13, 2000).  “The Court [was] not persuaded by Plaintiffs argument that [the prescriber] was not an independent intermediary because he was part of an investigational team” that studied the type of product and surgery at issue.  To the contrary, such study “further support[ed] the finding that [the prescriber] knew about the risks associated with such devices,” and thus defeated causation.  Id. at *9.  Likewise, in a Texas trial court decision neither Murthy nor DOPHI cited, the plaintiff “contend[ed] that [defendant’s] alleged . . . misconduct influenced [the prescriber’s] treatment recommendations because of the fees he received.”  Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *24 (Tex. Dist. Harris Co. June 7, 1999), aff’d mem., 2000 WL 991697 (Tex. App. July 20, 2000).  The court gave that allegation the back of its hand.  “This contention has been rejected.”  Id.

In In re Trasylol Products Liability Litigation, 2011 WL 2117257 (S.D. Fla. May 23, 2011) (applying Alabama law), allegations that the prescriber was “biased because he was a consultant for [defendant], and was paid to attend a Trasylol conference” failed to prevent summary judgment under the learned intermediary rule. Id. at *4.

Plaintiff’s assertions that the learned intermediary doctrine should not apply because [the prescriber] is biased and failed to exercise independent medical judgment do not persuade me. . . .  Plaintiff does not offer evidence that [the prescriber’s] choice to prescribe [the drug] for [plaintiff] was not an informed one, or that he did not exercise individualized medical judgment in making that decision.

Id.

In less routine situations, allegations that prescriber held stock in the defendant or received large sums in compensation have not affected the applicability of the learned intermediary rule.  In one of Bexis’ Bone Screw appeals, Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999) (applying Virginia law), the prescriber was a an equity holder in, and a paid consultant for, the defendant.  Id. at 164 (paid to teach surgical procedures, annual $250,000 consulting fee, travel budget, research funds, and 25,000 shares of stock).  The plaintiff argued that, because of these ties, the prescriber “cannot be considered an intermediary, learned or otherwise.”  Id.  Summary judgment under the learned intermediary rule was affirmed because that evidence was not connected to anything that occurred in the plaintiff’s treatment.  “[T]here is no evidence that the consulting relationship between [the prescriber] and [defendant] interfered with [his] independent medical judgment in treating [plaintiff].  On the contrary, the evidence suggests otherwise.”  Id.  Whether financial ties caused injury by lack of “independence” was a “complex question would depend on the nature of the relationship between the manufacturer and the physician and the extent to which the physician was in fact afforded independence in making medical judgments.”  Id. The Trasylol decision followed Talley.  2011 WL 2117257, at *4.

In In re Zyprexa Products Liability Litigation, 2010 WL 348276, at *11 (E.D.N.Y. Jan. 22, 2010) (applying Illinois law), the plaintiff “contend[ed] that summary judgment should not be granted on learned intermediary grounds” because his prescribing physician was “biased” by having “conducted paid research for at least ten pharmaceutical companies, including defendant,” having been “a paid speaker for at least six pharmaceutical companies, including [defendant],” and having “accepting $490,000 in compensation from” drug companies.  Id. at *11.  Such facts did not oust the learned intermediary rule because nothing showed any “bias specific to” the drug or towards the defendant.  Id.

Allegations of compensation of a similar magnitude did not impair California’s learned intermediary rule in In re Vioxx Cases, 2006 WL 6305292 (Cal. Super. Dec. 19, 2006).  A plaintiff argued that his prescriber could “not play the role of learned intermediary because it paid him hundreds of thousands of dollars over the years to conduct research and give lectures.”  Id.  Absent “evidence of actual bias” the compensation didn’t matter:

Payment to a physician, standing alone, does not deprive the physician of learned intermediary status. Such payment for research is a widespread practice, yet the court was unable to find a case where a physician who was paid for research was considered to have abrogated his or her role of learned intermediary.  Therefore, such payments alone do not constitute a “special circumstance” for purposes of setting aside the learned intermediary doctrine.  Indeed, if such payments alone sufficed, a manufacturer would have to obtain the patient list of every physician it pays for research in order to somehow provide direct warnings.

Id.

Nor does Murthy itself have much of a track record.  DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601 (S.D.N.Y. 2012), rejected Murthy’s rationale notwithstanding plaintiff’s allegation that her prescriber “may have had a direct financial relationship with [defendant].” Id. at 613.

This argument fails on both the law and the facts.  On the law, plaintiff has not cited any New York decision that adopts an exception to [learned intermediary rule] where physicians received compensation from drug manufacturers.  Murthy applied Texas law, and plaintiff has not demonstrated that Murthy is part of any trend supporting an exception . . . where drug manufacturers compensate physicians.  On the facts, moreover, plaintiff’s allegations that [defendant] compensated [the prescriber] are completely speculative, based entirely on what [defendant] allegedly did in other cases involving other physicians.

Id. at 616 (citation and footnote omitted).  Even assuming what plaintiff claimed was true, however, would not oust the learned intermediary rule, because “[i]t is not clear . . . that manufacturer-compensated physicians would in fact neglect their professional duties to an extent that would undermine” the rule.  Id. at 616 n.6.  See also Calisi v Abbott Laboratories, 2013 WL 5462274, at *3-4 (D. Mass. Feb. 25, 2013) (refusing to follow Murthy and rejecting any “physician compensation exception” to the learned intermediary rule).

Finally, similar emolument-related allegations have failed as challenges to otherwise uncontradicted prescriber testimony.  In Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (applying Oklahoma law), summary judgment for the defendant was affirmed under the learned intermediary rule on the basis of the prescriber’s prior independent knowledge of the relevant product risks.  Id. at 1019.  Even with the benefit of a heeding presumption, the plaintiff could not successfully assert the prescriber’s “research for several pharmaceutical companies” as a basis for creating a credibility issue.  Id. at 1024.  Such pharmaceutical affiliations, “standing alone, however, merely offer speculation as to [the prescriber’s] motives for testifying and they are clearly insufficient to call into question either [her]  credibility or the veracity of her statements.”  Id.  “Absent evidence suggesting [the prescriber] was otherwise influenced by the defendants, we . . . find no reason to question her credibility or the truth of her testimony.”  Id.  See Miller v. Pfizer, Inc., 196 F. Supp.2d 1095, 1129 & n.108 (D. Kan. 2002), (“no reasonable jury” could “discredit” unrefuted prescriber testimony based on “bias . . . arising from his business relationship with [defendant], i.e., the fact that at or near the time he prescribed [the drug] for [plaintiff, he] was a paid consultant”), aff’d, 356 F.3d 1326 (10th Cir. 2004).

Based on the above, we believe there is no legal basis for an “exception” to the learned intermediary rule predicated on a prescribing physician having a pre-existing relationship, financial or otherwise, with a defendant manufacturer of prescription medical products.  Perhaps, in an extreme case, there might be actual evidence of bias affecting a particular plaintiff’s medical treatment, but we have yet to see any such case.  Even in the case of significant emoluments, see Talley, Zyprexa, Vioxx, supra, plaintiffs have been unable to establish a jury submissible case of actual, causal bias.  Murthy and DOPHI, exceeded the proper role of federal courts exercising diversity jurisdiction, and their novel predictions are belied by extensive contrary precedent.

In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in surgery.  Surgeonless surgery would “allow[] work around the clock with higher productivity, accuracy, and efficiency as well as shorter hospital stays and faster recovery.” Science, at 28.  The listed drawbacks were:  “technical difficulties in the midst of a surgery,” the “loss of relevance of surgeons,” and “how to equip artificial intelligence with tools to handle . . . inherent moral responsibility.”  Id.

Fascinating.  In addition to driverless cars, do we also need to contemplate surgeonless surgery?  We’ve long been aware of the advent of robots as an adjunct to surgery.  Bexis filed a (largely unsuccessful) PLAC amicus brief in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), but the surgical robot in Taylor in no way threatened to displace the surgeon, and the applicability (if not application) of the learned intermediary rule in Taylor was undisputed.  Id. at 526-28.

We checked the Internet, and sure enough there were plenty of articles from reputable sources:

Completely automated robotic surgery: on the horizon?” (Reuters)

Autonomous Robot Surgeon Bests Humans in World First” (Inst. of Electrical & Electronics Engineers)

Would you let a robot perform your surgery by itself?” (CNN)

The Future Of Robotic Surgery” (Forbes)

Science fiction?  Apparently not anymore.  As the last article stated:

Having totally automated procedures was once a thing of science fiction, very futuristic and not very practical. . . .  But over the last three or four years, technology has evolved and this has become a possibility.  I think potentially we’ll see some automated tasks in the medical field in the next five years.

All these articles are from 2016.

Since we’ll still be practicing law in five years, we thought we’d better start thinking about this.

First, will there be product liability litigation involving autonomous surgical robots at all?  Existing surgical robots appear to have been “cleared” by the FDA, Taylor, 389 P.3d at 520, so there hasn’t been much of a preemption barrier to bringing suit.  We’re not FDA regulatory specialists, but we have some doubt about how a fully autonomous surgical robot – described as something out of “science fiction” in the articles – could be marketed as “substantially equivalent” to existing devices.  If autonomous surgical robots, or the software that runs them, must go through FDA pre-market approval, then they would be protected by preemption, subject only to “parallel claims” that the manufacturer somehow violated relevant FDA regulations.  We are assuming, perhaps incorrectly, the continuity of the current preemption regime for medical devices.

Second, what happens to the learned intermediary rule where the product itself – an autonomous surgical robot – stands in the shoes of the traditional learned intermediary?  Plaintiffs would, of course, give the same answer as always:  Abolish the rule as outdated.  We disagree.  Any consideration of the jurisprudential reasons for the learned intermediary rule, discussed here, suggests just the opposite.  The rule exists because patients can’t be expected to understand for themselves the complexities of prescription medical products, so the law demands that the scientific and technological information necessary to make intelligent use of these products be provided to trained, professional “learned intermediaries,” who are then expected to counsel their patients about individualized treatment decisions.

Does this rationale apply to autonomous surgical robots?  Absolutely.  These products will be some of the most advanced and complex medical technology yet produced, and the law cannot expect their manufacturers simply to provide patients with the instructions for use, tell them to “have at it” and make up their own minds.  More than ever, patients will need medical professionals to explain the risks, benefits, and alternatives of automated surgery.  Who, then, becomes the learned intermediary when the traditional role of the surgeon is performed by a “product” in a potential legal action?  Looking to the purposes of the learned intermediary rule, our answer, at this point, is whichever physician whose legal duty it is to conduct the informed consent discussion with the patient.  The learned intermediary rule exists in large part to ensure that the doctor who will be advising the patient has adequate information to do so.  The professional standard that the medical community ultimately adopts to handle informed consent in automated surgery is its own business.  But however the medical community resolves that issue, the duty of the robot manufacturer should be the same as ever:  to provide information about the product adequate to enable the learned intermediary to evaluate that information, along with the patient’s medical history, in order to make proper treatment decisions and to explain these decisions to the patient.

Third, what will the advent of autonomous surgical robots do to the legal distinction between “services” and “product sales” that has traditionally protected health care providers – including hospitals − from strict liability?  We don’t know.  The answer probably depends on how the medical community integrates these robots into the health care system generally.  If robotic surgery is carried out under the close supervision of medical professionals, then probably not much will change in terms of the sales/services distinction.  That has been the case with currently available robot-assisted surgery.  See Moll v. Intuitive Surgical, Inc., 2014 WL 1389652, at *4 (E.D. La. April 1, 2014) (robot use did not remove surgical claim from scope of malpractice statute).

However, if cost consciousness leads to “routine” automated surgery being conducted with only technicians on hand to ensure that the robots are functioning properly, then the entire exercise starts to look more like the use of a product than the provision of medical services. Once again, it will be up to the medical community to develop its standards of care for the use of autonomous surgical robots.  If necessary, the law will adapt.

A number of sources of potential liability associated with automated surgery, such as failure to detect an unexpected cancer,or a non-robot-related intra-operative complication (like an adverse reaction to anesthesia) would appear to implicate medical malpractice theories of liability (e.g. “lost chance”) rather than product liability.  How will courts handle claims at the intersection of medical malpractice and product liability − that, however good the robotic software is at its intended surgical use, it does not allow the robot to react to the unexpected like human surgeons can?

Fourth, in terms of product liability, what’s the “product?”  Here, we mean whether the software, including the MRIs, CAT scans and other patient imaging data, is considered something separate from the physical robot itself.  Is the software purchased, or provided, separately from the hardware that is the visible robot?  This distinction could make a big difference in available theories of liability.  It could also be important in determining component part liability in cases where the hardware and software manufacturers point fingers at one another.  In such cases, possible defendants include healthcare professionals, hospitals that maintain the robots, manufacturers of robotic hardware, and providers of software – both the software that runs the robot and patient-specific electronic scans.  As now, there is also the possibility that the patient may not follow proper instructions.  Will autonomous surgical robots be required to have aviation-style “black boxes” to provide post-accident information?

The prevailing view under current law has been that software is not a “product.”  “Courts have yet to extend products liability theories to bad software, computer viruses, or web sites with inadequate security or defective design.”  James A. Henderson, “Tort vs. Technology: Accommodating Disruptive Innovation,” 47 Ariz. St. L.J. 1145, 1165-66 n.135 (2015).  The current restatement defines a “product” as “tangible personal property.”  Restatement (Third) of Torts, Products Liability §19(a) (1998).  In a variety of contexts, software has not been considered “tangible.”  See 2005 UCC Revisions to §§2-105(1), 9-102; Uniform Computer Information Transactions Act §102(a)(33) (NCCUSL 2002); ClearCorrect Operating, LLC v. ITC, 810 F.3d 1283, 1290-94 (Fed. Cir. 2015); United States v. Aleynikov, 676 F.3d 71, 76-77 (2d Cir. 2012); Wilson v. Midway Games, Inc., 198 F. Supp.2d 167, 173 (D. Conn. 2002) (product liability case); Sanders v. Acclaim Entertainment, Inc., 188 F. Supp.2d 1264, 1278-79 (D. Colo. 2002) (product liability case).  However, a couple of cases have gone the other way.  Winter v. G.P. Putnam’s Sons, 938 F.2d 1033, 1036 (9th Cir. 1991) (dictum in case involving books); Corley v. Stryker Corp., 2014 WL 3375596 at *3-4 (Mag. W.D. La. May 27, 2014), adopted, 2014 WL 3125990 (W.D. La. July 3, 2014).  Also of possible note, a legally non-binding 2016 FDA draft guidance considers software to be a “medical device” subject to FDA regulation in situations that would probably include autonomous surgery.

The availability – or not – of strict liability could be a big deal in cases alleging injuries arising from fully automated surgery performed by autonomous surgical robots.  What caused the injury?  Was there a problem with the robot’s hardware (such as a blade or needle malfunction)?  Was the robot incorrectly maintained?  These issues would not implicate the robot’s software.  On the other hand, was there a defect in the surgical software’s algorithms (that is, a design defect)?  Was the software designed properly but somehow corrupted (that is, a manufacturing defect), or hacked (intervening cause).  Or, to introduce a different defendant, was there some sort of error in the electronic patient-imaging files that told the robot how to operate on this particular patient?

In strict liability, a “product” defect is the key element of liability (as is a “good” for warranty claims).  A product malfunction, in the absence of reasonable secondary causes, in many jurisdictions can establish a jury submissible case.  In negligence, the plaintiff must also prove breach of duty, and an accident is not generally considered probative of such a breach.  Res ipsa loquitur – the negligence version of circumstantial proof of defect – is almost unheard-of in the context of medical treatment.  If there is a “product,” then strict liability is available.  If there isn’t a “product,” the plaintiff is obliged to prove negligence.  This distinction can be important, given how difficult proof of defect is likely be.  Cf. Pohly v. Intuitive Surgical, Inc., 2017 WL 900760, at *2-3 (N.D. Cal. March 7, 2017) (rejecting theory that invisible “microcracks” caused burns during robot-assisted surgery).

These are the issues that jump out at us as we consider the possibility of autonomous surgical robots for the first time.  There are undoubtedly others.  The technological possibilities are amazing.  As defense lawyers, it is our job to ensure that these possibilities are realized, and are not put out of reach by excessive liability.

 

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case.  Applying a ruling on in limines from one case to another can be a dicey proposition as potentially significant differences in the facts, law, claims and defenses asserted, and other rulings can usually be identified.  Plus, many pre-trial decisions on evidence do not last once doors get opening and evidence can be cumulative, among other reasons why judges’ minds change.  Still, we do posts on rulings on motions in limine that we guess might have some relevance to other cases our readers have.  When we do, we can be hamstrung by the limited information in these opinions on the facts, allegations, and other rulings, such as rulings on motions for summary judgment that would typically be rendered before the in limines are decided.

In In re Depakote, No. 15-CV-702-NJR-SCW, 2017 WL 2126837, *2 (S.D. Ill. May 16, 2017), we have rulings on a grab bag of motions in limine after the court issued partial summary judgment for the drug manufacturing defendant based on “preemption of label changes related to development delay” after fetal exposure of the medication.  If this summary judgment ruling sounds familiar, then you might need a hobby.  You also might have read any number of our posts on the Rheinfrank case and the ultimate affirmance of its preemption decision and defense verdict by the Sixth Circuit.  Like here, here and here.  As we said of the appellate decision, “The court held, ‘[g]iven, then, that as of 2008 the FDA did not believe the state of the data supported a developmental delay warning, it stands to reason that as of 2003, with even less data to go on, the FDA would similarly have rejected a developmental delay warning.’ Thus, Rheinfrank joins those courts that have drawn a preemptive line barring all plaintiffs who used a drug prior to an FDA insufficient evidence decision concerning the risk at issue.”  We also wondered how the case got to a jury given trial court’s preemption decision and the requirements of Ohio law.  We have similar wonderment at the instant case, which involved 2006 fetal exposure.  The decision is sparse on facts, but it is hard to imagine a viable product liability claim for the plaintiff’s injury when plaintiff cannot prove that the label in place when the drug was prescribed to the mother should have said something different about the risk of the injury in question.  Some sort of warnings claim seems to be pending, along with a claim for punitive damages.

With that background, we turn to the subset of the 28 total motions in limine that we think matter most.  First, consistent with the preemption ruling and the applicable regulation, plaintiff could not preclude the manufacturer from explaining that a proposed change to the label through the CBE regulation is still subject to FDA’s decision to accept, reject, or modify the proposed change.  2017 WL 2126837, *2.  What the CBE regulation has to do with plaintiff’s surviving warnings claim or whether it could have used (e.g., based on new evidence of safety) is unclear. Second, plaintiff’s red herring argument about whether FDA is required to do its own post-marketing studies did not preclude the defendant from presenting evidence that it followed labeling regulations.  Third, while the court allowed some speculative evidence from the plaintiff’s mother in connection with the inquiry on proximate cause for failure to warn—which should not happen unless a different developmental delay warning has been articulated—this opened the door to some amount of evidence on what she knew and how she behaved. Id. at **2-3.

As to the defendant’s motions, the post-conception labeling and regulatory communications were excluded and defendant agreed not to raise pre-conception discussions with FDA about labeling changes that were not yet approved. Id. at *3.  (With the limited information presented in the opinion, we cannot say if there was evidence that FDA rejected or discouraged whatever labeling change plaintiff was allowed to urge in the case.)  The court also excluded a 2009 FDA alert about the risk of birth defects with the drug, although plaintiff was allowed to discuss any pre-conception studies that went into the alert. Id. at *4.  Limiting warnings evidence to what existed before the prescription at issue makes sense, but it also makes sense that there needs to be a claim based on what the warnings should have said instead at that point.  Along those lines, plaintiff was not allowed to argue that the drug should have been contraindicated for use in pregnancy because plaintiff offered no expert who disclosed such an opinion. Id. (And such an opinion would have had some preemption problems, we think.)  Plaintiff was allowed, however, to offer evidence about foreign labels for the drug in place before plaintiff’s conception, holding that the manufacturer’s knowledge of these labels was relevant to its duty to warn. Id. at **7-8.  Breaking somewhat from its previously firm line on the irrelevance of the post-conception evidence to the warnings claim, the court did not foreclose the possibility that some post-conception marketing materials could be relevant if “they contain pre-2006 facts.” Id. at *6.  Again, we would think the pre-2006 facts would need to relate to whatever about the 2006 warnings for developmental delay that plaintiff was allowed to claim should have been different.

There was one last ruling that bears some discussion.  The defendant had pleaded guilty to a misdemeanor and paid a very, very large fine related to allegations of off-label promotion for use of the drug for schizophrenia and elderly dementia, which were not labeled indications. Id. at *9.  The plaintiff’s mother did not use the drug for these conditions and there was no evidence to “connect these activities with the 2006 Depakote teratogenicity warning.” Id. So, there was far too much prejudice compared to the probative value to let the jury hear about the plea or fines.  However, plaintiff was allowed to “introduce evidence regarding the off-label marketing and sales efforts . . . regarding bipolar disorder,” which was an indication added during 2006 (based on our quick look). Id.  The court saw this evidence as supporting plaintiff’s claim for punitive damages.  It seems to us that a plaintiff’s punitive damages evidence is not relevant unless it tends to show that the underlying conduct giving rise to liability was done with the requisite intent.  It does not sound like there is any connection between an alleged, non-preempted issue with the 2006 warnings for developmental delay and any off-label promotion issue, but maybe that link was just not spelled out in the opinion.

 

 

However a drug/device product liability is styled, it will almost always be focused on a claim of failure to warn.  Why do plaintiffs insist on inserting a cause of action for manufacturing liability when there is not a whiff of evidence that anything went wrong on the production line?  Seldom do we see the pharma equivalent of a mouse in the Coke bottle or, thinking of a more recent case, a bat in the salad.  Similarly, a design defect claim is often a make-weight claim.  How should the design have been improved?  Not selling the product at all is hardly a design improvement.  An entirely different product is not a safer alternative under the law of any enlightened state.  Changing the molecule or the device design cannot be done without FDA approval, so preemption should apply (even if courts often miss this point).  No, failure to warn is where the action is.  In the wake of Wyeth v. Levine, it seemed that preemption would be a tough row to hoe in such cases, but keep hoeing that row because the preemption defense might still be available – as a motion to dismiss, summary judgment motion, directed verdict, or argument to the jury.

 

The recent case of Amos v. Biogen Idec, Inc. et al., 2017 WL 1316968 (W.D.N.Y. April 10, 2017), makes every one of these points for us.  The court granted summary judgment to the defendants in that case, holding that all of the claims were fundamentally about failure to warn, the warning was adequate as a matter of law, and the FDA’s earlier rejection of proposed warnings meant that the plaintiff’s claims were preempted.  The facts of Amos present the sort of situation defendants encounter all too often, but which make for a hard sell to a jury: something very sad happened to an innocent patient, but it was nobody’s fault.  The patient had Multiple Sclerosis too severe to respond well to the usual treatments.  Her doctor recommended Tysabri.  That medicine came with a black box warning that it might increase the risk of Progressive Multifocal Leukoencephalopathy (“PML”), a viral infection of the brain that is as incurable as MS is.  The patient eventually contracted PML and died.  Her estate filed a lawsuit that included claims for negligence, negligent misrepresentation, strict liability, and breach of implied warranty. 

 

From the recital of facts in the Amos case, it appears that the manufacturer of Tysabri was quite diligent and proactive.  It also appears that the defense attorneys did an excellent job of mining the administrative record.  The manufacturer continued to perform clinical trials after initial approval, and promptly alerted the FDA of whatever risks it observed.  Among other things, the company asked the FDA to add information in the label about screening for certain virus antibodies that might increase the risk of PML.  The FDA rejected this proposal a couple of times, finding insufficient evidence at those times to support the label change.  The FDA ultimately relented and approved a label change in 2012 – after the plaintiff’s decedent died.

 

In considering the defense motion for summary judgment, the court concluded that all of the plaintiff’s claims turned on the sufficiency of the warnings.  New York law applied, and there was ample precedent under New York law that adequate warnings precluded claims for negligence, strict liability, breach of warranties, or fraud.  What’s more, the learned intermediary applied to claims regarding prescription drug warnings, and the record was replete with evidence that the prescribing doctor was well aware of the increased risk of  PMI.  It certainly helped the defense that the defendant, in collaboration with the FDA, had created a program called Tysabri Outreach: Unified Commitment to Health (“TOUCH”), which required that, prior to prescribing Tysabri, a physician had to acknowledge in writing that he/she understood the risks of PML and obtained a written acknowledgment from the patient that the patient understands the PML risk. The existence of the TOUCH program was one of several facts that made Amos a hard case for the plaintiff to win.

 

Even so, we all know that no matter how comprehensive and informative a warning label is, a good plaintiff lawyer can flyspeck it and find, or make up, some gaps.  The plaintiff lawyers in the Amos case are well known to us, and are very, very good.  They argued that the Tysabri warnings were inadequate because they failed to include information regarding the correlation between the virus antibodies and PML, and failed to inform doctors of the risks associated with duration of treatment and prior treatment with an immunosuppressant.  To our eyes, the plaintiff lawyers made the best arguments they could.  In too many courts, such an argument would furnish enough of a crutch for a plaintiff-leaning (or lazy-leaning) judge to mutter ‘factual dispute’ and deny the motion in a post-card ruling.  But not this court.  The judge analyzed New York law and held that even without the details regarding specific risk factors, “when read as a whole, the warnings unmistakably conveyed the seriousness of PML and its association with Tysabri treatment.”  That “read as a whole” point is important.  Do not let a court tell you that it is the jury’s duty to read the warnings as a whole.  It is the court’s job to assess whether the warning is adequate as a matter of law, and plaintiff post hoc fly-specking should not be enough to plant a case in front of twelve citizens good and true (and half-asleep and inflamed with sympathy and anti-corporate hatred).    

 

Even aside from the conclusion that the Tysabri warnings were adequate as a matter of law, the court offered an alternative basis for dismissing the case:  the claims were preempted as a matter of law.  Wyeth v. Levine ruled against preemption on the (at least partially specious) ground that drug companies can unilaterally ramp up warnings through the Changes Being Effected (“CBE”) process.  But the Amos court accurately observed that CBE is not available in all situations, and definitely is not available to add or change a black box warning, which is what was at issue in this Tysabri case.  Moreover, “the evidence of record leads inescapably to the conclusion that the FDA would not have approved a change to Tysabri’s label prior to 2012.”  With respect to Tysabri, there were two “smoking gun” rejections from the FDA. 

 

Also notable in Amos:  a second defendant in the case, a distributor of Tysabri, received summary judgment on preemption grounds.  The distributor did not own the drug’s New Drug Application, and thus had no power under the FDA scheme to alter warnings in any way.  The distributor’s inability to act independently to change warnings meant that, under the Mensing and Bartlett decisions, all claims against it were preempted.

 

There have been other cases around the country where courts arrived at similar rulings that Tysabri warnings were adequate as a matter of law and that failure to warn claims were preempted.  Perhaps plaintiff lawyers will do their best to distinguish these cases on their facts.  We will, doubtless, hear that “smoking gun” has become the standard for the Wyeth v. Levine “clear evidence” standard. We heard something nearly as silly from our home appellate court recently.  But reading the Amos case in the same way that the Amos court read the Tysabri label – as a whole – there is an awful lot of comfort in that case for drug and device defendants.

   

 

This guest post — only our second post ever on European issues — is brought to you by Reed Smith partner Marilyn Moberg and (in the UK) associate Bond, Kathryn Bond (sorry, couldn’t resist).  Our previous (and only) foray into European product liability was not a happy one.  This post, however, discusses a much more favorable product liability development in Britain, and with Brexit we’re hoping that the Brits build on this decision and thumb their noses at the prior decision by the EU Court of Justice.

So without further ado, here are Marilyn and Kathryn.  As always, our guest posters deserve 100% of the credit (and any blame) for what follows.

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For many years now I have been reading this excellent blog prepared by my colleagues and thinking “how can they be so prolific and witty time and time again”? I have continued to tell myself that “I need to do a guest post” sometime, but alas have never found the time to do it. Perhaps the idea of delving in and being compared to the posts of the others was–, OK, I will admit it–, intimidating even after many years of practice. I guess, living in LA, the analogy is like those various guest hosts who were asked to step in for a night for Johnny Carson (yes, I am showing my age). But, hey, Joan Rivers and Jay Leno did OK, so here goes.

For the blog today though we are traveling across the pond to “merry old England,” and my London colleague (Kathryn Bond) and I will discuss a topic very familiar to those of us in the US: the Metal on Metal litigation (and no, I don’t mean the Anvil heavy metal album).

While this litigation has been going for years here, it is in its infancy in the UK, with the first two group product liability actions against manufacturers of metal-on-metal hip prostheses due to be heard by the English Courts this year, with trials scheduled to take place in October 2017.

However, and as Bexis has confirmed “blogworthy,” there has already been a landmark English High Court decision in one individual case concerning a metal-on-metal hip prosthesis. The case is Wilkes v. DePuy International Limited [2016] EWHC 3096 (QB). It was decided in the Queen’s Bench Division of the English High Court.  For those of you – most of you – unfamiliar with the UK’s court structure, the High Court is a senior court that typically deals with first instance decisions of important and/or high value cases, but also handles appeals over decisions made by inferior courts. The High Court has three divisions: the Queen’s Bench Division, the Chancery Division and the Family Division. The Wilkes case was heard in the Queen’s Bench Division (a division that most commonly handles disputes relating to personal injury, negligence, breach of contract, breach of a statutory duty and libel). Appeals against civil decisions made by the Queen’s Bench Division are heard in the Court of Appeal. Appeals against Court of Appeal decisions are heard in the Supreme Court (the highest court in England).

The decision is favorable for the defense, both in its result and in its interpretation of UK law governing allegedly defective products. For those of you not familiar with the law, here is a short primer. Under UK product liability law, irrespective of any rights an individual may have under contract, there are two key actions available to an individual who claims to have suffered personal injury from a defective product. These are:

1. Common law negligence;

2. Consumer Protection Act 1987 (the “CPA”).

The Wilkes case concerned a claim under the CPA.

The CPA imposes strict liability on manufacturers of defective products for any harm caused by their products. “Strict liability”, like in the US, means that it is irrelevant whether the manufacturer was at fault. The injured party just has to prove that the product was defective and that the defect caused him harm.

Section 3 of the CPA states that a product is defective if “the safety of the product is not such as persons are generally entitled to expect,” taking into account “all the circumstances”. For ease, we will refer to this as the “safety expectation test”. This reminds us of the “consumer expectation” test for design defect that applies in some United States jurisdictions for certain products. The Wilkes case is significant because of its interpretation of this section 3 of the CPA.

It has been about 16 years since the UK courts have dealt with this issue, and before Wilkes, the leading case on the concept of “defect” was A v. National Blood Authority (2001) 60 BMLR 1 (“A v. NBA”), from 2001. In that case, the claimants were infected with hepatitis C as a result of blood transfusions.

In determining whether the blood was “defective” under the CPA, the A v. NBA Court took the following approach:

  • first, identifying the harmful characteristic that caused the injury (in other words, identifying a causal link between the defect and the harm suffered);
  • determining whether the product was “standard” or “non-standard” (i.e., does the product perform as the manufacturer intended); then
  • taking into account the relevant circumstances, depending on whether the defect was “standard” or “non-standard.”

A v. NBA held at paras [55], [80] and [173] that the infected blood was “defective” even though the manufacturer could not have known that the specific blood bags concerned were infected — no test for the screening of hepatitis C had been introduced in the UK at the time of the transfusions. The mere fact that there was an inherent risk of the blood being infected was not enough to protect the defendant because the public at large was entitled to expect that the blood transfused to them would be free from infection. In other words, the inherent risk of infection was not publicly known or socially accepted as such a risk. The A v. NBA decision has been criticized in the years since it was decided as being overly harsh on manufacturers.
The Wilkes case is significant because the Court departed from this long standing precedent—and in a way that is jolly good for the defense (or, as they would say in Britain, the “defence”).

Some basic info: Wilkes received a hip replacement implant in 2007, which fractured 3 years later. The implant was a steel femoral shaft called a “C-stem” manufactured by DePuy. Wilkes claimed at paras [55]-[56] of Wilkes that a component of the C-stem was defective, relying in particular on the judgment in A v NBA.

The Court rejected Wilkes’s product defect claim (and more generally the A v NBA approach to product defect) for the following reasons:

1. First step causation test: the first test used by the Court in A v NBA does not work because it is circular – you cannot prove a causal link between the defect and the harm without finding out whether there is actually a defect. The focus should be on identifying the defect itself. [See para [58] of Wilkes]

2. Identifying the defect – the safety expectation test:

(a) All relevant circumstances to be taken into account: There should not be a rigid set of rules specifying which circumstances should be taken into account in determining whether the product satisfies the safety expectation test. The issue of defect is “necessarily one of open-textured judgment, untrammelled by any rigid rules outside the few that appear in the [CPA] itself”. [See paras [76]-[79] of Wilkes]

(b) Risk-benefit analysis and avoidability: The Court acknowledged that no medicinal product is 100% safe – something that will seem obvious to our US readers, but which is a major advance in the UK. There needs to be a risk-benefit analysis to ensure that the potential benefits of the product are balanced against its inevitable risks. The ease and extent to which the risks can be avoided or mitigated is also relevant. For example, there is a risk of stem fatigue in any hip implant (a C-stem is generally expected to last for 10-15 years). According to DePuy’s expert, the risk of a failure in the relevant component of the C-stem was very low (0.004%). Furthermore, the changes required to remove the risk would make the prosthesis more uncomfortable and potentially more likely to fail on other respects. [See paras [81]-[89] and [119] of Wilkes]

(c) Categorization of standard/non-standard defects to be ignored: In A v NBA, the Court intentionally excluded the risk-benefit analysis for non-standard products. The Court in Wilkes believed that the distinction between standard and non-standard products was “unhelpful” and “positively dangerous.”  Whatever the type of product concerned, all relevant circumstances should be taken into account. [See paras [90]-[96] of Wilkes]

(d) Compliance: As medicinal products and medical devices are highly regulated, the fact that the product complies with such regulations is (although not an automatic defense) strong evidence that the product has a level of safety that passes the safety expectation test. In Wilkes’s case, it was an important fact that the C-stem went above and beyond the applicable regulatory requirements. [See paras [99]-[101] and [124] of Wilkes]

(e) Warnings and learned intermediaries: Warnings given to the consumer do have an impact on the level of safety that persons are generally entitled to expect.  In the case of Wilkes’s C-stem, the information provided to the healthcare professional responsible included a warning about the risk of fatigue failure caused by various factors, including obesity and activity levels (both of which may have played a role in the C-stem failing earlier than anticipated).  The intermediary of a healthcare professional was not considered in much detail in A v NBA, save for noting at para [55] that “doctors and surgeons knew [the risk of infection of transfused blood], but did not tell their patients unless asked, and were very rarely asked”. Although the Court acknowledged at para [108] in Wilkes that giving warnings to the healthcare professional did not provide an automatic defense, it was sufficient in the circumstances that the warning was given to the healthcare professional in accordance with UK law, even though it was not given to the patient directly. In particular, it was noted that there is often no interaction between the manufacturer of the C-stem and the patient. It would therefore be appropriate for information about risks relating to the C-stem to be passed on to the patient by the treating surgeon. [See paras [102]-[108] Wilkes]

The Wilkes Court concluded that, although the C-stem fractured earlier than anticipated, the C-stem was not defective because it passed the safety expectation test. The C-stem’s premature failure was brought about by a “constellation” of variable factors, which (although expressly warned about) could not have been predicted by the manufacturer.

The Wilkes judgment adopts many of the doctrines and principles that apply in the US and should continue to apply to these products:  risk/benefit, learned intermediary doctrine, and compliance with regulations as evidence of standard of care.  This is welcome news for manufacturers who sell medical products in the UK.  It will be interesting to see what approach the English Courts will take in the two group actions due to take place later this year and we will continue to monitor this.  So assuming we are “invited back,” you can look forward to another “guest post” that Jay Leno would (hopefully) be proud of …