Source: http://newslawonline.blogspot.com/2015/01/
Timestamp: 2019-04-24 19:02:40+00:00

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[MMIT Manifest YOUR Miracles! Top experts share how!
Save the date! Feb 6th - my interview on Make Your Miracles!
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We’ve just learned that an Arizona appellate court has held, in effect, that the learned intermediary rule can’t apply in direct to consumer cases because it – get this – it supposedly violates the Uniform Contribution Among Joint Tortfeasors Act (UCATA). The case is Watts v. Medicis Pharmaceutical Corp., 2015 Ariz. App. Lexis. 12 (Ariz. App. Jan. 29, 2015). Arizona is one of the relatively few states where the highest court has never passed on the learned intermediary rule. According to our Head Count post, the Arizona Court of Appeals has followed the learned intermediary rule three times: Piper v. Bear Medical Systems, Inc., 883 P.2d 407, 415 (Ariz. App. 1993); Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978); Dyer v. Best Pharmacal, 577 P.2d 1084, 1087 (Ariz. App. 1978). But not anymore, according to Watts, at least not if a plaintiff claims that s/he was personally influenced to seek a drug by false direct to consumer advertising.
The UCATA rationale is so unusual that we’ll need some time to dissect it. However, we believe, for reasons expressed a few years ago in the second half of this post, the traditional causation regime under the learned intermediary rule easily incorporates situations where direct to consumer advertising allegedly influenced a plaintiff to influence a prescribing physician to obtain a drug.
All we can say right now – after 5 on a Friday − is that Watts (1) is inconsistent with three prior rulings of the same court; and (2) is based on a rationale that nobody has adopted anywhere – not even in West Virginia.
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It feels like we have been talking about Weeks for years. Two slightly different versions of the same decision have allowed the “innovator liability” theory of recovery to survive in Alabama against manufacturers of drugs that the plaintiff did not take. Each appeared on our bottom ten list over the last two years. Too many posts to link have discussed how Weeks is on the wrong side of the weight of authority on what started with Conte years ago. In the first five months after its feeble re-do, we did not see cases considering whether to extend Weeks. We now have, with Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073 (N.D. Ala. Jan. 14, 2015). And that led us to find an older Weeks case that took a while to appear in “print,” Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014). So, we present an end-of-the-week two-fer on Weeks from the federal judges in the northern part of this southern state.
Both cases involve plaintiffs who died sometime after taking generic amiodarone, a prescription anti-arrhythmia drug, and who sued various manufacturers, including the company that brought the branded drug to market long before the plaintiff got the generic. Both cases also involve other issues we often discuss, like TwIqbal, preemption, and the learned intermediary doctrine, but we are not discussing those issues here. Instead, we are limiting ourselves to how these cases limit Weeks and do not allow the plaintiffs to proceed against the branded manufacturer on the allegation that it owed a duty to each plaintiff to provide him with the Medication Guide that would have made clear that his physician was prescribing the drug off-label and that it had various risks. (If we were talking about the risk of these cases, we might talk about how little apparent connection there seems to be between the information gap alleged with each brief prescription and the remote injuries.) Amiodarone was originally approved as a “special needs” drug to be used as “a last resort,” and has a regulatory history with a fair amount of back-and-forth on discouraging (and not encouraging) physicians from prescribing it as first or second line therapy. Plaintiffs apparently did not contend that the Medication Guide hid the ball on the drug’s indication or risks.
In Weeks, the Alabama Supreme Court held that "a brand-name-drug company may be held liable for fraud or misrepresentation . . . based on statements it made in connection with the manufacture of a brand-name prescription drug, by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company." Id. at *23 (emphasis added). However, unlike the plaintiff in Wyeth, Plaintiff does not allege that the Medication Guide was false or deceptive. In fact, Plaintiff in his reply brief states that the "Medication Guide clearly and unequivocally states that 'off-label' and non-'drug of last resort' use of amiodarone should not occur and provides a clear warning of the dangers of death and severe injury." Plaintiff instead faults Wyeth for failing to ensure that Mr. Dreher received the Medication Guide. Thus, Plaintiff does not challenge the sufficiency of the warning but only that Mr. Dreher was not provided a Medication Guide. As such, Weeks does not control the case at hand.
2015 U.S. Dist. LEXIS 4073, *12 (internal record citations omitted). With Weeks relegated, there was no basis for finding a duty the innovator could have breached. Id. at *13. After all, Medication Guides are to be provided to distributors of the drug, not to patients, let alone to patients who take some other company’s drug.
Unlike the facts before the court in Wyeth, Inc., v. Weeks, 2014 Ala. LEXIS 109, 2014 WL 4055813 (Ala.2014), the plaintiffs here do not allege that the defendants "falsely and deceptively misrepresented or knowingly suppressed facts about [the medication] such that [the treating] physician, when he prescribed the drug , was materially misinformed and misled about the likelihood that the drug would cause dyskinensia and related movement disorders." 2014 Ala. LEXIS 109, [WL] at * 2. Plaintiffs allege only that defendants failed to warn them, not Mr. Stephens' doctor. Plaintiffs fail to allege that defendants misrepresented anything to Mr. Stephens' doctor. Put simply, the plaintiffs fail to allege that but for defendants' misrepresentations or suppressions about amiodarone, Larry Stephens' doctor would not have prescribed this medication. Similarly, while plaintiffs allege "Larry was not aware that his use of the medication was for an 'off-label' use," the relevant inquiry is whether his physician was aware of this.
In Count II, the plaintiffs allege that amiodarone was unreasonably dangerous and given its inherent dangerousness, did not contain adequate warnings. The plaintiffs continue that had amiodarone contained adequate warnings, Mr. Stephens would not have taken the drug. SAC, ¶ 105. This is again a failure to warn claim, despite plaintiff's attempts to make it otherwise. See e.g, Wyeth v. Weeks, 2014 Ala. LEXIS 109, 2014 WL 4055813, * 4 (Ala.2014) (holding fraudulent misrepresentation concerning the dangers of a medication is not a claim that the drug ingested was defective, but rather a claim that defendant suppressed information about the manner it was to be taken, removing it from the realm of products-liability actions). Plaintiffs do not assert that amiodarone should have never come to the marketplace because of inherent dangerousness, or that there was a reasonable, safer alternative to the medication. Rather, plaintiffs assert that defendants failed to warn Mr. Stephens that amiodarone was a medication of last resort for ventricular fibrillation and that his doctor's prescribing the same for atrial fibrillation was an "off label" use.
2014 U.S. Dist. LEXIS 180568, **14 & 17-18. Ignoring that plaintiffs ignored the learned intermediary in their allegations, these are pretty run-of-the-mill product liability allegations. If Weeks does not allow innovators to be tagged for such claims, absent fraud allegations that will need to be pleaded in detail and eventually supported by lots of evidence, then the effect of Weeks may end up being pretty narrow.
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We are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.
We adopted a Drug and Device Rescue Cat this week. Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago. We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted. And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.
In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case. Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.
Forest moved for summary judgment, arguing that (1) federal law preempted plaintiff’s state law claims; 2) the warning was adequate; 3) there was no evidence that a different warning would have prevented decedent’s suicide; and 4) there was no evidence to support an award of punitive damages. Muzichuck, 2015 U.S. Dist. LEXIS 5440 at *2-3.
Faced with strong preemption arguments, plaintiff conceded in her opposition brief that she did “not claim that Forest could have added a Black Box warning to Lexapro’s label, or could have provided a Patient Medication Guide, without prior FDA approval.” Id. at *16. The Court, telegraphing its position, commented, “[I]t is hard to see how preemption continues to play any role in this case.” Id. Lexapro, however, is an SSRI, and given the FDA’s history with SSRIs and suicide, there are good preemption arguments. See, e.g., Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp. 2d 1264 (W.D. Okla. 2011), and posts here and here. Nonetheless, those “impossibility preemption” arguments got short shrift from this court. Rather than discuss Forest’s regulatory facts in any depth, the court cited a bunch of bad SSRI preemption cases, disagreed with the good ones, and concluded that “clear evidence” did not support preemption. Id at *16-22. It’s an unfortunate but common post-Levine result, demonstrating only that balanced applications of Levine remain elusive. Here, given the good stuff coming up, it was not even necessary to address preemption.
Plaintiff’s specific causation expert argued that Lexapro’s warning was inadequate because it failed to provide information about early warning signs of incipient suicidality, and failed to warn that suicide risk was highest in the early months of treatment or when the dose was changed. Forest contended that the Lexapro package insert in effect when plaintiff’s decedent was treated included all of this information. Id. at *23-24. Plaintiff’s general causation expert conceded that these warnings were in the package insert, but argued that the warnings were inadequate because they did not include a black box or updated medication guide. Id. at *26. Oops. Those are precisely the claims that plaintiff conceded were preempted because Forest could not have taken those steps without prior FDA approval. To avoid preemption, plaintiff effectively ejected her own expert. Hence, as the Court observed, “Without the possibility of a black box warning or an updated medication guide, [plaintiff’s general causation expert’s] opinion is reduced to a ratification of Forest’s warning that he admits was placed in Lexapro’s April 2004 label. Thus, the Court concludes that there is no material issue of fact in dispute about whether Forest’s warning regarding the risk of suicide associated with the use of Lexapro was adequate.” Id. at *27 (internal quotation marks omitted). Now we are getting somewhere. And the good stuff continues.
1) sent a “Dear Doctor” letter to decedent’s prescribers; 2) sent a communication to decedent; or 3) updated Lexapro’s suicide warning based on the FDA’s October 2004 Public Health Advisory. Id. at *28.
The Court first commented that, “[c]ritically, none of these alternatives is based on expert testimony.” Id. (citations omitted). Oops number 2. The court went on to hold that, in any event, a “Dear Doctor” letter would not have provided decedent’s prescriber with any information he had not already seen, as the prescriber testified that he “routinely read package inserts in order to stay current on antidepressant medications.” Id. (internal punctuation and citations omitted), and Forest could not have sent a warning directly to decedent because there was no evidence that Forest was aware of decedent before he filled his prescription. Finally, the FDA’s Public Health Advisory specifically advised Forest not to implement labeling changes until it received agency notification, and that notification was not provided until a month after decedent’s suicide. Id. at *29-30. The Court concluded, “. . . [Plaintiff’s] contention that . . . the question whether a manufacturer’s efforts to warn were adequate is always for the jury regardless of the state of the evidence is erroneous.” Id. at *30. Because plaintiff had not submitted relevant expert testimony, and had adduced no “evidence that her proposed alternative means of warning were viable,” there was “no material fact in dispute about whether Forests efforts to warn by way of its package insert were adequate.” Id. at *31.
Here’s a final good point, on West Virginia law. There’s no learned intermediary rule, so the question becomes whether the patient was adequately warned. Here, the patient was dead and the prescriber unhelpful, so Plaintiff urged the Court to apply a “heeding presumption” to conclude that decedent would have read and heeded an adequate warning if it had been given. Id. at *32-33. The Court pointed out that West Virginia had never adopted a heeding presumption, id. at *33, and that other courts had explained that the presumption “operates to the benefit of the manufacturer where adequate warnings are in fact given.” Id. (citations omitted). Since the plaintiff’s own expert (except for the issues abandoned to avoid preemption), conceded that Lexapro’s suicide warning was adequate, and other evidence established that decedent had actually read the warnings in the package insert, the plaintiff came up short again. “Thus,” the Court held, “even if a heeding presumption were applied in this case, based on the evidence of record, it would not raise a genuine dispute of material fact.” Id. at *34.
The Court concluded, “Though [plaintiff’s] claims are not preempted, Forest has satisfied its burden of demonstrating the absence of any genuine issue of material fact regarding its alleged failure to warn.” As such, the Court demonstrated that a mass tort plaintiff with lifeless arguments and conflicting experts should not opt out, but should accept the gift of a guaranteed payday. Let’s hope the cat tool is as efficient.
This post is from the non-Reed Smith side of the blog only.
Having to report on a negative InFuse decision happens about as often as meteorologists correctly predict snowstorms. Boy did they get it wrong for New Jersey and Pennsylvania this week. Talk about deflated snowfall expectations. Speaking personally for a minute, this non-skiing, non-snowboarding, warm-weather-loving blogger was not disappointed at this turn of events. And, we actually feel a little sorry for weather forecasters whose sole job it is to predict the often unpredictable, but who are held to exacting standards. Next time a blizzard is predicted, people will mock the forecast, go to work, get stuck in ten inches of snow, slip and slide the whole way home, and then complain that the warning wasn’t strong enough. Meteorologists really can’t win.
Defendants in the InFuse litigation, however, usually do. But like meteorologists who occasionally hit it right on, sometimes an InFuse judge gets it wrong. When that judge is confined by having to apply Bausch v. Stryker Corp., 630 F.3d 546, 552 (7th Cir. 2010), the result isn’t completely shocking. Disappointing, but not shocking.
The basic allegations in Garross v. Medtronic, Inc., 2015 U.S. Dist LEXIS 6675 (E.D. Wis. Jan. 21, 2015) are like those in all of the other InFuse cases. The InFuse bone fusion system is a Class III, pre-market approved medical device. As such, plaintiff’s claims should only survive if they can squeeze through the “narrow gap” left after application of express and implied preemption. Notably, the Garross court called it only “a gap,” id. at *7, suggesting a more spacious opening then we believe is supported by the case law.
To try to wedge their claims into that narrow gap, the InFuse plaintiffs focus almost exclusively on allegations of off-label promotion which they allege should get them around express preemption. Most courts, however, have ruled that the majority of plaintiff’s InFuse claims don’t fit that tight space and that allegations of off-label promotion don’t change the equation. See prior InFuse posts.
So, where does this decision differ from the majority? First, the court places an over-emphasis on product use. For instance, in describing the PMA process, the court focuses on the fact that manufacturers have to specify the “intended use” of the product. Id. at *2. The court goes on to say that the “FDA has never approved use of the combination device in other parts of the body or in any other type of procedure.” Id. at *3. But this completely misses that the FDA approves products, not uses. Nor can the FDA prohibit surgeons from using a device anyway they see fit, including for an off-label use. And, as other InFuse courts have found, products liability isn’t about uses either, it’s about products. So how a plaintiff’s surgeon chose to use a device doesn’t alter the preemption analysis.
Next, the court found that each of plaintiff’s state law claims is premised on an “alleged underlying violation of federal law.” Id. at *8. The court ruled that plaintiff’s fraudulent misrepresentation and fraud in the inducement claims are based on off-label promotion which is prohibited by the FDCA. Id. Putting aside whether that is an overly broad interpretation of what is permissible under the FDCA, the court doesn’t distinguish between truthful and false off-label promotion. An untrue statement or misrepresentation could support a fraud claim while also not running afoul of FDCA prohibitions on untruthful off-label promotion, hence escaping express preemption. A claim for fraud premised more generally on off-label promotion regardless of veracity, should be impliedly preempted. A state law fraud claim requires a misstatement, a falsehood. Without that, plaintiff’s claim is actually one to enforce FDCA off-label promotion regulations. That’s not allowed.
The court then found plaintiff’s negligence, negligent misrepresentation, strict liability failure to warn, fraud and constructive fraud claims weren’t preempted because they were premised on “failure to report adverse events to the FDA and to submit a supplemental application seeking approval of the off-label use it was promoting.” Id. at *10. We know that for now at least we are stuck with the “failure to report adverse events” in the circuits that have allowed it. We find it a little discomforting that it could be used to support all of these state law claims, but the court seems to think they are all essentially failure to warn claims. Id. What we haven’t seen before is a claim for failure to submit a supplemental application which this court allowed without much separate discussion. Our guess is that the discussion wouldn’t look much different than the one that supports failure to report claims, but some recognition that it was adopting a new claim would have been nice.
Finally, the court upheld plaintiff’s design defect claim as premised on off-label promotion, failure to report, and failure to seek supplemental approval. Id. at *10-11. This is probably the court’s longest stretch to avoid preemption and it is where the court’s incorrect focus on use comes into play. Plaintiff’s argument is that the InFuse device was defectively designed “for the use Medtronic promoted.” Id. at *11. But the FDA has conducted a safety analysis (risk/benefit analysis) of the InFuse device and determined that it was appropriately designed. Any decision by a jury to the contrary would be in direct conflict with the FDA’s determination and therefore the claim is expressly preempted. Allegations of off-label use and promotion have no bearing on design.
I may be there, but not 100% sure yet. If I do go I'll probably have photos to share, but hard to commit to a set schedule. If I do have something I'll definitely post through the Climate Action Hub.
Also, you may want to add the date (Feb 7) into your post, as some people may think you're talking about this Saturday.
Anyone going? We would love a post or two ... or three?
Any time you find yourself drawing an analogy to asbestos lawsuits, you know you're in trouble. We have too often heard plaintiff lawyers or, worse, judges advocate for borrowing procedures from asbestos litigation. Almost always those procedures would make it easier for plaintiffs to 'prove' little things like product identification, and would abridge defendants' rights to seek certain discovery or file motions. If the symbol for the legal system is a scale, the symbol for the asbestos docket should be a meat-grinder. We had the experience earlier in our career of representing a tertiary asbestos defendant that really and truly had nothing to do with any harm inflicted on any asbestos plaintiff. It should never have been sued. But after the actual asbestos manufacturers went bankrupt, enterprising plaintiff lawyers sued any and every entity in sight so as to keep the asbestos gravy train rolling. Instead of winding down to extinction or at least to something with narrowly circumscribed limits, asbestos litigation entered second and third waves of opportunistic litigation. It is like what Hannah Arendt said about totalitarian regimes, how they constantly need to find new enemies and scapegoats. Asbestos litigation became a bizarre, parallel legal system, more characterized by (bad) social engineering than coherent rules and procedures. Our encounter with the asbestos maw was relatively brief. We represented a company that made components for automobile brakes. Mind you, the company did not use or touch asbestos at all. After the products entirely left our clients' hands, somebody else would add the asbestos. When we pointed out that fact to the plaintiff lawyers, they still insisted that we must pay a nuisance exit fee. When we sought to file a motion with the court, we were advised that the asbestos docket permitted no such motions until the eve of trial. Good system, huh?
We do not know a whole lot of the facts behind the New England Compounding Pharmacy MDL, but the first opinion we have seen from it (there will doubtless be many more) gave us an ugly asbestos flashback. The MDL stems from allegations that the New England Compounding Center (NECC) produced a contaminated medicine that caused people to suffer from fungal meningitis. NECC recalled the medicine. It then surrendered its pharmacy license, ceased production of all medical products, and filed for bankruptcy. The plaintiffs steering committee filed actions against NECC, naturally enough, and also filed actions against affiliated entities and individuals. The plaintiffs also filed complaints against not-so-affiliated entities and persons, including hospitals, clinics, and doctors. This is where we started thinking about asbestos cases. If there must be a remedy for every wrong, does that mean the remedy can be collected from someone who did nothing wrong? The NECC opinion we are looking at today, In re New England Compounding Pharmacy, Inc. Products Liability Litigation, MDL No. 13-02419-RWZ (D. Mass. Jan. 13, 2015), provides an interesting snapshot. This particular opinion relates to actions where plaintiffs alleged that Illinois medical providers played a role in administering the contaminated NECC medicine, thereby causing injuries. The claims were for medical negligence, violation of the Illinois Consumer Fraud and Deceptive Business Practices Act, failure to warn, strict product liability, and punitive damages.
The good news for the defendants was that the court dismissed the strict liability claim, because that theory could apply only if the defendants were predominantly providing a product rather than a service. The court, quite sensibly, concluded that the medical providers were predominantly providing a service rather than a product. But the rest of the opinion was bad news for the defendants. The defendants made an argument that rings true to our admittedly biased ears: that physicians have no duty to regulate pharmacies and drug manufacturers. But the court concluded that the master complaint passed muster because it alleged that the defendants had a duty to exercise reasonable care to ensure that the drugs they administered to patients were procured from drug companies that complied with pharmaceutical laws, made safe and effective drugs, and utilized proper quality control, safety, and sterility measures. Wow. The plaintiffs also alleged that physicians must take care that the drugs administered were not contaminated, and must inform plaintiffs of the sources of drugs (especially if there was "an unaccredited, mass producing, out of state, compounding pharmacy, unregulated by the FDA ... and the dangers associated therewith"). That is a fairly breathtaking litany of duties for doctors. The complaint also alleged that the defendants "deceptively concealed" information about the source of the medicine and failed to inform patients that they were being administered "an unsafe, unreasonably dangerous drug compounded by NECC." Those allegations were deemed enough to make out claims for negligence, consumer fraud, and failure to warn. Moreover, because the complaint said that the defendants went beyond mere inadvertence and, instead, constituted such utter disregard for the rights of others as to amount to "complete neglect for the safety of patients," and that the defendants "willfully and knowingly failed to abide by consumer safety regulations and withheld important safety information from patients," the claims for punitive damages could go forward.
The court did cite TwIqbal, but certainly did not appear to apply the standard with any rigor. As a result, the plaintiffs have gotten away with very vague, very broad allegations that rip large holes in the duty envelope. It will be interesting to see what sort of proof the plaintiffs have that the doctors actually knew what was going on at the compounder. Are these defendants now on the hook because they really were negligent, or merely because they were next?
Looking for diarist to post on this huge rally on Monday. Any takers?

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