The Eleventh Circuit has lately become a bit like Forest Gump’s box of chocolates—you never know what you’re going to get. The news today is positive.  The Eleventh Circuit recently issued a gem of an opinion on the learned intermediary doctrine under the law of Alabama, which also happens to be the home of the aforementioned Mr. Gump.

The Eleventh Circuit is not always so good. While the court got everything right in Tutwiler v. Sandoz, Inc., No. 17-13985, 2018 WL 1719024 (11th Cir. Apr. 9, 2018), readers of our 2017 Ten Worst post will recall that the Eleventh Circuit issued three of the ten worst drug and device opinions of 2017, making it 2017’s most noteworthy performer among the circuits.  Maybe we can read something into that.  Or maybe it was fate, like a feather floating in the wind.  After all, if Forest Gump taught us anything, it was that history is arbitrary and that sometimes bad things happen to good people.  The latter, of course, is a reference to Forest’s hard-luck childhood friend Jenny, played beautifully by a young Robin Wright in a performance that was both poignant and memorable.  (Much different, by the way, from Wright’s more recent portrayal of an Amazon warrior in 2017’s reboot of Wonder Woman, which awkwardly fell flat in what was otherwise a perfectly decent superhero film.  We have not yet binged the last season of House of Cards on Netflix, so we will withhold comment on Wright as the relentlessly power-hunger President Claire Underwood.  But we digress.)

So what flavor did the Eleventh Circuit recently give us on the learned intermediary doctrine? A good one, or two, or even three.  In Tutwiler, the plaintiff alleged that she suffered pulmonary issues as a result of taking generic amiodarone for non-life threatening atrial fibrillation.  2018 WL 1719024, at *1.  According to the plaintiff, she did not receive the patient Medication Guide that the manufacturer allegedly made available to distributors and thus did not know that her doctor prescribed the drug off label. Id.

The district court dismissed the plaintiffs’ failure-to-warn claims on two bases: (1) federal regulation of generic drug warnings impliedly preempted the state-law warnings claims and (2) the learned intermediary doctrine barred the plaintiff’s claims absent allegations that inadequate warnings to the physician proximately caused the alleged injury. Id..  The Eleventh Circuit affirmed under the learned intermediary doctrine.  This is slightly surprising, given that the Supreme Court’s opinion in PLIVA v. Mensing provides such a clear path to implied preemption in failure-to-warn claim involving generic drugs.

Regardless, the Eleventh Circuit’s opinion on Alabama’s learned intermediary doctrine is in equal parts concise and well reasoned. There are three takeaway points. First, the plaintiff alleged that her physician prescribed the drug off label.  But that did not make a difference to her failure-to-warn claims, nor should it have made a difference.  We have seen other plaintiffs try to establish or amplify failure-to-warn claims by highlighting that their physicians prescribed drugs off label.  It usually does not work, for the simple reason that a prescription drug manufacturer has a duty to warn about known and reasonably knowable risks, not uses.  Of course, some states’ laws might impose a duty to warn regarding dangers of a product’s foreseeable misuse.  Be that as it may, a bare allegation of off-label use does not an inadequate warning make.

Second, and most importantly in our view, the Eleventh Circuit rejected the argument that the learned intermediary doctrine did not apply because the drug manufacturer did not adequately warn the plaintiff’s physician—and all other physicians—of the drug’s dangers.  In other words, the physician lacked sufficient information to be considered a “learned” intermediary. Id. at *3.

We have seen this argument before too, and a small number of courts have regrettably fallen for it. It is nonsense.  The learned intermediary doctrine is not so named because drug and medical device manufacturers have a duty to create “learned intermediaries.”  The manufacturer’s duty is to warn about a product’s known and knowable risks, and the learned intermediary doctrine defines to whom that duty is owed—highly educated physicians who are already “learned.”  This in turn defines the two critical elements of a warnings claim in drug and medical device cases:  (1) whether the warnings are adequate and (2) whether any inadequacy in the warnings caused the alleged injury.  Those elements are defined by reference to a reasonable physician’s skill and knowledge (his or her “learnedness”) and the warnings’ impact on the prescribing physician’s conduct.

The Eleventh Circuit explained it this way:

[I]n Alabama, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product. The adequacy of the manufacturer’s warning is “measured by its effect on the physician, [ ] to whom it owed a duty to warn, and not by its effect on the consumer.”

. . . . In such a situation [where the patient alleges inadequate warnings] the patient must show that:  “[T]he manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient’s injury.  In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient.”

Id. at **2-3 (citations and quotations omitted).  In Tutwiler, the plaintiffs alleged that the drug warnings were insufficient, but that alone does not erase the learned intermediary doctrine.  She also had to allege causation.  That is where she failed:

On appeal Ms. Tutwiler again argues that the learned intermediary doctrine does not apply because she alleged that [the manufacturer] did not adequately warn Dr. Plumb. This argument, however, does not address Alabama’s separate requirement that she also plead proximate causation—that Dr. Plumb would not have prescribed her amiodarone had he known of its dangers.

Id. at *3.  Because the plaintiffs did not allege that different or additional warnings would have changed her physician’s prescribing physician, she failed to allege causation, and the learned intermediary doctrine barred her claim. Id.

Which brings us to our third takeaway.  The plaintiff could not avoid the learned intermediary doctrine by alleging that she would have avoided the drug had she known of its dangers.  “Regardless of what Ms. Tutwiler would or would not have done with the information, Alabama law requires a showing of what Dr. Plumb would have done with it.” Id. (emphasis in original).  Plaintiffs routinely give self-serving testimony or execute affidavits attesting that they would not taken the drug “had they known.”  That won’t work, at least not in Alabama.

The opinion’s only drawback is that it is not published. Still, the Eleventh Circuit has set a tone that we hope will continue throughout 2018 and beyond.  Run Forest Run.

This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to survive. And so far, plaintiff has been ping-ponging off the sides but hasn’t made it through the gap.

The case is Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. Apr. 4, 2018). Plaintiff had LAP-BAND surgery to aid with weight loss. The LAP-BAND is a PMA device. After seven years, plaintiff started to experience difficulty swallowing and frequent vomiting and upon investigation it was discovered that the LAP-BAND had eroded into plaintiff’s stomach and had to be removed. Id. at *2. Plaintiff conceded several of her claims. Those that remained for ruling by the court were negligence, failure to warn, and negligent or fraudulent misrepresentation. Id. at *3. Plaintiff’s primary allegation in support of these claims was that while defendant’s label reported a 1% risk of erosion, studies revealed a higher complication rate. Id. at *2.

Because the LAP-BAND went through the PMA process, plaintiff’s claims are preempted unless they satisfy the “parallel claim doctrine.” That means plaintiff has to show that the state law duties she alleges defendant violated and for which she seeks damages are “genuinely equivalent” to the federal requirements imposed on the device. Id. at *5. Only when the state and federal duties are parallel will plaintiff’s claim not run afoul of the provision of the Medical Device Amendments (“MDA”) that a state not impose requirements that are “different from or in addition to” federal requirements. Id.

Plaintiff’s first negligence claim was for negligent design and manufacture. However, while she made several allegations about the device having significant risks, nowhere did plaintiff allege how the manufacturer’s duty of care under state law “parallels the federal requirement that the [device] be manufactured according to the approved specifications for the medical device.” Id. at *6. If the device was designed and manufactured according to its PMA specifications, then allowing a jury to find it was negligently designed or manufactured would be imposing a different or additional requirement on the manufacturer. Therefore, claim preempted.

Next up was plaintiff’s negligent failure to warn claim. The court actually broke the claim down into 5 theories on which failure to warn was premised: negligent marketing, negligent labeling, negligent failure to update labeling, negligent reporting, and negligent surveillance. Id. It’s worth noting here that the court applies all the same reasoning in concluding that plaintiff’s strict liability failure to warn claim is similarly preempted. Id. at *8.

Here plaintiff did cite federal regulations but still missed the mark. For instance, plaintiff cited 21 C.F.R. §99.101 which provides:

[a] manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling…provided that the manufacturer complies with all other relevant requirements under this part.

Plaintiff alleges that the defendant violated this federal regulation by failing to provide additional risk information about the device. But all this section does is provide a guideline should a manufacturer choose to disseminate additional information. Choosing not to do so doesn’t violate the provision. Id. at *6.

Plaintiff also cites to the Changes Being Effected (“CBE”) provisions arguing that the defendant violated those provisions by failing to implement a CBE warning. However, a CBE labeling-change is permission to change a label “while a manufacturer awaits a written FDA order approving the PMA supplement.” Id. at *7. But plaintiff did not allege that the defendant was awaiting an FDA order on a PMA supplement, so it is unknown if the provision even applies.

Plaintiff also tried to base her failure to warn claim on an alleged violation of defendant’s federal duties to report adverse events to the FDA and to conduct post-market surveillance. Id. But the court considered both of those claims impliedly preempted on the grounds that they were unlawful attempts to privately enforce the FDCA. The court said failure to report sounds like it could be failure to warn, but the requirement is to report to the FDA, not to plaintiff. And there simply is no state law cause of action for post-market surveillance. Id.

Finally, the court had to dismiss plaintiff’s misrepresentation claim based on plaintiff’s vague pleadings. If what plaintiff was alleging is that defendant should have disclosed additional information and such a disclosure requirement exceeded FDA’s requirements, the claim would be preempted as not parallel. If, on the other hand, plaintiff was alleging that the defendant “held its product out as meeting a higher standard than that required by the FDA,” such a claim would not be preempted. Id. Since the former is more likely, it appears that a properly pleaded claim is likely preempted.

Yesterday happened to be the deadline for plaintiff to file an amended complaint, which she did. A quick skim of the amended complaint leads us to believe it contains most of the same allegations and therefore deficiencies the court has already addressed. And, plaintiff re-pleaded the claims she conceded as insufficiently pleaded the first time around. We suspect another round of preemption briefing in this case’s future.

Breaking news. This just in. Prescriber’s testimony linchpin in manufacturer’s victory over failure to warn claims. And the crowd gasped at this startling news. Actually, this news might be more the equivalent of an announcement that a 13 year-old boy made a snarky comment to his parents (current daily experience for this blogger). Not exactly a revelation. But we will say that the opinion entered by the magistrate in Harper v. Janssen Pharmaceuticals, Inc., 2018 U.S. Dist. LEXIS 58298 (M.D. Ala. Apr. 4, 2018) is strong and well-reasoned. A good addition to any learned intermediary library.

Plaintiff is the mother of a boy who was diagnosed with autism at the age of 4. From the age of around 5 or 6 until he was 10, plaintiff’s son was prescribed Risperdal among other medications. During that time he began gaining weight and experienced high prolactin levels. At the age of 16, plaintiff’s son was diagnosed with gynecomastia, an abnormal development of breasts in males. Id. at *5-8. Plaintiff filed suit alleging claims for failure to warn under common law and under the Alabama Extended Manufacturer’s Liability Doctrine (“AEMLD”), negligence, wanton misconduct, breach of implied warranty of merchantability, fraud, and negligent misrepresentation. Id. at *5.

At the core of all of plaintiff’s claims is an allegation that the manufacturer failed to provide accurate or complete information about the risk of gynecomastia with the use of Risperdal. So, there are two key areas of inquiry – what information did the manufacturer provide and what did the prescribing physician know. Starting with the Risperdal label, throughout the time plaintiff’s son was taking Risperdal, elevated prolactin levels and gynecomastia were included in the precautions section of the label. Further, at all relevant times, the label included a warning that “safety and effectiveness in children have not been established.” Id. at *9-10. Plaintiff focuses on studies done by the manufacturer that allegedly show that Risperdal had a greater risk of increasing prolactin levels than other anti-psychotic drugs in the same class and argue that this information was available to defendant at the time plaintiff’s son was prescribed the drug and it should have been part of the warning. Id. at *12-14.

Moving on to the prescribers – the first doctor to prescribe Risperdal to plaintiff’s son testified that at the time he prescribed he knew that safety and effectiveness had not been established for children, that he took that into consideration when prescribing, and that it was his practice to discuss with the parents of child patients that this was an off-label use. Id. at *15. He was also aware that the label called for periodic re-evaluations if the drug was used long-term and again it was his practice to do so and that he only continued patients on medications if he felt the benefits outweighed the risks. Id. at *16. And, the prescriber was aware that Risperdal was associated with weight gain and was also aware that prolactin-elevating compounds could lead to gynecomastia. He took both into account when prescribing Risperdal. Id. at *16-17. The second prescriber was likewise aware that Risperdal was not approved as safe and effective for use in children and would have considered that at the time he prescribed to plaintiff’s son. Id. at *19.

Before jumping into its legal analysis, the court made a few astute observations about the intersection between science and the law and in particular the uncertainty of medicine that are uncommon in legal opinions and so we decided to provide for you directly here:

To a significant degree, this case epitomizes the limitations of medical science, the law, and their interaction. The course of human history has seen profound improvements in our understanding of health, disease, and other afflictions. Recent advances in diagnosis and treatment of medical conditions, both physical and mental, are often little short of miraculous. Despite these advances, our understanding of maladies and their safe and effective treatment remains incomplete and imperfect. This is especially and poignantly true with respect to the broad category of mental health conditions. Doctors and the pharmaceutical industry have developed any number of powerful medicines for treatment of many of those conditions, with varying levels of effectiveness. All these medicines carry the burden of potential side effects for some or all users. Determining the origin of adverse conditions associated with certain drugs is often difficult.

Measuring the breadth and fixing the limits of legal liability for adverse drug reaction requires development and application of legal principles in an area of great medical uncertainty and conflicting economic and societal goals. Through federal and state legislation, administrative regulation and approvals, and the common law, we establish standards for patients, doctors, and pharmaceutical companies to govern their affairs. Legal concepts of proof and causation are often not readily applied where scientific knowledge is incomplete and uncertain. The twin aims of providing appropriate compensation to individuals injured by others while encouraging doctors and drug companies to advance the field of medicine frequently conflict, as in this case.

Id. at *21-22. We’ve blogged on occasion about the pitfalls of the law getting too far ahead of science and how making the two fields meet can be quite tricky – nice to see it in an opinion.

So, faced with a label that warned of the risk, and prescribers who knew and considered the risk, and imperfect scientific knowledge – what was left for the judge was to enter summary judgment. Plaintiff argued that while the Risperdal label contained some warnings, those warnings were incomplete or misleading about the extent of the risk (the studies noted above). However, the label was “not intended to be a risk profile for adolescents.” Id. at *28. The label explicitly stated the drug’s safety and effectiveness had not been established for pediatric patients and also went on to include both increased prolactin and gynecomastia in the precautions. More importantly, as noted above, the prescribers were aware of the risks. “The prescribing decisions of [plaintiff’s son’s] health care providers were made after weighing the risks and benefits of the medication. Critical to a plaintiff avoiding the learned-intermediary doctrine is a demonstration that the manufacturer failed to warn the physician of a risk not otherwise known to the physician.” Id. at *30 (citation and quotation marks omitted).

Further, as to the studies showing increased risk upon which plaintiff relies, plaintiff’s initial prescriber testified “that until a study is completed and the data analyzed, it is not available to him to rely upon in making his prescribing decision.” Id. at *29. Great support from the prescriber for keeping out science that post-dates prescription and usage of the drug. If the studies weren’t published until after the doctor stopped prescribing, they couldn’t factor into his prescribing decision and they shouldn’t factor into the court’s failure to warn analysis.  Putting all this together, the court concluded both that the defendant provided adequate warnings and that the “prescribing physicians knew use of Risperdal in children was an “off-label” use, independently knew of the risks associated with the medication or researched them prior to prescribing the medication, and chose to prescribe it anyway.” Id. at *31. Learned intermediary doctrine bars any failure to warn claim.

Plaintiff’s remaining claims fell away quickly as well. Wanton disregard requires a showing of recklessness or conscious disregard for the safety of others. Again plaintiff’s pointed to the label and argued it wasn’t enough. “The fact that the warnings could have been broader or stronger does not equate to reckless disregard or an indifference toward safety.” Id. at *33.  The label contained a warning of the very risk at issue, therefore, defendant was not indifferent to safety. Breach of implied warranty failed because (a) Alabama doesn’t recognize it for inherently dangerous products and (b) the drug served its purpose of treating mental health. Id. at *35-36. Finally, plaintiff’s fraud and misrepresentation claims fail because even if you assume all facts in the favor of plaintiff, she hasn’t established reliance by her son’s treaters or causation where the treaters knew of the risk and prescribed anyway. Id. at *38.

Learned intermediary may not be a hot new topic, but this testimony and the analysis by the court is pretty top-notch.

In Looney v. Moore, 2018 WL 1547260 (11th Circuit Mar. 30, 2018), the Eleventh Circuit confirmed Alabama law’s rejection of an “increased risk of harm causation standard and established that lack of informed consent plaintiffs must have a physical injury.

Looney is a clinical trial case. Parents of several infants who were born prematurely claimed that the infants suffered injuries as a result of their participation in a clinical trial aimed at analyzing the effects of differing oxygen saturation levels on premature infants. Plaintiffs made negligence, negligence per se, product liability, breach of fiduciary duty and lack of informed consent claims, and they sued the doctors involved in the study, as well as the independent review board and the company that made the medical equipment for the study. Defendants won at the summary judgment stage, and the Eleventh Circuit affirmed.

The simplest issue was causation. The Eleventh Circuit applied Alabama’s strict requirement that a plaintiff making a negligence claim must show that the negligence more than likely caused plaintiff’s injury. An “increase risk of harm” is insufficient:

The Alabama Supreme Court has made clear that, “to present a jury question, the plaintiff in a medical-malpractice action must adduce some evidence indicating that the alleged negligence (the breach of the appropriate standard of care) probably caused the injury. A mere possibility is insufficient. . . . . An alleged “increased risk of harm” is not sufficient to survive summary judgment under Alabama law, which requires proof that the alleged negligence probably caused the injury.

Id. at *3.

Confirming this standard turned out to be the end of plaintiffs’ negligence claims. That’s because no expert, whether it be for plaintiffs or defendants, was willing to say that the defendants’ negligence during the clinical trial probably caused any of the infants’ injuries. At their depositions, defendants’ experts said that the infants’ premature births probably caused their injuries, not participation in the study. Id. Plaintiffs’ own expert could only manage to say that the clinical trial “increased the risk of harm” to the infants, not that it more likely than not injured them. Id. This testimony gave a jury no basis to find for plaintiffs, and the Eleventh Circuit affirmed defendants’ summary judgment victory. Id. at *4.

Plaintiffs’ informed consent claim was a bit trickier. Plaintiffs argued that they did not need a physical injury to make this claim, something that Alabama law had not directly addressed. Id. The Eleventh Circuit sought help on this, certifying a question to the Alabama Supreme Court. But the Alabama Supreme Court declined to answer. Id. This left the Eleventh Circuit in the position of having to predict how Alabama law would decide the issue. Id.

To do this, the Eleventh Circuit first considered the Alabama Medical Liability Act. It required an injury. The Eleventh Circuit also considered Alabama Supreme Court informed consent decisions. In each instance, the court laid out the elements of any informed consent claim, but they did not explicitly include injury. The Eleventh Circuit was not troubled by this because, in each case, the plaintiff not only suffered an injury, but a serious one. Id. at *5.

Left looking for any support for their theory of a claim without physical injury, plaintiffs pointed to battery claims, in particular medical battery claims, which in Alabama do not require physical injury. Id. at *7. The Eleventh Circuit distinguished these claims. Battery claims are not based in negligence, but instead on a lack of any consent at all. Id. On the other hand, plaintiffs in lack of informed consent claims actually give consent to the procedure. They just claim that their consent was ill informed. Id. at *8. In other words, their claims are based on the negligence of the medical providers. And that brings us back to the strict requirement under Alabama law that a plaintiff making a negligence claim must establish that the negligence probably caused an injury. With that, the Eleventh Circuit upheld summary judgment against plaintiffs’ informed consent claims. Id. at *9.

We write this as key elements of the Drug and Device Law Passover Feast languish in the oven. Tomorrow, the Drug and Device Law Bubbie will force four generations of our family – the devout and the not and everyone in between – to read (aloud) the lengthy prayer service that precedes the meal.  The ritual includes much laughter, enthusiastic (if discordant) singing, and predicable misbehavior from those of us at the “kids’ table” (the 50- and 60-year-olds, as distinguished from our parents) that provokes sharp rebukes from the elders.  And, these days, the gathering is a little bit bittersweet (cue “Sunrise, Sunset”), as time’s toll on the eldest members of the clan is softened by the presence, each year, of more of our babies’ babies.  We complain about the cooking.  We grouse about the most troublesome relatives.  But we wouldn’t miss it for the world, though we should mention that “feast” is something of a misnomer, as many Passover staples are notorious for barely crossing the line into “palatable.”

Speaking of misnomers, earlier this week, one of our co-bloggers termed causation the “MVP” of mass tort practice. While we heartily agree in principle, we have read (and participated in) too many scenarios in which a passive judge “benched” this “player” to allow meritless cases to queue up in settlement inventories. On the flip side, we are heartened by the increase in Lone Pine orders demanding early causation evidence and by judges who refuse to allow plaintiffs lacking proof of causation to escape summary judgment.

Such was the result of today’s case, a Risperdal case out of the Northern District of Alabama. In Drake v. Ortho-McNeil-Janssen Pharms., 2018 U.S. Dist. LEXIS 47164 (N.D. Ala. Mar. 22, 2018), the plaintiff was an obese 36-year-old man who was diagnosed as schizophrenic at age 17.  He was initially prescribed Risperdal but was switched to other drugs several months later.   He was switched back to Risperdal about two years after that and then remained on the drug for about thirteen years before different drugs were again substituted.

Shortly after the plaintiff stopped taking Risperdal, a social worker noticed that he had large breasts and told his mother that he should be tested for gynecomastia, benign enlargement of glandular breast tissue in males. Antipsychotic medications have been associated with gynecomastia, which “is distinct from pseudo-gynecomastia, which is breast enlargement due to fat deposits in overweight males.  The two conditions may be differentiated only with a physical exam.” Drake, 2018 U.S. Dist. LEXIS 47164 at *4.  No exam took place.  The plaintiff was never diagnosed with gynecomastia, though his levels of prolactin were elevated.  Prolactin is a hormone that induces lactation, but it “does not have a direct grown-stimulating effect on the breast glandular tissue.” Id. at *6 (citation omitted).  Many of the drugs prescribed to the plaintiff were known to cause prolactin elevation.

The plaintiff’s complaint, asserting all of the usual causes of action, alleged that Risperdal caused him to develop gynecomastia. The defendant moved for summary judgement, arguing that the plaintiff could not meet his burden of establishing causation.  The judge emphasized that the plaintiff was required to prove both general and specific causation and that expert testimony was required for both.  The plaintiff’s expert was a certain former FDA commissioner who has testified that the risk of gynecomastia in children and adolescents was higher than Risperdal’s labeling represented.  But, as the court pointed out, while the expert’s “report and deposition testimony from other  cases might be sufficient to raise a question of fact regarding general causation, . . . his report and testimony contain[ed] no evidence regarding the cause of [the plaintiff’s] alleged injuries. Id. at *13.  And the plaintiff had no other causation expert.

As such, as the court put it, “the plaintiff’s evidence concerning specific causation [was] threadbare.” Id.  There was no evidence that the plaintiff had even been diagnosed with gynecomastia.  And while the plaintiff argued that, if his elevated prolactin level had caused “testosterone level drops leading to estrogen expression,” then Risperdal could “theoretically [have caused] gynecomastia,” there was “no evidence in the record regarding [the plaintiff’s] testosterone or estrogen levels, and evidence that Risperdal could theoretically cause gynecomastia [was] not sufficient to raise a disputed issue of material fact concerning specific causation.” Id. The court concluded, “In the absence of medical or expert evidence, a fact finder must speculate about the cause of [the plaintiff’s] enlarged breasts, and a verdict may not rest on speculation.” Id.  

In other words, maybes on top of maybes do not proof of causation make. If the plaintiff cannot be bothered to get a diagnosis or an expert, that plaintiff should not be in court.  Unassailable, although we’ve all seen too many such “easy” decisions go wrong.  We like this case.  We will continue to keep you posted on the good and the bad, and we wish happy gatherings to all celebrating any holiday this week.

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.

As the calendar turns from August to September, it is time once again to concede the strength of the Southeastern Conference.  You probably think we are referring to college football or basketball, in which teams from Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, Missouri, South Carolina, Tennessee, and Texas prevail with grinding monotony.  [We have a feeling that OJ’s old college squad, USC, will have an ugly time of it against Alabama in the ostensibly neutral site of Jerry World this weekend.]  But, no, we are talking about product liability law.  [For the moment, we are pretending that the Weeks innovator liability abomination in Alabama never happened.  Moreover, the Alabama legislature eventually cleaned up that mess.]  Today we are focusing on the safer alternative requirement in design defect cases.  It occurs to us that some very good cases on this issue come out of the SEC.  In the beginning of the year, we discussed a Mississippi case, Mealer v. 3M, where the court dismissed a case on the ground that an elastomeric respirator was not a safer alternative to a cheap paper respirator mask.  They were two entirely different products, fundamentally different in terms of operation, longevity, and expense.   Consumers might have all sorts of important reasons, aside from safety, to choose one over the other.

[Readers who are especially nerdy or possess especially good memories might point out that in July we bemoaned a Louisiana opinion permitting a plaintiff to suggest that other drugs could constitute a safer alternative to the drug at issue.  To our mind, different drugs, which consist of different molecules with entirely different risk-benefit profiles, are separate products and cannot be treated as a safer alternative that can shame other drugs out of existence.  Under the plaintiff’s (and, unfortunately, the Louisiana court’s) theory, jury verdicts might drive all drugs that treat, say, diabetes, out of the market except one.  And even that one would not be safe from attack.  Or, to veer away from drugs and devices, we might as well shut down Harley-Davidson, since motorcycles are less safe than other modes of motorized transportation.   Live to ride, ride to live?  Not anymore.  But don’t worry too much.  You can still sing “Born to be Wild” on your Hydra Glide.  The recent Louisiana error stands as an aberration.  As Bexis pointed out in a magnum opus blogpost that strolled down bone screw memory lane back in 2013, Louisiana has quite a lot of good safer alternative decisions.]

Today’s case, Hosford v. BRK Brands, Inc., 2016 Ala. LEXIS 91 (Ala. August 19, 2016), sees the Alabama Supreme Court apply an even stricter test in pouring out a plaintiffs’ case on the ground that the proposed safer alternative was a separate product altogether.  The facts of Hosford are grim.  A four-year-old girl died in a fire that destroyed her family’s mobile home in May 2011.  The fire began in a faulty electrical outlet in the girl’s bedroom.  Her family sued the manufacturer of the smoke alarms in their mobile home.  The theory was that the smoke alarms were defectively designed because they relied solely on ionization technology which, the plaintiffs alleged, failed to give adequate warning to allow an escape in the event of a slow smoldering fire.  There are dual sensor smoke alarms on the market that employ both ionization and photoelectric technology.  According to the plaintiffs, such alarms would have roused the family in time to save the little girl.  After the plaintiffs presented their case at trial, the defendant moved for judgment as a matter of law.  The trial court mostly granted that motion, and only one claim went to the jury.  The jury ultimately returned a verdict in favor of the defendant.

Continue Reading Alabama Supreme Court Imposes Tough Standard on Safer Alternative Design

Six months ago, we praised two Alabama federal court decisions for refraining from extending the poorly reasoned decisions in Weeks—that is, Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013) (withdrawn and superseded), and Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (en banc)—which kept alive a version of the innovator liability that had been rejected almost everywhere else.  The Alabama Supreme Court—in 2013 and again in 2014—deviated from the well-established principle of product liability that liability for an injury allegedly produced by a particular product may run to the manufacturer of that product but not to the manufacturer of some other product that did not allegedly injure the plaintiff.  Recognizing the weakness of Weeks, in 2015, the Alabama legislature re-affirmed the need for any product liability plaintiff to prove an injury from the defendant’s product, not just “a similar or equivalent product.”  Because Alabama’s law is not retroactive, there is a gap for plaintiffs in pending cases to try to impose liability on manufacturers of drugs they did not take.

Before we knew the days of Weeks were numbered, we highlighted how the Northern District of Alabama had distinguished the Weeks theory 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” from the plaintiff’s theory that the innovator should be liable for “failing to ensure that [plaintiff] received the Medication Guide,” which plaintiff conceded provided adequate information on risks and indications for the drug.  Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073. *12 (N.D. Ala. Jan. 14, 2015).  Without support from Weeks, no putative breach of a duty by the innovator could give rise to liability.  Id. at *13.  We characterized the holding in another case from the same district, Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014), as “If Weeks does not allow innovators to be tagged for [run-of-the-mill product liability] 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.”

Continue Reading The Elephant in the Room in Alabama

That didn’t take long.  Yesterday the Alabama House of Representatives passed SB-80, which abolishes the innovator liability theory created in the execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014 (discussed here and here, and named #1 worst decision of 2014 here).  Here is a copy of the enrolled bill.  The online legislative history indicates that SB-80 passed the Alabama Senate 32-0 and the House 86-14.

The relevant statutory language, imposing a product identification requirement in all cases seeking damages caused by a product, states:

Section 1. In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product.  Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury.  A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.

Continue Reading Alabama Legislature Abolishes Weeks Innovator Liability Theory

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.

Continue Reading Not The End Of Weeks But A Start