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A lot of time is spent in litigation on discovery. As tedious and non-exciting as it often is, cases can be won or lost depending on what happens during discovery. So, it’s not to be taken lightly. When we find ourselves arguing to the court about discovery, however, it is often without being able to point to much precedential case law. That’s because many courts simply rule from the bench perhaps entering only minute orders. And if case management orders are entered they often don’t rise to the level of being published, even electronically. We are then left scouring dockets looking for rulings or calling our colleagues hoping someone has an order that is helpful. So, we really appreciate when a helpful discovery ruling grabs our attention and we can in turn alert our readers to it.

One of the reasons that more routine discovery decisions don’t generate many opinions is that the rulings frequently turn on case specifics and common sense as opposed to more traditional legal analysis. That’s true of today’s decision. A lengthy order entered in the Abilify MDL setting forth essentially a list of decisions on multiple motions made by both plaintiffs and defendants. Certainly some are more case specific and not really worth much of a mention, so what follows is a list of the more general and most helpful rulings:

  • Confidentiality: The court allowed the parties to provisionally seal documents filed with their Daubert briefing and then at the conclusion of the briefing, the party who sealed the document had to show cause why the document should remain sealed. Defendants argued to keep certain very common categories of documents confidential:
    • Clinical case reports/adverse event reports: Defendants argued that these documents contain confidential patient identifying information and personal medical information. These aren’t plaintiffs – they are people who participated in studies or for whom an AER was prepared. They absolutely have a right to an expectation of privacy, not to mention the company has an obligation to protect that privacy. The court agreed – no public interest. In re Abilify Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 161660, at *7-8 (N.D. Fla. Sep. 29, 2017).
    • Internal company documents: Defendants sought to maintain confidentiality of several categories of internal, non-public documents and the court agreed as to most. Specifically, the court found that all of the following should remain under seal: “standard operating procedures, non-public regulatory submissions, drafts of non-public regulatory submissions, or internal communications regarding the pharmacovigilance process.” Id. at *9. All things plaintiffs like to use to try the case in the media. As to SOPs, the court concluded they are proprietary and developed by the company at considerable expense. With respect to the rest, disclosure “would have a chilling effect on the pharmacovigilance process.” Id. Keeping the pharmacovigilance process confidential actually enables manufacturers to participate in the process in a “frank, open, and honest” way. Id.
    • Expert reports and testimony: Here the court was unwilling to seal expert reports and transcripts across the board. They have to be redacted to the extent they discuss any of the documents or information that the court said should remain confidential. Id. at *10-11.
  • Privilege: Plaintiffs complained that they were unable to assess defendants’ claims of privilege as to its documents because defendants were not producing privilege logs simultaneous with their document productions. Defendants correctly noted that simultaneous privilege logs would significantly slow production down – a production would have to wait the finalizing of the log before it could be produced. The court agreed.  Simultaneous production would be inefficient. Id. at *17-19.
  • Document Retention Policies: Plaintiffs want them, defendants objected. Court ruled: “in the absence of any suggestion of spoliation Defendants’ document retention policies are not relevant.” Id. at *24.
  • Other Drugs: Plaintiffs’ discovery requests included documents about other similar drugs, claiming the information would go to defendants’ knowledge. The court sustained defendants’ objection on the grounds of relevance and proportionality. Id. at *25. While other drugs in the same class may be similar, they were developed later in time, have different mechanisms, and different indications – making them marginally relevant. When you balance only marginal relevance against the issues involved in the litigation – and what we assume to be massive discovery already taking place as to the actual drug at issue — we think the court reached a sound conclusion regarding proportionality to the needs of the case.
  • Trial Pool Discovery: Plaintiffs requested many different types of information, including financial information relevant to sales representatives, physicians, and other consultants. Defendants sought to limit that discovery to just the individuals related to the cases being worked up as trial bellwethers. Again the court agreed. For example, plaintiffs’ request to know about payments and incentives to sales representatives and doctors should be narrowly tailored to those doctors who treated the bellwether plaintiffs and the sales representatives who called on those doctors. Id. at *26-27. The same applied to other categories of “liability” discovery that were more appropriately limited to the bellwether cases. “Expanding the scope to all Plaintiffs would be a Herculean task and impossible to complete in the time frame set by the Court.” Id. at *28.

All in all the rulings were very defense-friendly and provide some good cites for your next motion to compel or motion to quash.

This post is from the non-Reed Smith side of the blog.

Do as I say, not as I do. A crutch used by parents worldwide to justify their own bad habits while trying to ensure their children don’t repeat them. Technically, it’s being a hypocrite. Sure, parents should strive to set an example through behavior. But frankly, sometimes we’ll settle for hypocritical. Well, a federal court in Massachusetts just said the same applies to the FDA. We’ll explain.

A group of plaintiffs brought a putative class action against a group of pharmaceutical companies alleging that their prescription eye drops were intentionally designed to dispense more liquid than the human eye is capable of absorbing. Gustavesen v. Alcon Laboratories, Inc., — F. Supp.3d –, 2017 WL 4374384, at *1 (D. Mass. Sep. 29, 2017). Plaintiffs allege that therefore, medication is wasted and they are required to more frequently re-fill their prescriptions than is necessary to the financial benefit of the defendants. Id. Plaintiffs sought recovery under various states consumer protection statutes as well as for unjust enrichment and “money had and received.” Id. at *2. Defendants filed a motion to dismiss alleging multiple reasons why plaintiffs’ claims fail as a matter of law. The court opted not to consider anything beyond preemption finding that that precluded all of the alleged claims.

To begin its analysis, the court did a nice walkthrough of what it calls the Supreme Court’s trilogy of impossibility preemption decisions. First, of course, is Wyeth v. Levine, where the Court said failure to warn claims are not preempted because of a manufacturer’s ability to make certain labeling changes without prior approval of the FDA, unless there is clear evidence that the FDA would have rejected the change. Id. at *4. Next up was Pliva v. Mensing. A generic drug is required to have the same labeling as the brand-name version. Therefore, a generic drug manufacturer does not have the same ability to change its label as the brand manufacturer. Id. at *5. And, finally came Mutual Pharmaceutical v. Bartlett. Here the Supreme Court said that plaintiff’s design defect claim was preempted because any attempt by the manufacturer to change the design of the drug would have resulted in a new, unapproved drug that the manufacturer would have been prohibited from marketing. Id. Moreover, the court rejected plaintiff’s claim that defendant could have simply stopped selling the drug – defendant is not required to “cease acting altogether to avoid liability.” Id. Put the three cases together and you have the following framework. If FDA regulations allow a manufacturer to make a change without prior approval, no preemption unless clear evidence change would have been rejected. If “a party cannot satisfy a state law without first obtaining the discretionary approval of a federal agency, the state law is preempted.” Id. at *5.

Against that legal backdrop plaintiff’s argued that they had 2 theories of liability that were not preempted. First, they alleged that defendants could have changed the eye dropper tip to deliver a smaller drop and that this would have been prohibited by the FDA. Id. at *7. There are 3 categories of changes for approved drugs – major, moderate, and minor. Moderate changes are the type of labeling change discussed in Wyeth that do not need pre-approval. Major changes on the other hand must be submitted to the FDA before the drug is distributed. Id. To determine whether something is a major change, the court looked to FDA regulations and FDA guidances interpreting those regulations. In this case, that would include a guidance that for sterile products, like eye drops, any change to the container closure system is a major change. Id. The opinion goes more in depth on these regulations – but the conclusion is what is important. Plaintiff’s proposed design change would be a major change that would require prior FDA approval – therefore, the claim is preempted.

Now we come to the “do as I say” part. In response to defendants’ argument that the design change suggested by plaintiffs would be a major change, plaintiffs cited to three occasions where they claim the FDA allowed a container change without prior approval. As to 2 of the events, the documents relied on by plaintiffs don’t support their position. Id. at *9. As to the third:

At most, this is evidence of the FDA’s failure to follow strictly its own guidance. It does not cast doubt on the plain language of the 2004 Guidance deeming all changes to the size or shape of a sterile product’s container to be major changes requiring preapproval.

Id. Also:

[P]laintiffs cite no law indicating that particular actions by an agency—as opposed to the agency’s official position—are relevant to interpreting a regulation. In fact, the Supreme Court has rejected invitations to apply the standards an agency follows in practice rather than the standards it officially promulgates.

Id. In sum, do as the FDA says, not as it does. The regulations and official guidances control over individualized instances where the FDA chose not to apply them. The court can’t be guided by internal decision-making processes in one-off situations.

Having found that a post-approval change of the eye drop container would have been a major change and therefore claims premised on that preempted, the court examined whether plaintiff could sustain a claim for a “pre-approval” design change. Meaning, could/should defendants have design the dropper tips differently before seeking FDA approval. This question was decided in defendants’ favor by the Sixth Circuit in Yates v. Ortho-McNeil-Janssen Pharm, Inc., 808 F.3d 281 (6th Cir. 2015) (see post here). After examining some other district court authority cited by plaintiffs, the court in this case decided Yates was more consistent with Mensing and Bartlett.

Going back to the trilogy – if a manufacturer can’t satisfy its state law duties without FDA permission, the claim is preempted. Well, it’s not possible for a manufacturer to market a re-designed drug because that drug “would require its own NDA to be marketed in interstate commerce.” Id. at *11. So, arguing that the defendant should have changed the design pre-approval runs straight into the same impossibility preemption as a post-approval design change. Moreover, arguing that the defendant should never have sold the product is virtually the same thing as arguing that it should have stopped selling the product – the theory rejected in Bartlett.

A nice preemption decision, especially the use of Mensing and Bartlett outside the generic realm.

Can you recall what you were doing back in March of this year? To be more precise the day before St. Patty’s Day and the day after the Ides. No? Well, apparently the defendants in the Risperdal and Invega Products Liability Cases pending in California state court were celebrating but they forgot to invite us to the party. We just learned about the very nice preemption decision entered by the trial court in that litigation. Since it’s never too late to celebrate a preemption victory, here are the highlights.

Before we get into the case specifics, the court’s general preemption analysis merits a minute of our time. ‘[I]f the tort plaintiff’s failure to warn theory was already tested by FDA action or inaction or would have required the use of a label on a prescription drug which the FDA would have prohibited,” the claim is preempted. Risperdal and Invega Product Liability Cases, 2017 WL 4100102 at *5 (Cal. Super. Mar. 16, 2017). What remains for private plaintiffs to challenge in a tort setting, therefore, is the adequacy of the label or the reasonableness of the manufacturer in updating the label based on new or additional information not already considered by the FDA. Id.

 In discussing whether information was presented to the FDA for consideration, of course, fraud-on-the-FDA and Buckman enter the discussion. The court nicely summarized the public policy reasons supporting Buckman preemption:

The understandable concern is that allowing a private right of action for “fraud on the FDA” would embroil the agency’s staff, particularly its scientific staff, in court litigation to the derogation of their performance of their primary duties. This would result both from the consumption of time in litigation activity and from a concern that their routine duties, decision-making processes and public communications would all have to be vetted with litigation avoidance in mind.

Id. at *6.

Next the court establishes that the Wyeth v. Levine “clear evidence” standard does not require indisputable evidence, but rather defendants must establish impossibility preemption by “clear and convincing evidence.” Id. And finally, the court found that preemption is a question of law, not fact and therefore an issue for the court, not the jury. To the extent deciding preemption requires the court to rule on a factual dispute regarding what the FDA would do, “the dispute is one regarding a legislative fact, not an adjudicative fact. Thus it presents a legal question for judicial resolution.” Id. at *7.

With that as background, we turn to the specific facts of the case. Risperdal is an anti-psychotic medication. Id. at *1. The Risperdal label that plaintiffs claim is inadequate was modified in 2006 to include language about prolactin elevation and the reported rate of gynecomastia (enlargement of male breasts) among Risperdal users. Id. at *3. Plaintiffs allege that defendants failed to adequately warn of this risk because the labeling did not include the “true” rate of gynecomastia and should have included an instruction to physicians to monitor blood prolactin levels. Id. at *1. Defendants moved for summary judgment on preemption grounds in 5 cases involving plaintiffs from 4 different states. Id.

With respect to the rate of gynecomastia set forth in the label, the FDA specifically approved the pooling of data from 18 studies to arrive at the rate that was used in the labeling. Id. The FDA re-examined the label in 2007-2008 and concluded that it required no labeling changes regarding gynecomastia or prolactin elevations. Id. Plaintiffs argue that the pooled average was lower and that defendants should have disclosed the higher incident rates observed in 2 of the 18 studies. Id. at *8. Because those 2 studies were among those considered by the FDA during the approval process, “the FDA’s position is clear [as to] how information regarding the 18 studies should be described in the label.” Id. This portion of plaintiffs’ claim is therefore preempted.

As to plaintiffs’ allegation that defendants failed to adequately warn about monitoring prolactin levels, plaintiffs rely on “Table 21.” This is a table containing an analysis of 5 studies purportedly showing a statistically significant association between elevated prolactin levels and gynecomastia. Id. The table was in a draft of a journal article but not in the final publication and therefore not submitted to the FDA during the approval process. The studies reviewed in the table, however, were among those considered by the FDA. Id.

 Plaintiffs argued that based on the information in the table, defendants should have independently changed their label under the Changes Being Effected (“CBE”) regulations. However, to implement a CBE label change without prior FDA approval, the change must be based on “newly acquired information” which is defined as

data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

Id. at *9. Table 21 doesn’t fit that definition. It may be a different analysis of the data, but it did not show a different type or greater severity or frequency of the risk of gynecomastia which is the focus of the CBE regulation. To the extent plaintiffs also tried to rely on their litigation experts’ analysis of the data, the court point out that that was a tactic tried and rejected in several other litigations as a means of avoiding preemption. Id. So, plaintiffs’ claims are also preempted because the data they rely on to suggest defendants could have changed the label is not newly acquired and could not serve as the basis for an independent label change.

Not only could defendants not have changed the label on their own, the court found clear evidence that the FDA also wouldn’t have approved it.  In 2012, one plaintiffs’ counsel submitted a Citizen’s Petition to the FDA alleging that the Risperdal label did not adequately address elevated prolactin levels, the need to monitor for elevated prolactin levels, or the rates of gynecomastia. Id. at *4. Essentially the same allegations raised in the litigation. In its response denying the petition, the FDA stated that it was commonly known that Risperdal increases prolactin and that gynecomastia is one of the manifestations of increased prolactin. Id. at *5. Based on that the court concluded:

This Court is persuaded that these reasons articulated by the FDA in response to the very claims alleged here provide the kind of “clear evidence” of “legislative fact” which the U.S. Supreme Court requires before a court can hold that impossibility preemption applies. By any standard, there is “clear evidence” that Plaintiffs’ entire theory of label inadequacy focused on prolactin levels was not only considered and rejected by the FDA but also rests on information (and allegations) known to the FDA and the medical community. The FDA’s review of the 18 clinical studies—which form the underlying data of any theory that Plaintiffs posit—both pre-approval and in subsequent reviews, and its subsequent inaction, seem to be the definite upshot of a conscious FDA choice on information before the agency. It is not this Court’s job to revisit a decision made by the FDA.

Id. at *11.

It may not be the court’s job to revisit FDA decisions, but it is certainly this blog’s job to visit strong preemption decisions like this one. So, just a reminder that if you get a good decision – forward it along. Don’t make us wait 6 months to join the party.

This post is from the non-Reed Smith side of the blog.

In our post earlier this week “No Causation, No ‘Parallel Claim’” we examined the enormous causation hurdle plaintiffs face in trying to prove a Stengel or Hughes type failure to warn claim in those jurisdictions where such a claim has been found not to be preempted. In that post, we commented that we “would have preferred an order finding the failure-to-warn claims preempted.” Well today, we bring you two that do just that. The first a complete preemption win, the other only a partial, but we’ll start with the good news.

Both Golden v. Brown, Case # 17CV30568, slip op. (Colo. Dist. Ct. Sep. 24, 2017) and Norabuena v. Medtronic, Inc., 2017 Ill. App. LEXIS 593 (Ill. App. Sep. 20, 2017) refused to recognize a failure to warn claim premised on a failure to report adverse events to the FDA – a Stengel claim if you’re in the Ninth Circuit and a Hughes claim if you’re in the Fifth. Now neither Colorado nor Illinois is in those circuits, but we’d like to think that regardless these state courts would have reached the same conclusion they did – neither Colorado nor Illinois law recognizes a claim for failure to warn the FDA. So, plaintiff can allege defendant violated a federal regulation by failing provide information to the FDA – but it isn’t “parallel” to any state law claim because there is no such state law claim. The Illinois appellate court summed it up nicely:

[A]lthough plaintiffs have identified a federal requirement that their complaint alleges Medtronic violated, there is no Illinois requirement that parallels it. Plaintiffs asserted claims for failure to warn. Although Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries, this is not synonymous with an affirmative duty to warn a federal regulatory body. The learned intermediary doctrine states that a manufacturer has a duty to warn prescribing physicians of a drug’s known dangerous propensities” under the understanding that those physicians will use their expert knowledge in adequately warning the patient. We cannot find that this duty is parallel to the federal requirement.

Norabuena, 2017 Ill. App. LEXIS 593 at **14. The Colorado court not only found that allegations of failure to report adverse events to the FDA don’t state a parallel claim, but also concluded that Stengel and Hughes “cannot be reconciled with 21 U.S.C. §360k(a) as interpreted in Riegel or 21 U.S.C. §337(a) as interpreted in Buckman.” Golden, slip op. at 3. In other words, failure to warn a learned intermediary is different from and in addition to federal requirements regarding reporting of adverse events and a claim for failure to provide information to the FDA is an improper attempt at private enforcement of the FDCA. Just what we’ve been saying since these two awful decisions came down.

Both decisions have a little more to discuss.

In Golden, plaintiff also attempted to base a parallel claim on alleged violations of Current Good Manufacturing Processes (“CGMPs”). Noting that it was joining the majority of courts to have considered the issue, the court ruled that the CGMPs are too “vague” and “open-ended” to serve as a basis for a parallel claim. Id. at 2. The court also found plaintiff’s breach of implied warranty of merchantability claim preempted as essentially an allegation that the device was not safe and effective which would directly contradict the FDA’s PMA decision that “there is a reasonable assurance of . . . safety and effectiveness” and therefore expressly preempted. Id. at 3. And finally, the court found plaintiff’s claims impliedly preempted because plaintiff failed to explain “how Defendant’s conduct violated state law duties absent the FDCA.” Id. Simply stating that her claims were premised on Colorado common law was insufficient – “true merely in title, not substance.” Id. Instead, plaintiff’s claim exist solely under the FDCA which is not allowed.

The Golden case also suffered from some pleadings defects, such as failure to allege facts to support either a defect or causation. Id. at 2. But even if those pleading deficiencies could be cured, none of plaintiff’s claims survived preemption, so the case was dismissed in its entirety.

Switching gears to Illinois – unfortunately the court ruled that one of the bases for plaintiff’s failure to warn claim was not preempted. The FDCA contains regulations against device misbranding, which includes advertising that is false and misleading. Norabuena, 2017 Ill. App. LEXIS 593 at **15. Plaintiff alleged that defendant’s advertising was false and misleading in that it concealed known risks of using the device in an off-label manner. Id. at **16. In reaching its conclusion, the court distinguished plaintiff’s claim as not an attack on the device’s label which would be preempted as having been specifically approved by the FDA during the PMA process. But rather, plaintiff was challenging allegedly deceptive marketing practices post pre-market approval. Id. at **17. But that is a distinction without a difference where plaintiff’s allegation is that in its advertising defendant should have included a warning different from or in addition to the warning the FDA approved. The FDA-approved warning is what must accompany product advertising. Think about what the court is saying – if the warning is in the product label it must adhere to the FDA-approved language. If the warning accompanies an advertisement for the product it does not. We do not believe that is something the FDA would allow. While we can understand how a court can find that a false statement made in product promotion may be both a violation of state law and FDCA misbranding regulations, where that falsity is alleged to be a failure to include a warning not approved by the FDA, we respectfully disagree.

But, all is not lost in Norabuena. The appellate court found that plaintiff’s claims were properly dismissed on another ground – failure to plead causation. The complaint apparently was replete with allegations of “omitted” risks, “[h]owever, there are no specific factual allegations in the complaint asserting that [plaintiff’s] surgeon encountered or relied on any of the asserted promotional marketing.” Id. at **21. If a tree falls in the woods. . . . It’s not enough to plead the act or omission, the complaint was also allege facts supporting proximate cause. This pleading deficiency wasn’t enough for a dismissal with prejudice, so the case is heading back to the trial court and plaintiff will have to re-plead her remaining failure to warn claim.

This post is from the non-Reed Smith side of the blog.

Search for Medtronic on this blog and you’re going to find preemption cases. Lots of preemption cases. Mostly preemption victories for the defense. An overwhelming body of preemption law has been made by Medtronic. They’ve certainly led the charge. So, if we say today’s post is a Medtronic case about a spinal implant, you’re likely thinking more preemption. While that wouldn’t be a bad thing, even here at the DDL blog we can get a little tired of beating the preemption drum (don’t let Bexis know). Everyone once and a while we like to sing a different tune.

After all, if you never flipped over to the B-side, you may have missed some really good music. We’ll now pause to explain B-sides to the iPod generation who may be completely unfamiliar with the old 45-rpm single. The single was meant to showcase an album’s prospective hit on its A-side with an additional song on the B-side. The B-sides were typically throw away tracks. But sometimes, an equally good, and some may argue better, song could be found by flipping the single over. For example, ‘I Am the Walrus’ was on the B-side of the Beatles ‘Hello Goodbye’ (that was a John v. Paul thing). Pearl Jam’s ‘Yellow Ledbetter’ was the B-side of ‘Jeremy’ until radio DJs made it a hit on its own. U2 originally only released ‘The Sweetest Thing’ as the B-side to ‘Where the Streets Have No Name.’ And, perhaps one of the best songs of all time (says this blogger and Sir Paul McCartney) – ‘God Only Knows’ was a B-side. To be fair it was the B-side to the Beach Boys ‘Wouldn’t It Be Nice?’ so isn’t that really like two A-sides?

In the case we’re bringing you today, Medtronic had previously won a motion to dismiss plaintiff’s fraud and consumer protection claims on the grounds of preemption (among other reasons). See our post here.  So, you’ve already heard the A-side.  But following that decision, plaintiff’s design defect and manufacturing defect claims under the Louisiana Products Liability Act (LPLA) remained. So Medtronic moved for summary judgement. As to design defect, plaintiff had to concede that it had no evidence of an alternative design, so that claim was dismissed with prejudice. See Lyles v. Medtronic Sofamor Danek, USA, 2016 U.S. Dist. LEXIS 38550, at *15 (W.D.La. Mar. 23, 2016). On manufacturing defect, plaintiff alleged res ipsa loquitur — welcome to the B-side of this record.  The district court granted summary judgment. See id. at *21-23. Plaintiff appealed. But the Fifth Circuit said the district court got it right.  Like the Stones got it right with ‘You Can’t Always Get What You Want’ on the flip side of ‘Honky Tonk Women’.

Plaintiff had multiple medical device components implanted in his spine to treat his spinal stenosis and cervical cord compression. Lyles v. Medtronic Sofamor Danek, USA, 2017 U.S. App. LEXIS 17534, at *3 (5th Cir. Sept. 11, 2017). X-rays taken within the first day of surgery showed something amiss with one of the implanted plates (experts disagree regarding whether the plate was broken or just misaligned). Id. at *3-4. Plaintiff sought additional treatment and underwent a second surgery, but the plate was not explanted and remains in plaintiff’s spine. Id. at *4-5.

To maintain a manufacturing defect claim under the LPLA, plaintiff has to prove that at the time the medical device left the manufacturer’s control, it materially deviated from its specifications or from other identical products from the same manufacturer. Id. at *9. Plaintiff offered no proof of either the device’s specifications or how the device used in his surgery deviated from those specifications. He relied instead on res ipsa loquitur – arguing that the only reasonable inference that would explain the device breaking was that there was a defect in how it was made. Id. at *10.

The Fifth Circuit does a nice job of explaining both how the doctrine is to be applied sparingly and then discussing those rare situations in which a plaintiff has been allowed and not allowed to use it in the products liability context. See id. at *10-13. In sum, “where there are other potential causes of injury, a plaintiff’s inability to exclude all known potential causes other than a manufacturing defect preclude his reliance on the doctrine.” Id. at *13.

In his opposition to defendant’s motion for summary judgment, plaintiff relied exclusively on two things – the short time between implant and breakage and his expert’s conclusion that he had no other reason for the breakage other than a defect. Id. at *13-15. What plaintiff failed to do was address any of the “multiple potential explanations,” offered by the defendant. Id. at *14. Putting aside for a minute that plaintiff can’t make an argument on appeal that he didn’t make below, his new argument to the Fifth Circuit was that there was no evidence for defendant’s alternative explanations. But plaintiff lost sight of his burden of proof:

[T]o succeed on the theory of res ipsa loquitur, [plaintiff] has the burden of producing evidence excluding other reasonable explanations. Though [plaintiff] argues that there is no evidence for any other cause for the [device’s] breakage, there is no evidence for a manufacturing defect either, which is why he is invoking res ipsa loquitur. The other reasonable explanations for the [device’s] breakage posited by [defendant] are equally as likely as a manufacturing defect. It is [plaintiff] who has the burden to adduce evidence excluding them.

Id. at *15-16. The issue isn’t whether there is evidence to support the other reasonable explanations, but rather what evidence plaintiff has adduced to exclude the other reasonable explanations. Id. at *18.

Further, plaintiff didn’t offer any evidence that any alleged defect existed when the device left the manufacturer’s control. Prior to plaintiff’s surgery, the device was stored at the hospital and any number of people had access to it. Id. at *16-17. The Fifth Circuit concluded that even if the district court had been wrong in not applying res ipsa loquitur, which it wasn’t, plaintiff’s manufacturing defect failed on this ground as well. Id. at *17.

Res ipsa loquitur is definitely a B-side to preemption but don’t overlook the B-sides or you might miss out on a winner.

Last week appears to have been a bit of a slow week in the drug and device litigation arena. It was after all a short work week. It was back to school week (at least in the North East), which while bringing delight to parents everywhere also brings the chaos of last minute school supply shopping, discovering sneakers no longer fit, and the start of chauffeur season where parents essentially become Uber drivers between school, lessons, practices, and games. And we know our friends in the South had a few other things on their mind as they prepared for Irma.

So, that leads us to look beyond our normal comfort zone to see what else might be going on. Sure, enough we found a discussion of Buckman preemption in an automobile emissions case.

The case comes out of the In re: Volkswagen “Clean Diesel” Marketing, Sales Practices, and Products Liability Litigation, MDL 3354 and specifically the case of Wyoming v. Volkswagen Group of America, Inc., 2017 U.S. Dist. LEXIS 142586 (N.D. Cal. Aug. 31, 2017). Volkswagen’s “clean diesel” issues have been widely publicized and were the subject of significant criminal penalties and civil settlements having to do with Volkswagen’s installation in its diesel cars of software to defeat emissions testing which allowed the vehicles to acquire the necessary new-vehicle certifications from the EPA. Id. at *805-806. Under EPA regulations, the installation of such a “defeat device” is prohibited and the EPA has authority to bring a civil action for violation of that regulation. 42 U.S.C. §§7522(a)(3)(B); 7524(b). Wyoming, among other states, sued Volkswagen alleging the defendant violated Wyoming’s State Implementation Plan (“SIP”). Trying not to delve too deeply into the law, essentially the Clean Air Act requires each state to develop a SIP to enforce the EPA’s national air quality standards. The individual states are supposed to focus on stationary sources (factories, plants) and are limited in how they can regulate motor vehicles. Id. at *810. Considering how freely and frequently (daily) motor vehicles cross state lines, we understand why individual state plans regulating car emissions would be almost impossible to enforce.

So, the Clean Air Act allows states to regulate the use of “registered or licensed motor vehicles” as opposed to new vehicles Id. at *823, citing 42 U.S.C §7543(d). For instance, states can require testing after sale to ensure cars continue to meet emissions standards. Along those lines, Wyoming’s SIP includes provisions that say you cannot remove or render ineffective any air pollution control device and you cannot use a device that conceals an emission. Id. at *810-811. It is these two provisions which Wyoming argues Volkswagen is liable for violating.

The Clean Air Act, however, also contains an express preemption clause:

No State or any political subdivision thereof shall adopt or attempt to enforce any standard relating to the control of emissions from new motor vehicles or new motor vehicle engines subject to this part. . . .

42 U.S.C. § 7543(a). “States accordingly may not adopt their own rules prohibiting defeat devices in new vehicles, nor may they attempt to enforce EPA’s rule barring defeat devices in new vehicles.” Id. at *829. If you interpret Wyoming’s SIPs the way Wyoming is asking, they would run afoul of the express preemption clause. The SIPs are fine if you are talking about a mechanic tampering with a device so a car passes emissions inspection. That’s something for the state to regulate.

The court found additional support for its preemption analysis in Buckman. Wyoming is essentially bringing a fraud-on-the-EPA claim. Like the authority vested to the FDA for drugs and medical devices, Congress has given the EPA the same authority to both regulate and enforce new-vehicle emissions standards. Id. at *832-834.

If, despite this authority, States could bring actions against vehicle manufacturers based on deceit of EPA during new-vehicle certification, manufacturers would be forced to comply with EPA regulations “in the shadow of 50 State” regimes, which would “dramatically increase the burdens” manufactures would face in bringing new vehicles to market.

Id. at *833-34 (quoting Buckman).

Therefore, the court dismissed Wyoming’s claims as preempted and perhaps foreshadowed a similar demise for claims brought by other states. And while that is a great result, there is one glitch in the decision. This court apparently missed our post on the demise of the presumption against preemption in express preemption cases. As it begins its preemption analysis, the court states that part of its “interpretative framework” would include the presumption against preemption. Id. at *819. Fortunately, the presumption plays no further role in the court’s analysis and ultimate conclusion – because it shouldn’t it. The court even quotes Medtronic v. Lohr, that the presumption applies “unless [preemption] was the clear and manifest purpose of Congress.” Id. at *818 (quoting Lohr 518 U.S. 481, 485 (2006)). An express preemption clause like the one quoted above is fairly clear and manifest. And, if that wasn’t enough, the Supreme Court has been even more explicit:

[B]ecause the statute “contains an express pre-emption clause,” we do not invoke any presumption against pre-emption but instead “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016). Done and done. So, while we laud the conclusion, we also use the decision to remind our readers that the presumption against preemption has been definitely knocked out of express preemption cases.

 

We’ve made no secret of our dislike of the so called “heeding presumption.” We have a tag on this subject with multiple posts decrying this presumption — that juries may presume that if an alternative adequate warning had been given, it would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber). That is essentially a shift of the burden of proof on warning causation from plaintiffs to defendants without any justification. Warnings are ignored all the time.

Our posts note that it is a fairly even split between jurisdictions rejecting and those adopting the heeding presumption. But we’ve taken special note of New York law on the issue because it is a bit muddled. In a post a couple of years ago we explained how a bad Second Circuit decision on the issue (Liriano v. Hobart Corp., 170 F.3d 264 (2d Cir. 1999)) overreached and ignored New York state court precedent spawning a line of cases which purport to recognize a general heeding presumption. At that time we predicted it would require a decision from the New York Court of Appeals to clean up the mess the federal and lower courts had made. We came close to such a decision last year in In re New York City Asbestos Litigation, 59 N.E.3d 458 (N.Y. 2016) (“NYC Asbestos”). Unfortunately, the court determined that the defendant had waived the issue of whether the heeding presumption existed in New York. But, in dicta, went on to say:

[Defendant’s] current complaint about the court’s instructions on the presumption is unpreserved. Of course, our rejection of [defendant’s] claim on preservation grounds should not be taken as an acceptance or rejection of the trial court’s heeding instructions on the merits, and regardless of the propriety of those instructions, trial courts must continue to ensure that their jury instructions honor the principle that the burden of proving proximate causation, which in a case like this one includes the burden of demonstrating that the injured party would have heeded warnings, falls squarely on plaintiffs.

Id. at 482 (emphasis added).

We are happy to report today that that dicta has not gone unnoticed in the drug and device context. Last week, a New York federal court ignored the line of cases from Liriano and instead cited NYC Asbestos and basic New York causation law to hold that New York doesn’t recognize a heeding presumption. The case is Adeghe v. Janssen Pharmaceuticals, 2017 WL 3741310 (S.D.N.Y. Aug. 30, 2017) and involves allegations that plaintiff developed gynecomastia as a result of his use of Risperdal. Id. at *1.  In addition to NYC Asbestos, the court relied on other cases for the general proposition that plaintiff bears the burden of proof that the alleged failure to warn was a proximate cause of his injury and that plaintiff’s burden “includes adducing proof that the user of a product would have read and heeded a warning had one been given.” Id. at *6.

The court provided a strong rationale for why the heeding presumption is not justified in drug/device cases:

Particularly in a case involving failure to warn of the risks of a pharmaceutical product, depending on the plaintiff’s condition and treatment alternatives, one may not reasonably assume that a patient or his treating physician will forego a drug because of disclosed risks.

 Id.

This is an important reminder about just what it means to apply a heeding presumption in a pharmaceutical case. The warnings at issue for drugs and devices are warnings about potential risks. Risks that the prescriber, the learned intermediary, needs to weigh against his knowledge of his patient, his patient’s medical condition, other available alternative treatments (and their risks), and his general medical knowledge. All of that cannot be swept under the rug with a presumption that an alternative warning would have tipped the scales toward non-prescription. Doctors prescribe drugs/devices everyday despite any number of risks inherent in their use.   At best a heeding presumption in a pharmaceutical case, if applied at all, should only go so far as to assume that the alternative warning would have been read by the prescriber. But, it is simply too huge a leap to presume the effect that new warning would have had on the prescribing decision given all the other variables.

In Adeghe, the court found no evidence (no prescriber testimony) that plaintiff wouldn’t have been prescribed Risperdal if a different warning had been given. Id. at *7. Moreover, plaintiff did not adduce any evidence that when the risks of the drug were balanced against its benefits, it would not have been prescribed. Id. “Plaintiff cannot rely on mere speculation as to this medical determination to defeat summary judgment.” Id. Kudos to the court for distinguishing prescription drugs and devices from household consumer goods.

Summary judgment was granted on plaintiff’s failure to warn claim (and on express warranty for lack of any affirmation, id. at *5), but several other causes of action remain because summary judgment was denied on medical causation. The court found plaintiff’s expert had done enough, reviewed studies and considered and addressed alternative causes, to survive a Daubert challenge. Certainly not the worst expert we’ve seen and hardly as important as the heeding presumption decision both for its help in further clarifying New York law and in its acknowledgement of why the presumption has no place in prescription drug and device cases.

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.

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.