A Truddle, not a Muddle, through Mensing and Buckman

The scope of Mensing is one of the hotter issues in drug and device law these days. (The Bartlett appeal is one example.) To our defense-hack eyes, Mensing seems perfectly straightforward: a claim is preempted to the extent it alleges that the risks of a generic drug were not adequately disclosed. But the doctrinal landscape has quickly grown messy and treacherous. There is already a lot of legal kudzu out there, courtesy of plaintiff-lawyer ingenuity or judicial discontent with Mensing. Some attorneys and judges do not like preemption at all. Some do not smile upon the differential treatment between brandeds and generics. Accordingly, we get clever arguments and brittle analyses that limp along the page, proudly indifferent to the manner in which they manage to muck things up. It reminds us of what must surely be one of the most cynical observations of all time, when Thomas Hobbes wrote that "Reason scouts and spies for the passions." Nice (in the sense of being foolish) distinctions are drawn to preserve bogus claims.




Still, every once in a while Reason seems to stand up quite well for itself. That is the case with Truddle v. Wyeth, LLC et al., 2012 WL 338715 (N.D. Miss. Aug. 14, 2012), where the court dealt with Mensing in as clean and fair and straightforward a fashion as could be expected. The case is sad. A nineteen year old man was treated for gastritis. The doctor prescribed metoclapramide. The young man began suffering from hallucinations, extreme restlessness (akathisia), and suicidal impulses. He eventually took his own life. His parents filed suit against both brand-name and generic manufacturers, alleging negligence, strict liability, breach of warranties, misrepresentation, fraud, and negligence per se, all grounded upon an alleged failure to warn of the risks of side effects. The plaintiffs' counsel withdrew from the case (the opinion does not tell us why, prompting us to engage in all sorts of pointless speculation), the case was removed to federal court, and the generic defendants filed a motion to dismiss the case because of Mensing preemption.



The generic defendants argued exactly what we would expect them to argue -- that Mensing governed the entire case because all of claims, no matter what the styling, were predicated on an alleged failure to warn, and the generic defendants lacked any power to add warnings. The generic defendants "anticipate[d] that the Plaintiffs would argue that the Generic Defendants should have used an additional means of communicating warnings to physicians, such as letters to health care providers, and suspended sales of the drug until the brandeds were changed." Truddle, 2012 WL 3338715 at *3. The defendants also anticipated that the plaintiffs might try to assert "design defect or other legal theories to escape the preemptive reach of Mensing." That's certainly a lot of anticipation, especially against a pro se plaintiff. Maybe it is smart to trot out, and then knock down, the other side's arguments, rather than wait for the court to endeavor to help out the pro se plaintiffs. In any event, the battle-lines are pretty well drawn in Mensing cases. The potential avenues for circumventing Mensing no longer arrive as a surprise.





The Truddle court granted the generic defendants' motion and dismissed all claims on the grounds of Mensing preemption. Even though the plaintiffs asserted various theories of recovery, "all theories stem from the Generic Defendants' alleged failure to warn of the side effects of the drug." Truddle, 2012 WL 3338715 at *4. Even when the plaintiff complained of activities that might at first blush seem different from disclosing risks on the label, such as failure to investigate or test, any knowledge that would have been acquired from such investigation or testing "would have been helpful" only insofar as it would have been "communicated through labeling - which would not have made any difference as long as the Generic Defendants were following the FDA's labeling regulations." Id. The generic defendants could not have unilaterally improved the labeling even if they wanted to -- that is the point of Mensing. The Truddle judge offers a healthy dose of clear-thinking, and we wouldn't mind seeing that spread to other courts, including a couple we can walk to in ten minutes.



That ends that. Or at least, it could. But the plaintiffs' fraud and misrepresentation claims attacked the defendants for fraud on the FDA, and the Truddle court seized the opportunity to bring some additional clarity on that issue. There was a need for clarity, because a couple of Fifth Circuit cases introduced some unnecessary puzzlement into the Buckman issue. In the first case, which we would like to call the "Bad case," but which the official reporter calls Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), the Fifth Circuit held that a state tort claim for negligence "that attempted to prove breach of a state law duty by asserting a violation of FDA regulations was not a fraud-on-the-FDA claim that would be preempted by Buckman." Truddle, 2012 WL 3338715 at *6. The negligence claim in Hughes was predicated on the manufacturer's failure to comply with the applicable federal statutes and regulations. Well, if there is no private right of action under the federal laws (and there isn't) what exactly are we talking about in Hughes? The negligence claim, pled under Mississippi law, charged, inter alia, that the defendant manufactured and distributed the product inconsistently with its FDA PMA approval by failing to report serious injuries and malfunctions of the device as required by MDR regulations. The Hughes court said that this theory was different from a fraud-on-the-FDA theory that would be preempted under Buckman. Maybe - but that does not make it a valid action under state law. Hughes looks like sheer nonsense, but it is Fifth Circuit nonsense, so the Truddle court had to navigate around it.



The Truddle court did so by holding fast to another case, which we like to call the "Good case," but which you will want to cite as Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012). In Lofton, the Fifth Circuit applied Buckman preemption, in contrast to the Hughes court's unconvincing effort to dodge it. The plaintiff in Lofton alleged that the manufacturer of Motrin had not warned consumers of the risk of autoimmune reactions to the drug. The failure to warn claim was brought under Texas law, which establishes a rebuttable presumption that a drug manufacturer is not liable for failure to warn if the FDA approved the warnings in question. Texas law is specific that such a presumption can be rebutted if the defendant withheld information from the FDA. The issue is whether that fraud-on-the-FDA exception was preempted by Buckman. Sound familiar? We've written about this issue before, discussing another pair of cases, with the good one being Garcia v. Wyeth-Ayerst Labs., 585 F.3d 361 (6th Cir. 2004), and the bad one (wretched, awful, horrible, etc - we're tempted to unload the thesaurus on this one) is Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff'd by an equally divided court sub nom. Warner-Lambert Co. LLC v. Kent, 552 U.S. 440 (2008). Desiano seems nutty in calling off Buckman preemption when fraud-on-the-FDA is part of an exception instead of the cause of action itself, and we would hate to see other courts latch onto the Desiano rationale. Mercifully, the Lofton court did not do so. In Lofton, the Fifth Circuit applied Buckman preemption because the relationship between the manufacturer and the federal regulator was central to the matter at issue.



The Truddle court, after being confronted with the sloppiness of Hughes and the sanity of Lofton, divined a unifying Buckman principle that it believed compelled preemption in the Truddle case: "It is likely that the Plaintiffs' fraud-on-the-FDA theory would be preempted under Buckman, as the theory concerns the 'inherently federal' relationship between the FDA and the Generic Defendants, which are entities regulated by the FDA." Truddle, 2012 WL 3338715 at *7. Now it may be that the Truddle court simply (and rightly)  preferred the interpretation of Buckman in Lofton, but it didn't have to go there because Mensing answered the question.  Lofton versus Hughes made no difference since, in either case (or in neither case) where a generic product is involved the statutory "sameness" rationale of Mensing controls (neither Hughes nor Lofton involved generics).  Clearly, the Truddle court did not merely use reason to scout and spy for a preordained result. It returned to first principles. Those first principles result in more vigorous applications of Mensing and Buckman.

Good Rulings on Experts and Summary Judgment from Mississippi

According to the novels penned by a certain Mississippi lawyer (and the movies based on said novels), corporate defendants are always bad, their lawyers are worse, and juries end up pounding both. Think of Jon Voight during his closing argument in The Rainmaker, wagging his finger at the jury while scolding them to "be just, be just," and then the jury burning out a calculator to arrive at their stratospheric verdict. It's a morality play, pure and simple -- with an emphasis on the "simple." Reality matters hardly at all. Legal rules matter even less.

Reality is different. We've been on panels with judges from Mississippi, and they have consistently impressed us as judges who are smart and serious-minded. They care a lot about following the rules. It's nice to highlight a recent case from Mississippi where the court applied the law carefully and a device company got a fair shake. In Smith v. Johnson & Johnson, 2011 U.S. Dist. LEXIS 98719 (S.D. Miss. Aug. 31, 2011), the plaintiffs claimed that vaginal mesh surgical material was defective and lacked adequate warnings. The defendant filed a summary judgment motion. As part of their effort to fend off that motion, the plaintiffs submitted reports and affidavits from their experts. Using an expert to cobble together an issue of material fact is easy, right? Maybe not, especially if the court is paying close attention.

One of the plaintiff experts was designated past the deadline. We've seen that before. In our experience, plaintiffs get away with late filings of pretty much anything (motions, exhibit lists, etc.) pretty much all the time. Defendants are held to a different standard. It's not remotely fair, but we've gotten used to it. And yet, remarkably, the Smith court actually enforced the deadline and precluded that expert from testifying. The court held that there was no sound explanation for the late designation (the plaintiffs predictably said they needed more discovery from the defendant, but the court didn't buy it), that the expert was important but not vital to the plaintiffs' case, that the defendant was prejudiced by the tardiness and might need to add experts or alter trial preparation, and that a continuance was not a proper cure because the plaintiffs had already gotten an earlier continuance and now it was time for the case to "proceed apace." 2011 U.S. Dist. LEXIS 98719 at **11-14.

As for the plaintiff experts who were timely designated, the court struck two of the reports because they offered "naked opinion," were "conclusory," and amounted simply to saying "it is so." Id. at **17-22. We've certainly seen plaintiff expert reports like that. The expert essentially says "I'm very smart and I think plaintiffs should win." And we're not just talking about expert reports; we've seen plaintiff expert trial testimony that sounds like that. Unlike some courts who practice the matador method and wave this sort of thing by, the court in Smith read the expert reports carefully and critically, and held that expert "opinions devoid of an underlying factual basis and explanation" cannot "create issues of material fact at the summary judgment." Id. at *21-22.

After cutting through the underbrush of tardy or flimsy expert reports, the court got to the key issue raised by the summary judgement motion: did the allegedly deficient warning make any difference? The court applied the learned intermediary doctrine and narrowed the issue down to whether more information about the mesh would have prompted the treating doctor to proceed differently. Interestingly, the court acknowledged the heeding presumption, but pointed out that "'heed' in this context means only that the learned intermediary would have incorporated the 'additional' risk into his decisional calculus. The burden remains on the plaintiff to demonstrate that t he additional non-disclosed risk was sufficiently high that it would have changed the treating physician's decision to prescribe the product for the plaintiff." Id. at *31 (citations omitted). That is, the heeding presumption is part of the causation analysis, but does not end it.

In Smith, the defendant conceded that the Adverse Reactions section of the label understated the number of known adverse reactions. A shrewd concession, that. It probably earned credibility with the judge. More important, it did not undermine the defendant's summary judgment motion because the treating doctor testified that he had read the Adverse Reactions section and disagreed with it -- he knew from his own experience that there were more adverse reactions. So he was not misled. Further, that doctor testified that he felt the package adequately warned him, that he thought the mesh was appropriately prescribed at the time, that he kept abreast of the relevant medical literature, and that the mesh product in question was the best product available at the time. Id. at **33-34. Further further, the doctor testified that the Contraindications section of the product insert functioned as a much stronger warning than the Adverse Reactions section, as it referenced potential infections and the need for subsequent removal. (Obviously this court would not buy the typical plaintiff lawyer insistence that nothing can be called a "warning" unless it resides in a section of the label called Warnings. That argument is silly. In the old Lost in Space television show Robbie the Robot would roll around and say things like "Danger Will Robinson!" or "Warning! Warning! Aliens are attacking!" Apparently, according to plaintiff lawyers, if Robbie just said "Aliens are attacking!" that wouldn't be a warning. While we're at it, can we agree that the Lost in Space show was flat-out creepy?)

In any event, putting aside what the doctor did say in his deposition, what was most important was what he did NOT say. The plaintiffs never could get him to say that a certain specific piece of additional information would have caused him not to choose the defendant's product. Plaintiffs almost never can do that. For that reason, most failure-to-warn cases should, like Smith, go away on summary judgment. Perhaps courts will figure out that one way to enhance judicial economy would be to front-end the warning causation issue and resolve it before requiring expensive discovery of company witnesses and files (especially ediscovery).

And if there was a way to shorten Grisham novels and make them more realistic -- well, we're in favor of that too.