Maybe it is the hopeful anticipation of the cherry blossoms or the long-awaited spring thaw, but we were feeling generous as we read three recent decisions that touched on some recurring issues in drug cases these days.  So, in part to save Bexis from having to address these with many others in his roundup, we re-enter the blogging fray with a post that attempts to tie together these decisions in something somewhat coherent.  (We invite the readers of the post to be hopeful and generous while they are reading this.)

The plaintiff in Chatman v. Pfizer, Inc., et al., No. 5:11-CV-69-DCB-JMR, 2013 U.S. Dist. LEXIS 44525 (S.D. Miss. Mar. 27, 2013)—not to be confused with the Chapman case that McConnell discussed in his poetry blog—sued three manufacturers of generic metoclopramide and three branded manufacturers of branded Reglan.  He apparently only took the generic stuff, which he said caused him to develop tardive dyskinesia.  We have blogged quite a bit about preemption of claims against generics under Mensing and about the general rejection of the “innovator liability” theory first articulated in Conte. We will not repeat the august discussion from past posts, decry the creation of new state law claims by a federal court sitting in diversity, or rail that plaintiff was allowed to proceed with one shaky claim against the branded manufacturers.  Rather, we present a thorough decision that actually addressed the issues presented to it.

In the context of a 12(c) motion, the court held that all asserted claims against the generic manufacturers were preempted.  Plaintiff argued that Mensing did not apply to his warnings claims because the generic labels were supposed to have been updated to match what was approved for the branded label in the years before plaintiff was prescribed the product.  Sounds like a good argument, but plaintiff also alleged that the branded label in circulation at the time did not match what had been approved.  Relying on the Fifth Circuit’s unpublished decision in Morris v. PLIVA, Inc., 2013 WL 563506, *2 (5th Cir. Feb. 14, 2013), which considered the same argument, the court held that the asserted warnings claims still required the generic manufacturers to do more than the branded manufacturers had done and were preempted anyway.  Id.at **9-11.  The court turned to claims asserted under the Mississippi Product Liability Act and common law that plaintiff claimed were not warnings-based.  Relying on Demahy and Mississippi district court cases and with a good dose of common sense, the court saw that the plaintiff had actually only pleaded claims based on the alleged inadequacy of labeling, which are preempted.  Id. at **11-19.  Nice, tidy, and done.

The Chatmancourt’s consideration of the asserted claims against the branded defendants, considered in the context of a summary judgment motion, was not quite as straightforward.  Some parts were pretty easy and welcome.  Plaintiff could not pursue product liability claims because Mississippi law (sensibly) requires that the plaintiff be injured by the defendant’s product.  Id.at *21.  Plaintiff also could not pursue claims for “failure to comply with the FDA’s rules or regulations” under BuckmanId.  The sticking point was for Conte-style—the accompanying song and dance are not as catchy as Gangnam Style—liability under the rubric of “misrepresentation.”  This is where our antennae usually go up searching for signs that federal judges are doing things that state court judges should do first—like recognizing state law causes of action.  Although the court ultimately permitted plaintiff to squeak by summary judgment on this claim alone, the decision was based on Mississippi precedent and the scope of the challenge made by the defendants.

We were pleased to see that the court acknowledged the “near universal rejected by other district courts” of Conte and that there was no more than the slightest hint that “fairness” required giving plaintiff somebody to sue where his claims against the manufacturers of the drugs he took were preempted.  Id.at **23-24.  Relying primarily on Lawson v. Honeywell International, Inc.,75 So. 3d 1024 (Miss. 2011), a decision allowing a non-MPLA claim to proceed against the designer of a car seatbelt made by someone else, the court concluded there was room for a common law negligent misrepresentation claim against a non-manufacturer.  Id. at **24-32.  To reach this conclusion required analysis that Mississippi law allowed for a duty without a direct relationship between the plaintiff and defendant.  Because Mississippi law, in the court’s estimation, did so allow, this is actually a fairly narrow ruling.  It is also narrow because the defendant’s motion was based on them not being the manufacturers of the pills the plaintiff took, which did not shift the burden to plaintiff to create an issue as to whether defendants assumed a special or fiduciary relationship with him, which would be necessary to advance a claim for misrepresentation by omission (as the court construed what plaintiff was really advancing).  Id. at *44.  Ultimately, plaintiff will have to prove such a relationship, the omission of material information from the branded label, reasonable reliance by the plaintiff, and the foreseeability of the plaintiff’s injury from taking generic drug, among other things.  We suspect that we will be seeing the case again on the direct consideration of those issues.  At the end, the court’s statement of the law does not describe a major opening for Conteclaims:  “. . . brand name manufacturers—provided they do not have some special relationship to consumers of generic drugs which this Court has overlooked—owe no duty to consumers of generic drugs as long as the warnings given to the generic drug consumers are not false and therefore contribute to the plaintiff’s injury.” Id. at 45.  In most cases, we think that will be seen as a product liability claim, which can only be maintained where the plaintiff actually took the defendant’s drug.

The day before Chatman, there were two decisions worth considering (at least here).  In Sadler v. Advanced Bionics, Inc., Non. 3:11-CV-00450-H, 2013 U.S. Dist. LEXIS 42256 (W.D. Ky. Mar. 26, 2013), we saw something we do not see very often—motions in limine rulings on someone else’s drug or device case.  As with most such rulings, this one was a mixed bag.  The evidence at issue related to three 483s and a warning letter that the defendant medical device manufacturer received and documents related to the filing and eventual settlement of a FDA civil monetary penalty (CMP) action.  As anyone who has been in trial for a drug or device manufacturer knows, these sort of documents can be highly impactful and create diversions from what the defendant might want the jury to focus on, like the medical causation or the actual elements of the asserted causes of action.  In splitting the baby—one of the 483s and all the CMP documents were excluded—the court focused on familiar requirements like Fed. R. Evid. 401, 403, 408, and 803(8), but was not terribly consistent.

  In excluding CMP documents, the court rejected the argument that they went to notice because “FDA filed its complaint for the CMP in 2007, two years after Advanced Bionic manufactured Plaintiffs’ [device] and one year after surgeons implanted Plaintiff B.S. with her [device].  Therefore, this evidence could not give notice of anything relevant to this suit.”  Id. at *11.  However, in rejecting the challenge to the relevance of a 2005 warning letter and 2007 483, the court noted “the information contained within these documents show evidence of Advance Bionics’ notice of [] problems with the [device].”  Id. at *5.  Moreover, the court found that the 483s and warning letter met the public records exception as “factual findings,” but noted that the CMP documents were not probative “because they do not represent the FDA’s final determination as to Advance Bionics’ alleged liability in the CMP.”  Id. at **6-7 & 9.  But 483s and even warning letters are not final determinations, either.  FDA’s website says “The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations” and “A Warning Letter is informal and advisory.  It communicates the agency's position on a matter, but it does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action on which it can be sued.”  And FDA recently told the same thing to the Supreme Court.  Maybe this is the sort of foolish consistency over which our small minds should not be troubled or maybe “warning letter” just sounded too scary to realize that it is informal not final.  At least the court got it right in excluding a 483 from 2001, which was before the device at issue was approved and only concerned “earlier generations.”  Id.at 4.  And it is always right to note that all claims based on failing to submit a PMA supplement or other regulatory materials are preempted.  Id. at **4-5.

Lastly—if you are still reading—Rhodes v. Bayer Healthcare Pharms., Inc., No. 10-1695 (W.D. La. Mar. 26, 2013), issued a nice opinion in knocking out the causation and liability opinions of Doctor of Pharmacy in a case involving an antibiotic and peripheral neuropathy.  The causation part contains several nuggets, like pharmacists cannot do differential diagnoses, adverse event reports are not reliable evidence of general causation, and there can be no evidence of specific causation offered absent admissible general causation evidence, none of which may be new but are always nice to see laid out.  Id.at **8, 14 & 16. We also liked the discussion of the exclusion of the expert’s labeling opinions and not just because it cited one of our first decisions excluding such opinions, In re Diet Drugs, MDL No. 1203, 2000 WL 876900, **11-12 (E.D. Pa. June 20, 2000).  As is often the case with experts who foray into drug labeling from other areas, the witness “had never held himself out to the community as an expert in labeling, appropriate labeling, or regulatory matters” and did not know basics like FDA’s standards for adding black boxes.  Id. at **19 & 21-22.  Lastly, the court noted the absence of reliable methodology used by the expert in arriving at his proposals to improve the drug’s label, which he could not justify in deposition with more than a “rough guesstimate.”  Id.at **22-23.  It seems to us that proposed revisions of labels from plaintiffs’ experts, when they even bother to offer them, tends be based on guesses or personal preference.  It is nice when a court sees through that.  Given that it is the plaintiff’s burden to establish proximate cause for failure to warn, plaintiffs’ experts should be offering proposed revisions and should have their labeling opinions kicked out when they cannot support their proposed revisions with more than guesses.  See, we were being hopeful.  And the bright spring sun has poked through the clouds.