It’s an old time Western movie cliché: after a shoot-out commences in a saloon, the piano-player meekly holds up his hands and pleads, “Don’t shoot me, I’m only the piano player.” He had no role in the fight. The phrase got subverted in Francois Truffaut’s second film, Shoot the Piano Player (that’s Tirez Sur la
What follows is another of our occasional guest posts, this time by fellow Reed Smith attorney Danielle Devens. As always with our guest posts, the author gets all the credit, and any blame, for the contents of his/her work.
This week, a panel of the Missouri Court of Appeals issued an opinion allowing a plaintiff to maintain a small subset of warning-related claims against a generic drug manufacturer. It also dismissed the claims against the brand name manufacturers, albeit reluctantly, pointing out the “inherent unfairness” of the supposedly “unjust result.” Finally, same opinion reversed the trial court decision dismissing plaintiff’s claims against a publisher of information disseminated by pharmacies, but only on statute of limitations grounds. The case is Franzman v. Wyeth Inc., No. ED100312, slip op. (Mo. App. Aug. 26, 2014) [ed note: Now at 2014 WL 4210207, as of this morning].
The plaintiff allegedly took generic version of the drug Reglan from March 2002 through October 2005, at which point she allegedly developed tardive dyskinesia, a known risk of this drug. She brought claims against the brand-name manufacturers, generic manufacturers, and a publisher. In a prime example of litigation tourism, plaintiff is a Kentucky resident pursuing claims under Kentucky law who filed her suit in the notoriously plaintiff-friendly St. Louis, Missouri. [Slip Op. at 2]
But even St. Louis was not that friendly to this plaintiff. The trial court knocked out plaintiff with a one-two-three combination, dismissing all claims against: (1) the generic manufacturers based on Mensing preemption; (2) the brand name defendants based on lack of legal causation because they did not make the product the plaintiff took; and (3) the publisher based on the Kentucky one-year statute of limitations. Plaintiff appealed each ruling.
We are sometime not sure what to make of pharmacy monographs. You know what we mean. Those sheets that pharmacists print out and give us with our prescriptions. They are not drug labeling, and they are not medication guides. They are summaries intended for patient perusal, with information taken from the labeling, but digested in a fashion intended for the lay reader. Notably, the FDA has not asserted any prerogative to review and approve pharmacy monographs, leaving publishers essentially self-regulated under an FDA action plan.
What is the best way to describe a collection of cases? If we talk about a school of fish, a pride of lions, a descent of woodpeckers, and (our favorite) a murder of crows, how does one denote cases in the plurality? A gaggle? A bindle? A flopstain? Anyway, a long Lexis-sheet of cases shows up on our monitor every week. How do we decide which ones merit a post? Maybe the other carpal tunnel-maimed wretches on this blog consult different standards, but here is the decision-ladder we climb: (1) the case must be useful or otherwise important for practitioners to understand; (2) we would rather publicize good (pro-defense) results; (3) powerful reasoning helps; (4) it is way more fun to report on a decision that is well written; and (5) when in doubt, we plump for opinions that can support a drawn-out, tendentious analogy to a film, tv show, or song currently rattling around our head. That last criterion is, of course, perfectly silly. But we stand by it.
A.G. v. Elsevier, Inc., 2013 WL 5630077 (1st Cir. Oct. 16, 2013), meets the first four elements of our test. It addresses two of a drug and device defense lawyer’s best buddies (proximate causation and the TwIqbal pleading standard), it affirms dismissal of a complaint that sought to impose a new and unusual form of liability, it employs iron-clad analysis, and it contains delicious prose.
Right from the start, the court tells us that this is “a curious case.” A.G., 2013 WL 563077 at *1. So it is. The plaintiffs, suing through their mothers, were minors who had previously lost medical malpractice actions against the doctors who delivered them. Now they were suing the authors and publisher of a peer-reviewed case report that had been used by the defendants in the malpractice trials. The plaintiffs claim that after losing their med-mal trials they discovered that the case report was phony. The plaintiffs sought compensation from those responsible for the case report because it had “caused” the jury to return a defense verdict. Id. The court called this allegation “optimistic,” “imaginative but unpersuasive,” and, most important, “unprovable.” Id. The plaintiffs’ claim does not reach the “plateau of plausibility” which, under Twombly and Iqbal, is the “new normal” in federal civil procedure.
For those of you who insist upon receiving some of the concrete facts, here you go. The plaintiffs were born with permanent brachial plexus injuries. They alleged in their medical malpractice actions that the injuries were caused by the application of excessive traction during delivery. The defendant doctors introduced into evidence a case report purporting to document an instance of brachial plexus injury occurring in a delivery without any physician-applied traction. Presumably, defendants cited the case report to support an argument against medical causation. The jury returned a defense verdict. Why? We do not know. That is exactly the point.
We were perusing the recent GAO report on electronic drug labeling in our spare time (we’re weird like that). We found a number of interesting points − such as what the FDA apparently told the GAO about its position on off-label promotion (“[a]ccording to FDA, if a drug manufacturer promotes a drug for off-label uses, such promotion may constitute evidence to support a violation of the [FDCA]”) (emphasis added). But the most interesting aspect of the GAO study for some of us was its description of the non-labeling information available to purchasers of prescription drugs, mostly through pharmacies:
Patients can receive written drug information provided along with their prescription drugs in the form of CMI [“consumer medication information”]. Unlike prescribing information, Medication Guides, and [patient package inserts], CMI is not approved by FDA, and drug manufacturers do not produce this type of drug labeling. Instead, it is produced by third parties and distributed to patients at the pharmacy when their drugs are dispensed. CMI can include information from the prescribing information and can also include additional information not contained in FDA-approved labeling, such as off-label uses of certain drugs. According to officials from third parties that produce CMI, they also use other sources, such as peer-reviewed literature, to develop the information for their CMI. FDA has not asserted the authority to require third parties to submit CMI for review by the agency before CMI is distributed,
according to agency officials.
GAO Report at 7.
This discussion started us thinking again about the novel – and we would add, reprehensible – assertion of product liability claims against some of the “third parties” mentioned in the GAO’s reports. We discussed our overwhelmingly negative reaction to so-called “publisher liability” claims back in 2011. Then, we pointed out that this sort of claim is almost always asserted by plaintiffs for ulterior motives (chiefly joining a non-diverse defendant to prevent removal to federal court), and that no state in the country has affirmatively permitted such a claim.…
Continue Reading Revisiting Publisher (Non)Liability
Some time ago we were highly critical of a potentially dangerous expansion of liability for failure to warn to publishers of medical literature.
That’s right, publishers.
In our prior post we went after Slater v. Hoffman-La Roche, Inc., 771 F. Supp.2d 524 (E.D. Pa. 2011), for giving credence to a claim that a publisher of medical reference products could somehow be liable under Pennsylvania law for alleged errors and omissions in the content of materials written by others. Slater did not say that there was such a claim, mind you. It only speculated (in the absence of any contrary precedent) that there could conceivably be such a claim. Slater was an fraudulent joinder case. The publisher defendant, Wolters Kluwer, had the misfortune of being headquartered in Pennsylvania. That meant it was non-diverse, so if the plaintiffs could merely hang a “colorable” claim on it, the case would have to be remanded to the Philadelphia Court of Common Pleas – at the time the #1 ranked Judicial You-Know-What according to ATRA.
Philadelphia isn’t ranked #1 anymore.
The Philadelphia Court of Common Pleas Complex Litigation Center (home to Philly’s notorious mass tort programs) is under New management.
As in Judge Arnold New.
Judge New recently issued an opinion, A.B. vs. Ortho-McNeil-Janssen Pharmaceuticals, 2013 Phila. Com. Pl. Lexis 84 (Pa. C.P. Phila. Co. April 5, 2013), sticking a much deserved fork in the concept of publisher liability. A.B. involved alleged injuries from certain atypical antipsychotic drugs. In addition to the manufacturer of the drug, the plaintiffs sued two publishers of medical information, Excerpta Medica and Elsevier. The publishers recently took the
bull***t by the horns and moved for summary judgment, on the ground that their role in “publishing scholarly books and journals” (Elsevier) and “developing medical literature . . . including articles published in peer-reviewed journals and posters and abstracts presented at medical conferences” (EM), id., at *4-5, couldn’t possibly give rise to liability to the plaintiff.
Not too long ago a case here in the Eastern District of Pennsylvania, Slater v. Hoffmann-LaRoche Inc., ___ F. Supp.2d ___, 2011 WL 1087240 (E.D. Pa. March 25, 2011), held that an inadequate warning claim against a “monograph publisher” survived the rather loose standard imposed upon fraudulent joinder.
That’s right, or at least that appears to be what this particular defendant, Wolters Kluwer Health, Inc., (“KWH”) does according to its website – it publishes textbooks (including Lippincott), reference products, journals, bibliographic and reference databases, drug information software, point-of-care tools, web-based information systems, online continuing education products, and electronic information.
A publisher can be liable in a product liability suit in Pennsylvania?
That’s a new one on us.
Let’s see how Slater purports to accomplish that feat. First of all, it’s crystal clear under Pennsylvania law that a pharmacist dispensing drugs is not liable for failure to warn about a prescription drug. Coyle v. Richardson–Merrell, Inc., 584 A.2d 1383, 1386-88 (1991); Makripodis v. Merrell–Dow Pharmaceuticals, Inc., 523 A.2d 374, 376-79 (Pa. Super. 1987); Ramirez v. Richardson–Merrell, Inc., 628 F. Supp. 85, 87-88 (E.D. Pa. 1985) (note: these are all Bendectin cases, and Bexis participated in their defense). The only way a pharmacist can be liable is for independently screwing up, such as filling a prescription with the wrong drug.
So the plaintiff didn’t sue the pharmacist.
However, pharmacists now include fact sheets – “patient education monographs” about the drugs they dispense. As Slater recognizes, this isn’t something that tort law mandates. In any event, somebody has to prepare and compile this information. KWH is one of those entities.
With a lot of you on the way out the door for Labor Day, here are a couple of new (at least to us) cases, that while not important enough to merit lengthy discussion, which contain something interesting (to us defense drug and device lawyers, that is).
Cheatham v. Teva Pharmaceuticals, 2010 U.S. Dist.…