Wednesday, January 09, 2013

An Amazingly Straightforward Approach to Fraudulent Joinder, TwIqbal, and Mensing

We were sad to learn of the passing of Los Angeles television personality Huell Howser.  In programs such as Visiting … with Huell Howser and California Gold, Howser introduced viewers to interesting or obscure Southern California people and places.  He hosted shows on topics such as lint or a field of horse manure.  Howser was originally from Tennessee and never lost his friendly drawl.  He was a big guy (ex-Marine) but came across as relentlessly gentle and approachable.  No matter how trivial or silly or quotidian the topic, Howser let loose with a hyperenthusiastic  exclamation, such as “Wow!” or “That’s ah-mayzzz-ing!”  Maybe his point was that if you viewed the everyday things around you with the right attitude of wonder and expectancy, they really were amazing.  Howser was frequently lampooned by comedians such as Adam Carolla and Dana Gould, but you got the sense that the ribbing was purely affectionate.  Howser even appeared on The Simpsons.  We admit to having a soft spot for Howser.  We can remember many nights holding the Drug and Device Law Daughter-Infant in front of the tv, watching California Gold.  Howser had a voice that soothed babies.  And cranky adults, too. 


In honor of Huell Howser, we will take a look at a couple of opinions that are amazing if only because they address some knotty issues with startling simplicity.  Both opinions are from the same case.  Incredible!  The case is White v. Mylan, Inc., 2012 U.S. Dist. LEXIS 182196 (W.D. Okla. Dec. 27, 2012), alleging wrongful death from a  Mylan Fentanyl Transdermal System (MFTS) pain patch.  The case was filed in Oklahoma state court, but was removed to federal court based on diversity jurisdiction.  The plaintiffs sued manufacturers and pharmacies.  One of the pharmacies, Allcare, was located in Oklahoma, which would seem to wreck diversity.  The removing defendants contended that Allcare should be disregarded as fraudulently joined because the plaintiffs had no valid claim against a pharmacy that had no duty to warn consumers about prescription drugs.  Exciting, right?


The White court began, as it had to, with the formidable standard for fraudulent joinder:  “The question is whether the alleged defect in their pleading is so obvious as to render Plaintiffs’ claims unsubstantial and thus allow Allcare to be simply disregarded as a party.”  White, 2012 U.S. Dist. LEXIS 182196 at *5-6.  But even with that tough test, the court had little difficulty determining that Allcare was, in fact, fraudulently joined.  Even the case cited by the plaintiffs made clear that the learned intermediary doctrine precluded any failure to warn claim against the pharmacy.  The underlying rationale for the learned intermediary rule is that “[w]here a product is available only on prescription or through the services of a physician, the physician acts as a ‘learned intermediary’ between the manufacturer or seller and the patient….  As a seller of prescription drugs, a dispensing pharmacy or pharmacist is protected by the doctrine. “  Id. at *8.  That’s amazing!  The plaintiffs attempted to avail themselves of an exception under Oklahoma law that removes the shield of the learned intermediary doctrine “[w]hen direct warnings to the user of a prescription drug have been mandated by a safety regulation promulgated for the protection of the user.”  Id. at *9.  But neither the Food and Drug Administration nor any other regulatory body mandated a direct warning to the user of the prescription drug product at issue in this case.  How about that?!  Finally (as far as the fraudulent joinder issue goes), the plaintiffs tried to maintain a  “negligence theory based on a pharmacy’s alleged duty to monitor the combination of prescription drugs dispensed to a single customer.”   Id. at *10.  But nothing in Oklahoma law suggests “any duty of a pharmacy to prevent a patient from, or warn a patient about, combining prescription drugs.”  Id.  Thus, no claim against Allcare, and no remand.  As Huell would say, fantastic!


In a separate opinion, the same court then dumped the claims on substantive grounds.  White v. Mylan, Inc., 2012 U.S. Dist. LEXIS 182491 (W.D. Okla. Dec. 28, 2012).  The plaintiffs claimed that the MFTS pain patch was defective in design and manufacture, and that Mylan failed to provide adequate warnings.  The plaintiffs identified the following negligent acts: 


Mylan allegedly a) failed to use ordinary care in designing, testing and manufacturing [MFTS] so as to avoid the high risk to users of unreasonable, dangerous side-effects…….;” b) “failed to accompany [MFTS] with adequate warnings that would alert doctors, consumers, and other users in the potential adverse side effects….” c) failed to conduct adequate pre-clinical testing and post-marketing surveillance;  d) “failed to warn Plaintiffs’ decedent…about the possibility of becoming disabled; e) “continued to promote the safety of [MFTS]… even after Defendants knew of the risk or [sic] injury or death;” and f) was “otherwise careless or negligent.” 


White, 2012 U.S. Dist. LEXIS 182491 at *6.  The plaintiffs also alleged that Mylan violated federal laws and regulations regarding labeling, post-marketing reports, and promotion of drugs for unlabeled uses.  Mylan moved to dismiss the complaint under Twombly and Iqbal, arguing that the complaint contained only conclusory allegations because it did not identify any particular defect in the product or warning.  Mylan also argued that the plaintiffs’ claims for failure to warn were preempted by Mensing.  Not surprisingly, the plaintiffs responded that, under a notice-pleading standard, their pleading adequately stated claim of negligence and strict products liability.  The plaintiffs also argued “that the holding of Mensing is inapplicable to strict products liability claims,” [huh?] and that Mensing does not preclude failure-to-warn claims involving MFTS because it is a “delivery system” and not a drug. [Double huh?]  Id. at *7-8. 


The court applied TwIqbal and dismissed the complaint because it lacked “sufficient factual allegations to state a plausible claim of strict liability or negligence.”    Id. at *8.  The complaint alleged that MFTS was defective, but never explained how.  For example, the complaint alleged that the design and manufacture of MTFS were inadequate to avoid “unreasonable, dangerous side-effects” and that Mylan’s safety warnings failed to alert users to “potential adverse side effects”  while also alleging that the decedent’s death was caused by a “mixture of drugs and toxicity poisoning.”  Id. at *9.  But the complaint never alleged what side effects were suffered by the decedent or how such side effects were related to toxicity poisoning.  Would you look at that?!  That sort of pleading is not exciting or beautiful or unique or amazing and it simply cannot satisfy TwIqbal


Lastly, due to the vagueness of the plaintiffs’ allegations, the court held it was “difficult, if not impossible, to ascertain the impact of Mensing on their claims, evening assuming MTSF is the generic equivalent to Duragesic and the holding of Mensing applies.”  Id. at *10.  To the extent that the plaintiffs claimed a labeling defect arising from Mylan’s failure to obtain permission from the FDA to include additional safety warnings or to update the product label with information from post-marketing reports, “[s]uch a claim may be foreclosed by Mensing.”   Id. at *11.  Wow – isn’t that great?


All that being said, the court gave the plaintiffs “an opportunity to amend their pleading to supply additional factual allegations to support their asserted theories of recovery.”  Id. at *12.  Shucks – even Huell Howser could not have mustered much enthusiasm about that. 

But that is no way to end our little remembrance of Huell Howser.  Here is a video of Huell fulfilling "the dream of a lifetime" by taking a dip in the Neptune Pool at Hearst Castle.  Even more than usual, he seems very, very happy.   



1 comment:

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