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

Federal Rule of Civil Procedure 8(a)(2) requires that a complaint contain “a short and plain statement of the claim, showing that the pleader is entitled to relief.”  TwIqbal requires a complaint contain sufficient facts to make the claim for relief “plausible on its face.” 

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Don’t major in minor things.”  A wise professor once shared those words and they’ve always stuck.  As a general approach to life, it makes a lot of sense.  Learning to let go of the small stuff is easer said than done, but it is usually well worth the effort.  But the same does not

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Today we bring you another generally favorable Essure preemption decision.  Plaintiff brought three causes of action against the manufacturer and the court dismissed two of them.  So, in the immortal words of Jim Steinman as belted out by Marvin Lee Aday, we shouldn’t be sad because two out of three ain’t bad.  And one of the two is actually quite good.  So, we certainly aren’t crying icicles like Meat Loaf.  More like when we went looking for a ruby in a mountain of rocks, we came up with a sapphire instead.   

We’ve written about Essure cases over the years, like here and here.  And in many ways Ortiz v. Bayer Corp., 2022 U.S. Dist. LEXIS 226472 (E.D.N.Y. Dec. 13, 2022), is not much different.  Plaintiff alleged injuries from a permanent contraceptive device and brought claims for failure to train, manufacturing defect, and breach of express warranty.  The types of claims that sometimes skirt around the twin guards of PMA preemption—Riegel express preemption and Buckman implied preemption.  The court dismissed the training and warranty claims but ruled plaintiff did enough at the pleadings stage to keep her manufacturing defect claim.

The failure to train warning took a double hit as both expressly and impliedly preempted.  First, to the extent plaintiff demanded training beyond what the FDA requires, they were asking the state to impose an obligation on defendants that was “different from or in addition to” federal requirements and therefore was expressly preempted.  Id. at *10.  That left plaintiff’s argument that they were pursuing a “parallel” claim that defendants breached a purported duty to train under New York law.  But the court ruled that a general negligent undertaking claim under state law falls short of any “clearly articulated state law duty or cause of action to parallel the federal training requirements.”  Id. at *11.  That’s a useful aspect of the preemption argument that negligent undertaking claims are too broad to be genuinely equivalent to a specific FDA physician training obligation. 

Continue Reading Two Out of Three Ain’t Bad

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Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. §§300aa-10, et seq.  That litigation, involving DTP and certain other childhood vaccines, nearly destroyed this country’s ability to vaccinate its children against often deadly diseases – much to the delight of antivaxxers everywhere.  After Congress acted in 1986, much to the delight of everyone else, the Act’s alternative compensation system, combined with its strong preemption provisions restricting post-compensation system litigation have largely restored the nation’s childhood vaccine supply to a sound footing.  The Supreme Court did its part in Bruesewitz v. Wyeth LLC, 562 U.S. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.

Continue Reading Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

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The world may never know how many licks it takes to get to the center of a Tootsie Roll Pop, but we do know it only took three judges on the California Court of Appeals to affirm a demurrer in Tootsie Roll’s favor. 

Did you know Tootsie Rolls first came on the market in 1896 and were originally delivered by horse and buggy?  Or that they were said to be Frank Sinatra’s favorite candy?  And long before the wise old owl bit into the Tootsie Roll pop, the candy was advertising on television dating back to the 1950s.  Tootsie Roll has had its home base in New York, New Jersey, and Chicago – where they are still manufacturing 64 million rolls every day.  So, what could possibly be wrong with a Tootsie Roll?  According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. Tootsie Roll Indus., 2022 Cal. App. LEXIS 982 (Cal. Ct. App. Nov. 30, 2022). 

Plaintiff alleged that she consumed Tootsie Rolls from 2010 to 2016 apparently without knowing that they contained artificial trans fats in the form of partially hydrogenated oils (PHOs).  Note: PHOs were on the label.  Having consumed the Tootsie Rolls, Plaintiff alleged she was at an increased risk for conditions like cardiovascular disease and type 2 diabetes.  PHOs aside, Tootsie Rolls are essentially chocolate flavored sugar.  So, sure they play their role in all those nasty obesity-related health conditions.  But that cannot serve as the basis for an Unfair Competition Law (“UCL”) claim or an implied warranty claim.  As it turns out, thanks to very specific language from both the FDA and Congress, neither could the presence of PHOs before 2018.

Continue Reading How Many Judges Does it Take to Toss Out a Tootsie Roll Case?

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Drug manufacturers are not insurers against injury from or while taking medications.  Neither are distributors or pharmacies.  Just because a patient experiences a complication while taking a medication, including the very condition the medication is supposed to help prevent, does not mean that some person or entity should be liable to the patient for her injuries.  Sometimes, there is no fault or liability to be found.  We do not think these are controversial principles, but we find that they apply to more than a few of the cases giving rise to the decisions about which we expound.

We also find that missing facts from complaints can speak volumes.  Similarly, when a plaintiff waits until the third complaint to add case-specific factual allegations that should have been there from the start or when factual allegations pop in and out of serial amendments you have to question the basis for those allegations.  At least we do.  As inveterate curmudgeons, we tend to think bare-bones, boilerplate allegations are unlikely to be supported if the case gets to the merits.  Of course, part of the game for some plaintiffs is to get past pleadings and hope the defendants opt for settlement instead of paying the costs of defense.  The Twombly and Iqbal decisions tightened pleading standards, and thus improved the chance of success on motions to dismiss in federal court and some states have followed along.  The hole, and source of our periodic grumbling, is how often dismissals are without prejudice and accompanied by leave to amend.  Too often, it seems that the provision in Fed. R. Civ. P. 15 that courts “should freely give leave when justice so requires” leads to leave even when it should be obvious that amendment will be futile, not to mention a waste of judicial resources.

Continue Reading Five Strikes Needed To Dismiss A Questionable Case

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The recent defense win in Dains v. Bayer HealthCare LLC, 2022 WL 16572021 (N.D.N.Y. Nov. 1, 2022), demonstrates why many plaintiff-side counsel are well-advised to steer away from cases involving PMA medical devices.  Between federal preemption and TwIqbal, not one of the plaintiff’s “seventeen separately enumerated causes of action” escaped the defendant’s motion to dismiss.  Id. at *3.

Continue Reading Preemption and Pleading Send Plaintiff Packing

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Today’s case is a favorable prescription drug preemption decision making a key holding on newly acquired information and adverse event reporting.  It is a one-off case involving the prescription drug Korlym which is used to treat Cushing’s Disease. Pietrantoni v. Corcept Therapeutics Inc., 2022 WL 16857262 (D. Mass. Nov. 10, 2022).  Plaintiff’s claims break down into three categories—design defect, failure to warn, and failure to monitor.  Plaintiff dismissed her design defect claims and the failure to monitor claims are based on fairly unique facts.  So, the case boils down to failure to warn which itself had two sub-categories—failure to warn based on product labeling and failure to warn based on failure to report adverse events.  One is dismissed and the other is delayed.

Korlym was approved by the FDA in 2012.  During the approval process, the FDA conducted a Medical Review of the drug which included information about endometrial thickening and the related complications experienced by users.  Id. at *6.  Therefore, the warnings that were approved to accompany the drug included the risks of vaginal bleeding and endometrial changes.  Id. (full warnings set out in opinion at *7).  The label was revised in 2016, but there was no change to these warnings.  Plaintiff was prescribed the drug in 2018 and used it for approximately 10 months.  She experienced complications that led to an emergency surgical procedure and further complications to future fertility.  Id. at *8. 

The opinion contains a nice recitation of the history of prescription drug preemption – Wyeth v. Levine, PLIVA, Inc. v. Mensing, Mutual Pharmaceutical Company v. Bartlett, and Merck Sharp & Dohme Corp. v. Albrecht.  These four cases makeup the “analytical framework” for prescription drug preemption.  Wyeth and Mensing establish that preemption hinges on the availability of the Changes Being Effected (“CBE”) procedure.  If a manufacturer can unilaterally change the label without prior FDA approval via the CBE procedure, a warning deficiency claim is not preempted.   Albrecht clarified, however, that even where the CBE procedure is available, if the manufacturer can demonstrate by clear evidence that the FDA would not have approved the change, the claim is preempted. 

Continue Reading Adverse Event Reports Not Newly Acquired Information for CBE Label Change