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Several of your Reed Smith bloggers are making plans to attend ACI’s annual Drug and Medical Device Litigation conference, as they celebrate the 27th anniversary of the event. We’re looking forward to great content and networking opportunities – and the chance to catch up with some of our loyal readers!

Since we’d like to see you at ACI, we wanted to share that the good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-999-DDLB when you register. You’ll save 10 percent.

We look forward to seeing you!

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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.

With that predicate, we turn to Meinhart v. Hy-Vee, Inc., 2002 IL App. (2d) 220042-U (Ill. App.. Ct. 2d 2022), in which a dismissal with prejudice on the fifth version of plaintiff’s complaint got her to an appeal, where she promptly waived two of her four grounds for appeal.  Plaintiff’s fundamental claim, boiled down from shifting allegations, was that she had seizures after shifting from one generic version of a prescription anti-epileptic medication to another.  Her blood levels of the medication were found to be below the therapeutic range, so she alleged the new generic must have been weaker than it was supposed to be and that this deviation must have caused her seizures to return.  We say return because the plaintiff was epileptic, had prior seizures on this same medication previously (apparently before her regimen was adjusted), and was also taking a second prescription anti-epileptic medication.  Failure of a prescription medication to prevent some manifestation of the underlying medical condition for which it was prescribed is generally not actionable under any legal theory.  The labeled indications for the medication primarily at issue in Meinhart are the “adjunctive therapy in the treatment” of various types of seizures in specific epileptic populations; there is nothing in the label coming close to a promise that the ingestion of the prescribed medication will prevent all seizures in all patients for all times.

Yet, plaintiff combined the post hoc ergo propter hoc fallacy with a range of legal theories offered against the pharmacy and generic drug manufacturer, as well as the pharmacist and pharmacy technician, although they were never served.  Plaintiff focused heavily on how the color of the pills she was taking when her seizures returned—filled more than a month before but started close to when the seizures began—were pink and the ones she had been taking for several years before were yellow.  They were both supposed to be 500 mg.  Curiously, plaintiff never offered any allegations as to what brand she had been taking or that testing of the new generic medication showed that did, in fact, contain less active substance than it was supposed to.  We spent a few minutes on some government websites—as the plaintiff lawyer might have when drafting one or more of the five complaints—and saw that 1) the 500 mg tablet from the branded manufacturer has been out since 1999 and is yellow, 2) a number of different generic versions came out starting in 2008 and the color of their 500 mg tablets varied, and 3) the 250, 500, and 750 mg tablets from the manufacturer defendant were each pink but bore a different “debossed” number on each.  It should have been pretty easy to see if the tablets at issue had the right number (22) on them and if they contained the right amount of active ingredient.  If, in the days leading up to the return of her seizures, the plaintiff had not been taking three tablets per day as directed by her physician and that was the reason for her low blood levels, however, then perhaps it would have been hard for plaintiff to admit that and still push her lawsuit.  But push she did.

We will not go through all the ins and outs of each complaint and their conflicting factual allegations.  The first complaint offered negligence and strict liability claims against the pharmacy, claiming that the pharmacy voluntarily undertook a duty to warn based on the pharmacist responding with “o.k.” when asked if the plaintiff could take pills of a different color.  2002 IL App. (2d) 220042-U, *2.  After all the claims in the initial complaint and a first amended complaint had been dismissed, plaintiff received leave to try to replead her strict liability claims, which had been dismissed without prejudice.  Id. at *4.  Plaintiff filed a “third [sic] amended complaint” that featured a new count for “res ipsa loquitar [sic]” and the defendant pharmacy again moved to dismiss.  Id.  As what should have been plaintiff’s third strike was heading to the outside corner of the proverbial plate, plaintiff was granted leave to add the manufacturer of pink generic drug as a defendant.  We do not think that should have happened—among other things, the manufacturer’s identify was known or easily knowable from the start—especially with the pharmacy still a defendant and subject to shifting claims and theories.  The “fourth [sic] amended complaint” included strict liability claims against the manufacturer, which moved to dismiss principally on preemption, citing the approval of its ANDA for 500 mg and other dosage tablets.  Id. at *4-5.  The purported res ipsa claims against both defendants were dismissed with prejudice, but the strict liability claims were dismissed without prejudice.  Again, we think it should have been clear at this point that amendment, including trying to plead a non-preempted claim against the manufacturer, would be futile.  Plaintiff was permitted to try one more time with her “fifth [sic] amended complaint” and all remaining claims were finally dismissed with prejudice after another round of briefing an argument.  Id. at *6-7.  (Maybe Illinois has unlimited judicial resources and/or its rule that “amendments may be allowed on just and reasonable terms” is even more pro-amendment than Fed. R. Civ. P. 15.)

On appeal, two of the issues that had featured prominently in the history below were “forfeited” by plaintiff’s failure to offer a serious and supported argument on them.  The first was whether a pharmacy could have duty to warn for purposes of strict liability given the adoption of the learned intermediary doctrine in Illinois.  The second was whether a strict liability manufacturing defect claim had been asserted, which would have involved a look at the quirky Tweedy doctrine, discussed here.  Despite these forfeitures, the court proceeded to assess whether the strict liability claims against the generic manufacturer would have been preempted.  We would normally dig in on the preemption analysis, but plaintiff again forfeited the argument that might have made the analysis more interesting:  that the tablets dispensed to plaintiff were “adulterated” as that term is used in the FDCA and that the manufacturer failed to warn of the adulteration, making the drug “misbranded” as that term is used in the FDCA.  Without that argument, this was straightforward preemption under the double whammy of Bartlett and MensingId. at *12-14.

Working backwards, the court considered the dismissal of the negligence claim against the pharmacy and the purported res ipsa claims against both defendants.  The former turned on the argument that, despite the learned intermediary doctrine meaning the pharmacy generally did not have a duty to warn the plaintiff of the risks of the drugs she was prescribed, the pharmacy somehow created and breached a duty through the pharmacist’s response to a question about the change in the color of the dispensed pills.  Illinois follows section 323 of the Restatement (Second) of Torts, so it does recognize a claim for negligence based on a voluntary undertaking, but “[a]s the trial court reasoned, [the pharmacy] did not undertake to do anything more than substitute generic for generic.”  Id. at *9.  Without a duty, there could be no breach.

As to the latter, we have made no secret that most attempts by plaintiffs in drug and device product liability cases are bunk.  (Like here , here, and here.)  It should not be a surprise that the plaintiff who misspelled “loquitur” when she tried to assert a new claim in her third complaint did not grasp that res ipsa loquitur is not a recognized cause of action.  The Meinhart court did:

Importantly, res ipsa loquitur is not a claim in of itself; rather, it is an evidentiary doctrine that allows a plaintiff to prove negligence under a unique set of proofs.  That is, satisfaction of the res ipsa loquitur elements is not sufficient to establish a cause of action for negligence.

Id. at *10 (internal quotation and citation omitted).  Plaintiff never got past the duty element of negligence.  As above, she failed to allege a legally recognized duty by the pharmacy.  She did not even try as to the manufacturer.

So, was this all a bunch of sound and fury, signifying nothing?  While we cannot say that MacBeth’s preceding clause applies, the answer is “pretty much.”  The lesson we hope judges take is not to allow serial amendment of futile claims.  We do not hold out hope that any potential plaintiffs will take the obvious lesson here for them

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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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Once again this week we turn to the aridities of personal jurisdiction.  Or is that perhaps a bit … harsh?  After all, last week personal jurisdiction had a rare moment in the public spotlight as a result of SCOTUS oral arguments in a case involving the law of Pennsylvania — our usually-fair-but-not-so-much-in-this-case Commonwealth.  The issue was whether Pennsylvania could condition a corporation’s right to do business in the Keystone State on that corporation’s consent to personal jurisdiction in our overly exciting court system. We’ve written about this consent theory before, and we previewed the SCOTUS case here. If Pennsylvania and other jurisdictions can get away with it, then the Bauman and BMS SCOTUS personal jurisdiction decisions become something very near to dead letters.  It seems that several of the Justices last week thought as much, as their questions evinced deep skepticism about this bogus jurisdiction-via-consent  scheme.  You’ve heard of long-arm jurisdiction statutes, right?  These are strong-arm jurisdiction statutes.  

But predicting SCOTUS rulings is a sucker’s game. 

Meanwhile, press coverage of the SCOTUS arguments was predictably daft. Some commentators bemoaned how rejection by SCOTUS of jurisdictional consent via coercive business registration statutes might make it harder to sue corporations. That is utterly wrong. One can sue the corporation where it is incorporated or headquartered, or where the the events at issue happened. What is unfair about that?  The only real losers would be plaintiff lawyers who apparently think there is a need and a right to sue companies where the plaintiff lawyers are located.  Nothing propinks like propinquity. But no one should shed any tears for lazy and/or cynical forum shopping.

Today’s case, Armstrong v. Atrium Med. Corp., 2022 U.S. Dist. LEXIS 195231 (E.D. Wash. Oct. 26, 2022), involves a more quotidian personal jurisdiction issue: can a product liability plaintiff drag a foreign parent company into court?  We’ve written about this issue before (here, for example).  Including a corporate parent in a lawsuit can be a nice bit of leverage for a plaintiff.  It is an annoyance. It is unnecessary. Fortunately, courts usually do not smile upon it. 

Continue Reading E.D. Wash. Finds No Personal Jurisdiction Over Swedish Parent Company
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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
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One of the stock P-side responses, in the post-Bauman personal jurisdiction environment, to a jurisdictionally-based motion to dismiss is to seek “jurisdictional discovery” – the more onerous the better – in an attempt both to slow the often-inevitable dismissal and also to drive up the nuisance value of the case.  That’s the main reason that on our personal jurisdiction cheat sheet we note when jurisdictional discovery is denied.

Continue Reading Jurisdictional Discovery Is Not Bigger in Texas
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A potential top-ten case came across our desks the other day, and even better, it comes out of our home state of California.  In Amiodarone Cases, No. A161023, 2022 WL 16646728 (Cal. Ct. App. Nov. 3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine.  Along the way, the Court disabused several harmful misconceptions on California’s learned intermediary doctrine and held that fraud claims based on journal articles and decades-old statements were bunk. 

The FDA approved amiodarone in 1985 as a last-resort treatment for ventricular fibrillation, and a few years later—in 1989 and 1992—the agency notified the manufacturer of statements that it considered false and misleading, including purported promotion for an unapproved use.  Id. at *1.  Fast forward a few decades, and hundreds of plaintiffs in a coordination proceeding in California have alleged that they experienced side effects after their doctors prescribed amiodarone off label.  Id. at *2. 

You read that correctly.  These plaintiffs were reaching back to alleged misstatements made 30 years ago.  Moreover, amiodarone has been available in generic forms since 1998, so the plaintiffs ginned up claims against generic manufacturers, too—that all defendants (branded and generic) failed adequately to warn plaintiffs of potential risks because they did not ensure that patients received FDA-approved Medication Guides with their prescriptions. 

This is not a new idea.  Amiodarone patients in other jurisdictions have made similar Medication Guide/warnings claims, and some have survived challenges to the pleadings, including in Wisconsin and Illinois.  You can see our take on these orders here and here.  Long story short, we disagreed with those results, especially the short shrift that those orders gave to implied preemption. 

Continue Reading California Appellate Court Reaffirms Federal Preemption, Learned Intermediary Doctrine in Amiodarone Cases
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Today’s guest post is by Jim Fraser of Greenberg Traurig.  Jim is a long-time product liability defense lawyer, but who also worked as a litigation attorney in FDA’s Office of the Chief Counsel (“OCC”).  Utilizing his FDA perspective, he offers some useful suggestions on the regulatory aspects of defending drug or medical device product liability cases.  As always, our guest-posters are 100% responsible for what they wrote, deserving all of the credit and (any) of the blame.

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Lawyers defending drug and medical device companies in product liability litigation routinely deal with FDA-related issues.  For example, they present expert witnesses to testify that their clients complied with the applicable regulatory requirements, they move to exclude purportedly “bad” FDA documents (e.g., FDA Form 483s and Warning Letters), and they file summary judgment motions arguing that the FDCA or FDA regulations preempt plaintiffs’ claims.

Continue Reading Guest Post – What a Product Liability Defense Lawyer Learned While Working for FDA.
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Bexis has already plugged the Reed Smith Life Sciences CLE programs this week, so we won’t replug  — except to remind you that Rachel Weil and the drudge/author of this post will tomorrow discuss the taxonomy and tactics of warning causation.  We talk in terms of taxonomy because there are so many interesting variations of the contents of the warning, the relevant audience, doctors who read, who didn’t read, who already know, and who would like to have known, as well as the rules and burdens of proof in jurisdictions around this great, over-warned country. 

It turns out that Kentucky offers some good pro-defense law on warning causation but, then again, there is some weird, unnerving stuff courtesy of the Sixth Circuit.  Tune in tomorrow for details.  In the meantime, we (obviously) have a preference for clear rules, even though the muddy areas are (obviously) where good lawyers can make a difference and earn their money.

There’s nothing wrong with being obvious.  In today’s case, Adamson v. Lupin Pharmaceuticals, Inc., 2022 WL 3448044 (W.D. Ky. Aug. 17, 2022), we get a blissfully clear and obvious ruling from a Kentucky court, and it is in our favorite legal area, preemption, to boot.  The plaintiff in Adamson alleged that he suffered from Stevens-Johnson Syndrome (SJS) — a serious disease that causes the top layer of the skin to die and shed — as a result of taking generic amlodipine besylate.  If you are one of those folks wrestling with hypertension, you might have some familiarity with amlodipine. 

The Adamson complaint included a messy mixture of claims for failure to warn, negligence, negligent misrepresentation, defective design, and breach of warranties.  The defendant moved to dismiss the complaint on the ground that all the claims were preempted by federal law.  The court agreed with the defendant, dismissed the complaint, and did not waste any time in doing so.

Continue Reading W.D. Kentucky Dismisses Amlodipine Claims on Preemption Grounds

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It’s the start of cold and flu season, so why not talk about cough syrup.  Most cough medicines come in two versions – daytime and nighttime.  The nighttime version typically contains an antihistamine which are known to cause drowsiness.  Daytime versions often contain an expectorant (to thin and loosen mucus) and a cough suppressant.  A common cough suppressant is dextromethorphan hydrobromide (DXM).  That is the ingredient at issue in Goldstein v. Walmart, Inc., 2022 U.S. Dist LEXIS 196743 (S.D.N.Y. Oct. 28, 2022). 

Walmart sells its own brand of OTC cough medicine containing DXM and the label says “Non-Drowsy.”  Plaintiff alleges she relied on that statement in selecting the medicine and she became unexpectedly drowsy after taking it.  She filed a putative class action alleging breach of express warranty, breach of the Magnuson-Moss Warranty Act, and violations of various state consumer protection laws.  Defendants moved to dismiss all claims as preempted.

The federal regulations governing OTC medicines are found in monographs which are promulgated by the FDA and set the approved active ingredients for a class of drugs as well as any conditions under which they are considered safe and effective.  Id. at *7-8.  There is a monograph for Cold, Cough, Allergy, Bronchodilator and Antiasthmatic drugs.  It requires certain products in this class to carry a warning that the drug may cause drowsiness.  DXM is not one of them.  Id. at *8. 

The FDCA has an express preemption clause for OTC drugs – requirements that are “different from or in addition to” or “not otherwise identical with” the FDCA are preempted.  Product liability claims have an exception, but this is not a products case.  The opinion does a thorough walk through of the relevant case law.  Id. at *21-31.  Plaintiff tried to squeeze her claims through a small gap in the preemption window: “preemption does not preclude a state-law claim if the state requirement is outside the scope of the relevant federal requirements.”  Id. at *23.  Courts within the Southern District of New York have approached the scope question and reached slightly different conclusions. 

Continue Reading Southern District of New York Puts Non-Drowsy Labeling Claims To Bed