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Almost a year ago we wrote a post called Learned Intermediary – Not Just for Failure to Warn about a California putative economic loss class action that was dismissed for failing to plead any allegations about whether the drug manufacturer had adequately warned plaintiff’s prescribing physician.  Fast forward about 9 months and we posted about

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We are just back from a lovely long weekend in Mexico.   We were delighted to find, on our DVR, a show we’d forgotten we set to record:  a special interviewing the cast and director of Love, Actually on the 20th anniversary of that film’s release.  This is our all-time favorite holiday film, and pretty close to our favorite film of any genre.  We love how it has crept into popular culture (the SNL parody of the flip cards scene, featuring Kate McKinnon as Hillary Clinton is nothing short of brilliant), and we find the film endlessly charming and restorative, no matter how many times we watch it.   Take a look at the special, if you missed it

Speaking of all-time favorites, today’s case deals with warnings causation, our all-time favorite doctrine.  (Along with our co-blogger, Mr. McConnell, we just presented a CLE on this topic.)  This is the doctrine:  to prevail on a failure-to-warn claim in a prescription drug or medical device case, a plaintiff must prove both that the products warnings were inadequate and that the inadequate warning proximately caused the plaintiff’s injuries. Subject to variations of local law, the general rule is that, to prove the warnings causation piece, a plaintiff must adduce evidence that a different or stronger warning would have altered her physician’s decision to prescribe the drug or device. 

In Brennan v. Johnson & Johnson, et al., 2022 WL 17219513 (C.D. Cal. Nov. 18, 2022), the plaintiff alleged that the warnings provided with her pelvic mesh devices were inadequate.  She asserted failure-to-warn claims sounding in negligence and strict liability, and the defendant moved to dismiss both, arguing that the plaintiff could not prove that any inadequacy of the warnings proximately caused her injuries because her prescribing physician had not testified that she would have acted differently in the face of a different warning. 

Continue Reading Lovely Warnings Causation (and More) Mesh Decision from the Central District of California

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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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Readers may recall our dissection of the ridiculous application of offensive, non-mutual collateral estoppel in Freeman v. Ethicon, Inc., 2022 WL 3147194 (C.D. Cal. 2022).  Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap.

We described the prior adverse decision that formed the ground for the collateral estoppel claim as “factual findings entered by a state-court judge after a bench trial in earlier false-advertising and unfair-competition litigation.”  That description doesn’t really do the prior decision (in)justice.  That decision, People v. Johnson & Johnson, 2020 WL 603964 (Cal. Super. Jan. 30, 2020), decided an action filed by the California attorney general that had essentially converted the allegations that product liability plaintiffs had been making against the defendants’ pelvic mesh into the basis for a statewide civil action under certain California consumer protection statutes.  Here is the result of that decision, in a nutshell:

Continue Reading Interesting Pelvic Mesh Due Process Certiorari Petition

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We wrote recently that California’s courts have never met a case they did not like.  We were speaking somewhat tongue in cheek of course, but still California remains a destination for litigation tourists trying to take advantage of laws and procedures that many view as plaintiff friendly.  One bulwark against blatant forum shopping is personal jurisdiction under the U.S. Supreme Court’s Bauman and Bristol-Myers Squibb cases, the latter reversing the California Supreme Court, which restored some measure of discipline to jurisdiction over out-of-state defendants.

Another potential bulwark is choice of law.  That is to say, even when a plaintiff sues in California, the applicable choice-of-law rules might compel the application of another state’s law, which could doom the plaintiff’s claims.

That is what happened this week in Nelson v. F. Hoffmann-La Roche, Inc., No. 21-cv-10074, 2022 WL 17259056 (N.D. Cal. Nov. 28, 2022) (to be published in F. Supp. 3d), where a Florida resident and Army veteran used a generic prescription drug while stationed in Kentucky and overseas and allegedly suffered complications.  But he chose to sue in California.  Why?  Because the manufacturer of the branded version of the drug (not the generic version that the plaintiff actually used) was based in California at the time he filed (having relocated from New Jersey), and California is one of a very few states that allows innovator liabilityi.e., holding an innovator/branded manufacturer potentially liable for a generic product that it did not make, did not sell, and from which it did not make any profit. 

Continue Reading Federal Judge In California Cabins Innovator Liability

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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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Like most judicial clerks (and, for that matter, judges) we found writing dissents more fun than writing majority opinions. Dissents free one from the need to articulate a consensus.  Moreover, since a dissent does not establish a precedent that others must at least pretend to follow, the dissent’s author can be less precise and can let the rhetorical fireworks fly.  To reverse the Spider Man rubric, with lack of responsibility comes great power to write colorfully.

We clerked on the Ninth Circuit.  The Ninth Circuit is often unjustly maligned. And yet the fact is that the Ninth Circuit more often than not gets things right.  Put another way, not every Ninth Circuit dissent hits the mark.  We certainly do not agree with the dissent to the denial of rehearing en banc in California Chamber of Commerce v. Council for Education and Research on Toxics, 2022 WL 14725243 (9th Cir. Oct. 26, 2022).  But it is a fun read. 

The underlying Ninth Circuit decision enjoined certain Proposition 65 litigation on first amendment grounds, and we discussed that decision last May.  Here is a brief refresher: Proposition 65 requires postings of warnings about substances “known to the state [of California] to cause cancer.” You see those warnings pretty much everywhere in California.  In truth, the warnings are so ubiquitous as to be useless.  

Continue Reading Ninth Circuit Dissent from Denial of En Banc re Injunction against Prop 65 Lawsuit: Sturm und Drang und Wrong

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California state court is not the place most products liability defendants want to end up.  Unfortunately, today’s case had to stay in state court because plaintiff sued the defendant’s device representatives who had direct contact with the plaintiff.  The reps, like plaintiff, were California residents and destroyed diversity jurisdiction. The decision, however, in James v.