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
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
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.
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.
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.
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.
We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. Wilkins v. Genzyme Corp., 2022 WL 4237528 (D. Mass. Sept. 14, 2022), is an even stranger claim, with the plaintiff seeking to hold the defendant liable for not manufacturing a prescription drug. Fortunately, in Wilkins, those claims (several theories alleging essentially the same thing) did not state a claim.Continue Reading No Liability for Not Manufacturing a Product
As we head past Halloween, your Reed Smith bloggers wanted to offer our loyal readers a treat: Reed Smith is once again offering its virtual “Life Sciences CLE Week” starting Monday, November 7. (See the end of this post for information on jurisdictions in which credit is offered. You can register for the webinars here.)
And we will now mix our holiday references to note that yes, Virginia, there is an Ethics Credit session.
Bexis will be kicking things off on Monday, November 7, at 2 p.m. ET with a presentation on “The Ebb and Flow of the Law – A Year of Drug, Medical Device, and Vaccine-Related Preemption Developments,” which will discuss significant preemption-related developments over the last twelve months, both favorable and unfavorable, in product liability litigation involving prescription drugs (including generics), medical devices, vaccines, and OTC drugs.
Next up, on Tuesday, November 8 at 12 p.m. ET, our colleagues Dave Cohen and Selina Coleman will discuss “Ethics and E-Discovery: Lessons Learned from the Alex Jones Cases and Others.” Dave and Selina will use the Alex Jones cases as a starting point for discussing Model Rules 1.1, 1.6, 3.1, 3.3, and 3.4 and other recent matters where sanctions or major fines were issued relating to discovery or information governance.
Recently, in describing a decision granting summary judgment in an IVC filter case, we identified some additional analyses we would have liked to have seen:
[W]hile interrelated, we think the concepts of a “compensable injury” and causation are separate. For instance, an exposure might cause a risk of future injury, but state law may hold that such a risk without present injury is not compensable. Or a subclinical injury like pleural thickening may not be compensable, in part because of the inconsistency with the principles of accrual of claims for statute of limitations purposes. Is a medical procedure not required by specific symptoms—regardless of what caused them—itself a compensable injury? We think not. A surgery may be part of the damages allegedly related to an injury allegedly caused by the drug/device/exposure, but is not an injury in and of itself. Gomez did not delve into this either.
That same day—but well after we had set our prescient post to publish—the court in Fuss v. Boston Sci. Corp., No. 2019-02348, 2022 Mass. Super. LEXIS 251 (Mass. Super. Ct. Oct. 20, 2022), did those same analyses in another IVC filter case. Rather than fall prey to the post hoc ergo propter hoc fallacy that plagues plaintiffs’ causation theories in so many drug and device product liability cases, we will admit this is mere coincidence. After all, compensable injury seems like an obvious threshold issue in an IVC filter case where perforation of the inferior vena cava (IVC) is the only claimed injury.
Given the facts of Fuss, we will go a step further and say that it would be better if there were a way to get rid of cases without compensable injuries without the time and expense of going through fact and expert discovery and briefing an all-issues summary judgment motion with accompanying Daubert motion. After a pulmonary embolism, plaintiff had his IVC filter implanted by an experienced vascular surgeon in 2007. It has remained in place, without embolism or any symptoms tied a complication, for the fifteen years since. Then plaintiff saw a lawyer advertisement, was sent by lawyers to get a CT scan ordered by a doctor he did not know and never met, and brought a lawsuit over an alleged perforation. After suing, plaintiff conferred with his implanting surgeon, who, with the benefit of an x-ray, concluded the filter was doing its job and required no treatment or intervention. In deposition, plaintiff admitted that he had been asymptomatic. After the parties completed discovery and teed up motions for both summary judgment and exclusion Massachusetts’s version of a Daubert motion on plaintiff’s catchall expert, plaintiff still had never received any treatment or intervention.Continue Reading No Muss, No Fuss In Disposing Of Litigation-Driven “Injury”
This post is from the non-Reed Smith side of the blog.
Defendants in Pizzitola v. Ethicon, Inc., filed motions to exclude two of plaintiff’s experts and both decisions (two orders issued) heavily favored the defense, rejecting recurrent design defect arguments by plaintiffs.
The product at issue is synthetic pelvic mesh. Plaintiff’s first challenged expert was a gynecologic surgeon. While is area of practice may overlap with issues in the case, his report went well beyond both relevant issues and his area of expertise. Namely, plaintiff’s expert wanted to opine that lots of things were alternative designs that in fact were not. Starting with a different medical procedure altogether. “It is not an alternative design of any product. In fact, it is not a product at all.” Pizzitola I, 2022 U.S. Dist. LEXIS 184352, *6 (S.D. Tex. Oct. 7, 2022). Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.” Id. at *7. The decision to perform a different medical procedure lies within the medical judgment of the treating surgeon and has no bearing on the design of the device at issue. Id.Continue Reading Two Strikes Against Plaintiff’s Experts in Texas Pelvic Mesh Case
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