We have not written much on data privacy lately, but it remains a hot topic and one that changes rapidly as governments around the world (including numerous U.S. states) enact new data privacy laws. One thing that has not changed is the standard for proving a data privacy breach under California’s medical confidentiality statutes. For
FDA Finalizes Guidance on Prescription Drug REMS
The FDA recently published its Final Guidance on REMS programs for prescription drugs, which we thought might interest our readers. The document is formally called “Format and Content of a REMS Document: Guidance for Industry” and you can download and review the Final Guidance here. You might be thinking two things at this moment:
Yes Virginia, Software Can Be A Product
The idea that software can be a product (as in “product liability”) is not new, but gray areas remain with regard to when that should be and how courts should handle it. Take for example a case that we wrote on a couple of years ago, in which a district judge in Virginia granted summary judgment for the manufacturer of an electronic health records (“EHR”) system. A patient suffered severe complications after a doctor entered post-op instructions into the hospital’s EHR computer system, but the hospital implemented the orders at the wrong time. Whose fault was that? We don’t know, but the district court ruled that, even though the patient’s experts identified software changes that would have made the system safer, they did not identify a standard of care that the EHR system failed to meet.
Well, a couple of weeks ago, the Fourth Circuit reversed and held that the experts had very well identified a standard of care and further that there was evidence sufficient to support a failure-to-warn claim. The case is Lowe v. Cerner Corp., No. 20-2270, 2022 WL 17269066 (4th Cir. Nov. 29, 2022), and the facts are worth repeating. Following surgery, the patient’s surgeon entered orders for “continuous pulse oximetry” into the EHR software developed by the defendant and deployed by the hospital. However, although the surgeon intended for pulse oximetry—i.e., checking blood oxygen—to be continuous, she chose “once” and “daily” from the system’s dropdown menus, which defaulted to 10:00 each day. The system correctly displayed that time on the order confirmation screen, but several orders were entered that day, and the surgeon did not scroll down to review them all. She clicked through some version of “accept all.” Unfortunately, checking blood oxygen at 10:00 was too late for this poor patient, who suffered severe and permanent disability. Id. at *2-*3.
Federal Judge In California Cabins Innovator Liability
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 liability—i.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
California Appellate Court Reaffirms Federal Preemption, Learned Intermediary Doctrine in Amiodarone Cases
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.
An Unwelcome Twist On The Learned Intermediate Rule In Alabama
Regular readers of the blog know and appreciate our focus (fixation?) on the learned intermediary rule. Not because it is fun to say and makes us feel smart. No, we follow and write on the learned intermediary rule because it is a cornerstone of the law on allegedly inadequate drug and device warnings. It holds
The Shelves Have Eyes
Okay, retail shelves don’t have eyes. We coined that phrase to mimic the title of the Wes Craven films featuring desert mutants and the horror they impose on unsuspecting travelers. We watched the original 1977 film The Hills Have Eyes while traveling a few years back and thought it was not that great. Imagine then
Stream of Commerce Jurisdiction Runs Shallow in Nebraska
Longtime readers of the Blog know we have a soft spot in our hearts for Nebraska. The state motto—“Equality Before the Law”—is both elegant and meaningful, and we should also call it progressive, given that it dates back to 1867—one year before ratification of the Fourteenth Amendment. We have also previously shared our affection for
Court Says No Way To Medical Device Plant Inspection
We came across something the other day that we don’t see very often, or really ever. The plaintiff in a medical device case served a request to inspect the two defendants’ manufacturing facilities, claiming that he was entitled to observe the premises where the device was made. Not so fast, said the defendants. And with
New Mexico Federal Court Makes The PREP Act Right Again
The world order has been restored. The clouds have parted, and all today is in perfect resonant harmony. Ok, we are exaggerating. A lot. But we are pleased to report that at least one federal district court has correctly interpreted and applied the PREP Act. We are sure you are as relieved as we are.