Montana became the first state to ban TikTok this month. You no doubt have seen the press and have read the spirited discussion condemning foreign spies on the one hand and championing First Amendment rights on the other. Litigation has already commenced. But, while all that was developing, you may have overlooked that Montana
E.D. Louisiana Dismisses Antiperspirant/Benzene Claims—Again
We are in New Orleans for the annual DRI Drug & Medical Device Seminar, so we would be remiss if we passed up the opportunity to write on a Louisiana case. The case will sound familiar. We reported six months ago on the dismissal of a case brought by the same plaintiff alleging that benzene
Dentists As Product Manufacturers? Bet On It In Nevada
Personalized medicine is the wave of the future. Whether treating disease or prescribing medical devices (or both), medical practitioners are taking individualized patient characteristics into account more and more as they treat their patients. Cancer therapy can now be targeted at the genetic level, and some medical devices can now be created to match patient
This Is Why FDA Is Not a Black Box
A federal judge in DC has reminded us that the government does not operate in secret, at least not always and usually not completely in connection with prescription drug approval. The case is Vanda Pharmaceuticals, Inc. v. FDA, No. 22-cv-938, 2023 U.S. Dist. LEXIS 51853 (D.D.C. Mar. 27, 2023), and the plaintiff was a
California Court Affirms Preemption Of Prop 65 Claims For OTC Drugs
We reported nearly two years ago on a California trial court that dismissed claims against generic over-the-counter drug manufacturers under California’s notorious Proposition 65, on the basis that federal law preempted those claims. You can read that post here, and you will see that we said at the end that an appeal was likely.
Ninth Circuit Holds The Line On Post-Ford Personal Jurisdiction
We have never been sued in Hawaii. At least not yet. It could be that someday someone will call us to task for eating too much shave ice or using the word “mahalo” incorrectly. But so far we have traversed the Aloha State unscathed by legal exposure. Our favorite Hawaiian island is Kauai, the Garden
Third Circuit Says The Government Overreached On This One
The federal government cannot compel pharmaceutical manufacturers to sell prescription drugs at a discount to unlimited numbers of pharmacies. That is the takeaway from the Third Circuit’s recent opinion in Sanofi Aventis U.S. LLC v. United States Department of Health and Human Services, No. 21-3167, 2023 WL 1098017 (3d. Cir. Jan. 30, 2023) (to
California Reaffirms Healthcare Data Privacy Standard And Rejects Class Certification
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.