Can a court decision be simultaneously depressing and exhilarating? You might be surprised how often that happens. In United States v. Facteau, 2020 WL 5517573, (D. Mass. Sept. 14, 2020), the court upheld criminalization of off-label promotion, but did so in a way that might signal the end of an era in which pharmaceutical
Off label
FDA Proposes to Delay Off-Label “Intended Use” Rule
Perhaps you have heard that elections have consequences. That is true not only for high-profile issues that hog the headlines on CNN and Fox News, but it is also true for drug and device litigation regulation. Such drug and device regulation can be just as important, if not considerably more important, than whatever current political…
The Rule of Law is the Best Medicine, Part 2
Last week, we summarized PhRMA’s comments on the FDA’s proposed amendments to regulations regarding “intended uses.” PhRMA showed how the FDA’s insistence that it could read manufacturer’s minds about intended uses made no sense on an evidentiary basis and ran afoul of First Amendment considerations. Today, we’ll tip our cyber caps to the Advanced Medical …
Court Rules that Prisoner is Entitled to Off Label Drug Treatment
Happy birthday to Eric Idle, one of the funniest members of the Monty Python troupe. In addition to writing bizarre, hilarious comedy skits, Idle also wrote songs. When he proposed a song for The Life of Brian, he ran into resistance. The song seemed insufficiently catchy. That song was “Always Look on the…
Just What the Doctor Ordered: Package Insert Does not Establish Standard of Medical Care
Like most Americans, we like our doctor. We like doctors in general. We are not looking to start another song battle with our friends over at the Abnormal Use blog, like when we competed to name as many law songs as possible, but there are certainly many excellent doctor songs. Listen to this top 10, and we guarantee you’ll feel better:
- Doctor, Doctor (Thompson Twins)
- Dr. Robert (Beatles)
- Bad Case of Loving You (Robert Palmer)
- Dr. Funkenstein (Parliament)
- Calling Dr. Love (KISS)
- Doctor My Eyes (Jackson Browne)
- Good Lovin’ (The Rascals)
- Doctor Wu (Steely Dan)
- Dr. Feelgood (Motley Crue)
- I Need a Doctor (Dr. Dre/Eminem)
Bexis proposes adding the following songs to our medical play-mix: Mother’s Little Helper (Rolling Stones), Go To The Mirror, Boy (Who), DOA (Bloodrock), and Comfortably Numb (Pink Floyd). Yes, Bexis really does have a dark side.
In addition, we must admit that there have been many fine medical shows (Dr. Kildare, Ben Casey, Marcus Welby, St. Elsewhere, ER, Grey’s Anatomy, House), whereas legal shows usually disappoint. It is possible that we nitpick at legal shows too much. Our experience and knowledge make us overly-demanding and cranky. Even so, we thoroughly enjoyed LA Law. Every Thursday night we gathered around a 19 inch tv (remember them?) with fellow clueless, struggling associates to watch the adventures of the McKenzie Brackman law firm, which had an odd mix of practice areas we have yet to see replicated in real life: M&A, divorce, criminal law (blue collar, not white collar), tax, and anything to do with sex. Richard Dysart, who played the part of presiding partner at McKenzie Brackman, once was the guest speaker at a legal charity dinner in L.A. He told the audience we could all consider him as our senior partner, and he actually gave out his home phone number in case we ever needed to call him for advice. Years later, another tv program showed us our curmudgeonly, crazy future as the Danny Crane character on Boston Legal, memorably portrayed by William Shatner. Many of his victories were celebrated with a cigar on an outside deck. (We’d hate to think of what would happen if all law firms had outside decks.) And, while we’re at it, we should blow a kiss at Goliath, a legal show currently running on Amazon. It stars Billy Bob Thornton and was co-created and written by an old AUSA colleague, Jonathan Shapiro. Give it a look. It is a smart, smoky, surly show that grabs you by the briefs.
Doctors are often codefendants in our cases. We try very hard to resist the temptation to point fingers in their direction. In the last ten years of litigating physical injury cases, we can think of only one time when part of our defense was to suggest medical malpractice, and that was a case where the doctor had been the sole defendant initially, and then he claimed that the problem was with our client’s medical device. So after we were added to the case as a defendant, we really had no option but to return fire. Much more often, we find that the interests of the doctor are well-aligned with those of the device or drug manufacturer. The characterization of the underlying reality that works for doctors usually also works for our clients. The legal defenses that work for the doctors are usually consistent with the ones that work for our clients. Indeed, it is not unusual for us to find a medical malpractice case that has things to say that can end up being important and helpful for our clients. That is true with the recent case of Doctors Co., insurer, for itself and for Annabell Torres, M.D. v. Plummer, 2017 Fla. App. LEXIS 599 (Fla. 5th D. Ct. App. January 20, 2017). Doctors Co. is a wrongful death medical malpractice case. The Florida appellate court overturned a plaintiff jury verdict, and at least one of the reasons why it did so is noteworthy for our practice area.Continue Reading Just What the Doctor Ordered: Package Insert Does not Establish Standard of Medical Care