Drug & Device Law

The definitive source for intelligent commentary on the law that matters for drug and device cases

Regular readers of this blog may recall that, each year at this time, we report on our cherished annual trip to the Westminster Kennel Club dog show. This year, the trip was modified at the outset by a work conflict (an argument in Kentucky that we knew we would keep us from attending any part of the first day of the two-day event). We hoped to make it to Madison Square Garden for the Tuesday…
Medical device sales representatives are often present in the operating room during surgical procedures, especially with procedures involving orthopedic devices.  With those kinds of devices (and others), the hospital typically contacts the sales representative in advance, and he or she is charged with delivering the device in the specified size and providing any specialized instrumentation required for implantation.  The system is logical and effective, but it still comes as a surprise to many lay people…
Roy Cohn would have turned 92 today, had he not died in 1986, a few weeks after being disbarred in New York. Cohn’s legal career was legendary. He was on the team that prosecuted the Rosenberg spy trial. He worked closely with Senator Joseph McCarthy. His clients included mafia figures, the owners of Studio 54, and the owner of the New York Yankees. (It is that last one that makes us most queasy.) Cohn mentored…
Earlier this month we explained that a “wrinkle removal,” was one that capitalized on a “wrinkle” in the language of 28 U.S.C. § 1441(b)(2), which provides that a case cannot be removed on the basis of diversity if any “properly joined and served” defendant is a citizen of the forum state.  But if the forum defendant has not yet been served, that “wrinkle” doesn’t apply.  Defendants, in our never-ending quest to get cases into federal…
Our recent post about the First Amendment decision in American Beverage Ass’n v. City & County of San Francisco, ___ F.3d ___, 2019 WL 387114 (9th Cir. Jan. 31, 2019) (en banc) (“ABevA”), holding unconstitutional a purported product “safety warning” was more than enough to set the old First Amendment juices flowing.  Ninth Circuit en banc decisions involve the largest panels of judges in the country, and ABevA featured no less than four different interpretations…
Bexis is known to say that nothing good ever comes out of Missouri, but the Missouri Supreme Court has proven him wrong.  We have long made exceptions to Bexis’ proclamation for Mark Twain, Maya Angelou, and Kansas City barbeque, and we can now add to that list the Missouri Supreme Court’s new opinion in State ex rel. Johnson & Johnson v. Burlison, No. SC96704, 2019 WL 581175 (Mo. Feb. 13, 2019), where the Missouri Supreme…
We’ve been waiting quite a while for the FDA to modernize its positions on the truthful off-label communications by regulated manufacturers.  Under current First Amendment practice, the FDA’s positions are quite likely unconstitutional as both speaker- and topic-based restrictions on the truthful communication of scientific information.  However, the best we’ve seen from the Agency to date was a “statement,” issued last June, that truthful off-label communications to third-party payers (or “payors,” if you’d…
We’ve written several times (here, for example) about the Biomaterials Access Assurance Act (BAAA), 21 U.S.C. section 1604 et seq., and how it issues a get-out-of-litigation-free card to suppliers of raw materials and components. Today’s case, Connell v. Lima Corp. et al., 2019 WL 403855 (D. Idaho Jan. 30, 2019), supplies another illustration of the BAAA’s power. The plaintiffs sued for injuries after a hip prosthesis fractured. The defendants initially included the manufacturer…
Ever since innovator liability burst onto our consciousness a decade ago with the horrific decision in Conte v. Wyeth, 85 Cal. Rptr.3d 299 (Cal. App. 2008), we have had nightmares about the potential impact of this theory.  After all: (1) over 90% of all prescriptions these days are for generic drugs, and (2) plaintiffs claiming injury from generic drugs are largely prevented from suing their actual manufacturers due to preemption.  Even if generic drugs, by…
It is easy to articulate the core principle behind the First Amendment right to free speech:  The government can’t restrict what you say or make you say what the government wants without a good reason.  Ah, but how good a reason and what kind of reason?  That is where it gets more complicated.  How do we distinguish, for example, between a law that requires every man, woman, and child to declare “All hail the mighty…