Sometimes it takes us a while to catch on to things. This is more than a little embarrassing for a Jersey guy to admit, but while many of our high school classmates were devout Springsteen fans after his first two albums, Greetings from Asbury Park and The Wild, The Innocent, and The E Street Shuffle, we would not commit until after the release of Born to Run, by which time Bruuuuuuuce had become a national phenomenon. For years we saw shaved kale salad on menus and passed it by, thinking that we probably did not like kale and definitely did not like shaving, so why bother? Now it is our go-to appetizer for when we want to feel vaguely virtuous. We were late adopters of on-line banking, Apple Pay, and Twitter. Our garage will surely be the last in the neighborhood with a hybrid powered car, a self-driving car, or a flying car. On the way back from visiting the Drug And Device Law Son in Moscow, the British Airways entertainment offerings included season 2 of Catastrophe, an Anglo-American miracle of fun and filthy television comedy. Now we are queuing up season one on Amazon Prime. We are complete-ists, even backwards, if nothing else. Better late than never, right?

Today we are taking a look at an old case (two and a half-years old, but turning up in our topic searches just now). The case is called Meredith v. Nuvasive, Inc., 2013 U.S. 190130 (W.D. Texas Dec. 9, 2013). The plaintiff in Meredith alleged injuries from malfunction of a neuromonitoring device during spinal surgery. Her claims were for manufacturing defect, breach of implied warranties, negligence, gross negligence, and res ipsa loquitur. There is nothing especially unusual in any of that. But here is the man-bites-dog aspect of the case: the product liability plaintiff moved for summary judgment against two relatively unusual defenses, the manufacturer defendant as a “health care provider” under the Texas malpractice statute, and lack of any sale of a medical device precluding warranty claims.

For those of you in need of an executive summary, know this: The plaintiff in Meredith went one for two. (1) The court held that a device manufacturer was not a health care provider under the relevant medical malpractice statute. (2) Because the device was simply used in the hospital, and not sold to the plaintiff or anyone else, the defendant had a real shot at picking off the warranty claims.

Continue Reading Texas Federal Court Says Device Manufacturer is not a Health Care Provider, but also not a Seller

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device never delivered the pain relief she had experienced during her pre-implantation pump trial, and she ultimately suffered complications. The device is a Class III medical device, requiring FDA premarket approval. Product liability litigation involving Class III devices does not get very far without bumping into federal preemption issues. Frere is no exception.

The problem with the plaintiff’s complaint was that it was either unclear or clearly preempted. The strict liability claims failed because they consisted of conclusory allegations that the purported defects or failure to warn caused her injuries. For example, in the manufacturing defect claim, the plaintiff alleged: (1) that “the catheters at issue were occluded, fractured, obstructed, and/or malfunctioning, which caused Plaintiff to suffer severe injuries and which required multiple surgeries and medical procedures to correct these defects”; and, (2) “as a direct result of the defects, Plaintiff suffered crippling injuries which left Plaintiff with permanent and significant disabilities compensable under the law.” There is no there there. Similarly, in connection with her failure to warn claim, the plaintiff alleged that “[a] foreseeable, direct and proximate result of [Defendants’] failure to warn Plaintiff, Plaintiff’s medical providers, and the FDA . . . about the defective condition of the [Device], Plaintiff suffered crippling injuries that left Plaintiff with permanent and significant disabilities.” The court refused to accept those mere “labels and conclusions.” The complaint was bereft of any facts as to how the alleged manufacturing defect and failure to warn caused her injuries. All we get is the conclusion of causation itself.

Continue Reading C.D. Cal. Dismisses Infusion Pump Complaint

Way back when – before Restatement (Second) of Torts §402A (1965) crystallized the concept of strict liability – courts around the country were poking around, trying to come up with viable theories of what we would now call “product liability.”  One method that gained some traction, prior to the advent of strict liability, was to strip contractual implied warranty of its historical requirement that the buyer and seller have been in “privity” (that is, that they dealt directly with each other).  New York was one of the states that started down that road.  In Goldberg v Kollsman Instrument Corp., 191 N.E.2d 81 (N.Y. 1963), the court held 4-3 that the manufacturer of a “thing of danger” (not otherwise defined, but in Goldberg, an airplane part that allegedly caused a crash) could be liable for breach of implied warranty without being in contractual privity with the plaintiff.  Id. at 83 (“at least where an article is of such a character that when used for the purpose for which it is made it is likely to be a source of danger to several or many people if not properly designed and fashioned, the manufacturer as well as the vendor is liable, for breach of law-implied warranties, to the persons  whose use is contemplated”).  This was problematic, because until §2-318 was amended in 1975, New York’s UCC hadn’t done away with privity in all personal injury cases.

But along came strict liability, and New York’s tentative steps down the road of privity-less implied warranty were largely forgotten.  Nobody paid much attention to warranty in the Empire State until the Court of Appeals held that strict liability and implied warranty were “not identical” in Denny v. Ford Motor Co., 662 N.E.2d 730, 739 (N.Y. 1995), in that strict liability utilized a risk/utility approach whereas implied warranty focused on consumer expectations.  Id. at 736.  While this distinction “may have little or no effect in most cases,” it can in some.  Id. at 738.

Continue Reading The Citadel Revisited – New York’s “Thing of Danger” Privity Exception Is Obsolete (and Another New York Note)

By all rights, it should be Sullivan writing about the Sullivan case.  But John is taking a well-deserved vacation.  We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes where one must dodge rattlesnakes and gila monsters, or if Sullivan is more like today’s correspondent, who is content to plop down in a BeNeLuxian cafe and down a couple of Chimays before staggering past museum walls adorned with Brueghel and van Ruisdael masterpieces.

Sullivan v. Aventis, Inc., 2015 WL 4879112 (S.D.N.Y. Aug. 13, 2015), is no masterpiece.  It offers a crabbed reading of Bartlett to support its stubborn refusal to expand that case’s generic preemption to brandeds, it conflates design defect and warning theories, and its reasoning often seems incomplete or incoherent. We’re not saying that the Sullivan case is a complete train-wreck, but it is not exactly pleasant beach reading either.

The Sullivan case was brought by a woman who claimed that she suffered birth defects because her mother had taken an allegedly defective fertility drug.  She alleged that the drug’s half-life was too long and that the manufacturer had failed to supply the requisite warnings.   The legal claims included design defect, manufacturing defect, failure to warn, misrepresentation, breach of express and implied warranties, and unjust enrichment.  New York law controlled.

Continue Reading SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest

October 8 is a fine day to reflect on American heroism.  Eddie Rickenbacker was born on October 8, 1890.  He became America’s ace fighter-pilot in World War I, with 26 aerial victories.  Rickenbacker won the Congressional Medal of Honor. The French gave him the Croix de Guerre.  Rickenbacker was also a race-car driver.  He later headed Eastern Airlines.  Ninety-six years ago on this selfsame date, Alvin York led an attack on a German machine gun nest.  He killed 28 enemy soldiers and captured 132.  He, too, earned the Congressional Medal of Honor and the Croix de Guerre, along with many other honors.  York had to struggle with his strong religious belief in pacifism before he could bring himself to kill for his country.  Good thing he did, as he was a keen shot and saved many American lives.  He was a corporal at the time of his amazing act of bravery, but was forever known by the rank he attained at the end of the war:  Sgt. York.  In 1942, Gary Cooper won an Academy Award playing Sgt. York. There is a statue of Sgt. York on the grounds of the Tennessee Capitol building in Nashville.

Without people like Rickenbacker and York, it is not clear that we would have the freedom to haggle over fine points of law. So today we will discuss a mixed bag of a case with gratitude for the good points and restraint on the not-so-good.  We are in a no-snark zone.

Continue Reading S.D. Illinois Dismisses Some Mirena Claims and Allows Others to Linger

This post is from the non-Reed Smith side of the blog only.

We are going to break from the traditional communal persona for just a minute because today’s case made me think of something my nine-year old son said just the other day.  He was watching a video with me on the evolution of dance

The geezers in our family have been busy recently ululating over the rule of three celebrity deaths. We are not sure we have ever before witnessed a trilogy quite like Roger Ebert, Margaret Thatcher, and Annette Funicello.  An aunt insists that it is actually a trilogy of three celebrity women, with fashion designer Lily Pulitzer

We honor Labor today by doing very little labor ourselves. If we had our druthers, today would consist of little more than barbecue and indolence. But some members of the family seize upon every holiday as a cue for shopping. There are sales upon sales. For at least a part of today, we expect to

Last Friday we were treating a client to another stop on our ongoing Philly burger tour. (We know – it’s amazing we’re not big time rainmakers, right?) We agreed that the brioche bun was a marvel, while the patty was just so-so. We’ve had a few sandwiches where the outside bread-bits were way better than