[DK GreenRoots] Jimmy Kimmel on climate science
this is "must watch tv" ... seriously ...
-- Adam
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Texas Federal Court Says Device Manufacturer is not a Health Care Provider, but also not a Seller
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.
Maybe it is because doctors have a powerful lobby, or because they are so gosh-darned popular, but actions against doctors are typically subject to restrictions that other defendants wish they could enjoy. The Texas Medical Liability Act (TMLA) imposes a cap on damages, and the defendant tried to invoke that cap here. The TMLA applies to "health care liability claims" and "health care providers." In Meredith, the defendant argued that its employee, who was in the operating room, was functioning as an independent contractor for the hospital. So this is an unusual case where the sales rep's presence in the operating room was possibly a good fact for the defense. In the alternative, the defendant argued that it was an "Affiliate" of the hospital, which would bring it within the sweet embrace of the TMLA. The court rejected both of those arguments. The manufacturer's employee had no contractual relationship with the hospital. It is not as if he had the sort of privileges that a doctor has. The hospital's willingness to provide access to the employee "subject to certain conditions does not fundamentally alter the relationship of the parties." Nor did the hospital control the manufacturer in the sense required to make it an affiliate. Thus, the court held that the defendant could not avail itself of the TMLA. (Since the Meredith case was decided, the issue has come up in other Texas cases. Bexis discussed one of those cases, and hypothesized about what it would take for a manufacturer defendant to benefit from the TMLA's provisions, here. It is possible that Bexis was a wee bit optimistic.)
The plaintiff's summary judgment motion against the warranty lack-of-sale defense was less successful. That is, it was unsuccessful. That is, the defendant was successful. The simple fact was that the product that allegedly malfunctioned had not been sold or leased to the hospital, surgeon, or the plaintiff. The plaintiff argued that there was Texas authority loosening up the privity requirement. Maybe so, but any such authority still involved a product that had been sold to someone, even if not the plaintiff. Not so here. The defendant's defense against the warranty claim would live to fight another day.
Of course, because the rulings in Meredith were on a summary judgment motion by a plaintiff, rather than a defendant, we do not have anything close to a definitive ruling on whether the plaintiff's claims are truly viable. But it is interesting to see what the court did with those defenses, and it is interesting (and a bit unnerving) to see a plaintiff muster the energy and creativity to file a motion for summary judgment.
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Eleventh Circuit Upholds Exclusion of Expert or . . . Not Hooked on a Feeling
In Witt v. Stryker Corp., 2016 WL 1583816 (11th Cir. Apr. 20, 2016), a Daubert decision in a Stryker knee replacement case, even ipse dixit seemed a bit generous. Roughly translated, ipse dixit means "he himself said it." But it's not clear that the expert in Witt said "it." His report didn't seem to venture an opinion at all, no less one that came from applying a scientific process to true and accurate data. It offered a feeling, almost a timid side note hoping not to be noticed: "I feel that the mechanical failure of the EIUS [the knee replacement system] Stryker components was the competent producing cause for the need for surgery on 04/17/2009 and for a revision arthroplasty to a total knee replacement." Id. at *5 (emphasis added). In case you thought this was just careless terminology, he did it again: "I feel that the mechanical failure of the EIUS System installed on 04/18/2008 was a competent cause for the need for subsequent surgeries on 03/30/2011 and on 01/17/2012." Id. (emphasis added).
-- We haven't studied the case law on feelings. But we are confident that, if it exists, it won't be favorable to this expert.
Things grew more timid at the deposition. It wasn't even clear what the expert was feeling:
Indeed, he explicitly disclaimed having any expert opinion about why the EIUS design was defective. Besides broadly referencing the likelihood that the device suffered some mechanical failure, Dr. Lubliner offered no explanation for why the defect was one of design and not of manufacture.
Id. (emphasis added). Oof.
Daubert didn't ever have to be written for us to know how the Eleventh Circuit was going to rule on this one. Finding his opinion, to say the least, undeveloped and unreliable, it upheld the trial court's exclusion of the expert:
Plainly, his sparse report and subsequent deposition do not explain how the looseness of the device is related to the failure of its mechanical operation, nor did the expert report so much as consider any alternative explanation. Because Dr. Lubliner's opinion regarding Witt's EIUS device could reasonably be termed undeveloped and unreliable, the decision to exclude his testimony fell well within the district court's exercise of discretion as a gatekeeper.
Id. Seeing no viable causation expert, the Eleventh Circuit then upheld the trial court's grant of summary judgment to the defendant. Id. at *7
The Eleventh Circuit issued two other rulings. It upheld the trial court's refusal to allow plaintiff to amend her complaint a third time to add a failure to warn claim based on studies published two years after the device was implanted in plaintiff. Id. at *3. We certainly understand that ruling. The Court also upheld the trial court's decision not to further extend the discovery deadline to allow more time for expert discovery. Id. at *4. Given the expert opinion that we saw, we had, you know, a feeling that would happen too.
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