We have a guest post today, from Luther Munford of Butler Snow. He’s been doing some thinking about how something analogous to the “two schools of thought” medical malpractice doctrine should apply to medical product liability cases. As always with out guest posts, our posters deserve 100% of the credit, and any blame, for
We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that “off-label use is generally accepted” and that under the law, “[p]hysicians may prescribe drugs and devices for off-label uses,” 531 U.S. 341, 351 & n.5 (2001), was one of our Bone Screw cases. Thus, we follow medical malpractice decisions, like Doctors Co. v. Plummer, ___ So.3d___, 2017 WL 242577 (Fla. App. Jan. 20, 2017), which we discussed recently, for what they have to say about off-label use. In malpractice cases, the dark side often attempts to equate “intended uses” listed in FDA-approved drug/device labeling with the medical standard of care. As we mentioned in that post, arguments that FDA-approved product labeling equals the medical standard of care are really attempts to turn off-label use itself into a tort.
The Doctors Co. decision prompted us to look back over our 9+ years of blogging output for where we addressed this issue previously. Surprisingly, there was only one, a 2007 Bexis piece that (even more surprisingly) didn’t cite any caselaw. We also found a 2009 law review article by our erstwhile co-founder, Mark Herrmann, which might have been prompted by the earlier blogpost. But nothing was on the blog itself that could qualify as useful research.
We rectify that today.
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.
We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a “health care provider” within the meaning of that state’s pretty restrictive laws regarding medical malpractice. While rejecting the manufacturer’s appeal on the record before it, the court in Verticor didn’t flatly say “no.” Instead, it held:
As the issue is framed here, [[manufacturer’s] license authorizes it “to provide” (at least in the sense of manufacturing and selling) the [device] − and nothing more. Consequently, [manufacturer] can be “licensed . . . by the State of Texas to provide health care” only if the [device] is, in itself, “health care” as the [statute] defines that term. . . . Under it, “health care” is distinguished by either of two nouns − “act” or “treatment” − that is “performed or furnished,” or should have been, “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.” The first alternative, an “act,” denotes some sort of deed or activity. As an inanimate object, [the device], in itself, could not be an “act,” although it might be utilized in acts that qualify as “health care,” such as surgery. Similarly, the other alternative, “treatment” also denotes some form of activity that is performed or furnished for or to a patient. Consequently, the [device] would not, in itself, be a “treatment,” although it might be utilized in a “treatment.”
Verticor, slip op. at 10 (footnotes omitted). All this manufacturer submitted was that it was licensed to manufacture medical
devices. That wasn’t enough. Texas medical malpractice tort reform was separate from that state’s product liability tort reform. Id. at 11-12. Further, the “common usage” (how such statutes are construed) of the term “health care” denoted something different from manufacturing:
In common usage, one associates “health care” with medical intervention, assistance, or other acts − e.g., one’s family doctor performing an annual physical or a nurse administering a flu shot − as opposed to the mere making or selling of a product used in providing such services. Focusing as it does on acts and treatment provided to patients, the [statute’s] definition of “health care” does not clearly depart from this basic notion.
Id. at 13.
Maybe our motto here at DDLaw should be “we read law review articles so you don’t have to.” Here are a couple of recent ones that looked interesting to us.
Tort Liability and Medical Innovation
The first one is Anna B. Laakmann, “When Should Physicians Be Liable For Innovation?,” 36 Cardozo L. Rev. 913 (Feb. 2015). The title caught our eye because of our interest in off-label use, which is sometimes (when not yet the recognized standard of care) considered medical “innovation.” Since Bexis’ 1998 law review article popularized the now-overwhelmingly adopted position that informed consent includes medical risks, not regulatory matters such as off-label use, we are particularly interested in patrolling that boundary. If a treatment is so new that its risks and benefits cannot accurately be assessed, then a warning about its experimental nature is appropriate, but that kind of warning is a small subset of “off-label use” as an FDA regulatory status.
Here is the article’s thesis:
This Article proposes a fiduciary framework to regulate physician innovation under conditions of endogenous [we think that means “inherent” in this context] uncertainty. The proposed approach could be described as a “libertarian paternalism” model of medical decisionmaking. It mandates close scrutiny of the decisionmaking process but deference to the substance of medical decisions. Under this framework, the physician should be held liable for failing to act in the patient’s best interests, taking into account the patient’s unique clinical condition and value preferences. Within these constraints, however, patients should have the freedom to choose − and assume the associated risks and uncertainties − from among a range of clinically acceptable alternatives. Properly applied, fiduciary principles can strike a desirable balance that respects patient autonomy, deters unreasonable risks, and encourages beneficial innovation.
Id. at 914. Okay, let’s see what this is all about.
Here’s another guest post by Reed Smith’s own Kevin Hara, this time about a recent Texas case holding that health care providers involved in clinical trials are still protected by a state medical malpractice statute, and thus were fraudulently joined. While we are of two minds about such statutes (making it harder to sue HCPs increases litigation against our clients), since HCPs are our clients’ clients, and thus the heart of their businesses – and we’re defense lawyers by temperament – in the end we come out in favor of less liability generally. This is an interesting use of fraudulent joinder that could well apply to the definition of “health care provider” under similar statutes in other states.
As always, our guest posters deserve all the credit and any blame for the contents of their posts.
When it comes to Texas, one might never know based on its jurisprudence that the state motto, and indeed the state’s moniker, is derived from “Tejas,” a Native American term for Friendship. At least from a defense perspective, the Lone Star State at times seemed mighty inhospitable; after all, Texas invented that awful “heeding presumption” back in 1972, touching off a Reign of Fire, as states followed suit, adopting a variety of feeding presumptions. It also allowed personal injury recovery under its consumer protection statute, made a big deal of Restatement Second §402B, and was the last of the large states to adopt the learned intermediary rule. While we’re at it, let’s not forget the decision that would never die, the Murthy case, making the worst decisions list in consecutive years in 2011 and 2012, giving us not just one opinion to lament, but Two for the Money.
But we’re forgiving, and won’t “mess with Texas” too much. Although it took until 2012, with some help from Bexis, for the Texas Supreme Court to finally adopt the learned intermediary doctrine, deciding that it was A Time to Kill an awful decision from 2010 whose name should have been Mud. Texas adopted the Third Restatement, which should kill the heeding presumption, and even if it doesn’t, that presumption now excludes prescription drugs and medical devices, at least forcing it into Submission. The Legislature amended the DTPA to eliminate personal injury damages, and we haven’t heard a peep from §402B in a while, and this section’s Failure To Launch into widespread acceptance is a good thing. Texas Daubert decisions have been outstanding. Not only that, a lot of excellent Reed Smith practitioners are based in our Houston office.
Texas has other positive attributes as well, including being the birthplace and home of Matthew McConaughey, and of baseball standout Nolan Ryan, who we believe, despite numerous accolades, remains underrated because of his somewhat pedestrian won loss record (which for pitchers reveals more about the team and much less about the individual). Seriously, seven no-hitters? Ryan pitched in an era where starters routinely went the distance, and they were their own closers; we urge you to check out his career innings pitched, hits allowed, complete games, and well, the strikeouts speak for themselves. No disrespect to Madison Bumgarner, who was otherworldly in the 2014 World Series, but who has 6 complete games in his career. Ryan had an incredible 222, including several years where he had more than 20. We realize that people smarter and more knowledgeable than we are will correctly we might add, mention that Ryan also walked many hitters and never won the Cy Young. That’s the beauty of sports.
But we digress. Back to the legal issues. It would be remiss not to note that Texas also has some very favorable statutes, including Civil Practice and Remedies Code 82.007, which provides a rebuttable presumption of nonliability for manufacturers and prescribers in pharmaceutical product liability actions involving failure to warn for FDA approved warnings, and 82.008, which provides a presumption of nonliability for compliance with government standards. See Tex. Civ. Prac. & Rem. Code §§ 82.007(a)(1) and 82.008. We were concerned that a recent Southern District of Texas decision would a la Murthy, run roughshod over state law like the TCU Horned Frogs in an 82-27 rout of Texas Tech this year or UCLA in a 66-3 drubbing of Texas in 1997 (the Longhorns’ worst loss ever). Fortunately, we were pleasantly surprised.
Things are often done differently down in Louisiana. For one thing, Louisiana is the nation’s only civil law state. It’s also the only state not to have enacted the Uniform Commercial Code. We blogged about one such difference before – the state’s unique claim for “redhibition.” Today we’re examining another Louisiana legal peculiarity. This peculiarity…
One of us had a conversation yesterday with a lawyer (who will remain nameless because we haven’t asked otherwise) about off-label use issues in a malpractice case against a doctor who used something called a Nidek Laser in eye surgery. We haven’t looked at any facts of any case or about the device. We know…