Medical Device Manufacturers as “Medical Service ProvidersInch
We’ve read an amazing new situation from Texas, Verticor, Limited. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. Application. November. 13, 2015), posing the issue whether a clinical device company could be a “health care provider” inside the concept of that state’s pretty restrictive laws and regulations regarding medical negligence. While rejecting the manufacturer’s appeal around the record before it, a legal court in Venticor didn’t flatly say “no.” Rather, it held:
As the problem is presented here, [[manufacturer’s] license authorizes it “to provide” (a minimum of meaning of producing and selling) the [device] ? and absolutely nothing more. Consequently, [manufacturer] could be “licensed . . . through the Condition of Texas to supply health care” only when the [device] is, by itself, “health care” because the [statute] defines that term. . . . Under it, “health care” is distinguished by of two nouns ? “act” or “treatment” ? that’s “performed or furnished,” or must have been, “for, to, or with respect to someone throughout the patient’s health care, treatment, or confinement.” The very first alternative, an “act,” denotes some kind of deed or activity. Being an inanimate object, [the unit], by itself, couldn’t be an “act,” although it may be found in functions that become qualified as “health care,” for example surgery. Similarly, another alternative, “treatment” also denotes some type of activity that’s performed or furnished for in order to someone. Consequently, the [device] wouldn’t, by itself, be considered a “treatment,” although it may be found in a “treatment.”
Verticor, slip op. at 10 (footnotes overlooked). All of this manufacturer posted was it had become licensed to fabricate medical devices. That wasn’t enough. Texas medical negligence tort reform was outside of that state’s defective products tort reform. Id. at 11-12. Further, the “common usage” (how such statutes are construed) from the term “health care” denoted different things from manufacturing:
In keeping usage, one associates “health care” with medical intervention, assistance, or any other functions ? e.g., one’s family physician performing a yearly physical or perhaps a nurse administering a flu shot ? instead of the mere making or selling of the product utilized in supplying such services. Focusing because it does on functions and treatment presented to patients, the [statute’s] meaning of “health care” doesn’t clearly leave this fundamental notion.
Id. at 13.
OK, however the court didn’t shut the doorway completely:
That isn’t to state, however, the functions or treatments distinguishing “health care” or “health care providers” underneath the [statute] cannot ever encompass some component of product manufacture or purchase that will implicate [the merchandise liability statute], or the other way around. In [the merchandise liability statute], for instance, the Legislature considered the defendants inside a “products liability action alleging that the injuries was the result of a failure to supply sufficient warnings or information regarding pharmaceutical products” might include “a healthcare provider”. . . . And a lot of our sister courts have held that persons or entities operating under licenses much like [the manufacturer’s] can, in certain conditions, fall within “health care providers” underneath the [statute].
Id. at 13-14 (footnotes and citations overlooked). The 2 cases reported involved manufacturer’s employees who custom made prosthetics for individual patients (Strobel v. Marlow, 341 S.W.3d 470 (Tex. Application. 2011)), or setup an administration system for any prescription medication in an individual patient’s residence (Dallas Extended Health Care, Corporation. v. Vasquez, 327 S.W.3d 193 (Tex. Application. 2010)). They went beyond simply manufacturing an item. Verticor, slip op. at 16-17. “Without more,” than simply manufacturing, a clinical device company couldn’t make use of the Texas medical negligence statute’s limitations – chiefly the expert opinion needs.
Here’s where we have seen this going. Ordinary defective products cases are most likely taught in holding in Verticor, and there are a variety of explanations why, like the learned intermediary rule, prescription medical product manufacturers would frequently resist being characterised as medical service providers. Therefore the lead to Verticor will probably be the overall rule, and even for good reason.
But there are several cases when that won’t be so. Verticor would be a medical device situation, so when we believe medical devices, we believe preemption (a minimum of regarding PMA devices). Among the avenues some plaintiffs used to flee preemption would be to include allegations the defendant’s sales representatives stated things or did things regarding a specific plaintiff’s prescribers/treaters that adversely affected the end result. The poorly reasoned Malander situation – discussed here ? is a good example of that. We’ve discussed several of these cases, which frequently assert Good Samaritan liability, which posts are collected under our “manufacturer’s representatives” subject. Given exactly what the court needed to say in Verticor, we feel that there’s an excellent shot (with respect to the particular sales repetition conduct alleged) these allegations about reps supposedly giving advice to doctors would fit inside the “health care provider” definition utilized in the Texas statute, and potentially in other claims that have enacted medical negligence reform. Thus, it is recommended that defense counsel faced with manufacturer’s representative allegations – usually, although not always, inside a preemption context – consider whether individuals allegations, that are outside of the manufacturing function, might subject the complaintant which makes them to numerous limitations enforced by medical negligence statutes.