For the decades that we have been handling drug and medical device product liability cases, it has been a given that we wanted to make it clear that our clients did not provide medical care or healthcare directly to patients.  For one thing, unauthorized practice of medicine would be bad.  Also, when dealing with prescription medical products, we do want the learned intermediary doctrine to apply.  In addition, in part because FDA does not regulate the practice of medicine, preemption based on the FDCA is not going to succeed as to claims based on the defendant’s provision of medical care.  There are other reasons why drug and device manufacturer defendants typically shout from the litigation mountaintops that they are not healthcare providers.  Not just in litigation, either.  There are plenty of venues for manufacturers to disclaim that they are not healthcare providers, not providing medical care, not providing medical advice, etc.  This applies to marketed products, as well as clinical trials that the manufacturer sponsors.

In Irwin v. Zoll Lab, Servs., LLC, — F. Supp. 3d –, 2025 WL 1249370 (S.D. Iowa Apr. 30, 2025), the plaintiff alleged that the device manufacturer defendant was a healthcare provider liable for medical malpractice.  For reasons peculiar to the case, the defendant admitted it was a healthcare provider that had taken an “active role” in monitoring and interpreting plaintiff’s cardiac data as part of her clinical care.  This allowed defendant to move for summary judgment or judgment on the pleadings when plaintiff missed the deadline for a certificate of merit affidavit required for med mal proceedings against providers.  As no discovery had yet occurred, this motion was properly treated as being for judgment on the pleadings, and plaintiff’s well-pleaded factual allegations were accepted as true.  The basic allegations were that plaintiff was prescribed a medical device to monitor her drug-induced tachycardia, the serial numbers on the device and its packaging did not match, defendant was supposed to use her device to monitor and report her heart rate and rhythm, but reported on another patient’s data, which resulted in medical decisions by her doctors to perform unnecessary surgeries to implant and later explant a pacemaker. 2025 WL 1249370, *1-2.  The decision is not terribly precise—it does not even identify the device by name—but it appears that plaintiff’s complaint characterized the defendant manufacturer as a healthcare provider in an attempt to frame her claims as being for medical malpractice rather than product liability.  When she failed to serve a certificate of merit affidavit sixty days after the defendant’s answer, the defendant leapt.

It might seem to be a relatively straightforward analysis:  plaintiff alleged that the defendant was a healthcare provider who provided healthcare to plaintiff, plaintiff based her claims on those allegations, defendant admitted those allegations, and plaintiff served no affidavit.  However, in responding to the motion, plaintiff was permitted to take the position that defendant was not a health care provider for purposes of the Iowa med mal statute that required an affidavit—and under which she had sued.  The court analyzed this reversal as one of waiver based on what defendant put in its answer.  Id. at *4-5.  To us, that does not seem like the right way to analyze the issue.  Even if the plaintiff should not be judicially estopped from taking a position contrary to his complaint—as far as we can tell, she had not won anything based on the position that defendant was a healthcare provider who provided her healthcare—then she cannot defeat a motion for summary judgment or a motion for judgment on the pleadings by contradicting her own pleadings.  These allegations appear to have been central to her claims and were not stated in the alternative or hedged as being on information and belief.  And the Iowa statute makes the timely service of a certificate of merits affidavit a predicate to proceeding, not an affirmative defense.  So, plaintiff should have had to lie in the bed she made.

But the Irwin court let plaintiff take a contrary position to her complaint in an attempt to keep her case alive.  In its merits analysis, the court did recognize that its job sitting in diversity was to predict what the Iowa Supreme Court would do absent controlling authority.  Id. at *3.  While it did not mention Erie deference, the pertinent issue was not really about expanding or contracting a claim or defense.  Instead, the issue was statutory interpretation of whether the pleadings established the defendant manufacturer as a health care provider under the catchall provision of “any other person who is licensed, certified, or otherwise authorized or permitted by the law in this state to administer health care in the ordinary course of business or in the practice of a profession.”  Id. at *5.  Even under the allegations and admissions from the pleadings, it was not.  The analysis largely turned on the decision that, as used in the statute, “authorized or permitted” meant there had to be “affirmative permission from a regulatory agency or similar oversight authority.”  Id. at *6.  The defendant “has no ‘license,’ ‘certification,’ or similar permission to administer health care in Iowa, nor is it subject to ongoing regulatory oversight under state law,” referring to some terms applicable to types of healthcare providers subject state licensure statutes.  Id. at *7.  The court rejected the defendant’s argument that its accreditation by CMS, which Iowa allows to suffice as an inspection for purposes of seeking state hospital licensure, was good enough, because the defendant was not a licensed hospital in Iowa.  Id. at *8.

We wonder if the court will accept all the implications of its ruling that defendant is not a health care provider for purposes of the Iowa med mal statute.  If it is not, then it cannot be liable under that statute and plaintiff’s claims should be dismissed.  Irwin implicitly recognized as much when it explained the rationale of requiring a certificate of merit application in cases against entities that provide medical care:  “It follows that if a plaintiff alleges a breach of the standard of care, it must establish at an early stage that there is a legitimate basis for that allegation.”  Id. at *9.  It also follows that a defendant cannot be liable for breaching a standard of care that does not apply to it.  Iowa has a Good Samaritan law, which should not provide a basis for liability here either.  So, plaintiff will probably have to assert product liability claims against the device manufacturer, something she chose not to do in the first place.  That makes sense because device companies are not healthcare providers.  Right?

(We have used both “healthcare” and “health care” in this post.  The Iowa statute uses the latter.  The pleadings seemed to use the former.  When describing a case where the complaint and answer agreed that defendant was a healthcare provider and the court disagreed, we did not think foolish consistency would matter.)