United States: Med Mal Case Dives Deep Into Device Regulation

Last Updated: July 23 2019
Article by Eric Alexander

Reading through Obermeier v. Northwestern Memorial Hosp., __ N.E.3d __, 2019 IL App. (1st) 170553 (Ill. App. Div. June 28, 2019), reminded us of scrolling through television channels in the middle of the day with time to kill. The opinion started off talking about the basic medical facts of the case and we were ready to buzz as our litigation memory twinged with talk of the plaintiff's regurgitant and prolapsed mitral valve being repaired with an annuloplasty ring back in 2006. The manufacturer of the ring–named after a pioneer in heart valves—was sued, but won summary judgment before trial. As the evidence at trial against the implanting surgeon and hospital was recounted, we were reminded of those game shows where one player describes a person, place, or thing without using proscribed words. Later, as the trial evidence grew stranger and stranger, we thought of the old game shows where the contestant has to determine if an unidentified speaker's self-description is made up and where actors improvise a scene based on seemingly disconnected prompts. At the end of the opinion—if not the end of the more than a decade long saga (or soap opera)—the defense verdict from trial was affirmed it looks like the good guys won.

As always, our focus is on the issues most relevant to drug and device law, even though there are some interesting evidentiary nuggets in the appellate court's rulings. The claims pursued at trial against the implanting surgeon and the hospital alleged that plaintiff was injured by the lack of adequate informed consent with regard to the use of the particular annuloplasty ring, called the Myxo ring. Plaintiff contended that the consent was inadequate because she was really in a secret clinical trial for an investigative device because the Myxo ring had not been cleared or approved at the time of surgery. Plaintiff did not contend that the ring was defective in its design or manufacture or that it malfunctioned. After the jury ruled in favor of the defendants, her appeal did not contend that the verdicts were unsupported by admitted evidence or that the trial court had erred in its jury instructions or verdict form. Rather, she contended that pre-trial rulings on motions to dismiss, motions for summary judgment, and motions in limine were in error. The discussion of actual trial evidence mostly provided context for why these rulings were correct or why any error was harmless.

Our somewhat condensed and reorganized summary of the trial evidence is as follows. Plaintiff's mitral valve regurgitation progressed over the course of more than twenty years to the point where her cardiologist suggested surgery and referred her to a prominent cardiac surgeon, Dr. McCarthy, who agreed that surgery was indicated. He obtained informed consent from plaintiff for the repair of her mitral valve using a medical device called an annuloplasty ring, although which one of the different rings available at the hospital would be used was to be determined in surgery and the plaintiff was not presented with a list of options. Dr. McCarthy chose to use the Myxo ring because he thought it was the best choice for plaintiff. He had also invented the ring based on his view that a "pre-bent ring" would have advantages over existing devices that had to be bent as needed. He worked with the manufacturer to develop prototypes, which was something he had done previously for other annuloplasty rings. The manufacture was responsible for determining and following the regulatory pathway for the device, manufacturing it, and labeling it. By the time of plaintiff's surgery, Dr. McCarthy considered the Myxo ring a marketed device and did not treat it like he did investigational devices. He and the hospital were familiar with clinical trials and investigational devices, but treated plaintiff's surgery like clinical care outside of a clinical trial because the Myxo ring was not considered an investigational device. For instance, there was no Investigational Review Board ("IRB") involvement, although plaintiff was included in a retrospective chart review and "Outcomes Registry." (Dr. McCarthy published peer-reviewed papers on the Myxo ring, among other aspects of his repair of mitral valves.)

A representative of the manufacturer at trial testified the company did not treat the Myxo ring as an investigational device at the time of plaintiff's surgery or have a clinical trial set up with Dr. McCarthy on the device. As a Class II device, the Myxo ring was evaluated by the company under the 1997 guidance on "Deciding When to Submit a 510(k) for a Change to an Existing Device." Based on its analysis, the company used a "Justification to File" for the device rather than submitting a 510(k) application (or something else) to FDA before initial marketing. The representative testified that Dr. McCarthy and the hospital were not parties to its decisions on the regulatory pathway for the device, but stood by them. (Although not discussed in the opinion, there was later interaction with FDA over this device and a subsequent 510(k) application was cleared.)

Plaintiff and the defendants presented dueling experts on whether plaintiff really was in a clinical trial on an investigational device according to FDA regulations and whether the sort of consent seen in clinical trials was required for plaintiff's surgery. They did agree, however, that the manufacturer is responsible for determining the regulatory pathway for the product and that a surgeon does not have to investigate whether the right pathway has been followed. Plaintiff's star witness, Dr. Rajmannan, had worked with Dr. McCarthy at the defendant hospital and maintained that there really was a clinical trial on an investigational device without appropriate consent or other measures being followed. She opined that plaintiff might have been injured by the ring pinching an artery or a suture being placed in an artery (as could happen with any annuloplasty). This is where things got interesting. Dr. Rajmannan, who appears to be a cardiologist by training, had no experience with cardiac surgery or any official role with an IRB. She did, however, complain to the hospital about the Myxo ring back in 2007, refuse to participate in the internal investigation, get suspended, and get fired from the hospital. Then she reported Dr. McCarthy to a state board, brought a qui tam action for damages against Dr. McCarthy, contact multiple media outlets, contact the Senate, contact the President, publish blog posts (!!!), and self-publish e-books. All of these apparently focused on advancing essentially the same theory that plaintiff claimed at trial about an improper clinical trial about an investigational device, as opposed to the clinical use of a marketed medical device that the surgeon and hospital assumed had followed the right regulatory path to market.

Stranger than fiction, but why are we posting on it? Buckman and the lack of a private cause of action for violation of FDA regulations, of course. After plaintiff lost with the jury, some of her appeal focused on the claims against the manufacturer. As an initial matter, her claims for battery against the manufacturer and for lack of consent and battery against the hospital were estopped because the jury had rejected that any inadequate consent had caused plaintiff any injury. There is a practice point in here about how plaintiff's election to have a general verdict rather than detailed jury interrogatories worked against her on appeal. There is also a discussion of Illinois law on when a hospital owes a duty to get a patient's consent, because the court went to the merits despite the estoppel. The battery claim against the hospital—remember from law school or the bar that battery is an intentional offensive contact without the consent of the other party—did not work because the plaintiff consented to the operation, including an operation that would use some annuloplasty ring, and the failure to specify the ring that would be used did not make it unauthorized. For the battery claim against the manufacturer, the plaintiff contended that it was responsible for "registering the Myxo ring with the FDA and for ensuring that it was properly cleared or approved by FDA," such that the failure to do so made all subsequent uses a battery on the patient. A creative theory, but it was premised on a violation of the FDCA. The U.S. enforces FDCA violations under 21 U.S.C. § 337(a). And Buckman "conclusively determined that a private litigant may not sue a medical-device manufacturer for violating the FDCA." Short and sweet.

After addressing whether the manufacturer could be liable under a strict liability theory if Dr. McCarthy was its agent—it cannot because, among other things, agency requires control—the court returned to Buckman. Plaintiff framed a failure to warn claim against the manufacturer based solely on the failure to disclose that the device was allegedly investigational and was on the market as a result of the violation of FDA regulations.

Plaintiff's argument appears to be that. Regardless of whether the Myxo ring was defective in any way, Edwards had a duty to warn patients that it had not been properly cleared by the FDA. To allow plaintiff to recover on her failure to warn claim without any allegation that the Myxo ring was defective would amount to creating a cause of action for violation of the FDCA, which, as described above, is precluded under Buckman, 531 U.S. 341, 349 n.4 (2001).

Accordingly, summary judgment on that claim was affirmed.

The rest of the opinion concerns certain documents relating to peer review the court had held to be privileged and the court's denial of certain motions in limine plaintiff filed on the cross of Dr. Rajmannan and Dr. McCarthy's testimony about royalties. We will not discuss those rulings except to note that plaintiff's contention that her star witness's own history of allegations and statements did not go to bias fit right in with the wackiness of the facts of this case.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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