The patient is male, middle-aged and has just suffered a massive heart attack. For now, he's sedated, covered by blue cloth and being operated on by a female surgeon, with another attending surgeon and two residents standing nearby in the darkened room.
Today's course of treatment will not be the same given to nearly 600,000 Americans who experience a heart attack each year. Instead the man will be given a device called the Parachute-a small device that looks like a small coffee filter that is inserted into the heart through a novel catheter-based delivery system. Once inside the heart, it expands-like a parachute, as its name suggests-to block off blood flow to the part of the heart hosting tissue damaged during ischemic heart failure.
The procedure is relatively simple, explains the surgeon, who talks while she operates on the patient.
"I guide the parachute into the heart, and open it so it will block off the damage caused by his heart attack," she says. "It should keep the rest of his heart from working so hard while it heals."
"That is crazyballs," erupts a nearby resident physician, a copy of the device clearly displayed in her hand.
There's just one problem: Almost none of this is real. The patients, surgeon, and residents are all paid actors; the operating room, a set-all part of a February 2013 episode of the television show "Grey's Anatomy."
But part of the scene is very much real. The Parachute device, manufactured by California-based CardioKinetix, is a real device, and is currently undergoing clinical testing under an Investigational Device Exemption (IDE) application approved by the US Food and Drug Administration (FDA).
Which raises a broader question: Does this scene constitute promotion?
A Matter of Precedence
It's a tricky question, but one with some precedent.
In May 2012, a medical device manufacturer by the name of ThermaSolutions received a relatively unusual Warning Letter from the US Food and Drug Administration (FDA) that cited, among other things, the company's participation on the popular TV show "Grey's Anatomy."
ThermaSolution's investigational device, a hyperthermic intraperitoneal chemotherapy (HIPEC) product, operates by raising the core temperate of a patient's peritoneum, increasing the efficacy of chemotherapy drugs that are introduced separately.
FDA's Warning Letter chided the company for hosting the "Grey's" segment in which it product was featured in on its website.
"The caption next to the video states, '[t]he popular show 'Grey's Anatomy' of ABC featured the Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure with ThermaSolutions' HT-1000 in last year's episode,'" FDA explained. "'One of our team members participated in the program to make sure the procedure and equipment was used the way our clients do too . . . .'"
FDA's regulators didn't dwell much on the episode itself except to note that the combination of the video, the accompanying explanation of the device, and their presence on the company's website all constituted an alleged deficiency on the part of the company.
ThermaSolutions later sent Regulatory Focus a statement saying that it had remedied the alleged deficiencies, and the video clip in question is no longer available on its website, but did not comment further.
Same Show, Similar Problems
And just as ThermaSolution's letter raised eyebrows in 2012, so too is CardioKinetix's participation raising similar eyebrows in 2013.
The scene described above included another actor, on screen for just a few seconds and standing next to the surgeon as she operated. As ABC News reports, that person was Dr. Marco Costa, a cardiovascular specialist who is a clinical investigator for CardioKinetix and has made numerous presentations on its behalf.
To hear Costa tell it, he was deeply involved in making sure the device was used properly.
"We rehearsed a little so she [the actor] would understand all the little steps take place," Costa said to ABC. "I think she did very well," he added.
But is this participation allowed under FDA rules and regulations?
Some experts are skeptical. Dr. Westby Fisher, a well-known industry commentator, explained on his website that the show could very well have run afoul of numerous standards.
The actor's exclamation of "Crazyballs," for example, could actually represent a claim regarding the device's performance, and thus run afoul of either FDA or Federal Trade Commission (FTC) advertising guidelines, Fisher explained.
Fisher also noted statements made by Costa to ABC. "This kind of attention is important to create awareness and to help people that are out there that have a heart problem and have been given no option of therapy to learn that there is an option," Costa said. To Fisher, "Statements like those might run afoul of the FDA guidance statement for the recruitment of study subjects."
What Kind of Claim is 'Crazyballs?'
The company could run into other problems as well. The device is currently operating under an approved IDE application, which companies must obtain before they may initiate clinical testing of a device.
An IDE basically exempts the product from interstate commerce restrictions under the Federal Food, Drug and Cosmetic Act (FD&C Act), which otherwise make it a crime to ship an unapproved medical device to clinical testing sites. In return for that exemption, however, companies are supposed to abide by a strict set of restrictions.
One such restriction comes under 21 CFR 812.7, Prohibition of Promotion and Other Practices, which prohibits sponsors from "represent[ing] that an investigational device is safe or effective for the purposes for which it is being investigated."
In a statement to Regulatory Focus, Leland Keyt, senior manager of RA/QC for CardioKinetix, said the show's producers had first come to them. "With respect to last week's episode, Case Western Reserve University and Dr. Costa were approached by Grey's Anatomy regarding the storyline. CardioKinetic reminded Case Western/Dr. Costa of the regulations and guidance for promoting of investigational devices."
"Although, all inquiries and discussions from the show were handled by Case Western, we made sure they understood the regulatory status of the device and importance of making sure the technology was presented as investigational and the fact that there could be no promotional claims made," Keyt continued. "Additionally, CardioKinetix informed FDA of the episode."
This information raises an altogether odd question for regulators: Is "crazyballs" a claim regarding safety or efficacy? Or is it just an ambiguous phrase meant to convey the novelty of the device as a whole? And can a company really have control of the script a show uses to describe its device?
Other Potential Issues
Yet another question for regulators will be if the promotion of an investigational device on a nationally-syndicated television show represents a violation of 21 CFR 812.7. In the past, FDA's litmus test for activating its enforcement procedures seems to fall along the personal involvement of the company or its representatives.
As Keyt's statement above explains, the company was to a limited extent involved, but the majority of participation seems to have been done by their investigator, Costa.
That, too, raises a number of questions.
Costa's statement that the device is an "option of therapy" for treating heart attacks is potential misbranding, but an issue for regulators would be if the investigator was acting on his own behalf, or on behalf of the company.
But if ThermaSolution's 2012 Warning Letter is any indication, CardioKinetix may be safe from receiving a Warning Letter of its own. The ThermaSolutions letter calls particular attention to the fact that the company has itself hosted the video. To date, CardioKinetix has not made the video available on its website.
So will US Food and Drug Administration (FDA) regulators find the promotion to be "crazyballs," or just a harmless incidence of a company cooperating with a TV show to showcase an up-and-coming medical technology?
Time will tell, but until then, Fisher advised the company to steer clear of signing off on similar promotions in the future.
"Don't star in Grey's Anatomy while your experimental device is demonstrated by faux doctors performing faux procedures on faux patients," he recommended. "People might think you are a faux doctor helping the other faux doctors install a faux heart failure device."
"Remember: real doctors with real medical devices that they are hoping to get FDA approved would never think of doing such a thing," he concluded.