United States: Summer Movie Review

We are on vacation this week. The aim was to stay in this hemisphere, yet get the feel of being in an old European city. Less air travel, but still with the overcharging and the hard stares in response to our dodgy foreign language skills. So with that hint, guess away as to our present location. As part of vacation prep, we downloaded a bunch of movies on our Netflix account for viewing on the plane and in case of a rainy day. A couple of days ago, with gritted teeth, we hit the play button for a documentary film called "The Bleeding Edge." We deal all the time with claims of failure to warn, but in this instance we have no such claim. We had been fully warned that the film was a thoroughly one-sided screed against the medical device industry. Pity the poor defense lawyer picking a jury tainted by this particular work of art. The case studies in the film involve hip implants, a contraceptive, vaginal mesh, and robotic surgery. Rotten Tomatoes gives the film a score of 100%. This film must be a banger, right?

Well, it is certainly effective. True to its title, it draws blood – emotionally, anyway. It conveys a series of stories, it makes you feel sorry for victims, and it makes you mad. It feels very much like an extended 60 Minutes segment. 60 Minutes has been on the air for 50 years. That's 50 years of confronting corporate and government malefactors. 50 years of crooks scurrying away from cameras. 50 years of righteous indignation. Many times over those 50 years, 60 Minutes worked its forensic magic on us. We were just as swept up in the disillusionment and the urge to punish as any other viewer.

And then, when we began our stint at a law firm, we worked on a case that received lots press coverage. To our shock, the press got at least half the story wrong. The account of who, what, where, when, why, and how was terribly tilted – more a morality play than factual reportage. Eventually, it occurred to us that perhaps the press didn't distort reality only for stories about our cases. Maybe, just maybe, flaws riddle press stories fairly (or unfairly) often.

We have worked on litigation involving only one of the products at issue in "The Bleeding Edge." All of the stories are compelling, with human beings who earn sympathy. Some suffered terrible physical injuries. Even beyond that, some of their lives were ruined in other ways, with awful impacts on family members. You'd have to have a heart of stone to be unmoved. For the story dealing with the product we know a little something about, vaginal mesh, the story turns out to be a half-story. The viewer will see nothing about the vast majority of patients who had their lives bettered by mesh – whose stress urinary continence, which had devastating, embarrassing consequences for quality of life, had been fixed. Instead, we hear from a plaintiff lawyer who delivers a mini-closing argument against mesh. He says that when the science conflicts with the marketing, "the marketing always wins out." That's catchy, but that's also a canard. From what we have seen, medical device marketing claims must run the gauntlet of careful medical, regulatory, and legal scrutiny before any member of the public sees them. We also hear from ubiquitous plaintiff expert David Kessler, a former head of the FDA, who rips into the 510(k) "loophole". You will not hear a hint of why that provision was deemed necessary and how there was at one time enormous discontent about undue delays in making beneficial medical devices available to patients. If there is a legitimate, nuanced debate about whether the scope of the 510(k) process should be adjusted, or whether that regulatory pathway should be bolstered or adjusted when the underlying predicate devices are withdrawn, you won't hear that nuanced debate here. It's all black and white, albeit in cinematic color. Then we hear from another plaintiff expert who wields a rhetorical axe, not scalpel, against mesh. Immediately afterward, we hear from a plaintiff. When she mouths a critique of vaginal mesh, she says she has heard it is like trying to remove rebar from concrete. Guess where she heard that? That is precisely the imagery used by the plaintiff medical expert in his trial testimony. To our jaundiced eyes, these interviews were cleverly curated and assembled for maximum negative impact. That is not documentary; it is choreography.

If "The Bleeding Edge" is one-sided – and it is – its defenders will say that is the fault of the companies. At the end of the film, we get the typical screen notification that the filmmakers invited the companies to appear, but the invitation was declined. Can you blame the companies? First, it was clear that the filmmakers was dead set on putting scalps on the wall. It was inevitable that the questioning and editing (more on the latter in a moment) would be deployed to make the companies look bad. The filmmaker, not the interviewee, has final cut. Second, companies in litigation know that any public statement could be used against them. By contrast, a plaintiff lawyer can say whatever he wants without worrying that an inaccurate statement might be used against one of his clients. Thus, there is a structural reason why public reporting on matters in litigation usually favors plaintiffs. There is also the same bias one sees in scientific journals in favor of finding significant results. "Product Injures Thousands" will attract more eyeballs or clicks than "Company Responsibly Pursues Innovation." For good reason is the film entitled "The Bleeding Edge." If it bleeds, it leads.

There is an appearance in the film by the CEO of AdvaMed, the medical device industry association. We first see him making a presentation to the MedTech Conference. In the excerpt selected by the Bleeding Edge filmmakers, the CEO says that medical device makers "have more power in this room than most governments around the world." End of excerpt. As placed in the film, it sounds a wee bit sinister. It is as if the documentary is trying to depict the CEO as a Bond villain. Cue the terrifying henchmen, the white cat, the trap door, and the plan for world domination. But context is all. The speech was actually about the industry's power to innovate. Rather different, isn't it? Not that it makes a difference to the filmmakers. After all, in more than one place in the film, the concept of innovation is belittled, even ridiculed. And yet, would anyone really prefer that the government stifle innovation? We've read reviews of the film that conclude by advising viewers to question their doctors when innovative treatment is proposed. It is good for patients to ask questions. But it is not so good for them to be cynical. Hello, vaccine-avoiders. And it is not so good for patients or doctors to harbor preconceptions against innovation. Later in the film, the AdvaMed representative submits to an interview by the filmmakers. What he says is appropriate and above reproach. But, again, something interesting happens with the editing. After the AdvaMed rep answers the questions, the camera holds on him for an uncomfortable pause. The fellow looks at the camera. Then he looks around. Then he lifts his paper cup of coffee. Only after the camera plays its little trick of creating discomfort does it finally cut away. What is the purpose of that? Whose bias is actually being exposed? We are reminded of the scene in the Michael Moore movie where a government official is shown combing his hair before the interview. Context can convey skepticism and derision.

Needless to say, the film-makers employed no such editing maneuvers during the interviews of the plaintiff litigation team.

Again, the film is effective at doing what it wants to do. It makes a case. But do not for a moment mistake it for what it is not – a balanced examination of the truth.

[P.S.: Happy Birthday to the Drug and Device Law Son. We will always be hopelessly biased in his favor.]

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

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