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The Bleeding Edge, an independent documentary directed by Kirby Dick and produced by Amy Ziering through their production company, Chain Camera Pictures, unearths systematic corruption within the “$400 billion medical device industry” (The Bleeding Edge 2018). The film takes a deep dive into the healthcare impacts of medical device “innovation” (Dick 2018). Both
Dick and Ziering specialize in investigative journalism and documentary having produced the
Emmy Award-winning and Academy Award-nominated documentary, The Invisible War (The Bleeding Edge 2018).
In all of their documentaries, Dick and Ziering focus on issues of “breaking news,” aiming to inform public opinion, and influence policy (Fuchs 2018). According to Ziering, in an interview by No Film School, when she and Dick decide to make a film they “first get intrigued, then outraged, and then [they] decide to make a movie” (Buder 2018). In the case of The Bleeding Edge, the topic of the film arose when one of Chain Camera Picture’s producers, Amy Herdy, came forward with “this crazy story” about one of her neighbors, who had experienced complications due to an untested medical device (Buder 2018). The disbelief following the interview resulted in an in-depth investigation into this “breaking news,” where research was conducted, and interviews with survivors, professionals, scholars, and doctors were recorded
(Fuchs 2018). This information was then synthesized and analyzed, before getting compiled into a commercially consumable film that informs the public of the fractured health system that “has devolved into [a] business” (Fuchs 2018)
The Bleeding Edge is an independent film, meaning that,t was not produced in Hollywood and is not backed by any super PACs or the government (Grove 2014). In order to receive funding for the production of The Bleeding Edge, Dick and Ziering received a fiscal sponsorship from Utah Film Center (Dick 2018). Dick and Ziering received a grant from The 2
Grant Me the Wisdom Foundation, which provides funding to organizations or efforts that are educating the public about the health care of women and girls around the world (The Grant Me
The Wisdom Foundation). The focus of The Bleeding Edge aligns with the foundation’s mission by extensively covering the debilitating effects of Essure, a female sterilization implant. Dick and
Ziering received a second grant from the Perspective Fund, whose goal is to support independent “documentaries that raise awareness, connect people, inspire action, and create impact around human rights and social justice” (Perspective Fund 2018). The Bleeding Edge is a perfect example of an independent documentary affecting change around human rights
(patient rights). Just a few months after the film’s release, it has already had a significant impact, which is projected to continue and grow with time (The Bleeding Edge 2018). The Bleeding Edge has also received funding from two individual contributors, Berry Liberman, and Jill Cunniff, in memory of her son, Danny (Dick 2018). Berry Liberman has a history of providing funding to initiatives aimed at educating the public about social issues like health, which is likely why she chose to support the production of The Bleeding Edge (Horn 2015). Jill Cunniff likely provided funds for this particular documentary because of her less than optimal experience with the healthcare system when her son Danny died in 1998 from leukemia (Breslin 1998).
In order to receive funding and grant money, the film proposal had to meet certain requirements. However, the film already aligned so heavily with the mission statements of both the foundations and the values of the individual contributors, that there was likely very little influence from the sponsors in shaping the agenda of the documentary to be different than the filmmaker’s vision.
The rights to distribute The Bleeding Edge were bought by Netflix, which has the ability to provide content to 104 million subscribers (Greenberg 2017). Dick commented in an interview with PopMatters that, “Netflix is perfect for this film,” as it reaches such a wide audience, 3
allowing for a larger number of viewers to become educated and invested in an issue (Fuchs
2018). Making a Murderer, a Netflix’s docu-series is a great example of how Netflix documentaries can influence the public. Millions of people watched the series and hundreds of thousands of people signed a petition calling for Avery, the subject, to be released. Unlike commercial networks or public broadcasting, platforms like Netflix have the option to show documentaries that may not bring in the most significant amount of revenue because they have so many other films that can compensate (Greenberg 2017). Because Netflix does not need to draw in large revenues from documentary films it can experiment with less mainstream, as well as more controversial, documentaries (Greenberg 2017). As a powerful global corporation itself,
Netflix can “speak truth to power,” without fearing the consequences, allowing a space for controversial documentaries like The Bleeding Edge to actually effect change (Fuchs 2018). Documentary filmmakers Kirby Dick and Amy Ziering have a history of exposing certain social issues and facilitating conversation around them in the hopes for change. In an interview
with Film Comment, Kirby Dick states: “We have an opportunity, as documentary filmmakers, to speak to issues around social justice, particularly when information about injustice is covered up and allows the injustice to continue. From a cinematic point of view, it's also very dramatic to have a film actively uncovering and investigating this cover-up” (Lucca, 2012). This sentiment is made glaringly clear by the intent of their previous films: The Invisible War and The Hunting Ground. In The Invisible War, Kirby Dick exposes the cover-up of rape by the U.S. Army. After the showing of the film, Amy Ziering stated that “as a documentarian, what you always dream of is real political impact” (Lucca, 2012). After winning the audience award at the Sundance Film
Festival, the film was shown to 16 senators and eight Congressional representatives (Lucca, 4
2012). Shortly after, Secretary of Defense Leon Panetta saw the film and held a press conference vowing to institute some of the changes the film actually pointed out.
Dick and Ziering tackle a similar issue in The Hunting Ground where they focus on the neglected sexual assault epidemic on college campuses. After thousands of screenings across college campuses, the film garnered enough of a response to trigger a wake-up call for a culture change. Dick says that after people watch The Hunting Ground in screenings they start “talking about [the issue] publicly for the first time and [start] breaking it down… if it’s affecting people that way, hopefully it will help to make change” (Allen). Dick and Ziering had an explicit intent to make these films to actively investigate cover-ups about issues around social justice by uncovering them.
The Bleeding Edge is no different. From the get-go, the intent of the documentary was clear: expose the medical devices industry for what it is and the phony medical devices approval processes used by the FDA. Kirby Dick states of what he wishes to accomplish with The Bleeding Edge: “[change] has to happen at a national level and it has to be directed at the corporations” (Fuchs, 2018). For Dick and Ziering, the format and production of the film revolve around the idea of maximizing the impact of the change that they wish to fulfill.
When considering the methods that Dick and Ziegler used to achieve their intended impact with The Bleeding Edge, the film uses its expository mode to a significant degree to expose how the medical device industry utilizes loopholes in governance as well as the new relationship between the FDA and the industry’s lobbyists to destroy the lives of the patients it has been tasked to protect and heal, all in the name of profits. However, Dick goes beyond just examining the industry’s development and its impact on patients, he does so in a way that both captivates and motivates the viewer to action. There are two specific examples that show Dick’s use of documentary storytelling and artistic methods that allow his film to make his intended 5
impact and galvanize the audience to action: the moment of rolling thunder as Angie Firmalino first mentions Essure and the revisiting of Ana Fuentes and her deteriorating situation throughout the film. Each carries out a specific task in promoting Dick’s intentions, as well as representing a key aspect of documentary storytelling, especially in the expository mode.
When we are first introduced to Angie Firmalino, we hear her life story and are shown images of her family life with her interview dubbed over footage of her daily life. The moment that her interview turns to her decision to have the Essure procedure, the film shows Angie outside with her son tending to a garden. Right as Angie’s dubbed over dialogue says, “Essure,” the interview audio cuts out, and the audio shifts to her in the garden with her son, which coincides with a deep, rumbling thunder that overpowers the scene. It is a master class of audio editing by Dick, as we are first introduced to the name of the product that inspires the rest of the film by an incredibly ominous sound. This use of audio and natural sound has a distinct impact on the audience, as we are now primed to expect that the word Essure will have a negative connotation throughout the film, which, of course, it does. The use of audio to present a key theme of a film is common in almost all types of film, but it is normally left out of the expository mode of documentary. Instead, Dick uses the sound at the beginning of the film to immediately emphasize the negative connotation that should be associated with Essure.
The next aspect of the film that Dick utilizes for effective storytelling is the chronicling of
Ana Fuentes’ experience after she used Essure. Fuentes experience is different because she does not have the support systems that Angie and the other Essure patients use to fight back against their pain and the industry. Fuentes’ story strictly shows how much Essure, simply the product and procedure, destroyed her life. As Dick returns to her story throughout the film, we see a continuously deteriorating situation. Fuentes’ moves from a married mother of four to a woman in so much pain she is jobless to the point that she must put her children in foster care 6
because she cannot provide them the basic necessities that a mother should. The most painful situation is when they are driving to a hotel after having to move out of their house and one of her daughters exclaims, “Mommy, there’s a homeless,” in a worried and scared voice. The juxtaposition of her situation, directly caused by Essure, and what her child fears is an incredibly poignant moment in the film, which Dick capitalizes on to show just how much these medical devices can destroy lives. This leaves the audience saddened, but more importantly, angry and inspired.
Within Dick’s intended audience, there are three specific players with three specific roles: the general public, who he wants to inform and galvanize, doctors, who he wants to push to a higher standard of research prior to using these medical devices, and policymakers, who he wants to crack down on the ease with which these devices are introduced to the market.
According to Dick, “A wide range of people know about the problems with pharmaceuticals, but very few people know about the medical device industry and the fact that it is even less regulated than pharmaceuticals. We felt it was very important that the public, doctors, and policymakers know about this because right now medical device companies can get away with just about anything.” (The Guardian 2018). Dick’s ability to release the documentary on Netflix, as well as his position as a renowned documentary filmmaker, allowed the documentary to reach critical acclaim, but still able to be accessed by a large audience on a wide scale, with a very low effort threshold for the audience to view the film due to the simplicity of Netflix. This made distribution challenges almost non-existent because the extent to which the general public saw the film was much greater due to its increased access through Netflix. Dick’s film, strictly on its content and his storytelling, galvanized the public to reach out to doctors and policymakers, extending the scope to the entire intended audience, and thus maximizing the potential impact. 7
The Bleeding Edge was released on Netflix on July 27, 2018, and received widespread critical acclaim. The online film review aggregator, Rotten Tomatoes gave The Bleeding Edge a fresh score of 100%, IMDb gave it a 7.8/10, and Metacritic gave it an average score of 74%.
Ken Jaworowski from the New York Times states that “Mr. Dick smartly summarizes complex procedures and cites exasperating statistics.” While Owen Gleiberman, a critic at Variety, states that the film “roots its critique in an intimate look at the lives and medical complications of ordinary folks who'd put their faith in their physicians, only to emerge betrayed” (Variety, 2018).
A week before Netflix released The Bleeding Edge, Bayer notified the FDA that Essure will no longer be sold or distributed after 2018 (FDA, 2018). The FDA threatened Bayer “with civil and criminal penalties if it didn’t do more to warn patients about the product’s serious health risks” which prompted Bayer to remove Essure from the market (Bloomberg, 2018). While Bayer did not name the film as a reason for recalling Essure, as of January 2018, over 16,000 women had filed Essure lawsuits to Bayer. This number projected to exponentially expand after the film released (Weyant, 2018). Bayer did criticize the film for being inaccurate and misleading. Bayer accuses Dick of cherry-picked facts to fit his storyline (Variety, 2018). Bayer’s actions show that the film inspired press coverage and exerted pressure on the FDA have led to the film’s early success in meeting its goal of raising awareness at the national level of life-saving medical technologies that harm thousands of people of just a few weeks after its release date.
It’s likely that The Bleeding Edge will inspire other companies to make a public confession that their medical devices are defective and recall it from the market. The film constantly calls out the FDA for its weak medical device approval system and we are seeing the beginning steps to reform. In April, the FDA released a “Medical Device Safety Plan” and stated that they are receptive to proposals for “new policies to drive innovation to create safer medical devices and to better understand and address risks of devices that are already on the market” 8
(FDA, 2018). The film mentioned other harmful medical devices such as CT scans or the Da
Vinci Surgical System. It is likely that these devices will be further examined given the FDA’s priority to “spur innovation towards safer medical device[s]” (FDA, 2018).
The Bleeding Edge has yet to directly influence legislation in Congress. In July, the House repealed the 2.3% tax on medical devices because it “distort[ed] the medical device industry, led to higher prices, less pharmaceutical research, and fewer job opportunities (Tax
Foundation). Now it’s up to the Senate to repeal the tax. The groups featured in The Bleeding Edge are encouraging everyone to take action by either researching a device, filing a citizen petition, lobbying to their Congressmen and women, etc. If enough constituents lobby to their
Congressmen, they can push their senators to repeal the tax in hopes for higher quality pharmaceutical research. The film provides convincing evidence which can prove to legislators that we are in need of robust research and protocols for medical devices. As for the controversial 510(k) Clearance approval pathway, physicians have offered a variety of solutions online and the film reiterated those solutions. The film interviewed specialized physicians, the editor of JAMA Internal Medicine, and most importantly, the former Commissioner of the FDA who all criticized the current system and posed solutions. Lawmakers have the opportunity to hear from and be convinced by credible individuals that the medical device system is broken.
As previously stated, the film already met its goal of exposing the medical devices industry for its flaws only days after its release date. Bayer was forced by the FDA to remove
Essure from the market and there is reason to believe that interest groups similar to the ones in the film will push the FDA put pressure on other medical device companies to be more transparent and to prioritize their customers’ safety. There can be change at the national level like Dick and Ziering hope for if Congress and other public figures believe what interest groups, victims, and the film have to say. 9
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