Over the course of the last several days, there has been a flurry of discussion regarding Netflix’s latest documentary, The Bleeding Edge. Much like its predecessors (Making a Murderer, The Keepers, Evil Genius), this hour and forty-minute film (directed by Kirby Dick and produced by Amy Ziering) takes a very raw and uncensored look at the $300 billion medical device industry and how, every year, thousands of innocent people fall victim to its profit-driven agenda; begging the ultimate question, what price is the American public paying for the sake of advancing medical science?
Sadly, The Bleeding Edge is rife with examples of the price Americans are paying for the sake of advancing medical science. Interviews with women having received the Essure permanent birth control device reveal how over 35,000 women have had their lives reduced to chronic pain, autoimmune disorders, and hysterectomies as a result of Bayer’s failure to report the side effects associated with its device. Individuals having received metal hip implants discuss their development of cobalt chromium metal poisoning and the related onset of debilitating neurological deficits. Other women detail the multiple and painful surgeries they have undergone in an attempt to remove the vaginal mesh strangulating their bodies, which had originally been used to help stabilize and reinforce weakened pelvic muscles often caused by childbirth and aging. Even more women discuss how sections of their colon exploded from their bodies following their surgeons’ use of the robotic, da Vinci System.
For years, industry has pushed this idea that newer is better and that new and “innovative” medical devices put us on the “cutting edge” of science. However, The Bleeding Edge most accurately dispels this myth, delving into the world of medical devices, exposing the stark reality of how industry’s push for “innovation,” coupled with a lax regulatory system, actually puts us on The Bleeding Edge of science, as every time a patient agrees to the implantation of a medical device, he or she is unknowingly subjecting his or herself to unimaginable harm, or even death.
THE MEDICAL DEVICE INDUSTRY IS ONE OF THE MOST POWERFUL INDUSTRIES IN THE WORLD
Over the last ten years, 70 million Americans have been implanted with a medical device. These devices are a part of our everyday lives, ranging from dental floss and tongue depressors, to pace makers and catheters. Stryker, one of the leading manufacturers of hip and knee replacement components had a net revenue of $12.7 billion in 2017. Bayer, the manufacturer of several contraceptive devices, including, Mirena and Essure, made well over $40 billion in revenue, and Johnson & Johnson, a manufacturer of vaginal and hernia mesh made over $76 billion in revenue in 2017. The profit margin of the medical device industry is frightening in that it has afforded these companies the opportunity to infiltrate our lives under the guise of medical advancement, all the while exposing us to perilous harm.
THE PROCESS BY WHICH THE FDA APPROVES MEDICAL DEVICES IS SIGNIFICANTLY OUTDATED
The Bleeding Edge highlights the misconception under which many Americans operate – that their medical device has been adequately tested and deemed safe and effective for use by the FDA. Since 1976, it has been the responsibility of the Food and Drug Administration (FDA) to regulate the approval of medical devices. However, since 1976, the complexity, type, and number of medical devices has vastly increased, but whether they are released for public use is still based on a system created over 40 years ago; one clearly incapable of contemplating today’s technology.
98% of all medical devices are not tested prior to approval. Rather, manufacturers are able to acquire approval of medical devices by the system known as the 510(K) process. To obtain approval under the 510(K) process, a manufacturer is only required to show that its device is substantially similar to another (predicate) device that was previously approved by the FDA; absolutely zero safety testing is required. This is true even if the predicate device was taken off the market for safety concerns. Per the FDA, in considering a 510(K) application, it does not check the predicate device for safety issues, or to see if it has been removed from the market; it only looks to confirm that it was actually approved by the FDA. Consequently, much like a genetic mutation, approving a product that is based on the design of a device that has been found to be unsafe, promotes the production of faulty devices in generations to come.
WE CAN NO LONGER RELY ON THE MEDICAL DEVICE COMPANIES AND THE FDA TO DO WHAT IS IN THE BEST INTERESTS OF PATIENTS
Even more, The Bleeding Edge calls attention to the seemingly biased and corrupt workings of the FDA. FDA officials and physicians charged with the responsibility of determining whether a device should be approved, more often than not, have stock or other monetary interests in those exact devices before them for approval. For example, prior to Dr. Scott Gottlieb (current FDA Commissioner) being appointed commissioner, he not only worked as a consultant to a range of medical industries, but he worked for a venture capitalist firm, New Enterprise Associates, that specialized in the investment of startup medical device companies, which has invested $14 billion in over 500 companies, including the development of the very controversial permanent birth control device, Essure.
MEDICAL DEVICE MANUFACTURERS ARE NOT HELD ACCOUNTABLE
Another misconception addressed by The Bleeding Edge is that the FDA has the data it needs to regulate or recall medical devices. Some safety issues with a device do not become apparent until after the device is already on the market. In these instances, a manufacturer has an absolute obligation to monitor and report such safety issues (adverse events) to the FDA. If enough adverse events are reported for a particular device, the FDA will then decide if the device needs: further safety testing; stronger warnings; or to be pulled from the market altogether. However, if the FDA is unaware of the adverse events, it cannot make the decisions necessary to protect us. The disturbing and unfortunate reality of the situation is that only 3-4% of adverse events are reported by device manufacturers, and the more severe an event, the less likely it is to be reported. Thus, the whole idea of the FDA relying on a company to essentially “tell on itself” when something goes wrong with a device, when billions of dollars of profits are at stake, is not only counter intuitive, but a system that completely fails the American people.
Leaders in industry argue that to impose stricter regulations on how medical devices are approved, is to stifle innovation. However, as Bleeding Edge explains, the aim of regulation is not to stifle innovation, but to call real attention to the safety risks that these newer and “innovative” devices pose to patients. After all, innovation doesn’t necessarily mean better. It means “massive adoption of new technology with little evaluation of the outcomes”, or “putting untested devices on the market.”
HOW THE YOST LEGAL GROUP CAN HELP
For years the attorneys at The Yost Legal Group have litigated cases against device and drug manufacturers all in an effort to not only bring awareness to the same issues addressed by The Bleeding Edge, but to hold those same manufacturers accountable for the devastating injuries they have caused our clients. Presently, our firm is involved in the following litigations against various device and drug manufacturers.
- ESSURE PERMANENT BIRTH CONTROL: Currently investigating cases against Bayer, involving women who have had to have a hysterectomy following their implantation of the permanent birth control device, Essure.
- HERNIA MESH: Currently investigating claims against several manufacturers, including Johnson & Johnson, C.R. Bard, and Atrium Medical, on behalf of individuals having suffered serious complications from synthetic mesh implanted during hernia repair surgery.
- IVC BLOOD CLOT FILTERS: Currently investigating cases against device manufacturers, C. R. Bard, Cook Medical, and Cordis, involving individuals having suffered serious side effects, including death, following their implantation of an IVC blood clot filter.
- SMITH & NEPHEW HIPS: Currently investigating cases against Smith & Nephew, involving individuals who have had to have additional hip replacement surgeries following their implantation of the Birmingham Hip Resurfacing (BHR) System, or the R3 Acetabular System, both of which have multiple components made of cobalt chromium metal.
- STRYKER LFIT V40: Currently investigating claims against Stryker, on behalf of individuals who have had to have additional hip replacement surgeries following their implantation of the Stryker Rejuvenate Modular Primary Hip System, the AGB II Modular Hip System, or the LFIT V40 femoral head, all of which contain metal on metal components.
- MIRENA IUD: Currently investigating cases against Bayer involving women who have been diagnosed with intracranial hypertension following their implantation of the intrauterine device (“IUD”), Mirena.
- DIABETES MEDICATIONS (Januvia, Janumet, Tradjenta, Byetta, Victoza, Onglyza, etc.): Currently investigating claims against various manufacturers, on behalf of individuals having been diagnosed with pancreatic cancer following their use of medications belonging to a class of drugs known as incretins (Januvia, Janumet, Tradjenta, Byetta, Victoza, Onglyza, etc.), prescribed to treat type 2 diabetes.
If you or a loved one has been injured as a result of a faulty medical device or defective drug, The Yost Legal Group may be able to help. Our team of experienced legal professionals is here to offer you free, individual consultation. We serve as the voice of our clients to hold Big Pharma accountable and obtain the justice each one so rightfully deserves. Call The Yost Legal Group (1-800-YOST-LAW) today. Let us be your voice.