Why You Need a Defective Medical Device Lawyer When Facing the Horrifying Truths of the Big Medical Industry
A shocking Netflix Original documentary, The Bleeding Edge, exposes the dark underbelly of the $400 billion medical device industry in America.
The large industry is responsible for many defective medical devices including hernia mesh, hip implants, and IVC filters, all of which are known to have potentially life-threatening side effects. The Bleeding Edge focuses on five specific devices that have severely impacted the lives of thousands.
If you or a loved one have been injured by a medical product, you may be able to take legal action against the manufacturer. While The Bleeding Edge brings awareness to the dangers behind poorly researched products, countless individuals continue to suffer from the decisions of medical device manufacturers.
A defective medical device lawyer can help you face these large companies to receive the compensation you deserve for the pain and suffering their products have forced you to endure.
“More Harm Than Good?” The Central Question Of The Bleeding Edge
Released on July 27th, 2018, the documentary probes deep into the uncharted territory of the industry by examining poor regulations, corporate cover-ups, and profit-driven incentives that put unknowing patients in danger.
In addition to investigating these hidden truths, the film includes heart wrenching stories of people whose lives have been forever damaged by a medical device, asking the question: “Does the ‘life-saving’ technology pushed by big corporations actually do more harm than good?”
While the film isn’t intended to be a thriller, the answer to this question is quite terrifying.
“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,” Academy Award nominated director Kirby Dick told the Guardian. “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.”
Why Do Faulty Devices Get Approved?
Throughout The Bleeding Edge, the filmmakers interview a handful of doctors and patients who personally suffered from a medical device. Many of these individuals, and the documentary as a whole, place part of the blame on the U.S. Food and Drug Administration (FDA).
The filmmakers argue that the approval process new devices go through before reaching the American market is outdated and poorly regulated. Products have become much more complex, however, the FDA’s research and testing procedures have been updated very little since they began regulating approvals in 1976.
“Even if we take these five devices that we focus on the film off, the problem isn’t solved,” warned Ziering, the film’s producer. “It’s a system that needs to be much more vigilantly regulated.”
The Bleeding Edge specifically takes issue with the FDA’s 510(k) pathway provision, which essentially allows a manufacturer to bypass clinical testing in humans and obtain approval for a device if they can prove that it is “substantially equivalent” to another device already on the market.
The method was created mainly to cut costs and establish an easier way for manufacturer’s to get new devices approved. The problem with devices that are approved this way is that their effectiveness and safety are not properly tested before they reach the market, so patients aren’t warned of any potential risks until it’s too late.
Fighting For Change
The documentary has not only pushed viewers to ask more questions about the devices they’re considering but is also exposing the industry and inspiring people to fight for change.
A week before The Bleeding Edge was released, Bayer announced that it would stop selling Essure by the end of 2018. One of the products featured in the documentary, Essure is a coiled birth control implant that has caused serious health issues in many women.
The film tells the stories of several women who suffered after receiving the implant but were never warned of the potential side effects. Bayer continues to emphasize Essure’s safety and stated that they are dropping the product for “business reasons.”
Directors Ziering and Dick said in a statement about Bayer’s announcement, “This is exactly why we do this work. This film has already changed policies and changed history.”
The medical device industry is, unfortunately, not transparent when it comes to the dangers of their products. This is a problem because, as this eye-opening documentary has proven, “what you don’t know can hurt you.” You can view the trailer for The Bleeding Edge below and watch the full documentary on Netflix.
How A Lawyer Can Help
While the end to Essure in the United States is a success, there is still much needed change that must occur within the industry to ensure the safety of consumers.
Millions of people have already had their lives altered by defective products and, if improvements are not made, more will continue to be harmed.
Cases involving faulty medical technology need to be evaluated by a lawyer. Too many individuals don’t know if they have a case or, if they do, they don’t understand how to move forward in the legal process.
Filing a lawsuit and demanding justice against a big corporation can be intimidating, overwhelming, and might even seem impossible.
We understand how frustrating and painful it can be to suffer life-changing injuries from a device you trusted. In many cases, individuals require additional surgery or experience irreversible side effects that reduce their quality of life.
Device manufacturers simply cannot get away with this. At the Goldwater Law Firm, we represent clients across the United States that have been injured by defective products. We can review your case and help get you on the path to receiving the compensation you rightfully deserve.