Many Americans are familiar with the tremendous toll of dangerous pharmaceuticals, including injuries and illnesses caused by medications consumers were led to believe would help them. That’s due in large part to not only major lawsuits and class actions involving dangerous drugs, but also a heightened focus on the problems surrounding Big Pharma. However, less people are aware of the problems involving the medical device industry which, despite being far less regulated, has not received the same type of scrutiny or widespread criticism as pharmaceuticals.
The most alarming aspects of the $4 billion / year medical device industry stem largely from its prioritization of profits over people, as well as its lax regulatory oversight. These two factors make for the perfect storm when it comes to risks patients face as a result of dangerous and defective medical devices. While any medical device comes with risks for adverse reactions, the companies behind these devices are often able to escape scrutiny and avoid sufficient research and testing on their path to profitability and the U.S. market.
This systemic problem, which is now being thrust in the spotlight by a new Netflix documentary called The Bleeding Edge, has a lot to do with the power medical device companies have in terms of pushing their products quickly onto the market in hopes of profitability. Here are a few of the most pressing issues surrounding the medical device industry and the risks it poses to patients:
- Lax and outdated regulation – Medical companies have taken advantage of lax regulatory oversight to drive their profits. The FDA approval process has generally remained the same since the agency began regulating medical devices in the 1970s, and has not evolved to match the advancement of the medical device industry and the complexity of products today.
- Legal loopholes – One way medical device companies are able to fast-track their products onto the market, even without much clinical testing, is by taking advantage of legal loopholea. While new devices are supposed to be evaluated through a premarket approval process similar to what’s used for pharmaceuticals (i.e. testing in humans for effectiveness and safety), manufacturers can cite a provision called the 501(k) pathway to obtain approval if they are able to show they device is “substantially equivalent” to another device already on the market. Although the pathway is intended to provide an exception in certain cases, it has now become the norm, and is leveraged by corporations to approve many devices, including chains of new, though arguably “equivalent” devices that don’t have any recent or substantial testing. A former FDA commissioner has called the pathway a loophole, and states that the vast majority of medical devices in the U.S. are regulated under the framework.
As noted in the documentary, these two underlying issues can have disastrous consequences for patients and consumers who utilize untested devices and products which later turn out to be unsafe and hazardous to their health. Over the years, many defective medical devices have made headlines for the widespread and devastating consequences they have yielded. This includes Bayer’s Essure birth control device, which can create scar tissue, organ perforation, and cause sterility), and is now the center of tens of thousands of lawsuits filed by women throughout the country. It also includes a number of other dangerous devices which have formed the basis of cases our legal team at Spangenberg Shibley & Liber LLP has handled – from transvaginal mesh and the Mirena IUD birth control product to IVC filters and defective hip replacements.
Spangenberg Shibley & Liber LLP: Protecting Victims’ Rights
Unfortunately, the issues surrounding the medical device industry are not new or surprising, as they have been well-documented throughout the years. In fact, we recently blogged on the American Association for Justice’s report on the Worst Corporate Misconduct of 2017, which cited Johnson & Johnson’s production of dangerous medical devices and drugs (including its artificial hip replacements and talcum powder) among the top offenses. Although the problems may be known, there is clearly a need for greater awareness and efforts to address them. The new documentary The Bleeding Edge may help with that, as will the many civil lawsuits these companies must face from the victims they harmed.
At Spangenberg Shibley & Liber LLP, our Ohio trial lawyers know the risks patients face as a result of the medical device industry’s overwhelming focus on profits, as we maintain an active practice representing victims and families who have suffered as a result of unsafe drugs and products, including a range of dangerous medical devices. As civil trial attorneys, we take pride in using our experience and insight to not only expose corporate shortcuts, but to also protect the rights of victims who deserve justice and full compensation for their losses.
If you would like more information about unsafe medical devices, a potential case, and how our award-winning legal team may be able to help you, contact us for a FREE and confidential consultation.