How the Medical Device Industry Fails to Protect Patient Safety

If you pay attention to the news, you’ll see that recalls issued for consumer products, foods, pharmaceutical medications, and medical devices happen on a daily basis. While some of these recalls don’t pose immediate dangers to consumers or the people who use them, or simply don’t get attention because they don’t impact a large group of people, others reveal significant risks that can substantially increase the risks of injury or death – especially when they involve medical devices.

Systemic Problems & Defective Medical Devices

Most Americans are familiar with dangerous drugs and medications that have been the center of major recalls and litigation throughout the years, including dangerous pharmaceuticals like Fen-Phen or Pradaxa. However, not everyone is aware of the serious problems affecting the medical device industry which, although less regulated than the pharmaceutical industry, has historically not been targeted with the same level of criticism or scrutiny.

Although the medical device industry and defective medical devices may not be a focal point for many, the problem is still significant. In fact, a recent study released by Stericycle Expert Solutions, found an incredible spike in medical device recalls during the first three months of this year. As the report notes, the 126% increase in medical device recalls during the first quarter was the greatest increase since 2005.

With figures like these, understanding the scope of the medical device industry’s problems is critical to enacting desperately needed changes. One way that’s being accomplished is through a recently released Netflix documentary called The Bleeding Edge, which highlights the some of the most concerning issues behind the $4 billion dollar per year medical device industry. These include:

• Lack of Regulation – Corporations that produce medical devices have long capitalized on the lack of regulatory oversight and outdated regulations that surround the industry. In fact, the FDA process used to approve medical devices now is essentially the same since the agency first started regulating medical devices in the 1970s. Those regulations have also failed in evolving with the industry’s advancements and the complexity of devices which exist today.
• Loopholes – The corporations behind medical devices are ultimately focused on their financial interests, which is why many take advantage of legal loopholes within the industry to increase profitability as fast as possible. For example, one loophole created by the Medical Device Amendment of 1976, which was designed to align the FDA’s oversight of medical devices more closely with how it regulates drugs, has allowed many companies to skirt costly and time-consuming requirements by classifying their products into lower risk categories. It also allowed potentially dangerous devices and offshoots of those devices which existed prior to the legislation to be classified as medium risk until the FDA ruled otherwise, allowing many dangerous products (like the infamous metal-on-metal hip replacements) to remain on the market.
• Fast Tracking – One of the most concerning loopholes within the medical device industry is the ability of companies to fast track approval of their products. Unfortunately, that means devices often hit the market, and are used by patients, without sufficient evaluations or clinical testing that may have otherwise revealed potential risks. By taking advantage of the 501(k) pathway, medical device manufacturers can obtain faster approval of their products when they can prove they are “substantially equivalent” to another existing device already used by patients. While the pathway was initially intended to provide an exception in rare cases, it has now become the status quo in the industry, and is utilized by manufacturers to quickly approve potentially dangerous devices, including offshoots of arguably “equivalent” products. Many experts, and even outspoken former executives of the FDA, note that the 501(k) pathway provides the framework through which the majority of medical devices are regulated.
• Profits Over People – As with many issues involving corporations that wield tremendous power and influence, the medical device industry is often subject to the whims and influence of corporate powers that care more about profits and their financial interests than the people their devices are intended to help. A large part of the industry’s stagnant regulatory oversight can be credited to the efforts and lobbying of these major powers to block proposed legislative changes.

Fighting for Victims Injured by Defective Products

Our legal team at Clark, Fountain, La Vista, Littky-Rubin & Whitman has earned national recognition for our work protecting the rights of injured victims and families, including many who suffered injuries as a result of defective products. Our work in the area of product liability law – from defective auto parts to dangerous pharmaceuticals and medical devices – is driven by over 220 years of combined experience, the insight of Board Certified trial lawyers, and a passion for helping victims fight back against powerful corporations and product manufacturers.

While medical devices can help patients live healthier, more productive, and pain free lives, the reality is that there are always risks created by manufacturers that fail to take reasonable steps in ensuring the safety of their products and the patients who use them. Fortunately, victims have rights, and our Florida Trial Lawyers have the experience and resources to help. If you would like to discuss a potential case involving injuries caused by a medical device or any other defective product, contact us for a free case evaluation.