Inadequate Testing of Medical Devices Could Mean Potential Dangers for Patients with Implants

The advancement of modern medicine and technology have enabled humans to live longer, healthier, and more productive lives, especially when it comes to medical devices designed to improve function, restore mobility, and treat a range of conditions. Medical devices implanted into our bodies are still not without their risks, however, especially major implants like artificial joints, pacemakers, surgical mesh, cardiac stents, and more. These risks are not only exacerbated by medical malpractice and the negligence of health care providers who implant them, but also inadequate product testing.

According to Medical Journalist Jeanne Lenzer, a former physician’s associate and author of “The Dangers Within Us,” a new book detailing the potential dangers of medical devices, millions of Americans with implanted medical devices face substantial risks posed by poor product testing. That’s because medical devices are subject to much less scrutiny than prescription drugs, are approved with less oversight, and often go to market without clinical trials. This systemic oversight and inadequacy can make the cures we seek a potential cause of injury and, in some cases, death.

As Lenzer and other safety advocates note, the issue of inadequate testing stems from a long-standing pattern of regulatory failures and the financial interests of corporations. This results in:

• Lack of Data – The U.S. Food and Drug Administration (FDA) does not require manufacturers to report how many patients are implanted with their medical devices – something they could do with relative ease. This means there isn’t a full or accurate representation of how often devices are unnecessary or how many people they harm.
• Post-Market Approval – When the FDA took over regulatory control of medical devices in 1976, it allowed existing devices (such as pacemakers and artificial hips) to remain on the market. These devices were classified into three classes (low, medium, and high risk), and manufacturers of devices deemed high risk were required to prove that they were safe AFTER they were already made available to the public. Today, it is still not uncommon for manufactures to make implanted devices available without clinical trials, and to only prove their safety after they are on the market.
• Profits Over People – Part of why medical devices are so often pushed onto the market without adequate testing and safety assurance is that our health care system enables providers to set fees for services such as medical implants, which are then paid for by Medicare or private insurance. This makes it easier for patients to afford what can be extremely costly devices and procedures, and incentivizes manufacturers to quickly develop and release products and implants in order to take advantage of a large market and potential profits.
• Research Controlled by Industry – While research institutes and universities are designed to function as independent systems of inquiry that impartially report their findings on certain issues and dangers, that began to change when the Bayh-Dole Act was passed in 1980. The Act encouraged technology transfer, where universities and the academic world partner with private industry. Unfortunately, private industries like the medical device industry are filled with corporations that have financial interests in supporting their products or actions. As a result, a great deal of research and testing of medical devices (as well as other products or safety issues) are controlled, funded, and influenced by the industry itself. Studies show research and studies conducted by private industry as opposed to independent sources generally focus on the positives of a product and sidestep the negatives, even to the point of unlawfully suppressing or concealing data that makes them look bad or shows their products or actions cause harm and death.

Companies like those producing and marketing medical devices are first and foremost corporations, which means they have financial interests in pushing products onto the market and increasing their bottom line, even if they pose risks to consumers and patients. As long as they have the ability to make money, they will continue to push untested and potentially unsafe products onto the market, back biased research, and lobby to keep and take advantage of poor regulatory oversight.

FIGHTING BACK: PROTECTING THE RIGHTS OF VICTIMS & PUBLIC SAFETY

Although the prioritization of profits over people is a tremendous problem in the medical device industry, and waging efforts to enact changes that protect Americans no easy feat, there still exists one way everyday citizens can level the playing field with powerful corporations and make their voices heard – the civil justice system. Through lawsuits filed against these manufacturers, victims can hold them accountable for failing to ensure the safety of their products and valuing profits more than people’s lives. This not only allows victims to secure the justice and compensation they deserve, but also helps raise awareness, promote efforts to change the system, and help protect others from suffering preventable harm and losses.

At Hare Wynn, our nationally recognized trial lawyers are committed to helping clients harness the power of the civil justice system following serious injuries and death that could and should have been prevented – especially when they are up against powerful corporations. By leveraging our experience, resources, and unwavering commitment, we fight for the rights of victims and play a role in pushing needed changes forward.

If you have questions regarding a potential case – including one involving defective medical devices or medical malpractice, we encourage you to contact our firm for a FREE consultation. Call 800-568-5330 to speak with a member of our team.