Dangerous Medical Device Defect Attorneys

Dangerous Medical Devices: Side Effects & Injuries

Making decisions about personal medical procedures is never easy. We rely on medical professionals and product manufacturers to ensure that medical devices are safe and effective. The majority of time the products are safe, helping millions of individuals each year improve their quality of life. But what happens when medical devices are defectively designed or manufactured, or sold with inadequate warnings regarding risks, complications, and side effects? What happens when medical devices malfunction or fail?

It’s not uncommon for defects in certain medical devices to cause serious side effects and injuries in those who rely on them. This includes a variety of devices, such as:

  • Artificial hips, knee joints, and spine discs
  • Pacemakers and automatic external defibrillators
  • Pain patches, infusion pumps, and blood glucose monitoring strips
  • Breast implants, IUD’s, surgical meshes, and catheters
  • Renal replacement systems, and hernia repair systems
  • Imaging and surgical devices
  • Bone grafts, dental implants, and surgical eye devices

Have You Been Injured? We Can Help

At Robinson Calcagnie, Inc., we understand the devastating effects defective medical devices can have on the lives of our clients. If you have experienced injury, serious side effects, or revision surgery as the result of a defective medical device or product, our products liability attorneys can help you understand your legal rights and options. Please contact us today to schedule your free, confidential consultation.

Dangerous Devices on the Market

It’s unfortunate, but some medical device manufacturers fail to fully disclose potential product risks to patients and their doctors in an effort to avoid cutting into sales and profits. In fact, it is not uncommon for some approved medical devices to be recalled after they have already been implanted in thousands of patients. As a result, a number of people each year suffer personal and catastrophic injury, undergo multiple corrective surgeries, and even lose their lives.

The  attorneys at Robinson Calcagnie, Inc. have decades of experience representing victims of defective products, and holding negligent medical device manufacturers and sellers accountable for their actions and for the harm they have caused. As a nationally recognized leader in products liability, we have the expertise and legal resources to go up against large medical device companies and their lawyers. We currently represent clients in cases involving the following devices:

The Increasing Demand for Medical Devices: Risks and All

More and more individuals suffering from health-related problems are saying “yes” to medical devices. The increasing availability of healthcare options and technological advancements make medical device implantation an attractive option to improve function, and relieve pain and other symptoms associated with various medical disorders. In fact, the number of individuals exercising this option is staggering:

  • According to the U.S. Centers for Disease Control and Prevention, U.S. hospitals perform 48 million medical procedures each year.
  • The U.S. population creates about half of the global market demand for medical devices.
  • The rapidly growing global medical device industry is expected to generate $228 billion in sales by 2015, up from $164 billion in the year 2010.[1][2]

Taking advantage of today’s remarkable medical technology and available procedures is a good thing for most, but it also exposes many patients to a number of failures and devastating outcomes, particularly where device manufacturers have acted negligently in manufacturing, designing and selling their products.

When Medical Devices Fail

Despite the best efforts of the U.S. Food and Drug Administration (FDA) to protect the public against dangerous devices, medical manufacturers continue to make, market and sell faulty products. Devices continually enter the market after being approved by the FDA without adequate testing or full disclosure of potential risks and known dangers. Even when products go through rigorous FDA approval processes, there is still no guarantee they will be free from defects or that manufacturers will adequately warn the public as they become aware of potential dangers and problems.

The FDA recently released a report showing a 97 percent increase in medical device recalls over a 10-year period, bringing to light the magnitude of failure rates. Even though medical devices range from simple items like test kits to implants and laser surgical devices, the report focused on those with high amounts of adverse use reports such as external defibrillators, ventilators, and infusion pumps.[3]

The good news: The FDA is keeping track of dangerous and injurious medical devices to enhance awareness. The bad news: Many defective devices have already been used or implanted, leaving hundreds of thousands of people with personal injuries and financial losses, including:

  • Debilitating pain and suffering
  • Infections and organ damage
  • Permanent physical disability
  • Emotional distress
  • Multiple painful and risky corrective surgeries
  • Medical bills and rehabilitation expenses
  • Loss of income and earnings capacity
  • Fatal injuries

Women and Medical Devices

One of the primary areas of growth in the medical device industry has been in products made for women including implanted birth control, vaginal and bladder support devices, artificial hips, and more. These types of devices can be positively life-changing for those who suffer from medical conditions, yet studies show that a significant number of women endure pain, debilitating injuries, and worse as a result of product defects. Unfortunately, some of these devices have never undergone adequate pre-market testing, which could have prevented harmful outcomes in innocent victims.

As part of National Women’s Health Week in May, the American Association for Justice (AAJ) released a report noting that women have suffered disproportionately from dangerous products over the years.

According to the report:

“Women are historically underrepresented in medical trials, even in those marketed specifically for women. In almost every case, women were put at risk for years, while corporations squeezed every last drop of profit from their products. Even when dangers become public knowledge, companies frequently continue to market them and play down the dangers, anticipating that any repercussions down the road will be more than justified by a continuing stream of profits.”[4]

Who is Responsible When Medical Devices Become Dangerous?

Medical device manufacturers generally design, manufacture, market and sell their products to hospitals and physicians with the best intentions; however, some do not. When their devices cause injuries, which could have been prevented with adequate warnings, innocent patients pay the price.

 As noted by UCSF Professor of Medicine Rita Redberg, MD, “Examples of avoidable outcomes include hundreds of failures and five deaths arising from use of the modified Sprint Fidelis defibrillator electrical lead wire made by Medtronic, Inc., prompting a recall, and a similar recall of defibrillator leads marketed by St. Jude Medical, Inc., after 227,000 had been implanted in patients.”[5]

Holding Manufacturers Accountable

While the FDA is responsible for regulation of drugs and medical devices, the ultimate responsibility under the law for device safety, effectiveness, quality and performance, lies with manufacturers. Medical devices are a multi-billion dollar industry, and today’s innovations fortunately save many lives. The industry employs approximately 400,000 Americans directly, not to mention the 2 million who supply and support it.[6] It is considered one of the most profitable and most competitive sectors in the healthcare industry, with medical companies rushing to invent and release new surgical equipment, artificial prostheses, cardiac devices, and more. In the process, some manufacturers put profits before public health and safety.

Medical device manufacturers who sell defective or unreasonably dangerous products, or fail to adequately warn physicians and consumers about their products, may be held liable in a court of law for resulting injuries and damages to users of their products. This not only provides compensation to the victims, but it also prevents others from being harmed. As the United States Supreme Court stated in a decision only a few years ago:

“State tort suits uncover unknown hazards and provide incentives for manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-Warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their labeling at all times.”[7]

At Robinson Calcagnie, Inc., Your Rights are Important

If you have suffered injuries as a result of a medical device, please contact us today and our attorneys will assist you in determining whether or not you may be entitled to compensation under the law, and whether legal action should be taken to protect your rights. You may be able to recover monetary damages for past and future medical care and rehabilitation, as well as damages for pain and suffering, lost wages and lost earning capacity. Our attorneys are highly skilled at recovering damages for victims of medical devices and defective products. Initial consultations are free, and if you are unable to visit one of our offices, we can schedule a time to meet at your home or a convenient location. We are here for you every step of the way.


[1] UCSF.edu, A Call to Prevent Unsafe, High-Risk Medical Devices from Reaching Patients, January 28, 2013

[2] Medical Devices Industry Market Research & Statistics, http://www.reportlinker.com/ci02249/Medical-Devices.html

[3] U.S. Food and Drug Administration (FDA), Medical Device Recall Report, FY2003 – FY2012

[4] American Association for Justice, Unequal Harm: The Disproportionate Damage to Women from Dangerous Drugs and Medical Devices, May 15, 2013

[5] UCSF.edu, Patient Safety Merits New Clinical Data Review For Modified Medical Devices, March 24, 2014

[6] Forbes.com, U.S. Medical Device Industry in Critical Condition, July 24, 2013, http://www.forbes.com/sites/henrymiller/2013/07/24/u-s-medical-device-industry-in-critical-condition/

[7] Wyeth v. Levine, 555 U.S. 555, 579, 129 S. Ct. 1187, 1203, 173 L. Ed. 2d 51 (2009)