October 26, 2021
Thanks to ongoing advances in medical technology, there are a wide range of medical devices available that help treat certain medical conditions, repair injuries, and improve quality of life. These devices are closely monitored by the United States Food and Drug Administration (FDA), whose job it is to ensure that the devices are safe and effective and to take the necessary steps if a serious safety issue should arise.
If a medical device is rushed through the approval process, it can have devastating consequences, particularly for female patients. According to recent studies, including research by the American Association for Justice (AAJ), women are much more likely to suffer a serious injury from a defective medical product than male patients.
Why Are Women at Greater Risk for Injuries Associated With Medical Devices?
In recent years, there have been a number of medical devices that have disproportionately impacted women, from defective breast implants to transvaginal mesh implants. Even gender-neutral devices, like hip implants, joint replacements, and heart implants are more likely to cause harm to female patients. According to one researcher, there are gender biases in how medical devices are designed and used, including the following:
- Product design: Device designers do not always consider the biological and social differences between men and women. Medical devices go through rigorous testing before they are approved, yet the lab tests that are used to ensure that medical devices, like heart implants or joint replacements, do not always consider the fact that women may react differently to materials.
- Clinical trials: In order for a medical device to be approved, the medical device company must conduct clinical trials to ensure that the device is safe and effective. However, researchers found that a disturbing number of medical devices are brought to market without the necessary clinical data to back it up. In addition, when companies did conduct the necessary clinical trials, women were either excluded from the data, or researchers failed to analyze the data for gender differences. They also found that the FDA often approves medical devices, despite having any data that addresses gender differences.
- Doctor-patient relationship: The gender of the doctor who is implanting the medical device can have a significant impact on the patient’s overall experience. For example, there are significantly more male surgeons than female surgeons, so the patient is more likely to be treated by a male doctor. Some evidence suggests that male doctors often treat female patients in a paternalistic way, rather than taking a patient-centered approach. In addition, researchers found that some surgeons do not address important safety issues with their female patients. For example, if a female patient is recovering from hip replacement surgery, the doctor should discuss when it is safe to have sexual intercourse.
What Are Examples of Defective Medical Devices That Impact Women?
Research shows that dangerous drugs and medical devices cause significantly more injuries and health complications to women than men. For decades, women have developed serious infections, nerve damage, incontinence, and potentially deadly forms of cancer from defective devices.
For example, the transvaginal mesh is a device that is implanted to treat pelvic organ prolapse and treat urinary incontinence. However, if the device is defective, it can cause pain, bleeding, and infections, and it is difficult to completely remove.
Power morcellators are surgical instruments used in laparoscopic hysterectomies and fibroid removal. However, in 2014, the FDA warned that power morcellators could shred undiagnosed cancerous tissue, causing it to spread into the abdominal cavity, which would make the cancer more difficult to treat.
Women are also more likely to suffer injuries from hip replacements. One articular surface replacement hip implant caused a range of serious complications, including inflammation, painful growths, dislocations, and toxicity. In addition, a study found that this hip implant was twice as likely to fail in women than in men. This is likely due to the fact that the devices are gender-neutral,, despite the fact that there are clear differences in the way men and women walk and do other basic activities that involve the hip.
What Are the Different Types of Defective Medical Device Claims?
Defective medical device claims are categorized into three subgroups. In order to hold the negligent party liable for your injuries, you must be able to pinpoint the stage in the chain of distribution that the defect occurred. The types of defective medical device claims include:
- Defective design: If there is a defect in the design, this can have very serious implications since it will impact the entire product line rather than one individual product. For example, if there was a defect in the design of an artificial knee implant, preventing it from properly connecting to the thigh bone, it can cause patients to suffer severe pain and other complications, even if the device was manufactured and implanted properly. In addition, some products can begin to deteriorate over time if they have been on the market for a long period of time. If you are able to prove that the distributor or manufacturer was aware of these complications, you may have a viable defective design claim.
- Manufacturing defect: These can occur in the manufacturing facility, the retail supplier, a doctor’s office, during shipping, or any phase of the distribution process. If you believe that your injury was caused by a manufacturing defect, determining liability can be challenging since there are multiple phases in the manufacturing process. For example, if you received a defective asthma inhaler in the mail and the device used to dispel the medication was not working, the defective device is likely a manufacturing issue, but you will need to determine at what point in the process the defect occurred.
- Marketing defect: If you suffered a serious injury after using a medical device that did not provide clear instruction on how to use the product or failed to include a disclaimer about the possible side effects, you may have a viable marketing defect claim. For example, EpiPens are commonly used for people with severe peanut allergies. However, if the product does not provide clear instructions on how to properly inject the medicine, the patient could suffer an overdose or go into anaphylactic shock.
Who Is Liable for a Defective Medical Device?
If you suffered an injury from a defective medical device, there are a number of parties that may be held liable. Keep in mind, however, that a medical device goes through multiple phases before it can be used in patients. In order to pursue a medical products liability claim, you must identify the defendant. The following are examples of potential liable parties:
- Device manufacturer: Oftentimes, companies produce large quantities of devices. If there was a defect in the design of the device, a manufacturing defect, or marketing defect, the manufacturer may be liable for your injuries.
- Doctor: If your doctor recommends a medical device but fails to discuss possible side effects, safety issues, or how to properly use the device, they may be liable for your injuries.
- Retail supplier: In most cases, medical devices are sent to you directly through the mail. However, some devices are available for purchase in drug stores, pharmacies, or from other retailers. If the device becomes damaged during the distribution process, the retail supplier may be considered at fault.
- Medical sales representative: Device manufacturers often hire a team of sales representatives who meet with physicians to discuss the benefits of the product in an effort to meet their sales quota. If the medical device that the sales representative recommended was defective and caused your injuries, they could be held liable.
Philadelphia Defective Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Represent Clients Injured by Faulty Medical Products
Some research suggests that women might be more prone to serious injuries from defective medical products. If you suffered a serious injury or a health complication from a defective medical product, do not hesitate to contact our Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler. Call us today at 215-569-4000 or contact us online to schedule a free consultation. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.