A medical device, according to the U.S. Food and Drug Administration (FDA), is any instrument, machine, implant or apparatus which has been designed for use in diagnosing, curing, treating or preventing a specific disease or medical condition.
Before a newly-developed medical device can make it to the U.S. market and be used in hospitals or doctor’s offices, manufacturers must first go through the FDA’s 510(k) process for review. Once a device is approved and goes to market, many manufacturers consider their work is done, but that is not necessarily true.
While this process may act as a public safety measure, it is generally after these devices get on the market when problems begin to arise. Dangerous devices can be left on the market, not recalled by manufacturers. Even in instances when a recall is issued, it may be only after countless people have been injured or killed as a result of the defective device.
One of the problems, according to a study reported in the Journal of the American Medical Association, is the lack of information provided to the public as to the safety and effectiveness of medical devices.
If you or a loved one has been injured by a medical device – whether it was implanted or used during the treatment process – it is important you seek legal representation at once. The attorneys at Techmeier Law Firm have years of experience in medical device litigation and a passion for standing up for the rights of patients and their families. We serve clients in Milwaukee and throughout Wisconsin. Call or contact us online today for a free consultation.
Holding Manufacturers Accountable for Defective Medical Devices
If you have suffered complications or injuries from a medical device, it is crucial to meet with a lawyer as soon as possible. An attorney can begin conducting an investigation.
In some cases, the defective device may be part of a more widespread problem. It may have been recalled or claims from other victims may have been filed against its manufacturer. The lawyer will work to determine whether the exact make and model of the device in your case is, in fact, the subject of a recall, medical studies or ongoing litigation.
At this point the lawyer will need to decide, based on evidence gathered, whether grounds exist to hold the manufacturer liable. Common grounds for a defective medical device lawsuit include:
- An inherent flaw or defect in the device’s design,
- Defective manufacturing (a flaw arose when it was made), or
- A failure to warn (the company knew or should have known that complications could arise even when the device was used as intended).
Negligence, strict liability and breach of expressed or implied warranties are other grounds for which a lawsuit or claim could be filed.
If numerous victims have suffered similar injuries due to the same medical device flaw or defect, the case may become part of a class-action lawsuit or multidistrict litigation (MDL).
A class-action is a type of lawsuit where one individual sues on behalf of a larger group of individuals. Rather than each individual filing their own lawsuit, a class-action lawsuit covers them all so long as the issues in question are common to all members of the lawsuit.
Multidistrict litigation is a federal procedure through which complex legal cases can be consolidated in one court to provide better management of the different cases as well as to expedite the legal process.
The primary goal in these types of cases is to be able to hold negligent manufacturers accountable so the victim’s medical issues can be addressed and just compensation can be sought. Another, equally important objective is to take action so as to prevent others from suffering similar harm in the future.
Defective Medical Device Cases Our Law Firm Handles
Although our firm has handled numerous medical device cases over the years, including pacemakers, hernia patches, valve implants and joint replacements, we are now actively reviewing the following defective medical device cases:
Transvaginal Mesh Implants
Defective transvaginal mesh implants have been brought to market by a variety of manufacturers. One of the primary manufacturers of these implants is Ethicon, a subsidiary of Johnson & Johnson.
Ethicon’s Gynecare mesh implants, while designed to help treat pelvic organ prolapse and stress urinary incontinence, have reportedly caused more than 25,000 women to file lawsuits seeking damages for tearing, pain and other complications caused by mesh erosion, Reuters reports.
Other pelvic mesh manufacturers include Boston Scientific Corp., C.R. Bard, Inc., and American Medical Systems, Inc.
Due to the volume of transvaginal mesh implant cases and the number of manufacturers involved in this litigation, they have been consolidated and centralized in multidistrict litigation taking place in West Virginia.
Reuters reports that seven different transvaginal mesh manufacturers are facing nearly 100,000 lawsuits in state and federal courts across the country.
Despite the volume of claims, not all of these companies have completely removed their products from the market. Some, like Boston Scientific, still claim its products are not defective.
Metal-On-Metal Hip Implants
Reportedly defective metal-on-metal hip implants, also referred to as acetabular components or systems, have been made by a several manufacturers. The manufacturers and brands of metal-on-metal hip implants which the FDA is reporting have been recalled so far include: Smith & Nephew R3 Metal Liners of the R3 Acetabular System, DePuy ASR TM XL Acetabular System and Zimmer Durom® Acetabular Component.
In some hip replacement surgeries, metal-on-metal implants (both the ball and socket components are made of metal) have led to patients needing revision surgeries. According to the FDA, concerns about these components have been raised due to the potential for:
- Particles becoming lodged in nearby tissue
- Metal ions getting into the bloodstream
- Painful soft tissue damage
- Long-term damage to bone, muscles and nerves surrounding the implant.
Deterioration may cause stiffness in the joint and lead to walking difficulties. If the damage is too severe, the risk of falls is increased, and additional surgeries may be required.
Power morcellators are tools, often employed in minimally-invasive, gynecological surgeries, which use tiny spinning blades to cut into tissue to allow pieces of the uterus and other areas to be removed. Johnson & Johnson’s Ethicon subsidiary is one of the largest manufacturers of the allegedly defective device.
In July 2014, MarketWatch reported that Johnson & Johnson voluntarily withdrew the device from the worldwide market, as it had been linked to instances of undiagnosed uterine sarcomas and other tissue being spread throughout the body. If this occurs, it can accelerate cancer risks and lower patients’ chances of survival.
The New York Times reported in May of 2015 that the F.B.I. has launched an investigation into these devices. This investigation stems not only from reports of the devices causing undetected cancers in some women to progress more rapidly, but also due to suspicions as to “whether medical device makers, doctors and hospitals broke the law by failing to report problems.”
Contact a Milwaukee Defective Medical Device Attorney
If you or someone you love has been injured or experienced complications from a medical device, you may have grounds to file a lawsuit seeking damages from the device’s manufacturer. However, time is of the essence. Your case may be part of an already pending class-action lawsuit or MDL.
To get your questions answered and find out the next steps you need to take, contact Techmeier Law Firm today. We can provide a free, timely consultation about your case.
Sources / More Information
- What is a Medical Device?S. Food and Drug Administration (FDA)
- 510(k) Submission Process, FDA
- Studies, Commentary, Viewpoint on the FDA, Medical Devices, JAMA Network
- Judge Sets 26 Ethicon Mesh Cases for a Single Trial, Reuters
- Boston Scientific Ordered to Pay $100 Million in Transvaginal Mesh Trial, Reuters
- Concerns about Metal-on-Metal Hip Implants, FDA
- Metal-on-Metal Hip Implants: FDA Safety Communication, FDA
- J&J to Call for Voluntary Return of Morcellators, MarketWatch
- B.I. Investigates Whether Harm From Surgical Power Tool Was Ignored, New York Times