Unsafe Medical Products
- Medical Devices
- GE CT Scan
- AED Heart Device
- AMO MoisturePLUS
- Da Vinci Surgical Robot
- Defective Heart Devices
- DePuy Implant Recalls
- Drug Coated Stents
- Fixodent Denture Cream
Practice Area Attorneys
- Lawrence R. Cohan, Shareholder
(Environmental & Toxic Torts Law, Vaccines, Biomedical Tissue Services, Pharmaceutical Liability, Dangerous Drugs)
- Thomas Anapol, Shareholder
(Environmental and Toxix Torts Law, Medical Malpractice, Wrongful Death, Pharmaceutical Liability, Dangerous Drugs)
- Stephen J. Pokiniewski, Jr. Non-Equity Partner
(Medical Malpractice, Wrongful Death, Failure to Diagnose Meningitis)
The Potential Dangers of Defective Medical Devices
Medical devices encompass a broad range of equipment that include complicated machines that are only used by trained professionals in a hospital and everyday things such as denture cream or blood testing equipment that are used by patients at home. Despite the diversity of products, the products have two important things in common. First, medical devices are intended to improve or maintain a patient’s health and second, when medical devices are defective they can cause serious injury or death.
Our clients have come to count on the Pennsylvania medical device lawyers at Anapol Schwartz to watch out for recall notices and news reports concerning potentially unsafe implants and medical devices. Call us at 866-735-2792 if you believe you have suffered an injury from a consumer medical product or implant and wish to know about your legal options. Below are just a few of the medical devices we have been tracking:
In 2005, the Food and Drug Administration gave DePuy Orthopedics special clearance to market its ASR hip replacement systems without first performing clinical trials to prove safety and effectiveness. This was done largely because the new product was supposed to be a modest refinement of existing hip implant systems. However, the FDA began to receive a steady stream of complaints from patients who had the new implant. In 2010, DePuy Orthopedics issued a voluntary recall of its ASR XL Acetabular Hip Systems and ASR Hip Resurfacing Systems. The devices have a very high rate of failure in the early years after being implanted; about 12 percent of patients will need follow-up “revision surgery” to replace the implant and repair damage caused by its failure.
When hip joints have deteriorated to the point where pain and lost mobility has severely damaged a patient’s quality of life, a physician may recommend hip joint surgery: either a hip resurfacing or a total hip replacement. One recent innovation in hip surgery has been the metal-on-metal hip implant system, where all components are made of metal rather than earlier metal-plastic or metal-ceramic systems. Unfortunately, the abrasive effects of walking causes metal particles to flake away from the implants and invade surrounding tissues. In some cases, metal ions can even leach into the bloodstream and be deposited in other organs of the body, affecting the normal function of the heart, thyroid, kidneys, and nervous systems.
The DePuy Pinnacle hip implant, manufactured by a subsidiary of Johnson & Johnson, has already been recalled from markets, due to persistent metal contamination problems and a high failure rate. However, but thousands of similar devices remain within patients’ bodies.
Transvaginal mesh is similar to lightly woven fabric, designed to be implanted during surgery to help support sagging internal organs (medically known as pelvic prolapse, bladder prolapse, and similar terms). Johnson & Johnson, Bard, American Medical Systems, and Boston Scientific are the primary manufacturers. In recent years, the Food and Drug Administration has issued warnings of complications from transvaginal mesh implants. These unfortunate results have included urinary problems; mesh erosion and shrinkage; bleeding; pain; and infection. Hundreds of lawsuits have been filed on behalf of women suffering because of these implants.
Knee replacement is a surgical technique to substitute a man-made artificial joint—made of metal or plastic components—for a natural knee joint that has become damaged by injury or arthritis. The NexGen Knee Replacement System, manufactured by Zimmer, is one of the most popular implants for this purpose, with some models designed to fuse naturally with the bone rather than rely on adhesive. Beginning in 2009, orthopedic surgeons began to complain that too many NexGen implants were failing to bond with the bone, leading to pain and inability to walk. Patients often need revision surgery to replace the implants. Zimmer has not recalled these products, and blames the failure of the implants on poor surgical technique.
Primary responsibility for ensuring the safety and effectiveness of medicine in the United States falls on the federal FDA. Critics, however, say that the FDA has been compromised by “regulatory capture”—that the agency is too concerned with protecting the pharmaceutical industry’s interest and too little worried about how bad drugs can harm consumers. At Anapol Schwartz, we maintain a steady watch for prescription drugs and over-the-counter medications that can injure or kill unsuspecting patients.
What To Do If You’ve Been Injured by a Defective Medical Device
If you’ve been injured by a defective medical device, the first thing that you should do is seek prompt medical treatment. The emergency room doctor, or your regular physician, will advise you on how to treat your medical symptoms.
After your immediate medical needs have been attended to it is important to contact an defective medical device attorney. The experienced defective medical device lawyers of Anapol Schwartz represent people who have been hurt, or who have lost loved ones, because of defective medical devices. Please contact us today for a free confidential consultation