Virginia Beach Medical Devices Lawyer
Medical devices can transform the lives of people across the United States, but while they have revolutionized the field of medicine, some devices cause more harm than good. At Cooper Hurley Injury Lawyers, our Virginia defective medical device attorneys help consumers who have suffered terrible side effects and injuries from medical devices. Our injury lawyers fight vigorously against big pharma to get you the result you deserve for your injuries.
In recent years, defective and dangerous drugs have caused terrible side effects like cancer and led to massive class action lawsuits. Some of the same big pharmaceutical companies have also been hit with massive verdicts and pay-outs over their faulty medical devices.
Cooper Hurley Injury Lawyers helps people who have been harmed by these devices in Virginia, North Carolina, West Virginia, and across the nation. We will provide you with experienced personal representation and make sure your claim is properly handled among the others in the mass tort litigation. We provide trusted local representation in the fight against the big pharmaceutical companies.
Severity of Unsafe Medical Devices
In an ideal world, the drug and device manufacturers would learn from their mistakes. Sadly, there is little evidence that this is happening. Big pharma puts profits above consumer safety and only acts when under pressure from mass lawsuits or action by the U.S. Food and Drug Administraiton (FDA).
A spike in defective device recalls was reported in the first quarter of 2018, according to the U.S. Recall Index. The index highlighted a 126 percent increase in medical device recalls in the first quarter of the year — the most in a single quarter since 2005. Pharmaceutical recalls rose 52 percent in the same period. This is in line with a longer-term pattern. In the decade from 2003, the number of recalls of medical devices rose 97 percent, according to the FDA.
Often, patients do not know of the dangers of the products that have been implanted or used in their bodies until the FDA issues a warning. The manufacturers or sellers may have failed to warn the consumers and their doctors of the side effects of their products.
Why Are Untested Medical Devices Being Used on Patients?
The ease with which pharmaceutical companies get their products on the market was recently highlighted by Consumer Reports. In the case of many implants and other high-risk devices, a manufacturer needs to do nothing more than file the paperwork and pay the FDA approximately $4,000 to start selling a product that can quickly make that company millions of dollars. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients. In other words, the patients are habitual guinea pigs.
Companies such as Johnson & Johnson took advantage of the FDA’s fast-track 510(k) approval process for metal-on-metal hip implants. It meant that the manufacturer never had to perform clinical trials with the devices to prove their safety. It only had to show that the components were similar to other hip components already on the market.
In some cases, manufacturers have bowed to pressure and removed devices from the market. In July 2018, Bayer announced it would no longer sell the birth control device Essure after the FDA restricted its sale to doctors and healthcare providers who used strict controls. The action was only taken after thousands of women suffered severe pelvic pain, perforations and even lost their lives from using the product.
What Are The Most Dangerous Medical Devices on the Market?
There are essentially two kinds of dangerous medical devices. Devices that are implanted in patients such as defective hips or transvaginal mesh cause terrible side effects in some cases. You may also have been injured by a medical device used on you in a hospital such as the DaVinci robot. Medical devices that have led to lawsuits against the manufacturers in recent years include:
- Metal on Metal Hip and Knee Replacements – Hip and knee replacements manufactured by DePuy ASR, a subsidiary of Johnson & Johnson, Stryker, or other manufacturers for worn out knee and hip joints, have failed, causing acute pain, dying tissue, and bone and metal poisoning. The damage often requires further surgery to rectify. In 2017, Johnson & Johnson was ordered to pay $246 million to six patients injured by defective Pinnacle hip implants. Our Virginia Beach defective medical device attorneys continue to take on these cases.
- Transvaginal Mesh – Thousands of women are suing a group of manufacturers, claiming this mesh product, which is used to prevent pelvic organ prolapse, caused damage such as organ perforation and erosion of mesh into vaginal tissue. The complications often require further surgery to correct.
- Inferior Vena Cava (IVC) Filters – Manufactured by CR Bard, these filters are placed in the vena cava, a large vein that carries blood into the heart of a patient with deep vein thrombosis to prevent blood clots breaking off and traveling to the heart, the lungs or the brain. The filters can break up and migrate, perforating the vena cava, heart and lungs and cause respiratory problems, hemorrhage, or even death.
- Physiomesh – Hernia mesh is a sheet of flexible mesh used to patch a weakness or plug up the hole instead of stitching after a patient receives hernia surgery. The Johnson & Johnson subsidiary Ethicon makes Physiomesh Flexible Composite Mesh, a product intended to reinforce the abdominal wall and prevent further hernias. Thousands of patients claim the product failed. Complications include mesh migration, bunching, shrinkage or folding. These failures led to a return of hernias, bowel obstruction, severe pain, and inflammatory reactions.
- Mirena IUD – This birth control device, manufactured by Bayer Healthcare, is prescribed for heavy menstrual bleeding. It can cause sepsis, uterine wall perforation, intestinal perforation and life-threatening ectopic pregnancies. Migration of the device may require surgery.
- NuvaRing – The contraceptive ring manufactured by Merck is placed in the vagina and releases hormones to stop pregnancies. It is linked to thromboembolic complications such as blood clots that can travel to the lungs and can be fatal.
- DaVinci Robot – The DaVinci robot, manufactured by Intuitive Surgical, has proved popular in hospitals for less invasive surgical procedures. The lawsuits are also piling up, claiming the robots caused tearing and burning of the intestines, internal bleeding, nerve damage and death.
- Laparoscopic Power Morcellation – Power morcellators are surgical devices used in hospitals to treat uterine growths. In late 2017, the FDA discouraged the use of LPM devices in hysterectomy and myomectomy surgery. It warned they may increase the risk of spreading uterine tissue that could contain cancer.
- Bair Hugger Blankets – This device has been used for decades in a majority of American hospitals but it has come under increased scrutiny after its inventor called for a recall, and some patients claimed it led to infections.
- Essure Birth Control – Essure is linked to a wide range of painful side effects and deaths. Some women say the coils caused device fracture, leading to damage of body tissues, organ perforation, autoimmune problems and even deaths More than 17,000 lawsuits have been filed against the manufacturer, Bayer.
Lawsuits Over Defective Devices
Johnson & Johnson (J&J) was hit by a massive jury verdict over a link between baby powder and cancer in 2018. The previous year, a federal jury in Dallas ordered J&J and its DePuy Orthopedics unit to pay $247 million to six patients who said they were injured by malfunctioning Pinnacle hip implants. Johnson & Johnson was reported to have set aside $4 billion for outstanding metal-on-metal claims.
Boston Scientific was hit by a $100 million verdict in a transvaginal mesh case in June 2015. It agreed to pay $119 million to settle 3,000 cases. Merck reportedly agreed to settle more than 1,700 NuvaRing lawsuits for $100 million. If you have been injured by any defective medical device, it’s important to act fast as there may be deadlines to file suit or take part in the settlements.
How Can a Medical Device Manufacturer Be Held Liable?
The manufacturer of a medical device has a duty to make a reasonably safe product and to test it before it goes on the market. However, the fast-track procedure can remove safeguards related to testing.
The benefits to the comsumer must outweigh the risks. The manufacturer of a medical device may be held responsible for shoddy manufacturing practices, negligent design, and failure to warn patients of serious risks it was aware of. The company may also be held accountable for failing to follow FDA rules. The manufacturer may be sued for a device that fails and leaves the recipient requiring further surgery.
Cooper Hurley Injury Lawyers has represented clients in cases involving dangerous devices and helped them join class action lawsuits. People who are hurt by devices intended to help them often suffer years of physical and emotional pain and suffering. Taking on big pharma is daunting and difficult on your own. Our Virginia Beach medical devices attorneys are well versed in these products and their dangers. Time may be short to make your claim as some of the settlements will close to “new” cases in the near future.