Thousands of injuries have been reported to the Food and Drug Administration (FDA) from the sterilization device Essure since its approval in 2002. Recently, the FDA’s panel on Obstetrics and Gynecology met to discuss the safety of Essure and how doctors and patients can best avoid serious complications. Our team of dangerous medical device lawyers details this meeting below.
In July 2015, a resident of the Warren Barr rehab center in Chicago died from Legionnaires’ disease. One month later, dozens of residents of a veteran’s home in Quincy, Illinois contracted Legionnaires’ disease, causing seven deaths.
Legionella is a bacterium that causes a severe form of pneumonia called Legionnaires’ disease. Legionella thrives in lukewarm water, making the end of summer an ideal season for bacterial growth and spread. Legionnaires’ disease does not spread by human-to-human contact, but by inhaling air contaminated with legionella, such as from an air conditioner or water fountain.
As early as 2010, reports of dangerous fractures and migrations in inferior vena cava (IVC) filters were being made public. The FDA issued a safety warning regarding these devices, stating it had received nearly 1,000 adverse event reports since 2005. Our team of IVC filter lawyers details the dangers of these filters and pending litigation against the manufacturers.
IVC filters are small, cage-like medical devices implanted into the large vein that carries blood from the lower body to the heart. They are designed to capture blood clots before they reach the lungs, heart or brain. These filters are implanted in patients, either temporarily or permanently, who are not able to receive other blood-thinning treatments.
Five years ago, the inventor of a popular surgical device requested that hospitals stop using his device because he believed it posed a danger to patients. The device, a heated blanket that keeps patients warm during implant surgeries, is now linked to severe joint infections. Our teams of hip and knee replacement lawyers are now accepting cases of infection and revision surgery from this device.
Motorola employees recently filed suit for their exposure to toxic substances in manufacturing facilities, resulting in birth defects to their children and other conditions. Another suit was filed by a man employed in the plastics industry after he was diagnosed with leukemia. Toxic exposure lawyers at Pintas & Mullins detail these two cases and others like it we are currently handling.
About 13 plaintiffs are currently joined in the Motorola suit, claiming that the company routinely ignored scientific research and government warnings about the safety of various chemicals in its manufacturing facilities. Because of its negligence, Motorola employees were exposed to various toxic substances such as arsenic, radiation, ethylene glycol ethers, and fluorine compounds.
This is the fifth toxic exposure lawsuit filed against Motorola since 2011. This specific lawsuit claims the exposure caused birth defects such as hearing loss, asthma, Down syndrome, and ADHD among other conditions. The plaintiffs worked at Motorola’s manufacturing facilities at various times from 1965 to 2001.
Our team of uterine cancer lawyers report on a settlement recently reached between a power morcellator manufacturer and a man whose wife died from uterine cancer. The woman died less than one year after undergoing a hysterectomy using a power morcellator.
The plaintiff, a 53-year-old widower named Scott Burkhart, filed suit against Lina Medical ApS after he learned that the power morcellator used during his wife’s hysterectomy caused her hidden cancer to fatally spread. His wife, Donna, died in 2013 just 11 months after undergoing the hysterectomy for heavy bleeding. She was unaware she had cancerous cells before undergoing the surgery.
Hip replacement parts made by Zimmer were recently recalled because of serious adverse effects in patients. The company’s femoral stems and necks were defectively made so that excess metals can infect patient’s blood, bone and nearby tissue after implantation. Hip implant lawyers at Pintas & Mullins report on this recall below.
The recalled products’ official name is the Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks. These parts are made from a specific metal alloy blend called Tivanium, which is titanium enriched with nitrogen. Tivanium is supposed to have minimal particulate release, making it safe even for patients who are extraordinarily metal-sensitive.
Many patients have true metal allergies, which can present serious problems when they require hip or knee implants. According to a paper by a Seattle joint surgeon, patients receiving Tivanium implants perform quite well and do not have issues with metal sensitivity.
In early May 2015, Zimmer found process monitoring failures in its Tivanium hip implant manufacturing. These failures caused high amounts of metal residue on the implants, which can leak out into patients, resulting in various side effects, such as:
- Device failure and forced revision surgery
- Allergic reactions, or metallosis
As spring moves into summer, children and teens head outside to bike, play sports and be active. By June each year, pediatric doctors typically treat double the patients as they do in the winter months. Accident and injury lawyers at Pintas & Mullins highlight the most dangerous activities and how to prevent brain injuries, broken bones, and other serious injuries.
Injuries start increasing in April, when winter begins to subside, with most injuries occurring in children aged eight to eleven. Pediatricians note that adolescents are more vulnerable to injuries during periods of rapid growth, because bones have special areas of cartilage (called growth plates) during this time to allow the bone to grow. Hormones produced during this time also render growth plates weaker than normal, making injuries even more likely.
Fortunately, children heal much faster than adults due to better circulation and constant bone production. Children who specialize in a specific sport often over-train certain muscle groups, increasing the risk of injury. In particular, much attention has been brought on mild and traumatic brain injuries in young athletes.
Forearms injuries are the most common injuries seen in ER and urgent care clinics, normally from playground and sports injuries, when kids stick out their arms to catch their fall. Scooter and bicycle injuries are also extremely common, along with trampoline injuries and foot injuries from wearing inadequate shoes.
A patient suffering severe vein damage by a surgical robot recently sued the robot’s manufacturer for marketing a defective device and improperly training physicians who use it. Surgical robot injury lawyers at Pintas & Mullins detail this case and others like it we are currently handling.
This case was filed by a woman who underwent a myomectomy, a minimally-invasive surgery to remove uterine fibroids. Her surgeon used the da Vinci Surgical System, which is a remotely-controlled robotic system made by Intuitive Surgical. The doctor performed the surgery under the guidance of an Intuitive Surgical representative, Jeanette Lee, who is also named in the suit.
During the procedure the surgeon was having trouble operating the system and asked Lee for permission to switch to a traditional open procedure. Lee instructed the doctor not to switch, which is why she is named in this lawsuit. The patient suffered extensive vein damage during the surgery causing her severe pain and forced additional surgeries.
The patient’s husband claims the defective robot deprived him of consortium of his wife, as she remains disabled and unable to work. The plaintiffs claim Intuitive promotes the da Vinci System to consumers and doctors but has failed to test its long-term impacts. They also claim Intuitive improperly trains doctors on how to use the system, resulting in complications ranging from burns and tears to sepsis, organ damage and even death.
Hundreds of thousands of surgeries are performed using robots every year, with Intuitive enjoying billions in revenue. The company aggressively markets the system, pitting hospitals against each other in a race to score the next ‘it’ innovation. As the da Vinci’s popularity grows, however, so do reports of patients injuries and questions over the system’s actual safety.
Intuitive faces mounting litigation for injuries caused by the da Vinci robots; even the company’s investors have filed suit over a defect in the surgical equipment. Investors claimed the company made false financial reports in failing to warn investors about the defect. The defect caused patients to be electrocuted during surgery.
Intuitive was unaware of the defects until doctors and hospitals started filing reports of patient injuries. The company then issued secret recalls to correct the problems, resulting in an FDA safety probe in January 2013.
A different federal agency, the FBI, is investigating another medical device manufacturer – Johnson & Johnson – for a different device commonly used in myomectomies. We have written extensively on power morcellators and their ability to spread uterine cancer and we are currently accepting cases of uterine cancer from myomectomies and hysterectomies.
Thousands of women who underwent fibroid removal surgery or hysterectomies are suffering from late-stage cancer from a device used in their surgeries. Now, device manufacturers are facing liability as these women and their families file suit. Our team of uterine and ovarian cancer lawyers is constantly updating our clients as soon as new information becomes available.
The device at issue is called a power morcellator, which many top American hospitals and health insurance companies have now banned. These bans were based largely on FDA warnings on the use of power morcellators in gynecological procedures, confirming that they may spread undiagnosed uterine tumors and should not be used on most women.
HCA Holdings, Aetna, and several other insurers and hospitals have dropped use of the device. Aetna is the country’s third-largest insurer, with about 23 million health members. Power morcellation will no longer be covered under most circumstances; doctors will have to get prior approval for any procedure using the device. Exceptions include women who could suffer severe, life-threatening complications from alternative methods.
Power morcellators work to remove fibroids or the uterus by cutting them into tiny pieces to be removed through minimally-invasive incisions. However, uterine fibroids can contain cancerous cells and tumors that cannot be detected prior to surgery. If a power morcellator breaks up a fibroid that contains cancer cells, the cancer is then spread throughout the uterus, abdomen and pelvis.
Cancer spread significantly lowers the chance of survival, rendering an otherwise benign cancer contained within the uterus into a ravenous late-stage illness affecting multiple organs. The FDA estimates that about one in every 350 women undergoing fibroid surgery has cancer cells hidden in fibroids.
After this came to light in 2014 Johnson & Johnson pulled its power morcellators from global markets. Although J&J was the largest morcellator manufacturer, other companies have kept their devices on market. One of these companies, Olympus America, was recently hit with lawsuits by women who developed cancer from morcellation surgery.
The women claim Olympus should have been aware of the cancer risks of its device, the PKS PlasmaSORD Bipolar Morcellator. They argue there was medical evidence available to Olympus, yet the company failed to respond to published studies and reports describing the risk of spreading and worsening cancer with morcellator use.
Plaintiffs point to articles published in medical journals in the 1990s that illuminate the potential for morcellators to spread cancer tissue. They argue that Olympus made it difficult for patients to know about these risks, misrepresenting the device as totally safe. Misrepresenting the device this way prevented doctors from screening for and diagnosing cancer, further worsening patient survival rates.
Still, some doctors continue to encourage the continued use of morcellators. Many doctors believe that the decision to use a morcellator should lie with the patient and her doctor and that banning them completely would be a disservice to certain patients.
This, on paper, seems a fair and reasonable argument. In reality, however, patients are not always fully informed on the true risks of their options and doctors do not always have time to make sure women completely understand the procedure, its alternatives, and their unique risks versus benefits.