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When we need medical help after being injured or suffering from a disease or illness, we trust that the doctors and medical professions helping us are using quality products for our treatment or surgery. Unfortunately, many companies choose to rush out new devices to market before they have the opportunity to conduct successful clinical trials and properly evaluate their safety. This can result in additional complications to your condition or lead to another personal injury.
At Colling Gilbert Wright & Carter, we represent people who have suffered a serious personal injury due to the negligence of another. This is especially true for cases against companies, manufacturers, and distributors of defective medical devices and products. Defective medical product or dangerous drugs lawsuits require detailed medical records and extensive knowledge of this area of the law. Our attorneys can guide you through this process and make sure you and your family get justice and compensation for your pain and suffering.
If you or a loved one has suffered injury or death due to a defective medical device or product, please contact our personal injury lawyers today at 407-712-7300 to discuss your potential product liability claim. Our law firm serves clients in Orlando, Florida and nationwide.
- What is a Defective Medical Product?
- Filing a Defective Medical Product Claim
- Defective Medtronic Defibrillator Leads
- Transvaginal Mesh Complications
- da Vinci Surgical System Robot Defects
- Bair Hugger Complications
- Stockert 3t Heater-Cooler System Complications
- Defective IVC Filters
What is a Defective Medical Product?
Medical devices are created to aid in the diagnosis, prevention, and treatment of a variety of diseases and injuries. However, when these products are defective, it can put your life in danger.
Product liability claims for medical devices must prove the defect occurred in one or more of these phases:
- Medical Product Design: The design of the product is not safe to use for its intended purpose or reasonably anticipated uses, or the design is unacceptably dangerous.
- Device Manufacturing: Several aspects of the manufacturing process can lead to a defective medical device such as human error, faulty gears, broken or aging machinery and other factors.
- Product Marketing: Representatives of the manufacturing company are responsible for marketing the device correctly, which involves clearly stating how the device is meant to be used and how it could potentially be misused and lead to injury. If the marketing efforts fail to properly educate physicians, hospitals and other medical providers about the device, the company could be held accountable for failing to warn consumers and healthcare professionals of the risks associated with the product.
A minor defect doesn't necessarily mean a medical device is unreasonably dangerous. The product defect must have caused the patient significant harm to constitute a defective medical device claim. Unfortunately, defective medical devices can lead to catastrophic injuries and in some cases, wrongful death.
Filing a Defective Medical Product Claim
Filing a defective medical product claim requires ample proof of your injuries and that the product manufacturer was negligent in some way. For example, this negligence may involve a breach of duty in that the company failed to warn you or your physician of the risks associated with the product. You must also prove that this negligence directly led to your injuries or the wrongful death of a loved one and your damages warrant compensation.
Makers of medical devices and products often employ multiple attorneys to ensure they aren't sued or to prevent the company from losing in court. It's vital to the outcome of your case to consult with an experienced product liability attorney about your case. Our lawyers in Orlando specialize in these claims and can help you gather the necessary evidence to prove the medical product caused injury to you or a loved one.
When you are looking for compensation against a powerful opponent like a medical device or product manufacturer, you want to work with a law firm with sufficient experience and expertise to pursue your case with the maximum likelihood of success. Although we cannot guarantee we will win your case, we can guarantee we will work hard to reach the best possible outcome. Our reputation for aggressive and effective representation is well known and you can look at our verdicts and settlements to see examples of how we have helped clients in the past.
Defective Medtronic Defibrillator Leads
A defibrillator is a device that monitors a person’s heartbeat and keeps it regular. To circulate blood effectively throughout the body, the heart needs to pump strongly and regularly, but in some cases of heart disease, it can go into ventricular defibrillation. This means that it pumps too rapidly and ineffectively, so that blood circulation is impaired and the patient’s life is at risk.
On October 15, 2007, Medtronic, Inc., a Seattle manufacturer of medical devices, issued a warning to physicians about a family of leads (electrical wires) connected to one of its defibrillators and asking them not to use them. The risk was that the lead might fracture and put the patient at a potentially fatal risk.
This particular lead is one of a family of leads named Sprint Fidelis, with model numbers of 6930, 6931 and 6949. They were manufactured between September 2004 and October 14, 2007, and have been used in about 60 percent of Medtronic’s implantable defibrillators.
About 235,000 people have been implanted with this defibrillator, and Medtronic has estimated that about 2.3 percent (about 4,000 to 5,000 people) could have this lead fracturing within two-and-a-half years of it being implanted. The company has written warning letters to all of them, advising them to have computerized testing done on their defibrillator wires.
Transvaginal Mesh Complications
The transvaginal mesh can be thought of as a safety net designed to support pelvic organs that have slipped out of place, causing discomfort or dysfunction. Transvaginal mesh was never studied in detail before it was approved for these indications. Instead, manufacturers took advantage of a regulatory loophole to take a shortcut route to approval.
They compared the use of mesh for these procedures to the surgical mesh used in hernia repair and pointed to the fact that doctors were already experimenting with it for use in the treatment of pelvic organ prolapsed (POP) since 2002 and stress urinary incontinence (SUI) since 1996. As a result, many have expressed concerns that these potentially defective medical devices are not safe and effective for use in these procedures.
The high rate of complications for the transvaginal mesh when used for POP includes increased risk for:
- Additional surgeries
- Organ damage
- Vaginal erosion
- Mesh exposure
- Abdominal or vaginal pain
- Painful intercourse
- Unexplained infections
- Loss of skin and tissue in the treatment area
Unfortunately, if you experience these complications, you may undergo multiple surgeries but never see the same level of improvement you might have seen with traditional surgery. As a result of the transvaginal mesh, you may suffer pain and dysfunction for the rest of your life.
da Vinci Surgical System Robot Defects
Approved by the FDA in 2000, multiple patients who have undergone procedures with the da Vinci Surgical System subsequently suffered serious injury. The da Vinci system is designed to enable surgeons to perform a major procedure using minimally invasive incisions.
Doctors and hospitals have used the da Vinci surgical robot for a variety of different procedures, including:
- Heart surgery
- Prostate surgery
- Kidney surgery
- Bladder surgery
- Gallbladder surgery
- Transoral surgery
- Surgery for uterine fibroids
- Bariatric surgery
Intuitive Surgical, Inc. has marketed the da Vinci system as an alternative to manual laparoscopic surgery. The manufacturer claims robot-assisted surgery is more precise and requires less recovery time than traditional laparoscopy.
Complications from da Vinci surgery have been attributed to faulty design and malfunction of the robotic components. One specific concern is insufficient insulation on the tips of the system’s surgical instruments, potentially exposing the inside of a patient’s body to electrical current.
Some of the serious injuries patients have suffered due to robot-assisted surgery include:
- Internal bleeding
- Internal burns
- Perforation of organs and tissue
- Postoperative infection
Surgical complications aren’t always readily apparent once a procedure is over. Unfortunately, this means that patients might not begin experiencing symptoms until the injury is more severe, potentially necessitating emergency treatment, additional surgeries, and other costly intervention.
Bair Hugger Complications
Warming blankets help maintain a normal blood flow during surgery to prevent hypothermia and reduce bleeding and recovery time. Warming devices are used to make surgery safer, but the lawsuits involving the Bair Hugger machine allege that it may actually increase the patient’s risk of infection, specifically in surgeries performed to place implants such as hip and knee replacements.
The medical device uses a forced air warming (FAW) system and was the first of its kind to do so. Bair Hugger therapy pushes warm air into a blanket on top of or underneath the patient through a hose. The air is then released beneath the surgical table.
Lawsuits allege that the hot waste air pushed out under the table can potentially cause bacteria and germs to spread around the operating room and land inside the surgical site by dispersing or disturbing contaminants from the floor. This may lead to severe infections such as MRSA and sepsis.
While scientific research linking infections with Bair Hugger machines are unproven so far, the inventor, Dr. Scott Augustine, himself has warned the public and the device manufacturer, Arizant, of and concealed the dangers associated with the device. Dr. Augustine has also said that he believes the device poses a danger to patients and that the forced air can spread bacteria associated with hospital-acquired infections.
Stockert 3t Heater-Cooler System Complications
Heart surgery inherently comes with risks but the use of the Stockert 3T Heater-Cooler System during the procedure carries an additional and unreasonable risk of infection. Surgeons commonly use the 3T device during heart surgery in order to regulate the patient’s temperature, but this specific system has caused patients across the world to develop life-threatening infections after the procedure. The FDA issued a recall in July 2015, but it can take years for patients to exhibit symptoms of infection.
Additionally, the Stockert 3T system has:
- Shown a high complication and injury rate
- The potential to fail to perform as intended
- Required patients to need additional surgeries
- Lead to severe and irreversible injuries
Product liability lawsuits have been filed against the 3T manufacturer—LivaNova PLC (formerly Sorin Group Deutschland GmbH)—due to the company’s deceptive measures. The manufacturing company repeatedly misled the FDA, the medical community and the general public on the device’s safety and efficacy.
Defective IVC Filters
The Inferior Vena Cava (IVC) is the major vein responsible for moving blood from your lower body to your heart. An IVC filter is a wire device that is placed into the IVC vein in patients thought to be at an increased risk for pulmonary embolism. The IVC filter is used to prevent blood clots from reaching the brain, heart or lungs. The filter stops blood clots in the bloodstream, which allows them to degrade over time.
When used on the right patient, an IVC filter can significantly reduce the risk of pulmonary embolism. However, the FDA now recommends that the device only be used temporarily in patients who haven’t responded to anticoagulant medication or who aren’t eligible to take anticoagulants due to another medical issue or condition. Additionally, the FDA recommends that patients who already have an IVC filter speak with their doctor to discuss whether the medical device should be removed.
The FDA hasn’t issued a recall for the defective medical product, but they have compiled a guide to help patients and physicians better understand when an IVC filter is necessary and when it poses a greater risk than benefit.
The biggest and most serious risk associated with IVC filters are:
- Organ damages from its potential to break apart
- Migration from their targeted area
- Pulmonary embolism
Contact Our Experienced Defective Medical Device Attorneys Today
To learn more about your legal rights in connection with any of the above-mentioned cases, call our experienced defective medical product attorneys in Orlando at 407-712-7300 for a complimentary case review. We will assess your situation and gather more information to prepare a case for you and will work for you on a no recovery, no fee basis. Colling Gilbert Wright & Carter serves clients in Orlando, Florida and nationwide.