Defective Medical Products

Representing Orlando and Nearby Areas of Florida

Defective Medical Devices and Products | Orlando LawyersWhen it comes to medical products, we typically trust our doctors and don’t have a tendency to ask a lot of questions in regards to what products they might be using 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. At Colling Gilbert Wright & Carter, we represent people who have sustained a personal injury due to the negligence of another.

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 in Orlando today at (855) 880-4741 to discuss your potential product liability claim. Our law firm serves clients in Orlando, Florida and nationwide.

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.

Some details we believe our clients should know about defective medical products and cases we handle include:

What Constitutes a Defective Medical Product?

Medical devices are created to aid in the diagnosis, prevention and treatment of a variety of diseases and injuries. Some products such as the Bair Hugger warming blanket are used during surgery to maintain your body temperature, while others such as the Medtronic Defibrillator are permanently implanted into your body to keep you in good health. 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 health care 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.

In many of these instances, complaints are sent to the FDA about specific medical products causing injury or failing to do their job properly. When enough complaints have been received, the FDA will look into the matter and in some cases will ask the manufacturer to withdraw the product from the market, pending further studies and adequate testing.

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How to File 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.

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Medtronic Defibrillator Leads

Medtronic, Inc. is a Seattle manufacturer of medical devices. On October 15, 2007, the company issued a warning to physicians about a family of leads connected to one of its defibrillators and asking them not to use them. The risk is that the lead (wire) might fracture and put the patient at a potentially fatal risk.

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.

This Medtronic defibrillator is implanted near the shoulder and connects to the heart through one or more leads—electrical wires—threaded through veins which travel to the heart. It monitors the heartbeat, and when it senses an irregularity, it sends an electrical shock to the heart, which restores regular pumping.

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.

If the defective wire of your Medtronic defibrillator were to crack one or more of three things would happen:

  • It might beep, warning the patient to contact his physician at once—and this would not be a problem.
  • It might send a strong electrical shock to the patient’s chest—which would deliver a tremendous impact and could be fatal.
  • It might drain the defibrillator battery—which would stop the device from working and could be fatal as well.

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.

Some doctors are in favor of removing these defective leads, but that could be a risky procedure. Why? Because the leads are inside veins, and the body gradually grows scar tissue around them. If the device has been in place for more than about two years, there would be more scar tissue, and removing the lead could cause excessive bleeding from the vein and even damage to the (already damaged) heart muscle, which could be fatal. If the device has been in place for about six months or less, the risk would be smaller.

An alternative would be to thread a second wire in that vein, connecting it to the heart, and cap off the first one. Medtronic has also offered to reprogram these defibrillators to beep if the lead breaks. The FDA is considering whether to change the stress tests it has required before these leads are marketed.

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Transvaginal Mesh Complications

Surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) can be performed without a transvaginal mesh. It may even be just as effective and much safer when performed without the mesh. However, manufacturers of transvaginal mesh do not promote the fact that there is no definitive evidence of the medical benefits of the mesh, and certainly risks associated with the mesh have been downplayed. Transvaginal mesh is a product whose marketing was driven by profit rather than by medicine.

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 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 transvaginal mesh was supposed to help surgeons repair injured organs that led to pain and dysfunction, but it often caused more serious injuries.

The very high rate of complications for the transvaginal mesh when used for POP includes increased risk for:

  • Additional surgeries—8.5% of patients needed additional surgery within one year, almost 50% more than with traditional surgery!
  • Organ damage
  • Vaginal erosion
  • Mesh exposure—about 6% of patients experience this complication
  • Abdominal or vaginal pain
  • Painful intercourse
  • Unexplained infections or signs of infection such as foul odor in the treatment area or fever
  • Loss of skin and tissue in the treatment area

Unfortunately, if you experience these complications, you may undergo several 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.

If you’ve suffered injury after having transvaginal mesh, our lawyers can help you file a product liability claim for this defective medical product.

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da Vinci Surgical System Robot

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 what would normally be a major procedure using minimally invasive incisions. Sitting at a special console, the surgeon controls the device’s robotic arms to perform surgical tasks with a variety of instruments. A camera mounted on one of the arms transmits a 3D image of the body’s interior to the console.

Doctors and hospitals have used the da Vinci surgical robot for a variety of different procedures, including:

  • Heart surgery
  • Hysterectomy
  • Prostate surgery
  • Kidney surgery
  • Bladder surgery
  • Gallbladder surgery
  • Transoral surgery
  • Surgery for uterine fibroids
  • Colectomy
  • 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.

Multiple patients have reported suffering serious injury and permanent disability after treatment with the da Vinci surgical robot. Some even died after developing severe complications.

How Our Defective Medical Product Lawyers Can Help

It’s hard to imagine a more vulnerable person than a fully anesthetized surgery patient or a young child, yet unsuspecting patients such as these are some of the most common victims injured by these defective medical products that have entered the market and caused harm to consumers.

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.

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 (855) 880-4741 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. 

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