When you require help for a medical condition, you expect and trust that the personnel, equipment, and treatments you receive are of the best quality and further help your recovery. Unfortunately, there are medical devices that are used to help people that end up causing more harm. Just as in drug injury cases in which prescription drugs are given to treat a condition only to cause serious side-effects or worsen the patient’s condition, defective medical devices can cause more harm than good as well.
The experienced mass tort lawyers at Portner & Shure, P.A. understand the seriousness of these types of cases and aggressively pursue justice and compensation on your behalf. No one should suffer a serious personal injury while seeking medical help and our lawyers can help you hold the responsible parties liable for your pain and suffering.
If you believe you’ve been the victim of medical device injury, please call our experienced lawyers today at 410-995-1515 or 301-854-9000 for assistance in Maryland, 703-734-8790 for service in Virginia, 804-916-1577 in Richmond, and 202-554-1449 in Washington D.C. for a free initial consultation. We work on a contingency basis, which means that we don’t get paid unless your case is successful.
- What are Defective Medical Devices?
- IVC Filters
- Bair Hugger
- Hernia Mesh
- Compensation We Can Pursue
What are Defective Medical Devices?
A medical device is a tool or gadget that is used by medical professionals to aid in the treatment of a given disease, illness, or medical condition. As with any product, there is a trust between the consumer and manufacturer that the product is safe for its intended use. Unfortunately, cases of defective products causing serious harm to those who purchase them happen all too often. This is also true for medical devices used in treating certain ailments and conditions.
While all defective product cases are serious, one can argue that a defective medical device is even more egregious; for as a patient in need, you are more vulnerable than ever and expect that the treatment being used will help and not harm.
A medical device injury case is based on the elements of any product liability claim. Just like a defective product, a defective medical device must have certain qualifications to meet the standards for a claim. All defective product claims must meet one of the following three elements:
- The medical device was defectively manufactured
- The medical device was defectively designed
- The medical device was defectively marketed
Because most medical devices are manufactured and distributed by large corporations, medical device injury often falls under mass tort litigation. Mass tort cases are those in which a large number of people suffer injuries and bring a claim against one or a few defendants, generally in state or federal court.
In the sections below, we outline some of the more recent and common medical device injury claims. If you’ve suffered injury as a result of one of these medical devices, our experienced lawyers can help you in your claim.
Essure is a hysteroscopic sterilization procedure wherein a soft metal spring like device is implanted into the fallopian tubes. The device is made up of polyester fibers, nikel, titanium, platinum, silver-tin and stainless steel. Essure is a permanent, irreversible, non surgical birth control device. Doctors do not need to cut into the body. Doctors go through the vagina, cervix and uterus and implant the device. The coils expand to a length of about 1.5 inches and anchor to the walls of the tubes. The procedure itself takes about ten minutes and can be performed in your physicians office. Most woman can leave the office in less than an hour. After Essure is placed in the fallopian tubes for about three months, tissue grows around the device to form a blockage, which prevents contraception. Doctors then use a transvaginal ultrasound or vaginal x-ray to confirm the fallopian tubes are blocked.
The Essure lawsuit against Bayer and Conceptus (the manufacturers) claims the birth control device is defectively designed and can break apart and move into a woman’s body. This failure can puncture a woman’s uterus and fallopian tubes. There have been more than 750,000 devices implanted in women worldwide.
In February of 2016, the FDA issued a warning and announced that it will require a black box warning and will require a Patient Decision Checklist. The black box warning is the FDA’s strongest warning. In 2018, the FDA made further changes and indicated that now both the doctor and the patient must sign off on the Patient Decision Checklist acknowledging the potential problems. If the Essure implant breaks or moves, attempted removal of the device often requires multiple surgeries and sometimes removal of the entire uterus (hysterectomy).
Thousands of woman in the United States and Worldwide reported serious side effects which led to the device being recalled. Bayer recently announced that it would no longer sell Essure and removed it from all markets outside the U.S. In July 2018 Bayer confirmed that it would be removed from the U.S. by the end of the year. If woman would have known the risks involved, they may have chosen a different form of birth control.
According to the FDA, side effects from Essure include:
- Mild to chronic pain
- Pelvic or back discomfort
- Unintended pregnancy, including ectopic pregnancy
- Fetal death
- Movement through the fallopian tubes into the lower abdomen and perforation of the uterus or fallopian tubes
- Joint pain, fatigue, and other autoimmune disease symptoms
- Painful sex
- Sexual problems
- Weight gain
- Hair loss
- Bowel or bladder injury
- Metal allergies
We are currently reviewing cases where clients have suffered injuries and complications from receiving the Essue Birth Control device.
The Inferior Vena Cava (IVC) is a large vein in the body that carries deoxygenated blood to the heart. IVC filters are devices that are implanted in the Inferior Vena Cava of patients at risk for a blockage in their lungs. These devices are designed to prevent blood clots from traveling to the lungs.
Patients with IVC Filters placed inside them have suffered serious injuries as a result of the device failing while inside the body. In many cases, the filter breaks and metal fragments then move through the blood and damage an organ. Manufacturers of the device failed to warn about these complications, and there have even been allegations that they had research that showed the dangers of these filter and subsequently hid the results in order to gain FDA approval.
Several different complications have been reported as a result of IVC Filters, including:
- Heart or lung injury
- Wrongful death
In many cases, the filter has fallen out of place or simply broken apart. The device is metal, so when it breaks apart or falls out of place, there are metal pieces that can travel in the bloodstream and hit a vital organ causing significant damage which can lead to serious health complications.
The Bair Hugger device is a warming blanket that helps keep a patient’s body warm during surgery. The Bair Hugger device uses a forced-air heater to push warm air through a hose in the blanket. Warm air is then released under the surgical table. These warming blankets are used to help reduce bleeding and speed up recovery time after surgery.
Nearly 80% of all hospitals use Bair Hugger temperature management systems during surgery. However, numerous patients have developed infections after surgery as a result of using these devices.
Surgeries involving implants have a higher risk of infections, and use of Bair Hugger devices greatly increases that risk. In fact, there are studies that indicate that devices like Bair Hugger could increase the risk of infection during surgery. Bair Hugger manufacturer 3M tried to discredit these studies and failed to warn of an infection risk associated with its device.
When bacteria are being spread throughout the operating room during a surgery, infections can easily develop inside a patient’s body. The most serious risk caused by using a Bair Hugger blanket is deep joint infections. Use of the blanket is common during joint replacement surgeries, like hips and knees, thereby making it very easy for infections to develop deep in the joints. Amputation is required in the most severe cases.
More than 1 million hernia repair surgeries are performed each year in the United States. A significant portion of these procedures involves a composite hernia mesh to repair the tear. Since 2005, Atrium C-QUR patches have been used and since 2010, Ethicon Physiomesh has been used in these surgeries.
Composite mesh is made of polypropylene, as many hernia meshes are, but composite mesh also has a coating around the barrier of the mesh. This coating is what causes complications because it does not properly integrate with the body once the mesh is in place. The body’s healing process begins immediately after the mesh is implanted, however, the coating can take several months to fully degrade, which then interrupts the healing process.
Since 2010, composite hernia mesh complications have risen dramatically, specifically among two main products: Atrium C-QUR and Ethicon Physiomesh. Numerous patients who have had a composite hernia mesh implanted inside them have required a subsequent surgical intervention to correct complications. In May 2016, Ethicon voluntarily recalled their product after clinical trials were terminated due to concerns of increased adverse events. Numerous lawsuits have been filed against Atrium as well.
Both products were first placed on the market despite several concerns, not to mention that they received approval through the FDA’s 510(k) process. This approval process does not require testing by the FDA, instead only requiring the manufacturer to show that their product is “substantially equivalent” to a previously approved product.
The most serious complication of using a composite mesh to repair a hernia is the need for an additional surgical procedure to either remove the mesh and/or correct recurrence. Other common side effects include:
- Bowel obstruction
- Mesh migration
Sometimes the surgical correction is not so simple and is quite extensive in order to repair the damage caused by the composite mesh.
Compensation We Can Pursue
When it comes to defective products, especially medications, our experienced lawyers fight to make sure that you’re taken care of in your time of need. To have a successful lawsuit you must have been using one of the above medications and incurred problems as a result of taking the drug, and suffered physical, emotional, or financial losses. If this applies to you, we can pursue compensation related to:
- Medical expenses
- Rehabilitation bills
- Lost wages from missed work
- Pain and suffering
- Funeral expenses (in the event of wrongful death)
Contact Our Experienced Lawyers Today
The experienced medical injury lawyers at Portner & Shure, P.A. want to assure you that every case we take is handled professionally and with an aggressive approach to pursuing justice and compensation on your behalf. We believe that justice is the right of everyone and employ Spanish, Vietnamese, Korean, Mandarin Chinese and Cantonese Chinese speaking paralegals to help those in need.
Please contact us by filling out the form on this page or by calling us at 410-995-1515 or 301-854-9000 for assistance in Maryland, 703-734-8790 for service in Virginia, 804-916-1577 in Richmond, and 202-554-1449 in Washington D.C. for a free initial consultation.