medical malpractice | Blizzard Law PLLC

The Intertwined History of Pelvic Mesh and Hernia Mesh

October 23, 2017/in Defective Devices /by damg

For women suffering from pelvic organ prolapse, pelvic mesh seemed like a miracle cure. Unfortunately, the lack of clinical testing of pelvic mesh products led to massive recalls and lawsuits after women began experience debilitating and permanent injuries. Transvaginal mesh injuries are the same types of injuries suffered by hernia mesh patients, which should come as no surprise considering both products are made out of the same material. This has left many hernia mesh victims wondering why manufacturers didn’t take the hint.

For women who have given birth or patients who have undergone surgery, the pelvic muscles can stretch and weaken causing organs like the bladder to sink lower in the body than normal. This is called pelvic organ prolapse and in the late 1990s, the first pelvic mesh was developed to treat the condition. Pelvic mesh is made out of polypropylene plastic, a material that is cheap to produce and abundantly available. Polypropylene plastic is also preferred because it is not biodegradable and it will not absorb into human tissues.

Three years after hitting the market, pelvic mesh products were subject to recalls. However, the original approval allowed other pelvic mesh devices to be approved through the controversial 501(k) approval process. The U.S. Food and Drug Administration (FDA), allows medical devices and prescription drugs to go through a much less stringent approval process if the device or drug is similar to one currently approved by the FDA.

Even though the first pelvic mesh product was eventually recalled, its approval allowed for the eventual approval of nearly sixty more pelvic mesh products. None of these devices were ever subject to clinical studies to prove their safety and efficacy. As a result, patients were unaware of the dangers associated with pelvic mesh, including bleeding, erosion of the device, the abnormal connection of two organs or tissues, nerve damage around the mesh, and migration of the mesh. Now thousands of woman are suffering from mesh erosion, vaginal scarring, urinary incontinence, painful intercourse, injury to the bladder, and other debilitating injuries.

Pelvic organ prolapse and hernias were once thought to be very similar conditions, so manufacturers designed hernia mesh based on pelvic mesh devices. Hernia mesh products produced a similar history when the FDA began recalling hernia mesh devices for causing complications. However, through the 501(k) approval process, dozens of hernia mesh manufacturers flooded the market. Because it is made out of the same material as pelvic mesh, hernia mesh has produced similar complications, including producing scarring, inflammation, bleeding, nerve damage, migration, and the connection of two organs.

All patients deserve to know the risks associated with medical devices and procedures. Both pelvic mesh and hernia mesh patients were not warned of the dangers, even after polypropylene plastic mesh products proved to be dangerous. The dangers of this type of mesh have been well known by manufacturers for over ten years, but to preserve profits, manufactures did not warn patients.

What’s Wrong With Zimmer Biomet Shoulder Implants?

October 9, 2017/in Defective Devices /by damg

For over seven years, shoulders implants with high rates of fractures have been used in thousands of patients. The Zimmer Biomet Shoulder Implant has caused many patients to suffer permanent and debilitating injuries, including lack of function, lack of mobility, and chronic pain.

What Is The Zimmer Biomet Shoulder Implant?

The Comprehensive Reverse Shoulder device manufactured by Zimmer Biomet is used in reverse shoulder replacements. Reverse shoulder replacements are much less common than ordinary shoulder replacements and are usually performed on large rotator cuff tears that have caused arthritis in the joint. Many patients undergoing a reverse shoulder replacement have already undergone unsuccessful shoulder replacement surgeries.

During a normal shoulder replacement surgery, an artificial implant is used that is designed to replicate the normal anatomy of a shoulder. However, in a reverse shoulder replacement surgery, the artificial joint is designed to be the opposite of arm’s natural anatomy. By working in reverse, the joint and shoulder utilize different muscles in the arm for movement.

A reverse shoulder implant can be beneficial for patients who have suffered a rotator cuff injury because the shoulder will rely on the deltoid muscle, rather than the previously injured rotator cuff, to operate the arm.

A History of Recalls

Several models of Zimmer Biomet’s reverse shoulder implant have been recalled throughout the years. The device was approved in 2008, and by 2010 the company recalled certain implants after receiving reports of device fracture. However, in December 2016, Zimmer Biomet initiated another recall of some of its reverse shoulder implants after more reports of device fracture. Several months later, the U.S. Food and Drug Administration (FDA) issued warning letters to patients and surgeons cautioning that the fracture risk associated with Zimmer Biomet’s reverse shoulder implants is much higher than what the company advertised on the label.

When a Zimmer Biomet shoulder implant fails, it can cause a variety of dangerous conditions for patients. Fractures in the implant can require additional surgeries, cause permanent damage, permanently limit mobility, and cause chronic pain.

First Bellwether Trials Scheduled in Taxotere Litigation

September 18, 2017/in Dangerous Drugs /by damg

For women who suffered permanent hair loss after undergoing cancer treatment, many questions were left unanswered by the manufacturer of the popular breast cancer drug, Taxotere. Luckily, federal court lawsuits filed against the company are making progress, and four bellwether trials have been scheduled.

Federal court Taxotere lawsuits have been centralized in a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Louisiana. The lawsuits allege Taxotere’s manufacturer, Sanofi-Aventis, knew about the permanent hair loss risk, but failed to warn patients and doctors.

The labels for Taxotere in several other countries were updated in recent years to include information about the permanent hair loss risk, but the company’s U.S. arm decided not to update labels.

Studies have shown Taxotere can cause permanent hair loss, called alopecia, in approximately 9% of patients. However, there are safer and equally effective alternative treatments available. Many plaintiffs in the consolidated litigation state that had they known about the permanent hair loss risk, they would have sought alternative treatment options.

Women who suffered permanent hair loss after being treated with Taxotere are seeking to hold Sanofi-Aventis responsible. While several settlement conferences are scheduled throughout the next year, the court overseeing the litigation has also scheduled four bellwether trials beginning in 2019. The bellwether trials will be begin on:

January 28, 2019
April 8, 2019
July 15, 2019
November 4, 2019

While the first trial is over a year away, Sanofi-Aventis is likely considering its options very closely. There are already hundreds of lawsuits in the MDL and the number is expected to continue growing. The company will have to decide if pursuing each case in court is the best option, or if they should agree to a settlement.

Pelvic Mesh Manufacturer Settles For $750 Million

August 22, 2017/in Defective Devices /by damg

For women suffering from pelvic mesh complications, holding the manufacturers responsible for their defective devices is incredibly important. Luckily, for some victims, a resolution to their claims has finally arrived. One popular pelvic mesh manufacturer, Endo International PLC, has agreed to pay $750 million to settle 22,000 pelvic mesh lawsuits.

Women have been complaining of severe complications from vaginal mesh products for many years, and in 2016, Endo decided to shut down one of its units that was producing the devices. The decision came after the company was faced with thousands of pelvic mesh lawsuits.

This latest settlement is not the first the company has made. Endo has agreed to several large settlements over the past few years totaling $2.6 billion. Endo might now be able to wash its hands of the defective devices, but other manufacturers are still drowning in tens of thousands of transvaginal mesh lawsuits.

Healthcare giant Johnson & Johnson (J&J) is facing over 54,000 pelvic mesh lawsuits. Unlike Endo, J&J has gone to great lengths to fight its defective mesh lawsuits in court, but the company hasn’t been very successful. This past January, the first pelvic mesh case to go to trial against J&J was finally concluded when the Supreme Court of New Jersey declined to hear an appeal from the manufacturers. The original verdict awarding the plaintiff $11 million in damages was upheld. J&J has lost four consecutive pelvic mesh trials, including the most recent verdict in June that awarded the plaintiff $2.16 million in damages.

Endo’s settlement and J&J’s courtroom losses are having a profound effect on pelvic mesh litigations against other manufacturers. Other manufacturers like Boston Scientific, C.R. Bard, and Cook Medical, among others, might decide to follow Endo’s example and settle their losses now, rather than suffer J&J’s multiple multimillion-dollar losses in court.

Court Rulings Will Stick

The first transvaginal mesh case to go to trial finally came to a conclusion in January 2017. The plaintiff was a South Dakota woman named Linda Gross who experienced severe complications from the transvaginal mesh product she had implanted. Although Ms. Gross’s trial concluded in 2013, device manufacturer defendants Johnson & Johnson and Ethicon fought the verdict for over three years. However, the Supreme Court of New Jersey declined to hear an appeal from the manufacturers, allowing the original jury verdict to stand. This sends a clear message to vaginal mesh manufacturers that jury verdicts and awards will stand up to appeals.

Stockert 3T Device More Dangerous Than Anticipated

July 17, 2017/in Defective Devices /by damg

When the U.S. Food and Drug Administration (FDA) sent out a warning letter to patients and physicians in 2015 regarding infections from the Stockert 3T heater-cooler device, it was thought the full scope of the risk was understood. However, nearly two years later a new study has found the infection risk was more widespread than previously believed.

The Initial Problem

The Stockert 3T is manufactured in Germany by LivaNova. In early 2015, the company began to receive complaints from European patients about infections connected to the device. The heater-cooler device has been linked to rare bacteria called mycobacterium chimaera, or M. chimaera.

Studying The Infection Risk

Researchers from Pittsburgh looked into the infection risk presented by the Stockert 3T by collecting samples from across the country. Researchers tested 89 samples from 23 difference states, the District of Columbia, and Canada and found 33 units were contaminated with M. chimaera. The Stockert 3T is used in approximately 60% of hospitals for regulating patient body temperatures during cardiac/thoracic surgery, so the threat to patients is very real.

M. chimaera is a particularly dangerous bacteria because it presents very generic symptoms, making it difficult to diagnose. Last year, the FDA reported 79 instances of patient infections from the device, including at least 12 deaths. However, the agency believes many cases go unreported.

Infection Risk In Children

Recently, children who underwent cardiothoracic surgery in which the Stockert 3T was used have developed life-threatening infections because of the device.

Nearly one dozen children were infected with mycobacterium abscessus, or M. abscessus, a fast growing bacteria resistant to many types of antibiotics after undergoing surgery at the Children’s Hospital in New Orleans. M. abscessus can cause skin to become red, tender to the touch, swollen, or even painful. Infected skin can also develop boils. M. abscessus can also cause fever, chills, and muscle aches, among other symptoms.

Unfortunately, the Children’s Hospital in New Orleans is concerned there could be even more patients infected. Bacteria spread into open surgical wounds can lay dormant for months or even years before manifesting symptoms.

M. abscessus is most commonly spread in a hospital setting by contaminated medical equipment. Invasive procedures using contaminated medical equipment can expose a patient’s open surgical wound to the bacteria.

Informing Patients

After the latest findings from researchers, some hospitals are reaching out to patients to inform them they may have been exposed to the risk. Because it can take months or even years for infection symptoms to manifest, it is incredibly important for cardiac surgery patients to watch out for signs of an infection. If you underwent cardiac or thoracic surgery within the last five years, talk to your doctor about your infection risk.

Cancer Prevention and Breast Implants

June 5, 2017/in Defective Devices /by damg

In 2011, the U.S. Food and Drug Administration issued a warning to patients and doctors across the country informing them that certain types of breast implants have been associated with a rare type of breast cancer. Every year, hundreds of thousands of women undergo breast augmentation surgery, meaning millions of women have been exposed to this increased cancer risk.

Breast implants can cause anaplastic large cell lymphoma (ALCL), a rare form of non-Hodgkin’s lymphoma. Patients with breast implant associated anaplastic large cell lymphoma – BIA-ALCL for short – require implant removal and/or removal of surrounding tissue and may require chemotherapy to treat the cancer.

Cancer Prevention

For women considering breast implants, evaluating the cancer risk is important. Research has shown some types of breast implants are more likely to cause cancer than other types. Women seeking to reduce their cancer risk from breast implants should select non-textured implants. Although patients typically prefer textured implants, patient with textured implants have a 67.6 times greater risk of developing cancer.

Signs To Look For

For women who already have breast implants and are concerned about their cancer risk, it is important to know the signs of BIA-ALCL. Catching cancer in its early stages gives patients the best odds for recovery. BIA-ALCL typically develops 3-14 years after implantation and is often identified by these signs:

Lumps – Women with breast implants need to be on the lookout for any unusual lumps in their breasts. It is important to note that lumps caused by BIA-ALCL can also occur in the armpit area.
Swelling – BIA-ALCL occurs in an accumulation of fluid around the breasts. This fluid causes swelling of the breasts.
Asymmetry – Women who begin to notice asymmetry in their breasts should immediately contact a doctor, as this could be a sign of BIA-ALCL

Unfortunately for patients, BIA-ALCL can also cause very generic symptoms – like fever, fatigue, night sweats, and weight loss – that are difficult to diagnose. However, with the help of scans and diagnostic tests, doctors can identify BIA-ALCL and offer treatment.

Hernia Mesh Litigation Update

May 22, 2017/in Defective Devices, Medical Malpractice /by damg

For thousands of patients who have undergone surgery to correct their hernias, recovery has proven to be much more challenging than expected. Defective hernia mesh products are causing a variety of severe complications for hernia mesh patients, but patients are fighting back with lawsuits filed against hernia mesh manufacturers.

Physiomesh Lawsuits

Ethicon, Inc., a subsidiary of Johnson & Johnson (J&J), manufactures Physiomesh hernia mesh. Ethicon recalled its Physiomesh products in 2016 due to high rates of failure. Over a dozen lawsuits have already been filed against Ethicon, and these lawsuits have been consolidated in a multidistrict litigation (MDL).

In August 2017, the attorneys in the Physiomesh litigation convened for a status conference in the U.S. District Court for the Northern District of Georgia. The status conference addressed procedural, case management, and discovery issues during the litigation; and, afterwards, Judge Richard W. Story, who is overseeing pretrial proceedings, issued a court order to keep the momentum going in the litigation.

The court order states both parties in the litigation must meet together to prepare an order allowing additional lawsuits to be filed directly in the Northern District of Georgia. The court order also set a schedule for monthly status conferences to ensure the litigation doesn’t suffer any lag time. In February 2018, the court decided on a trial date for the first bellwether lawsuit. The federal court overseeing the Physiomesh litigation set a trial date for September 16, 2019.

C-Qur Lawsuits

Atrium Medical Corporation manufactures C-Qur hernia mesh, which has been on the market for over 10 years. After years of failing to comply with FDA regulations, the FDA issued a permanent injunction against the company in 2015 to prevent it from producing more unsafe hernia mesh products.

This past December, over 300 C-Qur hernia mesh cases were consolidated in an MDL in New Hampshire and are currently undergoing pretrial proceedings.

Kugel Mesh Settlement and Remaining Lawsuits

Kugel Mesh products manufactured by Davol are some of the most widely used hernia mesh products in the country. Despite Davol Kugel Mesh being the subject of recalls dating as far back as 2005, it remains available on the market today. In 2011, Davol paid $185 million to settle approximately 2,600 hernia mesh lawsuits. However, the company still faces over 1,000 hernia mesh lawsuits in an MDL in Rhode Island.

Patients Fighting Back

Although there are three separate hernia mesh litigations, the outcome of each could affect the outcome of the others. If one litigation sees large trial verdicts or settlements, the other two might follow suit. While it will be some time before a hernia mesh case goes to trial, once the litigation begins in earnest, the results will have profound implications for patients across the country.

Posts