Defective Devices | Blizzard Law PLLC

NeuroBlate Timeline of Key Events

April 15, 2019/in Defective Devices /by damg16

April 1, 2013 – FDA cleared the NeuroBlate System for use in the U.S.
- It’s important to note that the NeuroBlate System was never approved by the FDA. Instead, it was merely “cleared” by the 510(k) process, meaning the FDA permitted Monteris to market the device because it was substantially equivalent to a device already on the market.
- Therefore, Monteris never conducted any controlled clinical trials on the NeuroBlate System before putting it on the market.
October 5, 2017 – The NeuroBlate System is recalled due to unexpected heating of its laser probes. In some cases, the laser probes were interacting with the MRI system to cause unexpected heating, and consequently, unanticipated heating of surrounding brain tissue.
- The FDA identified this as a Class I recall, the most serious type of recall, as the use of these devices could cause serious injuries or death.
- FDA recommended health care providers should strongly consider treating patients using alternative procedures if available.
October, November, and December 2017 – Monteris issued “Advisory Notices” about the unintended heating of the laser probes.
- These notices emphasized that Monteris was NOT requesting return of any product from the health care providers’ possession.
- Instead, Monteris recommended physicians take certain precautionary steps to mitigate the risk to patients, including limiting MRI scans while the probe is in the patient. This effectively encouraged health care providers to continue using the NeuroBlate System, despite the Class I recall.
- None of the three Advisory Notices issued by Monteris mention the Class I recall of the laser probes.
- While these Advisory Notices can be found on Monteris’ website, there is no mention of the Class I recall on the company’s website.
March 22, 2018 – FDA issued a Safety Alert to health care providers warning them that the Advisory Notices issued by Monteris are not sufficient to mitigate the risk of unintended laser probe heating.
- The Safety Alert noted that the unintended heating and damage to the probe appears to have been caused by an interaction between the thermocouple in the probe (which contained metal) and the MRI environment.
- The Safety Alert stated the FDA had received medical device reports (MDRs) related to overheating of the probe, including one patient who experienced an intracranial hemorrhage and died.
- The Safety Alert by the FDA reiterated that health care providers should strongly consider treating patients using alternative procedures if available.
April 24, 2018 – FDA issued a letter to health care providers warning that the MR thermometry, which is used to monitor the changes in temperature at the laser ablation site, was potentially inaccurate and may not account for continued spread of energy to the surrounding brain tissue.
- The letter stated the FDA had received medical device reports (MDRs) and literature reports which describe the following adverse events when these devices were used to treat intra-cranial lesions: neurological deficits, increased intracerebral edema or pressure, intracranial bleeding, and/or visual changes.
- The FDA recommended that health care providers consider and discuss with your patients the benefits and risks of these devices, as well as the availability of any alternative treatment.
July 30, 2018 – Monteris submitted its application for FDA clearance of a new laser probe for its NeuroBlate System, which no longer contained a metal thermocouple.

October 15, 2018 – FDA cleared Monteris’ new laser probe for its NeuroBlate System. The new probe was called the NeuroBlate Optic Laser Probe.
- The new design replaced the metal thermocouple inside the laser probe with a non-metallic fiber optic temperature sensor, thus eliminating any risk of unintended probe heating.
- According to Monteris company officials, this change to the laser probe’s design raised the probe’s safety profile by preventing overheating targeted tissue.
November 8, 2018 – FDA issued a letter to healthcare providers alerting them that Monteris received FDA clearance for a new probe with a non-metallic thermocouple sensor.
- The FDA made clear that the safety risks associated with the old probe containing the metallic thermocouple sensor still remain.

If you had “minimally-invasive” laser ablation surgery with the NeuroBlate System after October 5, 2017 (date of Class I recall) and before October 15, 2018 (date new probe was released) ask yourself the following:

Were you injured as a result of the surgery (e.g., brain bleed, edema, neurological deficits, visual changes, motor deficits)?
Did your doctor tell you the device was subject to a Class I recall?
Did you know that the NeuroBlate laser probe could cause unintended overheating of surrounding brain tissue?
Did you know FDA had received medical device reports (MDRs) related to overheating of the probe, including one patient who experienced an intracranial hemorrhage and died?

Even if you had surgery after October 15, 2018 (date new probe was released), it’s possible your doctor used the old probe that was subject to the Class I Recall. We can help you find out. Contact our firm today.

NeuroBlate Injury Lawsuit Filed

March 7, 2019/in Defective Devices, Medical Malpractice, News /by damg16

Blizzard Law, PLLC filed a petition on behalf of nine-year-old Millie Barr and her parents for life-altering damages caused by Daniel J. Curry, M.D. (“Dr. Curry”), Texas Children’s Hospital (“Texas Children’s”), and Monteris Medical in Harris County Civil District Court.

On August 7, 2018, Millie Barr, a nine-year-old child, suffered a massive hemorrhage in her brain eighteen days after having a “minimally-invasive” laser ablation surgery performed by Dr. Curry at Texas Children’s to treat her epilepsy. Unbeknownst to Millie and her parents, Dr. Curry performed the surgery with a laser probe manufactured by Monteris Medical Company that had been recalled by the FDA just months earlier due to the unanticipated heating of surrounding brain tissue. Millie suffered a bleed during the surgery but was discharged just days later without a thorough evaluation of the damage done to the blood vessels in her brain. Eighteen days after her surgery, while in Florida with her family, a “pseudoaneurysm” in her brain ruptured and Millie was required to have multiple surgeries and procedures just to save her life. Although her life was saved, the brain bleed and the procedures required to treat it left Millie with no short term memory and severe vision loss, as well as other cognitive and motor deficits.

NeuroBlate Medical Device Recall

NeuroBlate Laser Delivery Probes are small, carbon dioxide (CO2)-cooled catheters that allow minimally invasive entry into a patient’s brain. The probes are part of the Monteris Medical NeuroBlate System, which is used during surgical procedures to remove (ablate), thicken or solidify (coagulate), or destroy (necrotize) cells in the brain tissue. The FDA initiated a formal Class I Recall of the device on October 5, 2017, sending a letter to physicians using the device on March 22, 2018, noting, “health care providers should strongly consider treating patients using alternative procedures if available.”

Mere weeks after Millie Barr’s catastrophic surgery results, Monteris Medical, the manufacturer of the recalled device used during her brain surgery, issued an announcement regarding the safety – or lack thereof – of its device. In pertinent part, the announcement notes the device’s metal thermocouple was replaced with a non-metallic fiber optic temperature sensor to improve its safety profile and to allegedly prevent overheating the targeted tissue. In addition to the new temperature sensor, the updated NeoruBlate System features TruTemp™ Technology, which increases the device’s accuracy and safety.

Ed Blizzard stated, “Millie Barr’s parents traveled all the way to Houston from Israel on the promise of a safer medical treatment for their child at Texas Children’s. Unfortunately, Dr. Curry and the hospital negligently used a recalled and defective device to treat the child, against the recommendation of the FDA, and without informing her parents. The life of a little girl was forever changed and we will hold those responsible accountable in court.”

NeuroBlate Injury Lawsuit Lawyers

Blizzard is no stranger to working hard in court on behalf of injured children and their families. He has served in high-profile national leadership positions in various litigations affecting children, including birth defect litigation against the manufacturers of anti-depressant medications. Blizzard and attorney Anna Greenberg will be taking the case to trial.

The Intertwined History of Pelvic Mesh and Hernia Mesh

October 23, 2017/in Defective Devices /by damg16

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 damg16

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.

Pelvic Mesh Manufacturer Settles For $750 Million

August 22, 2017/in Defective Devices /by damg16

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 damg16

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 damg16

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 damg16

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.

IVC Filters Offer No Benefit to Trauma Patients

October 17, 2016/in Defective Devices /by damg16

For years, Inferior Vena Cava filters (IVC filters) were used to help mitigate the risk of blood clots in patients who cannot take traditional blood thinners. An increasing number of lawsuits claim IVC filters are defective, cause serious side effects, and have incredibly high rates of fracture. A new study published in the Journal of The American Medical Association (JAMA) found IVC filters did not provide any benefits to trauma patients.

IVC Filter Usage

Patients who have experienced some type of trauma, like an accident or surgery, cannot take blood thinners to reduce their risk of blood clots because it could cause dangerous bleeding. Instead, surgeons often utilize IVC filters to catch blood clots before they travel into the heart or lungs and cause a life-threatening condition called pulmonary embolism (PE).

The newly published JAMA study advises doctors to rethink the use of IVC filters in trauma patients. The study looked at both patients who had received IVC filters and those who had not received IVC filters and found no difference in mortality rates regardless of whether a filter was used. Doctors also discovered only 8% of IVC filter patients had their device removed within 3.8 years of implantation. The FDA recommends filters removal between 29 and 54 days after implantation to decrease the risk of suffering complications.

The study recommends IVC filter use “should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place.”

The seven most dangerous IVC filters most commonly named in lawsuits include:

1. Cook Günther Tulip Filter – Approved by the FDA in 2003, the Günther Tulip was one of Cook Medical’s first IVC filters. However, a study in 2012 in Cardiovascular and Interventional Radiology found 86% of patients with Günther Tulip IVC filters experienced device perforation of the inferior vena cava wall.

2. Cook Celect Filter – Released onto the market in 2008, it did not take long for reports of Celect filter device failure to come in. The Celect proved to be no better than its predecessor, the Günther Tulip, at resisting failure.

3. Bard Recovery Filter – The Recovery filter was C.R. Bard’s first IVC filter to hit the market in the U.S. when it received approval in 2002. However, as early as 2004, the company received reports that the devices were causing serious complications. In 2005, Bard voluntarily removed the Recovery filter from the market.

4. Bard G2 Filter – While the Recovery filter was being recalled, Bard released the G2 filter onto the market. Although the G2 was supposed to have enhanced fracture resistance, the FDA continued to receive reports of device failure.

5. Bard G2 Express – Released shortly after the G2, the G2 Express proved to be just as dangerous. The G2 Express has a fracture rate of 12%, and only half of fractured devices can be successfully removed.

6. Cordis OptEase – Not only was the OptEase by Cordis dangerous for its failure rate, a labeling error printed an arrow pointing the wrong direction, causing devices to be implanted upside down. Only when the device is in the upright position can it be anchored in place by the struts. The printing error led to many patients having the device migrate through the body, causing severe complications.

7. Cordis TrapEase – Although the Cordis TrapEase filter contained better labeling and instructions, a 2011 study found the TrapEase had a higher risk of fracture compared to other IVC filters.

IVC Filter Litigation

Patients in the various IVC filter litigations believe manufacturers like C.R. Bard, Cook Medical, and Cordis Corporation failed to adequately warn them of the risks associated with the defective medical devices. Thousands of IVC filter lawsuits now seek justice from more than a dozen manufacturers. The first Cook Medical IVC filter lawsuits will go to trial in early 2017.

IVC Filter Litigation Update

July 24, 2016/in Defective Devices /by damg16

Lawsuits surrounding Inferior Vena Cava Filters (IVC Filters) has been surging lately as the first lawsuits are prepared to go to trial this September. Manufacturers like Boston Scientific, C.R. Bard, Cook Medical, and Cordis Corporation are all facing lawsuits both in the United States and in Canada.

What Is An IVC Filter?

IVC filters are medical devices implanted into the largest vein in the body, the inferior vena cava, to carry blood from the body to the right atrium of the heart. The purpose of an IVC filter is to prevent blood clots in the lower extremities from traveling into the heart or lungs. They are commonly used in patients at risk for Pulmonary Embolism (PE), patients who have experienced trauma, or patients who have recently undergone surgery.

In 2010, the Food and Drug Administration (FDA) released a safety communication warning doctors and patients that IVC filters could cause severe and life threatening side effects. Between 2005 and 2010, the FDA received 921 reports of device failure of IVC filters. Of these reports, 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the inferior vena cava wall, and 56 involved filter fracture. The FDA also warned that the risk of experiencing one or more of these complications greatly increases with time in the body.

C.R. Bard, one of the largest IVC Filter manufacturers in the world, has contested liability every step of the way. Currently facing over 3,000 lawsuits, the company will face its first bellwether trial on March 14, 2018 in an Arizona court. U.S. District Court Judge David Campbell is overseeing what is anticipated to be a several weeks long jury trial.

The bellwether plaintiff alleges Bard failed to warn of the failure risk associated with its IVC Filters. Once implanted, IVC Filters can tilt, migrate, fracture, and perforate the vein, making removal difficult if not impossible. As one of the largest IVC Filter manufacturers, the outcome of Bard’s litigation could set a precedent for other IVC Filter litigations.

Expert Witness Testimony

Bard lost its bid last December to have all of the plaintiffs’ expert witnesses disqualified. Plaintiffs engaged the expertise of four doctors from Northwestern University’s Interventional Radiology department who had extensive experience with Bard’s IVC Filters. The judge overseeing the case ruled three of the four doctors could give testimony.

2018 and Beyond

While no other IVC Filter trials have been scheduled for 2018 so far, it is likely Bard will face more bellwether trials this year. Other IVC Filter manufacturers like Cook Medical, Cordis Corporation, and Boston Scientific, among others, will likely use Bard’s experience as a litmus test for their own litigations. Cook Medical came close to settling its cases last year, but both sides were unable to finalize an agreement. However, depending on the outcome of Bard’s bellwether trials, manufacturers might go back to the negotiation table.

IVC Filter Lawsuits

With thousands IVC filters implanted in patients each year, the litigation against IVC filter manufacturers has quickly grown. The first manufacturer to go to trial this year will be Cook Medical. Cook has tried to settle its cases since February, but the two sides were unable to come to an agreement and the first bellwether trials are scheduled for this September.

The outcome of Cook’s lawsuits could set a precedent for other IVC filter manufacturers like Bard, facing its own trials scheduled to begin in mid-2017. The bellwether selection process is underway and it is anticipated to conclude in January or February of next year.