IVC filter lawsuits say faulty retrievable IVC filters punctured veins, fractured and migrated to other parts of the body, causing organ damage and other serious complications. Manufacturers Cook Medical and Bard currently face a combined 5,800 IVC filter lawsuits in federal court.
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If you were inserted with an IVC Filter and are experiencing one of the following complications, you may be eligible for compensation.
Number of LawsuitsMore than 5,900
Plaintiff InjuriesFilter fracture; device migration; blood clots; organ perforation; organ damage; impossible filter removal
DefendantsBard; Cook Medical Inc.
Litigation Status Active
Class-Action Status Ongoing
Bellwether Trial Dates Cook Medical – October 23, 2017, April 30, 2018, and September 10, 2018; Bard – TBD
MDL Locations Cook Medical- Southern District of Indiana; Bard-District of Arizona
Attorneys are currently accepting cases on behalf of people who suffered permanent and continuous injuries as a direct result of “defective and unreasonably dangerous” IVC filters. This includes people directly injured by the devices as well as surviving relatives of those who died as a result of the devices.
Cook Medical Inc. and Bard are two IVC filter manufacturers at the center of lawsuits. They are accused of negligence, failure to warn of risks and designing defective devices.
Bard has settled some individual cases for undisclosed amounts. Cook has yet to publicize settlements.
Meanwhile, thousands of remaining federal IVC filter lawsuits have been transferred to courts in Indiana and Arizona and consolidated into two multidistrict litigations, or MDLs.
Bellwether trials have begun in the Cook MDL. The Bard MDL is in the process of preparing for the first set of trials. The outcome of these trials could affect settlement talks.
People who were implanted after 2003 with an IVC filter manufactured by Bard or Cook may be eligible for compensation through a lawsuit if the IVC filter failed or caused medical complications, such as organ damage or blood clots.
Manufacturers designed IVC filters to prevent life-threatening blood clots in the lungs called pulmonary embolisms.
However, the U.S. Food and Drug Administration says it has received hundreds of reports of adverse events associated with these devices, including device migrations, filter perforations, filter fractures and embolization, which is movement of the entire filter or fractured fragments to the heart or lungs.
IVC filter lawsuits allege defects in the design of retrievable IVC filters make them more likely to fracture, migrate, tilt or perforate the inferior vena cava, causing severe injury or death.
More than 6,000 lawsuits pending in federal court claim these events are the result of negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty and negligent misrepresentation on the part the manufacturers and their subsidiaries.
In particular, lawsuits against Bard and Cook Medical say the companies are guilty of negligence and manufacturing defective products. According to court documents, the companies knew their products were defective but continued to sell them without telling the public about risks.
IVC filter cases pending in federal court generally allege:
Misrepresentation in marketing
Failure to warn doctors and patients
IVC filter brands named in lawsuits include:
Cook Celect filter, Cook Günther Tulip filter, Bard Recovery filter, Bard G2 filter and Bard G2 Express filter are the five devices most often named in IVC filter lawsuits.
Cook Medical Inc. manufacturers the Celect and Günther Tulip filters. Bard manufactures the Recovery, G2 and G2 Express filters.
As of November 2017, Cook IVC filters were the subject of 3,081 pending lawsuits and Bard devices were named in 3,085 more.
There are two IVC filter multidistrict litigations, or MDLs, happening right now: one for lawsuits filed against Cook and another for lawsuits filed against Bard.
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The U.S. Judicial Panel on Multidistrict Litigation establishes MDLs to centralize many cases with similar claims against a defendant into one judge’s courtroom to simplify the pretrial proceedings.
Lawsuits against Cook have been moved to a court in Indiana. A judge in Arizona is overseeing the Bard MDL.
Although the lawsuits in an MDL are transferred to one court and handled by a single judge, the cases remain individual, meaning each case may be tried separately and may result in a different verdict or settlement.
In October 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal lawsuits filed against Cook Medical into an MDL in the Southern District of Indiana.
At the time, 27 lawsuits were pending in 11 districts. They all claimed that defects in the design of Cook’s IVC filters make them prone to complications.
The panel assigned the MDL to Chief Judge Richard L. Young. It chose Indiana because Cook is headquartered in the state, and it’s “where relevant documents and witnesses are likely to be found,” according to the Oct. 5, 2014, transfer order. In addition, more than half of the actions pending at that time were in the Southern District of Indiana and almost all were before Judge Young.
The MDL (known as MDL -2570 IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation) grew to include 3,124 lawsuits. A total of 3,081 remained pending as of November 2017.
In August 2015, the U.S. Judicial Panel on Multidistrict Litigation ordered all federal cases against C.R. Bard Inc. and Bard Peripheral Vascular be centralized in the District of Arizona under an MDL.
At the time, 22 actions had been filed in 16 different courts. The lawsuits accuse Bard of negligence, among other wrongdoing.
Even though no related action was pending in the District of Arizona, the panel chose the district because Bard is headquartered there. The panel assigned the MDL to U.S. District Court Judge David G. Campbell.
The number of actions filed under MDL-2641 IN RE: Bard IVC Filters Products Liability Litigation surpassed 3,175. As of November 2017, 3,085 lawsuits remained pending.
In November 2017, the judge in the Bard MDL denied the company’s attempt to have all the cases against it dismissed. The company argued the lawsuits were preempted under federal law because the FDA had approved the company’s IVC filters.
Judge David Campbell, in his ruling, found Bard’s argument was “without merit.” His ruling pointed out that Bard’s IVC filters had been approved through the FDA’s 510(k) process. It requires manufacturers to show their medical device is substantially similar to devices already on the market. But the process allows products to be sold without going through the agency’s more rigorous Premarket Approval (PMA) process.
Bard has settled some individual cases for undisclosed amounts, according to court records. Still, neither Bard nor Cook has announced a global settlement to resolve the remaining nearly 5,800 lawsuits.
Between 2013 and 2015, Bard settled at least three IVC filter lawsuits that accused the company of misrepresenting the G2 filter and Recovery filter as safe and for failing to warn patients of the risks associated with the devices.
Lisa Davis sued Bard after a G2 filter implanted in 2006 fractured and migrated to her heart in 2008, causing ongoing heart issues. Davis declined to have open heart surgery to remove the fragment and must take blood thinners for the rest of her life. She claims Bard failed to warn her physician of the G2’s risks and misrepresented the device as safe. She sued for physical trauma, anxiety and impaired ability to earn wages. Davis filed her lawsuit against Bard in 2011 in the U.S. District Court Eastern District of Michigan Southern Division. Attorneys notified the judge on March 6, 2013, that the parties had settled.
Kelly Vlasvich and her husband Chris Vlasvich filed their lawsuit against Bard in 2013 in the U.S. District Court for the Northern District of Illinois. The suit claims a G2 filter implanted in Mrs. Vlasvich in 2009 fractured in 2011. The device migrated to various parts of her body, damaging her heart and lungs. She claims the device caused a loss of normal life, pain, suffering, disability, disfigurement, impairment and emotional trauma. Mr. Vlasvich claims to have suffered a loss of consortium – or society and companionship – with his wife. According to the lawsuit, Bard was negligent in its design and misrepresented the filter as safe and effective. A December 10, 2014, docket entry said the parties were close to settling the case. The parties filed a stipulation of dismissal the following month, and the judge closed the case.
In 2015, Bard settled a case brought by Kevin Philips. The settlement came 10 days after trial began in the U.S. District Court for the District of Nevada. According to the lawsuit, the Bard Recovery IVC filter broke inside Philips’ body and one of the small metal legs traveled to his heart, perforating it. The tear forced him to have open heart surgery and endure a lengthy recovery.
The judge overseeing the Cook IVC filter MDL scheduled a series of settlement talks in 2015 in hopes of resolving the cases before trial. The following year, however, the judge moved forward with pretrial proceedings and selected the first bellwether cases, or test cases, out of the hundreds of Cook IVC filter lawsuits in the MDL. These cases are the first to go to trial and the verdicts in bellwethers may influence the likelihood of a global settlement agreement later.
The first IVC filter lawsuit filed against Cook ended in a victory for the company in November 2017. Two other bellwethers were set to go to trial in 2018.
Parties in the Bard MDL are in the process of preparing for the first group of bellwether trials. No dates had been announced as of November 2017.
Judges pick bellwether cases from a list of recommendations from defendant and plaintiff lawyers. These cases are supposed to represent the majority of IVC filter cases. They may also represent cases that are outside the typical case.
The outcome of these cases helps attorneys gauge a jury’s reaction to the facts presented in trial and can influence result of other cases in the MDL.
Plaintiffs in the Cook trials used Celect and Günther Tulip filters and allege a number of injuries. The bellwether trials began in October 2017.
Hill v. Cook Medical, Inc., et al, 1:14-cv-6016 (Celect)
The first Cook IVC filter bellwether trial lasted three weeks and returned an unanimous verdict for the company on November 9, 2017. Cook Medical picked the case, which involved a Celect filter. In her complaint, Elizabeth Jane Hill of Florida claimed doctors discovered her filter had become embedded in her intestine and had punctured the vena cava vein. Doctors couldn’t remove the filter, and after three years, Hill suffered from “persistent severe gastrointestinal symptoms, fatigue, diarrhea, vomiting and abdominal pain.” Hill bounced from hospital to hospital to have the filter removed. The lawsuit claims Cook concealed the “known risks and failed to warn of known or scientifically knowable dangers.” Following the verdict in favor of Cook Medical, the company's vascular division vice president, Mark Breedlove, said Cook was "pleased with this outcome" and promised the company would "vigorously devend our IVC filters in future trials."
Gage v. Cook Medical, Inc. et al., 1:14-cv-1875 (Günther Tulip)
Gage v. Cook Medical Inc., also a Cook-selected case, is the only case involving the Günther Tulip filter that was selected as a bellwether. In the lawsuit, Arthur Gage says the Günther Tulip filter perforated his vena cava and can’t be removed. According to Cook, about 45 percent of the patients in the MDL had a Günther Tulip implanted. Attorneys for the plaintiffs raised concerns over the fact that both the Hill and Gage cases were selected by Cook as bellwether cases. “To further this end, the court must choose cases that are the most representative of the types of cases at issue in this MDL,” Chief Judge Young said. “Therefore, the court does not consider Hill and Gage to be defense ‘picks’; rather, the court considers them solely as bellwethers.”
Brand v. Cook Medical, Inc. et al., Case No. 1:14-cv-6018 (Celect)
Tonya Brand will be the third plaintiff to go to trial against Cook. Before her scheduled back surgery, 51-year-old Brand was implanted with a Celect filter because she had experienced a deep vein thrombosis in 2007. More than two years after surgery, Brand found out the Celect filter had two fragmented legs, according to her lawsuit. Several attempts to remove the filter failed, and so four years later, she underwent an open surgery. Doctors removed the filter but could not recover the fractured pieces from the filter. The pieces remain in her body.
Some people who received Bard IVC filters filed three class-action lawsuits against Bard in Florida, Pennsylvania and California courts.
The lawsuits argue plaintiffs with Bard Recovery, G2 and G2 Express filters that have not fractured or migrated must receive medical monitoring because of Bard’s negligence, misrepresentation and concealment of data.
The plaintiffs claim people who had one of the devices implanted make up a class that should be compensated for medical monitoring expenses.
In 2016, plaintiffs who still had Bard IVC filters implanted in them filed a lawsuit against Bard seeking class action certification. The complaint was transferred to the Bard IVC filter MDL in the Southern District of Arizona.
In September 2017, Judge Campbell refused to grant class certification, which means the case cannot proceed as a class action.
Campbell concluded the claims fail to satisfy the requirements for certification, and he found the claims lacked cohesiveness.
Class members have different filters that carried different warnings from the manufacturers being sued, and they were implanted at different times, Campbell noted.
A number of factors may influence the amount of compensation plaintiffs receive from filing an IVC filter lawsuit. If a case goes to trial, the jury may consider several questions.
Multiple studies have highlighted the risks of IVC filters. In addition, hundreds of reports submitted to the FDA further underscore the potential dangers of these devices.
A 2013 study in the Journal of the American Medical Association (JAMA) examined the management and complications of IVC filters in 952 patients. About 680 patients received retrievable IVC filters, and doctors were only able to successfully remove 58 of them. Doctors made 13 unsuccessful removal attempts, 11 of which occurred in those who had their filters for more than 85 days
Of the 13 unsuccessful removal attempts:
8 PATIENTS couldn’t have their filters removed because the devices were embedded
3 PATIENTS couldn’t have their filters removed because the filters protruded through a blood vessel
2 PATIENTS couldn’t have filters removed because the devices migrated to an abnormal position
1 PATIENT had a blood clot located inside the filter
A study published in Cardiovascular Interventional Radiology found that 100 percent of Cook’s Celect and Günther Tulip IVC filters punctured patients’ vena cava wall within 71 days of being implanted. The study also found that 40 percent of the filters tilted out of position.
The FDA received 300 reports of adverse events linked to Bard’s Recovery filter alone. Results from a study showed about a quarter of the Recovery filters failed, causing the device to break apart. The device is linked to at least 27 deaths, according to an NBC News investigation.
Combined, the Recovery, G2 and G2 Express filters have a 12 percent fracture rate, a study revealed.
The Lehmann report found that Bard’s IVC filters suffered more complications than its competitors.
Less than a year after the launch of its Recovery filter, Bard received complaints of device malfunctions indicating the legs of the device were prone to break loose and travel to other parts of the body. Although Bard knew about the problem with the IVC filters, the company did not inform the public or the FDA.
The company hired independent consultant Dr. John Lehmann to prepare a report that compared the fracture and migration rate of the new filters to previous models in 2004. In December 2004, Lehmann completed his study that found the Recovery filter experienced complication rates higher than its competitors. Lehmann concluded that further investigation was necessary.
The company’s lawyers distributed copies of the document to employees on a need-to-know basis and stated that it should be kept a secret.
When product liability lawsuits reached courts, the Lehmann report became public. However, Bard argued that the report should remain confidential under the work-product doctrine, a law that would protect the company’s internal documents if they were produced in anticipation for future litigation.
The company’s lawyers accidentally disclosed the Lehmann report during a lawsuit in 2012. In accordance with a federal rule, the defendants asked for a protective order to require the plaintiff’s attorneys to destroy all copies of the Lehmann report in their possession and to prohibit the plaintiff from using the contents of the report in the case.
Numerous court rulings differ on the issue of whether the Lehmann Report is covered by the work-product doctrine. In the case of Giordano v. Bard, a California state court denied Bard’s request for a return of the documents. However, the U.S. District Court of Nevada ruled that the report could not be used in another case.
A 2015 NBC News investigation revealed that Bard may have known of the Recovery filter’s risks before early adverse event reports and the Lehmann report.
When its application for FDA clearance was initially denied in 2002, the company hired a regulatory specialist named Kay Fuller to help it receive clearance. However, Fuller grew concerned about the safety of the device based on early data from clinical trials. She refused support Bard’s request for clearance to market the device.
Yet, Fuller’s name and signature appear on an application for the device, which led to clearance from the FDA. Fuller told NBC she did not sign the form and that the signature on the application was included without her knowledge.
Emily Miller is an award-winning writer who has held editorial positions with reputable print and online publications around the U.S. As the editor of Drugwatch.com, Emily draws on her background as both a patient and a journalist to ensure her team of writers provides consumers with the latest and most accurate information on drugs, medical devices, procedures and related lawsuits. Emily holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science, the Society of Professional Journalists and the Society for Technical Communication.
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