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Former recipients of retrievable IVC filters – devices designed to capture blood clots before they enter the lungs – filed legal claims against manufacturers for poor design, manufacturing and failing to warn of risks. Faulty filters punctured veins, fractured and migrated to other parts of the body causing complications.
Plaintiffs filed the first lawsuits against Bard in California and Pennsylvania state courts in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) consolidated lawsuits against Cook from 11 districts to an MDL in the Southern District of Indiana. The number of lawsuits against Cook has increased to more than 100.
In February 2015, C.R. Bard settled the case of Kevin Philips 10 days after the trial began. According to the lawsuit, the Bard Recovery IVC filter broke inside his body and one of the small metal legs traveled to his heart, perforating it. The tear forced him to have open heart surgery and a lengthy recovery.
The U.S. Judicial Panel on MDL consolidated lawsuits against Bard to the U.S. District Court District of Arizona in August 2015. More than 50 lawsuits are pending in the MDL.
A number of lawsuits are still pending in federal and state courts.
Various lawsuits claim negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty and negligent misrepresentation on the part the companies and their subsidiaries.
In August 2016, Judge U.S. District Judge Richard L. Young in the Southern District of Indiana picked the first bellwether cases out of hundreds of Cook IVC filter lawsuits in multidistrict litigation. The judge scheduled the first trials for 2017. Plaintiffs in these trials used Cook's Celect and Günther Tulip filters.
The first plaintiff to go to trial will be Elizabeth Jane Hill of Florida. Doctors discovered Hill's filter imbedded in the intestine and punctured the vein causing "persistent severe gastrointestinal symptoms, fatigue, diarrhea, vomiting and abdominal pain."
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. Jury verdicts in bellwethers may also influence the likelihood of a global settlement agreement later on.
Claimants 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 had not fractured or migrated must receive medical monitoring because of Bard’s negligence, misrepresentation and concealment of data. The plaintiffs claim everyone who had one of the devices implanted in them make up a class which should be compensated for medical monitoring expenses.
While there are class actions pending, other attorneys instead chose to file individual lawsuits for consolidation in multi-district litigation (MDL). According to attorneys, class actions may force plaintiffs to take lower recoveries while paying higher attorney's fees. Currently, the IVC MDLs for Bard and Cook have more than 1,600 cases combined.
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.
Kelly Vlasvich and her husband Chris Vlasvich filed a lawsuit against Bard after 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 to have suffered a loss of normal life, pain, suffering, disability, disfigurement, impairment and emotional trauma. Mr. Vlasvich claims to have suffered a loss of consortium – society and companionship – with his wife. According to the lawsuit, Bard was negligent in its design and misrepresented the filter as safe and effective.
Larry Johnson and his wife Brenda Johnson accused Cook of recklessly designing, testing and manufacturing its Celect filter. A doctor implanted the filter in Mr. Johnson after a knee surgery in 2010 and it fractured and migrated to his heart in 2014. Mr. Johnson lost consciousness while driving and underwent three surgeries as a result of the complication, according to the lawsuit. The complaint seeks damages for Mr. Johnson’s pain, emotional suffering, inability to enjoy daily living, scarring and lost wages and Mrs. Johnson’s loss of consortium.
Currently, there are no settlement and verdicts and IVC filter litigation is ongoing. According to attorneys, plaintiffs are hopeful that an upcoming conference could lead to settlement in the MDLs. Initially, the judge set the date for March 2016 but later postponed it to give defendant attorneys more time to review medical studies. If negotiations fail, the cases will proceed to trial.
A number of factors may influence the amount of compensation plaintiffs receive after filing an IVC filter lawsuit.
If the case goes to trial, the jury will also weigh the following damages:
Were there any lost wages incurred by the patient or caregivers?
If the case is an IVC filter wrongful death case, how many people were dependent on the person who died?
What are the past and future medical expenses, pain and anguish caused by IVC filter injuries?
The seriousness of IVC filter complications such as vein perforation or filter migration. For instance, did the injury require surgery or hospitalization?
Did the plaintiff's spouse suffer loss of companionship?
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:
Less than a year after the launch of the 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. 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.
Although Bard knew about the problem with the IVC filters, the company did not inform the public or the FDA. In December 2004, Lehmann completed his study which 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 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 messed up when they accidentally disclosed the Lehmann report during a lawsuit in 2012. The defendant’s lawyers argued the plaintiff’s lawyers should return or destroy the reports.
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.
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. Numerous court rulings differ on the issue of whether the Lehmann Report is covered by the work-product doctrine.
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.
However, Fuller’s name and signature appears 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.