Manufacturers designed IVC filters to prevent life-threatening blood clots in the lungs called pulmonary embolisms (PEs). However, the U.S. Food and Drug Administration (FDA) 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 fracture fragments to the heart or lungs.
IVC filter lawsuits 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 C.R. Bard, Cook Medical and Boston Scientific 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.
Devices named in lawsuits include:
- Cook Celect filter
- Cook Günther Tulip filter
- Bard Recovery filter
- Bard G2 filter
- Bard G2 Express filter
- Boston Scientific Greenfield filter
Cook Medical IVC Filter Litigation
By 2014, nearly 30 lawsuits in about a dozen federal court districts alleged that defects in the design of Cook’s IVC filters make them more likely to fracture, migrate, tilt or perforate the inferior vena cava, causing injury.
The number of Cook IVC filter lawsuits pending in federal court swelled to more than 2,570 as of Septemb2017.
Cook Medical IVC filter cases pending in federal court generally allege:
- Defective design
- Misrepresentation in marketing
- Failure to warn doctors and patients
Cook Cases Centralized in Federal Court
In October 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated federal lawsuits filed against Cook Medical into a multidistrict litigation (MDL) in the Southern District of Indiana. At the time, 27 lawsuits were pending in 11 districts. By establishing an MDL, the panel aimed to centralize the many cases with similar claims against one defendant into one judge’s courtroom to simplify the pretrial proceedings.
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 Chief Judge Young.
At its peak, the MDL (known as MDL -2570 IN RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation) included 2,690 lawsuits.
In 2015, Chief Judge Young scheduled a series of settlement talks 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. 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.
Celect and Günther Tulip Bellwether Trials
Chief Judge Young scheduled the first bellwether trials for 2017. Plaintiffs in these trials used Cook’s Celect and Günther Tulip filters and allege a number of injuries. A study published in Cardiovascular Interventional Radiology found that 100 percent of Celect and Günther Tulip IVC filters punctured patients’ vena caval wall within 71 days of being implanted. The study also found that 40 percent of the filters tilted out of position.
According to an order signed by Chief Judge Young, the three cases set for trial in 2017 are:
October 23, 2017
Hill v. Cook Medical, Inc., et al, 1:14-cv-6016 (Celect)
The first plaintiff to go to trial will be Elizabeth Jane Hill of Florida. Cook Medical picked the case, which involves a Celect filter. According to Hill’s complaint, doctors discovered Hill’s filter imbedded in the intestine and punctured the vein. They 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. Now, she suffers from “narrowing at the explant site of the inferior vena cava and the bowel.” The lawsuit claims Cook concealed the “known risks and failed to warn of known or scientifically knowable dangers.”
April 30, 2018
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.”
September 10, 2018
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.
The Hill and Gage bellwether cases are in the discovery phase, which is scheduled to be completed by June 22, 2017. Discovery for the Brand case is set to end by November 20, 2017.
Status of Cook IVC Filter Litigation
The Hill and Gage bellwether cases are in the discovery phase, which is scheduled to be completed by June 22, 2017. Discovery for the Brand case is set to end by November 20, 2017. As of September 2017, 2,650 actions remained pending in the MDL.
The Cook Medical IVC filter cases pending in the MDL generally allege:
- Defective design
- Misrepresentation in marketing
- Failure to warn doctors and patients
Bard IVC Filter Litigation
Hundreds of people who say C.R. Bard’s IVC filters cause injuries have filed lawsuits against the company. According to court records, Bard has settled some individual cases for undisclosed amounts. Still, more than 2,213 cases remain pending in federal and state court. The lawsuits accuse Bard of negligence, among other wrongdoing.
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.
According to the lawsuit, Bard was negligent in its design and misrepresented the filter as safe and effective.
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.
Class Action Lawsuits
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 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 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.
Federal Multidistrict Litigation
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, alleging that defects in the design of Bard’s retrievable IVC filters make them more likely to fracture, migrate, tilt or perforate the inferior vena cava, causing injury. 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 Judge Campbell.
Defects in the design of Bard’s IVC filters make them more likely to fracture, migrate, tilt, or perforate the inferior vena cava, causing injury.
The number of actions filed under MDL-2641 IN RE: Bard IVC Filters Products Liability Litigation surpassed 2,630. As of September 2017, 2,563 actions remained pending, and parties were in the process of selecting six cases to serve as bellwether cases. According to court documents, bellwether trials are to begin in fall 2017.
Report Revealed Bard Knew of Risks
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.
Disclosure of the Lehmann Report
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 Lehmann report found that Bard’s IVC filters suffered more complications than its competitors.
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.
Bard May Have Forged Signature on FDA Application
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.
Boston Scientific IVC Filter Wrongful Death Lawsuit
Boston Scientific was hit with a product liability lawsuit in 2015 over allegations that its Greenfield Vena Cava filter caused severe internal injuries and death. The family of Cinthia K. Ratliff filed the wrongful death lawsuit in the U.S. District Court for the Southern District of Ohio on Jan. 12, 2015.
According to allegations raised in the wrongful death lawsuit, design defects with the Boston Scientific Greenfield Vena Cava filter caused the device to fail and perforate her vena cava, resulting in severe internal bleeding, from which Ratliff died on May 3, 2013. According to an autopsy performed, the immediate cause of death was determined to be “Perforation of Inferior Vena Cava by Greenfield Filter with Retroperitoneal Hemorrhage.”
According to the lawsuit, Ratliff received the IVC filter in April 2004 for treatment of blood clots in the legs known as deep vein thrombosis. The device failed and punctured Ratliff’s vena cava, resulting in severe internal bleeding and causing her death on May 3, 2013. The family claims the device was defective and that Boston Scientific knew or should have known that the device carried the risk of fracturing, migrating, perforating the vena cava and causing serious injury or death, according to the complaint.
Study Supports Claims of IVC Complications
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
Factors That Influence IVC Filter Compensation
People are filing lawsuits against the manufacturers of IVC filters to hold them accountable for the injuries their devices allegedly cause. They also are filing lawsuits to secure compensation for their pain and suffering, lost wages and medical expenses, among other damages. 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. These include:
- 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?
- How serious is the IVC filter complication and did the injury require surgery or hospitalization?
- Did the plaintiff’s spouse suffer loss of companionship?
Emily Miller 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 and the American Association for the Advancement of Science. Emily was diagnosed with a chronic illness as a child and has firsthand experience with many of the topics she writes about as a member of the Drugwatch team. She is an award-winning journalist who has reported on health and legal news for reputable organizations, including the South Florida Sun Sentinel, San Antonio Express-News, UF Health News and Reporters Committee for Freedom of the Press. She draws on her background as both a patient and a journalist to help readers understand complex health and legal topics.