Court Sets Lineup for Cook IVC Filter Bellwether Trials

Cook Celect® IVC Filter
Cook Celect® IVC Filter

US District Judge Richard L. Young, overseeing Cook Medical, Inc., IVC Filters Product Liability
Litigation, MDL 2570, ruled that the first bellwether trial will focus on the Celect IVC filter, and the second on the Gunther Tulip filter.

The current lineup is:

  1. Hill v. Cook Medical, Inc., 1:14- cv-6016-RLY-TAB. In this case, the Celect filter was implanted before Ms. Hill’s scheduled back surgery. She claims the filter migrated and perforated her vena cava and duodenum. She was 57 years old at the time. After at least one failed retrieval attempt, the Celect filter was successfully removed percutaneously two years after implant using advanced retrieval techniques.
  2. Gage v. Cook Medical, Inc., 1:14-cv-1875-RLY-TAB. Mr. Gage was implanted with the Günther Tulip filter after experiencing gross hematuria while on anti-coagulation medicine. He was 61 years old at the time, and has a history of pulmonary embolism and deep vein thrombosis. Mr. Gage alleges that the Günther Tulip filter perforated his vena cava and cannot be removed.
  3. Brand v. Cook Medical, Inc., 1:14-cv-6018-RLY-TAB.  Ms. Brand was implanted with a Celect filter before her scheduled back surgery, as she had experienced a deep vein thrombosis in 2007. She was 51 years old at the time of the implant. More than two years after surgery, she learned that the Celect filter had two fragmented legs. An attempt to remove the filter percutaneously was abandoned after several unsuccessful attempts to snare the hook of the filter from her caval wall. Four years later, she underwent an open surgery, wherein the filter was removed but the fractured pieces from the filter could not be recovered and remain in her body.

900+ cases

More than 900 cases against Cook Medical are consolidated in a multi-district litigation docket (MDL) in the Southern District of Indiana in Indianapolis. The small, umbrella-like devices are implanted for prevention of pulmonary embolism and they perforate the vena cava, migrated out of position or fracture, sending fragments or metal shards into the heart or lungs.

“Gage is more representative than Brand of the types of injuries and retrieval challenges at issue in this MDL,” Judge Young wrote. Furthermore, according to Cook, approximately 45% of the plaintiffs in the  MDL had a Günther Tulip filter implanted. Gage is the only Günther Tulip case selected as a bellwether. “For these reasons, the court finds trying Gage second furthers the goals of the bellwether selection process. Accordingly, Gage will be the second bellwether trial.”

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New Research: IVC Filters Don’t Save Lives in Trauma Patients

Bard Denali IVC Filter
Bard Denali IVC Filter

New research in JAMA Surgery concludes that IVC filters don’t save lives in trauma patients, who are at increased risk of bleeding and thrombosis, and the devices should not be placed in trauma patients in an effort to decrease all-cause mortality.

“The research herein demonstrates no significant difference in survival in trauma patients with vs without placement of an IVC filter, whether in the presence or absence of venous thrombosis. The use of IVC filters in this population 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 study concludes.

See Association Between Inferior Vena Cava Filter Insertion in Trauma Patients and In-Hospital and Overall Mortality by Shayna Sarosiek, MD, Denis Rybin, PhD, Janice Weinberg, ScD, Peter A. Burke, MD, George Kasotakis, MD, and J. Mark Sloan, MD.

Should not be placed in trauma patients

“The use of IVC filters in this population 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 researchers said. “Given the expected morbidity of long-term IVC filter use, filters should be removed as soon as a patient’s contraindication to anticoagulation resolves.”

“Overall, these data indicate that IVC filters should not be placed in trauma patients in an effort to decrease all-cause mortality.”

Litigation against the makers of IVC filters is one of the largest mass torts today. “All these products are defective,” Mass Tort Consultant John Ray said, speaking in a webinar presented by The National Trial Lawyers. “I cannot say that one product is less defective than other.”

  • There are 886 cases in Bard IVC Filter Litigation in MDL 2641 before Judge David G. Campbell in US District Court in Arizona.
  • There are 993 cases in Cook Medical IVC Filter Litigation in MDL 2570 before Chief Judge Richard L. Young in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark.
  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Ray.
  • Similarly, there is no MDL for cases against Rex Medical and Argon Medical. Plaintiffs have filed cases in the Philadelphia Court of Common Pleas before Judge Arnold New, who has assigned them to the complex litigation track.

Venous thromboembolism is a significant cause of death in the United States. Approximately 900,000 patients per year have a clinically significant deep vein thrombosis or pulmonary embolism. Since the invention of the permanent percutaneous IVC filter in 1973 and the retrievable IVC filter in the 1990s, its use has become a standard part of treatment for select patients with acute lower-extremity venous thrombosis who cannot receive anticoagulation.

 

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No Deposition for Bard President over Memo on IVC Filter Study

Jim C. Beasley Group President
Jim C. Beasley
Group President

US District Judge David G. Campbell ruled that plaintiffs in the Bard IVC Filters Products Liability Litigation cannot depose a top company executive about a 2010 memo he wrote to six Bard executives about a filter study.

However, the plaintiffs are free to try again later.

The executive, Jim Beasley, is a group president of C.R. Bard Inc. and was president of Bard Peripheral Vascular Inc. from 2007 to 2012. At the time Beasley was responsible for hundreds of Bard products.

The plaintiffs want to question him about the mystery memo, but the judge said “no” on August 29.  There Are 810 cases pending in MDL 2641, Case No. 15-md-2641 (Click to see sample long form complaints).

“The Court concludes that Beasley ‘is clearly a high-level executive,’ and that the apex doctrine therefore applies,” the judge held.  Klungvedt v. Unum Grp., Case No. 2:12-CV-00651-JWS, (D. Ariz. Feb. 13, 2013). “The relevant questions, then, are ‘whether the executive has unique, first-hand, non-repetitive knowledge of the facts at issue in the case and whether the party seeking the deposition has exhausted other less intrusive discovery methods.’”

The exhibits provided by Plaintiffs:

  • Suggest that someone named Mark was going to talk to Beasley about a filter study.
  • Confirm that Beasley was the author of a management memo written in 2010.
  • Beasley addressed the memo to Tim Ring and copied to at least five others.
  • It contained speculation by Daniel Orms about what Beasley might have known or done in connections with the memo.

However, the materials did not show that Beasley has unique, first-hand, non-repetitive knowledge of the facts at issue in this case, nor that Plaintiffs have exhausted other less intrusive discovery methods to obtain relevant information.

“The Court therefore concludes that Beasley should not be deposed at this time. If Plaintiffs conclude that they can make the required showing at a later point during the discovery period, they may raise this issue again with the Court.”

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New IVC Filter Lawsuit Filed in Arizona MDL

Bard Meridian IVC Filter 2011
Bard Meridian IVC Filter 2011

A woman who was injured by a defective Meridian IVC Filter made by C.R. Bard has filed a lawsuit, according to the Daily Hornet.

The lawsuit was filed by Juliette Boyd, a woman from Florida who was implanted with the Meridian® Vena Cava Filter in September 2012. She is represented by Ben C. Martin of the Law Offices of Ben C. Martin in Dallas, Texas.

She accuses C.R. Bard of negligence for selling a defective medical device, failing to warn about side effects, and concealing safety risks.

It took the FDA 10 years to issue a safety communication stating on May 6, 2014 that “the risk of having an IVC filter in place is expected to outweigh the benefits.” Later that year the FDA started a nine-month investigation and issued two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC-filters facilities.

800 lawsuits

US District Judge David G. Campbell has ordered that cases be heard together in In Re Bard IVC Filters Product Liability Litigation, MDL 2641, where at least 810 lawsuits are pending against C.R. Bard. Another 800 lawsuits are pending in a similar litigation against Cook Medical.

Meridian is a temporary filter that is implanted in the inferior vena cava (IVC). It catches blood clots before they travel to the lungs and cause a pulmonary embolism.

The Meridian is very similar to other IVC filters made by C.R. Bard — including the G2 and Recovery — which have been linked to a 12% fracture risk in recent studies.

The FDA now recommends removing temporary IVC filters within 29-54 days. The longer they remain implanted, the higher the risk of complications.

The case was consolidated in a Multi-District Litigation (MDL No. 2641)

The lawsuit was filed on August 19 in the U.S. District Court for Arizona, Case No. 2:16-CV-02791.

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Federal Court Orders Bellwether Trials in Cook IVC Filter Cases

Cook Celect® IVC Filter
Cook Celect IVC Filter

U.S. District Judge Richard Young ordered that three IVC filter cases pending against Cook Medical go to trial in 2017. The cases will be tried in MDL No. 2570 IN RE: Cook Medical, Inc., in the Southern District of Indiana.

Judge Young on July 19 identified three trial plaintiffs and types of filter:

  • Brand v. Cook Medical, Inc. et al., Case No. 1:14-cv-6018 (Celect)
  • Gage v. Cook Medical, Inc. et al., 1:14-cv-1875 (Günther Tulip)
  • Hill v. Cook Medical, Inc., et al, 1:14-cv-6016 (Celect)

Hundreds of Cook and Cordis IVC Filter cases are already filed, and hundreds of thousands of potential clients nationwide who need attorneys.

Rapacious greed of two companies

The cause of the litigation is the rapacious greed of the two companies competing to get market share, rolling out one defective product after another for the last 16 years, brushing aside reports of patient deaths and lying to the FDA about it.

  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • Bard IVC Filter Litigation is consolidated in MDL 2641 (multi-district litigation docket) in US District Court in Arizona.
  • Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. The federal district court has created a short form complaint.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.

The small, umbrella-like devices are implanted for prevention of pulmonary embolism and they perforate the vena cava, migrated out of position or fracture, sending fragments or metal shards into the heart or lungs.

On May 12, Magistrate Baker denied Cook’s motion for a protective order. “Cook tries to distinguish Bard [Bard IVC Filters Products Liability Litigation, MDL 15-02641-PHX DGC (D. Ariz. April 1, 2016] on the basis that the defendant in that case had received an FDA warning letter, whereas Cook has not. This strikes the Court as the proverbial distinction without a difference. Warning letter or not, case law supports a finding that this information is relevant and discoverable,” he wrote.

 

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IVC Filter Litigation Is the Hot, Trending Practice Area

Lawyer Troy Brenes
Troy Brenes

Litigation involving Cook and Cordis IVC Filters is now the hot, trending practice area for mass tort lawyers, with hundreds of cases already filed, and hundreds of thousands of potential clients nationwide who need attorneys.

“These devices cause the one thing they are design to prevent —  blood clots,” says said Troy Brenes of Aliso Viejo, California, a lawyer who is active in IVC Filter litigation. “They cause the development and increase risk of thrombosis and pulmonary embolism.”

The cause of the litigation is the rapacious greed of the two companies competing to get market share, rolling out one defective product after another for the last 16 years, brushing aside reports of patient deaths and lying to the FDA about it.

  • Cordis IVC Filter Litigation is centered in the California state courts, where hundreds of cases are up for consolidation. Cordis Corporation is organized under the laws of Florida, with its principal place of business in Fremont, California.
  • Bard IVC Filter Litigation is consolidated in MDL 2641 (multi-district litigation docket) in US District Court in Arizona.
  • Cook Medical IVC Filter Litigation is consolidated in MDL 2570 in US District Court for the Southern District of Indiana. The defendants are Cook Medical, LLC and Cook Inc., both of Bloomington, IN, and William Cook Europe APS, Bjaeverskov, Denmark. The federal district court has created a short form complaint.
  • There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” says Mass Tort Consultant John Ray.

Brenes and John Dalimonte of Boston spoke on a recent webinar about the litigation sponsored by the Consumer Attorney Marketing Group. 

Plaintiff Numerosity

John Dalimonte
John Dalimonte

The number of potential plaintiffs is immense: Since 2000, Cook has sold 264,006 Tulip Filters and 129,089 Celect Filters. Attorneys Brenes and Dalimonte estimate that 200,000 Cordis filters have been inserted into patients.

Settlement values of the cases are unknown, and a settlement conference on June 7 with Cook “went nowhere.” The first bellwether trials are scheduled for next year.

IVC filters are small, cage-like devices that are inserted into the inferior vena cava – a major vein leading directly to the heart. They were supposed to capture blood clots and prevent them from reaching the lungs.

However, Dalimonte identified three issues with the Cook Tulip and Celect IVC Filters:

  • Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
  • Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
  • Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.

“There are a lot of cases out there,” Dalimonte says, because the manufacturers conducted off-label marketing directly to bariatric patients, trauma patients and orthopedic surgery patients.

Brenes and Dalimonte will be speaking at the upcoming AAJ annual convention, July 22-25 in Los Angeles. 

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Class Action Charges Company Lied to Cover Up Defective Bard IVC Filter

Bard Recovery IVC Filter
Bard Recovery IVC Filter

A federal judge consolidated a new class action lawsuit — brought by patients in 16 states against C.R. Bard, Inc., makers of the defective Bard IVC Filter — into a multidistrict litigation docket in Arizona.

The class action charges that Bard executives:

  • Promoted its defective blood clot filters starting in 2004 despite immediate and many reports of patient deaths.
  • Lied to the government about the widespread extent of patient deaths and adverse events.
  • Lied to its own sales force about the dangers of the medical device to preserve its market share and to boost its stock price.
  • Repeatedly introduced new models that had the same design and manufacturing defects as the older models.
  • Used a regulatory shortcut to bypass the FDA’s more rigorous approval process for new devices, and obtained “clearance” under Section 510(k) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act

Tragically, it took the FDA 10 years to issue a safety communication stating on May 6, 2014 that “the risk of having an IVC filter in place is expected to outweigh the benefits.” Later that year the FDA started a nine-month investigation and issued two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC-filters facilities.

US District Judge David G. Campbell, acting on a stipulation by the parties on June 22, 2016, ordered that the case be heard together with hundreds of other cases in In Re Bard IVC Filters Product Liability Litigation, MDL 2641.

The case is Maria E. Barraza v. C.R. Bard, Inc., and Bard Peripheral Vascular, Inc., Case 2:16-cv-01374-DGC. The lead attorneys are Ramon R. Lopez of Lopez McHugh in Newport Beach, CA, and Wendy R. Fleishman of Lieff Cabraser Heimann & Bernstein of New York.

In a Master Answer, Bard denies that there is any factual or legal basis for relief.

Medical monitoring

The plaintiffs are seeking an injunction to create a court-supervised medical monitoring fund for plaintiffs. It would pay for:

  1. A notice campaign to all class members informing them of the availability and necessity of the medical motoring protocol
  2. A “catheter venography” to be performed on every class member who still has a Bard IVC filter installed by an interventional radiologist who will consult with the class member’s physician within 60 days to decide if retrieval is clinically necessary.

Also the plaintiffs seek +$5 million in damages for negligent design and manufacture, and fraudulent concealment of dangers Bard was aware of.

The lawsuit outlines the history of IVC filters that Bard rolled out:

  • Recovery Filter System, launched in 2004
  • G2 Filter System (permanent), launched in 2005
  • G2 Express System (removable), launched in 2008
  • Eclipse Filter System, launched in 2010
  • G2X System, launched in 2011
  • Meridian Filter System, launched in 2011
  • Denali Filter, launched in 2013

“The design of the Meridian is based on the Eclipse filter, which, in turn, is based entirely on the G2 filter, which, in turn, is based on the Recovery Filter,” the complaint says. All the “IVC filters were fracturing, perforating, migrating, and/or tilting in the patients in which they were implanted.”

“These devices are potential ticking time bombs implanted in unsuspecting patients.” An IVC filter is designed purportedly to filter or “catch” blood clots that travel from the lower portions of the body to the heart and lungs.

Patient injuries include:

  • Death
  • Hemorrhage
  • Cardiac/pericardial tamponade (pressure caused by a collection of blood in the area around the heart)
  • Cardiac arrhythmia and other symptoms similar to myocardial infarction
  • Severe and persistent pain
  • Perforations of tissue, vessels and organs

FDA shortcut

Read our shocking report: How did IVC Filters Obtain FDA Approval without Proving they were Safe and Effective

To rush the devices to the market, Bard repeatedly used the Section 510(k) shortcut to get a “clearance,” from the FDA, claiming the filter was substantially similar to its existing device. A 510(k) review is completed in an average of 20 hours by the FDA.

Bard avoided the more rigorous “premarket approval” (PMA) process, which must include data sufficient to demonstrate that the IVC Filters is safe and effective. The FDA takes 1,200 hours to complete a PMA review.

Section 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed quickly.

Once placed on the market, Bard immediately became aware of numerous confirmed events where its Recovery filter fractured, migrated, or perforated the inferior vena cava, caused blood clots, and caused serious injury, including death. About a month after the full-scale launch of the Recovery filter, on February 9, 2004, Bard received notice of the first death associated with this filter.

On July 9, 2004, a Bard safety analysis found that the Recovery filter had a reported failure rate that was 28 times higher than all other IVC filters.  Peer-reviewed medical literature found that among 363 patients implanted with the Recovery filter and 658 patients implanted with the G2 filter, the devices experienced fracture rates of 40% and 37.5%, respectively, after five and a half years.

A review of the FDA MAUDE database from 2004 through 2008 shows that Bard IVC Filters are responsible for the following percentages of all IVC filter adverse event reports:

  • 50% of all adverse events
  • 64% of all occurrences of migration of the IVC Filters
  • 69% of all occurrences of vena cava wall perforation
  • 70% of all occurrences of filter fracture.

Cover-up campaign

Instead of pulling the Recovery filter off the market, Bard started a coverup. By April of 2004, at least three deaths had been reported to Bard. The company concealed this information from doctors and patients and hired the public relations firm Hill & Knowlton to address anticipated publicity that could affect stock prices and sales.

Bard lied to its own sales force to keep pushing the IVC filters. By December 2004, Bard’s own internal safety procedure deemed the Recovery filter not reasonably safe for human use. Yet the company gave mandatory scripts to its Bard IVC filter sales force, which required salespeople to falsely tell physicians that the Recovery filter was safe because it had the same reported failure rates as all other filters, according to the complaint.

Meanwhile Bard gave false information to the FDA’s MAUDE adverse-events database. The FDA discovered that Bard had reported multiple serious injuries and a death as non-injurious “malfunctions.”

FDA finally acts

In 2010, the FDA issued an advisory to physicians and clinicians noting that it had received 921 device adverse event reports involving IVC filters. But the FDA said only that it was “concerned” about the retrievable IVC filters. It recommended that physicians consider removing the filter as soon as protection from a pulmonary embolism is no longer needed.

In 2014, the FDA issued Bard two Form “483” letters in which it identified various deficiencies and violations by Bard at its IVC filter facilities. An audit showed that Bard had underreported 274 out of 939 adverse events.

Finally, on May 6, 2014, the FDA issued an updated safety communication about IVC filters. The FDA reported that “the risk of having an IVC filter in place is expected to outweigh the benefits.”

Accordingly, the plaintiffs’ proposed Medical Monitoring Protocol aims to reduce complications by aiding in the detection and remediation of any malfunction and also generally provides awareness of the issue so it can be investigated. Without this protocol, many if not most patients implanted with these IVC Filters will not even be aware of the serious risk they are in.

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FDA Warns Public about Dangerous IVC Filter Side Effects

Bard Denali IVC Filter 2013
Bard Denali IVC Filter 2013

In a public safety communication, the U.S. Food and Drug Administration (FDA) says it has received approximately 920 adverse event reports related to the use of IVC filters, It issued a public report to inform medical professionals and patients about the potential risks associated with using the small, cage-like device. Adverse events reported by the FDA include:

  • Filter fracturing of the device
  • Migration of the pieces
  • Embolization of fractured device or device components
  • Tearing of the inferior vena cava vein.

Cordis IVC Filter Litigation is consolidated in California State Court. Bard IVC Filter Litigation is consolidated in MDL 2641. Cook Medical IVC Filter Litigation is consolidated in MDL 2570.

There is no MDL for Boston Scientific Corp IVC Filter Litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be formed in an effort to form an MDL,” said Mass Tort Consultant John Ray.

According to one of the many product liability cases filed against IVC Filter manufacturers:

“Defendants knew or should have known that its Cook Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death to patients.”

The case is Olenda Homes et al. v. Cook Medical Inc. et al. (Case No. 5:16-cv-00066).

Patients who cannot use traditional blood-thinning drugs are usually the typical users of IVC filters. The devices are surgically implanted into a patient’s inferior vena cava vein and are designed to catch blood clots from the legs before they migrate to the heart and lungs, which could cause a pulmonary embolism if it reached these important organs. The filters are meant to only be used temporarily, according to the FDA, and hold the clot until it naturally disappears and until the threat of blood clots is no longer an issue.

IVC filters have come under more intense scrutiny and have been the subject of many lawsuits due to allegations that they have fractured with pieces subsequently migrating away from the original insertion point to other parts of the body. The pieces can tear veins and organs, and embed in other “high risk” areas of the body where they cannot be surgically removed, thus causing significant and long-term risks for the patient.

In its report, the FDA identifies a number of potential symptoms of migrating pieces that patients should be on guard for that include out of the ordinary heart rhythms, dizziness, fainting, heart palpitations, and chest pain.

 

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Bard IVC Filter Lawsuits Move Forward, as MDL Court Approves Master Long Form and Short Form Complaints

 

Bard Recovery IVC Filter
          Bard IVC Filter MDL

Dozens of IVC filter lawsuits involving C.R. Bard Inc.’s retrievable inferior vena cava (IVC) filters continue to move forward in the multidistrict litigation underway in the U.S. District Court, District of Arizona. According to a Case Management Order dated December 17th, the Court has approved the use of Master Long Form and Short Form complaints. Beginning on December 28th, any plaintiff whose case would be subject to transfer to the multidistrict litigation may file directly in the Court via the Short Form Complaint. (In Re: Bard IVC Filters Products Liability Litigation – MDL No. 2641)

“Our firm is investigating a number of cases involving injuries allegedly caused by the tilting, fracture or migration of Bard IVC filters. The adoption of the Master and Short Form Complaints will do much to streamline the process for filing a claim in the federal litigation,” says Sandy A. Liebhard LLP, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently evaluating IVC filter lawsuits on behalf of individuals who may have been seriously injured by these products.

Pulmonary embolism

IVC filters are implanted in the inferior vena cava in patients at risk for a dangerous type of blood clot called a pulmonary embolism. Once implanted, the wire, cage-like device captures blood clots before they can travel to the lungs. Retrievable products, such as C.R. Bard’s Recovery and G2 IVC filters, are intended to be removed once the threat of pulmonary embolism has passed.

Court records indicate that at least 72 Bard IVC filter lawsuits have been filed in the litigation now underway in Arizona. Plaintiffs claim that a number of the company’s retrievable filters, including the Recovery and G2 devices, are associated with high rates of fracture, migration and tilting, which may result in perforation of the inferior vena cava, embolization and other life-threatening complications. They further allege that C.R. Bard has failed to provide doctors with adequate warnings regarding the importance of filter removal, as failure to retrieve an IVC filter in a timely manner greatly increases the risk of injury and complications.

Since 2010, the U.S. Food & Drug Administration (FDA) has issued two safety alerts regarding the use of retrievable IVC filters. In March 2010, the agency disclosed that it had received more than 900 adverse event reports involving the devices, including incidents of migration, fracture and embolization, and perforation of the inferior vena cava. In May of last year, the FDA issued a second notice to remind doctors that retrievable IVC filters should be removed within 29 to 54 days of their implantation.

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