IVC Filter Lawsuits: FDA Warning Letter Sent To C.R. Bard For Violations And Failure To Warn Of Its IVC Filer Devices

   

Bard G2 IVC Filter Lawsuits Allege That The Recovery, G2, and Other Retrievable IVC Filters Marketed By C.R. Bard, Inc., Allegedly Caused Serious Complications Including Perforation Of The Heart, Lung And Other Organs.

bard-ivc-filter-lawsuit-southern-med-lawIVC filter lawsuits have been filed across the country alleging C.R. Bard Inc.’s retrievable inferior vena cava filters can cause serious complications such as heart or lung perforation, hemorrhagic pericardial effusion, other hemorrhage, cardiac tamponade or pericardial pamponade, punctured vena cava an even death.

Southern Med Law has recently learned the U.S. Food and Drug Administration (FDA) has issued a warning letter to Bard citing a number of violations and their failure to warn of complications from their IVC filter. The July 13 IVC filter warning letter issued from the FDA’s Los Angeles district office, claimed the company misfiled consumer complaints, including a death, and manufactured its Recovery Cone Removal System Model RC-15 without first receiving marketing clearance or approval, which violates the federal Food, Drug and Cosmetic Act. The warning letter also stated that Bard failed to inform the FDA about medical device malfunctions, and filing complaints as malfunctions that should have been filed as serious injuries. The FDA warned Bard that until the company correct the violations addressed in the warning letter, the FDA will not clear or approve any premarket submissions for high-risk Class III medical devices “to which the non-conformances are reasonably related.”
[fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm, July 13, 2015]

The law firm is currently investigating claims on behalf of individuals who experienced such life-threatening injuries as punctured vena cava, perforated aorta and perforation of the heart, lung or other organs, allegedly due to Bard IVC filters. To schedule a free, no-obligation legal consultation, call Southern Med Law today at 205-547-5525.

The FDA’s warning letter also mentioned Bard’s Quality System Regulation violations at its two facilities that included a complaint about embolization of a detached filter arm related to the G2 IVC was filed “as a malfunction Medical Device Report and should have been filed as a death.” Additionally, Bard’s Tempe facility was cited for failing to inform the FDA within 30 days of receiving complaints or information suggesting that one of its devices, the IVC Denali Filter Delivery System, malfunctioned and is likely to lead to death or serious injury.

Bard said in its latest Securities and Exchange Commission (SEC) filing, that the FDA’s warning letter stemmed from the agency’s two inspections of Bard’s facilities in October 2014 and November 2014. While the company said it “intends to fully implement corrective actions to address the concerns identified in the Warning Letter,” the company “cannot give any assurances that the FDA will be satisfied with its response to the Warning Letter or to the expected date of resolution of matters included in the Warning Letter.”
[sec.gov/Archives/edgar/data/9892/000119312515262438/d932880d10q.htm, July 24, 2015]

Bard IVC Filter Lawsuits

Court documents indicate IVC filters are small devices that are implanted into the inferior vena cava to catch blood clots that form in the deep veins and stop the clots from traveling to the heart or lungs. The IVC filter lawsuits assert that Bard’s products are associated with an increased risk of fracturing, titling within the inferior vena cava, perforating the wall of the inferior vena cava and migrating through the body. The IVC filter lawsuits assert that the Bard’s G2 IVC filter devices lack efficacy and may actually increase the risk of pulmonary embolism. The complaints allege that Bard IVC filters are defectively designed and the company failed to adequately warn doctors and their patients about the risks associated with its medical devices.

In May, a motion was filed by plaintiffs involved in Bard IVC filters lawsuits seeking to transfer 25 pending lawsuits to either the U.S. District Court, Northern District of Texas or the U.S. District Court, District of Nevada for coordinated pretrial proceedings. The U.S. Judicial Panel of Multidistrict Litigation is scheduled to hear oral arguments on the consolidation motion on Thursday, July 30. (In Re: Bard IVC Filters: Product Liability Litigation – MDL No. 59)

About Southern Med Law And Filing An IVC Filter Lawsuit

Southern Med Law Is a Full Service Law Firm Providing Legal Representation To Men and Women across the country in lawsuits regarding personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Southern Med Law
2224 1st Ave., North
Birmingham, AL 35203
Phone: (205) 547-5525
Fax: (205) 547-5526
francois@southernmedlaw.com
www.southernmedlaw.com

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