IVC FIlter

  • IVC Filters Side Effects Lawsuit - Medical Record Review | Neural IT

An Inferior vena cava filter (IVC filter), earlier popularly known as Greenfield filter,  is a medical device implanted in the inferior vena cava just below the kidneys to capture blood clots, preventing them from reaching the heart and lungs, thereby, safeguarding against life-threatening pulmonary emboli (PE). IVC filters were only cleared for use through the 510(k) process since 1976 and are not approved by the Food and Drug Administration (FDA). C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, Bard) and Cook Incorporated, Cook Medical LLC, and William Cook Europe ApS (collectively, Cook) are the main manufacturers of retrievable IVC filters. Other manufacturers include Rex Medical, Johnson & Johnson, ALN, B. Braun Medical, and Rafael Medical.

The IVC Filter deployment is done by interventional radiologists or vascular surgeons. It is generally recommended to patients for whom anticoagulation therapy is contraindicated or ineffective.

Serious Alleged Injuries may include:

  • Device-associated morbidity
  • Device migration
  • Recurrent DVT/PE
  • Filter fracture
  • Thrombotic complications
  • Insertion-site thrombosis
  • Perforation of the vena cava
  • Filter embolization
  • Vena cava thrombosis

FDA SAFETY WARNINGS:

The FDA received nearly 1000 adverse event reports related to vena cava filter side effects.

In 2005, the Greenfield Vena Cava Filter produced by Boston Scientific was recalled by the FDA, which was terminated in November 2006.

On August 9, 2010, an Advisory Letter was released by the FDA, recommending health care providers to consider removing the temporary filter as soon as protection from a PE is no longer needed.

In 2013, the FDA announced a recall mentioning a labeling correction of a retrievable IVC filter manufactured by Cordis Corporation.

On May 6, 2014, the FDA recommended removal of temporary IVC filters within 29-54 days through the release of another Advisory letter.

In 2015, the FDA sent a warning letter to C.R. Bard Inc. for violations and failure to warn of its IVC filter devices.

Lawsuit Allegations:

Two MDLs have already been formed each with more than 1500 cases.

MDL No. 2570-RE: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Products Liability Litigation, formed in October 2014. The Plaintiffs allege defect, misrepresentation in marketing, and failure to warn doctors and patients. The cases are co-ordinated in the Southern District of Indiana and assigned to Judge Richard L. Young and Magistrate Judge Tim A. Baker.  The first bellwether for Cooks IVC Filter trial that began on October 23, 2017, went in favor of the defendant. The second bellwether is scheduled for April 30, 2018, and the third on September 10, 2018.

MDL: 2641-IN RE: Bard IVC Filters Products Liability Litigation was formed in August 2015, in the U.S. District Court District of Arizona presided by U.S. Federal Judge David G. Campbell.  The plaintiffs claim that the Bard filters injured them. The first trial in this is scheduled for March 13, 2018, and the second trial in that litigation will get underway on May 15, 2018.

Class action suits have also been filed against Bard accusing the company of negligence, concealment, and misrepresentation of data concerning the safety of its filters.

Evidences:

  • Usage of IVC filters in operative records.
  • Indications for the usage of IVC filter from medical records
  • Evidence of injury in follow up medical records

Medical Record Review and claim validation of IVC FIlter case should take approximately 6 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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