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C.R. Bard faces a class action lawsuit that calls for a medical monitoring program that is designed to help detect IVC filter complications for individuals who had the devices implanted to prevent blood clots from causing a pulmonary embolism.
There are currently more than 600 Bard IVC filter lawsuits pending throughout the federal court system, each involving allegations that individuals suffered severe and sometimes fatal injuries when the small, spider like filters implanted into the inferior vena cava (IVC) migrated out of position, punctured the vein or fractured, causing small pieces to travel to the heart and lungs.
A complaint (PDF) filed late last month seeks class action status to represent thousands of individuals nationwide who received a Bard Recovery, Bard G2, Bard Meridian or Bard Denali filter, and have not yet had the device removed or filed an individual lawsuit over personal injuries suffered in connection with the filter. The lawsuit calls for medical monitoring, and for the manufacturer to pay other damages for selling an unreasonably dangerous and defective medical device.
“[Bard’s] IVC filters are prone to break into parts (fracture) such that struts break away from the device and ultimately can become lodged in a vein, artery, or even an organ, such as the heart or lungs. The filters also tend to break loose from the point of implantation and to migrate to other locations in the bloodstream or to become lodged in the heart or lungs. The filters further have a significant chance of tilting within the IVC, perforating the vena cava and/or causing the formation of blood clots,” according to the lawsuit. “Any and all of these adverse events have the potential of causing serious and life threatening medical conditions for patients implanted with the IVC filters. In so doing, they significantly increase the risks of injury and death for those patients. However, many of these conditions can be asymptomatic in the patient prior to the manifestation of significant and sometimes fatal injuries.”
In the federal court system, all injury lawsuits over Bard IVC filters are currently consolidated as part of an MDL, or multidistrict litigation, which is centralized before U.S. U.S. District Judge David G. Campbell in the District of Arizona for coordinated discovery and pretrial proceedings, including a series of early “bellwether” trials, which are designed to gauge how juries may respond to testimony and evidence that will likely be repeated throughout the cases.
In an order (PDF) issued June 21, Judge Campbell indicated that the Bard IVC filter class action for medical monitoring will be consolidated with other cases in the MDL, since it raises similar questions of fact and law.
The class action lawsuit will have to adhere to a fact discovery deadline that has already been set for October 28, 2016.
As part of the coordinated litigation proceedings, Judge Campbell previously directed the parties to identify two dozen Bard IVC injury cases for part of a bellwether trial group, which will go through case specific discovery and be eligible for early trial dates.
While the outcomes of these bellwether Bard trials will not be binding on other cases in the litigation, they will be closely watched by lawyers involved in the litigation, and they may influence eventual negotiations to reach IVC filter settlements and avoid the need for hundreds of individual trials to be scheduled in courts throughout the U.S. If a medical monitoring program is established for individuals who have not yet experienced an injury, the number of claims filed against Bard would likely increase dramatically, as would the liability exposure for the manufacturer.
In addition to lawsuits over Bard filters, a number of Cook IVC filter lawsuits and Cordis IVC filter lawsuits have been filed against manufacturers of other similar devices, raising nearly identical allegations.