Issuing several orders about discovery and trial dates, US District Judge Dennis G. Campbell is pushing forward C.R. Bard IVC Filter Litigation in MDL 2641 consolidated in Arizona federal court.
- The defendants failed to conduct appropriate testing, including human clinical testing, to determine how the devices actually functioned in the body.
- Published medical studies have found many complications including fracture, device migration, perforation of the vena cava wall, organ penetration, and increased risk for venous thrombosis.
- The defendants misrepresented the risks with retrievable ICVs and failed to issue appropriate safety warnings to patients and physicians.
At least 27 deaths have been associated with Bard’s Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade. Government data shows about 300 other non-fatal problems have also been reported with the Recovery.
Even as death and injury reports were climbing, the company decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.
Following the fourth Case Management Conference, the court set time, place and manner limitations on depositions. In one order on June 21, the court said, “Any Federal Rule of Civil Procedure and/or Local Rule purporting to limit the number of depositions shall not apply in this MDL proceeding. If either side believes that the other is taking unnecessary or irrelevant depositions they may bring the issue to the Court for appropriate resolution.”
In a second order on June 21, Judge Campbell reaffirmed the October 28, 2016 fact discovery deadline. He said he will consolidate a recently-filed a medical monitoring class action, Barraza, et al. v. CR Bard, Inc., et al., Case No. CV-16-1374-PHX-DGC (D. Ariz. May 5, 2016).
The next Case Management Conference on August 23, 2016 in Phoenix.
The FDA issued a warning letter one year ago citing Bard with a number of violations and their failure to warn of complications from their IVC filter. It charged that:
- 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 federal law.
- Bard failed to tell the FDA about medical device malfunctions, and filing complaints as malfunctions that should have been filed as serious injuries.
- Until the company correct the violations, 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.”
Cases set for trial
The court also set several cases for trial:
- By June 29, 2016, the parties will exchange of lists identifying 24 representative cases each selected from the Initial Plaintiff Pool. Those 48 cases will constitute Discovery Group 1.
- By December 9, 2016, the parties will exchange lists of 10 cases selected from Group 1. The parties can each designate 4 cases on those lists for automatic inclusion in Discovery Group 1. After exchange of lists, the parties will confer to name the remaining 4 additional cases that will be included in Discovery Group 1.
- By December 16, 2016, the parties will complete submit a list of twelve 12 cases they jointly recommend as Discovery Group 1.
- By March 1, 2017, the parties will exchange lists of 6 proposed selections from Discovery Group 1 for bellwether plaintiffs. The parties will confer to agree upon a group of 6 cases to constitute Bellwether Group 1.
- After this group is confirmed, trial dates will be set.