Product News and Recalls

Lopez McHugh IVC Trial Ends With Settlement

On January 26, 2015, Lopez McHugh represented a plaintiff in the second lawsuit in the nation to proceed to trial against Bard for its defective inferior vena cava filters. Ramon Rossi Lopez was lead trial counsel in the case, which involved a Recovery Filter that migrated to and punctured a hole in the plaintiff’s heart, leading to emergency open heart surgery. After 11 days of trial, Bard made a confidential settlement offer, which was accepted by the Plaintiff.

At trial, Lopez McHugh attorneys presented evidence that Bard knew that the Recovery Filter was not reasonably safe for human use and exposed patients to significantly higher risks than other available IVC filters. This evidence included:

  • By early 2004, Bard was aware that failures of the Recovery filter were causing patient deaths and severe injuries.
  • Multiple internal tests in early 2004 revealed the Recovery filter failed to meet its own minimum safety specifications.
  • Bard’s testing also revealed that the filter was substantially more likely to dislodge and migrate within the body when impacted by blood clots compared to other available IVC Filters.
  • In March 2004, two of Bard’s own physician consultants warned Bard that the Recovery was a “wimpy” filter that needed a better design to assure stability.
  • In July 2004, Bard’s own internal analysis revealed that the Recovery filter was reported to fracture at a rate 28.3 times higher than all other devices combined.
  • In December 2004, Bard’s own internal analysis revealed that the Recovery filter was reported to cause death, fracture, migrate, and perforate the vena cava at rates that were substantially higher than all other available IVC filters. However, Bard continued to deceptively market the device as being as safe and effective as all other available IVC filters.
  • According to Bard’s internal safety procedure, the Recovery filter posed an unacceptable risk to human health and required corrective action by no later than December 2004. But instead of warning the public about these problems or issuing a recall, Bard created a task force to downplay and conceal these risks from the public.
  • Bard’s own experts acknowledged that Bard misrepresented the safety and efficacy of its device in marketing and labelling messages.

When presented with this evidence, the physician who placed the Recovery Filter in the plaintiff testified that he would never have used the Recovery Filter if he had been told about these issues. Similarly, the Bard sales representative who promoted the filter testified that she would not have marketed the device if she had known.

This evidence and testimony raises a safety concern that may affect thousands of consumers who have one of these filters. Bard has never warned physicians about the low resistance against migration of the Recovery filter, or that tilt may further reduce this migration resistance to even more dangerous levels. Thus, many physicians may have advised their patients to refrain from removing a tilted or perforating filter because they were unaware of the increased risks known by Bard and its own experts.

Bard continues to withhold important safety information about these earlier versions of their IVC filters from physicians and patients despite there being an estimated 100,000 of these devices still implanted in patients. Medical literature and recent safety alerts from FDA reveal that every one of these patients are at significant risk of serious complications from the defective design and manufacture of these products.

Lopez McHugh continues to represent numerous other consumers relating to Bard’s defective IVC filters.