IN RE: Bard IVC Filters Products Liability Litigation (“MDL 2641”) was formed in 2015 to consolidate nationwide claims that pharmaceutical giant C. R. Bard, Inc.’s inferior vena cava filters are defective and, compared to other blood clot filters on the market, have higher risks of tilting, perforating the IVC, or fracturing and migrating to vital organs.
Currently, there are thousands of personal injury cases pending against Bard in MDL 2641 and the first bellwether trial, Sherr-Una Booker v. C.R. Bard, Inc., et al., will soon be in the hands of an Arizona jury.
Recently, District Judge David G. Campbell issued a ruling on Bard’s summary judgment motion that will define the issues for the second bellwether trial which is currently scheduled to begin on May 15, 2018.
The Second Bellwether Trial: Plaintiffs Doris and Alfred Jones
The second Bard IVC case selected for trial was brought by Doris and Alfred Jones. Almost five years after being implanted with a Bard Eclipse IVC filter, Mrs. Jones went to the emergency room with complaints of lightheadedness and arm pain. A chest scan revealed a fractured filter limb that had embolized in the right pulmonary artery. The filter was removed but the fractured IVC filter limb remains in place.
Jones asserted various claims under Georgia law. While a number of counts were voluntarily withdrawn, Bard sought summary Judgment on several claims. With his recent ruling, Judge Campbell clarified the issues that will be presented to the jury in mid-May.
Bard’s Failure to Warn of Dangers with its IVC Filters
Like many defective product cases, a key issue in the litigation concerns Bard’s failure to warn about the known dangers associated with its line of IVC filters. To establish a failure to warn claim under Georgia law, the plaintiff must show that the defendant had a duty to warn, the defendant breached that duty, and the breach was the proximate cause of the plaintiff’s injury. The manufacturer’s duty may be breached in two ways: (1) failing to adequately communicate the warning to the ultimate user or (2) failing to provide an adequate warning of the product’s potential risks.
Duty and Adequate Warning: Bard’s Learned Intermediary Defense
In medical devices cases, Georgia applies the ‘learned intermediary’ doctrine. Under this doctrine, the manufacturer has no duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and manufacturer.
In opposition to Bard’s Motion, Jones alleged that Bard failed to adequately warn her physicians about the known defects and higher complication rates associated with its filters. Jones claims that this failure constitutes a breach of Bard’s duty to warn and proximately caused their injuries.
However, Bard contended that proximate cause is lacking because: (1) Mrs. Jones’ doctor did not read the Eclipse filter’s instructions for use; and (2) the doctor had actual knowledge of the risk of fracture.
Doctor’s Failure to Read the Eclipse Instructions for Use
Bard argued that Jones cannot show that any warning inadequacy proximately caused her injuries because her doctor did not read the Eclipse instructions before implanting the device. However, the Court noted that case law makes clear that failure to read instructions “does not bar recovery where the plaintiff is challenging the adequacy of the efforts of the manufacturer … to communicate the dangers of the product to the buyer or user.”
Jones argued that Bard breached its duty to warn by not “providing instructions for safe use” or “communicating the information and dangers” of its filters to physicians. Jones noted that medical device warnings are provided in various ways, including “dear doctor” letters, product pamphlets, and statements by the company sales representatives.
Accordingly, the Court held that, given Jones’ claim that Bard breached its duty to warn by failing to adequately communicate warnings to physicians through means other than instructions for use, the fact that her doctor may not have read the instructions is not dispositive on causation.
Bard Argues its IVC Filter Complications are Well Known to Doctors
Bard also argued that “proximate causation” is lacking in this case because Jones’ doctor was aware of IVC filter complications – including fracture. Specifically, Bard argued that it cannot be liable for failure to warn because IVC filter complications are well known by the medical community. Jones conceded that Bard warned physicians about filter complications generally, but contended that the warnings were inadequate because Bard did not disclose that the risk of complications for the Eclipse filter was higher than those of other filters.
Jones presented evidence that the Eclipse and its predecessor devices, the Recovery and G2 line of filters, involved substantially greater risks of fracture than other IVC filters. Jones claimed that her doctor was not aware of the higher risks, and that he would have wanted to know this information when deciding whether to implant the Eclipse.
Her doctor testified that his initial understanding was that the fracture rates for Bard filters were very low. He further stated that the time period in which he treated Mrs. Jones “predates the peak of his concern and the release of the warnings about the complications of filters.” He made clear that if Bard knew about higher complication rates associated with its filters before Mrs. Jones’s surgery, he would have wanted to know that information.
The Court held that a jury reasonably could infer from the doctor’s testimony that he would not have implanted the Eclipse filter in Mrs. Jones had he been warned about higher fracture rates. In rejecting Bard’s argument, the Judge stated that Georgia law is clear that summary judgment is warranted on the issue of causation only where the physician testifies unequivocally that he would have made the same decision despite the proposed warning.
Jury Question: Was Bard’s Warning Inadequate Regarding the Extent of Risk?
Bard argued that its warnings were adequate because they included a risk of fracture – the complication experienced by Jones. In response, Jones argued that the warnings were inadequate because they did not include risk rates or disclose that the risks associated with the Eclipse filter were higher than other IVC filters.
The Court found that whether Bard’s warnings were adequate is a “question of breach, not duty” and therefore the alleged failure to warn about the rate of complications raises a jury question over the adequacy of Bard’s warnings. “The general rule in Georgia is that the adequacy of the warning is an issue for the jury [unless] . . . the facts support only one conclusion, that is, the warning and its communication were adequate.”
The Court stated that question that must be answered by the fact finder is “whether the warning given was sufficient or was inadequate because it did not provide a complete disclosure of the existence and extent of the risk involved.” Therefore, whether the warnings should have included comparative risk rates will be for the jury to decide.
The Jones trial is set to begin on May 15, 2018 at 9:00 a.m.