Treating Physician’s Informed Consent Process and Decision-Making in Device Selection Lead to Partial Summary Judgment for Device Manufacturer

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A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively prune a plaintiff’s ambitious product defect claims. Conn v. C.R. Bard, Inc., No. 4:14-CV-298.

In 2006, plaintiff’s physicians discovered a blood clot in his inferior vena cava. An IVC filter was inserted to prevent the blood clot from causing potentially fatal further injury. Because of plaintiff’s young age, the physician chose a removable filter. Plaintiff reported abdominal pain just four days after the IVC filter was placed. The blood clot was found to have moved and extended through and above the recently placed filter, and the physicians initiated anticoagulant therapy.

In 2007, plaintiff began to experience chest pain. In September 2012 plaintiff learned that the filter had fractured and that a piece had migrated to his heart. He filed suit in February 2014, alleging a variety of claims based on the 2006 clot and the fracture, which he related to his 2007 chest pain.

The defendants moved for summary judgment on multiple grounds, resulting in a series of opinions. First, the court addressed defendants’ claim that plaintiff’s entire suit is barred by Texas’ two-year statute of limitations. The court split the analysis into two categories of injuries — damages relating to the blood clotting in 2006, and damages relating to the other complications that had allegedly caused chest pain as early as 2007. As to the latter category, the court held that the discovery rule precluded summary judgment because it was not clear whether and to what extent plaintiff was aware of any related complication with his filter prior to September 2012. As to the blood clots, though, the court noted that the plaintiff had experienced pain and received medical attention just days after receiving his filter to address those very issues. The court concluded that a diligent person would have inquired into a possible link. The court reasoned that the physician who inserted the filter discussed IVC occlusion (i.e., clotting in the IVC) as a possible complication of filter insertion, during the informed consent process. Plaintiff was therefore on inquiry notice when he was later diagnosed with that very outcome, and his claims were deemed untimely. This holding serves as a useful reminder that, although the learned intermediary doctrine renders a plaintiff’s knowledge of possible outcomes less important to causation than that of the physician, the plaintiff’s knowledge can be critically important to other issues, such as the statute of limitations.

The court next turned to defendants’ argument that plaintiff’s negligence claims failed for lack of expert testimony establishing the relevant standard of care in designing, manufacturing, and marketing a medical device such as an IVC filter. Defendants argued that plaintiff needed expert testimony on this point but had only proffered unsworn expert reports. The court agreed, holding that expert testimony was needed and that the unsworn reports were not competent evidence under Rule 56 of the Federal Rules of Civil Procedure. Plaintiff later sought reconsideration, arguing that the unsworn reports and affidavits should have been considered because they could have been reduced to admissible evidence in accordance with Rule 56(c).  However, the court explained that the argument was untimely and that in any event some of the experts were not qualified to offer opinions on the standard of care and others did not provide enough detail to supply what was lacking. Accordingly, plaintiff’s negligence claims were dismissed.

Finally, the court addressed plaintiff’s strict liability claims for design defect and failure to warn. The court denied summary judgment on the failure to warn claim, holding that the sufficiency of the warnings and causation issues were both questions for the jury. As to design defect, though, the court noted that Texas law requires a plaintiff to identify a safer alternative design.

The plaintiff sought to meet this requirement in several ways, all of which failed. First, plaintiff alleged that the prior version of the filter was a safer alternative design. But the precursor filter was “designed to remain permanently installed in the human body” and plaintiff’s physician had specifically chosen to use a retrievable IVC filter for plaintiff’s care. Therefore, the permanent filter was a “substantially different product,” not an alternative design.  Plaintiff also pointed to a competitor’s IVC filter.  But the only evidence regarding the competitor filter came from an expert witness who the court had already excluded because he was “clearly unqualified to opine on what constitutes a safer design.” Accordingly, plaintiff had failed to offer expert support for his claim as to the competitor filter. Finally, plaintiff’s conclusory argument that there were “other IVC filters” with safer alternative designs was unavailing. Plaintiff’s design defect claim was therefore dismissed.

This case serves as a good example of the power of a coordinated multi-prong attack on the plaintiff’s claims to drastically narrow the scope of the case. Following the summary judgment rulings, plaintiff’s expansive case was limited to a more manageable claim for failure to warn based solely on the alleged injuries related to the fracture of the device. It also illustrates the importance of fully exploring (1) the informed consent process, which produced useful evidence here on the statute of limitations issues and (2) the treating physician’s reasons for choosing the particular product at issue to treat the plaintiff, which paid dividends here on the issue of safer alternative design.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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