Today’s post involves Couturier v. Bard Peripheral Vascular, Inc.,  2021 WL 2885903 (E.D. La. Jul. 8, 2021).  This products liability action was remanded from the MDL In re: Bard IVC Filters Products Liability Litigation, MDL 2641 (D. Az.).  Plaintiff alleged injuries suffered after being implanted with an Inferior Vena Cava (“IVC”) filter medical device manufactured by defendants.  An IVC filter is a device that is designed to filter or “catch” blood clots that may travel from the lower portions of the body to the heart and lungs.  IVC filters have been on the market for decades but were limited to patients who could not manage their DVT/PE with prescribed medications.  Defendants were the first medical device manufacturer to obtain FDA clearance for marketing a “retrievable” IVC filter in July 2003.

Defendants moved for summary judgment on all claims asserting a lack of proof of causation.  Plaintiff’s suit was governed by Louisiana law which means his exclusive cause of action was under the Louisiana Products Liability Act (LPLA).  To prevail under any theory under the LPLA, a plaintiff must establish four elements: (1) defendant manufactured the product at issue; (2) plaintiff’s injury was proximately caused by a characteristic of the product; (3) this characteristic made the product unreasonably dangerous; and (4) plaintiff’s injury arose from a reasonably anticipated use of the product by plaintiff or someone else. Stewart v. Capital Safety USA, 867 F.3d 517, 520 (La. 2017) (citing Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 260-61 (5th Cir. 2002)). A “proximate cause” is generally defined as any cause which, in natural and continuous sequence, unbroken by an efficient, intervening cause, produces the result complained of without which the result would not have occurred. Marable v. Empire Truck Sales of Louisiana, LLC., 221 So. 3d 880, 901 (La. Ct. App. 2017). Under Louisiana law, plaintiff bringing products liability action must prove not only causation-in-fact, but also that product was most probable cause of injury. Wheat v. Pfizer, Inc., 31 F.3d 340, 342 (5th Cir. 1994) (citing Brown v. Parker-Hannifin Corp., 919 F.2d 308, 311 and n.9, 312 (5th Cir. 1990)).

The court first addressed the design defect claim, noting the plaintiff must show that an alternative design existed for the product at the time it left the manufacturer’s control, and the alternative design was capable of preventing the plaintiff’s damage. Bernard v. Ferrellgas, Inc., 689 So. 2d 554, 558 (La. Ct. App. 1997). If there was no alternative way to make the product safer, the defendant could not have prevented plaintiff’s injuries and therefore, the defendant is not liable under a design defect theory.  Louisiana courts have determined whether an alternative design was capable of preventing plaintiff’s damage through a cause-in-fact analysis,  Defendant argued that plaintiff’s experts conceded that all IVC filters can fracture and perforate. As these are known risks, warned about on the label, they cannot constitute design defects.  Because plaintiff failed to provide evidence of a design defect or of an alternative filter that could have prevented his injuries, defendants were entitled to summary judgment on plaintiff’s design defect claims.

Turning to the failure to warn count, the court noted that a manufacturer’s duty to warn is a continuing one; the court concluded that a genuine issue of material fact existed whether the alleged  increased rate of failure of the filter rendered defendants’ warnings inadequate. Therefore, summary judgment was denied on  this question.

Defendants’ motion was granted on the warranty count, as plaintiff failed to provide sufficient evidence that any statements by defendants ever induced the use of the filter. In fact, the prescriber testified that the only factor causing him to use the specific filter was the fact that it was the only IVC filter the hospital had available.  Therefore, plaintiff’s breach of express warranty claim failed.

Finally, the court denied plaintiff’s motion for summary judgment on defendant’s affirmative defenses.

Failure to mitigate and comparative fault-  The plaintiff had failed to seek treatment for five years after the IVC filter was implanted and ignored his physician’s recommendations after the perforation was first discovered.

Comparative fault of non-parties: This defense was supported by adequate evidence to create an issue of fact based on the surgeon’s testimony that he did not follow the manufacturer’s guide in several material ways.  He conceded that he did not measure plaintiff’s inferior vena cava prior to implanting the filter.  And that he could not remember the amount of pressure that was used when injecting the contract medium through the dilator and thus could not confirm if it was more or less than specified.

Assumption of the risk: Plaintiff’s spouse had signed an informed consent form acknowledging  that plaintiff’s surgeon advised him of all known risks and that plaintiff accepted all those risks by undergoing the surgery.

Nearly a clean sweep.