Nelson v. C. R. Bard, Inc.

44 F.4th 277

Dennis NELSON; Kathy Nelson, Plaintiffs—Appellants,

v.C. R. BARD, INCORPORATED; Bard Peripheral Vascular, Incorporated, Defendants—Appellees.

No. 21-60689

United States Court of Appeals, Fifth Circuit.

FILED August 10, 2022

Richard Massie Martin, Jr., Esq., Lamothe Law Firm, L.L.C., New Orleans, LA, for Plaintiffs-Appellants.

Lori Gail Cohen, Greenberg Traurig, L.L.P., Atlanta, GA, Justin Lewis Bernstein, Greenberg Traurig, L.L.P., Austin, TX, Joseph P. Griffith, Attorney, Greenberg Traurig, L.L.P., Dallas, TX, Elizabeth Ross Hadley, Jesse Wadell Wainwright, Greenberg Traurig, L.L.P., Austin, TX, Heather Camille Papini-Chapla, Attorney, Greenberg Traurig, L.L.P., Denver, CO, for Defendants-Appellees.

Before Higginson, Willett, and Ho, Circuit Judges.

Stephen A. Higginson, Circuit Judge:

In this products liability case, plaintiffs, Dennis Nelson and his wife, Kathy Nelson ("the Nelsons") sued defendants, C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. ("Bard"), due to complications Dennis Nelson experienced after implantation of a filter used as a medical device. The Nelsons now appeal the district court's grant of summary judgment to Bard on their failure to warn and design defect claims. We AFFIRM.

I.

A.

The Nelsons brought this product liability action after Dennis Nelson experienced complications following the implantation of an inferior vena cava filter, called the Recovery IVC Filter (the "Filter"). Generally, such filters are placed inside the body in an effort to prevent blood clots from reaching critical organs such as the heart, lungs, or brain. The Filter, a "venous interruption device[ ] designed to prevent pulmonary embolism," is designed, manufactured, marketed, and sold by Bard. It was approved by the FDA as an optional retrievable filter in 2003 and could thus be used permanently or temporarily.¹

Each Filter comes with an Information for Use pamphlet ("IFU") that sets forth various pieces of information, including warnings, precautions, and instructions. Under the bolded "Warnings " heading, the IFU read, in relevant part:

8. Filter fracture is a known complication of vena cava filters. There have been reports of embolization of vena cava filter fragments resulting in retrieval of the fragment using endovascular and/or surgical techniques. Most cases of filter fracture, however, have been reported without any adverse clinical sequelae.

9. Movement or migration of the filter is a known complication of vena cava filters. This may be caused by placement in IVCs with diameters exceeding the appropriate labeled dimensions specified in the IFU. Migration of filters to the heart or lungs have been reported in association with improper deployment, deployment into clots and/or dislodgment due to large clot burdens.

(emphasis added). The IFU also contained a section titled "Potential Complications," and this section included the following information (bold at end in original):

Procedures requiring perculaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure.

Possible complications include, but are not limited to, the following:

• Movement or migration of the filter is a known complication of vena cava filters. This may be caused by placement in IVCs with diameters exceeding the appropriate labeled dimensions specified in the IFU. Migration of filters to the heart or lungs have also been reported in association with improper deployment, deployment into clots and/or dislodgment due to large clot burdens.

• Filter fracture is a known complication of vena cava filters. There have been reports of embolization of vena cava filter fragments resulting in retrieval of the fragment using endovascular and/or surgical techniques. Most cases of filter fracture, however, have been reported without any adverse clinical sequelae.

• Perforation or other acute or chronic damage of the IVC wall.

• Acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.

• Caval thrombosis /occlusion.

• Extravasation of contrast material at time of venacavogram.

• Air embolism.

• Hemaloma or nerve injury at the puncture site or subsequent retrieval site.

• Hemorrhage.

• Restriction of blood blow.

• Occlusion of small vessels.

• Distal embolization.

• Infection.

• Intimal tear.

• Stenosis at implant site.

All these above complications have been associated with serious adverse events such as medical intervention and/or death. The risk/benefit ratio of any of these complications should be weighed against the inherent risk/benefit ratio for a patient who is at risk of pulmonary embolism without intervention.

The Filter was restricted to sale "by or on the order of a physician."

As early as May 2004, Bard internal emails referencing the Filter began to note that there were complications associated with it. Then, on December 17, 2004, Bard's medical director issued an internal document titled "Health Hazard Evaluation" concerning a consultant's report on the Filter. The internal Bard document stated, in part:

An analysis of reporting rates of serious adverse events for all inferior vena cava filters, as determined by analysis of the MAUDE and IMS databases by a consultant, revealed that reporting rates for Recovery are significantly higher than other filters. However, these databases are subject to known, significant biases that make calculation or comparison of incidence rates among products unreliable and inadvisable .... Nevertheless, the number of reported complaints, and the size of the differences between Recovery and other filters, warrant further investigation.

The document continued:

Reports of death, filter migration (movement), IVC perforation, and filter fracture associated with Recovery filter were seen in the MAUDE database at reporting rates that were 4.6, 4.4, 4.1, and 5.3 higher, respectively, than reporting rates for all other filters. These differences were all statistically significant. Recovery's reporting rates for all adverse events, filter fracture, filter migration, and filter migration deaths were found to be significantly higher than those for other removable filters.

On May 16, 2005, Dr. Daniel DeVun implanted Dennis Nelson with a Filter. Dr. DeVun performed this procedure as a prophylactic measure to prevent deep venous thrombosis and pulmonary embolism prior to Dennis Nelson's temporary cessation of anticoagulation medication in anticipation of a liver transplant. Medical imaging taken fourteen years later in 2019 revealed that the Filter had fractured. Some of the struts of the Filter had penetrated through the inferior vena cava wall, and some migrated to other parts of Nelson's body. Nelson underwent three surgical procedures to remove the Filter and its fragments. Though the procedures were partially successful, one fragment remains in Nelson's pulmonary artery.

B.

In September of 2017, the Nelsons brought a product liability action against Bard, as a part of a multidistrict litigation suit. The case was transferred to the Southern District of Mississippi in September of 2019. In March of 2021, both the Nelsons and Bard filed motions for summary judgment. Thereafter, the district court held a hearing on the dueling motions.

On August 6, 2021, the district court granted Bard's motion for summary judgment. It first addressed the Nelsons' failure to warn and design defect claims under the Mississippi Products Liability Act (MPLA). The court held that the IFU "expressly warned" the treating physician of the "very complications" that Nelson ultimately suffered; thus, the warnings were adequate as a matter of law. The district court also addressed Plaintiffs' theory that the warning was inadequate "because the IFU did not list the comparative rates of occurrence of complications relative to a predecessor Bard device and other IVC filters," and held that it had no merit. The court reasoned that Mississippi law does not support the conclusion that a failure to provide comparative-risk information renders a warning inadequate and that requiring comparative risk information to be included would be a problematic slippery slope.

On the design defect claim, the district court held that even though the Nelsons' expert, Dr. McMeeking, had testified to a design defect, the Nelsons had nevertheless "failed to adduce sufficient evidence to create [a] jury question on the issue of causation in fact," since "[t]here is no testimony or evidence cited by the Plaintiff that ties the specific design defect identified by Dr. McMeeking to the damages for which Plaintiffs seek recovery." Alternatively, the district court held that the Nelsons had failed to raise a genuine issue of material fact as to a feasible design alternative under Mississippi law.² The Nelsons appealed.

II.

We review a grant of summary judgment de novo. Doe v. United States , 831 F.3d 309, 317 (5th Cir. 2016). Summary judgment should be granted "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." FED. R. CIV. P. 56(a). When weighing the evidence at summary judgment, all factual inferences are viewed in the light most favorable to the party opposing the motion. Baker v. Am. Airlines, Inc. , 430 F.3d 750, 753 (5th Cir. 2005).

In diversity jurisdiction actions, the substantive law of the state in which the district court hearing the action sits controls. Erie R.R. v. Tompkins , 304 U.S. 64, 78, 58 S.Ct. 817, 82 L.Ed. 1188 (1938) ; Capital City Ins. Co. v. Hurst , 632 F.3d 898, 902 (5th Cir. 2011). Both parties agree that Mississippi law controls this case. Under Mississippi law, the Mississippi Product Liability Act (MPLA) "applies ‘in any action for damages caused by a product,’ " including actions asserting failure to warn and design defect claims....