Blackwell v. C R Bard Incorporated

 NORTHERN DISTRICT OF TEXAS FILED IN THE UNITED STATES DISTRICT COUR FOR THE NORTHERN DISTRICT OF TEXA JUN - 9 2024 AMARILLO DIVISION JAMES BLACKWELL, § CLERK, US. pista vot § By Deputy Plaintiff, § § V. § 2:19-CV-180-Z § C. R. BARD, INC., and BARD § PERIPHERAL VASCULAR, INC., § § Defendants. § MEMORANDUM OPINION AND ORDER Before the Court is Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.’s (collectively “Bard”) Motion for Summary Judgment (ECF No. 42). Having considered the Motion, the related pleadings, and the applicable law, the Court finds Defendants’ Motion should be GRANTED. The Clerk is DIRECTED to unseal ECF Nos. 45 and 47. See ECF No. 53 (denying without prejudice Defendants’ Motion to Seal). FACTUAL BACKGROUND Inferior vena cava (“IVC”) filters are prescription medical devices designed to prevent blood clots (or “thrombus”) from reaching the heart and lungs to prevent potentially fatal pulmonary embolism (“PE”). IVC filters are placed in the IVC, the large vein leading from the lower extremities to the heart. Plaintiff James Blackwell was treated with Bard’s “Denali” IVC filter after Plaintiff developed deep vein thrombosis (“DVT”) while recovering from thoracolumbar surgery. ECF No. 43 at 12.! The Denali filter consists of two tiers of struts that make up its “arms” and “legs,” and ' All citations are to the ECF-generated number at the top of the document, not the page numbers in the footer. can be introduced into the IVC via a small puncture in the jugular vein or the femoral vein. Jd. at 10. Four of the six legs have cranial anchors; these are designed to keep the Denali from moving towards the head. Jd. at 10-11. The other two legs have caudal anchors; these are designed to keep the Denali from moving towards the feet. Jd. at 11. The Denali was designed for permanent or temporary placement. Jd. The snare hook is used during the removal of the filter. Denali (2013) Snare Hook JA Legs —$—$—$——— / 9 \ poorors ECF No. 46-1 at 55-61, 16-21, 88-89. Plaintiff further alleges each of 4 See, e.g., Ebel v. Eli Lilly & Co., 536 F. Supp. 2d 767, 773 (S.D. Tex. 2008) (applying Texas law) (“Where the crux of the suit is based on a failure to adequately warn, the learned intermediary doctrine may apply to strict liability, negligence, misrepresentation, and breach of warranty claims.”). 5 Plaintiff failed to disclose the patient brochure during discovery and did not actually disclose the brochure until after Bard had filed its motion for summary judgment. Plaintiff provided no consistent explanation for this late disclosure. The Court frowns upon this litigation tactic, but, as it does not affect the outcome, proceeds to analyze the evidence as properly disclosed. Cf FED. R. CIv. P. 37(c). these contain inadequate warnings about the potential complications and risks of using the device. The Court will only consider Plaintiff's allegations regarding the IFU and the patient brochure. Plaintiff has made no argument why the product brochure is relevant to this case.° The IFU that accompanied Plaintiff's filter “specifically mentions the circumstances complained of.” Ackermann, 526 F.3d at 208. Plaintiff alleges that his filter failed due to “occlusion of the IVC filter.” ECF No. 43-1 at 31,69. And Dr. Blackman, Plaintiffs expert, stated that Plaintiffs filter induced “thrombosis [and] led to venous occlusion.” Jd. at 67. Under the bolded heading “Potential Complications,” the IFU warns “Caval thrombosis/occlusion,” “Deep vein thrombosis,” and “Occlusion of small vessels.” ECF No. 46-1 at 58-59. Additionally, the IFU stated in bold text that these complications “have been associated with serious adverse events such as medical intervention and/or death.” Jd. at 59. Because the IFU specifically warns of the circumstances complained of, the warnings are adequate as a matter of law. Plaintiff's arguments to the contrary are unpersuasive and rely heavily on non-admissible testimony. The expert report of John Ladisa Jr. cited in footnotes 51 and 53 of Plaintiff's Response is hearsay. Dr. Garcia’s report cited in footnotes 52, 53, and 54 has been excluded by this Court’s Order. See ECF No. 68. Dr. Blackman’s Declaration cited in footnote 55 has also been excluded by this Court’s Order. See ECF No. 69. Lastly, Plaintiff argues “{mJultiple courts presented with 6 As explain in part A.2, under Texas law, the physician is required to have read or encountered the allegedly defective warnings. Plaintiff has offered zero evidence on if, when, where, or how Plaintiff's implanting physician, Dr. Archer, encountered the product brochure. Thus, the materials in the product brochure are irrelevant to this case. Because the product brochure is irrelevant, the Court has no need to address Plaintiff's allegations that the product brochure is misleading because of the font size and location of the warnings included therein. But even if the Court considered Plaintiff's allegations, they are unsupported by any admissible expert testimony. See Gen. Motors Corp. v. Saenz, 873 S.W.2d 353, 360 (Tex. 1993) (“Every warning can always be made bigger, brighter and more obvious.”); see also Goodyear Tire & Rubber Co. v. Rios, 143 S.W.3d 107, 117-18 (Tex.App.—San Antonio 2004, pet. denied) (“A jury could not have determined, without the benefit of expert testimony, which, among many, warnings and instructions should be printed on a sidewall. When a lay person's general experience and common sense will not enable that person to determine the issue, expert testimony is required.”) (citing Tex. R. Evid. 702). a similar record ... have rejected Bard’s arguments that its warnings through the IFUs are adequate as a matter of law.” ECF No. 46 at 16. Yet, Plaintiff offers no explanation on how these other court records were similar. Moreover, none of these other cases involved a Denali filter and, more importantly, all of them but one were decided under the Jaws of other states. The only case cited that applied Texas law contains no reasoning or precedential value. See Sweezey v. C_R. Bard, Inc., No. 3:19-CV-2172-S (N.D. Tex. Mar. 12, 2020), ECF No. 125 at 3 (Mem. and Order). Plaintiff's concluding statement that “Bard’s failure to provide adequate warning in its IFU and brochures about the specific risks and circumstances complained of here is evidence of its inadequacy” is a circular argument that does nothing more than argue that Bard’s failure to warn is evidence of its failure to warn. ECF No. 46 at 16-17. 2. Plaintiff has failed to show that Bard’s warnings were a producing cause of his injuries Even if Plaintiff had produced evidence of an inadequate warning, Plaintiff still would have to show, under the second prong of the learned-intermediary doctrine, that “the failure to warn was a producing cause of the plaintiffs injury.” Porterfield, 183 F.3d at 468. “Causation entails two distinct factual predicates: first, that the doctor would have read or encountered the adequate warning; and second that the adequate warning would have altered his treatment decision for, or risk-related disclosures to, the patient.” Jn re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Prod. Liab. Litig., 888 F.3d 753, 775 (Sth Cir. 2018) (emphasis in original). Bard argues that it is entitled to summary judgment on Plaintiff's failure to warn claims because Plaintiff failed to depose the implanting physician, Dr. Archer,’ and therefore there is no evidence regarding whether Dr. Archer ever encountered the warnings. The Court agrees. 7 Plaintiff offers no explanation for failing to depose Dr. Archer. As Bard noted in its Reply, this is not a case where Plaintiff was unable to locate Dr. Archer. A quick internet search shows that Dr. Archer still practices in Amarillo, Texas (where he implanted Plaintiff’s filter) and is still affiliated with the same facility where he implanted Plaintiff's Plaintiff failed to meet the first “factual predicate” for establishing causation because he presented no record evidence that Dr. Archer read or encountered any warning from Bard. Plaintiff does not allege that Dr. Archer ever read the IFU or product brochure. Supra, n. 5. Instead, as in Inre DePuy, Plaintiff relies on his own statements in lieu of the implanting physician’s testimony, which is a losing argument. See In re Dupuy, 888 F.3d at 775 (‘“[P]laintiffs cite only their own statements for support... But these snippets say nothing of how the doctors came to hold their respective views. ... The jury was left to guess, and plaintiffs’ claims fail as a result.”). Plaintiff's sole attempt to distinguish Jn re Dupuy fares no better. In addition to Plaintiff's own testimony about the conversations between Dr. Archer and himself,® Plaintiff alleges Dr. Archer provided Plaintiff with a Denali patient brochure that appears to have been signed by Dr. Archer the day of the procedure.” ECF No. 46-1 at 88-89. But there is no evidence that Dr. Archer ever read the brochure. Plaintiff's counter-argument — that Dr. Archer’s alleged signature on the brochure equates with Dr. Archer having read the brochure — is pure speculation. The signature does not establish that Dr. Archer read the brochure or relied upon it. Nor does it establish where Dr. Archer received the brochure, whether he received it from Bard or some other source, when he received it, or the circumstances under which he received it.!° filter—Baptist St. Anthony Hospital. ECF No. 50 at 6 n. 16 (citing U.S. NEWS &WORLD REPORT, https://health.usnews.com/doctors/richard-archer-308373 (last visited Mar. 3, 2021); ECF No. 43-1 at 69. 8 Knight v. Kellogg Brown & Root Inc., 333 F. App’x 1, 6 (5th Cir. 2009) (“{S]ummary summary judgment evidence cannot be based on inadmissible hearsay.”); Fowler v. Smith, 68 F.3d 124, 126 (Sth Cir. 1995) (“Evidence on summary judgment may be considered to the extent not based on hearsay or other information excludable at trial.”). 9 This is the same brochure that was not produced in discovery even though Bard requested it on several occasions. Supra, n. 5; of. FED. R. CIv. P. 37(c). '© Moreover, the signature on the brochure appears to be hearsay. Plaintiff's argument is that Dr. Archer’s signature is tantamount to Dr. Archer writing “I, Dr. Archer, read this document.” But that would clearly be hearsay. So too then is the shorter, simpler statement of “Dr. Archer.” B. Plaintiff's Design Claims (Counts III and IV) fail because Plaintiff lacks any evidence of a safer alternative design. To prevail on a design defect claim in Texas, a plaintiff must prove by a preponderance of the evidence that, among other elements, a safer alternative design existed. Jn re Dupuy, 888 F.3d at 753. A safer alternative design is one that “would have prevented or significantly reduced the ‘risk of the [plaintiff]’s personal injury . . . without substantially impairing the product’s utility.” Id. at 765. The plaintiff must prove that a safer alternative design was economically and technologically feasible at the time the allegedly defective product was manufactured. Casey v. Toyota Motor Eng’g &Mfg. North America, Inc., 770 F.3d 322, 331 (Sth Cir. 2014). For a design to be technologically feasible, the plaintiff must prove that the proposed design existed at the time the allegedly defective product was manufactured. Jd. at 334. Furthermore, the Fifth Circuit has stated “[u]nder Texas law, ‘expert testimony is generally encouraged if not required to establish a products liability claim.’” Norman v. Grove Cranes U.S., LLC, 750 Fed. App’x 269, 273 (Sth Cir. 2018) (quoting Sims v. Kia Motors of Am., Inc., 839 F.3d 393, 409 (5th Cir. 2016)); id. “Moreover, numerous intermediate Texas courts and federal district courts have granted judgments in favor of defendants where no admissible expert testimony was offered to prove the existence of a safer alternative design.”). Plaintiff argues that the ALN filter is a safer alternative device. But Plaintiff has no admissible expert evidence to support this claim. The Court struck Dr. Blackman’s Declaration — Plaintiff's only expert report on this topic —- for good cause. See ECF No. 69. Plaintiff's argument that the Declaration merely supplements his existing opinions is unavailing. The two opinions offered in the Declaration relate to a safer alternative design. These opinions are an entirely new topic that was not addressed in his original expert report or during his deposition. Nowhere in his original report does Dr. Blackman mention “safer,” “alternate” or “alternative,” or “different” designs. Nor does his original report identify any other filter designs or models he believes would have been safer for Plaintiff than his Denali filter. 10 Likewise, Dr. Blackman did not identify or discuss a safer alternative design during his deposition, except to say that he is “not suggesting that [Plaintiff] should have any filter in particular.” Id. at 3. Without expert evidence, Plaintiff is unable to meet his burden to show a safer alternative . design at the summary judgment stage and his Design Claims thus fail. Because both Plaintiff's Warning and Design Claims have failed, Plaintiff’s derivative punitive-damages claim must fail as well.!! CONCLUSION For the reasons explained above, the Court determines there are no genuine issues of material facts on any of Plaintiff's claims. Accordingly, the Court GRANTS Defendants’ Motion for Summary Judgment (ECF No. 42) in its entirety. Plaintiff's claims are DISMISSED WITH PREJUDICE. □ SO ORDERED. June _7, 2021 nates —~ TED STATES DISTRICT JUDGE '! Because Plaintiff lacks any evidence of a safer alternative design, the Court need not decide whether comment k to the Restatement (Second) of Torts § 402A applies to the Denali filter. For the same reason, the Court need not decide te Civil Practice and Remedy Code § 82.008 establishes a presumption of non-liability as to all of Plaintiff's 11