Opinion
CIVIL ACTION NO. 2:19-cv-135-KS-MTP
2021-08-06
Dennis NELSON and Kathy Nelson, Plaintiffs v. C.R. BARD, INC., and Bard Peripheral Vascular, Inc., Defendants
Richard Massie Martin, Jr., Lamothe Law Firm, LLC, New Orleans, LA, Julia Reed Zaic, Pro Hac Vice, Laura Smith, Pro Hac Vice, Heaviside Reed Zaic, Newport Beach, CA, Mark S. O'Connor, Pro Hac Vice, Beus Gilbert McGroder, PLLC, Phoenix, AZ, for Plaintiffs. Elizabeth Ross Hadley, Charles Mark Stratton, Pro Hac Vice, Greenberg Traurig, LLP, Austin, TX, J. Carter Thompson, Jr., Robert Christopher White, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, Jackson, MS, C. Wade Bowden, Pro Hac Vice, Jason H. Okleshen, Pro Hac Vice, Greenberg Traurig, PA, West Palm Beach, FL, Eric W. Swanis, Pro Hac Vice, Greenberg Traurig, LLP, Las Vegas, NV, Jonathan Bass, Pro Hac Vice, Greenberg Traurig, LLP, Dallas, TX, Lori G. Cohen, Greenberg Traurig, LLP, Atlanta, GA, for Defendants.
Richard Massie Martin, Jr., Lamothe Law Firm, LLC, New Orleans, LA, Julia Reed Zaic, Pro Hac Vice, Laura Smith, Pro Hac Vice, Heaviside Reed Zaic, Newport Beach, CA, Mark S. O'Connor, Pro Hac Vice, Beus Gilbert McGroder, PLLC, Phoenix, AZ, for Plaintiffs.
Elizabeth Ross Hadley, Charles Mark Stratton, Pro Hac Vice, Greenberg Traurig, LLP, Austin, TX, J. Carter Thompson, Jr., Robert Christopher White, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, Jackson, MS, C. Wade Bowden, Pro Hac Vice, Jason H. Okleshen, Pro Hac Vice, Greenberg Traurig, PA, West Palm Beach, FL, Eric W. Swanis, Pro Hac Vice, Greenberg Traurig, LLP, Las Vegas, NV, Jonathan Bass, Pro Hac Vice, Greenberg Traurig, LLP, Dallas, TX, Lori G. Cohen, Greenberg Traurig, LLP, Atlanta, GA, for Defendants.
MEMORANDUM OPINION AND ORDER
KEITH STARRETT, UNITED STATES DISTRICT JUDGE This cause comes before the Court on both Plaintiffs’ Motion for Partial Summary Judgment [87] and Defendants’ Motion for Summary Judgment [103]. Both motions have been fully briefed, and the Court held oral argument on June 20, 2021. Having considered the parties’ submissions, argument, and the relevant legal authorities, the Court finds, for the reasons set forth herein, Plaintiffs’ Motion will be denied and Defendants’ Motion will be granted.
I. BACKGROUND AND UNDISPUTED MATERIAL FACTS
This is a products liability action involving the Recovery® Filter System (the "Recovery Filter" or "the filter"), which is designed, manufactured, marketed, and sold by the Defendants, C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. Plaintiffs, Dennis Nelson and his wife, Kathy Nelson ("Plaintiffs"), brought this action for damages related to alleged complications Mr. Nelson experienced related to the implantation of a Recovery Filter.
The Recovery Filter is a medical device that is designed for use in the inferior vena cava to prevent pulmonary embolism. [87-8]. The Recovery Filter comes with an Information for Use pamphlet ("IFU") that sets forth information related to the description, use, warnings, precautions, and potential complications, as well as instructions for use and procedure for removal. [87-8]. Under the bolded heading "Warnings ," the IFU reads, in part:
• 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.
• Movement or migration of the filter is a known complication of vena cava filters.... 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.
Under the bolded heading "Potential Complications ," the IFU reads:
Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with 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.... 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.
• 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.
• Restriction of blood flow.
• Occlusion of small vessels.
• Distal embolization.
• Stenosis at implant site.
• All of 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.
[87-8] (all emphasis in original).
The Recovery Filter was designed to act as a permanent filter, but it may also be removed and was cleared through the FDA as an optional retrievable filter on July 25, 2003. [87-8]; [87-3]. The Recovery Filter was available to patients only via a physician. [87-8].
On May 16, 2005, Daniel A. DeVun, M.D. implanted a Recovery Filter in Mr. Nelson's inferior vena cava as a prophylactic measure to prevent deep venous thrombosis and pulmonary embolism prior to Mr. Nelson's temporary cessation of anticoagulation medication in anticipation of a liver transplant. [109] at p. 1. Plaintiff later underwent a successful orthotopic liver transplant on January 10, 2006. [103-1] pp. 16, 28, 62.
Medical imaging taken of Mr. Nelson in mid-2019 revealed that the Recovery Filter had fractured. [87-11] 41:4-10. Some of the struts of the filter had penetrated through the inferior vena cava wall and some had migrated to other parts of his body. [87-10]; [87-11] 40:6-19; [87-12] 31: 7-21; 44:2-47:1. He underwent three surgical procedures to remove the filter as well as fragments of the device. [87-12] at 61:3-8, 74:19-23; 91:11-14. However, these surgical procedures were not completely successful, as there remains one filter fragment in Mr. Nelson's right pulmonary artery. [87-15]; [87-12] 91:11-93:23.
The first removal procedure occurred on December 4, 2019 by Patrick Patten M.D., who removed the filter and found it had fractured; he noticed a metallic fragment in the lung, which had not been present in prior imaging. [87-13]; [87-11] 41:21-24, 57:23-25, 60:5-14, and 66:15-19. A second procedure was performed by Marshall Walker, M.D., on December 18, 2019 to remove the fragment from the lung, as well as a filter leg embedded in the wall of the vena cava. [87-14]; [87-12] at 73:3-21. During this second procedure, Dr. Walker also determined there were two struts in Mr. Nelson's pulmonary artery. [87-14]; [87-12] 78:5-22. Dr. Walker was unable to remove one of the struts in a branch of the right pulmonary artery. [87-14]; [87-12] 88:2-10. Dr. Walker performed the third procedure December 30, 2019 to retrieve this fragment. [87-15]; [87-12] 91:11-14. He made multiple attempts at retrieval but was unable to retrieve the fragment due to the delicate nature of the pulmonary artery and a clot (embolism ) in the blood vessel. [87-15]; [87-12] 91:11-93:23.
On December 17, 2004 Defendants’ medical director issued an internal document called a Health Hazard Evaluation (HHE) concerning the Recovery Filter, which states, "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" and that "[r]eports 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 filters. These differences were all statistically significant." [87-22].
MAUDE is an FDA database that houses medical device reports (MDRs) submitted to the FDA by mandatory reporters, including device manufacturers, and voluntary reporters such as health care professionals, patients and consumers. [118] at p. 9.
Earlier documentation from May 2004, including emails referencing the Recovery Filter, notes that the rate of fracture for the Recovery Filter was higher compared to other filters on the market; that the filter was tilting in a certain percentage of implantations; and that the filter had significantly higher rates of complication than other filters at a 95% confidence. [134-31]; [134-32]; [134-33].
Plaintiff also includes documentation addressing rates of death; however, the Court finds this evidence irrelevant because any purported failure to adequately warn of potential risk of death is irrelevant here because Mr. Nelson is still alive. Cf. Austin v. Bayer Pharms. , No. 5:13-CV-28-KS-MTP, 2013 WL 5406589, at *7, 2013 U.S. Dist. LEXIS 137480 at *20-21 (S.D. Miss. Sep. 25, 2013) (dismissing plaintiff's claim for failure to warn of side effects which plaintiff did not experience because drug maker's alleged failure to warn of them did not cause any injury).
Plaintiff has retained two medical experts, Dr. Darren Hurst and Dr. Derek Muehrcke, who opine that the warnings for the Recovery IFU were inadequate because they did not warn of these supposed higher rates of complications in the Recovery Filter as compared to the Simon Nitinol Filter ("SNF") and other IVC filters. [109-7] 118:14-119:9; [111] at p. 16; [134-51] 136:12-137:21.
The SNF was a permanent IVC filter that was manufactured and sold by Bard beginning in 1995 prior to the Recovery Filter. [135] at ¶ 1.
Facts relating to the design defect claim will be discussed within the body of the analysis.
II. DISCUSSION
A. Summary Judgment Standard
Rule 56 of the Federal Rules of Civil Procedure states, in part, "The court shall grant summary judgment 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). The moving party bears the initial burden of showing there is no genuine issue for trial. Skotak v. Tenneco Resins, Inc. , 953 F.2d 909, 913 (5th Cir. 1992), cert. denied , 506 U.S. 832, 113 S.Ct. 98, 121 L.Ed.2d 59 (1992) (quoting Latimer v. Smithkline & French Labs. , 919 F.2d 301, 301 (5th Cir. 1990) ). If the moving party meets this burden, the nonmoving party who will have the burden of proof at trial must come forward with summary judgment evidence establishing the existence of a genuine issue. Celotex Corp. v. Catrett , 477 U.S. 317, 321, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
At the summary judgment stage, when reviewing all evidence in the record, "the court must draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence." Reeves v. Sanderson Plumbing Prods., Inc. , 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000) (stating also that "[c]redibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge" and quoting Anderson v. Liberty Lobby, Inc. , 477 U.S. 242, 255, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986) ). B. Plaintiffs’ Remaining Claims and the Law Governing Those Claims
1. Only the failure to warn and design defect claims remain.
On September 18, 2017, this case was directly filed in the multi-district litigation ("MDL") as part of the In Re: Bard IVC Filters Products Liability Litigation , MDL No. 2641, centralized in the District of Arizona. The MDL Court entered a series of case management orders ("CMOs") and ordered the use of Short Form Complaints as a manner of efficiently managing thousands of cases for pre-trial proceedings. Plaintiff filled out a Master Short Form Complaint in compliance with the MDL procedures. On September 10, 2019, the Arizona court transferred the case to this Court via 28 U.S.C. § 1404(a), with a Second Amended Master Short Form Complaint ("Complaint") attached as the operative pleading. [18]. No further amendments have been made to Plaintiffs’ Complaint while in this Court.
In their Complaint, Plaintiffs indicate they are bringing claims for strict products liability (Counts I-III), negligence (Counts IV-VII, IX), negligent misrepresentation (Count VIII), breach of express warranty (Count X), breach of implied warranty (Count XI), fraudulent misrepresentation (Count XII), fraudulent concealment (Count XIII), and a Mississippi Consumer Protection Act ("MCPA") claim. [18] at pp. 66-68.
In their Motion for Summary Judgment, Defendants contend that all claims have been subsumed into the Mississippi Products Liability Act ("MPLA") and seek summary judgment as to all claims. In response, Plaintiffs agree that "several" of their claims are subsumed by the MPLA and that, by withdrawing any manufacturing defect claim, only the design defect and failure to warn claims remain. [134] at p. 3. As to other claims, Plaintiffs request leave to amend their complaint to comply with the MCPA and make a "reasonable attempt to resolve any claim through an informal dispute settlement program approved by the Attorney General" as is required under the Act and Mississippi law. [134] at p. 4 (quoting Joan Cravens, Inc. v. Deas Constr. Inc. , 1:15-CV-385-KS-MTP, (S.D. Miss. June 23, 2016); Miss. Code. Ann. § 75-24-15(2) ). The Court declines to do so, as this case is well beyond the amendment stage.
More to the point, however, according to the Mississippi Supreme Court, "the MPLA provides the exclusive remedy for products-liability claims." Elliott v. El Paso Corp. , 181 So.3d 263, 268 (Miss. 2015) (internal quotation mark omitted). Because this case clearly involves the recovery of damages related to an allegedly defective product, the Court finds that the 2014 amendments to the MPLA and the decision in Elliot make clear that any potential MCPA claim, as well as any other common law tort claims, under the facts of this case, would be subsumed by the MPLA. See Hall v. Smith & Nephew , No. 5:19-cv-13, 2020 WL 3452621, at *1 (S.D. Miss. May 29, 2020) (finding all of plaintiff's state common law claims, including an MCPA claim, were governed by the MPLA). Therefore, with all claims falling under the MPLA, the Court will address only the remaining failure to warn and design defect claims.
2. The Mississippi Products Liability Act governs Plaintiffs’ claims.
In diversity actions in this district, the substantive law of the State of Mississippi controls. Erie R.R. v. Tompkins , 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938) ; Capital City Ins. Co. v. Hurst , 632 F.3d 898, 902 (5th Cir. 2011). The MPLA applies "in any action for damages caused by a product," with deviation defects, warnings or instruction defects, design defects, and where a product breached an express warranty. Elliott , 181 So. 3d at 268 (Miss. 2015). In pertinent part, the MPLA provides:
(a) The manufacturer, designer or seller of the product shall not be liable if the claimant does not prove by the preponderance of the evidence that at the time the product left the control of the manufacturer, designer or seller:
(i) 1. The product was defective because it deviated in a material way from the manufacturer's or designer's specifications or from otherwise identical units manufactured to the same manufacturing specifications, or
2. The product was defective because it failed to contain adequate warnings or instructions, or
3. The product was designed in a defective manner, or
4. The product breached an express warranty or failed to conform to other express factual representations upon which the claimant justifiably relied in electing to use the product; and
(ii) The defective condition rendered the product unreasonably dangerous to the user or consumer; and
(iii) The defective and unreasonably dangerous condition of the product proximately caused the damages for which recovery is sought.
Miss. Code Ann. § 11-1-63. In essence, in Mississippi, there are three categories of product defects: (1) design defects; (2) warnings/instruction defects, and (3) manufacturing defects. See Smith & Nephew , 2020 WL 3452621, at *2.
III. ANALYSIS
Defendants move for summary judgment on both the failure to warn claim and the design defect claim, arguing initially that both claims fail due to Plaintiffs’ inability to establish proximate cause. Plaintiffs move for partial summary judgment only as to the failure to warn claim. Due to the commonality of the arguments on the cross-motions on the failure to warn claim, the Court will rule on that issue first.
Briefly, regarding this initial argument, it is true that to prevail on either MPLA claim, Plaintiffs must show proximate cause. See Miss. Code 11-1-63(a)(iii). However, on the failure to warn claim, because the Court finds infra that the warnings were adequate as a matter of law, there is no need to address proximate cause on this claim. As such, the Court will address proximate cause only on the design defect claim.
A. Failure to Warn Claim
1. Mississippi law on a failure to warn claim
In order to assess the propriety of summary judgment on an MPLA failure to warn claim, the Court must first determine what the law is in Mississippi. State law is determined by looking to the decisions of the state's highest court. St. Paul Fire and Marine Ins. Co. v. Convalescent Servs., Inc. , 193 F.3d 340, 342 (5th Cir. 1999). The Mississippi Supreme Court made clear that the MPLA provides the roadmap for products liability claims in Mississippi, warning that "since [the enactment of the MPLA], products-liability claims have been specifically governed by statute, and a claimant, in presenting his case, must pay close attention to the elements of the cause of action and the liability limitations enumerated in the statute." Elliott , 181 So. 3d at 268. Thus, we begin with the statute.
The Mississippi statute elucidates that on a failure to warn claim, a plaintiff must prove by a preponderance of the evidence that "[t]he product was defective because it failed to contain adequate warnings or instructions," "[t]he defective condition rendered the product unreasonably dangerous to the user or consumer," and "[t]he defective and unreasonably dangerous condition of the product proximately caused the damages for which recovery is sought." Elliott , 181 So. 3d at 273. On this particular claim, the statute goes further and provides that a plaintiff must also show "that at the time the product left the control of the manufacturer, designer or seller, the manufacturer, designer or seller knew or in light of reasonably available knowledge should have known about the danger that caused the damage for which recovery is sought and that the ordinary user or consumer would not realize its dangerous condition." Miss. Code Ann. § 11-1-63(c)(i) (emphasis added).
Going a step further, the statute also provides that "[a]n adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger [that was known and that caused the damage at issue] and that communicates sufficient information on the dangers and safe use of the product." Miss. Code Ann. § 11-1-63(c)(ii). It then goes on to codify what is known as the "learned intermediary doctrine," meaning that in cases involving medical devices, such as the Recovery Filter in this case, which are available only through physicians, the duty to warn extends only to the "learned intermediary," i.e., the physician. See id.; Smith v. Johnson & Johnson, Inc. , 483 F. App'x 909, 913-14 (5th Cir. 2012).
Thus, from a plain reading of the statute, to establish liability on the part of a medical device manufacturer on a failure to warn claim, a plaintiff must show that (1) a product was unreasonably dangerous because it failed to contain adequate warnings to the professional prescribing the product (2) of a danger that caused the damage for which plaintiff seeks recovery, (3) of which danger the manufacturer knew, or should have known. As this Court has put it, citing to a seminal decision from the Mississippi Supreme Court, "The dispositive question [ ] is whether the warnings Defendants gave to the learned intermediary ... were enough to warn him of the possible complications." Lim v. Ethicon, Inc. , No. 3:20-cv-780, 519 F.Supp.3d 380, 387 (S.D. Miss. Feb. 12, 2021) (citing Wyeth Labs., Inc. v. Fortenberry , 530 So. 2d 688, 691 (Miss. 1988) ).
It has long been held (since before the MPLA) that "[a] manufacturer has a duty to adequately warn the prescribing physician of any known adverse effect which might result from use of its product." Cather v. Catheter Technology Corp. , 753 F. Supp. 634, 640 (S.D. Miss. 1991) (citing Wyeth Labs. , 530 So. 2d at 691 ). When it comes to the adequacy of a warning, ordinarily it is a factual matter and usually will be determined by the trier of fact. See Union Carbide Corp. v. Nix , 142 So. 3d 374, 389 (Miss. 2014). However, "In Mississippi, a warning may be held adequate as a matter of law where the adverse effect was one that the manufacturer specifically warned against." Williams v. Manitowoc Cranes, L.L.C. , 898 F.3d 607, 616 (5th Cir. 2018) ; Austin v. Will-Burt Co. , 361 F.3d 862, 868 (5th Cir. 2004) (holding that warnings on a telescoping news truck mast clearly warned that contact with power lines could cause death); see also Adah v. Bayer Corp., No. 3:12-cv-785, 2016 WL 5173512 (S.D. Miss. April 4, 2016) (granting summary judgment in favor of drug manufacturer because package inserts warned the prescribing physician of the risk of vision loss and vision impairment, the exact conditions complained of by plaintiff); Cather , 753 F. Supp. at 640 (finding manufacturer's warnings adequate as a matter of law because venous thrombosis and embolism were specifically mentioned in the manufacturer's physician warning as possible side effects of the use of the device); Johnson & Johnson, Inc. v. Fortenberry , 234 So. 3d 381, 393-94 (Miss. 2017) (reversing and rendering judgment in favor of drug manufacturer because label was adequate as a matter of law when it warned the treating physician specifically of the danger of a known condition that plaintiff exhibited).
2. Plaintiffs’ Motion for Partial Summary Judgment Fails
In response to Defendants’ motion and in support of its own motion for summary judgment, Plaintiffs argue that Defendants’ warnings in the IFU were inadequate, not because they failed to list, or did not sufficiently state, the complications encountered by Mr. Nelson, but because the IFU did not list the comparative rates of occurrence of complications relative to a predecessor Bard device and other IVC filters. Aside from the fact that this is a novel theory, as Defendants point out, Plaintiffs have failed to cite any authority, and the Court has also been unable to find any case law holding that a warning was inadequate as a matter of law. Plaintiffs’ attempt to establish such, or even raise an issue of fact as to the warning's inadequacy, fails under Mississippi law for the following reasons.
Dr. Hurst and Dr. Muehrcke both testified that the IFU also does not warn of a risk of a retained, irretrievable foreign body. [109-7] at p. 8; [111-2] at p. 164. To the extent this is another ground for arguing the IFU was inadequate, as this appears to be one of the dangers that Plaintiffs allege caused the damage for which recovery is sought, the argument likewise fails. Not only does the risk of a retained foreign body as a further complication from the initial fracturing of the filter for which the Defendants warned, but also under the MPLA, Defendants may be held liable only for failing to warn against a known danger. See Miss. Code Ann. § 11-1-63(c)(i). In other words, there must be evidence that Defendants knew, or should have known, that filter fragments would be irretrievable. The Court could find no evidence in the record that Defendants knew at the time the filters left their control that there was a known danger of irretrievable foreign bodies.
a. Mississippi law does not support a finding that failure to provide comparative risk information renders a warning inadequate.
Plaintiffs bear the initial burden to show that the Recovery Filter "was defective because it failed to contain adequate warnings or instructions" See Miss. Code Ann. § 11-1-63(a)(i)(2). Unfortunately, Plaintiffs put the proverbial cart before the horse and spend the lion's share of their argument on proximate cause, i.e., that had the comparative risk information been included, Dr. DeVun would not have implanted a Recovery Filter. By doing so, they fail to establish that the warning that was given would be deemed inadequate under Mississippi law.
Plaintiff focuses on the arguments that "an adequate warning would have prevented Dr. DeVun from implanting the Recovery Filter in Mr. Nelson" and "Plaintiff's injuries would not have occurred if the Recovery Filter had not been implanted." [89] at pp. 15, 19. It is only after a warning is deemed inadequate that causation comes into play. As the Fifth Circuit once noted, "The Mississippi Supreme Court, interpreting the MPLA's proximate cause element for failure-to-warn claims, requires plaintiffs to ‘demonstrate that some other warning would have given them additional information that they did not already know and that they would have acted upon that new information in a manner that would have avoided the injuries.’ " See Williams v. Manitowoc Cranes, L.L.C. , 898 F.3d 607, 620 (5th Cir. 2018). Showing that the comparative failure rate information would have changed Dr. DeVun's decision to implant the filter does not, a fortiori , establish that the warning provided was inadequate.
Plaintiffs only legal support for the theory that the warnings were inadequate because they did not include comparative failure rates is a Ninth Circuit case interpreting Georgia law wherein the Court stated, "A warning may be inadequate when a manufacturer knows its product carries a higher risk of injury than its competitor's similar product, and does not share that information with physicians." [89] at p. 14 (citing In re Bard IVC Filters Product Liability Litigation , 969 F.3d 1067, 1076 (9th Cir. 2020) ). While courts in other states and circuits may have allowed claims to proceed under the theory that comparative risk information should be included in warnings, none of those rulings involved Mississippi law, and Plaintiffs have failed to establish why this Court should rule in their favor on this issue of first impression under Mississippi law, and to the contrary, the Court finds that it cannot. Not only is there no Mississippi law expressly supporting Plaintiffs’ theory, the Court finds that the 2017 Mississippi Supreme Court case of Johnson & Johnson v. Fortenberry, supra , in light of the facts in this case expressly does not.
Plaintiffs also cite to a quote from Windham v. Wyeth Labs., Inc. , 786 F. Supp. 607, 612 (S.D. Miss. 1992) for the proposition that "[i]f undisclosed product comparative risk information would have prevented the physician from using the product, the failure to provide that information becomes a proximate cause of plaintiff." [89] at 14. However, this quoted language cannot be found anywhere in Windham , nor any other decision. Counsel is strongly reminded to exercise extreme caution in quoting the law/holdings to this Court or any other court for that matter.
Fortenberry was a case involving the antipsychotic medication Risperdal from which the plaintiff allegedly developed a motion disorder called tardive dyskinesia. 234 So. 3d at 386. The case went to trial and the jury found in favor of the plaintiff on a failure to warn claim. Id. To prove that the warning for Risperdal was inadequate, Plaintiff had introduced the Defendants’ promotional materials, internal documentation, and expert testimony. Id. at 392. On appeal from a denial of a motion for judgment notwithstanding the verdict, the Mississippi Supreme Court reversed and rendered the verdict, holding that the warning for Risperdal was adequate as a matter of law despite testimony from an expert neurologist who testified that the safest antipsychotic medications were two other brands and had the plaintiff been prescribed either of those, rather than Risperdal, it would be very unlikely she would have developed tardive dyskinesia. Id. at 390, 392.
The court also held that the plaintiff's attempt to prove her failure to warn claim through the Defendants’ marketing materials and internal documentation expanded the claim beyond the statutory scope of the MPLA. Id. at 393. The high court relied on its prior case of Janssen Pharmaceutica, Inc. v. Bailey , 878 So. 2d 31 (Miss. 2004) and found that, because the Bailey court had focused only on the actual drug label, it would not consider the Defendants’ marketing materials or internal documents as support for a failure to warn claim under the MPLA in determining the adequacy of the label. Id. Further of note for this case, the court held that the warning was adequate as a matter of law even though there was also testimony that the warning provided was cookie cutter and meaningless because the same information was on every antipsychotic medication. Id. at 392.
Here, Plaintiffs rely on Bard's HHE and other of Bard's internal documentation in an effort to show that the Recovery Filter had higher rates of complications compared to other Bard filters and other brands of IVC filters. This Court, like the court in Fortenberry , finds that Plaintiffs’ theory of liability utilizing Defendants’ internal documentation to argue that the warning was inadequate goes beyond the statutory scope and takes us far afield from a manufacturer's duty under Mississippi law. The inquiry is relegated to the label itself. The only evidence that Plaintiffs have presented that the IFU, as written, is inadequate is Dr. Hurst's testimony wherein he stated, "The IFU for these devices basically gives a myriad of risks, a laundry list, kind of a generic approach with so many possible complications that it dilutes out any information that you could possibly glean that would be important in your decision-making." [134-52] 86:1-14. Dr. Hurst's testimony is similar to the expert's in Fortenberry , which the high court found was not an obstacle to finding that the warning was adequate as a matter of law. Plaintiffs’ argument is premised on the fact that the warning should have included additional information, but the Plaintiff never adequately rebuts the fact that the IFU as written was inadequate to warn Dr. DeVun, the prescribing physician, of the known complications associated with the Recovery Filter.
The MPLA is a codification of decades of strict liability principals. The governing rule of strict liability arose from section 402A of the Restatement (Second) of Torts (1965), which states "[o]ne who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer." Swayze v. McNeil Laboratories, Inc. , 807 F.2d 464, 467-468 (5th Cir. 1987). The statute now makes clear that a manufacturer will not be held liable unless a plaintiff establishes by a preponderance of the evidence that a manufacturer knew of a danger and failed to adequately warn against that danger and protect the consuming public from injury. Here, Defendants knew of fracturing, migration, and perforation and specifically and clearly warned of those dangers/complications. That is all Mississippi law requires. Accordingly, Plaintiffs’ theory is not sustainable.
Mississippi first adopted strict products liability in State Stove Mfg. Co. v. Hodges , 189 So. 2d 113 (Miss. 1966). See Swayze , 807 F.2d at 467. The MPLA went into effect procedurally on July 1, 1993 and substantively on July 1, 1994. See Smith v. Mack Trucks, Inc. , 819 So. 2d 1258, 1261 (Miss. 2002).
b. Finding that failure to include comparative risk information makes the warnings inadequate would be problematic.
Having established the lack of legal support for Plaintiffs’ position, the Court finds that potentially liability for failure to include comparative risk information, such as the comparative failure rates in this case, is problematic in other ways. First, Plaintiffs rely on several portions of testimony stating that physicians and patients expect that kind of information to be put into the IFU. [111] at p. 15; However, subjective expectations are not the standard for liability in Mississippi. To find that Bard may potentially be found liable for failing to include comparative risk information in warnings based on the expectations of physicians and patients, regardless of the reasonableness of such expectations, would create new law in Mississippi, which this federal district court is not willing to do. Also, Dr. Hurst testified that he has never seen comparative risk information included in any IFU for an IVC filter. [109-7] at p. 5. The Court agrees with Defendants that Plaintiffs’ "failure to disclose comparative risk" theory effectively charges manufacturers and sellers with having to know their competitors’ products’ failure rates, ignores the informational biases associated with the latency with which manufacturers or sellers receive complaints for new products as compared to established products, and creates new liability in every instance where one product is alleged to have higher risk of complication than another—regardless of whether any such difference has clinical significance.
For this Court to deem that the warnings were inadequate because they did not include information on the likelihood of occurrence would be to embark on a slippery slope. At present, a manufacturer's duty is to adequately warn of known adverse effects. To go beyond that and find that, even though a manufacturer warned of a known danger, it can be liable because it failed to give the frequency of the danger or the percentages of danger compared with other products makes legal compliance nearly impossible and potential liability wholly unpredictable. As defense counsel pointed out during oral argument, rate of failure statistics would change on a regular basis. How often would such information need to be disseminated? Would the percentage of failure rate be tied to finding the product is unreasonably dangerous? Dr. DeVun testified that he could not say whether the complication rates in the HHE were necessarily high or low and admitted that complication rates can be significantly different, but still acceptable. [140-6] 119:14-19; 120:20-23.
Additionally, if a warning were inadequate because it failed to include information that would show how likely a complication is to occur, a manufacturer would now be subject to liability for failing to warn as to the "degree" of the danger. Such a proposition, again, goes beyond the requirements of the MPLA. The statute requires only that manufacturers adequately warn of known dangers, not the amount of risk associated with that known danger. By their very nature, comparative failure rates involve complications that are encountered with all IVC filters. Dr. DeVun testified that these complications are known in general to occur with IVC filters. [140-6]128:5-12.
It seems reasonable that once a known complication is warned of, one must assume such complication will occur in order to properly assess whether the risk of use outweighs the benefit. Indeed the IFU states: "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." [87-8]. The fact that a danger exists without a proper warning of its existence is what makes a product potentially unreasonably dangerous, not whether the danger is more likely than not to occur.
Based on the foregoing, the Court finds that Plaintiffs’ argument that the warnings were inadequate because they failed to include comparative risk information is unsustainable under Mississippi law. Therefore, Plaintiffs’ motion for partial summary judgment will be denied.
3. Defendants prevail on summary judgment
Defendants argue that the warnings in the IFU for the Recovery Filter were adequate as a matter of law, and after reviewing the plentiful record and arguments of counsel, the Court agrees. Defendants are entitled to summary judgment under Mississippi law because the IFU warned of each of the specific complications that Plaintiff encountered. The medical imaging showed that Mr. Nelson's filter had fractured, perforated the vena cava wall, and fragments had migrated to other parts of his body, including the lungs and pulmonary artery, where a fragment has embolized. The Recovery IFU addresses these very issues.
Plaintiffs argue "[t]he mere mention of possible injury or failure mode, is not necessarily adequate." [89] at p. 14. (citing Stahl v. Novartis Pharms. Corp. 283 F.3d 254, 266-67 (5th Cir. 2002) ). Not only is Stahl a case decided under Louisiana law, but here, there is not just a mere mention of possible injury. The IFU clearly states that perforation was a potential complication, and fracture and movement or migration are listed not simply in a small font laundry list of things that "may occur ," the IFU specifically warns that these two adverse effects are "known complications." Fracture and movement or migration are mentioned not just once, but twice, under the headings of both "Warnings" and "Complications."
• Under the bolded heading "Warnings ," the IFU reads:
• "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."
• "Movement or migration of the filter is a known complication of vena cava filters.... 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."
• Under "Potential Complications ," the IFU reads, in part, that "Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to, the following," and again the IFU states:
• "Movement or migration of the filter is a known complication of vena cava filters.... 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."
• "Perforation or other acute or chronic damage of the IVC wall."
• "All of 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."
[87-8] (all emphasis in original).
"An adequate warning is one reasonable under the circumstances." Fortenberry , 234 So. 3d at 391 (quoting Wyeth Labs. , 530 So. 2d at 692 ); Miss. Code Ann. § 11-1-63(c)(ii). If the product warning is adequate, "then the product was not unreasonably dangerous, and defendants’ conduct was neither unreasonable nor negligent." Wyeth Labs. , 530 So. 2d at 692 (citing Swayze , 807 F.2d at 467 ); Smith v. Johnson & Johnson , Civ. A. No. 3:08-cv-245, 2011 WL 3876997, at *10 (S.D. Miss. Aug. 31, 2011). These warnings are clear and explicit and were sufficient to warn Dr. DeVun of these possible complications. Mr. Nelson's filter fractured; fragments migrated; fragments perforated the vena cava wall; fragments embolized; and these complications resulted in medical intervention, i.e., the three removal procedures. Because Defendant's warnings expressly warned Dr. DeVun, as the learned intermediary, of these very complications, under Mississippi law, Defendants’ warnings in the Recovery IFU were adequate as a matter of law and Defendants are entitled to judgment as a matter of law on this issue.
Mr. Nelson claims to have experienced leg and back pain, but the evidence shows that these were not caused by a defective intact filter. Rather, as Plaintiff tacitly concedes, the pain was caused by the filter's fracturing and migrating—two conditions that were warned of. [135] at ¶¶ 41-43, 64, 128.
B. Defective Design Claim
To prevail on design defect claim, a plaintiff must prove by the preponderance of the evidence that at the time the product left the control of the manufacturer (1) the product was designed in a defective manner; (2) the defective design rendered the product unreasonably dangerous to the user; and (3) defective and unreasonably dangerous design of the product proximately caused the damages for which recovery is sought. See Miss. Code Ann. § 11-1-63(a)(i)(3), (ii), (iii) ; Brown v. Ford Motor Co. , 121 F. Supp. 3d 606, 611 (S.D. Miss. 2015) (citing 3M Co. v. Johnson , 895 So. 2d 151, 161 (Miss. 2005) ). Additionally, in particular to a design defect claim, Plaintiffs must produce evidence to show that: "(i) [t]he manufacturer or seller knew, or in light of reasonably available knowledge or in the exercise of reasonable care should have known, about the danger that caused the damage for which recovery is sought; and (ii) [t]he product failed to function as expected and there existed a feasible design alternative that would have to a reasonable probability prevented the harm without impairing the utility, usefulness, practicality or desirability of the product to users or consumers." Miss. Code Ann. § 11-1-63(f)(i)-(ii).
Defendants argue they are entitled to summary judgment because Plaintiff has failed to put forth any evidence that: (1) the Recovery Filter was designed in a defective manner; (2) a defective condition rendered the Filter unreasonably dangerous; (3) the defective and unreasonably dangerous condition of the filter proximately caused Plaintiffs’ damages; and (4) there existed a feasible alternative design that would to a reasonable probability have prevented the harm without impairing the utility, usefulness, practicality, or desirability of the Filter. [104] at p. 34.
1. Evidence of a Defective Design
Defendants, as the moving party may discharge their summary judgment burden by pointing out to the Court that there is an absence of evidence to support the nonmoving party's case. See Celotex , 477 U.S. at 325, 106 S.Ct. 2548. To avoid summary judgment, in response, Plaintiffs must make a sufficient showing on this essential element of their case on which they have the burden of proof. Id. at 323, 106 S.Ct. 2548. Defendants contend there is no evidence to establish that the Recovery Filter was designed in a defective manner, and evidence of a specific design defect is required. See Austin v. Bayer Pharms. Corp. , No. 5:13-CV-28-KS-MTP, 2013 WL 5406589, at *6, 2013 U.S. Dist. LEXIS 137480, at *15-16 (S.D. Miss. Sept. 25, 2013) (dismissing design defect claims for failure to state a claim because "[p]laintiff failed to identify [the product's] design defect. She alleged that it is defective in design, but she did not explain — even in the simplest terms — what the defect is").
Defendants also argue that Plaintiff has no case-specific expert to testify that the design was defective. In their response, Plaintiffs concede that their case specific experts, Drs. Hurst and Muehrcke, do not provide an opinion on a specific design defect, but point out, and the Court agrees, Defendants cite no authority that would indicate only case-specific experts may provide evidence regarding the filter's defective design.
See [134] at pp. 9, 12.
Plaintiffs rely on the opinions of Dr. Robert M. McMeeking, a structural and mechanical engineer, who testified in the MDL proceedings. Plaintiffs have submitted a number of excerpts from Dr. McMeeking's testimony; however, the Court finds that the only testimony that addresses how specifically the Recovery Filter is supposedly defective in design is as follows:
Q: Let's talk about your specific opinions as to the various failure modes you've identified. First, I'd like to talk about tilt. What's the basis for your opinion that the design of the Recovery version of the filter leads to tilt?
A: Well, the design leads to tilt because the shape of the filter means that it is a spring. It's a relatively -- the shape of the spring is quite complicated but in the end, it's a spring and springs always want to expand when you compress them. So if I take the feet and press them together the legs always want to expand back again to the original width that was between them before I squeezed them and therefore these springs always want to expand. That's what -- the simplest way to see it (indicating).
And if I take this as a simpler spring to represent the filter, so this is representing one foot of the filter, and this is one foot of one limb or leg of the filter. This is representing one foot or one leg on the other side of the filter, and when the filter is inside the IVC, it's squeezed, and it's trying to expand again, which is why it's pushing against my fingers.
And one way it can expand if I don't move my fingers is by rotating out of the line between my fingers. So by tilting the distance between the feet can get -- can become greater and that's the essential reason why the filter wants to -- wants to tilt. And I can explain that in terms of an everyday understanding which is that if you're crossing a street and you go across the street straight across that you cover -- you go across the street by the shortest distance that you can cover whereas if you go at an angle if you go diagonally the distance that you cover is that much greater.
And so by the filter going from directly from one side of the street to the other to being at an angle to the straight across direction of the street, the filter has expanded the distance between its feet and therefore relieved some of that force that is associated with the filter wanting to expand.
[135] at p. 26 (quoting from [134-58] 92:12-94:5). All of the other excerpts submitted by Plaintiffs seem to assume a design defect exists because Dr. McMeeking discusses only the effect of the alleged defect. For example, when asked what his opinions are as to the design of the recovery filter. He testified as follows:
The design is such that it's likely to have -- to cause serious complications that create significant risks for the patient and these risks are included and are
associated with tilt, with movement or migration of the filter within the IVC, with puncture, perforation or penetration of limbs of the IVC through the wall of -- through the - sorry. Let me say that again, puncture or perforation or penetration of the limbs of the filter through the wall of the IVC and its fracture due to fatigue of the material. And the design is such that it did not eliminate these risks or reduce them to the extent feasible. And as I mentioned before, it's a situation where one complication can lead to another so that, for example, tilt can lead to movement of the filter. It can lead to perforation, and that, in turn, can lead to fracture, whereas perforation can lead to tilt, and perforation can also lead to fatigue fracture of the limbs.
[135] at 26 (citing McMeeking Dep. [134-58] 91:15-92:11). This testimony does not identify what the actual defect in the design is—only the effects of a presumably defective design. Notwithstanding, the Court finds that the first quoted portion Dr. McMeeking's testimony, set forth above, is enough to raise a genuine issue of fact that the Recovery Filter had a defective design. However, it is incumbent on Plaintiffs to show that this design defect was the cause of Plaintiffs’ injuries.
2. Causation from Defective Design
Defendants argue that Plaintiffs must show both general and specific causation, and there is a failure to show specific causation in this case. However, regardless of whether Mississippi law requires that causation be addressed in terms of general and specific causation, it is an element under the MPLA that a plaintiff show that the defective design, which renders the product unreasonably dangerous, proximately caused the damages for which recovery is sought. See Miss. Code. Ann. § 11-1-63(a)(i)(3)(iii). The Court finds that Plaintiffs have failed to adduce sufficient evidence to create jury question on the issue of causation in fact. There 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. His testimony addresses how the design can cause the filter to tilt, but here the issue is fracturing and migration. There is no evidence submitted to the Court that ties a design defect to these particular issues. Therefore, the Court finds that summary judgment is warranted in favor of the Defendants on the design defect claim.
3. Feasible Design Alternative
Once again, another element of a defective design claim that a plaintiff must establish is that there "existed a feasible design alternative that would have to a reasonable probability prevented the harm without impairing the utility, usefulness, practicality or desirability of the product to users or consumers." Miss. Code Ann. § 11-1-63(f)(ii) ; Williams v. Bennett , 921 So. 2d 1269, 1275 (Miss. 2006). Defendants argue that they are further entitled to summary judgment because Plaintiff has no evidence that a feasible design alternative existed that to a reasonable probability would have prevented the harm to Plaintiff without impairing the utility, usefulness, practicality or desirability of the filter. [104] at p. 29.
Plaintiffs respond that the most obvious evidence that the Recovery Filter is defectively designed is that other IVC filter designs exist that are clearly safer and that Plaintiffs have presented evidence that Defendants own SNF, as well as other IVC filters on the market at the time of the Recovery Filters’ sale, had lower rates of fracture, migration, and perforation than the Recovery Filter. [134] at p. 14. Plaintiffs attempt to show a feasible design alternative misses the mark. First, Plaintiffs cite no legal authority holding, or even discussing, that a predecessor design of a product that carried the same risks but less chance of occurrence would legally suffice as a feasible design alternative. Second, regardless of any difference between a permanent filter and an optional retrievable filter, it is Plaintiffs’ burden to show that a feasible design alternative would have to a reasonable probability prevented the harm. Simply reducing the risk is not preventing it. Also, the evidence submitted by the Plaintiff fails to address the actual design of these other filters, only that these alternative products exist with lower incidence rates. The "mere mention of a design alternative" is insufficient. Williams , 921 So. 2d at 1275. There has been no evidence in the record cited that compares any designs to show how a particular alternative design would have prevented the harm.
Plaintiffs cite to Dr. McMeeking's testimony on alternative design. His testimony was as follows:
Q: And could you tell the jury what you believe are alternative design features that would resolve or at least minimize some of the failure mode and issues you have seen in the other filters?
A: So the features that would help in that regard are what is called a two-tier design which is what you have in this filter, which is the Simon Nitinol filter, it's also a Bard filter. And what that does is it enables some decoupling at the top of the filter from the bottom which will help in terms of mitigating the effect of tilt and perforation. The features of the upper umbrella will help to reduce perforation by the upper umbrella. Caudal anchors added to the filter which are effective would help to mitigate both tilt and caudal migration, caudal movement. Penetration and perforation limiters which are effective would help to limit penetration, and the consequences that that can bring about in terms of fracture by fatigue and detailed changes to the shape will improve the strain concentrations that would otherwise be present since strain concentrations are very sensitive to the exact shape of a device. So all of those would have improved the safety and the reliability of the filter.
[135] at pp. 30-31 (citing [134-58] 256:4-257:4). While this testimony addresses improving safety and reliability, it does not satisfy Plaintiffs’ burden under Mississippi law to show that these design elements would have, to a reasonable probability, prevented the harm without impairing the utility, usefulness, practicality, or desirability of the Recovery to Dr. DeVun or Plaintiff. Accordingly, the Court finds that Plaintiffs have failed to raise a genuine issue of material fact as to a feasible design alternative under Mississippi law, which also warrants summary judgment in favor of the Defendants.
4. Comment k § 402A of the Restatement (Second) of Torts
Defendants posit as a final ground for summary judgment that Comment k § 402A of the Restatement (Second) of Torts bars recovery under a design defect theory of recovery. [104] at 32. However, because, as Defendants concede, no Mississippi court has squarely addressed whether comment k may be extended to medical devices, and because the Court has granted summary judgment on numerous other grounds, the Court declines to address this issue of first impression.
IV. CONCLUSION
The Court finds that Plaintiffs have failed to establish their failure to warn claim as a matter of law and failed to raise a genuine issue of fact that the Defendants’ warnings regarding known complications of using the Recovery Filter were inadequate under Mississippi law. Plaintiffs have also failed to raise a genuine issue of material fact on the design defect claim on the elements of design defect, causation, and feasible alternative design.
Therefore, it is hereby ORDERED that Plaintiffs’ Motion for Partial Summary Judgment [87] is DENIED and Defendants’ Motion for Summary Judgment [103] is granted on the grounds stated herein. All remaining pending motions are denied as moot. Pursuant to Federal Rule of Civil Procedure 58, the Court will enter a separate judgment on even date herewith in accordance with this ruling.
SO ORDERED AND ADJUDGED this 6th day of August 2021.