Phillips v. C.R. Bard, Inc. et al

Filing 273

ORDERED that the Motions in Limine (## 199 , 200 , 214 , 218 ), the Motion to Bifurcate Trial (# 243 ), and the Motion to Seal (# 244 ) are GRANTED. FURTHER ORD that the Motions in Limine (## 195 , 205 , 217 ) are GRANTED IN PART and DE NIED IN PART. FURTHER ORD that the Motions in Limine (## 196 , 197 , 198 , 201 , 202 , 203 , 204 , 206 , 207 , 208 , 209 , 211 , 212 , 213 , 215 , 216 , 219 , 220 , 221 , 222 , 223 , 224 , 225 , 226 , 227 , 228 ) are DENIED. FURTHER ORD that the Motion in Limine (## 261 , 262 ) is STRICKEN as untimely. Signed by Judge Robert C. Jones on 1/20/2015. (Copies have been distributed pursuant to the NEF - DRM)

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UNITED STATES DISTRICT COURT

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DISTRICT OF NEVADA

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_____________________________________
KEVIN PHILLIPS,

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Plaintiff,

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vs.
C.R. BARD, INC. et al.,

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Defendants.

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3:12-cv-00344-RCJ-WGC
ORDER

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This case arises out of an allegedly defective surgically implanted medical device.

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Pending before the Court are twenty-five motions in limine, a motion to bifurcate trial, and a

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motion to seal.

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I.

FACTS AND PROCEDURAL HISTORY

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The inferior vena cava (“IVC”) is a vein that returns blood to the heart from the lower

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body. (Compl. ¶ 15, ECF No. 1-1). An IVC filter is a medical device residing in the IVC that

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catches blood clots or “thrombi” that travel from the lower portions of the body towards the heart

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and lungs, where they can cause serious injury or death. (Id. ¶¶ 14–16). IVC filters have been on

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the market since the 1960s. (Id. ¶¶ 13, 18). The first IVC filters were “permanent” filters, i.e.,

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designed to remain in the patient for the patient’s life. (Id. ¶ 18). In 2003, manufacturers began

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producing “optional” or “retrievable” IVC filters that can be removed from a patient once the

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risk of a blood clot has subsided. (Id.). At issue in the present case is the Recovery Filter System

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(“RFS”). Defendants C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. (C.R. Bard’s

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subsidiary) “designed, set specifications [for], manufactured, prepared, compounded, assembled,

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processed, marketed, distributed, and sold the Recovery Filter System and G2 Filter System

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(“G2FS”) to be implanted in patients . . . .” (Id. ¶¶ 3–4). Although Plaintiff makes general

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allegations concerning the G2FS, as well as the RFS, he alleges only having had a defective RFS

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implanted in him. (See id. ¶¶ 49–51).

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Due to manufacturing and design defects, the RFS has a high fracture and migration rate

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as compared to other IVC filters, and these defects can cause serious injury or death. (See id.

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¶¶ 25–30). Defendants failed to conduct clinical testing such as animal studies on the RFS, and

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even after they became aware of large numbers of adverse event reports (“AER”) from health

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care providers reporting serious injury or death due to the migration of the entire device or

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fractured pieces of the device, they failed to recall the RFS or even warn those who had been

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implanted with one, although they withdrew the RFS from the market. (See id. ¶¶ 31–35, 43–48).

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Plaintiff makes similar allegations concerning the G2FS, but again, he does not allege having

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been implanted with a G2FS. (See id. ¶¶ 36–42).

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Plaintiff was implanted with Defendants’ RFS on August 4, 2005. (Id. ¶¶ 49–50). The

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RFS subsequently failed and migrated to Plaintiff’s heart, perforating his heart and causing

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severe and life-threatening complications requiring emergency open-heart surgery on April 30,

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2010, and resulting in various economic and non-economic damages. (Id. ¶ 51). Plaintiff sued

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Defendants in state court for: (1) negligence; (2) strict products liability—failure to warn; (3)

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strict products liability—design defects; (4) strict products liability—manufacturing defects; (5)

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breach of the implied warranty of merchantability; (6) negligent misrepresentation; and (7)

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violation of the Deceptive Trade Practices Act (“DTPA”), Nevada Revised Statutes

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§§ 598.0915(5), (15), 598.0923(2), and 598.0925(1)(a). Defendants removed, demanded a jury

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trial, and answered. Defendants filed four motions in limine and a motion for summary

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judgment. The Court denied the motions in limine and granted the motion for summary

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judgment in part. Plaintiff has now filed sixteen motions in limine, and Defendants have filed

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eight.

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II.

LEGAL STANDARDS
A motion in limine is a procedural device to obtain an early and preliminary ruling on the

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admissibility of evidence. Black’s Law Dictionary defines it as “[a] pretrial request that certain

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inadmissible evidence not be referred to or offered at trial. Typically, a party makes this motion

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when it believes that mere mention of the evidence during trial would be highly prejudicial and

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could not be remedied by an instruction to disregard.” Black’s Law Dictionary 1171 (10th ed.

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2014). Although the Federal Rules of Evidence do not explicitly authorize a motion in limine,

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the Supreme Court has held that trial judges are authorized to rule on motions in limine pursuant

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to their authority to manage trials. See Luce v. United States, 469 U.S. 38, 41 n.4 (1984) (citing

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Fed. R. Evid. 103(c) (providing that trial should be conducted so as to “prevent inadmissible

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evidence from being suggested to the jury by any means”)).

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Judges have broad discretion when ruling on motions in limine. See Jenkins v. Chrysler

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Motors Corp., 316 F.3d 663, 664 (7th Cir. 2002). However, a motion in limine should not be

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used to resolve factual disputes or weigh evidence. See C&E Servs., Inc., v. Ashland, Inc., 539 F.

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Supp. 2d 316, 323 (D.D.C. 2008). To exclude evidence on a motion in limine “the evidence

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must be inadmissible on all potential grounds.” E.g., Ind. Ins. Co. v. Gen. Elec. Co., 326 F. Supp.

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2d 844, 846 (N.D. Ohio 2004). “Unless evidence meets this high standard, evidentiary rulings

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should be deferred until trial so that questions of foundation, relevancy and potential prejudice

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may be resolved in proper context.” Hawthorne Partners v. AT&T Tech., Inc., 831 F. Supp.

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1398, 1400 (N.D. Ill. 1993). This is because although rulings on motions in limine may save

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“time, costs, effort and preparation, a court is almost always better situated during the actual trial

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to assess the value and utility of evidence.” Wilkins v. Kmart Corp., 487 F. Supp. 2d 1216, 1219

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(D. Kan. 2007).

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In limine rulings are preliminary and therefore “are not binding on the trial judge [who]

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may always change his mind during the course of a trial.” Ohler v. United States, 529 U.S. 753,

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758 n.3 (2000); accord Luce, 469 U.S. at 41 (noting that in limine rulings are always subject to

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change, especially if the evidence unfolds in an unanticipated manner). “Denial of a motion in

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limine does not necessarily mean that all evidence contemplated by the motion will be admitted

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to trial. Denial merely means that without the context of trial, the court is unable to determine

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whether the evidence in question should be excluded.” Ind. Ins. Co., 326 F. Supp. 2d at 846.

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III.

ANALYSIS

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A.

Plaintiff’s Motions in Limine

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1.

Motion No. 195

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Plaintiff asks the Court to exclude references to his counsel’s practices, advertisements,

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or fees. The Court grants the motion in part. See Fed. R. Evid. 401, 402. Defendants object only

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that it should be permissible for counsel to ask jurors during voir dire whether they have seen

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advertisements about IVC filter litigation. Without yet deciding whether the Court will permit

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this question during voir dire, the Court will not categorically exclude it at this time.
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Motion No. 196

Plaintiff asks the Court to exclude reference to IVC filters as the “gold standard” of

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treatment for the relevant medical problems. The Court denies the motion. If Defendants have

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competent expert evidence that IVC filters are the preferred method of treatment, the expert may

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adduce the evidence as background information.
Motion No. 197/198 1

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3.

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Plaintiff asks the Court to exclude reference to surgical consent forms. The Court denies

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the motion because it cannot tell whether such evidence will be relevant without the context of

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trial. It is possible that consent forms may contain warnings relevant to the duty to warn or

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comparative fault.

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1 Some motions have been filed in both sealed and unsealed versions.

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4.

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Plaintiff asks the Court to exclude references to collateral sources of payment for

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Plaintiff’s medical bills. The Court grants the motion. See McConnell v. Wal-Mart Stores, Inc.,

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995 F. Supp. 2d 1164, 1169–73 & nn.1–3 (D. Nev. 2014) (Jones, J.). Defendants respond that

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they do not intend to offer such evidence, unless Plaintiff “opens the door” and makes such

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evidence relevant.

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5.

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Plaintiff asks the Court to exclude references to a “litigation crisis,” or the potential

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Motion No. 199

Motion No. 200

impact of a verdict in Plaintiff’s favor on the medical industry, the economy, or jurors

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themselves. The Court grants the motion. See Fed. R. Evid. 401, 402. Defendants respond that

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they do not intend to offer such evidence, unless Plaintiff “opens the door” and makes such

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evidence relevant.

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Plaintiff asks the Court to exclude references to the previous exclusion of Plaintiff’s

Motion No. 201

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expert witnesses in other cases. The Court denies the motion. The Court cannot say without the

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context of trial that such commentary or questions would be irrelevant or otherwise inadmissible

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in all cases. For example, such evidence may be relevant as impeachment of an expert’s claim of

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his or her qualifications made in front of the jury.

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7.

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Plaintiff asks the Court to exclude reference to FDA approvals of the device at issue of

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Motion No. 202/203

lack of any enforcement activities by the FDA against Defendants based on the device. The

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Court denies the motion. Such evidence is relevant to show whether industry standards have

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been complied with, which is relevant to whether Defendants were negligent.

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Motion No. 204

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Plaintiff asks the Court to exclude reference to failure rates, complication rates,

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percentages, or comparative analysis of injuries different from those asserted in this case. The

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Court denies the motion. The Court cannot say this kind of evidence would be irrelevant. The

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overall rate of injury for the device at issue is relevant to whether Defendants exercised due care.

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For example, a jury could rationally reason that a defendant is not negligent for distributing a

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device that has an overall injury rate of 0.1% if other similar devices have similar injury rates,

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even if the rates of a particular kind of injury are higher for the defendant’s device. That is,

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perhaps the device at issue had a higher injury rate for some kinds of injuries but a lower rate for

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other kinds of injuries, but the overall rate of injury was comparable. Certain kinds of injuries

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might also be more likely to cause more serious harm. This is a complex determination relating

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to whether Defendants were negligent that the Court will not take from the jury on a motion in

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limine.

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9.

Motion No. 205

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Plaintiff asks the Court to exclude argument or evidence relating to the fault of non-

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parties. The Court grants them motion in part. It is true that the jury may only apportion fault as

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between parties to the case. See Nev. Rev. Stat. § 41.141(2)(b)(2). Defendants respond that the

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statute does not prevent them from arguing “that non-parties” were negligent and are responsible

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to some degree.” Neither Plaintiff nor Defendants are completely correct. A jury may not

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apportion fault to non-parties, and evidence or argumentation directed to showing non-parties’

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comparative fault is therefore inadmissible, but “[n]othing in NRS 41.141 prohibits a party

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defendant from attempting to establish that either no negligence occurred or that the entire

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responsibility for a plaintiff’s injuries rests with nonparties . . . .” Banks v. Sunrise Hosp., 102

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P.3d 52, 67 (Nev. 2004) (emphasis added). That is, Defendants may argue that non-parties were

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entirely at fault and that Defendants were not at fault at all, and they may adduce otherwise

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admissible evidence in support. But they may not argue that non-parties are partially at fault or

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adduce evidence tending only to show comparative fault.
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Motion No. 206/207

Plaintiff asks the Court to exclude evidence that IVC filters are “lifesaving devices.” The

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Court denies the motion. Defendants may adduce testimony that this is true if they have it.

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Plaintiff also asks the Court to exclude statistics concerning thrombi and pulmonary embolisms

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in the general population. The Court cannot say that this would be irrelevant as background

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information.

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Motion No. 208/209

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Plaintiff asks the Court to exclude arguments that Defendants could not affix warning

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labels, given the physician additional warnings, or have enacted a recall without FDA approval.

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The Court denies the motion. Evidence of FDA requirements in changing warnings or the

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feasibility of having a particular warning changed by a particular date is relevant to whether

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Defendants were negligent in not changing warnings.

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12.

Motion No. 219/220

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Plaintiff asks the Court to exclude certain opinions of Dr. David Feigal, to wit: (1) that an

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epidemiological analysis determined there is no reliable evidence the IVF filter posed a greater

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risk of harm than other devices; (2) that complaint data cannot be used to make safety

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assessments or comparisons regarding medical devices; and (3) that there are “stimulated

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reporting” factors that could theoretically explain the higher reported failure rates for the IVF

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filter at issue. Plaintiff first argues that Dr. Feigal failed to apply reliable principles to sufficient

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facts or data as to the epidemiological analysis. The Court rejects this argument. The quoted

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segment of the deposition does not show that Dr. Feigal did not use reliable methods. It shows

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that Plaintiff’s attorney and Dr. Feigal disagreed about how closely he had followed Dr. Feigal’s

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own previously stated definition of an epidemiological analysis. Dr. Feigal’s failure (if it can be

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called that) to include certain of Defendants’ data in his analysis does not necessarily render his

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methods invalid or the data he used unreliable. Plaintiff may impeach Dr. Feigal by pointing out

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(if it is true) that there was certain relevant evidence available to him that he did not consider.

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Next, Dr. Feigal’s opinion that complaint data cannot be used to make safety assessments

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or comparisons of devices is not the kind of expert opinion amenable to a proper methods–

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sufficient data examination because the opinion is not the result of a scientific test. It is an

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opinion about what methods are appropriate in making a certain kind of assessment. Plaintiff

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may counter this opinion with that of his own expert or challenge Dr. Feigal’s reasoning on

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cross-examination. The same is true of Dr. Feigal’s opinion that there are “stimulated reporting”

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factors that could explain the higher reported failure rates for the IVF filter at issue. Plaintiff

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argues that Dr. Feigal has no support, apart from speculation, that any stimulated reporting

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phenomena occurred in this case. If that is true, the testimony may be inadmissible for a lack of

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foundation, but the Court cannot categorically exclude it at this time.

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Plaintiff asks the Court to exclude the testimony of Dr. Tsuda, who is expected to testify

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only that Plaintiff’s physician did not breach his own duty of care when he implanted the device.

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The Court denies the motion. It is not yet clear whether Plaintiff will argue at trial that An IVF

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filter should not have been used in his case.

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Motion No. 221/222

Motion No. 223/224

Plaintiff asks the Court to exclude testimony that the IVC filter was misplaced or could

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not be expected to perform as it was placed. The Court denies the motion. This kind of

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testimony would plainly be relevant to causation, i.e., whether any defect was a cause of the

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harm. Defendants must have competent evidence to this effect, but the Court cannot

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categorically exclude it.

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Motion No. 225/226

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Plaintiff asks the Court to exclude testimony that Plaintiff did not take his anti-coagulant

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medication as prescribed, and that if he had, he would not have developed clots. The Court

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denies the motion. Again, Defendants must have competent evidence of Plaintiff’s failure to

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take his prescribed medication, and any expert as to the likelihood of not developing clots if the

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medication had been taken must be admitted both as to his qualifications and his methods, but

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the Court cannot categorically exclude this kind of evidence, which is plainly relevant to

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causation and comparative fault.

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Motion No. 227/228

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Plaintiff asks the Court to exclude evidence of the Society of Interventional Radiology

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(“SIR”) Guidelines to show acceptable rates of complications. The Court denies the motion.

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Defendants will have to adduce a qualified expert as to the use of these guidelines in the industry

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to evaluate safety and that the guidelines at issue should apply to the device at issue, but if they

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can do so, industry standards are relevant to the negligence question.

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B.

Defendants’ Motions in Limine

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1.

Motion No. 211

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Defendants ask the Court to exclude evidence of other incidents of IVC failure if not

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sufficiently similar to the alleged failure in this case. The Court denies the motion. Failures of

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any kind causing injury occurring before the incident here are relevant to Defendants’ knowledge

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of the risk of harm to Plaintiff and thus to whether they exercised due care. The evidence would

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not be admissible to show causation, however, and Defendants might be entitled to a limiting

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instruction.

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2.

Motion No. 212

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Defendants ask the Court to exclude evidence of comparative failure rates of their IVC

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filter and other manufacturers’ IVC filters. The Court denies the motion. The Court must

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consider the basis of any such testimony in the context of trial. Knowledge of a higher failure

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rate than those of competitors may be relevant to the negligence issue.

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3.

Motion No. 213

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Defendants ask the Court to exclude evidence that Defendants withheld evidence from

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the FDA. The Court denies the motion. If Plaintiff has such evidence, it is as relevant as the

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FDA’s approvals. The parties must argue to the jury what this evidence means. Plaintiff may

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not argue that the FDA would not have approved the device had it had full disclosure and

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certainly may not bring a state law fraud claim based on such an argument. Those issues and

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claims are preempted. But the issue is still relevant to Defendants’ state of mind, i.e., to their

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knowledge of the risk, which is relevant to the negligence question. To rule otherwise would be

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to establish a “ceiling of care” based on FDA approval.

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4.

Motion No. 214

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Defendants ask the Court to exclude evidence of C.R. Bard’s criminal conviction in 1994

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based on conduct in the 1980s. The Court agrees that the evidence would be much more

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prejudicial than probative, unless Plaintiff intends to use the fact to impeach a witness in the

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present case who was personally responsible for the previous criminal activity at C.R. Bard.

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That does not appear to be the case. Plaintiff responds that the evidence is admissible under Rule

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404(b) as tending to show a “habit or custom” of Defendants. But that rule does not concern

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habits or customs, only “motive, opportunity, intent, preparation, plan, knowledge, identity, or

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absence of mistake.” Fed. R. Evid. 404(b). It is Rule 406 that concerns habit-type evidence, and

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there is no claim that Defendants have a “habit” of violating the law in some particular way

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relevant to this case. In any case, Rule 406 cannot be used to circumvent Rule 404 if it does not

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relate to some narrowly concrete habit of behavior, and one previous incident of a particular

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behavior is insufficient to show a habit. Scott v. ABC, 878 F.2d 386 (9th Cir. 1989) (“Rule 406

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may be invoked only where a high degree of specificity and frequency of uniform response is

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present.”).

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5.

Motion No. 215

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Defendants ask the Court to exclude argumentation of a financial motive for downplaying

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the risks of the device. The Court denies the motion. Such a motive, if it can be shown, and not

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merely speculated upon, is at least relevant to punitive damages.

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6.

Motion No. 216

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Defendants ask the Court to exclude evidence of state of mind, intent, motive, or ethics.

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The Court denies the motion. It targets too broad an area for the Court to make a categorical

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exclusion without the context of a particularized objection at trial.

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7.

Motion No. 217

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Defendants ask the Court to exclude arguments that Defendants had an independent duty

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to conduct additional testing or that liability can result merely from a failure to do so. The Court

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grants the motion in part. Evidence of testing, and whether any additional testing was performed

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based on knowledge of certain defects or rates of failure, is relevant to whether Defendants

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exercised due care. There is, however, no independent duty to test, and liability cannot be based

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purely on a failure to conduct certain kinds of tests. Plaintiff has correctly identified the

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distinction in response.

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8.

Motion No. 218

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Defendants ask the Court to exclude evidence of their financial condition during the

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liability phase. The Court grants the motion. See Nev. Rev. Stat. § 42.005(4). The Court for the

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same reason grants the motion to bifurcate the trial into liability and punitive damages phases.

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Of course, as Plaintiff notes in response, such evidence may become admissible to rebut

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testimony adduced on behalf of Defendants that certain tests or designs were economically

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unfeasible.

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CONCLUSION

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IT IS HEREBY ORDERED that the Motions in Limine (ECF Nos. 199, 200, 214, 218),

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the Motion to Bifurcate Trial (ECF No. 243), and the Motion to Seal (ECF No. 244) are

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GRANTED.

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IT IS FURTHER ORDERED that the Motions in Limine (ECF Nos. 195, 205, 217) are
GRANTED IN PART and DENIED IN PART.

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IT IS FURTHER ORDERED that the Motions in Limine (ECF Nos. 196, 197, 198, 201,

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202, 203, 204, 206, 207, 208, 209, 211, 212, 213, 215, 216, , 219, 220, 221, 222, 223, 224, 225,

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226, 227, 228) are DENIED.

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IT IS FURTHER ORDERED that the Motion in Limine (ECF Nos. 261, 262) is
STRICKEN as untimely. See Local R. 16-3(b).

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IT IS SO ORDERED.

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Dated this 20th day of January, 2015.

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_____________________________________
ROBERT C. JONES
United States District Judge

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