EXHIBIT A 

(Filed Under Seal)

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EXHIBIT B

(Filed Under Seal)

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EXHIBIT C 

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IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF TEXAS

DALLAS DIVISION

CYNTHIA JONES, §

§

Plaintiff, §

§

V. § Civil Action No. 3:13-CV-0599-K

§

C.R. BARD, INC., a foreign corporation, §

and §

BARD PERIPHERAL VASCULAR, INC., §

a foreign corporation, §

§

Defendants. §

ORDER

Before the Court are Defendants’ Motions in Limine to exclude:

1. Certain Evidence Concerning the Recovery Filter and Other Complications

That are Not Substantially Similar to the Incident at Issue (Doc. No. 122).

The Court defers ruling on this motion. The Court will conduct a hearing

outside the presence of the jury before the parties can go into anything

other than Plaintiff’s complications.

2. Plaintiff’s Comparative Failure Rate-Type Evidence (Doc. No. 123).

The Court DENIES this motion.

3. Evidence Regarding Alleged “Fraud on the FDA” and Purporting to

Interpret FDA Regulations (Doc. No. 124).

The Court DENIES this motion.

4. Evidence Prohibited Under Federal Rules of Evidence 402, 403, 404, and

609.

The Court defers ruling on this motion. Defendants are ordered to

produce a copy of the criminal consent decree/plea agreement that is the

subject of this motion to the Court for in camera inspection within five

(5) days from the date this order is signed.

5. Evidence or Argument Suggesting that Bard had a Financial Motive to

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Downplay Risks (Doc. No. 126).

The Court DENIES this motion.

6. Evidence or Argument Regarding Bard’s State of Mind, Intent, Motive,

and Ethics (Doc. No. 127).

The Court defers ruling on this motion. Plaintiff must approach the

bench before attempting to offer such evidence and/or make such

argument.

7. Evidence or Argument that Bard had an Independent Duty to Test the G2

Filter (Doc. No. 128).

The Court DENIES this motion.

8. Evidence of Financial Information During the Liability Phase of Trial

(Doc. No. 129).

The Court DENIES this motion.

Also before the Court are Plaintiff’s Motions in Limine to exclude:

1. Reference to Counsel Advertising, Counsel Specializing, Contingency Fee

Agreements, or the Circumstances Under Which Plaintiff Selected Counsel

(Doc. No. 131).

The Court GRANTS the motion as to any fee agreements. The Court 

DENIES the motion as to circumstances in which Plaintiff selected her

counsel. The Court GRANTS the motion as to general references to

counsel advertising or specialization. 

2. References to Inferior Vena Cava Filter Products Being the “Gold

Standard” or the “Standard of Care” or “Life Saving Devices” (Doc. No,.

132).

The Court defers ruling on this motion. Defendants must approach the

bench first before attempting to make any such reference.

3. Reference to Surgical Consent Forms (Doc. No. 133).

The Court DENIES this motion.

4. Reference to Collateral Sources of Payment or the Taxation of Plaintiff’s

Recovery (Doc. No. 134).

The Court GRANTS this motion.

5. Any Reference to the Adverse Impact of a Plaintiff’s Verdict (Doc. No.

135).

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The Court defers ruling on this motion. Defendants must approach the

bench first before attempting to make any such reference.

6. References to the Number of Times Plaintiff’s Experts’ Testimony has not

Been Accepted by Courts in Other Litigation (Doc. No. 136).

The Court DENIES this motion.

7. References to the Clearance of Bard IVC Filters by the FDA and Lack of

Enforcement Action as Proof of Safety and Efficacy, and Referring to the

Bard IVC Filters as “Approved” by the FDA (Doc. No. 137).

The Court defers ruling on this motion. Defendants must first approach

the bench before attempting to offer any such evidence and/or argument

and/or reference.

8. Reference of Failure Rates, Complication Rates, Percentages and

Comparative Analysis of Injuries Beyond Those Produced in Complaint

Files (Doc. No. 138).

The Court GRANTS this motion as it pertains to anything beyond what

has been produced in the complaint files.

9. Argument or Evidence Regarding Negligence of Third Party/”Empty Chair”

Defense (Doc. No. 139).

The Court GRANTS this motion.

10. References Suggesting that Defendants’ IVC Filters are Lifesaving Devices

and Statistics Regarding Thrombi and Pulmonary Embolism (Doc. No.

140).

The Court DENIES this motion.

11. Argument or Evidence that Defendants Could Not Have Added a Warning

to its Label or Effectuated a Removal/Recall Without FDA Consent or

Warned Physicians and Consumers Directly Regarding Increased Risks of

Harm (Doc. No. 141).

The Court GRANTS this motion.

12. Evidence of the “SIR Guidelines for the Purpose of Supporting Legal

Theories or Acceptable Rates of Complications and Safety Profiles (Doc.

No. 142).

The Court defers ruling on this motion. Defendants must first approach

the bench before offering any such evidence.

13. Defendants from Suggesting any Prior Medical Procedures Caused Cynthia

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Jones’ Filter to Fracture (Doc. No. 143).

The Court DENIES this motion.

These rulings on the aforementioned motions in limine are all temporary. These

rulings may be revisited by the Court at any time before or during trial, either at a

party’s request or sua sponte.

Also before the Court are: (1) the parties’ Joint Motion for Pretrial Conference

(Doc. No. 120) and (2) Defendants’ Motion to Bifurcate the Trial into Liability Phase

and a Punitive Damages Phase (Doc. No. 130). The Court DENIES both motions.

SO ORDERED.

 Signed February 12 , 2015. th

____________________________________

ED KINKEADE

UNITED STATES DISTRICT JUDGE

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EXHIBIT D 

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UNITED STATES DISTRICT COURT

DISTRICT OF NEVADA

_____________________________________

KEVIN PHILLIPS,

Plaintiff,

vs.

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

Defendants.

)

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 3:12-cv-00344-RCJ-WGC

 

 ORDER

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

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

motion to seal. 

I. FACTS AND PROCEDURAL HISTORY

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

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

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

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

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

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 

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

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

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

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

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

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

implanted in him. (See id. ¶¶ 49–51). 

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

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

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

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

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

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

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

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

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

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

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

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

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) 

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

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

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

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

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

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

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

eight.

II. LEGAL STANDARDS

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

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

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

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

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

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

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

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

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

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 

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

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

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

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

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

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

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

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

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

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

(D. Kan. 2007).

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

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

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

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

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

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

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

///

///

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III. ANALYSIS

A. Plaintiff’s Motions in Limine

1. Motion No. 195

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

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

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

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

this question during voir dire, the Court will not categorically exclude it at this time.

2. Motion No. 196

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

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

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

adduce the evidence as background information.

3. Motion No. 197/1981

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

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

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

comparative fault.

///

///

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

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4. Motion No. 199

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

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

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

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

evidence relevant.

5. Motion No. 200

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

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

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

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

evidence relevant.

6. Motion No. 201

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

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

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

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

his or her qualifications made in front of the jury.

7. Motion No. 202/203

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

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 

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

8. Motion No. 204

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

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

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

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

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

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

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

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

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

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

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

limine.

9. Motion No. 205

Plaintiff asks the Court to exclude argument or evidence relating to the fault of nonparties. The Court grants them motion in part. It is true that the jury may only apportion fault as 

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

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

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’ 

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

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

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

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

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

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

adduce evidence tending only to show comparative fault. 

10. Motion No. 206/207

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

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

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

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

information.

11. Motion No. 208/209

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

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

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

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

Defendants were negligent in not changing warnings.

///

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12. Motion No. 219/220

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 

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

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

13. Motion No. 221/222

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

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

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

filter should not have been used in his case. 

14. Motion No. 223/224

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

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

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

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

categorically exclude it.

15. Motion No. 225/226

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

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

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

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

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 

causation and comparative fault.

16. Motion No. 227/228

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

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

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

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

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

B. Defendants’ Motions in Limine

1. Motion No. 211

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

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

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

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

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

instruction. 

2. Motion No. 212

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

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

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

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

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3. Motion No. 213

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

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

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

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

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

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

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

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

4. Motion No. 214

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

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

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

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

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

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

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

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

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

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

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 

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

present.”).

5. Motion No. 215

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

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

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

6. Motion No. 216

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

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

exclusion without the context of a particularized objection at trial.

7. Motion No. 217

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

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

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

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

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

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

distinction in response.

///

///

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8. Motion No. 218

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

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

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

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

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

unfeasible.

///

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CONCLUSION

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

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

GRANTED.

IT IS FURTHER ORDERED that the Motions in Limine (ECF Nos. 195, 205, 217) are

GRANTED IN PART and DENIED IN PART.

IT IS FURTHER ORDERED that the Motions in Limine (ECF Nos. 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.

IT IS FURTHER ORDERED that the Motion in Limine (ECF Nos. 261, 262) is

STRICKEN as untimely. See Local R. 16-3(b).

IT IS SO ORDERED.

Dated this 20th day of January, 2015.

_____________________________________

 ROBERT C. JONES

United States District Judge

15 of 15

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EXHIBIT E 

Case 2:15-md-02641-DGC Document 8859-1 Filed 11/17/17 Page 24 of 51
United States District Court

For the Northern District of California

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IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

IN RE HEWLETT-PACKARD COMPANY

SHAREHOLDER DERIVATIVE

LITIGATION

THIS DOCUMENT RELATES TO: 

ALL ACTIONS

 /

No. 3:12-cv-06003-CRB

ORDER DENYING PENDING

ADMINISTRATIVE MOTIONS TO

FILE UNDER SEAL

This litigation now having been resolved, the Court must determine which documents, 

or portions thereof, should remain permanently shielded from public view. The Court has

received numerous motions to seal certain portions of documents which number in the

thousands of pages, most of which are heavily or entirely redacted. Specifically, the Court

now has before it the following pending motions: Hewlett Packard’s Administrative Motion

to File Under Seal (dkt. 337); Hewlett Packard’s Administrative Motion to File Under Seal

(dkt. 367); Objector A.J. Copeland’s Administrative Motion to File Under Seal (dkt. 378);

Objector Harriet Steinberg’s Administrative Motion to File Under Seal (dkt. 380); Objectors

A.J. Copeland’s and Harriet Steinberg’s Administrative Motion to File Under Seal (dkt. 390);

Hewlett Packard’s Objection re Unsealing in Part of Consolidated Shareholder Derivative

Complaint; Hewlett Packard’s Administrative Motion to File Under Seal (dkt. 398);

Directors’ Administrative Motion to File Under Seal (dkt. 401); and Objector Harriet

Steinberg’s Administrative Motion to File Under Seal (dkt. 404). 

Case 2:15-md-02641-DGC Document 8859-1 Filed 11/17/17 Page 25 of 51
United States District Court

For the Northern District of California

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2

For the following reasons, all pending motions to seal are hereby DENIED. As an

initial matter, 

 

 

 

 

p 

 f

 

 

 

It has also not escaped the Court’s attention that 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

p 

Case 2:15-md-02641-DGC Document 8859-1 Filed 11/17/17 Page 26 of 51
United States District Court

For the Northern District of California

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3

 

 

 

p 

Moreover, 

 

 

 

 

 

 

 

 

 

In that same vein, f

 

 

 

 

p 

 f

 

 

 

 

 

 

Case 2:15-md-02641-DGC Document 8859-1 Filed 11/17/17 Page 27 of 51
.~ 

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8 For the foregoing reasons, the pending administrative motions to seal are DENIED.

1 

9 IT IS SO ORDERED. 

10 

11 Dated: July 28, 2015 

12 

13 

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15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 1 No motion for reconsideration will be entertained unless HP identifies within three days "a 

limited amount of exceptionally sensitive info1mation that tmly deserves protection" under the 

26 "compelling reasons" standard ofKamakana v. City and Cty. of Honolulu, 447 F.3d 1172, 1178- 79 (9th 

Cir. 2006), outlined by page and line number and including "specific factual findings" for each. See 

27 O'Connorv. Uber Technologies, Inc., No. c-13-3826-EMC, 2015 WL355496, at *1 (N.D. Cal. Jan. 27, 

2015). In light of the "public interest in understanding the judicial process" as it relates to the settlement 

28 of these claims, the Comi will not countenance arguments that public filing would put HP at a 

competitive or legal disadvantage. See Kamakana, 44 7 F .3d at 1178- 79. 

4 

Case 2:15-md-02641-DGC Document 8859-1 Filed 11/17/17 Page 28 of 51
EXHIBIT F 

Case 2:15-md-02641-DGC Document 8859-1 Filed 11/17/17 Page 29 of 51
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UNITED STATES DISTRICT COURT

DISTRICT OF NEVADA

_____________________________________

KEVIN PHILLIPS,

Plaintiff,

vs.

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

Defendants.

)

)

)

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)

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)

)

 3:12-cv-00344-RCJ-WGC

 

 ORDER

This case arises out of an allegedly defective medical device. The parties settled during 

trial. Defendants have asked the Court to seal certain trail exhibits and portions of the trial 

transcript. 

A court may “make any order which justice requires to protect the party or person from 

annoyance, embarrassment, oppression or undue burden or expense” upon motion by a party or a 

person from whom discovery is sought. Fed. R. Civ. Pro. 26(c). “The mere fact that the

production of records may lead to a litigant's embarrassment, incrimination, or exposure to 

further litigation will not, without more, compel the court to seal its records. Kamakana v. City & 

Cnty. of Honolulu, 447 F.3d 1172, 1179 (9th Cir.2006). There is a strong presumption towards 

public access to judicial records. See id. at 1178. Under Kamakana, judicial records are 

Case 3:13-cv-00222-MMH-JBT Document 221-1 Filed 07/13/15 Page 1 of 3 PageID 13170 Case 2:15-md-02641-DGC Document 8859-1 Filed 11/17/17 Page 30 of 51 Case 3:12-cv-00344-RCJ-WGC Document 328 Filed 06/01/15 Page 1 of 3
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separated into two groups, each with its own standard to be met if litigants wish to seal them.

First, judicial records attached to dispositive motions must meet the “compelling reasons” 

standard in order for those documents to be sealed. Id. at 1180. Those compelling reasons must 

outweigh the competing interests of the public in gaining access to the judicial records and to 

understand the judicial process. Id. at 1178–79. Second, judicial records attached to 

nondispositive motions must meet the lesser “good cause” standard to be sealed. Id. A motion to 

seal transcripts and evidence adduced at trial must satisfy the “compelling reasons” test, because

a trial is a dispositive proceeding. In re Elec. Arts, Inc., 298 Fed. App’x 568, 569 (9th Cir. 2008).

The Court of Appeals has rejected requests to seal documents under the “compelling reasons” 

standard where the movant makes nothing more than “conclusory statements about the content of 

the documents—that they are confidential and that, in general,” their disclosure would harm the 

movant. Id. at 1182. 

Defendants argue that three categories of material should be sealed: (1) product design 

and testing, including confidential communications between Defendants and the FDA; (2) sales 

and marketing information; and (3) Defendant’s internal quality control procedures, complaint 

and adverse event responses, reporting and handling, device tracking procedures, and corrective 

action procedures. The Court finds that these categories of information do not satisfy the 

compelling reasons test. The only harm that could come to Defendants form the release of this 

information is the precipitation of further lawsuits against it. Preventing lawsuits due to the 

release of inculpating information is not a compelling reason to seal otherwise public legal 

proceedings. Indeed, the exposure of facts relevant to the material claims in a lawsuit is the 

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purpose of a trial, and these facts should remain public unless the harm likely to result from their 

release is unrelated to the nature of the claims. The information does not directly implicate trade 

secrets. 

Even if the test could be satisfied, Plaintiff correctly notes that Defendants have waived 

the issue because Defendants made no motion to seal the exhibits or testimony at the public trial.

See, e.g., Gambale v. Deutsche Bank AG, 377 F.3d 133, 144 & n.11 (2nd Cir. 2004); Littlejohn v. 

BIC Corp., 851 F.2d 673, 680 (3d Cir. 1988); Nat’l Polymer Prods. v. Borg–Warner Corp., 641 

F.2d 418, 421 (6th Cir. 1981); Level 3 Commc’ns, LLC v. Limelight Networks, Inc., 611 F. Supp. 

2d 572, 588 (E. D. Va. 2009) (“The First Amendment public right of access to these exhibits 

sprang into existence upon their being offered into evidence for the jury’s consideration at trial, 

and since no request was made to seal them prior to or at that time, Savvis waived any future 

right to assert any competing interest to be weighed by the Court and, thus, any objection to the 

public availability of the exhibits in the Court’s files.”).

CONCLUSION

IT IS HEREBY ORDERED that the Motion to Seal (ECF No. 317) is DENIED.

IT IS FURTHER ORDERED that the Motion (ECF No. 326) is DENIED without 

prejudice, as it has been incompletely filed.

IT IS SO ORDERED.

Dated this 29th day of May, 2015.

_____________________________________

 ROBERT C. JONES

United States District Judge

Dated this 1st day of June, 2015.

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EXHIBIT G 

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11/14/2017 Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2 Filter. - Study Results - ClinicalTrials.gov

https://clinicaltrials.gov/ct2/show/results/NCT00556426?sect=X430156&view=results#othr 1/18

Show less 

This study has been completed.

Sponsor:

C. R. Bard

ClinicalTrials.gov Identifier:

NCT00556426

First Posted: November 12, 2007

Last Update Posted: June 1, 2012

Full Text View Tabular View Study Results Disclaimer

How to Read a Study Record

We are updating the design of this site. Learn more.

Try the new test version at https://clinicaltrials.gov/beta/

Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the

Recovery G2 Filter. (EVEREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and

investigators. Listing a study does not mean it has been evaluated by the U.S. Federal

Government. Read our disclaimer for details.

Information provided by (Responsible Party):

C. R. Bard

Results First Submitted: May 26, 2009 

Study Type: Interventional

Study Design:

Intervention Model: Single Group Assignment; 

Masking: None (Open Label); Primary Purpose: Treatment

Conditions:

Pulmonary Embolism

Venous Thromboembolic Disease

Intervention: Device: Bard Recovery G2 Filter System

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 Participant Flow

 Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the

recruitment period and locations

Eleven Investigators at 11 sites enrolled a total of 100 study subjects between December 7, 2005 and July 24,

2006.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior

to group assignment

No text entered.

Reporting Groups

Description

All Patients Receiving the Filter All enrolled subjects

Participant Flow:   Overall Study

  All Patients Receiving the Filter

STARTED   100 

COMPLETED   91 

NOT COMPLETED   9 

Withdrawal by Subject                3 

Death                6 

 Baseline Characteristics

 Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether

analysis was per protocol, intention to treat, or another method. Also provides relevant details

such as imputation technique, as appropriate.

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No text entered.

Reporting Groups

Description

Participants Receiving a Filter Patients who were at temporary, increased risk of pulmonary embolism

requiring inferior vena cava (IVC) interruption, and for whom Recovery G2

Filter retrieval could reasonably be expected to occur within 6 months of

device placement.

Baseline Measures

 Participants Receiving a Filter 

Overall Participants Analyzed  

[Units: Participants]  100 

Age  

[Units: Years]

Mean (Standard Deviation)

 52.1  (16.7) 

Gender  

[Units: Number of participants]

Female   33 

Male   67 

Region of Enrollment  

[Units: Participants]

United States   100 

Indication for Placement 

[Units: Number of Participants]

active thromboembolic disease   43 

no active thromboembolic disease   57 

Patients with active thromboembolic disease (the presence of Deep Vein Thrombosis (DVT) or

pulmonary embolism (PE) within 3 months of study enrollment).

 Outcome Measures

 Show All Outcome Measures

1.  Primary:  Technical Success (Retrieval)   [ Time Frame: 1 month post filter retrieval

[1] 

[1]

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or through 6 months following implantation ]

 Show Outcome Measure 1 

2.  Primary:  Clinical Success (Retrieval)   [ Time Frame: Time of Retrieval or through 6

months of implantation ]

 Show Outcome Measure 2 

3.  Primary:  Percentage of Participants With Adverse Events Through 30 Days Post

Retrieval   [ Time Frame: 30 days post retrieval ]

 Show Outcome Measure 3 

4.  Secondary:  Filter Migration > 2cm   [ Time Frame: 30 days post retrieval or 6

months following filter placement ]

 Show Outcome Measure 4 

5.  Secondary:  Incidence of Filter Fracture   [ Time Frame: at 6 months or at retrieval

of the filter ]

 Show Outcome Measure 5 

 Serious Adverse Events

 Hide Serious Adverse Events

Time Frame No text entered.

Additional Description No text entered.

Reporting Groups

Description

All Patients Receiving the Filter All enrolled subjects

Serious Adverse Events

  All Patients Receiving the Filter

Total, Serious Adverse Events 

# participants affected / at risk   6/100 (6.00%) 

General disorders 

Discomfort due to device penetration † 

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# participants affected / at risk   1/100 (1.00%) 

# events   76 

Respiratory, thoracic and mediastinal disorders 

Pulomonary Embolism 

# participants affected / at risk   2/100 (2.00%) 

# events   76 

Vascular disorders 

Caval Stenosis 

# participants affected / at risk   1/100 (1.00%) 

# events   76 

Deep Vein Thrombosis 

# participants affected / at risk   1/100 (1.00%) 

# events   76 

Inferior Vena Caval Occlusion 

# participants affected / at risk   1/100 (1.00%) 

# events   76 

† Events were collected by systematic assessment

 Other Adverse Events

 Hide Other Adverse Events

Time Frame No text entered.

Additional Description No text entered.

Frequency Threshold

Threshold above which other adverse events are reported 0% 

Reporting Groups

Description

All Patients Receiving the Filter All enrolled subjects

Other Adverse Events

  All Patients Receiving the

Filter

† 

† 

† 

† 

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Total, Other (not including serious) Adverse Events 

# participants affected / at risk   70/100 (70.00%) 

Blood and lymphatic system disorders 

Anemia 

# participants affected / at risk   15/100 (15.00%) 

# events   15 

Lymphocytosis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pancytopenia 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Cardiac disorders 

Atrial Fibrillation 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Atrial Flutter 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Cardiac Failure Congestive 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Coronary Artery Disease 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Myocardial Infarction 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pericardial Effusion 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pericardial Hemorrhage 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Sinus Tachycardia 

† 

† 

† 

† 

† 

† 

† 

† 

† 

† 

† 

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# participants affected / at risk   2/100 (2.00%) 

# events   2 

Supraventricular Tachycardia 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Ventricular Tachycardia 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Ear and labyrinth disorders 

Ear Pain 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Gastrointestinal disorders 

Abdominal Mass 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Abdominal Pain Upper 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Constipation 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Diabetic Gastroparesis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Diarrhea 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Duodenitis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Dysphagia 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Esophagitis 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

† 

† 

* 

* 

* 

* 

† 

* 

† 

† 

† 

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Frequent Bowel Movements 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Gastric Ulcer 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Gastritis 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Gastrointestinal Hemorrhage 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Gastrointestinal Stenosis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Hiatus Hernia 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Ileus Paralytic 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Large Intestinal Ulcer Hemorrhage 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Nausea 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Pancreatitis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Rectal Hemorrhage 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Retroperitoneal Hematoma 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Vomiting 

# participants affected / at risk   2/100 (2.00%) 

* 

† 

† 

† 

† 

† 

† 

† 

* 

† 

† 

† 

* 

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# events   2 

General disorders 

Adverse Drug Reaction 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Chest Pain 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Edema Peripheral 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

General Physical Health Deterioration 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Heparin Induced Thrombocytopenia 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Pain 

# participants affected / at risk   4/100 (4.00%) 

# events   4 

Pyrexia 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Hepatobiliary disorders 

Cholecystitis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Immune system disorders 

Drug Hypersensitivity 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Hypersensitivity 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Infections and infestations 

Bacteremia 

* 

* 

† 

† 

† 

* 

† 

† 

* 

† 

† 

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# participants affected / at risk   1/100 (1.00%) 

# events   1 

Clostridium Colitis 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Endocarditis Staphylococcal 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Groin Abscess 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Infection 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Oral Candidiasis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Osteomyelitis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pelvic Abscess 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pneumonia 

# participants affected / at risk   12/100 (12.00%) 

# events   12 

Postoperative Infection 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Postoperative Wound Infection 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Respiratory Tract Infection 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Sepsis 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

† 

† 

* 

* 

† 

† 

* 

† 

† 

† 

† 

† 

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Sinusitis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Staphylococcal Infection 

# participants affected / at risk   4/100 (4.00%) 

# events   4 

Urinary Tract Infection 

# participants affected / at risk   12/100 (12.00%) 

# events   12 

Viral Infection 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Wound Infection 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Injury, poisoning and procedural complications 

Anemia Postoperative 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Clavicle Fracture 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Device Migration 

# participants affected / at risk   10/100 (10.00%) 

# events   10 

Incision Site Complication 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Patella Fracture 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Postmastectomy Lymphedema 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Seroma 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

† 

† 

† 

† 

† 

† 

† 

† 

* 

† 

† 

† 

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Wound Dehiscence 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Investigations 

Anticoagulation Drug Level Above Therapeutic 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Liver Function Test Abnormal 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Scan Adrenal Gland Abnormal 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Metabolism and nutrition disorders 

Dehydration 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Fluid Overload 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Hypoglycemia 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Musculoskeletal and connective tissue disorders 

Back Pain 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Chest Wall Pain 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Dislocation of Joint Prosthesis 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Hip Fracture 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Joint Dislocation 

† 

† 

† 

† 

† 

* 

† 

* 

* 

† 

† 

† 

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# participants affected / at risk   2/100 (2.00%) 

# events   2 

Muscle Spasms 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Musculoskeletal Pain 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Osteoarthritis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pain in Extremity 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Neoplasms benign, malignant and unspecified (incl cysts and

polyps) 

Breast Cancer in Situ 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Chondrosarcoma 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Colon Cancer Metastatic 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Nervous system disorders 

Dizziness 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Headache 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Metabolic Encephalopathy 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Paresthesia 

* 

* 

† 

* 

† 

† 

† 

* 

* 

† 

† 

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# participants affected / at risk   1/100 (1.00%) 

# events   1 

Restless Leg Syndrome 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Psychiatric disorders 

Acute Psychosis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Anxiety 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Confusional State 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Depression 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Insomnia 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Major Depression 

# participants affected / at risk   4/100 (4.00%) 

# events   4 

Obsessive Compulsive Disorder 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Psychotic Disorder 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Renal and urinary disorders 

Acute Renal Failure 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Dysuria 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

† 

† 

* 

* 

* 

* 

† 

† 

† 

† 

† 

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Micturition Urgency 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pyuria 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Renal Cysts 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Renal Failure 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Renal Impairment 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Renal Mass 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Reproductive system and breast disorders 

Scrotal Edema 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Respiratory, thoracic and mediastinal disorders 

Atelectasis 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Chronic Respiratory Disease 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Hiccups 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pleural Effusion 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Pneumothorax 

# participants affected / at risk   2/100 (2.00%) 

† 

† 

† 

† 

† 

† 

† 

† 

† 

* 

† 

† 

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# events   2 

Pulmonary Embolism 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Respiratory Failure 

# participants affected / at risk   3/100 (3.00%) 

# events   3 

Vocal Cord Paresis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Skin and subcutaneous tissue disorders 

Decubitus Ulcer 

# participants affected / at risk   2/100 (2.00%) 

# events   2 

Dermatitis Acneiform 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Pruritus 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Rash 

# participants affected / at risk   4/100 (4.00%) 

# events   4 

Vascular disorders 

Adrenal Hemorrhage 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Arterial Hemorrhage 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Catheter Site Hemorrhage 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Deep Vein Thrombosis 

# participants affected / at risk   13/100 (13.00%) 

# events   13 

Hematoma 

† 

† 

† 

† 

† 

† 

* 

† 

† 

* 

† 

* 

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# participants affected / at risk   1/100 (1.00%) 

# events   1 

Hemorrhage 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Lymphedema 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Thrombophlebitis Superficial 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Vena Cava Thrombosis 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

Vena Caval Injury 

# participants affected / at risk   1/100 (1.00%) 

# events   1 

† Events were collected by systematic assessment

* Events were collected by non-systematic assessment

 Limitations and Caveats

 Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants

analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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 More Information

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Certain Agreements: 

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights

to discuss or publish trial results after the trial is completed.

† 

† 

† 

† 

† 

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The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public

release and can embargo communications regarding trial results for a period that is less than or equal to 60

days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public

release and can embargo communications regarding trial results for a period that is more than 60 days but

less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot

extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is

completed.

Results Point of Contact: 

Name/Title: John Reviere, Director of Clinical Affairs

Organization: C.R. Bard

phone: 480-303-2644

e-mail: john.reviere@crbard.com

Responsible Party: C. R. Bard

ClinicalTrials.gov Identifier: NCT00556426 History of Changes

Other Study ID Numbers: BPV-RC-1332 

First Submitted: November 8, 2007

First Posted: November 12, 2007

Results First Submitted: May 26, 2009

Results First Posted: May 11, 2011

Last Update Posted: June 1, 2012

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