Petition for Writ of Certiorari — D R Burton Healthcare LLC, Petitioner v. Trudell Medical International Inc.

No.

____________________

In the Supreme Court of the United States

____________________

D R BURTON HEALTHCARE LLC,

Petitioner,

v.

TRUDELL MEDICAL INTERNATIONAL INC.,

Respondent.

____________________

ON PETITION FOR A WRIT OF

CERTIORARI

TO THE UNITED STATES COURT OF

APPEALS FOR THE FEDERAL CIRCUIT

____________________

PETITION FOR A WRIT OF CERTIORARI

____________________

ALBERT P. ALLAN

WILLIAM H. FRANKEL

Counsel of Record for Petitioner Counsel of Record for Respondent

Allan Law Firm, PLLC

Crowell & Mooring LLP

P.O. Box 360001

NBC Tower - Suite 3600

201 North McDowell Street

455 North Cityfront Plaza Drive

Charlotte, North Carolina 28236 Chicago, Illinois 60611

alallan@allaniplitigation.com

wfrankel@crowell.com

(704) 488-3170

(312) 321-4200

QUESTION PRESENTED

Whether a district court’s order changing the

time to trial in its case management order from

at least 326 days to 146 days, and its time for

completion of all discovery (including expert

discovery) from 231 days to 108 days,

constitutes a fair legal procedure under the due

process clause of the Fifth Amendment?

-i-

CORPORATE DISCLOSURE STATEMENT

There are no parent companies of D R Burton

Healthcare, LLC. No publicly held company

owns 10% or more of the corporation’s stock.

LIST OF DIRECTLY RELATED

PROCEEDINGS IN FEDERAL TRIAL AND

APPELLATE COURTS

1. Trudell Medical International v. D R Burton

Healthcare LLC; Civil Action No. 4:18-cv-00009;

United States District Court for the Eastern

District of North Carolina; Judgment entered

November 10, 2022.

2. Trudell Medical International v. D R Burton

Healthcare LLC; Case No. 2023-1777, -1779;

United States Court of Appeals for the Federal

Circuit; Judgment entered February 7, 2025;

Order denying petition for panel rehearing

entered April 1, 2025.

- ii -

TABLE OF CONTENTS

QUESTION PRESENTED……………………………..…i

CORPORATE DISCLOSURE STATEMENT………….ii

LIST OF DIRECTLY RELATED PROCEEDINGS

IN FEDERAL TRIAL AND APPELLATE COURTS…ii

TABLE OF CONTENTS…………………………………iii

TABLE OF CITED AUTHORITIES……..…………..…iv

CITATIONS OF THE OFFICIAL AND

UNOFFICIAL REPORTS OF THE OPINIONS

AND ORDERS ENTERED IN THE CASE…………….1

BASIS FOR JURISDICTION…………………………….2

CONSTITUTIONAL PROVISIONS AND

FEDERAL RULES INVOLVED…………………………3

STATEMENT OF THE CASE……………………………4

REASONS FOR GRANTING THE WRIT..……………7

CONCLUSION……………………………………………12

APPENDIX……..……………………………………Appx(i)

- iii -

TABLE OF CITED AUTHORITIES

Constitution

The Constitution of the United States,

Amendment 5……………………….i, 3, 9

Statutes

28 U.S.C. §1254………………………….…………………2

Rules

Fed. R. Civ. P. 1…………………………………….3, 9

Cases

Armstrong v. Manzo, 380 U.s. 545 (1965)………..10, 11

Dent v. West Virginia, 129 U.S. 114 (1889)…………..10

Matthews v. Eldridge, 424 U.S. 319 (1976).…10, 11, 12

Trudell Medical Int’l Inc. v. D R Burton Healthcare,

LLC, 127 F.4th 1340 (Fed. Cir. 2025)……………8, 9

- iv -

CITATIONS OF THE OFFICIAL AND

UNOFFICIAL REPORTS OF THE

OPINIONS AND ORDERS ENTERED IN

THE CASE

1. Case Management Order of 12/27/18; 4:18cv-00009; Document No. 55.

2. Revised Scheduling Order of 8/27/22; 4:18cv-00009; Document No. 229.

3. Judgment of 11/10/22; 4:18-cv-00009;

Document No. 308.

4. Opinion of 2/7/25; Trudell Medical

International Inc. v D R Burton Healthcare,

LLC, 127 F.4th 1340 (Fed. Cir. 2025).

5. Judgment of 2/7/25; 2023-1777, Document

No. 55.

6. Order denying request for rehearing of

4/1/25; 2023-177, Document No. 62.

-1-

BASIS FOR JURISDICTION

The United States Court of Appeals for the

Federal Circuit entered judgment and its order

on February 7, 2025.

The United States Court of Appeals for the

Federal Circuit entered its order denying

rehearing on April 1, 2025.

This Court’s jurisdiction is invoked under 28

U.S.C. § 1254.

-2-

CONSTITUTIONAL PROVISIONS AND

FEDERAL RULES INVOLVED

The Constitution of the United States,

Amendment 5.

No person shall be held to answer for a capital,

or otherwise infamous crime, unless on a

presentment or indictment of a Grand Jury,

except in cases arising in the land or naval

forces, or in the Militia, when in actual service

in time of war or public danger; nor shall any

person be subject for the same offence to be

twice put in jeopardy of life or limb; nor shall be

compelled in any criminal case to be a witness

against himself, nor be deprived of life, liberty,

or property, without due process of law; nor

shall private property be taken for public use,

without just compensation.

Federal Rule of Civil Procedure 1. Scope

and Purpose.

These rules govern the procedure in all civil

actions and proceedings in the United States

district courts, except as stated in Rule 81 .

They should be construed, administered, and

employed by the court and the parties to secure

the just, speedy, and inexpensive determination

of every action and proceeding.

-3-

STATEMENT OF THE CASE

In 2018, Trudell Medical International filed

a lawsuit alleging that D R Burton Healthcare,

LLC had infringed U.S. Patent No. 9,808,588. In

December 2018, the district court issued its

Case Management Order. (Appx26-42). The

order set forth deadlines for the parties to

follow, consistent with the Eastern District of

North Carolina’s Local Patent Rules, which

issued one month later in January 2019.

Local Patent Rules are fairly common at the

district court level. Typically, the rules set forth

proposed deadlines that the parties are to

follow, with a first phase including fact and

expert discovery, leading up to a hearing where

the district court defines certain terms in the

patent claims, then followed by a second phase

including additional fact and expert testimony,

leading to trial.

The Case Management Order in this case

called for discovery related to preliminary

infringement and invalidity contentions, as well

as preliminary claim construction, leading to a

claim construction hearing. Following the

issuance of a claim construction order, the Case

Management Order called for final infringement

contentions 30 days after issuance of the order,

final invalidity contentions 50 days after that,

-4-

and additional fact discovery for 120 days after

issuance of the order. (Appx40). Initial expert

disclosures by the party bearing the burden of

proof were then due 30 days after the close of

fact discovery, expert disclosures where the

opposing party bears the burden of proof were

due 30 days after that, and rebuttal expert

disclosures were due 14 days after that.

(Appx40-41). Following that, expert discovery

remained open for 37 days. (Appx41). Thus, the

Case Management Order called for 231 days

(120+30+30+14+37) for the parties to complete

their final contentions and complete their fact

and expert discovery.

Following the close of expert discovery, the

Case Management order called for 30 days for

the parties to prepare their dispositive and

Daubert motions, with 21 days for response

briefs and 14 days for reply briefs. (Appx41).

Once the Court acted on those motions, the Case

Management Order specified that the parties

make their pretrial disclosures 28 days before

the final pretrial conference, submit their

objections to the pretrial disclosures 21 days

before the final pretrial conference, and present

the proposed final pretrial order 7 days before

reopening the final pretrial conference.

(Appx41). Thus, even assuming the unlikely

scenario where the Court ruled on the

dispositive and Daubert motions the day after

-5-

reply briefs were filed, set the pretrial

conference for the minimum 28 days from

issuance of ruling on the dispositive and

Daubert motions, and set trial for the very next

day, trial would not begin until 95 days

(30+21+14+1+28+1) after the close of expert

discovery, or 326 days (231+95) after the close of

claim construction.

In this case, the court entered is final claim

construction order on June 14, 2022. However,

without warning, and in response to a joint

motion to extend the mediation deadline, on

August 26, 2022, the District Court unilaterally

shortened the post-claim construction schedule

to trial so that all discovery would be completed

by September 30th (less than one month later),

dispositive motions would be filed no later than

October 10th, responses would be due October

21st, replies would be due by October 26th, and

trial would begin on November 7th, 2022 (108

days after the final claim construction order).

(Appx43-44).

-6-

REASONS FOR GRANTING THE WRIT

This case presents an important question

regarding the extent of discretion given to a

district court to significantly shorten the time to

trial without good cause.

As Trudell Medical noted in its appeal to the

Federal Circuit, “the District Court was more

interested in a fast trial, than a fair trial.”

(Appellant Brief at 3). Trudell then noted

examples demonstrating the Court’s intent to

remove the case from the Court’s docket,

regardless of the consequences.

Shortly thereafter, at a routine

status conference held on August 24,

2022, the court expressed frustration

at the parties for the case having been

pending for so long, and suddenly

announced that it intended “to get

[this case] off [his] report” by

September 30 and set a new expedited

trial schedule. Appx1722(6:1-3). At the

time, fact discovery had not closed and

expert discovery had not commenced.

Nevertheless, the court reset the close

of all discovery for September 30, 2022

and set trial to commence on

November 7, 2022. Appx1744.

-7-

The court also made clear that it

sought to rush this case to conclusion

—no matter the means—for the sole

purpose of removing this case from is

Civil Justice Reform Act reporting

requirements. Appx1722(6:1-4). A few

exemplary comments made by the

court during the status hearing

include:

• “This case has gone on way, way too

long.” Appx1719(3:9).

• “You got all kinds of horizontal

movement and no vertical movement.

And I’m going to settle this case or

resolve it or dismiss it by September

30th. Just—that’s a head’s up.”

Appx1719(3:14-17).

• “Forget about the claims. What are they

going to do, reverse me? It goes to the

Federal Circuit, doesn’t it?”

Appx1721(5:13-15).

• “But I have to report this case by

September 30th and I’m going to get it

off my report. That’s the problem you

have. Did you know that?”

Appx1722(6:1-3).

• (Appellant Brief at 12-13).

On remand, the Federal Circuit citing many

of the same quotes, reassigned the case to

-8-

another district court judge, finding that “”from

the moment this case fell into his lap, the trial

judge’s statements indicate that he did not

intend to manage a fair trial with respect to the

issues in this case.” (Trudell Medical Int’l Inc. v.

D R Burton Healthcare, LLC, 127 F.4th 1340,

1352 (Fed. Cir. 2025)(Appx21-22)).

Rule 1 of the Federal Rules of Civil

Procedure states that the rules “govern the

procedure in all civil actions and proceedings in

the United States district courts, except as

stated in Rule 81” and “should be construed,

administered and employed but eh court and

the parties to secure the just, speedy, and

inexpensive determination of every action and

proceeding.” Fed. R. Civ. P. 1.

And the Fifth Amendment to the

Constitution requires that “no person . . . shall

be deprived of life, liberty, or property, without

due process of law.” United States Constitution,

Fifth Amendment.

Here, the district court’s decision to

significantly shorten the time to trial violated

the parties’ due process right to a fair trial.

Even Trudell Medical, as noted above, which

was represented by at least five attorneys who

actively participated in preparations for trial,

believed the schedule set by the district court

-9-

was based more on the desire to hold a fast trial,

rather than a fair one. But at least Trudell had

a sufficiently large law firm to meet the

demands of the accelerated schedule.

In contrast, D R Burton was represented by

present counsel, a sole practitioner, who was

forced to make decisions about what could or

could not be done in order to put D R Burton in

the best position for trial.

While some of those decisions were the basis

for Trudell’s successful appeal to the Federal

Circuit, they were also were made out of

necessity, and would never have been required

had the district court maintained its original

post- claim construction schedule and allowed D

R Burton sufficient time to prepare its case.

*

*

*

“The touchstone of due process is protection of

the individual against arbitrary action of

government.” Dent v. West Virginia, 129 U.S. 114,

123 (1889). Procedural due process, which is

applicable in civil as well as criminal proceedings

requires government officials to follow fair

procedures before depriving a person of life, liberty,

or property.” “The fundamental requirement of due

process is the opportunity to be heard “at a

- 10 -

meaningful time and in a meaningful manner.”

Matthews v. Eldridge, 424 U.S. 319, 333 (1976)

(quoting Armstrong v. Manzo, 380 U.S. 545, 552

(1965). “

Due process, unlike some legal rules,

is not a technical conception with a

fixed content unrelated to time, place

and circumstances. [D]ue process is

flexible and calls for such procedural

protections as the particular situation

demands. More precisely, our prior

decisions indicate that identification of

the specific dictates of due process

generally requires consideration of

three distinct factors: First, the

private interest that will be affected

by the official action; second, the risk

of an erroneous deprivation of such

interest through the procedures used,

and the probable value, if any, of

additional or substitute procedural

safeguards; and finally, the

Government’s interest, including the

function involved and the fiscal and

administrative burdens the the

additional or substitute procedural

requirement would entail.

“Matthews v. Eldridge, 424 U.S. 319,

334-35(1976) (internal citations

omitted).

- 11 -

“[P]rocedural due process rules are shaped by the

risk of error inherent in the truth-finding process . .

. .” Matthews v. Eldridge, 424 U.S. 319, 344 (1976).

Here, the Federal Circuit addressed the

unfairness of the proceeding as it pertained to

Trudell, but did not address the overall unfairness

of the proceeding as it pertained to D R Burton.

The lack of meaningful time to complete its

obligations to the Court and to prepare for trial in

the substantially reduced time frame set forth by

the court was a violation of D R Burton’s due

process rights.

CONCLUSION

This Court should issue a writ of certiorari to

determine whether the district court’s actions in

substantially reducing the time to trial violated D

R Burton’s right to due process.

June 30, 2025

s/Albert P. Allan

ALBERT P. ALLAN

Counsel of Record for Petitioner

Allan Law Firm, PLLC

P.O. Box 360001

201 North McDowell Street

Charlotte, North Carolina 28236

alallan@allaniplitigation.com

(704) 488-3170

- 12 -

APPENDIX

Appendix Table of Contents

Opinion Entered in Conjunction with

Judgment Sought to be Reviewed:

Trudell Medical Int’l Inc. v. D R Burton

Healthcare, LLC, 127 F.4th 1340 (Fed. Cir.

2025) Opinion entered 2/7/25; before Chief

Judge Moore, and Judges Chen and

Stoll….…………………………………………Appx1

Other Relevant Orders Entered in the Case:

Case Management Order of 12/27/18 (Docket

No. 55) Trudell Medical Int’l Inc. v. D R Burton

Healthcare, LLC, Case No.

4:18-CV-00009………………………………Appx26

Order Revising Schedule to Trial of 8/26/22

(Docket No. 229) Trudell Medical Int’l Inc.v. D R

Burton Healthcare, LLC, Case No.

4:18-CV-0009………………………………..Appx43

Order on Request for Rehearing:

Order Denying Petition for Panel Rehearing of

4/1/25 (Docket No. 62) Trudell Medical Int’l Inc.

v. D R Burton Healthcare, LLC, 2023-1777,

2023-1779……………………………………Appx45

Appx(i)

127 F.4th 1340

TRUDELL MEDICAL INTERNATIONAL INC.,

Plaintiff-Appellant v. D R BURTON

HEALTHCARE, LLC, Defendant/CounterClaimant-Cross-Appellant

2023-1777

2023-1779

United States Court of Appeals, Federal

Circuit

Decided: February 7, 2025

[*1344] Appeals from the United States District

Court for the Eastern District of North Carolina in

No. 4:18-cv-00009-BO, Judge Terrence William

Boyle.

Laura A. Lydigsen, Crowell & Moring, LLP,

Chicago, IL, argued for plaintiff-appellant. Also

represented by William Harry Frankel, Judy He,

David Lindner.

Albert P. Allan, Allan Law Firm, PLLC, Charlotte,

NC, argued for defendant/counter-claimant-crossappellant. Also represented by William Robert

Terpening, Terpening Law PLLC, Charlotte, NC.

Before Moore, Chief Judge, Chen and Stoll, Circuit

Judges.

- Appx1 -

Moore, Chief Judge.

Trudell Medical International Inc. (Trudell)

appeals the United States District [*1345] Court

for the Eastern District of North Carolina's decision

to allow D R Burton Healthcare, LLC (D R Burton)

to present infringement testimony by Dr. John

Collins at trial. Trudell also appeals the denial of a

motion for judgment as a matter of law (JMOL) on

infringement of claims 1-7, 9, and 18 of U.S. Patent

No. 9,808,588 or, in the alternative, a new trial on

infringement of claims 1-18 and 20-26 of the '588

patent (the Asserted Claims). See Trudell Med. Int'l

v. D R Burton Healthcare LLC, No. 4:18-cv-00009,

2023 WL 2315391 (E.D.N.C. Mar. 1, 2023) (PostTrial Order). We reverse the district court's

admission of Dr. Collins' testimony and its denial of

a new trial on infringement, and we remand the

case to be reassigned.1

BACKGROUND

Trudell owns the '588 patent, which relates to

portable devices for performing oscillatory positive

expiratory pressure (OPEP) therapy. '588 patent at

1:16-18, 50-51. OPEP therapy loosens secretions

from airways to improve respiration. See id. at

1:22-46. The three independent claims read:

1. A respiratory treatment device

comprising:

- Appx2 -

an inlet configured to receive exhaled air

into the device;

an outlet configured to permit air to exit

the device;

an opening positioned in an exhalation

flow path defined between the inlet and

the outlet;

a blocking segment configured to rotate

relative to the opening between a closed

position where the flow of air through

the opening is restricted, and an open

position where the flow of air through

the opening is less restricted; and,

a vane configured to rotate the blocking

segment between the closed position and

the open position in response to the flow

of air through the opening;

wherein a size of a blocking surface of

the blocking segment is equal to or

greater than a size of the opening.

9. A respiratory treatment device

comprising:

an inlet configured to receive exhaled air

into the device;

- Appx3 -

an outlet configured to permit air to exit

the device;

an opening positioned in an exhalation

flow path defined between the inlet and

the outlet, the opening having a

generally oblong cross-sectional shape

comprising a shorter first dimension and

an elongated second dimension

perpendicular to the first dimension;

and,

a blocking segment configured to

translate relative to the opening along

the shorter first dimension between a

closed position where the flow of air

through the opening is restricted, and an

open position where the flow of air

through the opening is less restricted;

wherein a size of a blocking surface of

the blocking segment is equal to or

greater than a size of the opening.

[*1346]

18. A respiratory treatment device

comprising:

an inlet configured to receive exhaled air

into the device;

- Appx4 -

an outlet configured to permit air to exit

the device;

an opening positioned in an exhalation

flow path defined between the inlet and

the outlet, and,

a blocking segment configured to

translate relative to the opening between

a closed position where the flow of air

through the opening is restricted, and an

open position where the flow of air

through the opening is less restricted;

wherein a side profile of the blocking

segment is shaped to mate with a side

profile of the opening, when the blocking

segment is in the closed position; and,

wherein a size of a blocking surface of

the blocking segment is equal to or

greater than a size of the opening.

Id. at 12:12-26, 49-63, 13:25-14:5 (emphases

added). D R Burton sells OPEP devices, including

the vPEP®, vPEP® HC, iPEP®, PocketPEP®, and

PocketPEP® Advantage products (collectively, the

Accused Products).

On January 29, 2018, Trudell sued D R Burton for

infringement of certain claims of the '588 patent.

After a claim construction hearing in October 2020,

- Appx5 -

the case was reassigned in January 2021 to United

States District Court Judge Terrence Boyle. Judge

Boyle assigned a new magistrate judge, who issued

a Memorandum and Recommendation (M&R)

regarding claim construction. J.A. 23-63. The

district court adopted the M&R in its entirety.

On August 26, 2022, the district court amended the

case schedule. At that time, fact discovery had not

closed and expert discovery had not yet

commenced. J.A. 1740 at 24:20-24. The district

court set the close of all discovery for September 30,

2022 and set trial to start on November 7, 2022.

Before the September 30 discovery deadline,

Trudell submitted expert reports on infringement

and damages. On October 21, 2022, D R Burton

filed a seven-page declaration from Dr. Collins in

support of its opposition to Trudell's motion for

summary judgment on infringement. The district

court denied Trudell's summary judgment motion.

Leading up to trial, Trudell filed motions in limine

seeking to exclude testimony from Dr. Collins on

invalidity and noninfringement and to exclude

testimony from any D R Burton witnesses on claim

construction. The district court did not rule on

Trudell's motion in limine until the pre-trial

conference on Friday, November 4, 2022. At the

pre-trial conference the district court initially

denied the motion in limine, J.A. 2035 at 3:1-2,

then on Monday, November 7, 2022—the first day

- Appx6 -

of trial—the district court reversed itself and

granted the motion in limine after Trudell filed a

motion for reconsideration, J.A. 2073 at 2:3-12. The

district court then doubled back moments later,

"reserv[ing] a ruling on [i]t until the end of

plaintiff's case." J.A. 2079 at 8:25-9:2. On the third

and final day of trial, after Trudell presented its

case, but before lunch, the district court ruled that

Dr. Collins would testify after the lunch break. J.A.

2476-77 at 36:24-37:15.

After a three-day trial, the jury returned a verdict

that the Asserted Claims were valid but not

infringed. Trudell filed a renewed motion for JMOL

of infringement or, in the alternative, a new trial.

The district court denied the motion. Post-Trial

Order, at *1-5. Trudell appeals the district court's

decision to allow Dr. Collins [*1347] to provide

noninfringement testimony at trial, as well as its

denial of JMOL or a new trial. Trudell requests

that, should this case be remanded to the district

court for further proceedings, the case be

reassigned to a different district court judge. We

have jurisdiction under 28 U.S.C. § 1295(a)(1).

DISCUSSION

I. Expert Testimony

We review a district court's decision to admit or

exclude evidence under the law of the regional

- Appx7 -

circuit. Siemens Med. Sols. USA, Inc. v. SaintGobain Ceramics & Plastics, Inc., 637 F.3d 1269,

1284 (Fed. Cir. 2011). The Fourth Circuit reviews a

district court's decision to admit expert testimony

for abuse of discretion. Sardis v. Overhead Door

Corp., 10 F.4th 268, 280 (4th Cir. 2021). "A district

court abuses its discretion when it misapprehends

or misapplies the applicable law." Wickersham v.

Ford Motor Co., 997 F.3d 526, 538 (4th Cir. 2021)

(cleaned up).

Federal Rule of Civil Procedure 26 requires parties

to identify expert testimony for use at trial, and,

subject to exceptions not present here, "this

disclosure must be accompanied by a written

report." FED. R. CIV. P. 26(a)(2)(B). The report

must contain:

(i) a complete statement of all opinions

the witness will express and the basis

and reasons for them;

(ii) the facts or data considered by the

witness in forming them;

(iii) any exhibits that will be used to

summarize or support them;

(iv) the witness's qualifications,

including a list of all publications

authored in the previous 10 years;

- Appx8 -

(v) a list of all other cases in which,

during the previous 4 years, the witness

testified as an expert at trial or by

deposition; and

(vi) a statement of the compensation to

be paid for the study and testimony in

the case.

Id.

Federal Rule of Civil Procedure 37(c)(1) states that

"[i]f a party fails to provide information or identify

a witness as required by Rule 26(a) or (e), the party

is not allowed to use that information or witness to

supply evidence on a motion, at a hearing, or at a

trial, unless the failure was substantially justified

or is harmless." FED. R. CIV. P. 37(c)(1). The

Fourth Circuit has held the following factors should

be considered in determining whether a party's

nondisclosure is substantially justified or harmless

for purposes of Rule 37(c)(1): "(1) the surprise to the

party against whom the evidence would be offered;

(2) the ability of that party to cure the surprise; (3)

the extent to which allowing the evidence would

disrupt the trial; (4) the importance of the evidence;

and (5) the nondisclosing party's explanation for its

failure to disclose the evidence." S. States Rack &

Fixture, Inc. v. Sherwin-Williams Co., 318 F.3d 592,

597 (4th Cir. 2003). The first four factors relate

- Appx9 -

primarily to the harmlessness exception, and the

fifth factor relates primarily to the substantial

justification exception. Id.

Trudell argues the district court should have

excluded Dr. Collins' testimony on noninfringement

because he did not timely serve an expert report on

noninfringement, and failure to comply with Rule

26 was neither substantially justified nor harmless.

To the extent any of the declarations submitted by

Dr. Collins are considered [*1348] an expert report,

Trudell argues Dr. Collins' testimony should have

nonetheless been excluded under Federal Rule of

Evidence 702 as unreliable and misleading.

D R Burton filed three declarations with testimony

from Dr. Collins. In May 2019, D R Burton filed a

declaration in support of its motion to amend its

invalidity contentions. In November 2019, D R

Burton filed an expert report by Dr. Collins in

support of its opening claim construction brief. On

October 21, 2022, D R Burton filed a seven-page

declaration from Dr. Collins in support of its

opposition to summary judgment of infringement.

We hold the district court abused its discretion in

allowing noninfringement testimony by Dr. Collins.

D R Burton did not disclose Dr. Collins'

noninfringement opinion in a timely expert report,

as required by Rule 26 and Fourth Circuit law. It is

undisputed Dr. Collins did not submit an expert

- Appx10 -

report on noninfringement during the discovery

period. Dr. Collins' seven-page declaration, to the

extent it could be considered an expert report, was

submitted almost a month after the close of

discovery on September 30, 2022. Under Rule 37,

therefore, the proper result is exclusion of Dr.

Collins' noninfringement testimony absent a

showing that the failure to disclose was either

substantially justified or harmless.

The district court did not, nor could it, explain why

allowing Dr. Collins' untimely noninfringement

testimony was substantially justified or harmless.

In its order denying Trudell's renewed motion for

JMOL, the district court "reaffirm[ed] its decision

to allow Dr. Collins's testimony." Post-Trial Order,

at *4. The district court, however, provided no

reasoning why D R Burton's failure to submit a

timely expert report by Dr. Collins on

noninfringement was substantially justified. Nor

does D R Burton make a colorable substantial

justification argument on appeal. D R Burton

references the accelerated discovery and trial

schedule, Appellee's Response Br. 18, but after the

district court amended the case schedule, D R

Burton indicated it did not intend to submit a

noninfringement expert report, J.A. 2031. The

accelerated case schedule therefore does not

provide substantial justification for D R Burton's

failure to disclose.

- Appx11 -

While the district court did not expressly state that

Dr. Collins' untimely testimony was harmless, the

district court reasoned that large portions of Dr.

Collins' testimony had been disclosed in his sevenpage declaration, and the district court's decision to

reserve ruling on Trudell's motion in limine

provided notice that Dr. Collins might testify at

trial. Post-Trial Order, at *4. But it is undisputed

that Dr. Collins' testimony constituted nearly all D

R Burton's evidence of noninfringement, Oral Arg.

at 24:02-20, and Trudell was afforded no

opportunity to depose him on the issue because Dr.

Collins' only declaration on noninfringement was

served weeks after the close of discovery. While

Trudell cross-examined Dr. Collins on

noninfringement, "the ability to simply crossexamine an expert concerning a new opinion at

trial is not the ability to cure." S. States Rack &

Fixture, 318 F.3d at 598.

D R Burton also argues Trudell was not prejudiced

by Dr. Collins' late declaration because Trudell also

submitted late expert reports. Appellee's Response

Br. 15, 18-19. Due to the accelerated discovery

schedule, D R Burton argues, expert reports from

both parties were untimely under Rule 26 and

exclusion of Dr. [*1349] Collins' testimony would

have also resulted in exclusion of testimony from

Trudell's experts. We do not agree. Trudell

submitted an infringement expert report on

September 20, 2022 and a damages expert report

- Appx12 -

on September 29, 2022. D R Burton contends these

reports were untimely under Rule 26(a)(2)(D)(i)

because they were served less than ninety days

before the start of trial on November 7, 2022.

Appellee's Response Br. 7. Importantly, however,

the ninety-day deadline expressly applies "[a]bsent

a stipulation or a court order." FED. R. CIV. P.

26(a)(2)(D). The district court's August 26, 2022

scheduling order allowed for discovery until

September 30, 2022, by which time Trudell had

submitted its expert reports. J.A. 1744. To the

extent D R Burton argues it was harmed by

Trudell's submission of its damages expert report

one day before the close of discovery, this is belied

by the parties' email communications indicating D

R Burton expressly stated that it did not intend to

conduct a deposition of this expert. J.A. 2031.

Finally, Dr. Collins' testimony exceeded the scope

of his declaration. Compare, e.g., J.A. 2532-33 at

92:8-13, 92:23-93:3 (Dr. Collins' trial testimony as

to whether the Accused Products "translate" as

required by the claims), with J.A. 1949-55 (Dr.

Collins' declaration which lacks reference to the

"translate" limitation). Even if Dr. Collins' sevenpage declaration was a timely filed, fully compliant

expert report, it failed to fully disclose the

noninfringement testimony given at trial. To the

extent the district court reasoned Dr. Collins'

untimely declaration sufficed to give Trudell notice

of his noninfringement testimony, significant

- Appx13 -

portions of his trial testimony went beyond the

bounds of the declaration.

Under these circumstances, Dr. Collins' untimely

report was neither harmless nor substantially

justified. Accordingly, the district court abused its

discretion by failing to exclude Dr. Collins'

testimony under the Federal Rules of Civil

Procedure and Fourth Circuit law. See FED. R.

CIV. P. 26(a)(2)(B), 37(c)(1); S. States Rack &

Fixture, 318 F.3d at 597.

The district court also abused its discretion by

failing to exclude Dr. Collins' testimony because—

even if his noninfringement declaration is viewed

as an expert report—his noninfringement

declaration was unreliable under Federal Rule of

Evidence 702. Rule 702 requires:

A witness who is qualified as an expert

by knowledge, skill, experience, training,

or education may testify in the form of

an opinion or otherwise if the proponent

demonstrates to the court that it is more

likely than not that:

(a)the expert's scientific, technical, or

other specialized knowledge will help

the trier of fact to understand the

evidence or to determine a fact in

issue;

- Appx14 -

(b) the testimony is based on sufficient

facts or data;

(c) the testimony is the product of

reliable principles and methods; and

(d) the expert's opinion reflects a reliable

application of the principles and

methods to the facts of the case.

Because expert testimony "can be both powerful

and quite misleading," the district court's

gatekeeping function under Rule 702 is an

important one. Daubert v. Merrell Dow Pharms.,

Inc., 509 U.S. 579, 595, 113 S.Ct. 2786, 125 L.Ed.2d

469 (1993) (citation omitted); see Sardis, 10 F.4th

at 283.

Here, Dr. Collins' noninfringement declaration was

untethered from the district [*1350] court's claim

constructions. For example, the district court

construed the term "a vane" as "a blade or plate

whose primary purpose is to convert kinetic energy

in the form of fluid movement into rotational

movement" and noted that this construction should

be understood broadly to include "one or more

vanes." J.A. 38. Dr. Collins, however, opined in his

declaration that the accused products do not

infringe because the patent "requires more than

one vane." J.A. 1953 n.1. Similarly, the district

court construed the term "rotate relative to the

- Appx15 -

opening" as "move a fixed body relative to the

opening about a point at a fixed radius" and

rejected D R Burton's argument that the term

required "a full revolution." J.A. 38-42. But Dr.

Collins opined in his declaration that "rotate

relative to the opening" in the context of the '588

patent meant "the vanes rotate in one direction

during expiration, round and round in a circular

manner," J.A. 1953 ¶ 11.2 The methodological

unsoundness of Dr. Collins' declaration provides an

independent basis by which the district court

abused its discretion in allowing Dr. Collins to

testify at trial. Therefore we vacate the jury's

finding of infringement and remand for a new trial.

II. JUDGMENT AS A MATTER OF LAW

Trudell argues that a new trial is unnecessary

because the district court erred in denying JMOL of

infringement. We review denial of JMOL under the

law of the regional circuit. ClearValue, Inc. v. Pearl

River Polymers, Inc., 668 F.3d 1340, 1343 (Fed. Cir.

2012). The Fourth Circuit reviews denial of JMOL

de novo, applying the same standard as the district

court. Johnson v. MBNA Am. Bank, NA, 357 F.3d

426, 431 (4th Cir. 2004). JMOL is granted if,

"viewing the evidence in a light most favorable to

the non-moving party and drawing every legitimate

inference in that party's favor, the court determines

that the only conclusion a reasonable jury could

have reached is one in favor of the moving party.”

- Appx16 -

Saunders v. Branch Banking & Trust Co. of VA.,

526 F.3d 142, 147 (4th Cir. 2008). The Fourth

Circuit has acknowledged that JMOL "may not be

granted lightly," and has indicated that a party

seeking JMOL who also bore the burden of proof

faces a particularly formidable burden. Thornhill v.

Donnkenny, Inc., 823 F.2d 782, 786 (4th Cir. 1987)

("The only possible basis for judgment n.o.v. on the

breach of contract claim is Donnkenny, Inc.'s

breach of fiduciary duty defense. We are satisfied

that the evidence supporting Donnkenny, Inc.'s

affirmative defense was not so overwhelming that

we cannot uphold the jury's rejection of that

defense.") (citing 9C C. WRIGHT & A. MILLER,

Federal Practice and Procedure § 2535 (1971)).

Trudell argues the district court erred in denying

its renewed motion for JMOL of infringement.

Trudell contends the only evidence of

noninfringement was Dr. Collins' testimony. Had

this testimony been properly excluded, Trudell

argues, the jury would have lacked a sufficient

evidentiary basis to find noninfringement. D R

Burton argues that, even without Dr. Collins'

testimony, there remains sufficient [*1351]

evidence to support the jury's verdict of

noninfringement. Appellee's Response Br. 19-20. In

addition to testimony from Dr. Collins, D R Burton

presented testimony from its founder and

president, Gregory Lau. See, e.g., J.A. 2503-04 at

63:19-64:25. Mr. Lau testified that, after reviewing

- Appx17 -

the patent, he believed Trudell's invention was a

"day and night differen[ce]" from D R Burton's

devices. J.A. 2503-04 at 63:19-64:4. D R Burton

contends this evidence supports a finding of

noninfringement.

Though we agree with Trudell that, without Dr.

Collins' testimony, D R Burton is left with minimal

evidence of noninfringement, the jury was free to

discredit the testimony of Trudell's expert, Dr.

Durgin, and find that Trudell failed to meet its

affirmative burden to prove infringement. For

example, D R Burton's cross-examination of Dr.

Durgin challenged his infringement testimony

particularly regarding the "generally oblong crosssectional shape" limitation. J.A. 2365-66 at

142:8-143:1. Credibility determinations are within

the sole province of the jury, and we do not reweigh

the evidence presented at trial. United States Sec.

& Exch. Comm'n v. Clark, 60 F.4th 807, 812 (4th

Cir. 2023). We hold that Trudell has not

established entitlement to JMOL of infringement

and therefore affirm the district court's denial of

Trudell's JMOL motion.

III. NEW TRIAL

We review a district court's denial of a motion for a

new trial under the law of the regional circuit.

Apple Inc. v. Wi-LAN Inc., 25 F.4th 960, 975 (Fed.

Cir. 2022). The Fourth Circuit reviews such denials

- Appx18 -

for abuse of discretion. United States v. Perry, 335

F.3d 316, 320 (4th Cir. 2003). A new trial is

warranted if the verdict is against the clear weight

of the evidence; is based upon evidence which is

false; or will result in a miscarriage of justice, even

though there may be substantial evidence which

would prevent the direction of a verdict. Minter v.

Wells Fargo Bank, N.A., 762 F.3d 339, 346 (4th Cir.

2014).

Trudell argues the district court abused its

discretion in denying the motion for a new trial on

infringement because the verdict is against the

clear weight of the evidence and resulted in a

miscarriage of justice. We agree.

The harmful and prejudicial admission of Dr.

Collins' testimony warrants a new trial on

infringement. The district court abused its

discretion in admitting Dr. Collins'

noninfringement testimony because it was

untimely, failed to comply with Federal Rule of

Civil Procedure 26, and was unreliable under

Federal Rule of Evidence 702. We vacate the

district court's denial of the motion and remand for

a new trial.

On remand, the record should be confined to

evidence already produced and admitted, with

exclusion of Dr. Collins' noninfringement

testimony. At this juncture, it would be improper to

- Appx19 -

reopen discovery where D R Burton previously

indicated to Trudell that it did not intend to

produce additional expert reports or depose

Trudell's experts. See J.A. 2031. Under these

circumstances, D R Burton should not now be

permitted to cure its failure to comply with the

disclosure requirements of Rule 26.

IV. REASSIGNMENT

We evaluate a request to reassign a matter to a

different judge on remand under the law of the

regional circuit. [*1352] TriMed, Inc. v. Stryker

Corp., 608 F.3d 1333, 1343 (Fed. Cir. 2010). Fourth

Circuit law provides for reassignment where "both

for the judge's sake and the appearance of justice

an assignment to a different judge is salutary and

in the public interest, especially as it minimizes

even a suspicion of partiality." G.G. ex rel. Grimm

v. Gloucester Cnty. Sch. Bd., 822 F.3d 709, 726 (4th

Cir. 2016) (quoting United States v. Guglielmi, 929

F.2d 1001, 1007 (4th Cir. 1991)), vacated on other

grounds by 580 U.S. 1168, 137 S.Ct. 1239, 197

L.Ed.2d 460 (2017). In determining whether

reassignment is warranted, the Fourth Circuit

considers: "(1) whether the original judge would

reasonably be expected upon remand to have

substantial difficulty in putting out of his or her

mind previously expressed views or findings

determined to be erroneous or based on evidence

- Appx20 -

that must be rejected, (2) whether reassignment is

advisable to preserve the appearance of justice, and

(3) whether reassignment would entail waste and

duplication out of proportion to any gain in

preserving the appearance of fairness." Id.

Trudell argues that reassignment to a different

trial judge is appropriate and necessary on remand.

Trudell points out that this case is particularly

analogous to a Fourth Circuit case, Beach Mart,

Inc. v. L&L Wings, Inc., 784 F. App'x 118 (4th Cir.

2019), in which the court ordered reassignment to a

different district court judge on remand. Indeed,

the same judge presided over both this trial and the

initial trial in Beach Mart. Trudell argues that, in

this case, the district court judge made

objectionable statements similar to those on which

the Fourth Circuit based its reassignment decision.

Several such statements in this case include:

"And I'm going to settle this case or

resolve it or dismiss it by September

30th. Just - that's a heads up." J.A. 1719

at 3:15-17.

"How about if I try the first case in early

September and forget about your

mediation." J.A. 1722-23 at 6:25-7:1.

"[O]ur duty is to get this case done. And

- Appx21 -

if you can't get it done, then I will. You

can get it done by settling it. I can get it

done by having a verdict in it." J.A. 2052

at 20:14-16.

We agree with Trudell that the statements of the

trial judge in this case are so similar to those in

Beach Mart, undermining the appearance of justice

and fairness, and we see no reason to decide this

case differently. See 784 F. App'x at 130. This case

is unique in that, as in Beach Mart, from the

moment this case fell in his lap, the trial judge's

statements indicate that he did not intend to

manage a fair trial with respect to the issues in this

case. See, e.g., J.A. 1722 at 6:1-3 ("But I have to

report this case by September 30th and I'm going to

get it off my report. That's the problem you have.

Did you know that?"). Likewise, the trial judge's

statements at trial in the presence of the jury

"undermin[ed] the appearance of fairness," 784 F.

App'x at 130. See, e.g., J.A. 2305 at 82:1-8 ("The

jury's just being tolerant of this, and it's painful.

My gosh. I should have put time limits . . . . I don't

think they understand they have to get through

this case."); J.A. 2356 at 133:3-6 ("THE COURT:

You [Trudell's counsel] can't do anything quickly.

What do you [the jury] want, do you want to hear

this stuff or do you want it kept moving along in

the case? SOME JURORS: Move along."). As in

Beach Mart, given the strength of his statements,

there is sufficient reason to believe that the trial

- Appx22 -

judge's conviction to quickly terminate the case will

be no different on remand. Finally, [*1353] as in

Beach Mart, reassignment would not result in

undue delay or wasted judicial resources, as the

trial judge presided over this case for only one of

the four years of this litigation. 784 F. App'x at 130.

For these reasons, we remand the case for trial

before a different district court judge.3

CONCLUSION

We have considered the parties' remaining

arguments and find them unpersuasive. For the

foregoing reasons, we reverse the district court's

decision admitting Dr. Collins' noninfringement

testimony and its denial of Trudell's motion for a

new trial on infringement. We affirm the district

court's denial of Trudell's motion for JMOL of

infringement. We remand for a new trial on

infringement consistent with this decision.

AFFIRMED-IN-PART, REVERSED-IN-PART,

AND REMANDED

COSTS

Costs to Trudell.

- Appx23 -

1. D R Burton cross-appealed the jury's verdict that

the Asserted Claims of the '588 patent were not

shown to be invalid. We need not reach this issue,

however, as D R Burton withdrew the cross-appeal

at oral argument in light of its failure to file a

renewed motion for JMOL pursuant to Federal

Rule of Civil Procedure 50(b). Oral Arg. at

27:20-28:09, available at https://

oralarguments.cafc.uscourts.gov/default.aspx?

fl=23-1777_10092024.mp3; A Helping Hand, LLC v.

Baltimore Cnty., Md., 515 F.3d 356, 369-70 (4th

Cir. 2008) ("a party's failure to file a postverdict

motion under Rule 50(b) leaves an appellate court

without power to direct the District Court to enter

judgment contrary to the one it had permitted to

stand" (quoting Unitherm Food Sys., Inc. v. SwiftEckrich, Inc., 546 U.S. 394, 400-01, 126 S.Ct. 980,

163 L.Ed.2d 974 (2006)) (internal quotation marks

omitted))).

2. Moreover, Dr. Collins also improperly compared

the accused products to the figures in the

specification rather than the claim language. J.A.

2520-23 at 80:8-83:25, 2528-29 at 88:19-89:4; Int'l

Visual Corp. v. Crown Metal Mfg. Co., 991 F.2d

768, 772 (Fed. Cir. 1993) (per curiam)

("Infringement is determined on the basis of the

claims, not on the basis of a comparison with the

- Appx24 -

patentee's commercial embodiment of the claimed

invention." (cleaned up)).

3. At oral argument, D R Burton indicated a related

case before the same trial judge is stayed pending

the outcome of this appeal. Oral Arg. at 26:09-37.

Judicial efficiency usually counsels consolidation of

related cases with a single judge. As the stayed

case is not before us, we have no power to order

reassignment of that case.

- Appx25 -

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF NORTH

CAROLINA EASTERN DIVISION

No. 4:18-CV-9-H-KS

TRUDELL MEDICAL

INTERNATIONA

)

)

)

Plaintiff,

)

) CASE

v.

) MANAGEMENT

) ORDER

D R BURTON HEALTHCARE ) (Patent

LLC

) Infringement)

Defendant.

)

This matter has been referred to the undersigned

for pretrial case management by Senior United

States District Judge Malcolm J. Howard. Pursuant

to Fed. R. Civ. P. 26(f) and this court's Local Civil

Rule 302.1, the parties have conducted a

scheduling conference by telephone and submitted

to the court a Joint Rule 26(f) Report and Discovery

Plan. Having reviewed the parties' proposed

discovery plan and having discussed it with the

- Appx26 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 1 of

parties at a telephonic, non-final pretrial

conference held on December 17, 2018, the court

hereby ORDERS as follows:

I. Discovery

A.

Initial Disclosures

Initial disclosures required by Rule 26(a)

(1) shall be made by January 4, 2019. Any

party making an appearance after this order

has been entered shall be required to confer

with the other parties and make disclosures

pursuant to Fed. R. Civ. P. 26(a)(1) within

twenty-one (21) days after the party's

appearance. Such party shall be bound by the

terms of this order unless the party moves for

and obtains amendment of this order by the

court.

B.

Subjects of Discovery

Discovery will be needed on the subjects

- Appx27 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 2 of

listed in Section 3 of the parties' Joint

Rule 26(f) Report and Discovery Plan.

C.

ESI/Protective Orders

The parties shall confer and submit, as

soon as reasonably practicable, any jointly

proposed orders governing disclosure of

confidential information and/or electronic

discovery. Any proposed protective order shall

set forth (i) the basis for a finding of good cause

for issuance of a protective order; and (ii) the

procedure for filing under seal documents

containing protected information in accordance

with Section V.G. of the court's Electronic Case

Filing Administrative Policies and Procedures

Manual, which is available on the court's

website at http://www.nced.uscourts.gov/pdfs/

cmecfPolicyManual.pdf.

- Appx28 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 3 of

D.

Discovery Limitations

Unless otherwise agreed by the parties

or ordered by the court, the following discovery

limitations shall apply:

1.

No party shall serve

more than twenty-five (25)

interrogatories, including discrete

subparts, to any other party,

except that each party shall be

permitted to serve up to an

additional five (5) interrogatories

for the sole purpose of identifying

proper custodians, proper search

terms, and proper timeframes for

separate email production

requests.

- Appx29 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 4 of

2.

No party shall serve

more than fifty (50) requests for

admission to any other party,

except that there shall be no limit

as to the number of requests for

admission posed for the sole

purpose of the authentication of

documents.

3.

Each Rule 30(b)(1)

deposition shall be limited to seven

(7) hours in duration.

- Appx30 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 5 of

4.

Depositions of

witnesses by a party pursuant to

Rule 30(b)(1) and 30(b)(6) shall not

exceed a total of eighty (80) hours,

inclusive of one deposition per

party to identify proper

custodians, proper search terms,

and proper timeframes for email

production requests.

5.

There shall be no

limit to the number of requests for

production of documents.

E.

Supplementation

Supplementation must be made

promptly after receipt of the supplementary

information by a party or its counsel in

accordance with Fed. R. Civ. P. 26(e).

- Appx31 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 6 of

F.

Modification of Discovery

Deadlines or Procedures

Pursuant to Rule 29 of the Federal Rules

of Civil Procedure, the parties need not seek

court approval of any agreements modifying the

procedures or deadlines for discovery, except

that the parties must obtain court approval of

any agreement that would interfere with the

time set for completion of discovery, for hearing

of a motion, or for trial.

G.

Discovery Disputes

Prior to the filing of any motion

concerning discovery, the parties shall meet and

confer, in person or by telephone, in an attempt

to resolve any disputed issues including,

without limitation, the scope or proportionality

of requested discovery and any claim of

privilege or need for a protective order. In the

event the parties are unable to resolve any

- Appx32 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 7 of

disputes through the meet-and- confer process,

the parties shall request a discovery conference

with the undersigned by filing a joint motion

with the court advising the court of the

general nature of any disputes, the efforts

taken to resolve such disputes, and the need for

the court's involvement in resolving any such

disputes.

Upon the court's receipt of a request for

discovery conference, the court may direct the

parties to submit short letter briefs or a joint

report outlining the parties' respective positions

and may hold a telephone or in-person

discovery conference. Alternatively, the court

may direct any party seeking relief to file a

discovery motion.

- Appx33 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 8 of

II. Alternative Dispute Resolution

A.

Mediation

This action has been selected for

mediation pursuant to the court's Alternative

Dispute Resolution Rules, Local Civil Rules

101-101.3, E.D.N.C. If the parties are able to

agree on a mediator, they shall file a statement

identifying the selected mediator and meeting

the other applicable requirements within

twenty-one (21) days after entry of this Order,

in accordance with Local Civil Rule 101.lc(a). If

a statement is not timely filed, the Clerk will

appoint a mediator from the list of courtcertified mediators, in accordance with Local

Civil Rule 101.1c(b). An initial mediated

settlement conference shall be conducted by

June 17, 2019, and mediation shall be

- Appx34 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 9 of

concluded within sixty-five (65) days following

entry of the claim construction order.

B.

Other Settlement Assistance

The parties may request the court's

assistance with settlement negotiations or

other alternative dispute resolution, such as a

court-hosted settlement conference or summary

jury trial, by making available a judge other

than the trial judge to explore these

possibilities.

C.

Notification of Settlement

The parties shall promptly notify the court

of any settlement reached in the case.

III. Non-final Pretrial Conferences

Due to the complex nature of this case,

the court finds that efficient case

administration will be facilitated by conducting

non-final pretrial conferences on a regular basis

- Appx35 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 10 of

to address matters that may arise during the

course of the litigation. Five days prior to any

such status conference, the parties shall confer

and jointly submit a report outlining (i) any

discovery disputes, scheduling issues or other

matters the parties desire to have addressed at

the pretrial conference; (ii) the parties'

respective positions with regard to such

matters; and (iii) the efforts made to resolve

any disputes without court intervention. In the

event there are no outstanding disputed issues,

the parties may jointly request a telephonic

status/scheduling conference in lieu of an inperson, Rule 16 pretrial conference by filing

with the court a joint motion at least two

business days prior to the scheduled conference.

- Appx36 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 11 of

IV. Motions & Pretrial Deadlines

A.

Joinder/Amendment

Any motion for leave to join additional

parties or to amend pleadings must be made

promptly after the information giving rise to the

motion becomes known and in no event later

than May 27, 2019.

B.

Dispositive Motions

All potentially dispositive motions shall

be filed within thirty (30) days of the close of

expert discovery.

C.

Daubert Motions

All motions to exclude testimony of

expert witnesses pursuant to Fed. R. Evid. 702,

703, or 705, Daubert v Merrell Dow Pharms.

Inc., 509 U.S. 579 (1993), Kumho Tire Co. v.

Carmichael,

526 U.S. 137 (1999), or similar case law shall be

- Appx37 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 12 of

filed within thirty (30) days of the close of expert

discovery.

D.

Claim Construction & Other

Deadlines

Subject to further order of the court, the

following deadlines shall apply in this case:

ACTION

DEADLINE

Rule 26(a)(1) Initial

Disclosures

January 4, 2019

Statement of Parties'

Selection of Mediator (LR

101.1c))

January 17, 2019

Disclosure of Asserted

Claims & Preliminary

Infringement Contentions

and associated document

January 25, 2019

Preliminary Invalidity

Contentions and associated

document production (LR

303.3 and 303.4)

March 11, 2019

Non-final Pretrial

Conference with the

Court

March 13, 2019 at

11:00 a.m.

Exchange of Proposed

Terms and Claim

Elements for

April 1, 2019

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 13 of

Exchange of Preliminary

Claim Constructions and

Extrinsic Evidence (LR

April 22, 2019

Joint Claim Construction

Statement (LR 304.3)

May 10, 2019

Non-final Pretrial

Conference with the

Court

Motions to Join Additional

Parties or to Amend

Pleadings

May 21, 2019 at 11:00

a.m.

Completion of Claim

Construction Discovery

(LR 304.4)

June 10, 2019

Initial Mediated Settlement

Conference

June 17, 2019

Opening Claim

Construction Briefs (LR

304.5(a))

June 24, 2019

Responsive Claim

Construction

Briefs (LR

July 15, 2019

Exchange of Privilege Logs

May 27, 2019

7 days before deposition

to which documents are

applicable and in no

event later than 60 days

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 14 of

Non-final Pretrial

Conference with the

Court in preparation

for Claim Construction

August 6, 2019 at 11:00

a.m.

Claim Construction

Hearing (if necessary)

(LR 304.6)

August 27, 2019, at

10:00 a.m.

Final Infringement

Contentions (LR 303.6(a))

30 days following

entry of claim

construction order

Final Invalidity

Contentions (LR 303.6(b))

50 days following

entry of claim

construction order

Conclusion of Mediation

65 days following

entry of claim

construction order

Post-Claim

Construction

Scheduling Conference

TBD (approximately

15 days after mediation

deadline)

Disclosure of Opinions of

Counsel (LR 303.8)

30 days prior to fact

discovery deadline

Fact Discovery Closes

120 days following

entry of claim

construction order

Initial Expert Disclosures

by Party Bearing Burden

of Proof (LR 305.1(b))

30 days after close of

fact discovery

Expert Disclosures Where

Opposing Party Bears

Burden of Proof (LR

30 days after service of

initial expert disclosures

pursuant to LR 305.1(b)

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 15 of

Rebuttal Expert

Disclosures (LR 305.1(d))

14 days after service of

expert disclosures

pursuant to LR 305.1(c)

Expert Discovery Closes

(LR 305.2)

Within 37 days of

rebuttal expert

disclosures pursuant to

Dispositive Motions &

Daubert Motions (LR

7.1(e))

30 days after close of

expert discovery

Rule 26(a)(3) Pretrial

Disclosures (LR 16.1b)

28 days before the final

pretrial conference

Objections to Pretrial

Disclosures (LR 16.1b)

21 days before the final

pretrial conference

Proposed Final Pretrial

Order (LR 16.1)

7 days prior to the final

pretrial conference

Final Pretrial Conference

(LR 16.1) & Motions

Hearing

To be set by separate

scheduling order

following the post-claim

construction scheduling

V. Other Matters

The parties are reminded that on consent

of all parties, and with the concurrence of the

District Judge, this case may be referred to a

- Appx41 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 16 of

KIMBERLY A. SWANK

Magistrate Judge for trial with a peremptory

trial setting and the right of direct appeal to

the Fourth Circuit. Should the parties desire to

have this case heard by a Magistrate Judge,

they should complete and file in CM/ECF a

Consent and Reference to Magistrate Judge

form. A copy of the form may be obtained from

the clerk or downloaded

at

http://

www.uscourts.gov/forms/civil-forms/noticeconsent-and-reference-civilaction-magistrate-judge.

This 27th day of December 2018.

KIMBERLY A. SWANK

United States Magistrate Judge

- Appx42 -

Case 4:18-cv-00009-H-KS Document 55 Filed 12/27/18 Page 17 of

IN THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF NORTH

CAROLINA EASTERN DIVISION

No. 4:18-CV-9-BO

TRUDELL MEDICAL INTERNATIONAL,)

Plaintiff,

)

)

v.

) ORDER

)

D R BURTON HEALTHCARE, LLC,

)

Defendant.

)

This cause comes before the Court on

the parties’ joint motion to extend the

mediation deadline. [DE 226]. A hearing was

held on the matter before the undersigned on

August 24, 2022, at Raleigh, North Carolina.

For the reasons discussed at the hearing, the

scheduling order in this matter is AMENDED

as follows:

- Appx43 -

•

All discovery shall close on September

30, 2022;

•

Dispositive motions must be filed not

later than October 10,2022;

•

Responses to dispositive motions must be

filed not later than October 21, 2022;

•

Replies to dispositive motions must be

filed not later than October 26,2022;

•

The jury trial in this matter shall

commence on Monday, November 7,

2022, at 10:00 a.m. at the United States

Courthouse at Elizabeth City, North

Carolina; and

•

The parties are free to mediate at any

time with a mediator of their choosing.

In light of the foregoing, the parties’ motion to

extend the mediation deadline [DE 226] is

DENIED AS MOOT.

SO ORDERED, this 26th day of August 2022.

s/TERRENCE W. BOYLE /

UNITED STATES DISTRICT JUDGE

- Appx44 -

Case: 23-1777

Document: 62

Page: 1

Filed: 04/01/2025

NOTE: This order is nonprecedential.

United States Court of

Appeals for the Federal

Circuit

TRUDELL MEDICAL INTERNATIONAL

INC.,

Plaintiff-Appellant

v.

D R BURTON HEALTHCARE, LLC,

Defendant/Counter-Claimant-CrossAppellant

2023-1777, 2023-1779

Appeals from the United States District Court

for the Eastern District of North Carolina in No.

4:18-cv-00009- BO, Judge Terrence William Boyle.

ON PETITION FOR PANEL

REHEARING

Before MOORE, Chief Judge, CHEN and STOLL,

Circuit Judges.

- Appx45 -

Case: 23-1777

Document: 62

Page: 2

Filed: 04/01/2025

PER

CURI

AM.

ORDER

D R Burton Healthcare, LLC filed a petition for

panel rehearing.

Upon consideration thereof,

2

TRUDELL MEDICAL INTERNATIONAL INC. v.

D R BURTON HEALTHCARE, LLC

IT IS ORDERED THAT:

The petition for panel rehearing is denied.

FOR THE COURT

April 1,

2025

Date

- Appx46 -