Gomez v. St. Jude Medical Daig Division Inc.

United States Court of Appeals
Fifth Circuit
F I L E D
IN THE UNITED STATES COURT OF APPEALS March 14, 2006
FOR THE FIFTH CIRCUIT
Charles R. Fulbruge III
Clerk
__________________________________

No. 04-30202

DANELL GOMEZ and MARTIN GOMEZ,

Plaintiffs-Appellants,

versus

ST. JUDE MEDICAL DAIG DIVISION INC., formerly known as Daig Corporation;
KENSEY-NASH CORPORATION; TYCO INTERNATIONAL; WYETH, formerly
known as American Home Products Corporation; TYCO HEALTH CARE GROUP
LP, formerly known as Kendall Company,

Defendants-Appellees.

Appeal from the United States District Court
for the Eastern District of Louisiana

Before KING and DAVIS, Circuit Judges, and ROSENTHAL, District Judge.*

LEE H. ROSENTHAL, District Judge:
In March 1999, Danell Gomez had a surgical catheterization to treat a blockage in an

artery leading to her left arm. When the procedure was complete, the surgeon used a medical
device known as an Angio-Seal to close the hole he had made in Gomez’s femoral artery to

access the blockage. The Angio-Seal deposits a small plug of collagen on the outside of the
artery wall at the puncture site. The collagen plug quickly causes a clot that stops the
bleeding. The Angio-Seal includes an “anchor” intended to keep any of the collagen from

*
District Judge for the Southern District of Texas, sitting by designation.
traveling to the inside of the artery, where it can cause a clot in the bloodstream. Gomez
alleges that the Angio-Seal worked improperly in her case, allowing collagen to travel to the

inside of her artery and cause a large blockage that had to be surgically removed. She
attributes her subsequent nine surgeries and persistent leg pain and weakness to the defective
Angio-Seal.

Gomez sued the manufacturer of the Angio-Seal under the Louisiana Product Liability
Act, seeking actual and punitive damages. Gomez’s husband joined in the suit seeking loss
of consortium damages. The district judge granted summary judgment as to Gomez’s state-

law design and marketing claims on the basis of federal preemption. The parties tried the

manufacturing defect claim to a jury. At the close of the evidence, the district judge granted

defendants’ motion for judgment as a matter of law under Rule 50(a) of the Federal Rules
of Civil Procedure. Gomez appealed.

We affirm the preemption determination, reverse the Rule 50 order, and remand to

the district court. The reasons are explained below.

I. Factual and Procedural Background
In 1999, Danell Gomez, then forty-four years old, saw her doctor complaining about

numbness and tingling in her left arm and hand. (Tr. at 399, 789). An arteriogram indicated

a blockage in the right subclavian artery in Gomez’s chest. Her doctor referred her to Dr.
Christopher White, an interventional cardiologist—defined as one who “performs procedures
such as angioplasties and stents”—at the Ochsner Clinic in New Orleans. (Tr. at 778).

Dr. White performed surgery to relieve the blockage and repair the artery. Dr. White
followed a standard procedure and accessed the subclavian artery through the right femoral
artery in the groin area, where the blood vessels are close to the skin. Dr. White inserted a

catheter through the opening he made in the femoral artery, passed the catheter to the

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subclavian artery, and inserted a balloon to open the blockage. The balloon did not have the
desired effect, requiring insertion of a stent, which was successful. Dr. White then withdrew

the catheter and other equipment through the femoral artery, leaving an opening that had to
be treated to stop the bleeding.
The evidence at trial described two common approaches to closing such an opening.

One approach is to use manual compression, applying pressure to the puncture area until a
clot forms and the bleeding stops. This approach can be uncomfortable for the patient
because of the pressure and because the patient must stay still for a long period—six to eight

hours—to avoid disrupting the clot. Complications such as prolonged bleeding and

pseudoaneurysms can result. The other approach is to use one of the recently-developed

puncture-closing devices, such as the Angio-Seal. The Angio-Seal operates by placing a
small plug of collagen on the outside of the artery wall to close the puncture site. Other

devices operate with a stitch or glue applied to the site. Dr. White and the Ochsner Clinic

had been involved in clinical studies leading to the FDA’s approval of the Angio-Seal and

Dr. White preferred it to other puncture-closing devices and to manual compression. Dr.
White testified that the use of closure devices like the Angio-Seal make the postoperation

procedure easier, faster, and less expensive for both the doctor and patient. Because both

closure devices and manual compression have approximately the same rate of
complications—although the complications are different—one approach is not inherently
more or less safe than the other.

The Angio-Seal consists of a guidewire, a carrier tube, a bypass tube, a bovine
collagen plug, and a T-shaped biodegradable polymer anchor. The Angio-Seal specifications
require that when the device is packaged for shipping, the T-shaped anchor must be in a

vertical position within the bypass tube, neither extending beyond the end of the tube nor

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inserted deeply within it. The bypass tube protects the anchor from damage during shipping
and during surgery. When the doctor inserts the Angio-Seal into the patient, the Angio-Seal

anchor must pass through a silicon hemostasis valve, which prevents the patient’s blood from
flowing back through the artery opening during the surgery. When the Angio-Seal is inserted
into a patient, the bypass tube—not the anchor—pushes open the hemostasis valve, the

anchor is inserted into the artery, and the collagen plug is deposited on the outside of the
artery wall.
During a surgery such as the one performed on Gomez, the surgeon enters the femoral

artery through a catheter. When the doctor has completed the procedure and is ready to

remove the catheter and close the entry wound using an Angio-Seal, the surgeon first inserts

the guidewire through the catheter that is already inside the patient’s femoral artery. The
catheter is then removed. The surgeon then inserts the Angio-Seal device, using the bypass

tube to push through and open the hemostasis valve before the anchor is released from the

bypass tube. The anchor is supposed to swivel ninety degrees once it is out of the bypass

tube, allowing the surgeon to pull the anchor flat, or flush, against the inner wall of the
artery. The surgeon cannot see the anchor, but relies on the tension felt when the suture is

pulled and the anchor is drawn perpendicular to, and flush against, the interior artery wall.

The surgeon then tamps the collagen plug attached to the suture on the outer artery wall,
causing rapid clotting at the puncture site. The anchor prevents the collagen from getting
into the inner portion of the artery, the patient’s bloodstream. If collagen enters the

bloodstream, the intended benefit of the Angio-Seal—rapid clotting—can instead cause
severe harm. Several medical witnesses testified that if collagen is introduced into a patient’s
bloodstream, significant complications can result. Dr. White, Gomez’s treating doctor,

described possible complications as including death, heart attack, stroke, bleeding, infection,

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limb loss, and “embolization,” which he described as the “breaking off [of] bits and pieces
of plaque in the artery [that] can go downstream and cause problems in toes and fingers and

[cause] stroke as well.” (Tr. at 787). All the witnesses agreed that humans have collagen
in their bodies, but only in the outer artery walls, not inside the arteries.
Dr. White did not experience any problem in using the Angio-Seal on Gomez on

March 12, 1999. The records show that the bleeding at the access puncture site stopped with
“no complications.” (Tr. at 792–93). After routine postsurgical monitoring showed no
problems, Dr. White discharged Gomez.

Less than two days after her surgery, Gomez experienced extreme pain in her right

leg. She returned to Dr. White approximately two weeks later, complaining of pain in the

right groin and thigh when she walked. Dr. White arranged for an ultrasound, which showed
a 70 % narrowing of the artery at the point he had entered it for the surgery. Dr. White

advised either an angioplasty or surgery to correct the narrowing. Dr. White testified at trial

that he believed scarring from the collagen plug caused a clot on the outer femoral artery

wall, which externally compressed and narrowed the artery. (Tr. at 856).
Gomez did not quickly obtain the treatment Dr. White recommended. Instead, she

decided that she wanted a doctor closer to her home. She consulted Dr. Diana Gilmore, a

cardiovascular surgeon, who referred her to Dr. Anthony Morales, an interventional
cardiologist. Gomez’s leg pain persisted during this period. On April 22, 1999, Dr. Morales
performed an arteriogram, which indicated a 99% blockage in Gomez’s right femoral artery.

(Tr. at 404–06). Dr. Morales tried but failed to clear the blockage using a catheter. He
testified that when he tried moving the catheter through the blockage he felt like he was
“hitting concrete.” He recommended surgery, which Dr. Gilmore performed on April 29,

1999.

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 Dr. Gilmore testified that she found a single embolus, or mass, inside Gomez’s right
femoral artery. She emphasized that the mass was not on the outside compressing the artery

wall, as Dr. White opined, but inside the artery itself, in the area known as the luma. The
mass was so large that it was pressing against the inside wall of the artery, known as the
intima. (Tr. at 753–54). Dr. Jerry Hudson, a pathologist, examined the mass and determined

that it consisted of suture material and collagen. (Tr. at 454–55). Dr. Hudson tested the
mass for the presence of Type IV (human) collagen, which he found, but did not test for the
Type I (bovine) collagen used in the Angio-Seal. (Tr. at 457).

Gomez continued to experience pain in her right leg and medical tests revealed

diminished blood flow. Gomez has seen a number of doctors, including a

hematologist/oncologist, who ruled out clotting disease as the cause of Gomez’s problems.
To treat the pain associated with clotting in her leg, Gomez saw a neurologist, who

prescribed several drugs. Through May 3, 2000, Gomez has undergone nine surgical

procedures, including seven catheterizations. Gomez has missed significant time at work and

will likely need additional medical procedures and drugs to treat pain and weakness in her
right leg.

On March 11, 2000, Gomez sued the Angio-Seal designer and manufacturer in federal

court. Gomez asserted causes of action under the Louisiana Product Liability Act, LA. REV.
STAT. ANN. §§ 9:2800.57(A) & (C) (West 1997), for unreasonably dangerous design, failure
to warn of the dangers of the Angio-Seal, failure to warn the public of the dangers that the

Angio-Seal posed for individuals with small blood vessels, failure to train medical personnel
to use the Angio-Seal properly, lack of informed consent, breach of express warranty,
redhibition, failure to communicate to the medical community the possibility of

complications discovered after the FDA approval process ended, failure to train physicians

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to address complications caused by the Angio-Seal, and failure to manufacture the device in
accordance with FDA specifications.

Kensey Nash Corporation developed the Angio-Seal and obtained the approval of the
Federal Food and Drug Administration through the premarket approval (PMA) procedure
under the Medical Device Amendments to the Food, Drug, and Cosmetics Act, 29 U.S.C. §

360k(a). Kensey Nash Corporation licensed the rights to the device to American Home
Products Corporation. In 1995, an American Home Products subsidiary, Quinton Instrument
Company, was designated as the device manufacturer. The Food and Drug Administration

approved Quinton’s manufacturing and quality procedures on September 26, 1996. In 1998,

American Home sold the rights to the device to Tyco International, which sold and marketed

the Angio-Seal through its affiliate, the Kendall Company LP, n/k/a Tyco Healthcare Group
LP (“Kendall”). Because Kendall was the only entity that owned and manufactured the

Angio-Seal when the device used in Gomez’s procedure was manufactured and sold, the

district court dismissed the other defendants.

The district court granted summary judgment in Kendall’s favor as to all Gomez’s
claims except manufacturing defect, on the basis that the Federal Medical Device

Amendments preempted the Louisiana product liability statute. The district court initially

granted summary judgment to Kendall on the manufacturing defect claim, but granted
Gomez’s Rule 59 motion after submission of previously-unavailable documents from the
FDA demonstrated genuine issues of fact material to determining whether the Angio-Seal

was made in accordance with the FDA-approved specifications. The district court convened
a jury trial for the manufacturing defect claim. At trial, Gomez claimed that the Angio-Seal
was defectively manufactured because the anchor extended past the bypass tube and did not

sit fully within the tube as the specifications required. Gomez argued, and presented

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witnesses who testified that, such a “positive extension” was a defect in the Angio-Seal.
These witnesses, whose qualifications under Rules 701 and 702 of the Federal Rules of

Evidence are not challenged, explained that this extension led to an improper position of the
anchor inside Gomez’s femoral artery when Dr. White used the Angio-Seal. Because the
anchor did not sit flush against the interior artery wall, it did not perform its intended

function of preventing the collagen from getting to the inside of the artery. As a result,
Gomez asserted, collagen did enter her bloodstream and caused the blockage and subsequent
circulatory problems in her leg.

Gomez relied on circumstantial evidence of defect and causation. The evidence

included information that the Angio-Seals sent to the Ochsner Clinic, including the one used

in Gomez’s surgery, came from two manufacturing lots. Predistribution tests showed a two
percent incidence of positive anchor extensions in the lot that supplied most of the Angio-

Seals sent to the Ochsner Clinic. Gomez also presented evidence that FDA adverse-incident

reports filed between November 1998 and April 1999 showed that six of the Angio-Seals in

the reports came from the same two lots that had supplied the Ochsner Clinic, and three of
those six resulted in occlusions, or blockages, in the patients.

At the close of the evidence, Kendall moved for judgment as a matter of law under

Rule 50(a), contending that the evidence was insufficient to show either a defect in the
Angio-Seal or that it caused the clot in Gomez’s femoral artery. The district court granted
the motion. Gomez timely appealed. Gomez contends that the district court committed error

in finding that federal law preempted her state-law claims for defective design, failure to
warn, breach of express warranty, negligence in training and consent forms, and redhibition.
Gomez also challenges the district court’s grant of Kendall’s motion for judgment as a matter

of law on the manufacturing-defect claim. Gomez also appeals from the district court’s

8
order, entered after final judgment and after she filed her notice of appeal, requiring Gomez
to pay certain deposition fees. Finally, Gomez claims that the district court erred in a

number of discovery and evidentiary rulings and asks this court to assign the case to a new
judge on remand.
We affirm the district court’s preemption decision, reverse the Rule 50 order, remand

for additional proceedings, and deny all additional relief as either moot or unwarranted.
II. The Standards of Review
This court reviews an award of summary judgment de novo, using the familiar

standard. Royal Ins. Co. of America v. Hartford Underwriters Ins. Co., 391 F.3d 639, 642

(5th Cir. 2004); FED. R. CIV. P. 56. Discovery and evidentiary rulings are reviewed under

a deferential abuse of discretion standard. See Freudensprung v. Offshore Technical Servs.,
Inc., 379 F.3d 327, 347 (5th Cir. 2004); Rubinstein v. Adm’rs of the Tulane Educ. Fund, 218

F.3d 392, 397 (5th Cir. 2000). This court reviews a district court’s ruling on a motion for

judgment as a matter of law de novo, applying the same standard as the district court.

Piotrowski v. City of Houston, 237 F.3d 567, 576 n.9 (5th Cir. 2001) (citing Rutherford v.
Harris County, Tex., 197 F.3d 173, 178 (5th Cir. 1999)). “The district court properly grants

a motion for judgment as a matter of law only if the facts and inferences point so strongly

in favor of one party that reasonable minds could not disagree.” Id. “In ruling on a rule 50
motion based upon the sufficiency of the evidence, we ‘consider all of the evidence—not just
that evidence which supports the non-mover’s case—but in the light and with all reasonable

inferences most favorable to the party opposed to the motion.’ ” Info. Commc’n Corp. v.
Unisys Corp., 181 F.3d 629, 633 (5th Cir. 1999) (quoting Boeing Co. v. Shipman, 411 F.2d
365, 374 (5th Cir. 1969) (en banc)) (additional citations omitted). In evaluating the Rule 50

9
motion, the district court cannot assess the credibility of witnesses or weigh the evidence.
Reeves v. Sanderson Plumbing Prod., 530 U.S. 133, 150 (2000).

III. Preemption
The district court held that the Medical Device Amendments of 1976, 21 U.S.C.
§§ 360c–l, to the Food, Drug and Cosmetic Act preempted Gomez’s state-law claims that

despite compliance with FDA requirements, the Angio-Seal was defectively designed,
defectively manufactured, and defectively marketed. The district court dismissed the claims
for failure to warn, breach of express warranty, negligence regarding training and consent

forms, strict liability, unreasonably dangerous per se, and negligence. This circuit’s

decisions in Martin v. Medtronic, Inc., 254 F.3d 573 (5th Cir. 2001), and Stamps v. Collagen

Corp., 984 F.2d 1416 (5th Cir. 1993), control this issue. Because the Angio-Seal was subject
to the FDA’s “rigorous” PMA procedure, we agree with the district court that these state-law

claims are preempted.

The Medical Device Amendments of 1976 classify medical devices into three

categories based on the potential risk to the public. 21 U.S.C. § 360c(a)(1)(A)–(C); Lohr v.
Medtronic, Inc., 518 U.S. 470, 476 (1996). “Devices that present no unreasonable risk of

illness or injury are designated Class I and are subject only to minimal regulation by ‘general

controls.’” Lohr, 518 U.S. at 476–77 (citing 21 U.S.C. § 360c(a)(1)(A)). “Devices that are
potentially more harmful are designated Class II” and must comply with a set of regulations
coined “special controls.” Lohr, 518 U.S. at 477 (citing 21 U.S.C. § 360c(a)(1)(B)).

Devices that present “a potential unreasonable risk of illness or injury” or which are
“purported or represented to be for a use in supporting or sustaining human life or for a use
which is of substantial importance in preventing impairment of human health” are designated

Class III. 21 U.S.C. § 360c(a)(1)(C). The Angio-Seal is a Class III medical device.

10
 Before a Class III device may be put on the market, the manufacturer must give the
FDA “reasonable assurance” that the device is both safe and effective. 21 U.S.C.

§ 360e(d)(2). A manufacturer provides “reasonable assurance” through the PMA process.
The PMA process requires the manufacturer to “submit detailed information regarding the
safety and efficacy of their devices, which the FDA then reviews, spending an average of

1,200 hours on each submission.” Lohr, 518 U.S. at 477. Significantly, the FDA’s
involvement with the devices continues even after the PMA is complete. See, e.g., 21 C.F.R.
§ 814.80 (prohibiting the production or labeling of any device in a manner inconsistent with

any conditions of approval specified in the approval order); 21 C.F.R. § 814.3a(d) (requiring

an applicant to submit a supplemental application setting forth any proposed changes for

FDA approval before implementing any changes).
Congress provided two exceptions to the PMA process. First, a grandfather clause

permits medical devices marketed before passage of the amendments to remain unless and

until the FDA initiates and completes the PMA process. See Lohr, 518 U.S. at 21; C.F.R.

at 478 (citing 21 U.S.C. § 360e(b)(1)(A); 21 C.F.R. § 814.1(c)(1)). Second, devices that are
“substantially equivalent” to a preexisting medical device are exempt from the PMA process

and instead subject to a streamlined approval process. See Lohr, 518 U.S. at 492–94

(describing the significant differences between the PMA and the “substantially similar”
process under § 510(k));1 21 U.S.C. § 360e(b)(1)(B).
The Supremacy Clause of the Constitution prohibits state laws from conflicting with

federal law. U.S. CONST. art. VI, cl. 2. A “state law that conflicts with federal law is
without effect.” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992). “In view of the

1
The procedure used to determine whether a device is “substantially equivalent” to a preexisting medical
device is often referred to as the “§ 510(k)” process, named after the number of the section in the original act.
Lohr, 518 U.S. at 478.

11
historic importance of federalism in these areas, the states’ police powers relating to public
health and safety are not preempted by federal law unless Congress’ intent to do so is clearly

expressed.” Kemp v. Medtronic, Inc., 231 F.3d 216, 222 (6th Cir. 2000) (citing Hillsborough
County, Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 715 (1985)). When Congress
enacts a specific preemption provision, that provision determines the preemptive effect of

the statute. Cipollone, 505 U.S. at 517.
The express preemption provision in the Medical Device Amendments governs the
extent to which it preempts state law. It states:

[N]o State or political subdivision of a State may establish or continue in effect
with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under
this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other
matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a). The FDA has promulgated regulations to assist courts in interpreting

this section, which states in part as follows:

State or local requirements are preempted only when the Food and Drug
Administration has established specific counterpart regulations or there are
other specific requirements applicable to a particular device under the act,
thereby making any existing divergent State or local requirements applicable
to the device different from, or in addition to, the specific Food and Drug
Administration requirements. There are other State or local requirements that
affect devices that are not preempted by section 521(a) of the act because they
are not “requirements applicable to a device” within the meaning of section
521(a) of the act.
21 C.F.R. § 808.1(d); see also id. at 808.1(d)(1)–(10) (listing examples).

This circuit has held that the PMA process “preempts state tort causes of action to
the extent that they relate to safety, effectiveness, or other MDA requirements” if the state-
law claims impose “substantive requirements” different from or inconsistent with the federal

law. Martin, 254 F.3d at 584. In Martin, this circuit examined its earlier preemption

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analysis in Stamps v. Collagen Corp., 984 F.2d 1416 (5th Cir. 1993) in light of the Supreme
Court’s decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Both Stamps and Martin

involved Class III medical devices subject to the PMA process; Lohr involved a device that
was subject to the less-demanding § 510(k) notification process. In Martin, the court
reaffirmed Stamps and held that the PMA requirements preempted Texas state product-

liability claims arising from a Class III medical device, including claims of defective design,
failure to warn, and inadequate labeling, because those claims related to areas specifically
covered in the PMA process and sought to impose requirements that were “different from

and, indeed, conflict with” the results of the PMA process. Martin, 254 F.3d at 584.

This circuit, and all but one of the appellate courts considering the issue, require a

district court to look through the general duties imposed by the state-law causes of action and
consider the effect a successful lawsuit asserting those causes of action would have and

determine whether they threaten the federal PMA process requirements. See, e.g., Horn v.

Thoratec Corp., 376 F.3d 163, 172–73 (3d Cir. 2004) (same); Brooks v. Howmedica, Inc.,

273 F.3d 785, 799 (8th Cir. 2001) (en banc); Kemp, 231 F.3d at 230, 236; Mitchell v.
Collagen Corp., 126 F.3d 902, 913–15 (7th Cir. 1997); Papike v. Tambrands, Inc., 107 F.3d

737, 742 (9th Cir. 1997); but see Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1377 (11th Cir.

1999) (holding that § 360k(a) does not preempt common-law claims involving PMA-
approved devices). This court and the other courts of appeals (save the Eleventh Circuit)
recognize that the FDA, through the PMA process, has imposed a set of specific regulations

on medical devices and their manufacturers that preempt state-law claims relating to the
same areas and seeking to impose different requirements. Through the decisions made in the
PMA process, the federal government has “weighed the competing interests relevant to the

particular requirement in question, reached an unambiguous conclusion about how those

13
competing considerations should be resolved in a particular case or set of cases, and
implemented that conclusion via a specific mandate on manufacturers or producers.” Papike,

107 F.3d at 741 (quoting Lohr, 518 U.S. at 501). That conclusion is entitled to preemptive
effect.
Because the Angio-Seal went through the PMA process, the cases discussing medical

devices subject to the less-demanding “substantially equivalent” process are not helpful.
Compare Martin, 254 F.3d at 584 (“[T]he fact that the § 501(k) process did not preempt state
causes of action in Lohr does not indicate that the PMA process cannot preempt state tort

causes of action.”) with Reeves v. Acromed Corp., 103 F.3d 442, 447 (5th Cir. 1997) (“[T]he

‘substantial equivalence’ provision did not preempt Reeves’ unreasonably dangerous per se

claim.”). The Martin/Lohr test applies to products liability claims against PMA-approved
devices such as the Angio-Seal. The district court correctly analyzed Gomez’s claims to

determine whether the state-law duties enforced by the causes of action she asserted would

threaten the federal duties imposed under the PMA process.

Gomez alleged strict liability defective design and negligent design causes of action
under Louisiana law. To prevail on her “unreasonably dangerous in design” claim, Gomez

had to prove that: (1) “[t]here existed an alternative design for the product that was capable

of preventing the claimant’s damage”; and (2) “[t]he likelihood that the product’s design
would cause the claimant’s damage and the gravity of that damage outweighed the burden
on the manufacturer of adopting such alternative design and the adverse effect, if any, of

such alternative design on the utility of the product. An adequate warning about a product
shall be considered in evaluating the likelihood of damage when the manufacturer has used
reasonable care to provide the adequate warning to users and handlers of the product.” LA.

REV. STAT. ANN. § 2800.56 (West 1997). The FDA studied the Angio-Seal design through

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the PMA process and approved it. To permit a jury to second-guess the Angio-Seal design
by applying the Louisiana statutory standard for unreasonably dangerous design would risk

interference with the federally-approved design standards and criteria. The district court
judge correctly found that federal law preempted this state-law challenge to the design of the
Class III FDA-approved Angio-Seal.2 Accord Horn, 376 F.3d at 176; Martin, 254 F.3d at

584–85; Papike, 107 F.3d at 741–42.
Gomez also alleged state-law causes of action for failure to warn and failure to train,
including a claim that because Kendall’s clinical studies underrepresented women, it failed

to give adequate warnings of risks more likely to occur in women as a result of generally

smaller blood vessels. See LA. REV. STAT. ANN. § 2800.57 (listing elements of inadequate

warning claims). Gomez claimed that Kendall provided inadequate warnings; that Kendall
should have been required to provide more specific information about the Angio-Seal; that

the consent forms should have required a physician to obtain a patient’s specific, informed

consent to the use of the Angio-Seal before its use; and that the material Kendall supplied

to train in the use of the Angio-Seal were inadequate. Gomez also sought recovery under a
theory of redhibition, which is Louisiana’s equivalent to a breach of implied warranty claim.

See LA. REV. STAT. ANN. § 2520 (West 1997).

The FDA approved Kendall’s warnings and instructions for physicians contained in
the Instructions for Use (“IFU”) through the PMA process. That process required the FDA
to approve clinical studies and evaluate the results, to specify the labeling requirements, and

2
Courts have permitted state law-based actions claiming that a defendant failed to build a medical device
in compliance with PMA-approved design specifications. See Martin, 254 F.3d at 582 n.8 (“However,
common law duties that incorporate the PMA process, such as the general duty to take due care to comply with
the PMA process and labeling or manufacturing, will never contain specific requirements that are additional
to or different from federal requirements. Therefore, claims based on those duties are not preempted.”) (citing
Lohr, 518 U.S. at 495). The district court permitted such a claim to go forward in this case, a decision Kendall
did not appeal.

15
and approve the label that issued. The FDA also approved the “Patient Guide” used to
provide information and warnings to patients, again through the PMA process. Kendall’s

training requirements were also subjected to, and approved in, the PMA process. To permit
a jury to decide Gomez’s claims that the information, warnings, and training material the
FDA required and approved through the PMA process were inadequate under state law

would displace the FDA’s exclusive role and expertise in this area and risk imposing
inconsistent obligations on Kendall. The district judge correctly found that Gomez’s state-
law claims that Kendall’s labeling, warning, information, and training were inadequate or

incomplete are preempted. Accord Horn, 376 F.3d at 176; Martin, 254 F.3d at 584–85;

Stamps, 984 F.2d at 1422; Mitchell, 126 F.3d at 913–14; Papike, 107 F.3d at 741–42.

Gomez argues that it is inappropriate to apply preemption to her warranty claims to
the extent she based them on a later-acquired knowledge theory. Gomez argues that even

if Kendall did not know the potential problems Angio-Seal presented for patients like her

when the device received FDA approval, it later learned more information about those risks

but failed to provide that information in updated warnings for patients and physicians. This
argument fails to overcome preemption. Medical device manufacturers such as Kendall have

ongoing obligations to report experience with the device to the FDA, and the FDA has

plenary authority to amend the regulations and requirements it imposed relating to the device,
up to and including removing it from the market. At the end of the PMA process leading to
approval, the FDA issues conditions of approval requiring the manufacturer to meet ongoing

reporting and other obligations. See 21 C.F.R. § 814.80; 21 C.F.R. § 814.3a(d). The record
shows that after the FDA approved the Angio-Seal, Kendall submitted a proposed change to
the warning label recognizing risk for patients with smaller veins, particularly females, and

recommending additional procedures to mitigate this risk. Gomez’s state-law claims related

16
to Kendall’s alleged failure to provide information obtained after the FDA approved the
Angio-Seal risk the same interference with the federal regulatory scheme as her other claims

and are preempted.
Gomez also claimed that Kendall breached express warranties imposed under
Louisiana law relating to the Angio-Seal. The Seventh Circuit has noted that express

warranties, which “arise[s] from the representations of the parties and are made as the basis
of the bargain between them” may “not necessarily interfere with the operation of the PMA,
and therefore” may not be preempted. Mitchell, 126 F.3d at 915. Both parties agree that the

Angio-Seal’s express warranty was part of the IFU, which is itself part of the PMA process.

This fact does not resolve the issue, however, because a lawsuit that simply parallels or

enforces the federal regulatory requirements without “threatening” or interfering with them
is not preempted. See Lohr, 518 U.S. at 495.

The Louisiana law governing claims of breach of express warranty reads,

A product is unreasonably dangerous when it does not conform to an express
warranty made at any time by the manufacturer about the product if the
express warranty has induced the claimant or another person or entity to use
the product and the claimant’s damage was proximately caused because the
express warranty was untrue.

LA. REV. STAT. ANN. § 9:2800.58 (West 1997). The district court held that the breach of

warranty claim was preempted because “the warranty is intertwined with the FDA’s
standards concerning the device’s design, testing, intended use, manufacturing methods,
performance standards and labeling.” (R. at 595). Unlike the alleged breach of express

warranty at issue in Mitchell, the Louisiana statute goes beyond merely enforcing the federal
requirements. The last part of the Louisiana provision requires proof that “the express
warranty was untrue.” LA. REV. STAT. ANN. § 9:2800.58. A jury hearing Gomez’s state-law

breach of express warranty claim would have to decide whether Kendall’s representations

17
about the Angio-Seal were true. Because those representations—including the label,
warnings, and IFU—were approved by the FDA through the PMA process, the duties arising

under the Louisiana breach of warranty statute relate to, and are potentially inconsistent with,
the federal regulatory scheme. The claim is preempted. Accord Baker v. Medtronic, Inc.,
No. 2:99-CV-1355, 2002 WL 485013, at *8 (S.D. Ohio Mar. 28, 2002) (“[E]xpress

representations are subject to comprehensive FDA regulation.”) (citing Martin v.
Telectronics Pacing Sys., Inc., 105 F.3d 1090, 1100 (6th Cir. 1997)).
Gomez also alleged several negligence-based state-law claims, including claims of

negligence per se. The district court denied Kendall’s motion for summary judgment that

federal law preempted Gomez’s state-law defective manufacturing claim. That statute

requires a plaintiff to show that: (1) defendant is a manufacturer of the product; (2) the
product proximately caused the plaintiff’s damage; (3) the damaging characteristic of the

product rendered it “unreasonably dangerous”; and (4) the plaintiff’s damage arose from a

reasonably anticipated use of the product. LA. REV. STAT. ANN. § 2800.54 (West 1997);

Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 261 (5th Cir. 2002). Gomez’s claims that
Kendall deviated from the FDA-approved specifications in manufacturing the Angio-Seal

used in her surgery survived summary judgment.

The district court properly granted summary judgment on Gomez’s negligence claims
that were based on aspects of the Angio-Seals’s design, manufacture, and marketing that
complied with the FDA-approved requirements. No negligence claims can be maintained

as to devices that complied with the FDA requirements because success on those claims
requires a showing that the FDA requirements themselves were deficient. These claims
cannot be presented to a jury because, if successful, they would be inconsistent with the

federal regulatory requirements. The district judge properly limited Gomez’s negligence

18
claims to a claim that the Angio-Seal used in her surgery was defectively manufactured
because it did not comply with the FDA-approved specifications. Cf. Mitchell, 126 F.3d at

913 (“The Mitchells’ negligence claims must be considered preempted to the extent that they
allege that Collagen was negligent despite its adherence to the standards required by the FDA
in its PMA for this specific product.”). The district court’s summary judgment ruling that

Gomez’s other state law-based claims were preempted by the MDA is affirmed.
IV. Rule 50
To prevail on a manufacturing defect claim under Louisiana law, the plaintiff must

show that when the product left the manufacturer’s control, it “deviated in a material way

from the manufacturer’s specifications or performance standards for the product or from

otherwise identical products manufactured by the same manufacturer.” LA. REV. STAT. ANN.
§ 9:2800.55 (West 1997). At the close of the evidence, the district court granted Kendall’s

Rule 50 motion on the ground that Gomez had failed to present evidence from which a

reasonable jury could conclude that the Angio-Seal used in her surgery was defective, or that

the alleged defect caused her injuries. To prevail on appeal, Gomez must point to record
evidence that could have supported a finding in her favor on defect and causation. In

reviewing the record, we must draw all reasonable inferences and resolve all conflicting

evidence in favor of Gomez and refrain from weighing the evidence or making credibility
determinations. Reeves, 530 U.S. at 150.
A. The Evidence of Defect

After Gomez’s surgery, the hospital destroyed Angio-Seal as medical waste. Gomez
had to rely on circumstantial evidence to prove that the Angio-Seal used on her was
defective. As the district court properly noted, however, the law does not distinguish

between circumstantial and direct evidence. See, e.g., Holland v. United States, 348 U.S.

19
121, 140 (1954) (noting that circumstantial evidence “is intrinsically no different” than direct
evidence). On a Rule 50 motion, the district judge could neither weigh the evidence

presented nor make credibility determinations about it. See Ellis v. Weasler Eng’g, Inc., 258
F.3d 326, 337 (5th Cir. 2001) (citing Reeves, 530 U.S. at 150) (additional citations omitted)).
After a thorough review of the record, we find that Gomez met her standard for defeating the

Rule 50 motion as it related to defect.
Dr. Seth Bilazarian, an interventional cardiologist, Dr. John Eidt, a vascular surgeon,
and Dr. Steven Jones, a biomechanical engineer, testified about the Angio-Seal and how it

worked to stop bleeding at a puncture site used to access the bloodstream in a catheterization

procedure. All gave testimony that supported an inference that a positive extension of the

anchor in relation to the bypass tube violated the FDA manufacturing specification, made the
device defective, and that the device used on Gomez in March 1999 contained this defect.

Dr. Bilazarian testified that he had extensive experience in using Angio-Seals. He

testified as to why he concluded that in Gomez’s case, the anchor did not perform its

intended function of keeping collagen from the inside of the artery. The pathology report
showed that the mass removed from Gomez’s right femoral artery contained fragments of

suture material and collagen. Dr. Bilazarian testified that both came from the Angio-Seal:

the suture is used to attach the anchor to the collagen plug; and Gomez’s own collagen would
not be found inside her blood vessel, but only in the artery wall itself. (Tr. at 169, 172). The
contents of the mass supported an inference that the Angio-Seal anchor did not operate

properly. Bilazarian testified that the pathology report was consistent with collagen causing
a clot to form inside Gomez’s artery, instead of on the outside artery wall. (See id. at 173).
Dr. Bilazarian testified that the medical records showed no evidence of other conditions,

such as a clotting disorder, that could explain the clot on the inside of the artery. Dr.

20
Bilazarian also testified that the medical records showed no evidence of causes for a collagen
deposit inside the artery wall—such as a separation or dissection of the artery walls when

the Angio-Seal was used—other than the improper operation of the Angio-Seal anchor.
The district court relied on a statement incorrectly attributed to Dr. Bilazarian in
granting Kendall’s Rule 50 motion. The district court stated that Dr. Bilazarian had testified

that if he saw an Angio-Seal with the anchor extending past the bypass tube, he would
simply tap it back into place and use it. The district court found this statement supported his
conclusion that there was insufficient evidence of defect to allow the case to go to the jury.

The record reveals that Dr. Bilazarian, along with other witnesses, testified that if he saw

such an extension, he would not push the anchor back inside the tube and would discard it.

(Tr. at 189).
Dr. John Eidt also testified that he would discard an Angio-Seal with a positive anchor

extension and explained why:

When you push [the bracket through the hemostasis valve], it’s kind of like
going through barroom doors, you kind of have to push them open to get
through.
I think there is—while the risk is that as you push the device through
this sort of rubber seal, that if the extension, if the anchor is sticking out the
end of the device it could malposition, it could cause it to rotate or change its
relationship to the device so that when you do pull on it, when you get it in the
artery instead of it being aligned the way it’s supposed to, it’s misaligned.
(Tr. at 319, 308–09).
Dr. Jones, the biomechanical engineer, explained that the hemostasis valve—the

barroom doors—are made of silicon, a sticky viscous material harder than the plastic of the
anchor. The bypass tube is intended to push through the hemostasis valve, while the anchor
remains in the tube’s protective sheath. Dr. Jones testified that if the anchor extended past

the bypass tube and was the part of the Angio-Seal pushing through the hemostasis valve, the

21
anchor could be damaged and mispositioned inside the artery. In its proper position, the
anchor is flat against the inner artery wall. If it is damaged when inserted into the artery, it

could be positioned at an angle to the artery wall instead of flush against it. When the
surgeon uses the tamping tube to tamp the Angio-Seal collagen plug, an angled anchor could
allow collagen to be tamped down into the artery itself. Dr. Eidt testified that he could move

a positively-extended anchor back into the bypass tube. He was not asked, and did not
testify, that he would do so before using the device on a patient.
Kendall argued that Gomez presented insufficient evidence that this deviation—an

anchor extending beyond the bypass tube—was present in the Angio-Seal used in her surgery

or that it was a defect. The evidence showed that the Angio-Seal specifications called for

the anchor to be fully within the bypass tube, no more than .05 inches away from the end of
that tube. (Tr. at 516). Dr. Jones testified that an “anchor extension” is on the list of “major

defects” for the Angio-Seal. The evidence at trial showed that the devices supplied to the

Ochsner Clinic came from two lots, 100804 and 100858. Kendall followed required

protocol and tested 100 randomly-selected Angio-Seals from each of these lots before
releasing them for shipment. The tests showed that in one of the lots, 2 % of the devices

tested had positive anchor extensions that were “nonconforming.” Jones testified that FDA-

approved quality assurance inspections require an entire lot to be discarded if a random test
of devices within the lot reveal a defect in 1 out of 1,000 devices (a defect rate of 0.01%).
Lot number 100804 had two defective Angio-Seals within the 100 samples: one with an

anchor extension of 0.13 inches and one with an anchor extension of 0.14 inches. (Tr. at
483). Lot number 100858 also had two Angio-Seals within the 100 samples with deviations
in the anchor position, but this lot had negative, not positive, anchor extensions. The record

showed that the bulk of the devices supplied to the Ochsner Clinic came from lot number

22
100804, which had a 2 % incidence of positive anchor extensions. (Tr. at 282, 328, 491–92;
Ex. 46).

The testimony supported an inference that the lot supplying the majority of the
devices shipped to the Ochsner Clinic during the relevant period had a positive anchor
extension rate of 1 out of 50 devices, or 2%, well in excess of the FDA standards requiring

disposal of the entire lot. Jones testified that a company releasing a lot with such a high
incidence of noncomforming devices is “pretty much guaranteed [to] send[ ] out devices that
exceed that specification.” (Tr. at 483).

Under Kendall’s FDA-required procedures, “[a] record of a nonconformance . . .

requires quarantine of the discrepant material, review, and disposition by the Material

Review Board, and a preventive action response by a designated individual.” (Id.). Tamara
Yount, the Kendall Quality Assurance and Regulatory Affairs directors when Kendall

released the two lots at issue, corroborated much of Dr. Jones’s testimony about the

specifications in the two lots that were the source of the Angio-Seals sent to the Ochsner

Clinic. Yount remembered the two lots with the anchor extensions and testified that these
were the only two lots that had such deviations. (Tr. at 641–43).

Yount served on the Material Review Board that reviewed the deviations from

manufacturing specifications and authorized the release of the devices. A Material Review
Board cannot authorize release of noncomforming devices unless it determines that the
deviation will have “no clinical effect.” (Tr. at 668). In her testimony, Yount conceded that

the positive anchor extensions were not in compliance with the specifications. (Tr. at 656).
Yount testified that the Material Review Board determined that the positive anchor
extensions would have no clinical effect on how the Angio-Seals operated. (Tr. at 650).

Yount admitted that the Board conducted no regular meetings and did not meet on this issue;

23
kept no minutes; and performed no tests to determine the potential effects of a positive
anchor extension in human surgical procedures.

Yount’s testimony showed that after Kendall discovered the anchor extension
problem, it determined the likely cause. The employees placing Angio-Seals in packages
were putting the devices too close to the package sealer bars, which could cause the tubes

to be pushed back when the package was sealed. Kendall retrained its employees to avoid
this problem. Yount agreed with Gomez’s witnesses that the purpose of requiring the anchor
to be inside the bypass tube is to have the bypass tube push past the hemostasis valve.

Yount’s testimony did not show that the Material Review Board specifically considered the

effect of having the anchor, rather than the tube, push open the valve.

The jury heard testimony from witnesses, including Dr. Bilazarian, Dr. Eidt, and Dr.
Jones, that the anchor could be damaged if it extended beyond the bypass tube and had to

push past the hemostasis valve. (Tr. at 650, 668–72). Kendall emphasizes that Dr.

Christopher White, Gomez’s treating physician and the only witness who actually observed

the Angio-Seal used, did not record any indication of a positive anchor extension and had
no recollection that he had ever seen one. Medical witnesses who had also used Angio-Seals

testified that a physician might not notice an anchor extension in preparing to use the device

at the end of a surgical procedure. (Tr. at 325). The fact that Dr. White disagreed with some
of Gomez’s expert and fact witnesses, however, or that there were inconsistencies in some
of the testimony of the witnesses Gomez called, does not support granting the Rule 50

motion. The evidence could support an inference that the Angio-Seal used on Gomez had
a positive anchor extension and that this condition was a defect. Gomez presented sufficient
evidence to have the jury weigh it and make the credibility judgments necessary to resolve

any conflicts. Accord Ellis, 258 F.3d at 337–38.

24
 B. The Evidence of Causation
Gomez was not required to eliminate every possible alternative cause of her injuries

to raise an inference that a defective Angio-Seal caused her injuries. Instead, under
Louisiana law, Gomez had to eliminate alternative causes with “reasonable certainty.”
Pipitone, 288 F.3d at 243 n.5 (applying Louisiana law); Wheat v. Pfizer, Inc., 31 F.3d 340,

342–43 (5th Cir. 1994) (same).
As noted, Dr. Bilazarian, Dr. Eidt, and Dr. Jones testified that the anchor prevents the
collagen used in the Angio-Seal from moving to the inside of the artery. They testified that

a positive anchor extension on the Angio-Seal used on Gomez could have caused the anchor

to be pushed out of position when it passed through the hemostasis valve into Gomez’s artery

and not sit flush against the inner artery wall. Dr. Jones testified that a positive anchor
extension could cause the Angio-Seal anchor to “stick into the wall of the artery” instead of

lining up flush against the artery wall. (Tr. at 522). Once the anchor is stuck against the

artery wall, and the surgeon goes to “tamp the collagen down, there is room, there is a space

there for collagen to get into the artery and, of course, come into contact with the blood.”
(Id.). Jones and other witnesses testified that an angled or improperly-positioned anchor

could allow collagen from the Angio-Seal plug to escape into the artery itself. (Id.). Such

testimony, if found credible, could support an inference that the positive-anchor defect in the
Angio-Seal caused Gomez’s injuries.
Dr. Bilazarian and Dr. Eidt testified about the medical evidence supporting the

conclusion that collagen from the Angio-Seal caused the blood clot to form in Gomez’s
femoral artery after the March 1999 surgery. Dr. Gilmore performed the surgery to relieve
a 99 % blockage from Gomez’s femoral artery one month after her initial surgery. The jury

heard Dr. Gilmore’s testimony that the mass she removed from Gomez was inside the

25
femoral artery. (Tr. at 753). Dr. Gilmore testified that she agreed with the pathology report,
which stated that the injury and the extracted lump were consistent with a “collagen plug.”

(Tr. at 754). The pathology report also showed suture fragments inside Gomez’s artery.
(See Testimony of Dr. Jerry Hudson, Tr. at 455–56).
Dr. Bilazarian and other medical witnesses rejected alternative causes for the presence

of collagen inside Gomez’s artery. They testified that artery dissection or physician error
were unlikely explanations for the presence of collagen and suture fragments inside the
artery. Dr. Bilazarian examined the report from Dr. Gilmore and could not think of any

alternative as to “how . . . that stuff [parts of the Angio-Seal] was in there and shouldn’t have

been in there.” (Id.). Dr. Bilazarian and other medical witnesses, including Dr. White,

testified that they could eliminate other causes for the formation of the blood clots, such as
a tendency to form clots or Gomez’s history of smoking. (Tr. at 181–82, 195–96, 577, 726,

848). Dr. White conceded that Gomez’s injuries were not caused by preexisting plaque in

her right femoral artery, an artery dissection, or vasospasm. (Tr. at 842–45). Dr. Bilazarian

also provided testimony from which the jury could have concluded that the injuries did not
result from a vasospasm. (See Tr. at 186).

Kendall argued that there was no evidence that the collagen found inside Gomez’s

femoral artery was bovine collagen, the substance used in the Angio-Seal. The pathologist
did not screen for bovine collagen, only human. As a result, there was no evidence that
collagen inside Gomez’s bloodstream was, or was not, bovine. Kendall contends that this

contributed to Gomez’s failure to meet her burden of proof that the Angio-Seal was defective
or caused her injuries. Because Angio-Seal contains bovine collagen, a definitive result one
way or the other would have provided significant evidence. The lack of that evidence

required Gomez to demonstrate defect and causation through other evidence. Gomez

26
introduced evidence that there should not have been any collagen inside her bloodstream at
all. She introduced evidence eliminating causes for the presence of collagen inside her

femoral artery other than the failure of the Angio-Seal’s anchor to prevent that from
occurring.
Kendall presented evidence that an external clot pressing on the artery from the

outside caused the femoral artery narrowing. Dr. White testified that a recognized
complication of a properly-manufactured and deployed Angio-Seal is that the collagen will
cause a large clot to form on the outside of the artery wall, which can compress and narrow

the artery. This conflicted with Gomez’s evidence that a clot inside the artery caused her

femoral artery narrowing because the Angio-Seal’s anchor failed to prevent the externally-

deposited collagen from coming inside the artery itself. The jury should have resolved this
conflicting evidence as to causation. Gomez did not, as Kendall asserts, simply rely on the

fact that she suffered injuries after the surgery and blame it on the use of a medical device

no longer available for inspection. Cf. Todd v. State, 699 So. 2d 35, 43 (La. 1997) (“Proof

which establishes only possibility, speculation, or unsupported probability does not suffice
to establish a claim.”) (citing Coon v. Placid Oil Co., 493 So. 2d 1236 (La. App. 3 Cir.

1996)). As with the defect issue, Kendall put forward substantial conflicting testimony and

evidence, but under the Rule 50 standard, the court must draw all reasonable inferences in
favor of the nonmoving party, Gomez, and may not weigh the evidence or the credibility of
the witnesses. The district court erred in granting the Rule 50 motion on the basis of

insufficient evidence as to causation.
C. Remand
Gomez asks this court to interpret Rule 50 to forbid a judge from granting a motion

for judgment as a matter of law after the evidence is concluded, to prevent the necessity of

27
retrial in the event the district judge is later reversed. Gomez asks this court to require a
district judge to withhold judgment on the Rule 50 motion, submit the case to the jury, and

then rule on the motion only if the jury returns with a plaintiff’s verdict. We decline to
impose such a rule. It may be prudent to allow the jury to consider a case before ruling on
a Rule 50 motion, but the language of Rule 50 does not require making this an inflexible

requirement. See, e.g., Unitherm Food Sys., Inc. v. Swift-Eckrich, Inc., 126 S. Ct. 980, 988
(2006) (citing and quoting with approval 9A CHARLES ALAN WRIGHT ET AL., FEDERAL
PRACTICE & PROCEDURE § 2533, at 319 (2d ed. 1995)); McPhillamy v. Brown & Root, Inc.,

810 F.2d 529, 533 (5th Cir. 1987) (“In reserving judgment here, the district court was

following a practice we have described as highly desirable and salutary.”) (internal citations

and quotations omitted). It is not necessary to create such a requirement to resolve this case.
The record shows that Gomez introduced sufficient evidence of defect and causation to allow

the jury to resolve her manufacturing defect claim. The district court’s order granting

Kendall’s Rule 50 motion is reversed and the case is remanded for a new trial.

Gomez makes a number of challenges to the district court’s evidentiary and discovery
rulings. The challenges primarily focus on the district judge’s refusal to allow Gomez to

discover or introduce into evidence information about the design, warnings, labels,

instructions, training materials, and other information based on the preemption ruling, and
about lots besides the two that were the source of the Angio-Seal used on Gomez. Because
we have affirmed the district judge’s dismissal of Gomez’s claims except the defective

manufacturing claim based on the theory that Kendall deviated from the FDA-approved
manufacturing specifications, we find these general limits on discovery and admission of
evidence appropriate. The evidence that the two lots that supplied the Ochsner Clinic’s

Angio-Seals during the relevant period were the only lots with positive anchor extensions

28
provides support for the district judge’s refusal to allow evidence about Angio-Seals that
came from other lots. We need not address Gomez’s objection to the district court’s

postjudgment award of costs, which is vacated in light of this ruling.
Gomez asks this court to use its supervisory power to reassign this case to a different
district court judge on remand. 28 U.S.C. § 2106; United States v. Williams, 400 F.3d 277,

283 (5th Cir. 2005) (per curiam). The record provides no support for this step. A federal
judge should not preside over a case if “his impartiality might reasonably be questioned.”
28 U.S.C. § 455(a). In evaluating disqualification under section 455, the question is whether

the court is biased against a party, not whether the court is annoyed with the party’s counsel.

See United States v. Andrews, 390 F.3d 840, 851 (5th Cir. 2004) (removing and reassigning

to a different judge where the trial judge exhibited “brazen antagonism” to both the
controlling law and the defendant during sentencing); Henderson v. Dep’t of Pub. Safety &

Corr., 901 F.2d 1288, 1296 (5th Cir. 1990) (“In order for bias against an attorney to require

disqualification of the trial judge, it must be of a continuing and personal nature.”) (internal

citations omitted).
Our review of the record indicates no grounds for reassignment on remand. The

district judge was obviously annoyed with counsel at times, but not without reason; the

record reveals that Gomez’s counsel failed to comply with the district court’s rules and even
the pretrial order. The record also shows that the district judge’s frustration was not limited
to one side, but at different times extended to counsel for both parties. The court took care

to instruct the jury that any indication of his own feelings should play no role in their
decisionmaking process. And the record shows that the judge displayed neither bias nor
favoritism in ruling on motions and objections. As expected in a complex, aggressively tried

case, both sides received favorable and unfavorable rulings from the district court. Gomez

29
has failed to demonstrate bias against her. Her request for reassignment to a different district
judge on remand is denied.

V. Conclusion
The district court’s preemption decision is affirmed. The district court’s Rule 50
order is reversed and the case is remanded for a new trial on the issue of whether the Angio-

Seal was defective as a result of Kendall’s failure to manufacture the product in accordance
with the FDA-approved specifications and whether that defect caused Gomez’s injuries. The
Gomezes’ additional requests for relief are denied.

AFFIRMED IN PART; REVERSED IN PART; AND REMANDED. ALL

OUTSTANDING MOTIONS DENIED AS MOOT.

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