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Benedi v. McNeil, PPC, Inc.

Must an inference of causation necessarily depend on statistical (epidemiological) evi­dence, or can clinical diagnostic evidence alone serve to reach a finding of causation? What about the relevance and reliability of anecdotal evidence in the form of medical case summaries or drug experience reports?

Benedi, who used the painkiller acetaminophen, suffered severe liver damage claimed to result from coincidental use of alcohol. In upholding a jury verdict for the plaintiff, the U.S. Court of Appeals [66 F.3d 1378 (4th Cir. 1995)] affirmed the admissibility of expert testimony under Daubert that relied on the same methodologies used daily by clinicians in treating patients.

The Daubert rule does not restrict expert testimony to opinions based solely upon epidemio­logi­cal data. It merely requires that expert testimony be both relevant and reliable. The trial court did not abuse its discretion in admitting testimony where an inference of causation was drawn from clinical diagnostic methods commonly used in the medical community. In this case, these included:

§ Acetaminophen found in the blood upon hospital admission, liver enzyme blood levels, and the microscopic appearance of the liver removed during a transplant.

§; LETTER-SPACING: -0.1pt; mso-bidi-font-size: 11.0pt"> History of several days' use of Tylenol after regular alcohol consumption of several drinks per day.

§ Lack of evidence of other causes of liver failure (alternative causation), such as a viral infection.

Furth­er, the court determined that drug experience reports (DERs) and medical case sum­maries sent to the drug manufacturer supported a jury finding of causation. Sixty reports had been received by McNeil at the end of 1992. These reports documented cases of liver injury asso­ciated with combining therapeutic doses of Tylenol with alcohol.

The manufacturer asserted, according to the Food and Drug Administration (FDA), case summaries and DERs do not establish that a particular drug is reasonably associated with a particular injury. However, FDA actually states these reports cannot serve as the basis for approving a drug. The agency does not say these case reports and DERs do not give rise to a duty to warn. Yet McNeil failed to warn of these dangers on Tylenol's label.

There is a message here that a finding of causation based on clinical diagnostic evidence, and not necessarily on human statistical (epidemiological) evidence, can meet the Daubert criteria for relevance and reliability. While case reports and DERs that further validate the diagnostic findings are not admissible as causal evidence per se, they are evidence enough to compel a duty to warn drug consumers.

October 26, 1995

http://www.law.emory.edu/4circuit/oct95/942596.p.html

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

No. 94-2596

(CA-94-345-A)

Antonio Benedi,

Plaintiff - Appellee,

versus

McNeil-P.P.C., Incorporated,

Defendant - Appellant.

O R D E R

The Court amends its opinion filed October 10, 1995, as follows:

On page 7, second full paragraph, line 8 -- the phrase "the district did not abuse its discretion" is corrected to read "the district court did not abuse its discretion."

For the Court - By Direction

/s/ Bert M. Montague

Clerk

PUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

ANTONIO BENEDI,

Plaintiff- Appellee,

v. No. 94- 2596

MCNEIL- P.P.C., INCORPORATED,

Defendant- Appellant.

Appeal from the United States District Court

for the Eastern District of Virginia, at Alexandria.

Albert V. Bryan, Jr., Senior District Judge.

(CA- 94- 345- A)

Argued: July 11, 1995

Decided: October 10, 1995

Before WILKINS and LUTTIG, Circuit Judges, and

JOSEPH F. ANDERSON, JR., United States District Judge for the

District of South Carolina, sitting by designation.

Affirmed by published opinion. Judge Anderson wrote the opinion, in

which Judge Wilkins and Judge Luttig joined

COUNSEL

ARGUED: George Clemon Freeman, Jr., HUNTON & WILLIAMS,

Richmond, Virginia, for Appellant. Patrick Allen Malone, STEIN,

MITCHELL & MEZINES, Washington, D.C., for Appellee. ON

BRIEF: David F. Dobbins, John D. Winter, PATTERSON, BEL-

KNAP, WEBB & TYLER LLP, New York, New York; Robert W.

Sparks, JONES, DAY, REAVIS & POGUE, New York, New York,

for Appellant. Robert F. Muse, STEIN, MITCHELL & MEZINES,

Washington, D.C.; Sandra L. Hughes, Chevy Chase, Maryland, for

Appellee.

OPINION

ANDERSON, District Judge:

Antonio Benedi suffered severe liver damage allegedly as a result

of combining Extra- Strength Tylenol and alcohol. Benedi filed suit

against McNeil- P.P.C. ("McNeil"), the manufacturer of the drug, for

negligent failure to warn of the possible dangers of mixing Tylenol

with alcohol and for breach of implied warranties. After a three- day

trial, the jury returned a verdict for Benedi. McNeil appeals claiming

that judgment as a matter of law should be entered in its favor

because Benedi failed to prove that Tylenol caused his injuries and

because the Tylenol label contained adequate warnings. In the alterna-

tive, McNeil seeks a new trial based upon the district court's allegedly

erroneous admission of certain evidence and testimony. For the rea-

sons discussed below, we affirm the judgment of the district court.

I.

Benedi was admitted to the hospital on February 10, 1993 in a

coma and near death due to liver and kidney failure. Benedi, who reg-

ularly consumed three to four glasses of wine a night during the week

and sometimes more on the weekend, had been taking Extra- Strength

Tylenol in normal, over- the- counter doses since February 5, 1993 for

flu- like aches.1 Blood tests performed shortly after his admission to

the hospital revealed that Benedi still had therapeutic amounts of

Tylenol in his blood, although he had not taken any for several days.

He did not, however, have any alcohol in his blood. The hospital doc-

tor determined that Benedis injuries were most likely caused by

acetaminophen (Tylenol) toxicity.

_________________________________________________________________

1 Both Benedi and his wife testified that his alcohol consumption did

not interfere with his work, and no one testified that Benedi was an alco-

holic.

2

On the night of February 12- 13, 1993, Benedi underwent an emer-

gency liver transplant. The new liver, which did not match Benedi's

blood type, restored Benedi's liver and kidney functioning. He was

released from the hospital on March 22, 1993. However, Benedi may

have to undergo kidney dialysis in a few years because the drugs that

he must take to keep his body from rejecting the new liver may cause

deterioration in his kidneys.

The hospital's pathologist examined Benedi's damaged liver and

concluded that the injury was characteristic of acetaminophen toxic-

ity. He did not find any evidence of a viral infection in the liver. The

transplant surgeon also examined Benedi's damaged liver and con-

firmed the pathologist's opinion. At trial, several liver disease experts

also confirmed Benedi's treating physicians' diagnosis of acetamino-

phen toxicity.

The infectious disease specialist who treated Benedi at the hospital

noted that Benedi had tested negative for herpes simplex virus on the

day he was admitted, but that two days later he tested positive. The

specialist concluded that the later positive result was likely due to

contamination from blood transfusions. During Benedi's first two

days in the hospital, he received eight units of blood from eight differ-

ent donors. The transplant surgeon testified that if herpes had

destroyed Benedi's liver, the disease would have also rapidly infected

and destroyed the transplanted liver.

Both parties retained liver toxicity experts to determine whether

herpes simplex could be ruled out as a cause of Plaintiff's liver dis-

ease. These experts compared slides of Benedi's liver with control

slides of a liver infected by the herpes simplex virus. McNeil's expert

testified that the slides did not reveal the "signature" for acetamino-

phen liver toxicity, and that the slides of Benedi's liver matched the

control slides. McNeil's expert took photos of the slides of Benedi's

liver and the control slides and testified to their similarity at trial. He

concluded that the herpes simplex virus was the cause of Benedi's

liver damage.

In contrast, plaintiff's expert testified that these photos were mis-

leading. After examining the actual slides, he concluded that the slide

3

of Benedi's damaged liver showed negative for the herpes simplex

virus.

At trial, Benedi called two liver disease specialists who both testi-

fied that a warning of the possible danger to heavy drinkers from

combining alcohol and acetaminophen should have been placed on

the Tylenol label since the mid- 1980s. These experts described

exactly how the alcohol- acetaminophen mixture can become a toxin

in the liver. They cited numerous treatises and articles published in

medical journals prior to 1993 that describe the increased risk of liver

injury when acetaminophen is combined with alcohol. One of plain-

tiff's experts referred to sixty reports that McNeil had received by the

end of 1992 documenting cases of liver injury associated with com-

bining therapeutic doses of Tylenol with alcohol.

The provisions of the Federal Food, Drug, and Cosmetic Act, 21

U.S.C. § § 301- 395 (1972 & Supp. 1995), as well as the regulations

of the Food and Drug Administration ("FDA"), govern the content of

labels and warnings on drugs. In 1972, the FDA convened a panel of

independent experts to evaluate over- the- counter analgesics, such as

aspirin and acetaminophen. The panel determined that chronic alco-

holics were susceptible to liver damage from acetaminophen, but that

acetaminophen was safe in normal over- the- counter doses. The panel

continued its research and hearings, and, in 1988, the FDA adopted

the panel's findings and decided against requiring a warning. Never-

theless, at the suggestion of the FDA, McNeil agreed in the summer

of 1993 (after Benedi's injury) to include a warning that persons who

regularly consume three or more alcoholic drinks a day should consult

a physician before using Tylenol or any other pain reliever.

Benedi filed suit against McNeil in March 1994, and the case went

to the jury on theories of breach of implied warranty and negligent

failure to warn. After a three- day trial, the jury awarded Benedi

$7,850,000 in compensatory damages and $1,000,000 in punitive

damages. The district court reduced the punitive damage award to

$350,000, the statutory maximum under Virginia law. Va. Code Ann.

§ 8.01- 38.1 (Michie 1992). Finding that the issues of causation and

warnings were properly submitted to the jury and that the evidence

supported an award of punitive damages, the district court denied

McNeil's post- trial motions.

4

McNeil appeals alleging that Benedi failed to prove that Tylenol

caused his injuries and that the Tylenol label contained adequate

warnings. Accordingly, McNeil asks us to reverse the judgment

below and enter judgment as a matter of law in its favor. In the alter-

native, McNeil seeks a new trial because, it claims, the trial court

erroneously admitted certain evidence and testimony. Specifically,

McNeil argues that the district court erred in admitting summaries and

case reports relating to prior cases of liver damage resulting from

alcohol- acetaminophen interaction. McNeil also claims prejudice

from plaintiff's introduction of a subsequent remedial measure by

McNeil - - the summer 1993 warning. Finally, McNeil argues that the

evidence does not support an award of punitive damages.

II.

McNeil appeals the district court's denial of its motion for judg-

ment as a matter of law and its motion for a new trial. We review a

denial of a motion for judgment as a matter of law de novo. Benesh

v. Amphenol Corp. (In re Wildewood Litigation), 52 F.3d 499, 502

(4th Cir. 1995). The court must determine whether substantial evi-

dence exists upon which the jury could find for the appellee. Id. "The

question is whether a jury, viewing the evidence in the light most

favorable to [Benedi], could have properly reached the conclusion

reached by this jury." Id. A denial of a motion for a new trial is

reviewed for abuse of discretion. Id. Likewise, we review evidentiary

rulings for an abuse of discretion. United States v. D'Anjou, 16 F.3d

604, 610 (4th Cir.), cert. denied, 114 S. Ct. 2754 (1994). Finally,

whether substantial evidence existed to submit the issue of punitive

damages to the jury is a question of law and is, therefore, reviewed

de novo. Richmond, Fredericksburg & Potomac R.R. v. United States,

945 F.2d 765, 768- 69 (4th Cir. 1991), cert. denied, 503 U.S. 984

(1992).

III.

McNeil first contends that Benedi failed to prove that combining

alcohol with therapeutic doses of acetaminophen causes liver disease.

McNeil argues that the district court erred in admitting Benedi's

allegedly unreliable expert testimony. McNeil asserts that without this

5

expert testimony, Benedi lacked sufficient evidence to submit the

issue of causation to the jury.

In the recent case of Daubert v. Merrell Dow Pharmaceuticals,

Inc., 113 S. Ct. 2786 (1993), the Supreme Court set forth the proper

standard for admission of expert testimony under the Federal Rules

of Evidence. Until Daubert, the courts were split on this issue - -

some had applied, and some had rejected, the "general acceptance"

standard as set forth in Frye v. United States, 293 F. 1013 (D.C. Cir.

1923). The Daubert Court noted that the Federal Rules of Evidence,

not Frye, govern the admissibility of expert scientific evidence,

because Frye predated the Federal Rules of Evidence by half a cen-

tury. Rule 702 of the Federal Rules of Evidence provides: "If scien-

tific, technical, or other specialized knowledge will assist the trier of

fact to understand the evidence or to determine a fact in issue, a wit-

ness qualified as an expert by knowledge, skill, experience, training,

or education, may testify thereto in the form of an opinion or other-

wise." Fed. R. Evid. 702.

In Daubert, the Court elaborated on this rule, noting that scientific

testimony or evidence must be both relevant and reliable. "Proposed

testimony must be supported by appropriate validation - - i.e., `good

grounds,' based on what is known. In short, the requirement that an

expert's testimony pertain to `scientific knowledge' establishes a stan-

dard of evidentiary reliability." Daubert, 113 S. Ct. at 2795. In deter-

mining whether to admit expert scientific testimony, the district court

must determine whether the experts testimony is based on scientific

knowledge that will assist the trier of fact in understanding or deter-

mining a fact in issue. Id. at 2796 (citing Fed. R. Evid. 104(a)).

The Court offered the following general guidelines:

Ordinarily, a key question to be answered in determining

whether a theory or technique is scientific knowledge that

will assist the trier of fact will be whether it can be (and has

been) tested. . . .

Another pertinent consideration is whether the theory or

technique has been subjected to peer review and publication.

. . .

6

Additionally, in the case of a particular scientific tech-

nique, the court ordinarily should consider the known or

potential rate of error, and the existence and maintenance of

standards controlling the technique's operation.

Finally, "general acceptance" can yet have a bearing on

the inquiry.

Id. at 2796- 97 (citations omitted). In offering these guidelines, the

court emphasized that it was not formulating a rigid test or checklist,

relying instead on the ability of federal judges to properly determine

admissibility. Id. at 2797 ("[t]he inquiry envisioned by Rule 702 is,

we emphasize, a flexible one"). In conclusion, the Court held that the

Federal Rules of Evidence, especially Rule 702, "assign to the trial

judge the task of ensuring that an expert's testimony both rests on a

reliable foundation and is relevant to the task at hand." Id. at 2799.

McNeil contends that because Benedi's experts did not rely upon

epidemiological data in formulating their opinions, their testimony is

inadmissible under Daubert. However, we do not read Daubert as

restricting expert testimony to opinions that are based solely upon epi-

demiological data. Daubert merely requires that the expert testimony

be both relevant and reliable; and Daubert clearly vests the district

courts with discretion to determine the admissibility of expert testi-

mony. Under the Daubert standard, epidemiological studies are not

necessarily required to prove causation, as long as the methodology

employed by the expert in reaching his or her conclusion is sound.

Benedi's treating physicians based their conclusions on the micro-

scopic appearance of his liver, the Tylenol found in his blood upon

his admission to the hospital, the history of several days of Tylenol

use after regular alcohol consumption, the liver enzyme blood level,

and the lack of evidence of a viral or any other cause of the liver fail-

ure. Benedi's other experts relied upon a similar methodology: his-

tory, examination, lab and pathology data, and study of the peer-

reviewed literature. We conclude that the district court did not abuse

its discretion when it determined that the methodology employed by

Benedi's experts is reliable under Daubert. We will not declare such

methodologies invalid and unreliable in light of the medical commu-

nity's daily use of the same methodologies in diagnosing patients.

7

In City of Greenville v. W.R. Grace & Co., 827 F.2d 975 (4th Cir.

1987), this court recognized that expert testimony need not be based

upon identical case studies or epidemiological data. In that case, the

City of Greenville brought suit after Grace used building materials

containing asbestos in constructing Greenville's city hall building.

The City's expert testified that even very low levels of asbestos could

cause serious harm. He based this testimony upon scientific infer-

ences drawn from data showing a correlation between asbestos-

related diseases and exposure to asbestos at relatively high levels. The

City's expert stated "that in the absence of scientific studies concern-

ing exposure to low levels of asbestos, one technique accepted in the

scientific community for predicting the risks associated with low-

level exposures is to extrapolate the risk downward from results

obtained in studies involving high- level exposures." Id. at 980 n.2.

Grace argued that the plaintiffs evidence was insufficient, however,

to prove that low levels of asbestos posed a serious risk for the build-

ing's occupants.

We held that the plaintiff's expert's testimony could reasonably

support the jury's finding for the City and that the defendant should

not be allowed "to escape liability simply because no occupant of the

city hall has yet developed an asbestos- related disease, or because

there are, as yet, no epidemiological studies concerning the health

risks associated with asbestos contamination of office buildings." Id.

In the instant case, the district judge found the experts on both

sides qualified and allowed their testimony under Federal Rule of Evi-

dence 702. The district court acted within its discretion when it found

that Benedi's experts satisfied Daubert's test of relevance and reli-

ability; therefore, the district judge properly admitted their testimony.

Because Benedi's experts presented sufficient evidence on the

issue of causation, the district judge properly submitted that issue to

the jury. It was the jury's role to assess the weight and credibility of

the evidence, and the jury found that Benedi proved causation. In

reviewing the jury's verdict, we must determine whether a jury, view-

ing the evidence in the light most favorable to Benedi, could have

properly found that Tylenol caused Benedi's liver failure. See Benesh

v. Amphenol Corp. (In re Wildewood Litigation), 52 F.3d 499, 502

(4th Cir. 1995). We find that ample evidence existed from which a

8

reasonable jury could find for Benedi; therefore, the district judge

properly denied McNeil's motion for judgment as a matter of law.

IV.

Next, McNeil contends that the district court erred in admitting into

evidence case reports, known as Drug Experience Reports (DERs),

and summary charts of the DERs. The district court found that the

reports were not hearsay, because Benedi offered them to prove

notice, and not for the truth of the matter asserted in them. First,

McNeil asserts that the district court should have excluded the reports

under Federal Rule of Evidence 403 because the danger of unfair

prejudice outweighed any probative value the reports might have.2

Second, McNeil contends that the cases reported were not similar to

Benedi's case and, therefore, are not admissible to prove notice.

McNeil points out that alcohol history was unknown in some of the

reports and that the acetaminophen dose was unknown in others.

McNeil also notes that most of the reports involving alcohol con-

sumption involved chronic alcoholics, but that Benedi was not an

alcoholic. Finally, McNeil claims that these reports are inadmissible

hearsay because Benedi relied upon them for the truth of the matter

contained in them, and not just to prove notice.

McNeil relies upon Ellis v. International Playtex, Inc., 745 F.2d

292 (4th Cir. 1984), to support its argument that the reports were

inadmissible. In Ellis, however, this court merely held that the lower

court did not abuse its discretion in excluding prior consumer com-

plaints under Rule 403. We recognized that the complaints in dispute

there related solely to the issue of notice, and that the district court's

statement to the jury that the defendant had received prior complaints

eliminated the need for the complaints themselves to be admitted. Id.

at 305. Ellis does not require all district courts presented with prior

_________________________________________________________________

2 McNeil claims that these reports were not necessary as to notice

because it conceded the notice issue in its pleadings. However, McNeil

continuously denied knowledge of any danger associated with use of

Tylenol at therapeutic doses; therefore, its notice of the extent of the

alleged danger remained an issue. McNeil does not dispute its receipt of

adverse reaction reports, but it does dispute that these reports put it on

notice of any danger associated with its product.

9

reports to rule in the same manner. Rather, district judges have the

discretion either to admit the prior reports or to exclude them under

Rule 403 and instruct the jury that the defendant received notice

through prior reports.

More on point is Worsham v. A.H. Robins Co., 734 F.2d 676 (11th

Cir. 1984), in which the court of appeals upheld the trial court's

admission of prior adverse reaction reports because the reports went

to the issue of notice. The Worsham court held that the reports were

properly admitted into evidence as proof of the defendant's state of

mind and, therefore, did not constitute hearsay. Id. at 687. The district

court instructed the jury that it could only consider the reports as

proof of notice and not as evidence that the information contained in

them was true. See also Kehm v. Procter & Gamble Mfg. Co., 724

F.2d 613, 625- 26 (8th Cir. 1983) (holding that prior complaints of

adverse reactions to a product are admissible to prove notice).

We find that the district court did not abuse its discretion in admit-

ting the DERs and case summaries, because the plaintiff offered the

evidence solely to prove notice. In addition, the district judge properly

gave a limiting instruction to the jury that it could only consider the

DERs and case summaries as evidence of notice to McNeil, and not

for the truth of the matter contained in them.

We also find that the district judge did not err in refusing to

exclude these reports under Rule 403. The probative value of these

reports was not outweighed by the danger of unfair prejudice, because

the reports were highly probative on the issue of notice and because

McNeil was free to, and did, offer testimony rebutting the signifi-

cance of these reports.

Furthermore, the dissimilarities between Benedi's situation and

those reported in the DERs do not affect the admissibility of the evi-

dence, but rather go to the weight that the jury gives to the evidence.

Khem, 724 F.2d at 626. McNeil explored these dissimilarities at

length. Whether the dissimilarities were significant was for the jury

to determine. When prior incidents are admitted to prove notice, the

required similarity of the prior incidents to the case at hand is more

relaxed than when prior incidents are admitted to prove negligence.

The incidents need only be sufficiently similar to make the defendant

10

aware of the dangerous situation. Cf. Gardner v. Southern Ry.

Systems, 675 F.2d 949, 952 (7th Cir. 1982); Young v. Illinois Central

Gulf R.R., 618 F.2d 332, 339 (5th Cir. 1980).3 Because all of the

reports at issue involved liver injury associated with therapeutic doses

(near or slightly above the recommended doses)4 of Tylenol in alco-

hol drinkers, we find that the DERs were sufficiently similar to

Benedi's case to be admissible on the issue of notice.

V.

Next, McNeil contends that insufficient evidence existed to submit

to the jury the issue of negligent failure to warn. In support of its posi-

tion, McNeil relies upon Thomas v. Hoffman- LaRoche, Inc., 949 F.2d

806 (5th Cir.), cert. denied, 504 U.S. 956 (1992), in which the plain-

tiff sued the defendant for failure to provide adequate warning. The

jury returned a $1,000,000 verdict for the plaintiff, but the district

court granted the defendant's motion for judgment notwithstanding

the verdict and set aside the jury verdict. Thomas is not determinative

in the present case, however, because Thomas is distinguishable from

this case in several important respects. First, Thomas involved a pre-

scription drug; therefore, in order to prove that the inadequate warn-

ing caused the plaintiff's injuries, the Plaintiff had to prove that an

adequate warning would have convinced her physician not to pre-

scribe the drug. Second, the defendant in Thomas notified physicians

of the possible risk associated with its product. Finally, the plaintiff

in Thomas argued that in order to adequately warn physicians, the

defendant needed to contraindicate its product.5

_________________________________________________________________

3 Although these two cases involved prior accidents, not prior com-

plaints, the same principle applies.

4 McNeil attempts to distinguish these reports by noting that many of

them involved overdoses of acetaminophen. The recommended maxi-

mum dose is 4 grams per day, but plaintiff's expert testified that consum-

ers often believe that "more is better" and, therefore, will take more than

the recommended dose. Plaintiff's expert testified that up to 6.5 grams

per day is still considered therapeutic. None of the case reports involved

massive overdose.

5 A typical warning lists the possible side effects and their likelihood,

whereas a contraindication is a direction to the physician not to use the

drug. Absent exceptional circumstances, a physician will not prescribe a

11

McNeil contends that the adverse reports do not establish that ther-

apeutic doses of acetaminophen combined with moderate amounts of

alcohol can cause liver damage. Accordingly, McNeil argues that it

had no knowledge of such a risk, which is required before it can be

held liable for negligent failure to warn. See Owens- Corning Fiber-

glas Corp. v. Watson, 413 S.E.2d 630, 634 (Va. 1992) ("[A] manufac-

turer has a duty to warn only if it knows or has reason to know that

its product is dangerous.").

McNeil states that, according to the FDA, case reports do not

establish that a particular drug is reasonably associated with a particu-

lar injury. McNeil also cites Weinberger v. Hynson, Westcott & Dun-

ning, Inc., 412 U.S. 609 (1973), and E.R. Squibb & Sons, Inc. v.

Bowen, 870 F.2d 678 (D.C. Cir. 1989), in support of this position.

However, the FDA and these cases merely state that case reports can-

not serve as the basis for approving a drug; they do not say that these

case reports do not give rise to a duty to warn.

Because we review a denial of a motion for judgment as a matter

of law de novo, we must determine whether substantial evidence

exists upon which a reasonable jury could find for Benedi. Benesh v.

Amphenol Corp. (In re Wildewood Litigation), 52 F.3d 499, 502 (4th

Cir. 1995). We find that sufficient evidence existed to support the

jury's finding that McNeil negligently failed to warn consumers of the

risks associated with combining therapeutic doses of acetaminophen

with alcohol.

Benedi introduced expert testimony that the Tylenol label should

have contained a warning against taking the medication while con-

suming alcohol. Benedi also introduced the DERs as evidence that

McNeil had notice of the dangers associated with combining thera-

peutic doses of acetaminophen with alcohol, yet failed to warn of

these dangers on Tylenol's label. Finally, Benedi presented evidence

_________________________________________________________________

drug when its use is contraindicated. Thomas, 949 F.2d at 815. There-

fore, the warning suggested in Thomas is very different from the warning

suggested in this case. A plaintiff asserting that a contraindication was

necessary would have to produce much stronger evidence of potential

harm than would a plaintiff challenging the absence of a typical warning.

12

that the FDA's 1988 "tentative final monograph"6 on Tylenol only

considered data collected up to 1980 because McNeil did not provide

approximately forty case reports that it collected from 1980- 1988 to

the FDA's monograph staff until after publication of the 1988 mono-

graph. The evidence supports the jury's decision that McNeil negli-

gently failed to warn consumers.

VI.

Next, McNeil contends that the district court erroneously admitted

into evidence a subsequent remedial measure and that the district

court therefore should have granted its motion for a new trial. Rule

407 of the Federal Rules of Evidence provides that subsequent reme-

dial measures are "not admissible to prove negligence or culpable

conduct in connection with the event. This rule does not require the

exclusion of evidence of subsequent measures when offered for

another purpose, such as proving ownership, control, or feasibility of

precautionary measures, if controverted, or impeachment." Fed. R.

Evid. 407.

At trial Benedi called Dr. Anthony Temple, McNeil's medical

director and corporate representative, as an adverse witness. Benedi's

counsel questioned Dr. Temple about discussions between McNeil

and the FDA in December 1992 concerning an alcohol warning on a

new Tylenol product, Extended Relief Tylenol, which was very simi-

lar to the product at issue in this case, Extra- Strength Tylenol. In

December 1992, an FDA official proposed to McNeil that the new

product contain the following warning: "If you consume more than

two alcohol- containing drinks on a daily basis, consult your physician

before using this product." These events all occurred prior to plain-

tiff's injury and evidence about them was properly put before the jury

without objection. However, Benedi's counsel then went further and

asked Dr. Temple if McNeil placed the warning on the new product,

_________________________________________________________________

6 In the early 1970s, the FDA convened a panel of independent experts

to evaluate over- the- counter analgesics (e.g., aspirin and acetaminophen)

and to make recommendations for labeling on the drugs it determined

were safe. The panel conducted years of research and hearings and pub-

lished monographs on these drugs throughout the period. The FDA did

not endorse the panel's tentative final monograph until November 1988.

13

and he responded that McNeil had done so, although it used a slightly

different warning: "[I]f you regularly consume three or more alcohol-

containing drinks every day you should consult your physician before

using this or any other pain reliever." Benedi's counsel then ques-

tioned Dr. Temple about the similarities between the new product and

the product involved in this case, and at that point McNeil objected.7

At side- bar, the judge instructed Benedi's counsel that because the

warning was placed on the new product after Benedi's injury, he

would not allow any post- February 18, 1993 activity of the FDA to

be injected into the case. McNeil did not ask the court to strike the

statement or to give a cautionary instruction.

Before closing arguments, the court instructed the parties that it

would allow plaintiff to refer to the pre- injury discussions between

McNeil and the FDA, but that it would not allow plaintiff to refer to

the post- injury label change. In closing argument, plaintiff's counsel

only referred to the 1992 discussions between the FDA and McNeil

concerning the FDA's proposed warning on the new acetaminophen

product.

In denying McNeil's motion for a new trial, the district court deter-

mined that the evidence was not offered solely on the issue of negli-

gence or breach of warranty, but rather, the testimony came about as

a result of defendant's expert's position on the prior informal proposal

to add an alcohol warning to the product's label. The district court

further noted that the sole reference to the warning that McNeil ulti-

mately placed on its new product in late 1993 was the subject of only

a passing reference during the trial and was not argued to the jury. In

short the district court found that the error, if any, was harmless.

In suggesting that the plaintiff's reference to the warning McNeil

placed on its new product after Benedi's injury justifies a new trial

due to prejudice, McNeil relies upon Werner v. Upjohn Co., 628 F.2d

848 (4th Cir. 1980), cert. denied, 449 U.S. 1080 (1981). The plaintiff

_________________________________________________________________

7 McNeil filed a motion in limine prior to trial seeking to bar any evi-

dence of post- injury warnings. The district court deferred ruling on this

motion and instructed plaintiff's counsel not to refer to any subsequent

warnings in his opening statement. When McNeil objected to plaintiff's

line of questioning, McNeil asked the court to rule on its motion.

14

in Werner suffered injuries in 1974 from a drug manufactured by

Upjohn, and the primary issue at trial was Upjohn's allegedly negli-

gent failure to provide an adequate warning. The district court

allowed the plaintiff to introduce evidence of a warning which was

placed on the product in 1975 and which expanded on the previous

warning in several significant respects:8 The district court allowed the

evidence under Rule 407 and instructed the jury that they could only

consider the evidence on the issue of feasibility. However, plaintiff

referred to this evidence several times during the trial and during clos-

ing argument without reference to feasibility. This court found that

plaintiff's repeated references to the subsequent warning were clearly

intended to prove negligence in not using the 1975 warning in 1974.

Id. at 853. We held that Upjohn's failure to object to plaintiff's imper-

missible use of the 1975 warning did not preclude Upjohn's claim

because an objection is not required when it would emphasize the

impermissible point. Id. at 854. Finally, we recognized that Rule 407

allows evidence of subsequent remedial measures to prove feasibility;

however, feasibility was not an issue in Werner, and the district court,

therefore, committed reversible error in allowing evidence of the 1975

warning. Id. at 854- 56.

McNeil contends that Werner mandates a new trial in this case.

However, Werner is distinguishable from the present case in several

respects. First, in this case the majority of plaintiff's questions to Dr.

Temple focused on December 1992 discussions between the FDA and

McNeil about a warning on its new acetaminophen product. These

discussions predated Benedi's injury. Second, plaintiff's closing argu-

ment mentioned only the pre- injury discussions between McNeil and

the FDA. Finally, once McNeil objected to plaintiff's reference to the

content of the warning that was eventually placed on the new

acetaminophen product in late 1993, plaintiff never mentioned the

subsequent warning again. In contrast, Werner involved repeated, fla-

8 Upjohn's drug was known to cause, and did cause, severe diarrhea in

the plaintiff. Plaintiff discontinued using the drug and began taking

Lomotil to relieve the pain; however, Lomotil was contraindicated for

PMC, a condition which plaintiff had developed from Upjohn's drug.

Plaintiff suffered severe injuries to his colon. Upjohn's 1975 warning

specifically warned against using Lomotil to alleviate the pain caused by

its drug.

15

grant attempts to rely upon the subsequent warning to prove negli-

gence.

We find that plaintiff's single reference to the subsequent warning

in a trial in which the transcript exceeds 800 pages does not justify

granting a new trial. The district judge confined all further testimony

to pre- injury discussions between McNeil and the FDA on warnings,

and plaintiff adhered to this instruction. The sole reference to the

1993 warning placed on the new product was harmless error in light

of the properly admitted and far more damaging testimony that prior

to Benedi's injury the FDA had suggested to McNeil that it place an

alcohol warning on its new acetaminophen product. This latter testi-

mony supports a finding that McNeil had prior knowledge that

acetaminophen was dangerous when combined with alcohol and that

its acetaminophen products needed an alcohol warning.

VII.

Finally, McNeil contends that the district court erred in submitting

the issue of punitive damages to the jury. In order for a plaintiff to

recover punitive damages under Virginia law, the plaintiff must prove

either malice or conduct "so willful or wanton as to evince a con-

scious disregard of the rights of others." Booth v. Robertson, 374

S.E.2d 1, 3 (Va. 1988).

We find that Benedi introduced sufficient evidence from which a

reasonable jury could find that McNeil acted with reckless indiffer-

ence to the health of its consumers. For example, Benedi introduced

evidence that McNeil failed to give the FDA the 1980- 1988 case

reports until after the FDA had issued its 1988 final monograph,

which concluded that an alcohol warning was not necessary. Benedi

also introduced evidence that McNeil instructed its sales representa-

tives to refrain from discussions with physicians about a scholarly

article, which outlined the dangers associated with combining

acetaminophen with alcohol. Finally, Benedi introduced evidence that

McNeil sent a letter to pharmacists and hospitals stating that there

was no link between liver damage and casual alcohol consumption

combined with acetaminophen.

McNeil dedicates numerous pages of its brief to refuting Benedi's

evidence of reckless conduct by McNeil and explaining the correct

16

interpretation of its actions. Because reasonable people could differ in

their evaluation of McNeil's conduct, it was the jury's job to weigh

the testimony of both sides and determine the motive underlying

McNeil's conduct. We will not overturn the jury's finding if substan-

tial evidence exists to support it. We find that the district court did not

err in submitting the issue of punitive damages to the jury because

sufficient evidence existed on this issue that would allow a reasonable

jury to find wanton and willful misconduct by McNeil.

For the foregoing reasons, the judgment of the district court is