E.R. SQUIBB AND SONS, INC., ET AL., PETITIONERS,
v.
BOYD B. FARNES, RESPONDENT

Fla. | 1997-06-19
No. 87632
KOGAN, C.J., and OVERTON, GRIMES, HARDING and ANSTEAD, JJ., concur., WELLS, J., dissents with an opinion.
697 So. 2d 825 Florida Supreme Court (1997) Negative Treatment
Cited by 44 cases

AI-generated. These summaries, headnotes, and key points are machine-generated and may contain errors or omissions. Always verify against the full opinion text below. Not legal advice.

Synopsis

The Florida Supreme Court reversed a District Court decision that had overturned a jury verdict in a vaccine injury case, holding that a trial court may grant a new trial when the manifest weight of evidence supports such action under an abuse of discretion standard. The Court found that reasonable persons could have disagreed with the jury's verdict that the flu vaccine manufacturer's package insert was inadequate to warn of the risk of Guillain-Barré Syndrome.


Holding

The trial court did not abuse its discretion in ordering a new trial. Under the abuse of discretion standard, if reasonable persons could differ as to the propriety of the trial court's action, there is no abuse of discretion. Here, reasonable persons could have concluded that the verdict was against the manifest weight of the evidence, as the package insert accurately reflected the state of medical knowledge in 1989 and was approved by the FDA and consistent with CDC recommendations.


Headnotes

[1] A trial court may grant a new trial if the manifest weight of the evidence is contrary to the jury verdict, even if there is evidence to support the verdict.

[2] Appellate review of an order granting a new trial applies a reasonableness test to determine if the trial judge abused discretion.

Previewing 2 of 6 headnotes on this case. FLexlaw’s editorially structured points of law — every proposition, pinpointed — are reserved for members.

Join FLexlaw to unlock all legal intelligence

Key Quotes

“the trial judge can and should grant a new trial if the manifest weight of the evidence is contrary to the verdict. In making this decision, the trial judge must necessarily consider the credibility of the witnesses along with the weight of all of the other evidence.”

Establishes the trial court's authority and methodology for granting new trials based on manifest weight of evidence

Previewing 1 of 3 key quotes on this case — the court’s exact language, pinpointed for members.

Join FLexlaw to unlock all legal intelligence

Facts & Procedural History

Boyd Farnes, working at a drug rehabilitation clinic, received a flu shot in October 1989 and subsequently developed Guillain-Barré Syndrome (GBS), a …

The full statement of facts, procedural history, and disposition for this case are member content.

Join FLexlaw to unlock all legal intelligence

© FLexlaw, Inc. — AI-generated enrichments are proprietary. All rights reserved.


Opinion of the Court
SHAW, Justice.

SHAW, Justice.

We have for review Farnes v. E.R. Squibb & Sons, Inc., 667 So. 2d 1004 (Fla. 3d DCA 1996), which conflicts with Smith v. Brown, 525 So. 2d 868 (Fla.1988). We have jurisdiction. Art. V, § 3(b)(3), Fla. Const. We quash Fames.

Boyd Fames worked at a drug rehabilitation clinic in the Florida Keys, and because his work entailed an increased risk of viral infection, the clinic offered, and he accepted, a flu shot. He was inoculated by nurse Cynthia Fox (by designation of Dr. Paul Jah-nig) in October 1989, and subsequently developed a recurrence of Guillain-Barré Syndrome (GBS), a rare neurological disorder. He sued Connaught Laboratories, Inc;, E.R. Squibb & Sons, Inc., and Henry Schein, Inc., the manufacturer and distributors of the vaccine (referred to collectively as “Con-naught”), alleging that the package insert was inadequate to warn of the risk of GBS.

The jury returned a verdict for Fames for $13,500,000, but the trial judge ordered a new trial, finding that the verdict was against the manifest weight of the evidence. The district court reversed, reasoning thusly:

A trial court may not properly grant a motion for a new trial where reasonable persons cannot differ that the verdict was not against the manifest weight of the evidence. Where, as in the instant case, each party had an expert witness testify at trial regarding causation, it is for the jury to resolve and weigh the conflicting testimony. Trial court judges do not have the discretion to substitute their judgment for that of the jury in regard to the conflicting testimony of expert medical witnesses.

Fames, 667 So. 2d at 1005 (citations omitted).

Fames claims that the trial court imper-missibly reweighed the evidence, and that the district court applied the proper standard for abuse of discretion. We disagree.

This Court addressed a similar scenario in Smith v. Brown, 525 So. 2d 868 (Fla.1988), wherein we described the circumstances under which a trial court “can and should” grant a new trial:

Clearly, it is a jury function to evaluate the credibility of any given witness. Moreover, the trial judge should refrain from acting as an additional juror. Nevertheless, the trial judge can and should grant a new trial if the manifest weight of the evidence is contrary to the verdict. In making this decision, the trial judge must necessarily consider the credibility of the witnesses along with the weight of all of the other evidence. The trial judge should only intervene when the manifest weight of the evidence dictates such action. However, when a new trial is ordered, the abuse of discretion test becomes applicable on appellate review. The mere showing that there was evidence in the record to support the jury verdict does not demonstrate an abuse of discretion.

Id. at 870 (emphasis added and omitted) (citations omitted).

Due to procedural concerns and the trial court’s favored vantage point, this “abuse of discretion” standard is highly deferential:

In reviewing [an order for a new trial], the appellate court should apply the reasonableness test to determine whether the trial judge abused his [or her] discretion. If reasonable [persons] could differ as to the propriety of the action taken by the trial court, then the action is not unreasonable and there can be no finding of an abuse of discretion.

Id. at 869-70 (emphasis added) (quoting Baptist Memorial Hospital, Inc. v. Bell, 384 So. 2d 145, 146 (Fla.1980)).

Applying this standard to the present case, we note that the package insert contained information about health-related risks and included the following statements:

CONTRAINDICATIONS

Immunization should be delayed in a patient with an active neurologic disorder, but should be considered when the disease process has been stabilized.

PRECAUTIONS

GENERAL

Prior to an injection of any vaccine, all known precautions should be taken to prevent side reactions. This includes a review of the patient’s history with respect to possible sensitivity to the vaccine or similar vaccine.

ADVERSE REACTIONS

Unlike the 1976 swine influenza vaccine, subsequent vaccines prepared from other virus strains have not been associated with an increased frequency of Guillain-Barré syndrome. However, this association has been questioned by other physicians.

Connaught argues that its package insert warnings could not have been the proximate cause of Farnes’s condition in light of nurse Fox’s testimony which demonstrated that she understood the warnings, knew the associated risks, but failed to conduct an adequate inquiry into Farnes’s medical history. In its order granting Connaught’s motion for a new trial, the court focused on the language of the insert and the other evidence, but first explained that Connaught’s duty was to warn the physician, not Fames:

Prescription or ethical drugs (which includes influenza vaccine) can be administered only under the direction of a physician, and Florida law requires that the manufacturer provide an adequate warning only to the physician, or “learned intermediary.” Whether the physician in fact reads the warning, or passes its contents along to the recipient of the drug is irrelevant. See, e.g., Felix v. Hoffmann-La-Roche, 540 So. 2d (Fla.1989); Buckner v. Allergan Pharmaceuticals, Inc., 400 So. 2d 820 (Fla. 5th DCA 1981). Pharmaceutical manufacturers discharge then-duty to warn the learned intermediary by way of a package insert which accompanies each vial of vaccine.

Fairly read, the Connaught insert advises that in 1976, influenza vaccine was associated with an increased risk of recipients contracting GBS, but that such a connection has not been demonstrated in subsequent years. This was an accurate statement of fact. Plaintiff offered no evidence the statement was untrue or inaccurate. Moreover, the insert followed the recommendation of the Advisory Committee on Immunization Practices, an expert panel commissioned by the CDC. The FDA approved the labeling prior to the release of the vaccine. The package insert, as its name implies, goes in the box with each 10-dose vial of vaccine. It necessarily does not expand at length on any particular point, relying on citations to reference materials and on the education and training of the “learned intermediary” to explore questions raised by reviewing the insert.

Fames contends Connaught should have been more emphatic in stating that a connection between influenza vaccine and GBS existed and could have tailored the warning to fit better his particular situation.... Florida law does not impose liability on the manufacturer of a properly made, medically necessary vaccine based on such a subjective standard.

Our review of the record shows that although there was an evidentiary basis for the jury verdict, there also was extensive evidentiary support for the trial court’s ruling. In fact, the key piece of information, i.e., that flu vaccines used since 1976 had not been associ ated with an increased risk of GBS, was uncontroverted. Further, as the trial court pointed out in its order, Farnes’s expert, Dr. Lichtenfeld, had himself suffered from GBS and could give no particular basis, other than personal preference, for his opinion that the insert was inadequate. Connaught’s expert, Dr. Weiderholt, on the other hand, presented convincing testimony that the insert accurately reflected the state of medical knowledge in 1989.

Based on the foregoing, “we are unable to say, after viewing the evidence as a whole, that reasonable [persons] could not have concluded that the verdict ... was against the manifest weight of the evidence.” See Smith, 525 So. 2d at 870. In short, reasonable persons could agree with the trial court.

We quash Fames and remand for proceedings consistent with this opinion.1

It is so ordered.

KOGAN, C.J., and OVERTON, GRIMES, HARDING and ANSTEAD, JJ., concur. WELLS, J., dissents with an opinion.

. We decline to address Connaught's claim that its package insert was adequate as a matter of law.

Dissent
WELLS, Judge,

WELLS, Judge,

dissenting.

I dissent because the Third District’s revised opinion does not conflict with Smith v. Brown, 525 So. 2d 868 (Fla.1988). I also dissent because the majority’s decision makes the judge a super-juror in violation of the respondent’s guaranteed right to a trial by jury.


Cases With Similar Vibessemantic neighbors from the corpus


Citator

Cited By (22 total)

  • …Corp. v. La-Fleur, 322 So. 2d 520 (Fla.1975); Wackenhut Corp. v. Canty, 359 So. 2d 430 (Fla.1978); Baptist Memorial Hospital, Inc. v. Bell, 384 So. 2d 145 (Fla.1980); Smith v. Brown, 525 So. 2d 868 (Fla.1988); and E.R. Squibb & Sons, Inc. v. Farnes, 697 So. 2d 825 (Fla.1997). We have jurisdiction. Art. V, § 3(b)(3), Fla. Const. For the reasons expressed, we conclude that the district court in this case erred in reversing the trial judge’s order because it did not apply the broad discretion standard adopted in…
    1 / 2
  • VAN v. Schmidt, 122 So. 3d 243 (Fla. 2013)
    …ve the reasoning of Schmidt to the extent that the First District’s analysis was consistent with this holding, and we disapprove Kuebler to the extent that the Fourth District interpreted this Court’s decisions in E.R. Squibb & Sons, Inc. v. Farnes, 697 So. 2d 825 (Fla.1997), and Brown v. Estate of Stuckey, 749 So. 2d 490 (Fla.1999), to require deference to a trial court’s conclusions of law, even where the trial court’s order was premised, at least in part, on an error of law. However, although a trial cour…
  • Citrus Cnty. v. McQUILLIN, 840 So. 2d 343 (Fla. 5th DCA 2003)
    …stantial evidence to support that award, we reverse that portion of the verdict. AFFIRMED in part; REVERSED in part. GRIFFIN and ORFINGER, JJ., concur. . Brown v. Estate of Stuckey, 749 So. 2d 490 (Fla.1999); E.R. Squibb and Sons, Inc. v. Farnes, 697 So. 2d 825 (Fla.1997); Smith v. Brown, 525 So. 2d 868 (Fla.1988). . Alejandre v. Republic of Cuba, 996 F.Supp. 1239 (S.D.Fla.1997) (over forty-nine million dollars awarded to families of three men killed when their plane was shot down by Cuban air force durin…

Previewing 3 of 22 citing cases — full citator treatment, depth of discussion, and citing context are member features.

Join FLexlaw to unlock all legal intelligence

Authorities Cited

Full citator, related cases, and AI research tools

Open in FLexlaw