Calhoun v. Hoffman-La Roche, Inc.

• Decision Date: 18 February 2000
• Docket Number: No. 98 CA 2770.,98 CA 2770.
• Citation: 768 So.2d 57
• Parties: Donald B. and Edith CALHOUN v. HOFFMAN-LA ROCHE, INC.
• Court: Court of Appeal of Louisiana — District of US

768 So.2d 57

Donald B. and Edith CALHOUN v. HOFFMAN-LA ROCHE, INC.

No. 98 CA 2770.

Court of Appeal of Louisiana, First Circuit.

February 18, 2000.

COPYRIGHT MATERIAL OMITTED

Damon J. Baldone, Houma, for Plaintiffs/Appellants, Donald and Edith Calhoun.

William F. Bologna, New Orleans, for Defendant/Appellee, Hoffman-La Roche, Inc.

Before: CARTER, LeBLANC, and PETTIGREW, JJ.

CARTER, J.

This is an appeal from a trial court judgment granting a motion for summary judgment in favor of a drug manufacturer in a products liability action.

FACTS

On February 17, 1995, plaintiff, Donald Calhoun, sought treatment from Dr. F.J. Graffagnino for a slow urinary stream. Dr. Graffagnino diagnosed Mr. Calhoun with a fibrous meatal stenosis of severe nature, but found that Mr. Calhoun had a normal prostate and an essentially normal urinalysis. Dr. Graffagnino recommended that the meatal stenosis be surgically corrected and that Mr. Calhoun undergo a urinary tract evaluation.

On February 22, 1995, Dr. Graffagnino performed an outpatient surgical procedure on Mr. Calhoun to correct the meatal stenosis and evaluate the urinary tract. After the procedure, Dr. Graffagnino directed his nurse to give Mr. Calhoun sixty milligrams of Toradol. Shortly thereafter, Mr. Calhoun experienced renal failure. As a result of the renal failure, Mr. Calhoun underwent dialysis for three weeks. Dr. Graffagnino opined that the renal failure was caused by the injection of Toradol.

PROCEDURAL HISTORY

On February 16, 1996, Donald Calhoun and his wife, Edith Calhoun, filed suit against Hoffman-La Roche, Inc. (Hoffman), the manufacturer of Toradol, alleging that Toradol was unreasonably dangerous in construction and composition, unreasonably dangerous in design, unreasonably dangerous because an adequate warning had not been provided to the treating physicians or Mr. Calhoun, and unreasonably dangerous because it did not conform to an express warranty by the manufacturer. In its answer to the petition, Hoffman asserted several defenses, one of which was that the Calhouns' claims were barred by the "learned intermediary" doctrine.¹

In April 1998, Hoffman filed a motion for summary judgment. In its motion and supporting memorandum, Hoffman again contended that the Calhouns' claims were barred in their entirety under the "learned intermediary" doctrine. Hoffman attached the affidavit of Dr. Michael Carter, the Director of Hoffman's Department of Drug Safety. According to his affidavit, Dr. Carter had experience with and personal knowledge of the regulatory process whereby Toradol was ultimately approved by the federal Food and Drug Administration (FDA) for distribution to the public as a prescription drug. According to Dr. Carter's affidavit, the package insert for Toradol included the following warnings:

Renal Effects: TORADOL and its metabolites are eliminated primarily by the kidneys, which, in patients with reduced creatinine clearance, will result in diminished clearance of the drug (see CLINICAL PHARMACOLOGY). Therefore, TORADOL should be used with caution in patients with impaired renal function (see DOSAGE AND ADMINISTRATION) and such patients should be followed closely. With the use of TORADOL, there have been reports of acute renal failure, nephritis, and nephrotic syndrome.

Because patients with underlying renal insufficiency are at increased risk of developing acute renal failure, the risks and benefits should be assessed prior to giving TORADOL to these patients. Hence, in patients with moderately elevated serum creatinine, it is recommended that the daily dose of TORADOL IV/IM be reduced by half, not to exceed 60 mg/day. TORADOL is contraindicated in patients with serum creatinine, concentrations indicating advanced renal impairment (see contraindications).

Dr. Carter attested that this insert was approved by the FDA for inclusion as a specific warning on the package insert for Toradol. Additionally, according to Dr. Carter, all of the pertinent information in the package insert is compiled and reflected in the entry contained in the Physician's Desk Reference (PDR) for Toradol, and the PDR is distributed to all doctors within the medical industry, free of charge. It is undisputed that Dr. Graffagnino had read the package insert referenced in the affidavit, and that Dr. Graffagnino had access to the PDR that contained the same information as that provided in the package insert.

Based on this affidavit and the content of the package insert, Hoffman argued that the warning about the possibility of renal failure was adequate as a matter of law. Thus, Hoffman asserted that there was no genuine issue of material fact that Dr. Graffagnino, the prescribing physician, was adequately warned of the risk of renal failure, and that all of the claims asserted by the Calhouns in their petition were barred by the "learned intermediary" doctrine.

The Calhouns filed an opposition to Hoffman's motion for summary judgment and attached an affidavit executed by Dr. Graffagnino. In the affidavit, Dr. Graffagnino stated that while he was aware that Toradol could cause problems with kidney function, he was not warned by the literature or otherwise that a single sixty milligram dose of Toradol could cause renal failure. The Calhouns argued that this statement by Dr. Graffagnino, as the prescribing physician, created an issue of fact regarding the adequacy of the warning, thereby precluding the application of the "learned intermediary" doctrine and making summary judgment improper.

Hoffman filed a reply memorandum contesting the Calhouns' argument that the subjective opinion of the treating physician that the warning is inadequate controls the manufacturer's obligation to warn of side effects. Instead, Hoffman contended that the adequacy of the warning, and specifically, whether the insert and/or PDR entry that is approved and mandated by the FDA, included an adequate warning regarding the claimed adverse reaction, was a question of law

The trial court held that the "learned intermediary" doctrine applied to the case, that there was an adequate warning in the package insert for Toradol, and that Dr. Graffagnino was informed concerning the possibility of renal failure associated with the use of Toradol. Thus, the trial court granted summary judgment in favor of Hoffman. The Calhouns appealed the trial court judgement, arguing that there were genuine issues of material fact that precluded the grant of summary judgment.

MOTION FOR SUMMARY JUDGMENT

A motion for summary judgment is a procedural device used to avoid a full scale trial when there is no genuine factual dispute. The motion should be granted only if the pleadings, depositions, answers to interrogatories, and admissions on file, together with any affidavits, show that there is no genuine issue as to material fact and that mover is entitled to judgment as a matter of law. Rambo v. Walker, 96-2538, p. 4 (La.App. 1st Cir.11/7/97), 704 So.2d 30, 32. The summary judgment procedure is favored and is designed to secure the just, speedy, and inexpensive determination of every action. LSA-C.C.P. art. 966 A(2); Rambo, 704 So.2d at 32.

The burden of proof is on the movant. However, if the movant will not bear the burden of proof at trial on the matter that is before the court on the motion for summary judgment, the movant's burden on the motion does not require him to negate all essential elements of the adverse party's claim, action or defense, but rather to point out to the court that there is an absence of factual support for one or more elements essential to the adverse party's claim, action or defense. Thereafter, if the adverse party fails to provide factual evidence sufficient to establish that he will be able to satisfy his evidentiary burden of proof at trial, there is no genuine issue of material fact. LSA-C.C.P. art. 966 C(2).

Appellate courts are to review summary judgments de novo under the same criteria that govern the district court's consideration of whether summary judgment is appropriate. Because it is the applicable substantive law that determines materiality, whether or not a particular fact in dispute is material can be seen only in light of the substantive law applicable to the case. Rambo, 704 So.2d at 32-33.

APPLICATION OF THE "LEARNED INTERMEDIARY" DOCTRINE

The Calhouns assert that Toradol is unreasonably dangerous because Hoffman did not provide an adequate warning of the risk of renal failure from the use of Toradol. A drug manufacturer's duty has been stated as follows:

The manufacturer of a prescription drug has the obligation to inform the prescribing physician of any potentially adverse side effects or risks from the drug's use....

The manufacturer has no duty to warn the consumer directly of any risks or contraindications associated with the drug. The manufacturer of the drug has fulfilled its obligation when it has informed the prescribing and treating physicians of the risks of harm from the drug so that they may intelligently decide on its use and advise the patient. The doctor acts as an informed intermediary. The decision to use the drug in a particular circumstance rests with the doctor and the patient, not with the manufacturer.

Cobb v. Syntex Laboratories, Inc., 444 So.2d 203, 205 (La.App. 1st Cir.1983) (citations omitted).

The jurisprudence has treated the adequacy of a warning as a legal issue and thus, determined whether a particular warning was adequate as a matter of law. See Kinney v. Hutchinson, 468 So.2d 714, 716-18 (La.App. 5th Cir.), writ denied, 472 So.2d 35 (La.1985); Anderson v. McNeilab, 831 F.2d 92, 93 (5th Cir.1987); and Bealer v. Hoffman-La Roche, Inc., 729 F.Supp. 43, 44-45 (E.D.La.1990). Thus, the adequacy of warnings becomes a question of law where the warning is "accurate, clear, and unambiguous." Beater, 729 F.Supp. at 44.

In the present case, the package insert for Toradol clearly and unambiguously warned that acute renal failure was...