Osburn v. Anchor Laboratories, Inc.

• Citation: 825 F.2d 908
• Decision Date: 28 August 1987
• Docket Number: No. 86-1094,86-1094
• Parties: , 23 Fed. R. Evid. Serv. 1061, Prod.Liab.Rep.(CCH)P 11,552 Clois OSBURN and Anita Osburn, Plaintiffs-Appellees, v. ANCHOR LABORATORIES, INC., Defendant, Rachelle Laboratories, Inc., Defendant-Appellant.
• Court: United States Courts of Appeals. United States Court of Appeals (5th Circuit)

Page 908

825 F.2d 908

56 USLW 2164, 23 Fed. R. Evid. Serv. 1061,

Prod.Liab.Rep.(CCH)P 11,552

Clois OSBURN and Anita Osburn, Plaintiffs-Appellees, v. ANCHOR LABORATORIES, INC., Defendant Rachelle Laboratories, Inc., Defendant-Appellant.

No. 86-1094.

United States Court of Appeals Fifth Circuit.

Aug. 28, 1987.

G. Luke Ashley, Thompson & Knight, Dallas, Tex., for defendant-appellant.

Dale D. Williams, Rod S. Squires, Williams, Pattillo & Squires, Waco, Tex., for plaintiffs-appellees.

Appeal from the United States District Court for the Western District of Texas.

Before WISDOM, RUBIN, and GARWOOD, Circuit Judges.

GARWOOD, Circuit Judge:

In this Texas law diversity case, plaintiffs-appellees Clois Osburn and Anita Osburn (Osburns) sued Anchor Laboratories, Inc. (Anchor) and Rachelle Laboratories, Inc. (Rachelle) for personal injuries under negligence and strict products liability theories. The Osburns alleged that due to the defendant drug manufacturers' failure to warn Mr. Osburn of the dangers to persons administering veterinary chloramphenicol and their failure to give him adequate instructions for its use, Mr. Osburn contracted leukemia. Answering special interrogatories, the jury found the defendants liable under both theories. The district court entered judgment on the verdict in favor of the Osburns. Rachelle appeals, claiming that federal law preempts the Osburns' tort claims for failure to warn, that the "learned intermediary" doctrine absolved it of any duty to warn Mr. Osburn directly, that the Osburns failed to prove causation, and that newly discovered evidence and an excessive damages award require a new trial, or, alternatively with respect to the excessiveness complaint, a remittitur.

Facts and Proceedings Below

When Clois Osburn was diagnosed as having leukemia, he was forty-two years old. For almost the entirety of his adult life, he had worked as a cowboy in the Texas panhandle, often caring for sick cattle and horses. In September 1982, Osburn obtained from Dr. Swain a prescription for veterinary chloramphenicol oral solution, which he immediately began administering daily to the sick calves he was caring for. Over the following eighteen months, he used ten to thirteen cases of chloramphenicol, each containing six sixteen-ounce bottles of the antibiotic. Of this total, two or three cases consisted of chloramphenicol produced by Anchor and the other eight to ten cases were of Mychel-Vet, the brand name for Rachelle's version of the drug.

Since the chloramphenicol came in plastic capped bottles into which a needle could not be inserted, each morning Osburn poured several bottles of the drug from their original bottles into other, same sized bottles with injectable rubber lids. These he carried in a medicine bag on his horse's saddle to pastures where the calves grazed. To administer the drug, Osburn straddled the sick animal, inserted a syringe into the rubber lid of a bottle containing chloramphenicol, filled it, and injected the calf with a 60cc syringe-full dose of the drug. In the process of filling the syringe, chlorampenicol leaked from previously-made syringe holes in the rubber lid. The chloramphenicol often ran down Osburn's hand and arm, getting into scratches and cuts on his arm. Osburn recalled that on one occasion so much of the drug got into a rope burn on his arm that he could taste its bitterness in his mouth. Osburn wore leather gloves on the job, and testified that by the end of each day the gloves were soaked through with chlorampenicol.

In February 1984, Osburn visited his family physician (Dr. Harlow), who detected a large knot near Osburn's spleen. Dr. Harlow hospitalized Osburn, performed tests, and tentatively diagnosed Osburn's condition as leukemia. Later that month Osburn underwent further tests, including a bone marrow biopsy, at the direction of oncologist Dr. Karim Nawaz. On February 28, 1984, Dr. Nawaz confirmed Dr. Harlow's diagnosis of leukemia, giving Osburn the specific diagnosis of chronic myelogenous leukemia. The doctors informed Osburn that from the date of diagnosis he could expect to live two to five years.

On August 8, 1984, the Osburns filed this suit against Anchor and Rachelle. Subsequently, Anchor and Rachelle filed cross-claims against each other for contribution. The defendants then impleaded Dr. Jack Swain, the veterinarian from whom Osburn obtained the chloramphenicol, demanding indemnity and contribution. Shortly before trial, the Osburns reached a settlement agreement with Anchor and Dr. Swain. ¹

The Osburns tried their case against Rachelle on December 2-6, 1985. Rachelle's motion for directed verdict at the close of all the evidence was denied. Answering special interrogatories, the jury found that Rachelle had failed to provide adequate warnings to Mr. Osburn regarding the risk of fatal blood disorders from absorption of chloramphenicol, that this failure was a producing (and proximate) cause of Osburn's leukemia, and, therefore, that Rachelle was liable under both strict products liability and negligence theories. Pursuant to the district court's instruction that if it found Rachelle liable, then as a matter of law Anchor was also liable, the jury apportioned causation at eighty-five percent attributable to Rachelle and fifteen percent attributable to Anchor. The jury awarded $2,500,000 damages to Clois Osburn and $500,000 damages to Anita Osburn. The district court entered judgment for the Osburns against Rachelle, awarding all damages minus the fifteen percent attributable to Anchor. Rachelle moved for judgment notwithstanding the verdict, and for new trial or, alternatively, a remittitur. The district court denied these motions and this appeal followed.

Discussion

I. Preemption

A. Preemption principles

Preemption doctrine finds its roots in the supremacy clause of the Constitution, which mandates that federal law shall be the "supreme Law of the Land." U.S. Const. art. VI, cl. 2. The Supreme Court has long interpreted this clause to authorize Congress to enact laws under its enumerated powers that preempt state laws governing the same subject. Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 210-11, 6 L.Ed. 23 (1824). State common law as well as state statutes and regulations can be preempted by federal law. See, e.g., Chicago & N.W. Transp. Co. v. Kalo Brick & Title Co., 450 U.S. 311, 101 S.Ct. 1124, 67 L.Ed.2d 258 (1981).

Preemption occurs in two general contexts. When Congress evidences, either expressly or inferentially through the comprehensiveness of the federal regulatory scheme, an intent to totally occupy a given field, state law falling within that field is preempted. Alternatively, even if Congress has not entirely displaced state regulation in an area, any state law that actually conflicts with federal law is preempted. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 104 S.Ct. 615, 621, 78 L.Ed.2d 443 (1984); Pacific Gas & Elec. Co. v. State Energy Resources Conservation & Dev. Comm'n, 461 U.S. 190, 103 S.Ct. 1713, 1722, 75 L.Ed.2d 752 (1983). Such a conflict arises when "compliance with both federal and state regulations is a physical impossibility," Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 83 S.Ct. 1210, 1217, 10 L.Ed.2d 248 (1963), or where state law "stands as an obstacle to the accomplishment of the full purposes and objectives of Congress." Hines v. Davidowitz, 312 U.S. 52, 61 S.Ct. 399, 401, 85 L.Ed. 581 (1941), quoted in Silkwood, 104 S.Ct. at 621.

B. Rachelle's argument

In this case, Rachelle argues that the Food, Drug and Cosmetic Act (FDCA), ² 21 U.S.C. Secs. 301-392, and the Food and Drug Administration's (FDA) implementing regulations governing veterinary prescription drug labeling, see 21 C.F.R. Secs. 201.105, 514.1-514.8, preempt the Osburns' state common-law tort claims based upon failure to warn. According to Rachelle, a direct conflict exists between the FDCA and the Osburns' tort claim under Texas law because it is impossible for Rachelle to comply with both the FDA labeling requirements and the state law duty to warn. ³ Rachelle bases this argument on an FDA regulation, 21 C.F.R. Sec. 201.105, which in the case of veterinary chloramphenicol requires, as part of the manufacturer's new animal drug application, a label approved by the FDA. Specifically, Rachelle argues that because the FDA regulation required it to use an FDA-approved label in order to escape criminal liability under the FDCA for dispensing a "misbranded" drug, it could not simultaneously comply with Texas tort law obligations that presumably mandated more extensive warnings than those provided in Rachelle's FDA-approved chloramphenicol label.

We find this argument unpersuasive in the present context. Unlike the FDA regulations for some products, the regulations pertaining to veterinary chloramphenicol did not set forth a particular mandatory label. Instead, the regulations required Rachelle to submit a proposed label of its own choosing, which the FDA would then approve or reject. See 21 C.F.R. Part 514 (New Animal Drug Applications); id. Sec. 514.2(b)(3)(iii). Of special significance is the fact that the FDA regulations specifically permitted Rachelle to add additional warnings to a previously approved label as soon as it became aware of the necessity to do so--without any need to first obtain FDA approval of the supplemental warnings. 21 C.F.R. Sec. 514.8. ⁴ The FDA regulations thus did not prevent Rachelle from adding to its label warnings of the dangers of fatal blood diseases associated with exposure to chloramphenicol as soon as it learned of such dangers. ⁵ We therefore conclude that federal law neither made it practically (nor legally) impossible, nor would it have posed an obstacle to accomplishing the objectives of the FDCA, for Rachelle to give warnings that would have satisfied its duty under Texas law. Since Rachelle has not convinced us that the FDA regulations actually conflict with its duty...