Eck v. Park Davis & Company

• Citation: 256 F.3d 1013
• Decision Date: 17 July 2001
• Docket Number: WARNER-LAMBERT,No. 00-7020,00-7020
• Parties: (10th Cir. 2001) MARK W. ECK, SANDRA K.ECK, TRAVIS ECK and MEGAN ECK, Plaintiffs-Appellants, v. PARKE, DAVIS & COMPANY,COMPANY, THE RUGBY GROUP, INC., AND RUGBY LABORATORIES, INC., Defendants-Appellees
• Court: United States Courts of Appeals. United States Court of Appeals (10th Circuit)

Page 1013

256 F.3d 1013 (10th Cir. 2001)

MARK W. ECK, SANDRA K.ECK, TRAVIS ECK and MEGAN ECK, Plaintiffs-Appellants, v. PARKE, DAVIS & COMPANY, WARNER-LAMBERT COMPANY, THE RUGBY GROUP, INC., AND RUGBY LABORATORIES, INC., Defendants-Appellees.

No. 00-7020

UNITED STATES COURT OF APPEALS TENTH CIRCUIT

July 17, 2001

Appeal from the United States District Court for the E.D. Oklahoma (D.C. NO. 99-CV-156-S) [Copyrighted Material Omitted] Steven E. Aldous, Slack & Davis, L.L.P., Austin, Texas, for Appellants.

Brad Smith(Mike Barkley with him on the brief) of Barkley Titus Hillis & Reynolds, Tulsa, Oklahoma, for Appellees Parke, Davis & Company and Warner-Lambert Company.

Thomas E. Steichen (Richard M. Eldridge with him on the brief) of Rhodes, Hieronymus, Jones, Tucker & Gamble, P.L.L.C., Tulsa, Oklahoma, for Appellees The Rugby Group, Inc. and Rugby Laboratories, Inc.

Before HENRY and MURPHY, Circuit Judges, and VAN BEBBER, District Judge.^*

HENRY, Circuit Judge.

Mark W. Eck, suffering from injuries sustained from an onset of liver failure, brought, together with members of his family, this products liability action¹ against defendants Parke, Davis & Company and Warner-Lambert Company (jointly, "Warner-Lambert") and the Rugby Group, Inc. and Rugby Laboratories, Inc. (jointly, "Rugby").² The Ecks contended that Mr. Eck's liver failure resulted from the interaction of two prescription drugs: (1) Dilantin, an anti-convulsant, which is manufactured and distributed by Warner-Lambert, and (2) Isocet (which contains acetaminophen, butalbital and caffeine), and which is distributed by Rugby. The defendants filed a motion for summary judgment in the district court, which the district court granted. The district court found that the Ecks' claims were barred by the learned intermediary doctrine. For the reasons set forth below, we affirm the district court's decision. We are called upon to decide only the liability of these defendants; the liability of other actors is not before us.

I. BACKGROUND

The following facts are undisputed. Mr. Eck is a pharmacist who owns and operates Eck Pharmacy in Healdton, Oklahoma. In 1992 or 1993, Dr. Mark Newey became Mr. Eck's treating physician. On March 13, 1994 and on January 19, 1995, Dr. Newey prescribed Isocet to Mr. Eck to treat his complaints of tension headaches. At the time the Isocet was prescribed by Dr. Newey, Mr. Eck was not taking Dilantin.

Mr. Eck has a history of mild temporal lobe seizures. In October 1996, Dr. Newey prescribed Tegretol, another anti-convulsant medication, after Mr. Eck began to experience seizures. While on the Tegretol, Mr. Eck developed a rash and Dr. Newey referred him in mid-December 1996 to Dr. Dan Udonta, who, in turn, prescribed Depakote in lieu of the Tegretol. Mr. Eck again developed a rash. On January 31, 1997, Dr. Udonta referred Mr. Eck to Dr. Nancy Rodgers, an epilepsy specialist.

Five days later Mr. Eck experienced another seizure-related episode. Dr. Newey came to Mr. Eck's house and consulted with Dr. Rodgers via telephone. Mr. Eck was admitted to the Healdton Hospital emergency room on February 5, 1997. Dr. Newey ordered a 900 mg loading dose of Dilantin that was given to Mr. Eck. He was discharged on February 6, 1997, and sent by Dr. Newey to see Dr. Rodgers. Thereafter, Dr. Rodgers removed Mr. Eck from the Depakote and prescribed Dilantin to control his seizures. Dr. Newey monitored his Dilantin levels during the time Dr. Rodgers prescribed Dilantin.

On April 5, 1997, Mr. Eck began to feel anxious. On April 7, 1997, he began experiencing a tension headache and took two Isocet tablets (each containing 325 mg of acetaminophen) from his January 19, 1995 prescription. During this period of time, Mr. Eck was also taking Dilantin, prescribed in February by Dr. Rodgers to control his seizures. He had taken 400 mg of Dilantin that day.

On April 8, 1997, Mr. Eck began vomiting repeatedly and his condition continued to deteriorate. Dr. Newey admitted him to Mercy Hospital in Ardmore, Oklahoma. At Mercy Hospital, Mr. Eck was diagnosed with acute liver failure and he was transported to Baylor Medical Center in Dallas, Texas. A liver biopsy revealed that Mr. Eck's liver failure was consistent with acetaminophen poisoning. As a result of his liver failure and related complications, Mr. Eck was in a coma and on a ventilator for 36 days. He underwent various surgeries and had an extended hospital stay.

In granting the defendants' motion for summary judgment, the district court found that Oklahoma's "learned intermediary doctrine" shielded Warner-Lambert and Rugby from liability because any failure to warn was not the proximate cause of Mr. Eck's injuries. The district court found summary judgment inappropriate with respect to the two related grounds of (1) no duty to warn when there is no known danger of the interaction of the drugs at therapeutic levels, and (2) the absence of medical causation. Because we affirm for the reasons given below, we need not address the appropriateness of the denial of summary judgment on these grounds.

On appeal, the Ecks challenge: (1) the district court's decision to limit its focus of inquiry to the testimony of Dr. Rodgers, the physician who prescribed Dilantin, and not to consider the testimony of Dr. Newey, the prescribing physician for Isocet; (2) the district court's conclusion that Dr. Rodgers' testimony rebutted the presumption that had an adequate warning been provided, it would have been read and heeded; and (3) the district court's finding that no issues of material fact regarding causation existed. After we review the progression and rationale of the learned intermediary doctrine, we shall discuss each contention in turn.

II. INITIAL MATTERS

A. Standard of Review

This diversity action is governed by Oklahoma's substantive tort law, but we are governed by federal law in determining the propriety of the district court's grant of summary judgment. See Pegasus Helicopters, Inc. v. United Techs. Corp., 35 F.3d 507, 510 (10th Cir. 1994). "We review the entry of summary judgment de novo, drawing all reasonable inferences in favor of the nonmovants. Summary judgment is appropriate only when the moving party shows there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law. To avoid summary judgment, the nonmovant must make a showing sufficient to establish an inference of the existence of each element essential to the case. The nonmovant may not rest upon mere allegation or denials of his pleadings, but must set forth specific facts showing that there is a genuine issue for trial." Hulsey v. Kmart, Inc., 43 F.3d 555, 557 (10th Cir. 1994) (quotations and citations omitted).

B. Failure to Warn and the Learned Intermediary Doctrine

The Ecks contend that Warner-Lambert and Rugby, by failing to label their products with adequate warnings of Dilantin's propensity to interact with acetaminophen, placed defective and unreasonably dangerous products in the market place that caused Mr. Eck's liver failure. The Ecks also contend the defendants were negligent in the designing, testing, warning, and marketing of their products through their failure to provide adequate instructions or warnings and by misrepresenting the safety of their products when used in conjunction with one another.

To recover in a failure to warn case, a plaintiff must establish both cause-in-fact (that the product in question caused the injury) and proximate cause (that the manufacturer of the product "breached a duty to warn of possible detrimental reactions"). McKee v. Moore, 648 P.2d 21, 23-24 (Okla. 1982). To qualify as a proximate cause of the injury, the breach of a duty or failure to warn must be a substantial contributing factor in bringing about the harm in question. See Woolard v. JLG Indus. Inc., 210 F.3d 1158, 1172 (10th Cir. 2000) (applying Oklahoma law) (noting that "a proximate cause is defined as one that, in the natural and continuous sequence, produces the plaintiff's injury and without which the injury would not have happened"); Van Buskirk v. Carey Canadian Mines, Ltd., 760 F.2d 481, 492 (3d Cir. 1985) (applying Pennsylvania law) (internal quotation marks omitted).

Oklahoma's products liability law "generally requires a manufacturer to warn consumers of danger associated with the use of its product to the extent the manufacturer knew or should have known of the danger." Edwards v. Basel Pharms., 933 P.2d 298, 300 (Okla. 1997). Certain products, including prescription drugs, are "unavoidably unsafe products" that cannot be made completely safe, but serve a public benefit. See id.; Restatement (Second) Torts 402A cmt. k (1965) (the "Restatement"). Oklahoma law recognizes that drug manufacturers cannot be strictly liable merely because of the dangerous propensities of such products. See Edwards, 933 P.2d at 300. Such products, if "properly prepared, and accompanied by proper directions and warning[s, are] not defective, nor [are they] unreasonably dangerous." Restatement 402A cmt. k; Edwards, 933 P.2d at 300 (stating that "the law regarding such products appears at Comment k of the Restatement").

Relying on Comment k, the Edwards court noted the exception to the manufacturer's duty to warn the ultimate consumer known as the "learned intermediary doctrine": where a product is properly prepared and marketed and proper warning is given to the prescribing physicians, the manufacturer is shielded from liability. Edwards, 933 P.2d at 300. "The reasoning behind this rule is that the doctor acts as a learned intermediary between the patient and the prescription drug manufacturer by assessing the medical risks in light of the patient's needs." Id.

The Edwards court adopted the rationale cited by the Kansas Supreme Court when it adopted the learned intermediary doctrine:

Where a product is available only on prescription or through the services of a physician, the...