Ellis v. C.R. Bard, Inc., No. 01-15182.

311 F.3d 1272

Donna ELLIS, as guardian for Mary Ruth Brown, Plaintiff-Appellant, v. C.R. BARD, INC. and Baxter Healthcare Corporation, Defendants-Appellees Baxter International, Inc., et. al., Defendants.

No. 01-15182.

No. 02-10332.

United States Court of Appeals, Eleventh Circuit.

November 12, 2002.

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Thomas J. Venker, Andrew R. Kirschner, Bedford, Kirschner & Venker, Atlanta, GA, for Ellis.

Donald L. Swift, III, Richard B. North, Jr., Matthew Brian Lerner, Nelson, Mullins, Riley & Scarborough, LLP, Dondra S. Bass, Alan F. Herman, Amy Michelle Hoffman, Hawkins & Parnell, LLP, Atlanta, GA, Maja Campbell Eaton, Tatjana Dragovic, Silas Findley, Sherry A. Knutson, Sidley, Austin, Brown & Wood, Chicago, IL, for C.R. Bard, Inc. and Baxter Healthcare Corp.

Appeal from the United States District Court for the Northern District of Georgia.

Before HULL, FAY and GIBSON^*, Circuit Judges.

PER CURIAM:

In this diversity case under Georgia law, plaintiff Donna Ellis alleges that the defendant manufacturers, C.R. Bard, Inc. ("Bard") and Baxter Healthcare Corporation ("Baxter"), are liable for her mother's brain damage because of their defective labeling and specifically their failure to warn adequately of the danger of having a person other than a doctor or patient activate the morphine pump that was prescribed for her mother. Ellis appeals the district court's order granting the defendants' summary judgment motions and denying her summary judgment motion. Ellis also appeals the district court's subsequent order denying her motion to reduce the costs awarded the defendants as prevailing parties. After review and oral argument, we affirm both of the district court's orders.

I. FACTS

The factual background in this case is largely undisputed. However, where disputes occur, we outline the facts in the light most favorable to the plaintiff.¹

A. The Product

The product at issue is the Bard Ambulatory Patient Controlled Analgesia Infusion Pump (the "PCA pump"). The PCA pump is a medical device used to deliver analgesic drugs to patients. The PCA pump is regulated by the Food and Drug Administration and is available only by a doctor's prescription. A doctor typically prescribes the PCA pump for the relief of acute and chronic pain in patients.

The PCA pump is programmed pursuant to a doctor's orders. Those orders control the timing and the amount of the prescribed drug delivered into the patient upon activation. Once programmed, a patient can activate the PCA pump to deliver the prescribed amount of pain medication — here morphine — by pressing either a button on the pump itself or a button on the end of a cord plugged into the pump. When so activated, a dose of the prescribed pain medication is delivered to the patient, either intravenously or via epidural.

The PCA pump is designed so that the doctor can set the amount of drug delivered to the patient upon activation. The PCA pump also can be programmed to have a delay or "lock-out" period between doses. During that period, no drug will be delivered to a patient, even if the activation button is pressed.

It is well known in the medical community that, absent a doctor's specific orders, only the patient should activate the PCA pump.

B. The Incident

In 1997 Mary Ruth Brown, plaintiff's mother, was admitted to the Georgia Baptist Medical Center ("GBMC")² for bilateral knee replacement surgery. The day after her surgery, Brown complained of increasing pain. Dr. David Sherbert, the on-call anesthesiologist at GBMC, prescribed to Brown a PCA pump to facilitate the administration of morphine into Brown to help control her post-surgery pain.

A GBMC nurse, Lori Hamilton ("Nurse Hamilton") programmed the PCA pump pursuant to Dr. Sherbert's prescription. That prescription permitted 2 milligrams of morphine upon activation of the PCA pump. There was also a prescribed (1) lock-out period of 8 minutes between patient-activated doses and (2) maximum hourly dosage of 8 milligrams of morphine per hour.

Nurses at GBMC were not authorized to permit a third party to activate the PCA pump unless told to do so by a doctor. Nonetheless, on February 18, 1997, Nurse Hamilton, without a doctor's authorization, instructed one of Brown's daughters, Debbie Guest, to press the PCA pump's activation button for Brown while she was sleeping so that she would not wake up in pain. According to Nurse Hamilton, she made this exception to the known general rule that only patients should activate the PCA pump because Brown appeared to be in great pain. Although Nurse Hamilton knew third-party activation could be dangerous, she did not tell Guest that there was any risk in having a third party activate the PCA pump.

That same day, Guest relayed Nurse Hamilton's instruction to Brown's other daughter, plaintiff Ellis. Ellis then pressed the PCA pump button once for Brown. Later that night, Guest also followed Nurse Hamilton's instructions and pressed the activation button. Guest continued to press the button for Brown while she slept through the night of February 18 and the early morning of February 19.

At around 7 a.m. on February 19, Brown's surgeon, Dr. Lee Cross, discovered that Brown was having difficulty breathing. Brown went into cardiac arrest, which led to anoxic brain injury. Brown's injuries, according to plaintiff Ellis, were caused by a morphine overdose due to her and Guest's having pressed the PCA pump's activation button for Brown while she was sleeping.

C. Source of the PCA Pump

In 1990, a division of defendant Bard, Bard MedSystems, manufactured the PCA pump that was prescribed to Brown. Defendant Bard sold that PCA pump in 1993 to a distributor, Bimeco, Inc., who then supplied it to GBMC.

Defendant Baxter did not manufacture the PCA pump that was prescribed to Brown. In 1993, however, defendant Baxter acquired the assets of Bard MedSystems. Following that asset sale, defendant Baxter continued to manufacture the same model of the PCA pump under the Bard name for about one year. After that and through 1999, defendant Baxter manufactured another model which was substantially similar to the PCA pump.

D. The Warning of Risk

Neither the PCA pump itself nor its user's manual contained a written label warning that third parties should not activate the PCA pump on behalf of the patient to whom it is prescribed. However, through its own sales force and its medical products distributor Bimeco, defendant Bard educated the GBMC staff about the risk of third-party activation and provided patient brochures to the GBMC staff advising that only the patient should press the PCA button.

More specifically, Bimeco sales representatives performed "in-service" training to GBMC's doctors and nurses, and representatives from defendant Bard often attended that training. Frank Burdette, a Bimeco employee who performed training at GBMC since 1994, stated that "[a]s part of this in-service training, it was my routine practice to tell the physicians and nurses in the Pain Service and at GBMC that only the patient should push the pump button, unless otherwise ordered by a physician." To illustrate why family members should not operate the pump, Burdette "would relate an anecdotal report about a family member who oversedated a patient by pushing the patient button."

In 1997 and "prior thereto," Burdette also gave the doctors and nurses at GBMC copies of a patient brochure about the PCA pump, which initially was prepared by defendant Bard in 1988 and later used by defendant Baxter. That brochure, entitled "Controlling your own pain relief — single-handedly," stated, "Important Note: You should be the only person to press your PCA button because only you know if you need it." (emphasis in the original). However, that brochure did not mention or warn what might happen if that directive were ignored. The brochures were provided to GBMC to be used with patients at the doctor's discretion. Nurse Susan Rhodes, who instructed Brown on the use of her PCA pump, confirmed that the patient brochure was used as part of the instruction to patients at GBMC.

Another Bimeco representative, Mark Jungers, also performed in-service training at GBMC during the early 1990s. Like Burdette, Jungers routinely told the staff at GBMC that only the patient should push the PCA pump activation button and shared the story about a family member oversedating a patient. Jungers further testified that he too gave copies of the defendants' patient brochures to the doctors and nurses at GBMC.

E. Actual Knowledge of Risk

Each doctor and nurse involved with Brown's medical care in 1997 was aware that only the patient should activate the PCA pump unless a doctor instructed otherwise. For example, Dr. Sherbert (Brown's prescribing doctor), indicated that he knew prior to 1997 that unauthorized "family member activation" of the PCA pump could result in sedation, which if left untreated "can lead to respiratory depression, respiratory arrest, or cardiac arrest."

The record also indicates that Brown, the patient here, was aware that only she should activate the PCA pump. Specifically, prior to her surgery, Nurse Rhodes instructed Brown on the use of the PCA pump. According to Nurse Rhodes, she routinely advised patients with the PCA pump that only they, and not third parties, should activate the PCA pump. Carol Brisbon, Brown's recovery room nurse, also instructed Brown about the PCA pump. Brisbon testified that it was also her practice to instruct patients that only they should press the activation button, and that family members should not.

As noted, the dangers associated with third-party activation are well known in the medical community. That common knowledge existed before the time of Brown's medical care at GBMC in 1997. Indeed, Dr. David C. Brandon, plaintiff Ellis's medical expert, testified that the medical community which uses PCA pumps has known of the dangers associated with...