Wright v. Abbott Labs.

Decision Date06 August 2001
Docket NumberNo. 99-3331,99-3331
Citation259 F.3d 1226
Parties(10th Cir. 2001) ERIC J. WRIGHT, a disabled minor, by and through The Trust Company of Kansas, Conservator of the Estate of Eric J. Wright, Plaintiff - Appellant, v. ABBOTT LABORATORIES, INC., Defendant - Appellee
CourtU.S. Court of Appeals — Tenth Circuit

Appeal from the United States District Court for the District of Kansas (D.C. No. 97-CV-1333-JTM) [Copyrighted Material Omitted]

[Copyrighted Material Omitted] Lynn R. Johnson, Shamberg, Johnson & Bergman, Chartered, Overland Park, Kansas for Plaintiff-Appellant.

June K. Gheezi, Jones, Day, Reavis & Pogue, Chicago, Illinois, (Tina M. Tabacchi, Jones, Day, Reavis & Pogue, Chicago, Illinois; Richard C. Hite, Hite, Fanning & Honeyman, L.L.P., Wichita, Kansas, with her on the brief), for Defendant-Appellee.

Before HENRY and MURPHY, Circuit Judges, and MILLS, District Judge.1

MILLS, District Judge.

I. BACKGROUND

Eric Wright was born on November 10, 1992, at Wesley Medical Center in Wichita, Kansas. Shortly after birth, his doctor prescribed intravenous treatments of unconcentrated sodium chloride because Wright suffered from low blood pressure. The hospital stocked its unconcentrated sodium chloride solutions in close proximity to its concentrated solutions and, tragically, a nurse mistakenly gave Wright two doses of concentrated sodium chloride. The concentrated doses caused Wright to sustain severe brain damage.

The Wright family claims that Abbott Laboratories knew that stocking the solutions together could result in the sort of inadvertent administration of concentrated sodium chloride that debilitated their son. The Wrights argue that Abbott had a duty to warn the hospital about the risk of inadvertent administration and that Abbott's failure to do so was the proximate cause of Eric's brain damage.

*

Abbott was the sole supplier of concentrated sodium chloride solution to Wesley Medical Center ("the hospital") from 1990 to 1992. On April 10, 1990, the United States Department of Health and Human Services, Food and Drug Administration ("the FDA") alerted manufacturers of concentrated sodium chloride about recent reports of serious adverse reactions following the inadvertent administration of concentrated sodium chloride solution. The letter was signed by Philip G. Walters, M.D. on behalf of John F. Palmer, M.D., and sent to three concentrated sodium chloride manufacturers: International Medication Systems, LTD. (IMS), Lyphomed, and American Regent.2 Of the three manufacturers, IMS produced and marketed concentrated sodium chloride solutions with concentrations of 14.6% and 23.4%; Lyphomed and American Regent only produced and marketed solutions with a 23.4% concentration.

The so-called "Palmer Letter" recommended that the manufacturers change the labeling and package inserts for their sodium chloride products and immediately notify their hospital customers about the reports and risks of inadvertent administration of concentrated sodium chloride. The letter also recommended that the manufacturers advise hospitals to institute the additional safety precaution of restricting the storage of hypertonic sodium chloride to the hospital pharmacies in order to eliminate the possibility of medication errors. The three manufacturers promptly sent "Important Drug Warning" letters to their hospital customers in April, May and June, 1990. Each of the "Important Drug Warning" letters sent by these manufacturers complied with all of the warnings and instructions recommended in the Palmer Letter. In particular, the letters warned that the storage of hypertonic sodium chloride should be restricted to hospital pharmacies in order to eliminate or reduce the possibility of inadvertently substituting one sodium chloride solution for another.

Apparently, the FDA only sent the Palmer Letter to manufacturers who produced 23.4% concentrated sodium chloride solution in April 1990. Since Abbott did not produce a 23.4% solution at that time, the FDA never sent Abbott a copy of the letter. Abbott did not learn about the Palmer Letter until August 1991, when Frederick Gustafson, its Director of Regulatory Affairs for the Hospital Products Division, received a copy during a deposition in another case involving injuries which resulted from an inadvertent administration of concentrated sodium chloride. At the time of this other deposition, Abbott was not aware of the facts surrounding the issuance of the Palmer Letter, but was led to believe that the letter had been sent to all manufacturers, regardless of the type of solution they produced. In response to this information, Abbott notified the FDA that it never received a copy of the Palmer Letter and submitted a label change for its 14.6% solution to the FDA. The FDA reviewed and approved Abbott's proposed label change, but it never requested or required Abbott to do anything else with respect to the Palmer Letter. Accordingly, Abbott did not send an "Important Drug Warning" letter to its hospital customers to warn them about the dangers of inadvertent administration, or instruct them to store concentrated sodium chloride in a pharmacy to minimize the risk of inadvertently administering concentrated sodium chloride. Gustafson and one of Abbott's staff attorneys decided that it "would not be of any major benefit" and would have been "confusing" if Abbott sent such a letter.

Since Abbott was Wesley Medical Center's sole provider of sodium solutions, and Abbott did not send a warning letter, the hospital never received written warning about the dangers of storing concentrated solutions with unconcentrated solutions. The hospital continued to stock Abbott's 14.6% sodium chloride solution in the same NSCU medication cart it stocked the normal saline solution throughout 1992.

* *

Shortly after Eric Wright's birth on November 10, 1992, the hospital transferred him to its Neonatal Special Care Unit (NSCU) because he had low blood pressure that required correction with intravenously administered fluids. Dr. Barry Bloom instructed NSCU Nurse Benjamin to "Piggyback normal saline, 20ccs over 30 minutes" in order to raise Wright's blood pressure. Nurse Diltz overheard Nurse Benjamin repeating Dr. Bloom's order, asked if she could help, and was told to prepare the solution.

Contrary to the hospital's nursing policies and her own nursing school training, Nurse Diltz did not read Dr. Bloom's order or the label on the sodium chloride vial she took from the NSCU cart before preparing the solution. The concentrated sodium chloride that Nurse Diltz took from the cart vial bore a large red legend that read "CONCENTRATE" and "CAUTION: MUST BE DILUTED FOR I.V. USE." It also warned in large red ink that the vial contained 14.6% solution. Nurse Diltz went to select a normal strength sodium solution for Nurse Benjamin to administer to Eric Wright, but she mistakenly picked up a concentrated sodium solution and gave it to Nurse Benjamin who administered it to Wright. Nurse Diltz repeated this mistake 30 minutes later when helping Nurse Benjamin to administer a second dose. Eric Wright suffered brain damage as a result of these two doses.

During the litigation which followed Wright's injury, his family contended that Abbott knew about the risk of storing concentrated sodium chloride next to vials of normal saline solution and that it had a duty to warn the hospital. They claimed that Eric's brain damage could have been avoided if Abbott informed the hospital of the dangers of storing concentrated and unconcentrated sodium chloride together.

However, testimony by hospital personnel indicated otherwise. The hospital's Director of Pharmacy Services, Mike Hurst, stated in his deposition that if he had received a copy of the Palmer Letter in 1990 it would have been used to determine "what actually would be required for patient safety." He may have "determined that no action [was] necessary at that point." He would have exercised his own judgment on the FDA's recommendations. In his opinion, recommendations from the FDA and manufacturers were not always useful or helpful; thus, the hospital did not always follow them.

Dr. Bloom testified in his deposition that he did not need the FDA to tell him about the risk of inadvertent administration of concentrated sodium chloride because that information was not new. He stated that immediate access to concentrated sodium chloride was sometimes necessary and it would have been irrational to remove electrolytes from the floor stock without having an alternative source that was at least as expedient. It was not until late 1993 or early 1994 that an alternative was available at the hospital, and even then nurses had access to concentrated electrolytes so they could be immediately administered to patients. The hospital knew at that time, as it did in 1992 and the years before, that there was a risk that nurses might administer the wrong solutions and that the practice of floor stocking medications increased that risk.

Abbott moved for summary judgment on the Wright's claim. In the course of allowing Abbott's motion, the district court struck Wright's Statement of Uncontroverted Facts because it contained irrelevant and inadmissible facts. The court entered summary judgment for Abbott on four separate grounds: 1) Abbott's warnings to the hospital were adequate as a matter of Kansas law; 2) Abbott had no duty to warn a sophisticated user like the hospital about any storage dangers since the hospital should have already known about the dangers; 3) that Restatement (Second) of Torts 402A Comment j barred Wright's suit; and 4) that Abbott did not proximately cause Wright's injury. Wright's family moved for reconsideration, but the district court denied their motion.

Wright's family appeals each of the district court's findings as well as its decision to strike their Statement of Uncontroverted Facts and deny their Motion for Reconsideration.

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