Mikell v. Hoffman-LaRoche, Inc.

649 So. 2d 75, 94 La.App. 1 Cir. 0242, 1994 La. App. LEXIS 3622, 1994 WL 739269
CourtLouisiana Court of Appeal
DecidedDecember 22, 1994
Docket94 CA 0242
StatusPublished
Cited by18 cases

This text of 649 So. 2d 75 (Mikell v. Hoffman-LaRoche, Inc.) is published on Counsel Stack Legal Research, covering Louisiana Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mikell v. Hoffman-LaRoche, Inc., 649 So. 2d 75, 94 La.App. 1 Cir. 0242, 1994 La. App. LEXIS 3622, 1994 WL 739269 (La. Ct. App. 1994).

Opinion

649 So.2d 75 (1994)

George L. MIKELL
v.
HOFFMAN-LaROCHE, INC., et al.

No. 94 CA 0242.

Court of Appeal of Louisiana, First Circuit.

December 22, 1994.

*76 Keith D. Jones, Baton Rouge, for plaintiff-appellant, George L. Mikell.

Brent A. Talbot, New Orleans, for defendant-appellee, Hoffman-LaRoche, Inc.

Before LOTTINGER, C.J., and SHORTESS and CARTER, JJ.

CARTER, Judge.

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

FACTS

In early March of 1984, plaintiff George L. Mikell sought treatment for acne from Dr. Thomas W. Graves, a dermatologist. Dr. Graves prescribed for plaintiff the prescription medication Accutane, which is manufactured by Hoffman-LaRoche, Inc. (Hoffman). The administration of Accutane was discontinued on several occasions by Dr. Graves because of various side effects experienced by plaintiff. Plaintiff last took Accutane in November of 1984. Thereafter, plaintiff suffered gastrointestinal problems and was diagnosed with inflammatory bowel disease, more particularly, ulcerative proctitis.

On June 4, 1986, plaintiff filed suit against Hoffman, alleging that Accutane is an unreasonably dangerous product, that Hoffman *77 failed to disclose the risk of developing ulcerative proctitis from Accutane use, and that Hoffman failed to give adequate warnings regarding the use of Accutane.[1] No further action was taken in the case until nearly five years later when, on February 21, 1992, Hoffman filed a motion to compel responses to certain interrogatories which had been served upon plaintiff on January 26, 1987.

On March 6, 1992, Hoffman filed an answer generally denying plaintiff's allegations and asserting that (1) plaintiff was contributorily negligent; (2) that there was an intervening cause; (3) that Hoffman had no duty to warn plaintiff directly; (4) that warnings are required to be made to the physician/health care provider who acts as a "learned intermediary" in deciding on the use/administration of such medication; (5) that its methods used in the preparation of Accutane were in conformity with the generally recognized state-of-the-art at the time of preparation; and (6) that Accutane, as prepared and provided by Hoffman, has been approved by the appropriate federal agencies.

On September 29, 1992, Hoffman filed a motion for summary judgment, claiming that there were no genuine issues of material fact in dispute and that it was entitled to judgment as a matter of law. In its memorandum in support of the motion for summary judgment, Hoffman asserted that plaintiff's condition was not caused by the use of Accutane and that Hoffman had provided an adequate warning by informing a learned intermediary (Dr. Graves) of the risks associated with the use of Accutane. Attached to the motion for summary judgment were the following documents:

(1) Affidavit of Dr. Graves;
(2) Dr. Graves's notes for the period of November 1984 through June 1985;
(3) A colonoscopy report from Dr. Barry Scott;
(4) A copy of the 1992 Physician's Desk Reference with regard to certain drugs which had been taken by plaintiff during the same period in which he had taken Accutane;
(5) Other medical records regarding plaintiff's treatment.

Dr. Graves's affidavit stated that plaintiff's last use of Accutane was on November 15, 1984. An attached report of a Barium Enema study and a proctoscopic exam performed on November 27, 1984, revealed normal results. The affidavit also stated the following: (1) that from January 8, 1985, through April 23, 1985, plaintiff had no gastrointestinal complaints or symptoms; (2) that, during the period of January of 1985 through April 23, 1985, plaintiff was prescribed medications other than Accutane; (3) that on or about August 1, 1985, plaintiff was taking Azulfidine for treatment of colitis; (4) that the attached medical records reflected that plaintiff's complaints at the time of the colonoscopy on June 26, 1985, consisted of persistent diarrhea with blood in the stool and pus cells; (5) that, if plaintiff developed colitis and/or ulcerative proctitis in the summer of 1985, it was not causally related to the ingestion of Accutane prior to or on November 15, 1984, as supported by the attached medical records; (6) that he is familiar with Accutane and has treated patients prior to and subsequent to plaintiff with Accutane; and (7) that the contraindications, warnings, precautions, and adverse reaction information which he received accompanying Accutane were adequate for his weighing of the risks against the benefits in prescribing Accutane for plaintiff.

In opposition to Hoffman's motion for summary judgment, plaintiff filed an affidavit, stating that, when he was first prescribed Accutane, he was provided with a brochure which did not disclose the risk of inflammatory bowel disease. Plaintiff also stated that, after he discontinued use of Accutane, he obtained a copy of a patient brochure, which *78 was released sometime after he had received the first brochure, disclosing risks of "severe stomach pain, diarrhea, [and] rectal bleeding." Copies of both brochures were also attached to plaintiff's memorandum in opposition to the motion for summary judgment.

On November 13, 1992, a hearing was held on Hoffman's motion for summary judgment. After argument of counsel, the trial judge denied the motion, but stated that the motion could be re-urged with additional evidence concerning Hoffman's warnings of the association between Accutane and inflammatory bowel disease. On June 16, 1993, Hoffman filed a supplemental motion for summary judgment. Attached to the motion were the affidavit of Mack R. Mericle, Group Director in the Department of Drug Regulatory Affairs for Hoffman, together with various attachments, and the affidavit of Dr. Graves.

In his affidavit, Mericle stated that he is familiar with warnings and other information disseminated by Hoffman regarding Accutane. According to Mericle, on August 25, 1983, Hoffman mailed to every physician in the United States a "Dear Doctor" letter, advising all physicians, among other things, that it had received reports of inflammatory bowel disease in association with the administration of Accutane and that, attached to the letter, was a revised package insert which reflected the fact that Hoffman had received such reports. The August 1983 letter and package insert were attached to Mericle's affidavit as Exhibit A. Mericle indicated that, in February of 1984, the annual Physicians' Desk Reference ("PDR") was distributed to physicians in the United States and that the 1984 PDR entry for Accutane includes a warning regarding the association between Accutane and inflammatory bowel disease. The 1984 PDR entry for Accutane was attached to Mericle's affidavit as Exhibit B.

In his affidavit, Dr. Graves stated the following: (1) that he is a physician licensed to practice medicine in Louisiana, specializing in dermatology; (2) that he prescribed Accutane to plaintiff for the treatment of acne beginning on March 16, 1984; (3) that, on or before March 16, 1984, he was aware of the 1984 PDR and the product information on Accutane contained therein; (4) that he was aware of the 1984 package insert, as published on page 1617 in the 1984 PDR, which states: "The following reactions have been reported in less than 1% of patients and may bear no relationship to therapy ...

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Bluebook (online)
649 So. 2d 75, 94 La.App. 1 Cir. 0242, 1994 La. App. LEXIS 3622, 1994 WL 739269, Counsel Stack Legal Research, https://law.counselstack.com/opinion/mikell-v-hoffman-laroche-inc-lactapp-1994.