Proctor v. Davis

• Decision Date: 11 July 1997
• Docket Number: 1-92-3513,Nos. 1-92-3151,s. 1-92-3151
• Citation: 291 Ill.App.3d 265,682 N.E.2d 1203
• Parties: , 225 Ill.Dec. 126, Prod.Liab.Rep. (CCH) P 15,048 Meyer PROCTOR and Marjorie Proctor, Plaintiffs-Appellants, Separate Appellees/Cross-Appellants, v. Michael J. DAVIS, M.D., Defendant-Appellee, v. The UPJOHN COMPANY, a Corporation, Separate Defendant-Appellant/Cross-Appellee.
• Court: United States Appellate Court of Illinois

Page 1203

682 N.E.2d 1203

291 Ill.App.3d 265, 225 Ill.Dec. 126,

Prod.Liab.Rep. (CCH) P 15,048

Meyer PROCTOR and Marjorie Proctor, Plaintiffs-Appellants, Separate Appellees/Cross-Appellants, v. Michael J. DAVIS, M.D., Defendant-Appellee, v. The UPJOHN COMPANY, a Corporation, Separate

Defendant-Appellant/Cross-Appellee.

Nos. 1-92-3151, 1-92-3513.

Appellate Court of Illinois First District, Fifth Division.

July 11, 1997.

Rehearing Denied July 24, 1997.

Goldberg & Goldberg, Chicago (Barry Goldberg and Ann Herbert, of counsel), David Novoselsky & Assoc., Chicago (David Novoselsky and Linda Bryceland, of counsel), for Plaintiffs-Appellants.

Hinshaw & Culbertson, Chicago (Stephen Swofford, of counsel) and Bollinger, Ruberry & Garvey, Chicago (Mauice Garvey, of counsel), for Defendant-Appellee.

Mayer, Brown & Platt, Chicago (Alan Salpeter and Laurie Gallancy, of counsel), Mayer, Brown & Platt, Washington, DC (Andrew Frey, Clifford Sloan and Alan Untereiner, of counsel) and Todd Kingma, Litigation Counsel, the Upjohn Co., Kalamazoo, MI, for Separate Defendant-Appellant.

Presiding Justice HARTMAN delivered the opinion of the court as modified upon rehearing:

Plaintiffs Meyer Proctor and Marjorie Proctor (sometimes collectively Proctor) filed this medical malpractice and products liability action against Dr. Michael J. Davis (Dr. Davis) and the Upjohn Company (Upjohn), alleging serious injury resulting from Dr. Davis' injection of the corticosteroid Depo-Medrol, manufactured by Upjohn, directly into Meyer Proctor's left eye on November 7, 1983. A jury exonerated Dr. Davis, but found against Upjohn, awarding Proctor compensatory damages of $3,047,819.76, and punitive damages of $124,573,750, the latter of which the circuit court remitted to $35 million. Proctor and Upjohn appealed from that judgment. Proctor also cross-appealed the denial of their motion for sanctions and attorney fees.

On June 28, 1994, a unanimous opinion was filed by this court affirming the jury's decision as to Dr. Davis and its award as to Upjohn, but reducing the punitive damages to $3,047,819.76. Upjohn's motion for rehearing was allowed and further oral argument ensued. The June 28, 1994 opinion was withdrawn. Two members of this court issued another opinion, affirming the verdict as to Dr. Davis, but reversing outright the jury's award as to Upjohn (Proctor v. Davis, 275 Ill.App.3d 593, 211 Ill.Dec. 831, 656 N.E.2d 23 (1995)), with a lengthy dissent. Proctor, 275 Ill.App.3d at 613-27, 211 Ill.Dec. 831, 656 N.E.2d 23. Our supreme court invalidated that opinion because one of the majority judges, Justice McCormick, had retired before the opinion was to become effective. This court was directed "to enter a constitutionally valid opinion or order disposing of the matters raised, briefed and argued subsequent to Upjohn's unanimously allowed rehearing petition." Proctor v. Upjohn Co., 175 Ill.2d 394, 397, 222 Ill.Dec. 384, 677 N.E.2d 918 (1997). Our opinion and companion Supreme Court Rule 23 order follow.

Upjohn's claims regarding its duty to warn and punitive damages will be considered, in part, in this opinion. All remaining issues and contentions will be determined in a separate Supreme Court Rule 23 order disseminated contemporaneously with this opinion.

In 1959, the Food and Drug Administration (FDA) approved Upjohn's "New Drug Application" (NDA) for Depo-Medrol, a sterile, aqueous suspension containing methyl prednisone acetate, a corticosteroid, for treatment of various inflammatory bodily disorders. The FDA's approval was limited to intramuscular (in the muscle), intra-articular (in the joint), and intralesional (in a lesion) injections. According to the evidence, Depo- Medrol is an insoluble, toxic material, which is intended to be released in the body over a period of six to eight weeks in human tissue with adequate blood supply; however, the human eye does not possess such a blood supply. Depositing Depo-Medrol into the eye meant that the drug would remain in the eye for a relatively long time. Because of its insolubility, its crystals had an effect on the body's response to it when inserted, including increased intraocular pressure and other trauma. It became a foreign body in the eye, which was very difficult, if not impossible, to remove once injected into the eye.

Shortly after Depo-Medrol's FDA limited approval, two ophthalmologists contacted Upjohn independently, each wishing to use the drug clinically for the treatment of ophthalmic conditions through an unapproved method of administration----periocular (near the eye) injections. ¹ This use of Depo-Medrol was neither approved by the FDA nor listed on Depo-Medrol's label (off-label use). Nevertheless, Upjohn immediately provided both with vials of Depo-Medrol without cautioning them that no animal studies had been initiated to test the reaction of the drug upon living tissue before embarking upon human use. Instead, Dr. Porter Crawford an Upjohn employee responsible for monitoring Depo-Medrol at the time, encouraged this unapproved off-label use, as follows:

"Thank you very much for * * * your interest in Depo-Medrol for subconjunctival injection in the treatment of uveitis. We do not have any reports concerning this use for the preparation and we would very much like for you to evaluate it in this way." (Emphasis added.)

Dr. Crawford sent vials of Depo-Medrol to the inquiring doctor and asked him to let him know when he needed additional supplies. Dr. Crawford also noted that Upjohn would "be anxious to learn how it performs when used this way."

Upjohn dispensed not only vials of Depo-Medrol but, also, financial assistance to doctors who would use Depo-Medrol for the unapproved off-label use of periocular injections, granting one in 1959, $3,000. This doctor later wrote Upjohn that he had given two talks in Chicago in the fall of 1960, extolling the use of Depo-Medrol for subconjunctival injections, although he knew otherwise, having written in the same letter that the "experimental work * * * fell flat since we are unable to find anything in the aqueous." (Emphasis added.) In response, Upjohn wrote back that the FDA "has not approved this use of Depo-Medrol because we have had no clinical work to show to them." Upjohn asked the doctor to prepare a write-up of his cases or publish an article in order to document this off-label use for possible FDA approval. Upjohn noted that "not too many people are actually using this type of therapy and your good results suggest that the work should be scattered about."

Upjohn itself undertook the task of "scattering about" the unapproved off-label use of Depo-Medrol to the medical community. In 1961, an article on the use of Depo-Medrol was written by the experimenting doctor to whom Upjohn had given $3,000. This doctor informed Dr. Crawford, on August 31, 1961, of the completion of the article, noting separately, however, that he was unable to use any of his animal experiments because the results were "very unsatisfactory." (Emphasis added.) Proctor's expert, Dr. Philip Walson, who reviewed this correspondence, believed the omission of the animal studies created a serious problem because collected data was ignored, and the animal studies, although "unsatisfactory," should have been included in the article touting this use of Depo-Medrol.

Upjohn nevertheless ordered and distributed 2,500 reprints of the article, 500 for "hospital sales" and 2,000 for "sales education," thus becoming part of the "literature" to which the ophthalmic community was exposed. ² On November 16, 1961, Upjohn requested reprints of another experimenting doctor's article for distribution, which also mentioned the use of subconjunctival injections of Depo-Medrol. ³ More "fodder" priming the sales pump.

On March 8, 1963, Upjohn's Dr. Samuel Stubbs wrote to a different experimenting doctor, requesting case histories on the patients he had treated with Depo-Medrol, which Upjohn would use to supplement its original NDA. Dr. Stubbs informed him that Upjohn would compensate him for his time, and that of his secretary, in preparing the case reports. In response, by letter dated March 14, 1963, the doctor stated that he would begin working on the case reports and requested that Upjohn meanwhile send him more Depo-Medrol, which, on March 19, 1963, Upjohn did without mentioning the information and precautions suggested by its Dr. Gerard to its salesmen in 1962. E.g., footnote 3.

Harry P. Davis, Jr., an Upjohn sales representative, wrote to Mr. Crissman at Upjohn on June 12, 1963, informing him that two Ohio physicians were using Depo-Medrol for "severe, chronic or acute, uveitis by retrobulbar injection," but that neither physician was aware that anything had been published on the use of this drug. Dr. Stubbs wrote to these two Ohio doctors on June 26, 1963, informing them of Upjohn's interest and asking for case reports of their experience with the drug. Further, if they were interested in publishing their work, Dr. Stubbs would make the "services of The Upjohn Writing Staff" available to them, would pay for their secretary's time, and would compensate the doctors for work on the case reports, admittedly intending to "plant the seed" in those doctors' minds about publishing an article.

On July 1, 1963, the Ohio doctors responded with eight case reports, which Dr. Stubbs referred to Harold Tucker, one of Upjohn's medical writers, for potential publication. ⁴ An article written as a result of Upjohn's "expert assistance" proclaimed that positive results from the subconjunctival injection of Depo-Medrol had been confirmed by others. ⁵ All the while, Upjohn's own expert, Dr. Stubbs, himself questioned the validity of the so-called studies. On September 19, 1963, he wrote to Jack Toole, Upjohn's hospital representative, criticizing the data, stating:

"I'm enclosing a copy of the letter I have written to him, and it is a mild rebuff for the lousy data h...