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07/11/97 MEYER PROCTOR AND MARJORIE PROCTOR v.

July 11, 1997

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.



Appeal from the Circuit Court of Cook County. Honorable Leonard L. Levin, Judge Presiding.

Rehearing Denied July 24, 1997. Released for Publication August 21, 1997. As Corrected September 5, 1997.

Presiding Justice Hartman delivered the opinion of the court as modified upon rehearing. Tully, J., concurs. DiVITO, J., dissents.

The opinion of the court was delivered by: Hartman

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 The June 28, 1994 opinion was withdrawn.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, 656 N.E.2d 23, 211 Ill. Dec. 831 (1995)), with a lengthy dissent. Proctor, 275 Ill. App. 3d at 613-27. 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, 677 N.E.2d 918, 222 Ill. Dec. 384 (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. *fn1 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. *fn2 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. *fn3 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. *fn4 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. *fn5 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 he sent us. This sort of thing may have gone through before the new regulations, but it certainly doesn't go now, and at the risk of not getting any more data at all I feel it's time to start setting down on some of these rather loose individuales [sic]. I think [this doctor] is a good friend of ours and I don't have to [sic] many qualms that he is going to be upset, but really the stuff that he let you send to me is almost worthless for reasons as I mentioned in the letter to him." (Emphases added.) *fn6

Dr. Stubbs nevertheless forwarded more vials of Depo-Medrol to this doctor, followed by another supply of Depo-Medrol, on January 21, 1964.

The practice of publicizing unapproved uses of drugs, when sponsored by the pharmaceutical company, is not approved by the FDA as proper advertising; it results in continuing, unapproved, potentially dangerous use. Dr. Stubbs was aware that those experimenting physicians would subsequently write publications which appeared in medical journals, *fn7 for which Upjohn paid secretarial and editorial expenses. These writings, of course, would be addressed to the medical community and become available to ophthalmologists, thereby becoming, incredibly, part of the current medical literature attempting to establish the standard of medical expertise.

In 1965, Dr. Stubbs collected articles in the medical literature and prepared a report for internal use by Upjohn. *fn8 Based on that report, he and his immediate supervisor recommended that Upjohn consider filing a supplemental NDA to obtain FDA approval for periocular administration of the drug. Without FDA approval, Upjohn could not include that use of Depo-Medrol as an approved method of administration on the drug's labeling. In order to supplement the NDA to provide for periocular administration of Depo-Medrol, Upjohn knew that it was "likely that animal tissue tolerance studies" would have to be performed.

Upjohn elected not to pursue a supplemental NDA for periocular administration. A corporate memorandum recommended that "no further Medical Development work be done with Depo-Medrol administered by [periocular] injection," and that "tissue tolerance studies in animals not be undertaken by Biomedical Research unless a request for [an NDA] supplement is initiated by Marketing, and approved in accordance with the currently effective Pharmaceutical New Product System procedures."

Upjohn stipulated that prior to November 7, 1983, it "had the capacity to perform in-house or refer out-of-house [experiments] to be done by private consultants' research in the form of animal studies and all four phases of human studies." Upjohn had in its employ, or available to it, physicians, toxicologists, pharmacologists, statisticians and epidemiologists. Dr. Stubbs admitted that the animal tissue tolerance studies could have been performed if the company had wanted to do them and had the funding to do so. Such studies were already ongoing with other applications of the drug. If Upjohn had begun the animal tissue tolerance studies on the periocular use of Depo-Medrol in 1969 or 1970, it would have had the results well in advance of the casualty involved in this and, perhaps, other cases. Dr. Stubbs acknowledged that the decision whether to go forward with animal studies and supplements on Depo-Medrol for subconjunctival use was left to Upjohn's marketing staff. Dr. Walson believed that marketing should not have been allowed to decide a medical safety and scientific issue.

Upjohn knew of potential adverse reactions to the drug, of which it learned over a period of preceding years from drug experience reports (DERs), *fn9 yet its labeling never referred to unapproved periocular injection of the drug, neither listing it as an appropriate method of administration, including any recommended dosages, nor stating any warnings regarding periocular use. Ophthalmologists, not having been advised of adverse reactions, began making extensive use of periocular injections of Depo-Medrol because the benefits seemingly outweighed the risks. Defendant Dr. Davis, himself, and four others testified to routine periocular administration of the drug.

In October 1980, in response to the FDA's global restructuring of labeling for all corticosteroids, Upjohn proposed a revised Depo-Medrol package insert. The proposed insert included the following statement:

"ADVERSE REACTIONS REPORTED WITH NONRECOMMENDED ROUTES OF ADMINISTRATION ***

Ophthalmic: (Subconjunctival )--Redness and itching, obtuse, slough at injection site, increased intraocular pressure, decreased vision. (Retrobulbar)--Blindness."

In September 1983, the FDA informed Upjohn that it should not make its proposed changes, but rather should "continue using currently approved labeling" until it received "notification" from the agency. The FDA also told Upjohn that "if important new labeling information becomes available, you should revise your approved product labeling under 21 C.F.R. 314.8." The circuit court excluded this evidence. *fn10

In April 1983, Meyer Proctor, a retired public relations worker, consulted Dr. Davis with complaints of blurred vision. Dr. Davis diagnosed Proctor's condition as uveitis, an inflammation of the eye, which can be chronic and can lead to permanent blindness. Dr. Davis began treating this condition with steroid medications applied to both of Proctor's eyes by means of eye drops, which proved to be of only limited value. In May 1983, Proctor developed cystoid macular edema (CME) as a complication of the uveitis, and the vision in his left eye deteriorated to the level of legal blindness. Dr. Davis referred him to a retinal-vitreal specialist for further evaluation and treatment, who concurred in the diagnosis of CME and prescribed Nalfon, a nonsteroidal anti-inflammatory medication. Some improvement in Proctor's vision occurred, but his sight was not restored to normal. After treating Proctor for several months, the specialist referred him back to Dr. Davis, recommending the use of a nonsteroidal anti-inflammatory drug (such as Nalfon), or the systemic or periocular administration of a steroid (such as Depo-Medrol) if continued impairment of vision made further treatment necessary.

On August 1, 1983, Dr. Davis examined Proctor and reinstituted treatment with Nalfon; however, his vision again began to deteriorate. On August 9, 1983, Dr. Davis decided to use periocular injections of Depo-Medrol to treat Proctor's condition, one shot around each eye. Within several weeks, Proctor's vision improved almost to normal, but in November 1983, Proctor experienced renewed problems with the vision in his left eye. In response, on November 7, 1983, Dr. Davis administered another periocular injection of Depo-Medrol near that eye.

All the ophthalmologists who testified at trial regarding the standard of care concluded that Dr. Davis' decision to administer Depo-Medrol via periocular injection both in August and again in November of 1983 was appropriate and within the applicable standard of care. None suggested that anything known at the time, or subsequently discovered, would have made this treatment inappropriate. There were risks associated with this treatment, however. Dr. Davis himself testified that in November 1983 he knew that an inadvertent intraocular injection was a risk of any periocular injection; Depo-Medrol could be "toxic" if inadvertently injected into the eye and cause damage to the eye, including blindness; he had never penetrated the globe of the eye (made an intraocular injection) in more than 1,600 prior periocular injections of Depo-Medrol in his entire career; and, he believed he would be able to deliver the drug to its intended location without incident in this instance.

During the November 7, 1983 injection, however, Dr. Davis mistakenly inserted the needle and Depo-Medrol into Proctor's left eye. Dr. Davis then referred Proctor to a specialist for evaluation and treatment, who determined that the appropriate treatment was observation, waiting for the drug to clear from the eye, and watching for possible retinal detachment, which eventually occurred. Proctor underwent surgery on November 23, 1983, the Depo-Medrol was removed from Proctor's left eye, and the retina was reattached. The retina again detached, however, and two subsequent operations, on December 13 and 29, 1983, failed to reattach it. In April 1984, Proctor's left eye, having become blind and painful, was surgically removed.

Proctor filed suit on February 14, 1984, against Dr. Davis and Upjohn. Discovery proceeded over a period of seven years, and trial began on September 4, 1991.

Proctor alleged that Dr. Davis violated the standard of care in one or more ways, directly and proximately causing the injury. Also alleged was negligence based on res ipsa loquitur and loss of consortium. Proctor's allegations against Upjohn were based on strict product liability, claiming that Depo-Medrol was defective, unsafe, and unreasonably dangerous, and that Upjohn's failure to warn Dr. Davis about the potential harm resulting from an intraocular injection directly and proximately caused the injury. Also alleged was loss of consortium and willful, wanton, or reckless acts or omissions that would support punitive damages.

On October 18, 1991, the jury returned verdicts in favor of Dr. Davis and against Upjohn. The jury awarded Meyer Proctor $3,047,819.76 in compensatory damages and $124,573,750 in punitive damages, and Marjorie Proctor $100,000 in compensatory damages. On September 3, 1992, the circuit court entered an order remitting the punitive damages to $35 million, but otherwise leaving the verdict intact. Proctor filed a notice of appeal as to the Dr. Davis verdict; Upjohn then filed its notice of appeal; and Proctor filed a notice of cross-appeal against Upjohn.

I

Upjohn first argues that, after considering all the evidence in the case in the light most favorable to Proctor, it was entitled to either judgment notwithstanding the verdict or a new trial because Proctor failed to prove that a warning was required, because the risk was too remote to require a warning, and because the specialized medical community was already aware of the risks. The standards for judgment notwithstanding the verdict (see Pedrick v. Peoria & Eastern R.R., 37 Ill. 2d 494, 229 N.E.2d 504 (1967) (Pedrick)) and for a new trial (see Maple v. Gustafson, 151 Ill. 2d 445, 603 N.E.2d 508, 177 Ill. Dec. 438 (1992) (Maple)) differ; Upjohn's contentions will be considered under both standards.

In Illinois, there is no duty to warn of a risk that is already known by those to be warned. Kokoyachuk v. Aeroquip Corp., 172 Ill. App. 3d 432, 526 N.E.2d 607, 122 Ill. Dec. 348 (1988). A duty to warn exists only when there is "unequal knowledge and the defendant, possessed of such knowledge, knows or should know that harm might occur if no warning is given." Kokoyachuk, 172 Ill. App. 3d at 439. In the context of prescription drug litigation, this principle means that a drug manufacturer need not provide a warning of risks known to the medical community. See Wooten v. Johnson & Johnson Products, Inc., 635 F. Supp. 799 (N.D. Ill. 1986). Further, pharmaceutical warnings for prescription drugs are given to physicians as "learned intermediaries." Northern Trust Co. v. Upjohn Co., 213 Ill. App. 3d 390, 572 N.E.2d 1030, 157 Ill. Dec. 566 (1991).

From the evidence it is clear that Upjohn knew or should have known that Depo-Medrol is an insoluble, toxic material which, because of its insolubility, when inserted in the eye, became a foreign body, and was very difficult, if not impossible, to remove. Upjohn, its manufacturer, must be held to the standard of an expert in the field ( McEwen v. Ortho Pharmaceutical Corp., 270 Ore. 375, 528 P.2d 522 (1974)) and had a "continuous duty *** to warn physicians of the dangers incident to prescribing the drug, to keep abreast of scientific developments touching upon the manufacturer's product and to notify the medical profession of any additional side effects discovered from its use. " (Emphases added.) Schenebeck v. Sterling Drug, Inc., 423 F.2d 919, 922 (8th Cir. 1970). If Upjohn did not know what it should have known, it failed in its duty as an expert. It could not fulfill that duty merely by waiting for what it considered sufficient proof of a cause-effect relationship before advising the medical profession with an appropriate alert or warning of the possibility of risk in the use of one of its products. See Mahr v. G.D. Searle & Co., 72 Ill. App. 3d 540, 564, 390 N.E.2d 1214, 28 Ill. Dec. 624 (1979) (Mahr). Nor can failure to do so be excused merely by the fact that the potentially endangered users are few in number. Mahr, 72 Ill. App. 3d at 560; Crocker v. Winthrop Laboratories, Division of Sterling Drug, Inc., 514 S.W.2d 429, 432 (Tex. 1974). The injury here clearly was within the scope of the dangerous propensities of the drug for which Upjohn must be held accountable. See McMahon v. Eli Lilly & Co., 774 F.2d 830, 835 (7th Cir. 1985).

The evidence revealed that Upjohn knew of Depo-Medrol's dangerous propensities before the instant occurrence took place in 1983 (e.g., footnote 3); yet, there was no reference in the 1983 label or insert that subconjunctival use of Depo-Medrol as practiced upon Proctor in this case was not recommended by Upjohn, nor that FDA approval was never secured for such application. There was no mention on the label that one cc. amount of the drug for use about and around the eye was an excessive dosage, according to one of its own experts. E.g., footnote 3. Tissue atrophy developed in some patients after injection, which could be considered as evidence of a toxic effect, also known by Upjohn before 1983. E.g., footnote 3. The 1983 package insert made no reference to the fact, known by Upjohn, that the drug should be administered intramuscularly as "probably the predominant steroid effect is going to be a systemic effect anyway." E.g., footnote 3. Nor did it point out that this preparation was a suspension and not a solution, and that the crystalline material in the area of sensitive subconjunctival tissue could be the cause in itself for injury. E.g., footnote 3. Dr. Walson, Proctor's expert, was of the opinion that, given Upjohn's knowledge of the foregoing facts in 1962, the drug company should have warned that periocular use of the drug was not recommended, and under the adverse reaction section of the warning, should have listed the toxicity of the drug.

As previously noted, the FDA had approved the use of Depo-Medrol only for certain other uses, involving three specific means of administration: intramuscularly, intra-articularly, and intralesionally; none of those approved uses included the periocular use to which the drug was put in this case. Federal law required Upjohn to include package inserts and labeling recommendations which referred only to the three approved forms of administration for its product. Upjohn should ...


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