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06/28/94 MEYER PROCTOR AND MARJORIE PROCTOR v.

June 28, 1994

MEYER PROCTOR AND MARJORIE PROCTOR, PLAINTIFFS-APPELLANTS AND SEPARATE APPELLEES AND CROSS-APPELLANTS,
v.
MICHAEL J. DAVIS, DEFENDANT-APPELLEE (THE UPJOHN COMPANY, SEPARATE DEFENDANT-APPELLANT AND CROSS-APPELLEE).



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

As Modified On Rehearing September 26, 1995. Released for Publication November 3, 1995.

Justice DiVITO delivered the opinion of the court: McCORMICK, J.,* concurs. Hartman, J. Dissents.

The opinion of the court was delivered by: Divito

MODIFIED ON REHEARING

Justice DiVITO delivered the opinion of the court:

Plaintiffs Meyer Proctor and Marjorie Proctor (collectively, plaintiffs) filed this action against The Upjohn Company (Upjohn) and Dr. Michael J. Davis (Davis), alleging injury resulting from Davis' mistaken injection of the corticosteroid Depo-Medrol, an Upjohn product, directly into Meyer Proctor's left eye on November 7, 1983. After three unsuccessful surgical attempts to reattach the retina, the eye, which had become blind and painful, was removed. After a five-week trial, a jury found in favor of Davis but against Upjohn, awarding plaintiffs compensatory damages of $3,047,819.76, and imposing punitive damages of $124,573,750. Later, the circuit court remitted the punitive damages to $35 million, but otherwise left the verdicts intact.

Upjohn now appeals from the judgment; plaintiffs appeal the judgment for Davis; and plaintiffs cross-appeal the denial of their motion for sanctions and attorney fees. In an opinion issued on June 28, 1994, we affirmed the judgment for Davis and the denial of the motion for sanctions, and affirmed the judgment against Upjohn but remanded the case to the circuit court and instructed it to enter a remittitur of the punitive damages to an amount equal to the compensatory damages, $3,047,819.76. Plaintiffs filed a petition for rehearing on August 2, 1994, which we denied. Upjohn filed a petition for rehearing on the same date, which we granted. Following plaintiffs' response to Upjohn's petition and Upjohn's reply, as well as a brief in support of Upjohn's petition from amicus curiae, and additional oral argument, we again affirm the judgment for Davis and the denial of the motion for sanctions, but we now reverse the judgment against Upjohn and enter judgment notwithstanding the verdict in favor of Upjohn.

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 the treatment of various inflammatory disorders throughout the human body. Upjohn established the safety of the drug for its intended uses through acute toxicity animal studies. The FDA-approved methods of administration of the drug were limited to intramuscular (in the muscle), intra-articular (in the joint), and intralesional (in a lesion) injections.

Shortly after Depo-Medrol's FDA approval, two ophthalmologists contacted Upjohn independently, each wishing to use the drug clinically for the treatment of ophthalmic conditions through a nonapproved method of administration--periocular (near the eye) injections. The technique of periocular injections was widely used in the medical community; by 1983 physicians were using it an estimated 1 million times each year. Physicians had previously used periocular injections with other steroids to avoid the side effects from other methods of administration, and to provide more direct action on the point of inflammation in the eye. As a new, longer-acting steroid, Depo-Medrol appeared to offer advantages for this type of use.

Upjohn provided these physicians, and others through the years, with financial and technical assistance and supplies of the drug. Between 1961 and 1964, several articles were published in the medical literature regarding periocular use of Depo-Medrol, including one instance in which a medical writer at Upjohn helped the treating physicians prepare the article.

In 1965, Dr. Samuel Stubbs, the Upjohn employee responsible for monitoring Depo-Medrol, collected articles in the medical literature and data supplied by these physicians, and prepared a report for internal use by the company. Based on that report, Stubbs 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. The materials included in Stubbs' report indicated that Depo-Medrol appeared to be effective for various inflammatory conditions of the eye and that the side effects associated with periocular use were minimal. At the time Stubbs prepared his report, Upjohn had not received notice of any incident involving adverse effects from inadvertent intraocular (in the eye itself) injection of the drug.

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 N.D.A. supplement is initiated by Marketing, and approved in accordance with the currently effective Pharmaceutical New Product System procedures." Once Upjohn made that decision, it neither conducted, sponsored, nor supported any further clinical investigations of Depo-Medrol for periocular injection.

Thus, between the date it first appeared on the market in 1959 and the date of the relevant injection in this case in 1983, Upjohn's Depo-Medrol labeling never made any reference to 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. Nonetheless, physicians remained free to use the drug in any manner that they wished, including those uses not indicated in the labeling (off-label uses). Ophthalmologists, in particular, made extensive use of periocular injections of Depo-Medrol because the benefits were seen to outweigh the risks. Defendant Davis himself had made more than 3,000 periocular injections (including 1,600 periocular injections of Depo-Medrol) during his career. Four other ophthalmologists who were asked about the subject at trial testified to routine periocular administration of the drug, and medical textbooks recommended this off-label use.

When a pharmaceutical company receives a report about an adverse reaction associated with the use of its product, it records it in a drug experience report and forwards it to the FDA. In the 24 years between the first marketing of Depo-Medrol and the injection of Meyer Proctor that led to this suit, Upjohn received 23 reports indicating adverse experiences associated with its use. The drug experience reports based on these communications were forwarded to the FDA, usually accompanied by a cover letter stating that the use involved was not a recommended one. Three of these reports (one in 1977 and two in 1983) concerned vision loss following periocular injections with unintentional intraocular injection. Additionally, the medical literature had reported other instances of accidental intraocular injections of corticosteroids like Depo-Medrol, some of which were followed by vision loss.

In October 1980, in response to the FDA's comprehensive 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."

Subconjunctive and retrobulbar injections are types of periocular injections. 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. However, 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.

In April 1983, Meyer Proctor, a retired public relations worker, consulted Davis, a board-certified ophthalmologist, with complaints of blurred vision. Davis diagnosed Proctor's condition as uveitis, an inflammation of the eye, which can be chronic and unremitting and can lead to permanent blindness. Davis began treating this condition with steroid medications applied to both of Proctor's eyes by means of eye drops. Topical administration of steroids, however, proved to be of only limited value in treating the uveitis.

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. Davis referred him to a retinal-vitreal specialist for further evaluation and treatment. The specialist concurred in Davis' diagnosis of CME and prescribed Nalfon, a nonsteroidal anti-inflammatory medication. The Nalfon produced some improvement in Proctor's vision, but did not restore his sight to normal. After treating Proctor for several months, the specialist referred him back to 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, Davis examined Proctor and reinstituted treatment with Nalfon, which Proctor had temporarily discontinued. When Proctor's vision again began to deteriorate, on August 9, 1983, after concluding that no other treatment option would be effective, Davis decided to use periocular injections of Depo-Medrol to treat Proctor's condition. Davis gave Proctor one shot around each eye. Within several weeks, Proctor's vision improved almost to normal for the first time in months. In November 1983, however, Proctor experienced renewed problems with the vision in his left eye. In response, on November 7, 1983, Davis administered another periocular injection of Depo-Medrol near that eye.

All the ophthalmologists who testified at trial regarding the standard of care testified that Davis' decision to administer Depo-Medrol via periocular injection both in August and again in November of 1983 was appropriate and well within the applicable standard of care. None of them suggested that anything known at the time, or subsequently discovered, would have made this treatment inappropriate. There were risks associated with this treatment, however. Davis himself testified that in November 1983 he knew that an inadvertent intraocular injection was a risk of any periocular injection. He also testified that, in his view, Depo-Medrol could be "toxic" if inadvertently injected into the eye and could in that event cause damage to the eye, including blindness. Davis had never penetrated the globe of the eye (made an intraocular injection) in more than 1,600 prior periocular injections of Depo-Medrol, or during more than 1,800 periocular injections of other drugs, and he had no reason to doubt that he would also be able to deliver the drug to its intended location without incident in this instance.

During the November 7, 1983 injection, however, Davis mistakenly inserted the needle into Proctor's left eye, injecting some Depo-Medrol into the eye. Realizing that a significant complication was possible, Davis referred Proctor to a specialist for evaluation and treatment. The specialist determined that the appropriate treatment was observation, waiting for the drug to clear from the eye, and watching for possible retinal detachment. The Depo-Medrol did begin to clear, but the retina became detached, whereupon Proctor was referred to the University of Illinois Eye and Ear Clinic for surgery. On November 23, 1983, the Depo-Medrol was removed from Proctor's left eye, and the retina was reattached. The retina became detached again, 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.

Plaintiffs filed suit on February 14, 1984, against Davis and Upjohn. Discovery having proceeded over a period of seven years, and motions in limine having been heard and ruled upon, trial began on September 4, 1991.

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

The only witnesses at trial were Davis, six experts, Stubbs, and plaintiffs.

On October 18, 1991, after hearing evidence for five weeks and deliberating for four hours, the jury returned verdicts in favor of 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. An order setting Upjohn's appeal bond at $51,780,000 was entered on September 30, 1992; this order also denied plaintiffs' motion for sanctions against Upjohn. Plaintiffs filed their notice of appeal regarding the judgment for Davis on September 10, 1992, Upjohn filed its notice of appeal on October 2, 1992, and plaintiffs filed their notice of cross-appeal against Upjohn on October 6, 1992.

I

Plaintiffs appeal separately the jury verdict in favor of Davis. They contend that they are entitled to judgment notwithstanding the verdict or, in the alternative, a new trial. In support of their contentions, plaintiffs assert that expert testimony established that Davis was negligent in his administration of the periocular injection to Meyer Proctor because he failed to utilize required safeguards. They also argue that the circuit court erred in refusing to allow them to impeach Davis and in refusing to give their tendered jury instructions. Davis responds that the jury's determination that he complied with the standard of care is supported by substantial evidence; that plaintiffs never attempted to impeach him; and that plaintiffs' jury instructions were properly refused because they were not supported by the evidence.

As Davis points out, the jury's verdict in his favor had nothing to do with plaintiffs' product liability claim against Upjohn. Plaintiffs' medical malpractice claim against Davis came down to a single issue: whether Davis' failure to rock the needle from side to side after it was inserted in order to see if the eye moved constituted a breach of the standard of care. Plaintiffs' expert, Dr. William S. Fagman, testified that in his opinion Davis violated the standard of care. Davis' expert, Dr. Conrad L. Giles, testified that in his opinion Davis did not violate the standard of care. A factual issue was thus established for the jury to resolve, and the jury resolved it by finding Davis not liable. Absent a showing that the judgment entered on the verdict was against the manifest weight of the evidence, we will not disturb the judgment.

During the trial, Davis testified that he rotated the needle to the beveled edge during the injection. In his discovery deposition, he never stated that he had done so. Plaintiffs assert that they should have been allowed to impeach Davis about the inconsistency in his testimony. However, Davis was never asked a specific question about the position of the bevel during his deposition. Further, at the time of the deposition, the position of the bevel was not an issue raised by the pleadings. Finally, plaintiffs were allowed, without objection, to cross-examine Davis concerning his deposition testimony, and Davis admitted that his deposition testimony made no reference to the placement of the bevel edge. Plaintiffs' claim that they were prejudiced by the court's rejection of their attempted impeachment of Davis lacks merit.

Related to this claim is plaintiffs' assertion that the circuit court erred when it refused to give their tendered jury instruction that Davis could be found negligent for failing to rotate the needle when a question of fact existed as to whether or not he had rotated the needle. A party has a right to have the jury instructed on his theory of the case as long as there is some evidence to support that theory. ( Erickson v. Muskin Corp. (1989), 180 Ill. App. 3d 117, 535 N.E.2d 475, 128 Ill. Dec. 964.) In this case, however, Davis testified that he did, in fact, rotate the needle, and there was no testimony to the contrary. The fact that his deposition did not include such a statement was before the jury, but that impeachment by omission did not amount to evidence that he did not do so. Under these circumstances, the circuit court was well within its discretion in refusing the tendered instruction, since there was no evidence in the case to support the theory underlying the instruction.

In Maple v. Gustafson (1992), 151 Ill. 2d 445, 455, 603 N.E.2d 508, 177 Ill. Dec. 438, the Illinois Supreme Court stated that "[a] court's ruling on a motion for a new trial will not be reversed except in those instances where it is affirmatively shown that it clearly abused its discretion." In this case, plaintiffs have not clearly demonstrated an abuse of discretion on the part of the circuit court in refusing a jury instruction, in limiting impeachment, or in entering judgment on the verdict. Consequently, we affirm the circuit court's judgment in favor of Davis.

II

Plaintiffs cross-appeal the circuit court's denial of sanctions in the form of attorney fees against Upjohn. Since plaintiffs fail to address this issue in their opening brief, however, the issue is waived, and this court need not consider it. 134 Ill. 2d R. 341.

III

Upjohn argues that the evidence that Depo-Medrol's labeling format was mandated by the FDA was compliance evidence vitally important to its case, and that its exclusion independently requires a new trial. Additionally, it argues that the evidence of post-1983 usage of Depo-Medrol was relevant to several critical issues in the case and that the exclusion of this evidence so seriously prejudiced it that it is entitled to a new trial.

A

Upjohn argues that the jury could very well have reached a different verdict had the evidence regarding its request for a change in the Depo-Medrol labeling, and the FDA's response to that request, been admitted. In particular, since the punitive damages were assessed because of Upjohn's allegedly willful and wanton conduct in failing to warn, Upjohn argues that it is likely that it was prejudiced in this area by the exclusion.

Upjohn attempted to introduce this evidence at trial through Stubbs, the former medical monitor for Depo-Medrol, who was familiar with the labeling issue and the requested change. Upjohn made it clear that it offered the evidence as relevant to both the failure to warn claim and the punitive damages claim. Plaintiffs objected to the admission of the evidence, claiming that the global label change request had no relevance to the specific warning label for Depo-Medrol. Plaintiffs further argued that the evidence would be relevant only to a federal preemption claim and that Upjohn had not raised such a claim as an affirmative defense. The circuit court upheld plaintiffs' objection and excluded three exhibits and Stubbs' proposed testimony.

In Illinois, as Upjohn points out, evidence of compliance with federal requirements is not limited to preemption cases, but rather is admissible as relevant evidence in product defect cases. The Illinois Supreme Court has so held on two occasions. In Rucker v. Norfolk & Western Ry. Co. (1979), 77 Ill. 2d 434, 396 N.E.2d 534, 33 Ill. Dec. 145, our supreme court addressed the admissibility of evidence tendered by the defendant to show the absence of a standard with respect to the particular design defect claimed by the plaintiff. The plaintiff had argued that a railroad tank car was defectively designed because it lacked a "headshield," a protective device that would shield the car from damaging contact. Federal regulations did not require such a device at the time the tank car was manufactured. The Illinois Supreme Court allowed the defendant ...


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