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, 1995, 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) injection.
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 "[i]f 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 retinalvitreal specialist for further evaluation and treatment. The specialist concurred in Davis’ diagnosis of CME and prescribed Nalfon, a non-steroidal 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 ipso 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.) 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, 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, 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 "head-shield,” 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 manufacturer to present this and other evidence of its compliance with federal standards on the grounds that it was relevont to whether there was a design defect. Rucker, 77 Ill. 2d at 436-39, 396 N.E.2d at 534-36.
Similarly, citing its opinion in Rucker, our supreme court stated in Moehle v. Chrysler Motors Corp. (1982), 93 Ill. 2d 299, 443 N.E.2d 575, that "evidence of a product’s compliance with governmental safety standards is relevant and admissible in a product liability case on the issue! ] of *** whether a defect in the product is unreasonably dangerous.” Moehle, 93 Ill. 2d at 304, 443 N.E.2d at 577.
The appellate court in Hatfield v. Sandoz-Wander, Inc. (1984), 124 Ill. App. 3d 780, 464 N.E.2d 1105, applied those holdings in a case similar to this one, where a pharmaceutical manufacturer allegedly failed to provide an adequate warning. Hatfield involved, among other things, compliance evidence regarding the FDA’s inaction. The defense was allowed to argue to the jury that the FDA, after learning of the plaintiffs injuries, had failed to require a warning. (Hatfield, 124 Ill. App. 3d at 786-87, 464 N.E.2d at 1109.) Upjohn argues that in this case, as well, it sought to apprise the jury of its compliance with FDA requirements.
The question here turns on whether the FDA’s response to Upjohn’s request amounts to an FDA requirement not to warn with which Upjohn complied. Initially, Upjohn had been asked to submit proposed labeling changes as part of a global change in labeling for an entire class of its products, along with several other manufacturers. Exhibit 2N, the FDA’s response to Upjohn’s request for a labeling change, advised Upjohn that this specific warning related to a specific product and did not fit within the proposed global change relating to all products, and the request to include it as part of the global change was rejected. Upjohn was to "continue using currently approved labeling” until the company received "notification” from the FDA. However, within this same letter, the FDA pointed out to Upjohn that "!i]f important new labeling information becomes available, you should revise your approved product labeling under 21 CFR 314.8.” Upjohn chose not to resubmit. While it is true that any changes to the Depo-Medrol labeling had to be approved by the FDA, and that the FDA disapproved of Upjohn’s proposed change in this instance, it is not true as Upjohn implies that it was merely complying with FDA requirements in not changing its labeling to include a warning of the risk. The FDA did not prohibit Upjohn from changing its labeling; it merely required it to submit its change in the proper manner. Thus, Rucker, Moehle, and Hatfield are simply not on point. The circuit court properly excluded the evidence as irrelevant on the issue of the duty to warn.
On the issue of punitive damages, however, this evidence arguably should not have been excluded. Upjohn reasonably could have maintained that, while it may have been mistaken regarding its rights and duties in light of the letter from the FDA, its actions based upon its interpretation of the letter fall far short of the willful and wanton conduct required for the imposition of punitive damages. The letter from the FDA was thus conceivably relevant to the issue of punitive damages, and arguably, Upjohn should have been allowed to place it before the jury. Because, however, we conclude that there was no duty to warn concerning a known risk under section IV, we need not resolve this issue.
Upjohn also sought to introduce testimony that all the ophthalmologists who testified as experts in this case — Drs. Fagman, Giles, Deutsch, and Levine — still administer Depo-Medrol periocularly to their patients. When the circuit court excluded that evidence in a pretrial motion, according to Upjohn, it enabled plaintiffs to create a false impression that prejudiced Upjohn.
Plaintiffs argue that the circuit court’s ruling here was consistent with its ruling that plaintiffs could not introduce evidence of post-1983 changes in the labeling of Depo-Medrol. The labeling change was excluded, however, because in Illinois subsequent remedial measures are inadmissible to show liability. (134 Ill. 2d Rules 342 through 351, 369; see Schaffher v. Chicago & North Western Transportation Co. (1989), 129 Ill. 2d 1, 14, 541 N.E.2d 643, 648.) The evidence of post-1983 usage of Depo-Medrol by the various expert ophthalmologists who testified at trial, on the other hand, arguably was relevant to the issues of causation (it tended to show that Davis would still have prescribed the drug even if Upjohn had provided warnings) and punitive damages (it tended to show that even if Upjohn could be held to have promoted periocular use of Depo-Medrol, such promotion could not be said to be the "deliberate[ ] inflict[ion of] a highly unreasonable risk of harm” required in Illinois by our supreme court in Loitz v. Remington Arms Co. (1990), 138 Ill. 2d 404, 416, 563 N.E.2d 397, 402). Thus, Upjohn arguably is entitled to a reversal and a new trial because this evidence was excluded. Again, however, because we conclude that there was no duty to warn concerning a known risk under section IV, we need not resolve this issue.
IV
In its appeal, Upjohn argues that because the specialized medical community was already aware of the risk that an inadvertent intraocular injection could cause blindness, plaintiffs failed to prove that a warning was required and, therefore, Upjohn is entitled to judgment notwithstanding the verdict. Plaintiffs respond that, under the standard of review for a motion for judgment notwithstanding the verdict required by Pedrick v. Peoria & Eastern R.R. Co. (1967), 37 Ill. 2d 494, 229 N.E.2d 504, Upjohn has failed to show that all of the evidence so overwhelmingly favors it that no contrary verdict could stand as a matter of law. They point out that this is a much sterner standard of review than that for a motion for a new trial, which requires that the jury verdict be against the manifest weight of the evidence and that the circuit court abused its discretion in denying the motion. (Maple v. Gustafson (1992), 151 Ill. 2d 445, 603 N.E.2d 508.) Upjohn, in its post-trial motion and in its brief on appeal, argues for either judgment notwithstanding the verdict or, in the alternative, a new trial.
Under Illinois law there is no duty to warn of a risk that is already known by those to be warned. (Kokoyachuk v. Aeroquip Corp. (1988), 172 Ill. App. 3d 432, 526 N.E.2d 607, appeal denied (1988), 123 Ill. 2d 559, 535 N.E.2d 402.) 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, 526 N.E.2d at 610.) 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. (N.D. Ill. 1986), 635 F. Supp. 799.) Further, pharmaceutical warnings for prescription drugs are given to physicians as "learned intermediaries.” Northern Trust Co. v. Upjohn Co. (1991), 213 Ill. App. 3d 390, 572 N.E.2d 1030, appeal denied (1991), 141 Ill. 2d 545, 580 N.E.2d 119, cert. denied (1992), 502 U.S. 1095, 117 L. Ed. 2d 418, 112 S. a. 1172.
In this case, no duty to warn existed because the risks at issue were already known to the medical community. Initially, we note that Upjohn did not need to warn Davis about the general risk of performing the action which forms the basis of this litigation: the risk of accidentally penetrating the eye while performing a periocular injection. According to all of the ophthalmologists who testified at trial, this was a risk which was inherent with periocular injections and which was known by the entire ophthalmological community. As Davis testified, he always had the "little thought in the back of [his] head” that he might accidentally penetrate the eye. Clearly, Upjohn did not have a duty to warn the ophthalmological community of this obvious risk. Kokoyachuk, 172 Ill. App. 3d at 439, 526 N.E.2d at 610 ("Where the danger is obvious and generally appreciated, nothing is gained by a warning and none is required”).
Nor did Upjohn have the duty to warn of the specific risk at issue in this case, that is, the risk of an inadvertent intraocular injection causing blindness. The pertinent question for determining whether there is a duty to warn in this instance is whether the medical community was aware of this risk. There is ample evidence that the medical community was aware in 1983 of the risk of vision loss following accidental intraocular injection of the drug. Indeed, Davis himself testified that he knew of this risk.1
In addition, there were several reports in the medical literature describing incidents in which blindness resulted from an inadvertent intraocular injection of Depo-Medrol. For example, a 1981 article by Keith Zinn reported an instance of an intraocular injection of Depo-Medrol in which the patient’s vision following the injection was measured at 20/400 (legally blind). (Zinn, Iatrogenic Intraocular Injection of Depot Corticosteroid and its Surgical Removal Using the Pars Plana Approach, 88 Ophthalmology 13 (1981).) A 1974 article by Schlaegel & Wilson reported six cases of accidental intraocular injections of corticosteroids, four of which involved Depo-Medrol. Of those four, two were followed by a complete loss of vision. Two of the other cases also suffered severe vision loss. (Schlaegel & Wilson, Accidental Intraocular Injection of Depot Corticosteroids, 78 Trans. Amer. Acad. Ophthalmology & Otolaryngology (1974).) A 1969 article by Moschini reported one inadvertent intraocular injection of Depo-Medrol that was followed by a complete loss of vision. (Moschini, Accidental Introduction of Sustained-Action Corticosteroid in the Vitreous Humor, 48 Boll. Oculist 426 (1969).) Several other articles and texts in the literature discussed the general dangers associated with the intraocular injection of steroids; still others reported incidents of intraocular injection of Depo-Medrol in which the adverse reactions were less than blindness or in which there were no long-term adverse reactions.
Physicians are held to a standard of medical expertise (see, e.g., Kirk v. Michael Reese Hospital & Medical Center (1987), 117 Ill. 2d 507, 517-18, 513 N.E.2d 387, 392-95) and may be expected to have knowledge of current medical literature. (See, e.g., 40 Fed. Reg. 15394 (April 7, 1975).) Moreover, Davis testified that he had read articles in the medical literature describing the adverse effects of the intraocular injection of Depo-Medrol. These facts further support the conclusion that the specific risk at issue here was known to Davis, as well as to the medical community.
Plaintiffs maintain that, while Davis may have been aware that Depo-Medrol injected into the eye could be an irritant, and that it could cause blindness, he was unaware that Depo-Medrol could not be removed from the eye if injected into it. They argue that the difficultly of removing the drug from the eye created the only risk relevant to this case and that Upjohn had a duty to warn of this danger.
The relevant question here is whether Upjohn had greater knowledge than the medical community about any difficulty in removing Depo-Medrol from the eye. Dr. Stubbs, Upjohn’s medical monitor for Depo-Medrol, testified that, based on information in the medical literature available in 1983, and in drug experience reports sent to Upjohn, he did not believe that Depo-Medrol would be particularly difficult to remove from the eye.2 Likewise, in the course of testifying about instances reported in the literature in which Depo-Medrol had been injected into the eye, plaintiffs’ expert, Dr. Walson, made a similar statement concerning the removability of the drug.3 In addition, of the three drug experience reports received by Upjohn which described an intraocular injection of Depo-Medrol, two reported that a vitrectomy had been performed and that the Depo-Medrol had been removed. Thus, the record before us does not support the conclusion that Upjohn had greater knowledge than the medical community of any difficulty in removing the drug in the event of an inadvertent intraocular injection. Hence, we cannot hold that Upjohn had a duty to warn of this potential danger.
Plaintiffs also point out that Davis testified he was unaware that Depo-Medrol was not approved for periocular injection and, further, that if he had been informed that Depo-Medrol was not recommended for periocular use in patients such as Meyer Proctor, he would not have used it. However, what Davis knew is not the issue. The relevant benchmark is not what a particular physician knows or does not know but, rather, what is known to the medical community.
A drug’s approved uses or indications are set forth in its labeling; Depo-Medrol’s labeling did not mention periocular administration. If the labeling does not list a particular use, then that use is ipso facto not approved. This is a fundamental fact of medical practice that any minimally trained physician should know. Davis’ testimony that he did not know that Depo-Medrol was not approved for periocular use is irrelevant. Through every label and package insert included with the drug the medical community knew, and that is enough.
Plaintiffs also contend that Upjohn had a duty to warn of the risks associated with the periocular use of Depo-Medrol based, in part, on its having received 23 drug experience reports regarding eye-related reactions to periocular injections of Depo-Medrol. Of these 23 reports, three describe instances of blindness resulting from intraocular injections. Arguably, these three reports provided Upjohn with knowledge of the risk that an inadvertent intraocular injection of the drug could cause blindness. However, as discussed above, both Davis and the ophthalmological community at large were aware of this risk.
The remaining 20 drug experience reports discuss various adverse reactions to the periocular administration of Depo-Medrol. Thus, they are not relevant to the specific risk of intraocular injection which is before us here. Moreover, many of the side effects described in the drug experience reports, such as allergic or hypersensitivity reactions, tissue atrophy and sterile abscesses, were, in fact, listed on the 1983 package insert under the section detailing general, additional adverse reactions to parenteral corticosteroid therapy. Furthermore, the medical literature available in 1983 was replete with listings of the complications associated with periocular administration of corticosteroids. (See, e.g., Giles, Bulbar Perforation During Periocular Injection of Corticosteroids, 77 Am. J. Ophthalmology 438, 438 (1974) ("Adverse effects, however, included elevated intraocular pressure, local irritation of tissue, infection at the site of injection, and perforation of the globe”); Schlaegel, Nonspecific Treat-merit of Uveitis, 4 Clinical Ophthalmology ch. 43, at 4 (rev. ed. 1978) ("[w]ill probably develop some adrenal suppression!;] [d]iscomfort with injection!;] [r]ed irritable eye and ptosis!;] [occasionally, white material is cosmetically objectionable!;] [s]ubconjunctival adhesions!;] [a]llergy to diluent!;] [m]av get orbital infection!;] [r]are intraocular injection of steroid!;] [u]lceration of conjunctiva after repeated injections if not given behind the eye[;] [e]xophthalmos and rugae in fundus!;] [p]apilledema”).) Therefore, even if we consider the 20 drug experience reports relevant to the specific risk at issue, we cannot conclude that they provided Upjohn with greater knowledge than the medical community of the general risks associated with the periocular use of Depo-Medrol.
Plaintiffs concede that if this case involved nothing more than the off-label use of a drug there would be no duty to warn. They maintain, however, that a duty must be imposed here because, by assisting ophthalmologists who engaged in clinical studies of Depo-Medrol in the early 1960s, Upjohn "planted the seed” that led to the widespread periocular use of the drug. We do not agree. However the periocular use of Depo-Medrol was initiated, the fact remains that from the time the drug came onto the market in 1959 until the injection in this case took place in 1983, the drug’s labeling never listed periocular injection as an appropriate method of administration. Moreover, in the approximately 20 years between the time Upjohn assisted the ophthalmologists and the injection at issue here, the periocular use of corticosteroids had become widely practiced (Davis testified that he alone had made 1,600 injections in his career) and was frequently recommended. (See, e.g., Nozik, Periocular Injection of Steroids, 76 Trans. Amer. Acad. Ophthalmology & Otolaryngology 695 (1972).) Whatever role Upjohn had in "planting the seed,” by the time of Meyer Proctor’s injection, the periocular use of Depo-Medrol was broadly accepted by a community of highly trained medical professionals who had made the decision to use the drug in an off-label manner. Because of this fact, we must conclude that the activities of Upjohn in the early 1960s did not create a duty to warn.
We note that our conclusion might have been different if, in fact, there had been a critical imbalance of information between Upjohn and the medical community; if, for example, Upjohn had vigorously and continuously promoted the off-label use while at the same time withholding crucial information about the drug to which only it had access. But, contrary to plaintiffs’ assertions, that simply is not the case before us. Plaintiffs argue that Upjohn never reported to the medical community that "satisfactory” animal studies had not been done on the periocular administration of Depo-Medrol. However, that information is implicit in the very fact that periocular use was an off-label use; a particular use can be recommended only if adequate studies have been submitted to and approved by the FDA. In short, the record demonstrates that the periocular administration of Depo-Medrol was an off-label use; that the ophthalmological community knew that inadvertent intraocular injections were a risk associated with periocular injections; and that it, and Davis in particular, knew that the intraocular injection of Depo-Medrol could result in blindness. To hold that Upjohn had a duty to warn, in light of these facts, would render the learned intermediary doctrine essentially meaningless. Under the circumstances, we see no reason for ignoring established precedent.
Relying on Mahr v. G.D. Searle & Co. (1979), 72 Ill. App. 3d 540, 390 N.E.2d 1214, appeal denied (1979), 79 Ill. 2d 612, the dissent maintains that a pharmaceutical manufacturer cannot evade its responsibility to warn of the risks of using its products by "hoping *** that the doctors will learn of the dangers themselves.” (275 Ill. App. 3d at 616.) In Mahr, where the plaintiffs brought a cause of action for wrongful death, the deceased was alleged to have died as the result of an occlusion of the left internal carotid artery caused by the regular use of Enovid, an oral contraceptive. Searle, the manufacturer of Enovid, was held liable, in part, because of its failure to adequately warn of possible adverse effects associated with using the drug. The court noted that "Searle had the duty to adequately communicate the adverse effects of Enovid to all members of the medical profession who came into contact with [the deceased] in a decision-making capacity during the time she was using the drug.” Mahr, 72 Ill. App. 3d at 562, 390 N.E.2d at 1230.
Mahr is simply not on point because, unlike the off-label use of Depo-Medrol at issue here, the Enovid in Mahr was used by the decedent in an on-label manner, that is, as an oral contraceptive. Thus, the duty described in Mahr was the duty to warn physicians of the adverse effects associated with the on-label use of a drug.
Here, however, the labeling for Depo-Medrol did not list periocular administration as an approved use. We do not have to "hope” that physicians will understand the general principle that there are risks attendant with the nonapproved use of a drug; this too is a fundamental fact of medical practice that any minimally trained physician should know. Nor, in this instance, do we have to hope that ophthalmologists will know the self-evident fact that there is a risk of penetrating the eye while performing periocular injections. Nor do we have to hope that ophthalmologists will know that inadvertent intraocular injections can cause blindness when that fact is known to the medical community, including, in this case, Davis himself.
The dissent also maintains that "Dr. Davis should not have used [the Depo-Medrol] as he did.” (275 Ill. App. 3d at 615.) This is not debatable, at least in the sense that he should not have performed an intraocular injection. What is debatable — more properly, what must be rejected — is the dissent’s implication that Davis and other ophthalmologists should not have been tising Depo-Medrol at all. The record is clear that before the accidental intraocular injection, Meyer Proctor had benefited from the Depo-Medrol treatment. In addition, none of the four ophthalmologists who testified at trial suggested that anything known at the time, or subsequently discovered, would have made this treatment inappropriate. Moreover, as discussed above, Upjohn was prepared to offer evidence that at the time of trial, the four experts who testified still administered Depo-Medrol periocularly to their patients. Except for the negative effect of an accidental intraocular penetration, the record in this case, which demonstrates the beneficial use of Depo-Medrol, provides no basis for concluding that it should not have been used.
The jury determined that there was a duty to warn in this case, and the circuit court found that determination was not against the manifest weight of the evidence. However, the jury’s determination was based upon a misapprehension of the law and a misunderstanding of the learned intermediary doctrine. A proper understanding of that doctrine demonstrates conclusively that the jury’s verdict was against the manifest weight of the evidence, and the circuit court therefore abused its discretion in denying the motion for a new trial. Further, because as a matter of law Upjohn had no duty to warn in this case, all of the evidence so overwhelmingly favors it that no contrary verdict can stand as a matter of law. Under the standard of review for a motion for judgment notwithstanding the verdict required by Pedrick, Upjohn is entitled to such judgment. We therefore reverse the judgment of the circuit court and enter judgment notwithstanding the verdict for defendant Upjohn.
Because we reverse on this ground, it is not necessary for us to reach Upjohn’s other contentions regarding the duty to warn, warning causation, evidentiary rulings, jury instructions, or the excessiveness of compensatory or punitive damages.
Affirmed in part and reversed in part.
McCORMICK,4 J., concurs.