Court Opinion

ID: 9728455
Source: CourtListenerOpinion
Date Created: 2023-08-26 14:08:22.824654+00
Date Added: 2024-06-11T18:25:48.790255
License: Public Domain

JUSTICE DiVITO, dissenting: Meyer Proctor suffered a painful and tragic injury. For that, however, Upjohn bears no responsibility. Succinctly stated, Proctor’s injury was the result of an accident involving Dr. Davis’ use of a needle, and Upjohn could not have prevented, nor was it responsible for, the doctor’s mistake. Judgment notwithstanding the verdict should have been granted because Upjohn had no duty to warn and, even if it did, there was no showing that any alleged failure to warn was a proximate cause of Proctor’s injury. Alternatively, reversal and a new trial are warranted because the circuit court improperly excluded critical evidence favorable to Upjohn. DUTY TO WARN In the 1995 opinion filed in this case (Proctor v. Davis, 275 Ill. App. 3d 593, 656 N.E.2d 23 (1995), invalidated by Proctor v. Upjohn Co., 175 Ill. 2d 394, 677 N.E.2d 918 (1997)), I wrote that Upjohn had no duty to warn. For the reasons I expressed in that opinion, incorporated by reference here, some of which I reiterate in this dissent, I continue to believe that Upjohn had no duty to warn. The majority holds that Upjohn is liable for Proctor’s injury because it knew that Depo-Medrol was toxic and difficult to remove if injected into the eye, and it failed to warn ophthalmologists of these risks. 291 Ill. App. 3d at 279-81. The record, however, does not justify that conclusion because it contains ample evidence that the medical community, including Dr. Davis, was aware of the risks associated with periocular injection of Depo-Medrol. Drs. Walson, Deutsch, Giles, and Fagman testified that the possibility of intraocular injection was a well-known risk of periocular use of Depo-Medrol. Dr. Walson, plaintiffs’ own expert, also testified that he thought that, in 1983, ophthalmologists were aware that inadvertent intraocular injection of Depo-Medrol had caused the loss of an eye for some patients. In addition, there were several reports in the medical literature describing incidents in which vision loss resulted from an inadvertent intraocular injection of Depo-Medrol. Physicians are held to a standard of medical expertise (see, e.g., Kirk v. Michael Reese Hospital & Medical Center, 117 Ill. 2d 507, 517-18, 513 N.E.2d 387 (1987)) and may be expected to have knowledge of current medical literature (see, e.g., 40 Fed. Reg. 15394 (April 7, 1975)). Included in the literature of which ophthalmologists would be expected to be aware was a 1981 article, which reported that a patient became legally blind as a result of an intraocular injection of Depo-Medrol. K. Zinn, Iatrogenic Intraocular Injection of Depot Corticosteroid and Its Surgical Removal Using the Pars Plana Approach, 88 Ophthalmology 13 (1981). A 1974 article discussed six cases in which corticosteroids were accidentally injected intraocularly. Four of these cases involved Depo-Medrol, and in two of those four cases, the patients suffered a complete loss of vision. In the two cases involving the injection of the other corticosteroid, the patients also suffered severe vision loss. T. Schlaegel & F. Wilson, Accidental Intraocular Injection of Depot Corticosteroids, 78 Transactions—American Academy of Ophthalmology & Otolaryngology 847 (1974). A 1969 article by Moschini reported that a patient suffered a complete loss of vision following an inadvertent intraocular injection of Depo-Medrol. G. Moschini, Accidental Introduction of Sustained-Action Corticosteroid in the Vitreous Humor, 48 Bollettino D’Oculistica 426 (1969) (as translated). Several other articles and texts in the literature discussed the general dangers associated with the intraocular injection of steroids; still others reported no long-term adverse effects or reported adverse effects less severe than blindness following the intraocular injection of Depo-Medrol. A 1976 textbook also contained the information that inadvertent intraocular injections of steroids had caused blindness. F.T. Fraunfelder, Drug-Induced Ocular Side Effects and Drug Interactions (1976). Not only were the risks associated with periocular use of Depo-Medrol well-known to the medical community, they were also evident to Dr. Davis. Although he testified that he did not know that Depo-Medrol could not be easily removed once injected into the eye, Dr. Davis knew that injecting it into the eye could lead to blindness. From reading medical literature, he knew that accidental intraocular injection was possible and that piercing of the eyeball could cause damage, including blindness. He also testified that he knew Depo-Medrol was toxic to the eye. Even as a medical resident, he and his fellow medical residents were well aware of the drug’s toxicity and knew that it should not be used intraocularly. The majority asserts that Upjohn had superior knowledge of the risks associated with periocular use of Depo-Medrol because physicians did not know of Depo-Medrol’s toxicity and did not know that it could not be removed once injected. 291 Ill. App. 3d at 279. The record, however, does not support a conclusion that ophthalmologists were unaware in 1983 that Depo-Medrol could be toxic if injected into the eye. No ophthalmologist testified that he was unaware that the drug could be toxic if used in this way, and Dr. Giles and Dr. Davis both testified that they were aware in 1983 that Depo-Medrol could be toxic if injected into the eye. With respect to the removability of the drug, the relevant question 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 information in drug experience reports sent to Upjohn, he did not believe that Depo-Medrol would be particularly difficult to remove from the eye. Likewise, in the course of testifying about instances reported in the literature concerning the injection of Depo-Medrol into the eye, Dr. Walson made a similar statement concerning the removability of the drug. In addition, two of the three drug experience reports received by Upjohn that described an intraocular injection of Depo-Medrol reported that the Depo-Medrol had been removed by performing a vitrectomy. 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. Even with the evidence viewed in the light most favorable to plaintiffs, therefore, Upjohn had no duty to warn in this case. The record demonstrates that the medical community and Dr. Davis were well aware of the potential danger associated with periocular injections of Depo-Medrol and that Upjohn did not have superior knowledge of these risks. FAILURE TO WARN AS PROXIMATE CAUSE Also, there is no basis for the majority’s conclusion, in its unpublished Rule 23 order, that plaintiffs established that Upjohn’s failure to warn was a proximate cause of Proctor’s injuries. Proctor v. Davis, No. 1—92—3151, slip op. at 5-8 (July 11, 1997) (unpublished order under Supreme Court Rule 23) (hereinafter Rule 23 order). As the majority states, in order to prove proximate cause, plaintiffs were required to show that Dr. Davis’ treatment decision would have been altered if he had received the warning they argue Upjohn should have provided. Rule 23 order, at 5, citing Ashman v. SK&F Lab Co., 702 F. Supp. 1401 (N.D. Ill. 1988). Dr. Davis did testify that he would not have given Proctor a periocular injection of Depo-Medrol had he known it was difficult to remove and might cause blindness. Certainly, it was the role of the jury to evaluate his credibility and to resolve conflicts in the evidence. See Maple v. Gustafson, 151 Ill. 2d 445, 452-53, 603 N.E.2d 508 (1992). Nevertheless, judgment notwithstanding the verdict was appropriate because, even viewing the evidence in the light most favorable to plaintiffs, it is clear that, despite his testimony to the contrary, Dr. Davis’ treatment decision would have been the same had he received the warnings plaintiffs contend were required. Dr. Davis’ testimony that he would not have treated Proctor with periocular injection of Depo-Medrol if he had received these warnings was completely contradicted by the remainder of his testimony. For example, he testified that he had found this treatment to be safe and effective and had used it without problem on 1,600 occasions prior to the accidental injection of Proctor’s eye. In fact, he had used it to restore Proctor’s vision when no other treatment had worked. Also contrary to his testimony that he would not have used Depo-Medrol periocularly if he had known the risks, Dr. Davis testified that, at the time he treated Proctor, he was aware that accidental intraocular injection and blindness were possible consequences of periocular injection of Depo-Medrol. Perhaps the best indicator of how knowledge of these risks would have affected his treatment decision was his testimony that, even after he accidentally penetrated Proctor’s eye, he continued to treat patients with periocular injections of Depo-Medrol. Dr. Davis’ testimony that periocular injection of Depo-Medrol was the only treatment alternative for Proctor also contradicted his testimony that warnings would have changed his treatment decision. The majority states that there were alternative treatments available (Rule 23 order, at 6), but the record does not support this conclusion. Dr. Davis explained that further use of Nalfon was not a feasible alternative because it had been used without success to treat Proctor’s condition. Dr. Davis also explained that intramuscular, that is, systemic, administration of steroids was contraindicated by certain health conditions Proctor had. As for the majority’s suggestion that Dr. Davis could have used a different formulation of Depo-Medrol, the record does not indicate that a different formulation would have been effective. By contrast, Dr. Davis knew that periocular injection was an effective treatment for Proctor because it had restored his vision in the past and it was not contraindicated by Proctor’s other medical conditions. The testimony of other ophthalmologists also indicated that the warning plaintiffs claim was required would not have changed Dr. Davis’ treatment decision. Expert witnesses, Drs. Giles, Fagman, and Deutsch, all testified that Davis’ decision to inject Depo-Medrol periocularly was in accordance with the applicable standard of care. Dr. Giles also testified that, even after he accidentally injected Depo-Medrol intraocularly, he continued to treat patients using periocular injection of the drug and found it to be safe and efficacious. It is clear from this evidence that the ophthalmologic community, including Dr. Davis, considered Depo-Medrol to be an appropriate treatment for Proctor’s condition and found periocular injection of this drug to be safe and effective despite the possibility of intraocular injection and vision loss. This uncontradicted evidence compelled the jury to conclude that Upjohn’s alleged failure to warn was not a proximate cause of Proctor’s injury. The only proximate cause of Proctor’s loss of his eye was Dr. Davis’ accidental injection of Depo-Medrol into the eye rather than periocularly. Consequently, the circuit court should have granted the motion for judgment notwithstanding the verdict. ERRORS IN EVIDENTIARY RULINGS Upjohn was prevented from presenting compelling evidence both on the issue of proximate cause and on the issue of punitive damages. 1. Post-1983 Usage of Depo-Medrol The circuit court excluded evidence of post-1983 usage of Depo-Medrol, but Upjohn made offers of proof that, after 1983, Drs. Giles, Deutsch, and Fagman continued to use periocular injection of Depo-Medrol to treat their patients. The evidence that, even after 1983, ophthalmologists continued to view periocular injection of Depo-Medrol as a safe and efficacious treatment severely undermines the argument that Dr. Davis would have treated Proctor differently had he known more about the drug. Moreover, such evidence was highly relevant to the issue of punitive damages. The circuit court erred in excluding this evidence. The majority holds that this evidentiary ruling was proper because it was consistent with the court’s exclusion of post-1983 labeling changes. Rule 23 order, at 13-14. The majority’s "consistency” rationale, however, is not persuasive because, although there are public policy considerations that support the exclusion of the evidence of post-1983 labeling changes, there is no legitimate basis for the exclusion of the evidence of post-1983 usage. Generally, evidence of subsequent remedial measures is inadmissible in negligence and product liability actions for public policy reasons: courts do not want to discourage defendants from making safety improvements, evidence of subsequent remedial measures is not probative, and the jury may view this evidence as proof of negligence. See Herzog v. Lexington Township, 167 Ill. 2d 288, 300-01, 657 N.E.2d 926 (1995); Smith v. Black & Decker (U.S.), Inc., 272 Ill. App. 3d 451, 456, 650 N.E.2d 1108 (1995). These policy concerns supported the circuit court’s exclusion of the post-1983 labeling changes, but they do not justify the exclusion of the post-1983 usage of Depo-Medrol. Despite the discretion accorded to trial courts in ruling on the admissibility of evidence, because this evidence was highly probative with respect to the issue of proximate cause and to the issue of punitive damages, the circuit court erred in excluding it. 2. Upjohn’s Effort to Add a Warning Also troubling is the circuit court’s exclusion of evidence of Upjohn’s attempt to add a warning to its labeling and its exclusion of evidence of FDA labeling controls. The majority acknowledges that, in Rucker v. Norfolk & Western Ry. Co., 77 Ill. 2d 434, 396 N.E.2d 534 (1979), Moehle v. Chrysler Motors Corp., 93 Ill. 2d 299, 443 N.E.2d 575 (1982), and Hatfield v. Sandoz-Wander, Inc., 124 Ill. App. 3d 780, 464 N.E.2d 1105 (1984), Illinois courts have held that evidence of compliance with federal requirements, including FDA requirements, is admissible. The majority distinguishes these cases, however, on the basis that the parties in those cases demonstrated compliance, and Upjohn did not prove that it complied with FDA requirements in this case. The majority, therefore, concludes that Upjohn was not entitled to present evidence of its attempted labeling change or of FDA labeling requirements because these were not relevant either to its duty to warn or to punitive damages. Rule 23 order, at 11. Although, unlike this case, in Rucker, Moehle, and Hatfield there was never any question as to the defendants’ compliance with federal standards, these cases do not support the exclusion of the FDA evidence in this case. In those cases, the courts held that evidence of compliance with federal standards is admissible; they did not hold that evidence of federal standards is inadmissible absent a showing of compliance. Evidence is relevant if it tends to prove a fact at issue or shows that a matter in dispute is more or less probable. Herman v. Will Township, 284 Ill. App. 3d 53, 61, 671 N.E.2d 1141 (1996). Even absent proof of compliance, the evidence of Upjohn’s attempted labeling change and FDA labeling requirements was highly relevant to the issue of punitive damages because it tended to show that Upjohn’s conduct was not willful and wanton. Even assuming, as the majority does, that Upjohn should have interpreted the FDA letter as requiring it to "submit its proposed change in the proper manner” (Rule 23 order, at 11), evidence of Upjohn’s attempt to add a warning should have been presented to the jury. This evidence was relevant to the issue of punitive damages because it would have permitted the jury to conclude that Upjohn did not disregard the safety of its customers because it had attempted, albeit improperly and unsuccessfully, to add a warning to its label. Furthermore, there was no basis for concluding from the record that Upjohn was not complying with an FDA directive when it continued to use labeling that did not contain a warning with respect to ophthalmic use. In response to the FDA’s request for format changes to all corticosteroid labels, Upjohn submitted a supplemental application, in which it proposed to revise the Depo-Medrol label to, among other things, include a new warning for ophthalmic uses. In September 1983, the FDA informed Upjohn that it was conducting further review of the labeling format and instructed it to continue to use existing labeling until the FDA notified it of the status of its supplemental application. The FDA further instructed Upjohn to revise its labeling through another supplemental application (see 21 C.F.R. § 314.8 (1984)) if "important new labeling information becomes available.” Unlike the majority, I do not interpret the FDA letter as requiring Upjohn to submit an additional supplemental application in order to add a warning to its label. At the time it received this letter, Upjohn had a supplemental application that included ophthalmic warnings pending before the FDA, and it did not have any "new” information about ophthalmic uses to add to the warning it had already submitted for approval. It was, therefore, logical for Upjohn to wait for the FDA to act on its pending application and to follow the FDA’s instruction to use its existing labeling until the FDA notified it of the status of its application. Had the jury been allowed to consider this letter, it might have reached the same conclusion as to Upjohn’s actions. 3. Evidence Concerning FDA Labeling Controls Upjohn also should have been allowed to present evidence of FDA labeling controls. The jury heard Dr. Walson’s testimony that the format of the Depo-Medrol labeling was misleading, but Upjohn was not permitted to counter this testimony with evidence that the FDA dictates the format of prescription drug labels. The exclusion of this evidence unfairly prejudiced Upjohn in its ability to justify its failure to warn of the risks associated with ophthalmic use of Depo-Medrol and likely contributed to the jury’s punitive damage award. The majority opinion itself demonstrates the prejudice that resulted from the exclusion of evidence of FDA requirements. According to the majority, Upjohn knew how to warn because it had warned against intrathecal use, and "Upjohn, in another line or two of print on the insert, easily could have mentioned potential adverse reactions to the drug when injected intraocularly” (291 Ill. App. 3d at 282). This statement ignores the restrictions that the FDA places on labeling. See W. Viscusi, Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale for the FDA Regulatory Compliance Defense, 24 Seton Hall L. Rev. 1437, 1440 (1994) ("the FDA possesses virtually total control over the content of the package inserts that accompany all prescription drugs”); L. Noah, The Imperative to Warn: Disentangling the "Right to Know” from the "Need to Know” about Consumer Product Hazards, 11 Yale J. on Reg. 293, 359 (1994) ("Although in theory drug manufacturers are .free to add warnings in advance of FDA approval, they may not enjoy any real flexibility to alter previously approved labeling”). The Depo-Medrol labeling included a warning against intrathecal use because the FDA required this warning. It is not clear what sort of warnings, if any, the FDA would have permitted for periocular use. The FDA must approve all post-marketing labeling changes (see Viscusi, at 1447 n.48) and, therefore, would not necessarily have permitted Upjohn to "easily” include a warning involving periocular use of the drug. In fact, the record demonstrates that when Upjohn submitted such a warning, it took the FDA several years to respond, and the response instructed Upjohn to continue to use its existing labeling. This evidence was relevant; there was no legitimate basis for its exclusion. The circuit court erred in refusing to allow Upjohn to present it, and its ruling unfairly prejudiced Upjohn. UP JOHN’S INVOLVEMENT IN THE OFF-LABEL USE OF DEPO-MEDROL Finally, the majority’s description of Upjohn’s activities with respect to the off-label use of Depo-Medrol must be addressed. The majority suggests that Upjohn acted improperly when it provided financial assistance, writing support, and free Depo-Medrol to ophthalmologists who wished to put the drug to an off-label use. See 291 Ill. App. 3d at 268-73, 283-84. The majority also criticizes Upjohn for ordering and distributing reprints of articles discussing the periocular injection of Depo-Medrol. 291 Ill. App. 3d at 270. According to the majority, "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.” 291 Ill. App. 3d at 272-73. These comments are unfair. Off-label use of drugs is not unusual or illegal (see Note, A Meaningful Choice: Two FDA Approved Drugs Are Combined to Perform Medical Abortions, 18 Women’s Rights L. Rep. 49, 56 n.116 (1996) (the American Medical Association estimates that 40% to 60% of all prescriptions in America are for off-label uses of drugs), and even the FDA has acknowledged that off-label use of a drug may be appropriate and rational (see Use of Approved Drugs for Unlabeled Indicators, FDA Drug Bulletin (Public Health Service, Md.) April 1982, vol. 12, No. 1, 4-5). In addition, contrary to the majority’s implication that Upjohn acted improperly by funding research into off-label uses and distributing reprints of articles discussing off-label uses, these practices have been common among drug manufacturers. See Comment, Products Liability and ''Off-Label” Uses of Prescription Drugs, 63 U. Chi. L. Rev. 275, 279 (1996) (Comment). Dr. Stubbs testified that it was not unusual to supply drugs to physicians who requested them, that fulfilling reprint requests was part of normal sales education, and that, in 1963 and 1964, it was normal for drug manufacturers to compensate doctors for secretarial help in preparing case reports and to supply writing support services. The FDA has recently restricted the manner in which manufacturers may communicate with physicians about off-label uses, but its policy with respect to such communications was not as strict during the period of time relevant to this suit. See W. Christopher, Off-Label Drug Prescription: Filling the Regulatory Vacuum, 48 Food & Drug L.J. 247, 249-54 (1993); Comment, at 279. The majority offers no authority for its suggestion that Upjohn’s activities would not have been approved by the FDA and the record does not permit such a conclusion. RESPONSE TO MAJORITY’S REPLY TO THIS DISSENT In four footnotes (see 291 Ill. App. 3d at 279-80 n.11, 281 n.13, 284 n.16, 285 n.17), the majority replies to what I have said in this dissent. For example, in footnote 11, after pointing out what I have said about the medical community being aware of the risks associated with periocular injections of Depo-Medrol, the majority states that its "decision also is based upon the insolubility and toxicity of Depo-Medrol of which Upjohn knew or should have known.” 291 Ill. App. 3d at 279-80 n.11. The majority then accuses me of "fail[ing] to recognize this issue.” This accusation is surprising given the considerable amount of space I have dedicated to the matter (see 291 Ill. App. 3d at 288-90). Moreover, as the majority itself recognizes (see 291 Ill. App. 3d at 270), 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 (1988), appeal denied, 123 Ill. 2d 559, 535 N.E.2d 402 (1988). I repeat: in this off-label use of Depo-Medrol, the risks were known to the medical community. Dr. Davis and every ophthalmologist who testified knew that an accidental penetration of the eye was a risk inherent in periocular injections. They, and the entire ophthalmological community, were well aware of the risk of vision loss following the accidental intraocular injection of the drug. Regarding the connection of the alleged failure to warn to the issue of proximate cause, the majority claims that I have disregarded the standard of review and have "usurpfed] the role of the fact finder.” (291 Ill. App. 3d at 281 n.13.) The majority insists that this court is required to uphold the jury verdict because Dr. Davis testified that he would not have treated Proctor with the periocular injection if he had received warnings and his statement that systemic use of Depo-Medrol was not contraindicated. The majority’s reliance on these isolated statements demonstrates a failure to view them in the context of the entire record. Although the standard of review requires us to view the evidence in the light most favorable to the nonmoving party, it does not require us to accept evidence that the remainder of the record demonstrates is implausible. As I have explained, except for the single statement on which the majority relies, Dr. Davis’ testimony overwhelmingly demonstrated that warnings would not have changed his treatment decision because he was already aware of the relevant risks and because, even after accidentally causing Proctor’s eye loss, he continued to use Depo-Medrol periocularly. In addition, although he may have testified that systemic use of Depo-Medrol was not contraindicated, he also testified that systemic use was contraindicated by Proctor’s medical conditions. The evidence in this case, therefore, does not support a finding of proximate cause. In footnote 17 (291 Ill. App. 3d at 285 n.17), the majority accuses me of not applying the proper standard of review concerning the circuit court’s evidentiary rulings. Let there be no doubt: the abuse of discretion standard is the one I applied in concluding that the circuit court had erred in making these rulings. The excluded evidence was highly relevant to the issue of proximate cause. Can its relevance to the issue of punitive damages be seriously questioned—in this case where the jury was not informed that a drug was deemed so efficacious that, at the time of trial, ophthalmologists were still using it in exactly the same way the majority deems so pernicious as to warrant over $6 million in punitive damages, and where the jury, not having information so relevant to Upjohn’s effort to counter evidence of its alleged willful and wanton conduct, returned a verdict of almost $125 million? CONCLUSION For the reasons given, the judgment against Upjohn should be reversed. Alternatively, because of the rulings that denied admissibility of evidence highly relevant both to the issue of proximate cause and to the issue of punitive damages, the judgment should be reversed and a new trial should be required. Accordingly, I respectfully dissent. APPENDIX Plaintiff’s exhibit 120 was a list prepared by Dr. Samuel Stubbs from 1965 until 1983 containing drug experience reports (DERs) with various patients of which Upjohn had notice, abstracted in part as follows: June 18, 1963—five abscesses developed in three patients given subconjunctival injections of Depo-Medrol; abscesses resulted from increased particle size in the suspension. June 20, 1963—patient developed a sterile abscess around the Depo-Medrol which was lying subconjunctivally; abscess ruptured; Depo-Medrol removed and the abscess evacuated; no side effects after removal. October 21, 1964—patient’s sloughing of conjunctiva at the site of subconjunctival injection, with a gradual decrease in reaction; not completely restored through surgery, which necessitated cutting through involved tissues. February 18, 1965—three patients exhibited pain, upper lid swelling, sheets of subconjunctival hematoma, and marked chemosis. The symptoms cleared slowly. March 20, 1967—more than five different patients with "swelling, redness and fluctuation.” May 1968—patient developed gray-white residue, which remained subconjunctivally six to eight weeks after injection. September 26, 1968—whitish residue left behind after Depo-Medrol injected; persists for many weeks after steroid activity ceased, gradually disappeared; similar reports noted by many other people. February 21, 1971—injection led to red, swollen eyelid and blurred vision. May 1971—adverse reactions filed—report of subconjunctival injection site inflammation and report of increased intraocular pressure. May 1972—deposit remaining at the injection site; report of a glaucoma-like picture in association with subconjunctival administration of Depo-Medrol. July 1974—several patients exhibited white precipitate that remained in the injection site for a period of one or two months. White deposit caused sufficient concern that physician stopped using the drug. September 25, 1974—injection of 1 cc. Depo-Medrol resulted in an immediate loss of vision. "21/a hours later had NLP in both eyes. Paralysis of upgaze. No pupillary response. White material in arterioles of fundus. Mental confusion. 36 hr. later vision began to return. Fundus showed scattered retinal edema. Vision now OD-CF at 10-12 degrees OS-CF at 18-20 degrees. Atrophy of temporal iris OD. Cloudy vitreous OD.” February 1976—increase in intraocular pressure; patient discharging Depo-Medrol "through three sites in necrotic conjunctiva in the lower fornix”; injection site incised—piece of soft, off-white tissue was removed; acute inflammatory reaction to the drug. Following removal of this material, the corneal oedema cleared almost immediately and patient made a good recovery. September 1977—accidental injection of Depo-Medrol into the eye of a patient when trying to inject subconjunctivally; patient lost vision. December 1977—blindness in one eye following an injection of the drug into the turbinate area of the nose. September 1978—small white spot developing following subconjunctival injections of Depo-Medrol; spot remained for a long time at the injection site in the mucosal. November 1978—temporary blindness accompanied by severe pain, following the injection of Depo-Medrol into the nose. November 1979—intense swelling around the eyes and nose; blockage of the ears following injection of Depo-Medrol subconjunctivally. September 1980—diminished vision in one eye following an injection of Depo-Medrol in the turbinates after nasal surgery. May 1983—conjunctival necrosis overlying the area of the injection 17 days after a conjunctival injection of Depo-Medrol. July 1983—blindness and eye damage following an implant into the eye with subconjunctival injection of Depo-Medrol. September 1983—inadvertent injection of Depo-Medrol into the vitreous of the eye instead of the retrobulbar space; vitrectomy performed and patient regained partial vision.