{ "id": 5276427, "name": "MAURICE TONGATE et al., Plaintiffs-Appellants, v. WYETH LABORATORIES, Defendant-Appellee", "name_abbreviation": "Tongate v. Wyeth Laboratories", "decision_date": "1991-08-16", "docket_number": "No. 1\u201490\u20140053", "first_page": "952", "last_page": "971", "citations": [ { "type": "official", "cite": "220 Ill. App. 3d 952" } ], "court": { "name_abbreviation": "Ill. App. Ct.", "id": 8837, "name": "Illinois Appellate Court" }, "jurisdiction": { "id": 29, "name_long": "Illinois", "name": "Ill." }, "cites_to": [ { "cite": "539 N.E.2d 1372", "category": "reporters:state_regional", "reporter": "N.E.2d", "opinion_index": 0 }, { "cite": "184 Ill. App. 3d 199", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 2641031 ], "weight": 2, "pin_cites": [ { "page": "205" } ], "opinion_index": 0, "case_paths": [ "/ill-app-3d/184/0199-01" ] }, { "cite": "543 N.E.2d 1304", "category": "reporters:state_regional", "reporter": "N.E.2d", "opinion_index": 0 }, { "cite": "129 Ill. 2d 351", "category": "reporters:state", "reporter": "Ill. 2d", "case_ids": [ 5567184 ], "opinion_index": 0, "case_paths": [ "/ill-2d/129/0351-01" ] }, { "cite": "591 F. Supp. 381", "category": "reporters:federal", "reporter": "F. Supp.", "case_ids": [ 3687391 ], "opinion_index": 0, "case_paths": [ "/f-supp/591/0381-01" ] }, { "cite": "666 F. Supp. 1483", "category": "reporters:federal", "reporter": "F. Supp.", "case_ids": [ 7404207 ], "opinion_index": 0, "case_paths": [ "/f-supp/666/1483-01" ] }, { "cite": "742 F. Supp. 239", "category": "reporters:federal", "reporter": "F. Supp.", "case_ids": [ 7386754 ], "weight": 3, "pin_cites": [ { "page": "262" }, { "page": "263" } ], "opinion_index": 0, "case_paths": [ "/f-supp/742/0239-01" ] }, { "cite": "95 N.M. 675", "category": "reporters:state", "reporter": "N.M.", "case_ids": [ 1575608 ], "weight": 2, "opinion_index": 0, "case_paths": [ "/nm/95/0675-01" ] }, { "cite": "560 N.E.2d 586", "category": "reporters:state_regional", "reporter": "N.E.2d", "opinion_index": 0 }, { "cite": "137 Ill. 2d 284", "category": "reporters:state", "reporter": "Ill. 2d", "case_ids": [ 3251657 ], "opinion_index": 0, "case_paths": [ "/ill-2d/137/0284-01" ] }, { "cite": "300 N.W.2d 356", "category": "reporters:state_regional", "reporter": "N.W.2d", "opinion_index": 0 }, { "cite": "100 Mich. App. 649", "category": "reporters:state", "reporter": "Mich. App.", "case_ids": [ 2196545 ], "opinion_index": 0, "case_paths": [ "/mich-app/100/0649-01" ] }, { "cite": "560 N.E.2d 315", "category": "reporters:state_regional", "reporter": "N.E.2d", "year": 1988, "opinion_index": 0 }, { "cite": "137 Ill. 2d 175", "category": "reporters:state", "reporter": "Ill. 2d", "case_ids": [ 3251812 ], "year": 1988, "opinion_index": 0, "case_paths": [ "/ill-2d/137/0175-01" ] }, { "cite": "525 N.E.2d 258", "category": "reporters:state_regional", "reporter": "N.E.2d", "opinion_index": 0 }, { "cite": "171 Ill. App. 3d 344", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 3617716 ], "opinion_index": 0, "case_paths": [ "/ill-app-3d/171/0344-01" ] }, { "cite": "719 F. Supp. 470", "category": "reporters:federal", "reporter": "F. Supp.", "case_ids": [ 572228 ], "opinion_index": 0, "case_paths": [ "/f-supp/719/0470-01" ] }, { "cite": "859 F.2d 517", "category": "reporters:federal", "reporter": "F.2d", "case_ids": [ 10528956 ], "weight": 2, "pin_cites": [ { "page": "521" } ], "opinion_index": 0, "case_paths": [ "/f2d/859/0517-01" ] }, { "cite": "516 N.E.2d 515", "category": "reporters:state_regional", "reporter": "N.E.2d", "opinion_index": 0 }, { "cite": "163 Ill. App. 3d 103", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 3547777 ], "opinion_index": 0, "case_paths": [ "/ill-app-3d/163/0103-01" ] }, { "cite": "508 N.E.2d 301", "category": "reporters:state_regional", "reporter": "N.E.2d", "year": 1987, "opinion_index": 0 }, { "cite": "155 Ill. App. 3d 475", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 3465404 ], "year": 1987, "opinion_index": 0, "case_paths": [ "/ill-app-3d/155/0475-01" ] }, { "cite": "540 So. 2d 102", "category": "reporters:state_regional", "reporter": "So. 2d", "case_ids": [ 7543721, 7543751 ], "opinion_index": 0, "case_paths": [ "/so2d/540/0102-01", "/so2d/540/0102-02" ] }, { "cite": "513 N.E.2d 387", "category": "reporters:state_regional", "reporter": "N.E.2d", "opinion_index": 0 }, { "cite": "117 Ill. 2d 507", "category": "reporters:state", "reporter": "Ill. 2d", "case_ids": [ 5545405 ], "weight": 4, "pin_cites": [ { "page": "517-18" }, { "page": "519" }, { "page": "538", "parenthetical": "Simon, J., concurring in part & dissenting in part" } ], "opinion_index": 0, "case_paths": [ "/ill-2d/117/0507-01" ] }, { "cite": "213 Ill. App. 3d 390", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 2605636 ], "opinion_index": 0, "case_paths": [ "/ill-app-3d/213/0390-01" ] }, { "cite": "368 N.E.2d 465", "category": "reporters:state_regional", "reporter": "N.E.2d", "opinion_index": 0 }, { "cite": "52 Ill. App. 3d 1034", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 3391077 ], "opinion_index": 0, "case_paths": [ "/ill-app-3d/52/1034-01" ] }, { "cite": "340 N.E.2d 627", "category": "reporters:state_regional", "reporter": "N.E.2d", "year": 1977, "opinion_index": 0 }, { "cite": "35 Ill. App. 3d 101", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 5307066 ], "year": 1977, "opinion_index": 0, "case_paths": [ "/ill-app-3d/35/0101-01" ] }, { "cite": "436 N.E.2d 598", "category": "reporters:state_regional", "reporter": "N.E.2d", "year": 1975, "opinion_index": 0 }, { "cite": "106 Ill. App. 3d 1012", "category": "reporters:state", "reporter": "Ill. App. 3d", "case_ids": [ 3034312 ], "year": 1975, "opinion_index": 0, "case_paths": [ "/ill-app-3d/106/1012-01" ] }, { "cite": "246 N.E.2d 285", "category": "reporters:state_regional", "reporter": "N.E.2d", "pin_cites": [ { "page": "287" } ], "opinion_index": 0 }, { "cite": "42 Ill. 2d 246", "category": "reporters:state", "reporter": "Ill. 2d", "case_ids": [ 2848008 ], "pin_cites": [ { "page": "248" } ], "opinion_index": 0, "case_paths": [ "/ill-2d/42/0246-01" ] } ], "analysis": { "cardinality": 1411, "char_count": 44526, "ocr_confidence": 0.799, "pagerank": { "raw": 1.873585371338592e-07, "percentile": 0.7266083852765162 }, "sha256": "a5498e1e7ff49fc450036c7dc491face12f3d958685e7963f795d4f0f5e5facd", "simhash": "1:2beb78d1930920b4", "word_count": 7259 }, "last_updated": "2023-07-14T21:04:36.621238+00:00", "provenance": { "date_added": "2019-08-29", "source": "Harvard", "batch": "2018" }, "casebody": { "judges": [], "parties": [ "MAURICE TONGATE et al., Plaintiffs-Appellants, v. WYETH LABORATORIES, Defendant-Appellee." ], "opinions": [ { "text": "JUSTICE EGAN\ndelivered the opinion of the court:\nThe plaintiffs, Maurice Tongate and his wife Constance Tongate, filed a complaint against Wyeth Laboratories (Wyeth) and Elston Industrial Clinic (Elston). The initial complaint and subsequent amended complaints alleged that after Maurice Tongate injured his finger at work he was taken to Elston, where he was given an injection of tetanus toxoid manufactured by Wyeth, and as a result of his receiving the injection he suffered severe and permanent neurological impairment. The complaints alleged that Elston was negligent because its agents failed to take a complete history from Tongate to determine whether the use of tetanus toxoid was contraindicated. The complaint against Wyeth alleged that the tetanus toxoid was unreasonably dangerous for its intended and foreseeable purposes because it failed to contain an adequate warning that would inform medical personnel of the possibility of an allergic reaction resulting in neurological impairment.\nThe trial judge granted summary judgment in favor of Wyeth and denied the plaintiffs leave to file an amendment to their complaint. The judge stayed the proceedings against Elston until this appeal has been completed. The plaintiffs contend that the order granting summary judgment and the order denying their motion to file an amendment are both erroneous.\nTongate testified at his deposition that on January 25, 1978, he injured his hand while at work, and he was taken to Elston. When he arrived at Elston, he was asked to fill out \u201ca little yellow card,\u201d and he was asked if he had ever had a number of different diseases and allergies. He answered that he had had rose fever. A doctor, later identified as Emilo Beltran, told a nurse to give Tongate a tetanus shot. Tongate told the nurse that he had previously received a tetanus shot, and he did not think he needed one. Beltran explained to him that it was the procedure and it was for his own good. Tongate asked the doctor, \u201cWhy do I need that?\u201d The doctor said, \u201cWhy, did you have one?\u201d Tongate told him that he had one about five or six years ago. He added, \u201cYou know, I don\u2019t think I need it.\u201d Beltran then said, \u201cWell, five, six years ago, that\u2019s long enough, we can give you another one.\u201d (In his deposition, Beltran denied that the plaintiff ever suggested that he did not need the injection.) Tongate did not remember telling Beltran anything more about his previous tetanus shot. A nurse gave Tongate the tetanus shot in his left shoulder.\nIn February Tongate went to see his family doctor complaining about numbness in his hands and feet. By May he felt more affected in the ankles, groin, knees and wrists when he moved. In June he began to experience \u201cflatfootedness,\u201d stinging in his mouth and difficulty in swallowing fluids. In July, after he found himself catching his breath and falling down, he saw Dr. Neil Allen, board certified in neurology and internal medicine.\nDr. Allen asked Tongate if he had had any injections, and Tongate asked whether a tetanus shot could have caused his problem. Dr. Allen told him that it could have caused the problem and asked Tongate to find out what type of tetanus injection he had been given. Dr. Allen diagnosed Tongate\u2019s condition as \u201cacute polyneuritis\u201d caused by an allergic reaction to the tetanus injection.\nTongate was examined by Dr. Kranzler, a neurologist, who told Tongate he believed his problems were caused by the tetanus injection. He subsequently went to Edgewater Hospital where he remained for one month; he was treated by Dr. Allen. On Dr. Allen\u2019s advice, Tongate contacted Dr. Sahgal at the Rehabilitation Institute of Chicago, and he was treated there during April, May and June of 1979. The doctors at the institute told Tongate that he had Guillain-Barre syndrome, a form of polyneuritis.\nWhen Tongate\u2019s deposition was taken on January 14, 1982, he was having plasma phoresis, a procedure in which blood plasma is removed. He was using crutches and a brace in his shoe because of foot drop.\n' A more detailed recitation of additional evidence is required when addressing the various arguments raised by the parties. For the sake of brevity, we will not recite them at this point. We would add, however, that this case centers on the information contained in \u201cinserts\u201d which are placed in each package of the tetanus toxoid manufactured by Wyeth. Wyeth maintains that summary judgment in its favor is required because the information contained in the inserts provided in each of the packages containing the tetanus toxoid was adequate as a matter of law; it cannot be liable based on the \u201clearned intermediary\u201d rule; and it cannot be liable because Dr. Beltran did not rely on the information provided in Wyeth\u2019s inserts when he prescribed the tetanus toxoid.\nThe plaintiffs maintain in their reply brief that Wyeth has waived the argument that the inserts were adequate as a matter of law on the ground that Wyeth did not raise that argument in its motion for summary judgment. As appellee, Wyeth responded correctly that we may affirm on any ground \u201cso long as the factual basis for such [ground] was before the trial court.\u201d (Shaw v. Lorenz (1969), 42 Ill. 2d 246, 248, 246 N.E.2d 285, 287.) The issue is whether or not there is a factual basis in the record for Wyeth\u2019s argument. Pursuant to our request during oral argument, Wyeth has referred us to those parts of the record which it claims will show that it did raise the argument in the trial court. We have examined those parts of the record, and we judge that Wyeth did not properly raise the argument in the trial court.\nThe grounds for summary judgment should be pleaded with sufficient specificity to alert the opposing party to what he must answer and the trial judge to what he may be expected to pass on. Wyeth\u2019s motion for summary judgment was based solely on the claim that Wyeth owed no obligation to warn the plaintiff, that its only obligation was to warn Dr. Beltran and that Dr. Beltran had sufficient information from both Wyeth and other sources to enable him to act as a learned intermediary. In its memorandum in support of its motion Wyeth denied that its warnings on the tetanus toxoid vaccine were inadequate and asserted that it would \u201cpresent evidence in support of its defenses at trial.\u201d It pointedly added: \u201cFor purposes of this motion, however, it is unnecessary to consider those issues, as the evidence before this Court is that the prescribing physician has testified that he knew of anecdotal reports of [the condition of which the plaintiff complains] following Tetanus Toxoid Administration in the medicine literature.\u201d Wyeth\u2019s reply memorandum stated in bold type: \u201cThe learned intermediary doctrine focuses on the defendant\u2019s \u2018duty\u2019 to warn; not the adequacy of the warning provided.\u201d It is clear, therefore, that the motion for summary judgment itself and the memoranda of Wyeth did not inform the judge that he was being asked to pass on the sufficiency of the information provided by Wyeth.\nWyeth also refers us to parts of the record in which its attorney expressed disagreement with any assertion that its inserts were inadequate. In our judgment, those remarks of Wyeth\u2019s attorney in response to statements made by the plaintiff\u2019s attorney do not meet the requirements of the law. Indeed, at one point, Wyeth\u2019s attorney took issue with the assertion by the plaintiff\u2019s attorney that the inserts were inadequate and at the same time conceded, \u201cThis really is not relevant to the motion.\u201d For these reasons, we conclude that Wyeth has not properly preserved the argument that summary judgment should be granted on the ground that the warnings provided by Wyeth in its inserts were adequate as a matter of law. See Beverly Bank v. Alsip Bank (1982), 106 Ill. App. 3d 1012, 436 N.E.2d 598; Mollihan v. Stephany (1975), 35 Ill. App. 3d 101, 340 N.E.2d 627, appeal on other grounds after remand (1977), 52 Ill. App. 3d 1034, 368 N.E.2d 465.\nNevertheless, we have considered the argument and examined the record. The plaintiffs submitted the depositions of Dr. James T. O\u2019Donnell, who held a doctorate degree in pharmacy, and Dr. Neil Allen. Both Dr. O\u2019Donnell and Dr. Allen expressed the opinion that the warnings contained in the package inserts supplied by Wyeth were inadequate. Dr. O\u2019Donnell was critical of Wyeth for failure to report neurological reactions and to warn of the dangers and contraindications connected with previous neurological reactions. Dr. Allen testified that, because enough information had previously been given in the medical literature on the association of tetanus toxoid with Guillain-Barre syndrome, \u201cit should, in fact, be listed as a potential complication.\u201d\nDr. Mahlon Bierly was the administrative assistant for marketed biologies and a member of the medical communications section for Wyeth responsible for the content of the warnings contained in the package insert for tetanus toxoid throughout the 1970\u2019s and 1980\u2019s. He testified that before 1978 he knew of reports of neurological events that had followed the administration of tetanus toxoid. Despite that knowledge there had never been any reference in the package inserts to the \u201creports of neurological events that had followed the administration of tetanus toxoid\u201d before 1987. Dr. Bierly testified that in 1987 Wyeth revised its package inserts, in part, as follows:\n\u201cCONTRAINDICATIONS: Use of this product is contraindicated in persons with a history of neurologic or severe hypersensitivity reaction following a previous dose.\nWARNINGS: Occurrence of neurologic disorders have been reported following administration of tetanus toxoid containing preparations. Central and peripheral nervous system disorders that have been temporally associated with the use of tetanus toxoid include *** Guillain-Barre Syndrome ***. A causal relationship has not been established.\u201d\nIn our judgment, Dr. Bierly\u2019s testimony buttresses the plaintiff\u2019s argument. No question of the admissibility of Dr. Bierly\u2019s testimony has been suggested by Wyeth. (Cf Northern Trust Co. v. Upjohn Co. (1991), 213 Ill. App. 3d 390 (subsequent amendment of inserts held inadmissible).) We conclude that whether the inserts were inadequate is a question of fact that could not be resolved by summary judgment. Our conclusion would be the same in the absence of the testimony of Dr. Bierly. Wyeth has cited cases which held warnings to be adequate as a matter of law. Suffice it to say that they are factually distinguishable.\nWe turn now to Wyeth\u2019s principal argument that the trial judge properly entered summary judgment in its favor based on the \u201clearned intermediary\u201d rule, which was adopted in Illinois in Kirk v. Michael Reese Hospital & Medical Center (1987), 117 Ill. 2d 507, 513 N.E.2d 387:\n\u201c[The learned intermediary] rule, as adopted in numerous jurisdictions, provides that manufacturers of prescription drugs have a duty to warn prescribing physicians of the drugs\u2019 known dangerous propensities, and the physicians, in turn, using their medical judgment, have a duty to convey the warnings to their patients. [Citations.]\u201d (117 Ill. 2d at 517-18.)\nThe court explained further:\n\u201cThe drug manufacturer generally communicates warnings relating to prescription drugs to the medical profession through package inserts, the Physicians\u2019 Desk Reference, \u2018Dear Doctor\u2019 letters, detailmen, and through other measures. [Citations.] The doctor, functioning as a learned intermediary between the prescription drug manufacturer and the patient, decides which available drug best fits the patient\u2019s needs and chooses which facts from the various warnings should be conveyed to the patient, and the extent of disclosure is a matter of medical judgment. [Citations.] As such, we believe the learned intermediary doctrine is applicable here and that there is no duty on the part of manufacturers of prescription drugs to directly warn patients. Certainly, if the manufacturer of a prescription drug has no duty to directly warn the user of the drug of possible adverse effects, it has no duty to warn a nonuser as [the plaintiff\u201d 117 Ill. 2d at 519.\nWhile Kirk instructs us as to the applicable rule, it is factually of no assistance in determining the question before us. In Kirk the plaintiff was injured while a passenger driven in a car by a person who had been given two prescription drugs. The complaint against the drug manufacturers alleged that the drugs were unreasonably dangerous because the manufacturer failed to warn that the drugs would diminish the physical and mental abilities of the driver. The supreme court upheld the dismissal of the complaint on the ground that the sequence of events that led to the plaintiff\u2019s injuries was not reasonably foreseeable to the drug manufacturers. We emphasize that the driver, who had used the drug, was a defendant, not a plaintiff, in the action. We also emphasize, as the dissenting opinion points out, that the majority assumed that the warnings were adequate. See 117 Ill. 2d at 538 (Simon, J., concurring in part & dissenting in part).\nWyeth maintains that the learned intermediary rule is applicable, and the drug manufacturer exonerated, if it is shown that the intermediary physician was properly warned, regardless of the source of the warning, of any potential dangers in the use of the drug and regardless of the inadequacy of the warning provided by the drug manufacturer. (See Felix v. Hoffmann-LaRoche, Inc. (Fla. 1989), 540 So. 2d 102.) The plaintiff does not disagree with that argument of Wyeth. The issue, therefore, is whether the record establishes, as a matter of law, that Dr. Beltran possessed sufficient information from any source that would show that he was properly warned before he prescribed the drug. A resolution of that question depends almost entirely on two depositions given by Dr. Beltran.\nDr. Beltran first gave a discovery deposition on August 25, 1983, in which he discussed his knowledge of tetanus toxoid. He testified that he was aware of three contraindications, or situations in which a drug should not be administered, for tetanus toxoid: (1) the patient has received tetanus toxoid within the last five years; (2) the patient has a present acute illness, such as a high fever, sore throat, or upper respiratory infection; and (3) the patient has a previous allergy to tetanus toxoid. He explained that a previous allergy is \u201cvery important,\u201d and noted that an example of an allergic reaction is one where a patient\u2019s whole body \u201cswells up.\u201d The following exchange then occurred between Tongate\u2019s attorney and Dr. Beltran:\n\u201cQ. Doctor, have you ever heard of a severe reaction to vaccines called post-vaccinal polyneuritis?\nA. Heard about it, but I don\u2019t have any experience of following it or seeing a case.\nQ. You heard about it in connection with this case, I imagine, or did you know about it before?\nA. Before that, before that.\nQ. Were you aware before January 25, 1978, that there is\u2014 it had been known that a small percentage of people had had rather severe reactions to vaccines called post-vaccinal polyneuritis?\nA. Yes, sir.\u201d\nDr. Beltran further testified that he believed the handbook provided by Elston contained a section on tetanus toxoid; however, he said that he only looked at the handbook \u201cin passing\u201d because he felt confident about relying on the protocol developed by Medical Emergency Service Associates (MESA), his full-time employer. He also testified that he was \u201cfamiliar\u201d with the insert that came in the multiple dosage box of Wyeth\u2019s tetanus toxoid, and that he read it every once in a while. Tongate\u2019s attorney asked Dr. Beltran if he had had an occasion to refer to the Wyeth package insert for information in connection with his use of tetanus toxoid; Dr. Beltran replied, \u201cNo, sir.\u201d\nBased on Dr. Beltran\u2019s deposition, the trial judge entered summary judgment for Wyeth. He said that he was \u201cconvinced that Dr. Beltran was informed of the specific risks that were involved in this type of situation.\u201d\nThe plaintiffs filed a motion to reconsider and a motion for subpoenas to take the evidence depositions of Dr. Beltran and Dr. Schiff, Beltran\u2019s employer. The trial judge allowed the plaintiffs to take those evidence depositions. At his evidence deposition, Dr. Beltran was asked a series of complex questions directed toward whether he had ever been aware of any warnings that severe neurological damage could be caused by an injection of tetanus toxoid. To all of these questions Dr. Beltran answered, \u201cNo, sir.\u201d He further testified as follows:\n\u201cQ. Doctor, have you had an opportunity to review and read the transcript of your discovery deposition taken on August 25, 1983 in this matter?\nA. Yes, sir.\nQ. Okay. Specifically, I want to draw your attention to page 106 where you provided responses to certain questions regarding your awareness of post-vaccinal polyneuritis. Do you recall answering yes to the question \u2018Were you aware prior to January 25, 1978, that it had been known that a small percentage of people had had rather severe reactions to vaccines called post-vaccinal polyneuritis?\u2019 Do you recall that?\nA. Yes, sir.\nQ. You may recall that the questions asked of you on page 106 were about vaccines generally, not Tetanus Toxoid Adsorbed specifically. Now, specifically, what was your awareness before January 25, 1978, as to persons experiencing post-vaccinal polyneuritis following the use of Tetanus Toxoid Adsorbed vaccine?\nA. I had not heard of any.\nQ. Okay. Would you explain what you meant when you said on page 106 of your discovery deposition that you were aware of the fact that a small percentage of people had severe reactions to vaccines called post-vaccinal polyneuritis?\nA. I was referring more on the swine flu and the DPT.\nQ. Okay. The DPT and swine flu are separate and distinct vaccines, are they not?\nA. Yes, sir.\u201d\nDr. Beltran later testified that even if the package insert had been revised to include warnings of neurologic reactions, he still would not have transmitted those warnings to Tongate. However, after taking a short break, he testified that if the package insert had included warnings of neurologic reactions and if he had been aware of Tongate\u2019s previous neurologic reactions following tetanus toxoid injections, he would have asked Tongate \u201cto contact his personal physician, to verify the allergic reaction\u201d and have the personal physician give the injection if indicated. Dr. Beltran added that if the patient was being difficult, he would \u201cconsult with the communicable disease control people about their opinion.\u201d\nIn their motion to reconsider, the plaintiffs argued that Dr. Beltran\u2019s testimony at his evidence deposition confirmed that the judge had misconstrued Dr. Beltran\u2019s earlier testimony in finding that he had been fully informed of the risks associated with tetanus toxoid.\nWyeth responded that the judge should not consider Dr. Beltran\u2019s evidence deposition, arguing that the plaintiffs were bound by Dr. Beltran\u2019s earlier unequivocal testimony at his discovery deposition. Wyeth further argued that it was entitled to summary judgment for the additional reason that Dr. Beltran testified that he had not relied on Wyeth\u2019s package insert.\nThe trial judge accepted Dr. Beltran\u2019s deposition but adhered to his original decision and granted summary judgment. He said that \u201cone of the key things\u201d is Dr. Beltran\u2019s statement \u201cthat the insert did not play a role in his decision.\u201d\nWe must first address the threshold issue of whether Dr. Beltran\u2019s second deposition may properly be considered. Wyeth argues that the evidence deposition contradicts Dr. Beltran\u2019s earlier testimony and, therefore, it may not be considered in support of the plaintiffs\u2019 motion to reconsider. Wyeth relies on Hansen v. Ruby Construction Co. (1987), 155 Ill. App. 3d 475, 508 N.E.2d 301, and Commonwealth Eastern Mortgage Co. v. Williams (1987), 163 Ill. App. 3d 103, 516 N.E.2d 515.\nIn Hansen, the plaintiff testified at his deposition that he had tripped over a rubber strip on a loading dock and fell. Later he executed an affidavit stating that he had actually tripped over a different object. The appellate court upheld summary judgment for the defendant, noting that the plaintiff\u2019s deposition testimony was unequivocal and constituted a binding judicial admission. In Commonwealth East ern Mortgage Co., the defendant testified at a deposition that the terms of a mortgage were not discussed. After the motion for summary judgment was filed, the defendant filed an affidavit in which he stated what the terms of the mortgage were to be. The appellate court held that the affidavit directly contradicted the deposition testimony and refused to consider the affidavit on review.\nThe holdings of Hansen and Commonwealth Eastern Mortgage Co. were extended to a party\u2019s expert witness in Adelman-Tremblay v. Jewel Cos. (7th Cir. 1988), 859 F.2d 517, also cited by Wyeth, in which the court stated:\n\u201cThe rule against creating \u2018sham\u2019 issues by submitting affidavits that contradict prior depositions thus far has been applied only to parties. [Citations.] We can think of no reason, however, not to apply this rule to the present case involving the testimony and affidavit of the plaintiffs [sic] sole expert witness. The purpose of summary judgment motions \u2014 \u2018to weed out unfounded claims, specious denials, and sham defenses\u2019 [citation] \u2014 is served by a rule that prevents a party from creating issues of credibility by allowing one of its witnesses to contradict his own prior testimony.\u201d 859 F.2d at 521.\nSee also Rohrbough v. Wyeth Laboratories, Inc. (N.D. W. Va. 1989), 719 F. Supp. 470 (a statement in an expert\u2019s affidavit that contradicts earlier deposition testimony may be disregarded if it constitutes an attempt by the nonmoving party to create a sham issue of fact).\nWe have a serious question whether Dr. Beltran\u2019s testimony is subject to the judicial admission rule. He is not a party, and he is not an expert witness in this case; he is an occurrence witness. But even if his testimony were subject to the rule, we believe that his discovery deposition was not so clear and unequivocal that his evidence deposition may be considered contradictory to the discovery deposition. At his discovery deposition he was asked if he had ever heard of a severe reaction \u201cto vaccines.\u201d He was not asked specifically if he had heard of severe reactions to tetanus toxoid vaccines. Consequently, his subsequent testimony that he was referring \u201cmore on\u201d swine flu and DPT vaccines, although arguably ambiguous, could be considered to explain his previous answer and to show that he did not refer to tetanus toxoid vaccines in his discovery deposition. See Schmall v. Village of Addison (1988), 171 Ill. App. 3d 344, 525 N.E.2d 258.\nWe turn now to the question of whether the evidence establishes, as a matter of law, that Dr. Beltran had prior knowledge from any source that tetanus toxoid could cause polyneuritis.\nDr. Beltran\u2019s testimony at both depositions shows that he had read Wyeth\u2019s insert from time to time. He was \u201cfamiliar\u201d with the insert. He looked at the handbook provided by Elston only \u201cin passing\u201d because he felt confident about relying on the protocol developed by MESA; consequently, the record shows that Dr. Beltran\u2019s information came from the insert and the MESA protocol. However, the MESA protocol also did not contain any contraindications for the use of tetanus toxoid.\nIn addition, Dr. Beltran testified that he was not aware before January 25, 1978, that tetanus toxoid could cause severe neurologic reactions; that there might be an association between tetanus toxoid booster shots and severe neurologic disorders; that persons with previous neurologic reactions to tetanus toxoid boosters were more likely to experience severe neurologic reactions; and that booster shots of tetanus toxoid were contraindicated for tetanus-prone injuries in persons having a history of a neurologic reaction following a previous booster shot of tetanus toxoid. He also testified that before January 25, 1978, he had never read or become familiar with any authoritative medical literature, package inserts or Physicians\u2019 Desk Reference (PDR) monographs for tetanus toxoid which warned physicians that a .5 cc booster shot of tetanus toxoid, which he always prescribed, could cause severe neurologic reactions.\nIf Dr. Beltran\u2019s testimony is to be believed, a fact finder could conclude that he had not been sufficiently warned that tetanus toxoid could cause polyneuritis. That being so, he would not be a learned intermediary.\nWyeth also argues that the record establishes, as a matter of law, that Dr. Beltran did not rely upon the Wyeth inserts when he prescribed the tetanus toxoid and that, therefore, the plaintiff is unable to establish a causal connection between any lack of information in its inserts and the injuries suffered by the plaintiff. (See Batteast v. Wyeth Laboratories, Inc. (1990), 137 Ill. 2d 175, 560 N.E.2d 315.) In support of its argument Wyeth cites Ashman v. SK & F Lab Co. (N.D. Ill. 1988), 702 E Supp. 1401, and Formella v. Ciba-Geigy Corp. (1980), 100 Mich. App. 649, 300 N.W.2d 356.\nIn Formella, the plaintiff, an elderly woman, complained to her physician of low back pain. He prescribed Tandearil. She returned to his office in two weeks, and he continued the drug treatment. No blood tests were conducted at any time during her treatment. About six weeks later, the plaintiff called the physician to complain of multiple bruises and tiredness. He immediately suspected that Tandearil had caused her to develop a blood dyscrasia. He ordered her to stop taking the drug and to report to a hospital for tests. His suspicions were confirmed. The plaintiff was extremely ill from the aplastic anemia which had occurred as a direct result of taking Tandearil.\nOne of the claims against the defendant drug manufacturer was that it failed to adequately warn the physician of the dangers of the drug. The appellate court affirmed the order directing a verdict in favor of the defendant and pointed out that the plaintiff\u2019s own expert had testified that the PDR warning and package insert warning were adequate, if read. The court concluded that the fact that the physician failed to read the package inserts and the PDR negated any possible negligence on the part of the defendant and that the physician\u2019s negligence was the intervening, independent and sole proximate cause of the plaintiff\u2019s illness. We do not see how the Formella case supports Wyeth\u2019s position. As we have previously noted, whether the Wyeth insert warnings were sufficient is a question of fact that cannot be decided on summary judgment.\nIn Ashman, the plaintiff\u2019s physician prescribed a drug, Tagamet, which was manufactured by the defendant. The physician subsequently prescribed Ativan, a sleeping pill, not manufactured by the defendant. The two drugs were co-administered for two years with no side effects. Two years later the physician prescribed the drug Halcion in place of Ativan. Before he prescribed the Halcion the physician consulted the package insert for Halcion and the Physicians\u2019 Desk Reference. Both the insert and the PDR discussed a potential interaction between Halcion and Tagamet. Nevertheless, the physician decided to prescribe Halcion even though there were other sleeping pills available. The Tagamet label did not specifically mention the interactive propensities of the drug with Halcion. While the physician had read the Tagamet label on previous occasions, he did not read it when making the decision whether to prescribe Halcion for the plaintiff.\nThe plaintiff ingested Tagamet, and four hours later he took the Halcion. The next morning he took an overdose of Ativan tablets which he had left over from the old prescription. He was then taken to a hospital in an unconscious state. His physician was not sure what had caused the plaintiff\u2019s condition but suspected cerebral hemorrhage and decided to do a lumbar puncture to confirm. Despite the fact that the plaintiff regained consciousness and was in a coherent state, the physician decided to proceed with the lumbar puncture. As a result of alleged negligence in the performance of the lumbar puncture, the plaintiff was partially paralyzed. The plaintiff\u2019s claim alleged that the defendant failed to provide an adequate warning of the interactive propensities of the two drugs. The district court granted summary judgment on two grounds: the injury caused by the negligence of the physician was not reasonably foreseeable and the physician was a learned intermediary.\nWyeth argues here that Ashman is applicable because the physician, as the district court noted, did not read the Tagamet label when he prescribed Halcion and, in this case, Dr. Beltran testified that he did not \u201crefer\u201d to the Wyeth insert \u201cfor information in connection with [his] use of tetanus toxoid.\u201d We believe that Wyeth has elevated an isolated fact of the Ashman case and an isolated fact in this case to an undeserved significance. First, in Ashman, the plaintiff conceded that the physician was a learned intermediary. (Ashman, 702 F. Supp. at 1404.) No such concession is present in this case; to the contrary. In addition, the district court held that the evidence clearly established that the physician was aware of the possible interactive effect when Tagamet and Halcion were co-administered. The plaintiffs\u2019 own expert testified that, based on the information provided both in the Halcion literature and the PDR, the interaction which occurred in the plaintiff was predictable. The district court pointed to the fact that there was no evidence that the physician consulted the Tagamet label at the time he prescribed the Halcion in response to the plaintiffs\u2019 argument that the failure to include a warning on the Tagamet label misled the physician.\nWe do not agree that Dr. Beltran\u2019s testimony establishes as a matter of law that he did not, to use Wyeth\u2019s word, \u201crely\u201d on Wyeth\u2019s insert. We set out the following pertinent testimony of Dr. Beltran:\n\u201cQ. Now, while you have been at Elston Industrial Medical Center, have you had occasion to receive any literature from Wyeth Laboratories pertaining to Tetanus Toxoid Adsorbed?\nA. That\u2019s included in the box, insert, multiple dosage box.\nQ. You are familiar with the insert, the package insert that comes with the product when it\u2019s delivered; is that right?\nA. Yes.\nQ. Have you had occasion to read that over from time to time?\nA. Yes, sir.\n* * *\nQ. Are you familiar with the package inserts that come with Tetanus Toxoid Adsorbed?\nA. I read that every once in a while.\n* * *\nQ. I want to show you what I have marked as Beltran Exhibit No. 2 which is a package insert of Wyeth Tetanus Toxoid Adsorbed, and ask you if prior to January 25, 1978, you have had a chance to read and review a document like that?\nA. Yes, I have read it.\nQ. Generally similar to that?\nA. Yes.\nQ. Okay. This is the type of thing that\u2019s found folded up in the package?\nA. In the box, yes.\nQ. If I understand you correctly, however, you have adopted protocols for its use associated with the emergency medicine practice that you have at Northwest Community Hospital; right?\nA. Yes, sir.\nQ. And you \u2014 have you had an occasion to refer to a package insert similar to the one marked as Beltran Exhibit No. 2 for information in connection with your use of Tetanus Toxoid?\nA. No, sir.\u201d\nSince the case is before us on summary judgment, the issue is not whether the record shows that it is more probably true than not true that Wyeth\u2019s negligence was the proximate cause of the plaintiff\u2019s injury. Instead, the issue is whether Wyeth\u2019s failure to provide adequate warnings may have proximately caused Tongate\u2019s injury. Gatlin v. Ruder (1990), 137 Ill. 2d 284, 560 N.E.2d 586.\nWe are unwilling to accept, as a matter of law, the conclusion that when Dr. Beltran, whose native language is not English, said he did not \u201crefer\u201d to the insert, he meant that he did not take into consideration the information (or lack of information) contained in the insert when he prescribed the tetanus toxoid for Tongate. It is reasonable to construe Dr. Beltran\u2019s testimony as a statement that he did not reread the Wyeth insert each time he prescribed tetanus toxoid. Cf Richards v. Upjohn Co. (1980), 95 N.M. 675, 625 P.2d 1192 (witness testified it is not standard medical practice to reread the PDR every time a drug is given.)\nSome cases from other jurisdictions are instructive. In Mazur v. Merck & Co. (E.D. Pa. 1990), 742 F. Supp. 239, a physician testified that he considered the defendant\u2019s package insert, the recommendations of the United States Center for Disease Control and the results of his own research before he selected the vaccine he prescribed. The defendant argued that even if it failed to provide an adequate warning, the physician\u2019s \u201creliance on [nondefendant] sources of information about\u201d the vaccine was the \u201ctrue proximate cause\u201d of the plaintiff\u2019s illness. (742 F. Supp. at 262.) The district court ruled that \u201c[t]here can be more than one proximate cause of an injury \u2014 and whether any inadequacy in the package circular was a substantial factor in causing harm to [the plaintiff], or whether what [the physician] did or failed to do caused that harm, or both, is a jury question.\u201d 742 F. Supp. at 263.\nIn two jurisdictions it has been held that a rebuttable presumption exists that a failure to warn was a proximate cause of the injury: Graham v. Wyeth Laboratories (D. Kan. 1987), 666 F. Supp. 1483 (citing Kansas law); Williams v. Lederle Laboratories (S.D. Ohio 1984), 591 F. Supp. 381 (citing Ohio law). In the case before us, there is evidence from which a fact finder could conclude that the warnings were inadequate. The evidence clearly shows that Dr. Beltran read the Wyeth inserts from time to time. The evidence also established that, if Dr. Beltran had been aware of Tongate\u2019s previous neurologic reactions following tetanus toxoid injections, he would have asked Tongate to \u201ccontact his personal physician to verify the allergic reaction\u201d and have the personal physician give the injection if indicated. In our judgment, the record establishes, at least, a rebuttable presumption that the failure to provide an adequate warning was a contributing cause of Tongate\u2019s injury. The right to summary judgment must be clear and free from doubt. (Pyne v. Witmer (1989), 129 Ill. 2d 351, 543 N.E.2d 1304.) Wyeth has not established that right. A fact question remains as to whether the warnings were adequate and, if iftadequate, whether the absence of an adequate warning may have proximately caused Tongate\u2019s injury.\nThe defendant also argues that Dr. Beltran would not have learned of Tongate\u2019s sensitivity to tetanus toxoid even if Dr. Beltran had been aware of the warnings which the plaintiffs\u2019 expert testified were required. It bases its argument, not on Dr. Beltran\u2019s testimony, but on Tongate\u2019s testimony that he did not realize that he had suffered neurological symptoms in the past. The plaintiffs claim that this argument was never raised in the trial court and is, therefore, waived. To refute that argument the defendant has referred us to the plaintiffs\u2019 motion to reconsider the order granting summary judgment, the defendant\u2019s response, the plaintiffs\u2019 reply and the oral argument heard on the motion to reconsider. Since we have decided to address the defendant\u2019s argument, we need not decide the question of waiver. Suffice it to say that, after reading the pertinent parts of the record, it is our judgment that if the defendant avoided waiver, it did so by the narrowest of margins. The principal thrust of the defendant\u2019s argument on the motion to reconsider was that Tongate\u2019s testimony concerning the adverse reactions he had had to tetanus toxoid inoculations before 1978 was entitled to no weight.\nAt his deposition Dr. Beltran was asked what he would have done if he had been aware of the contraindications, warnings and adverse reactions contained in Wyeth\u2019s 1986-87 revised package insert. He said that if that information had been contained in the package insert and if he had known that the plaintiff had experienced neurological reactions after previous tetanus toxoid booster shots he would not have prescribed another tetanus toxoid shot. He further testified that, if he had learned through questioning that the defendant had had what the doctor felt was a neurological reaction after a previous tetanus toxoid shot, he would have told the plaintiff to contact his personal physician to verify the allergic reaction and Dr. Beltran would leave it up to his personal physician to administer the shot. If he had difficulty convincing the patient, Dr. Beltran might have consulted with the communicable disease control people at the Center for Disease Control asking \u201cabout the situation.\u201d\nThe plaintiffs filed Tongate\u2019s affidavit in the motion to reconsider which was in part a repetition of his deposition testimony. In his affidavit he testified that before the tetanus toxoid shot he received on January 25, 1978, he had at least two other tetanus booster shots, one in 1972 when he was about 20 years old and another shot sometime before the age 10. Following the previous booster shots of tetanus toxoid he remembers that he experienced unsteadiness and weakness with unusual loss of sensation in both his hands and arms lasting for several weeks to a month. The loss of sensation, particularly in his hands and fingers, appeared as numbness with intermittent tingling. He did not experience pain, and the loss of temporary nerve sensation was not constant and appeared to completely \u201cresolve\u201d after about a month. At that time he had no reason to believe that he might have been experiencing a neurological reaction to the tetanus toxoid booster shots.\nTongate had previously testified at his deposition that Dr. Beltran never asked whether he had any allergies or reactions to medications generally or to tetanus toxoid specifically. He was asked by a woman receptionist before being treated by Beltran if he was allergic to penicillin or sulfa, and he responded, \u201cNo.\u201d\nAlso submitted on the motion to reconsider was the affidavit of Dr. Allen dated November 21, 1989, a considerable period after Dr. Beltran\u2019s deposition had been taken. In that affidavit Dr. Allen said that the package insert warnings for tetanus toxoid before January 1978 and the 1986-87 revised package insert provided by Wyeth contained inadequate warnings to the prescribing physician. Dr. Allen was specifically critical of the failure of Wyeth\u2019s warning to contain a requirement that a patient should be advised and questioned by the prescribing physician about whether the patient\u2019s history of previous tetanus inoculations was followed by any unusual neurological events or reactions. It was his opinion that simply asking patients whether they had had any allergies to medication was insufficient to elicit the history necessary for a physician to make an informed medical judgment to prescribe a tetanus toxoid booster.\nIt is the defendant\u2019s position that even if Dr. Beltran had asked Tongate whether he had suffered any unusual neuorological events or reactions following previous tetanus booster shots, Tongate would have answered, \u201cNo,\u201d because Tongate was not aware in 1978 that he had suffered unusual neuorological events or reactions. We can only speculate as to what Tongate would have said if he had been asked expressly by Dr. Beltran about previous reactions to tetanus shots. We certainly cannot accept, as a matter of law, the conclusion of fact advanced by the defendant.\nFor these reasons, the order granting summary judgment is reversed and the cause remanded for further proceedings.\nThe plaintiffs also maintain that the judge abused his discretion in refusing to allow the plaintiffs to amend their complaint to allege a new theory of liability. The complaint was filed March 31, 1980, and a second amended complaint was filed December 12, 1980, to include the claim of Constance Tongate for lack of consortium. On March 21, 1989, the plaintiffs presented a motion for leave to file a third amended complaint. Counts III and VI alleged that Wyeth\u2019s tetanus toxoid was unreasonably dangerous for its intended and foreseeable purposes for four reasons, three of which had previously been pleaded. Subparagraph (d) was as follows:\n\u201cFailed to warn of the necessity that an adequate history requires inquiry as to whether the patient had any nonlocal or systemic neurological reactions to previous [tetanus toxoid adsorbed] inoculations.\u201d\nAt a hearing on the plaintiffs\u2019 motion on March 21, 1989, the judge entered and continued the motion for hearing before the assigned trial judge. The plaintiffs filed their third amended complaint on March 21, 1989, and Wyeth filed its answer denying the material allegations directed against it in counts III and VI.\nOn June 29, 1989, the plaintiffs served Wyeth\u2019s counsel with notice that on July 6, 1989, they would present a \u201cA Motion for Leave to File Plaintiffs\u2019 Third Amended Complaint Previously Filed on 3/21/ 89.\u201d However, unlike the third amended complaint filed on March 21, 1989, paragraph six of the complaint contained a fifth subparagraph labeled \u201ce\u201d alleging that the tetanus toxoid was unreasonably dangerous because: \u201cWyeth failed to maintain an adequate system of adverse drug experience investigation and reporting.\u201d\nAt the hearing on July 6, 1989, before the trial judge, Wyeth\u2019s attorney objected to paragraphs (d) and (e) of paragraph six arguing that Wyeth would be prejudiced by the addition of a new theory of liability after discovery had been closed and after the case had been pending for nine years. The trial judge sustained the objection to sub-paragraph (e) and overruled the objection to subparagraph (d), and entered an order granting the plaintiffs leave to file their third amended complaint instanter with the exception of paragraph 6(e).\nThe plaintiffs argue that the trial judge\u2019s refusal to allow them to amend their complaint to add subparagraph (e) was an abuse of discretion. They maintain that subparagraph (e) was added because of statements made by Dr. O\u2019Donnell during his deposition, and they emphasize that their third amended complaint was filed \u201cshortly after\u201d his deposition. However, the defendant points out that subparagraph (e) was not a part of the third amended complaint filed on March 21, 1989.\nA trial court has broad discretion in motions to amend pleadings before the entry of final judgment, and a denial of a motion to amend is not erroneous unless there has been a manifest abuse of discretion. (Starnes v. International Harvester Co. (1989), 184 Ill. App. 3d 199, 539 N.E.2d 1372.) The factors to consider in evaluating the trial court\u2019s discretion in allowing a motion to amend a pleading are: (1) whether the proposed amendments would cure the defective pleadings, (2) whether they would cause prejudice or surprise to the defendants, (3) the timeliness of the proposed amendments, and (4) whether previous opportunities to amend the pleadings could be identified. (Starnes, 184 Ill. App. 3d at 205.) In this case, the plaintiffs\u2019 motion for leave to file their amended complaint came five weeks before trial, after discovery had been closed and after the case had been pending for nine years. As in Starnes, the plaintiffs had a previous opportunity to add a new cause of action, and this new claim could prejudice the defendant, as the defendant would need additional time to prepare its response. Under these facts, we cannot say that the trial judge abused his discretion in denying leave to file paragraph 6(e) of the plaintiffs\u2019 third amended complaint. The order denying leave to file subparagraph (e) is affirmed.\nJudgment affirmed in part, and reversed and remanded in part.\nRAKOWSKI, P.J., and McNAMARA, J., concur.\nThe expert was Dr. James O\u2019Donnell, the same expert who testified in this case.", "type": "majority", "author": "JUSTICE EGAN" } ], "attorneys": [ "Paul R. O\u2019Malley and Thomas D. Nissen, both of Paul R. O\u2019Malley, Ltd., of Chicago, for appellants.", "Wildman, Harrold, Allen & Dixon, of Chicago (Richard C. Bartelt, Ruth E. VanDemark, David A. Kanter, Francine J. Aren, and Frank T. Rivas, of counsel), for appellee." ], "corrections": "", "head_matter": "MAURICE TONGATE et al., Plaintiffs-Appellants, v. WYETH LABORATORIES, Defendant-Appellee.\nFirst District (6th Division)\nNo. 1\u201490\u20140053\nOpinion filed August 16, 1991.\nModified on denial of rehearing November 15, 1991.\nPaul R. O\u2019Malley and Thomas D. Nissen, both of Paul R. O\u2019Malley, Ltd., of Chicago, for appellants.\nWildman, Harrold, Allen & Dixon, of Chicago (Richard C. Bartelt, Ruth E. VanDemark, David A. Kanter, Francine J. Aren, and Frank T. Rivas, of counsel), for appellee." }, "file_name": "0952-01", "first_page_order": 974, "last_page_order": 993 }