holding that a plaintiff proceeding under a theory of liability based on negligent failure to warn must show that an adequate warning would have prevented the injury by altering the conduct involvedSummary of this case from Cavalier v. Werner Co.
Docket No. 85049.
Decided August 26, 1986.
James Leonard Elsman, for plaintiffs.
Kohl, Secrest, Wardle, Lynch, Clark Hampton (by Michael L. Updike), for Ayerst Laboratories, Inc., and American Home Products, Inc.
On June 27 and August 6, 1985, the circuit court for Oakland County, pursuant to GCR 1963, 117.2(1) and (3), entered orders of summary judgment in favor of defendants Ayerst Laboratories, Inc., and American Home Products, Inc., as to the issues of defendants' failure to test their drug product, Phospholine Iodide, and failure to warn plaintiffs of its dangers. Plaintiffs appeal as of right raising two issues: (1) whether a drug manufacturer has the duty to warn the ultimate consumer of the product's dangers; and (2) whether the trial court erred in finding that defendants' alleged failure to adequately test the drug product was not the proximate cause of plaintiff's injury.
Hereinafter, "plaintiff" refers to Bonnie Mowery. "Plaintiffs" refers to both Bonnie and Richard Mowery.
On August 26, 1981, at Crittenton Hospital, codefendant Dr. Rose Malach performed a cataract removal and implantation of an intraocular lens on plaintiff Bonnie Mowery's right eye. The procedure involved the removal of the eye's natural lens which has an opaque covering or a cataract and its replacement with an artificial lens. Preoperatively, Dr. Malach explained to plaintiffs this surgical procedure's known risks of detachment of the retina, the portion of the eye containing the rods and cones, which transmits images to the optic nerve allowing vision. Plaintiff Bonnie Mowery signed a consent form acknowledging her awareness of all of the risks of cataract surgery.
Postoperatively, on September 10, 1981, Dr. Malach discovered a detachment of the lower loop keeping plaintiff's intraocular lens in place. Dr. Malach explained to plaintiffs what was wrong and how she planned to correct it and prescribed an eye drop, Phospholine Iodide, an opthamologic therapeutic drug. In prescribing the drug, Dr. Malach verbally explained to plaintiffs the drug's risks, which were retinal detachment and complications with certain types of general anesthesia. She did not give them any written information from the manufacturer, defendant Ayerst Laboratories.
Despite the risks of retinal detachment with the use of Phospholine Iodide, Dr. Malach prescribed this eye medication because it could prevent dislocation of the intraocular lens. Such dislocation could damage the cornea's endothelium (the outer covering of the eye), which would require a corneal transplant.
Because plaintiff's intraocular implant lens was again dislocated on October 23, 1981, Dr. Malach discontinued the Phospholine Iodide. After several unsuccessful attempts to medically reposition the lens, Dr. Malach successfully surgically repositioned it. Phospholine Iodide was again used during that procedure. On November 13, 1981, plaintiff contacted Dr. Malach's office complaining of a change of vision in her right eye. Because Dr. Malach was ill, plaintiff sought treatment from Dr. Aragones, who diagnosed retinal detachment. Surgery was performed to correct this detachment. However, plaintiff claims that she has suffered "permanent or protracted vision loss."
On September 14, 1983, plaintiffs filed a complaint against Crittenton Hospital, Dr. Malach, and Ayerst Laboratories, Inc., alleging negligence for the failure to adequately test or warn. On October 20, 1983, plaintiffs filed an amended complaint adding American Home Products, Inc., as a defendant and alleging that both Ayerst and American (1) breached their express or implied warranty and were strictly liable because the drug Phospholine Iodide is defective, and (2) consciously misrepresented the safety of its product, a proximate cause of plaintiff's injuries. Following the taking of depositions, Ayerst and American moved on June 13, 1984, for summary judgment on grounds they did in fact adequately warn the treating physician of the risks of retinal detachment. On June 27, 1984, the trial court granted partial summary judgment on grounds there was no question of fact but that Dr. Malach had been adequately warned of the drug's risks. However, the trial court held that the motion for summary judgment regarding adequate testing was denied without prejudice.
On July 3, 1984, defendants filed a supplemental motion for summary judgment pursuant to GCR 1963, 117.2(1) and (3) regarding defendants' adequate testing of Phospholine Iodide. Defendants submitted an affidavit by Robert Lehman, Ph.D., who was the pharmacist primarily responsible for supervising the research and development of Phospholine Iodide (generic name: Echothiophate Iodide). Dr. Lehman claimed that extensive animal testing was done with this drug, during which retinal detachment was never observed. Phospholine Iodide was approved by the Food and Drug Administration in 1959.
Hereinafter the word "defendants" refers to Ayerst Laboratories, Inc., and American Home Products, Inc.
On July 13, 1984, plaintiffs submitted the affidavit of David Schneider, Ph.D., stating that he had reviewed the literature relating to this drug. Dr. Schneider believed that the warnings and package inserts given to physicians by defendants do not adequately set forth the specific danger of retinal detachment associated with this drug. Independent published research states the link between Phospholine Iodide and retinal detachment.
On July 25, 1984, the trial court granted defendants supplemental motion for summary judgment after finding that even if defendants' testing of Phospholine Iodide was inadequate, it was not the proximate cause of plaintiff's injury. While adequate testing would have allowed defendants to effectively warn plaintiffs and the treating physician of the risks of retinal detachment, Dr. Malach already knew of its risks, but chose to prescribe the drug and informed plaintiffs of the risks.
Following the filing of plaintiffs' claim for appeal as of right to this Court, defendants moved to dismiss the appeal. Defendants' motion was denied on July 26, 1985. On December 17, 1985, defendants' application for leave to appeal to the Michigan Supreme Court was also denied as the Court was "not persuaded that the question presented should be reviewed by this Court." 424 Mich. 861 (1985).
At the outset, plaintiffs contend that summary judgment was inappropriate as discovery was not yet complete. On this issue the standard of review is whether further discovery stands a fair chance of uncovering factual support for the opposing party's position. Goldman v Loubella Extendables, 91 Mich. App. 212, 218; 283 N.W.2d 695 (1979), lv den 407 Mich. 901 (1979); Huff v Ford Motor Co, 127 Mich. App. 287, 296; 338 N.W.2d 387 (1983); Kortas v Thunderbowl Lounge, 120 Mich. App. 84, 87; 327 N.W.2d 401 (1982). Here, plaintiffs filed their complaint approximately ten months before summary judgment was granted. Six depositions were taken and numerous interrogatories were answered by all parties. In light of Dr. Malach's and Bonnie Mowery's deposition testimony, we find that a sufficient period of time and sufficient amount of discovery occurred. It does not appear that further discovery will uncover factual support for either party's position.
On the substantive issue of a drug manufacturer's duty to warn, plaintiffs urge this Court to close the void in Michigan law created by the majority opinion in In re Certified Questions, 419 Mich. 686; 358 N.W.2d 873 (1984), by issuing an opinion requiring that a prescription drug manufacturer has the duty to directly warn the consumer of the drug's risks. We respectfully decline the invitation.
In 1979, our Supreme Court in Smith v E R Squibb Sons, Inc, 405 Mich. 79, 88-89; 273 N.W.2d 476 (1979), stated:
A manufacturer of a prescription drug has a legal duty to warn the medical profession, not the patient, of any risks inherent in the use of the drug which the manufacturer knows or should know to exist. McEwen v Ortho Pharmaceutical Corp, 270 Or. 375; 528 P.2d 522 (1974); Sterling Drug, Inc v Yarrow, 408 F.2d 978, 993 (CA 8, 1969); Love v Wolf, 226 Cal.App.2d 378, 395; 38 Cal.Rptr. 183, 192-193 (1964). However, this duty has been held to require warnings to the patient when the prescription drug is administered in a mass immunization program. E.g., Davis v Wyeth Laboratories, Inc, 399 F.2d 121 (CA 9, 1968). Determination of whether this duty has been breached in the context of a negligence claim necessitates that the warnings given be examined as to their reasonableness under the circumstances.
Between 1979 and 1984 the Supreme Court's holding in Smith that a drug manufacturer's duty to warn does not extend to the patient was followed in several decisions of the Court of Appeals. Reeder v Hammond, 125 Mich. App. 223, 226; 336 N.W.2d 3 (1983); Taylor v Wyeth Laboratories, Inc, 139 Mich. App. 389, 397; 362 N.W.2d 293 (1984), lv den 423 Mich. 852 (1985); Dunn v Lederle Laboratories, 121 Mich. App. 73, 79; 328 N.W.2d 576 (1982), lv den 417 Mich. 1098 (1983); Muilenberg v Upjohn Co, 115 Mich. App. 316, 332; 320 N.W.2d 358 (1982); Formella v Ciba-Geigy Corp, 100 Mich. App. 649; 300 N.W.2d 356 (1980), lv den 411 Mich. 995 (1981). However, Justice LEVIN in the Supreme Court's majority opinion, In re Certified Questions, supra, p 697, stated that the Court's prior statement in Smith, supra, was dictum and, therefore, did not establish a rule of law.
The allocation of the duty to warn patients is a public policy question involving the marketing system and economics of a major industry and the everyday practice of an essential profession. We believe that the Legislature is in a better position to allocate those duties. [ In re Certified Questions, supra, p 691-692.]
In a strong dissent, Justice BOYLE, joined by Chief Justice WILLIAMS and Justice BRICKLEY, distinguished the duty owed by a drug manufacturer of oral contraceptives and that owed by a manufacturer of a "therapeutic, diagnostic, or curative prescription drug." Justice BOYLE explained that the "learned intermediary" doctrine is an exception to the axiomatic principle that a manufacturer has a duty to warn the user of known dangers inherent to its product. This exception is applied to manufacturers of prescription drugs, who are required to warn only the prescribing physician, who acts as a "learned intermediary" between the manufacturer and consumer. 419 Mich. p 704.
The exception has also been justified by an assertion that direct manufacturer-consumer communication is difficult if not virtually impossible. Terhune, supra, p 14; Carmichael v Reitz, 17 Cal.App.3d 958, 988-989; 95 Cal.Rptr. 381 (1971).
In addition, it has been argued that a duty to warn the user directly would cause undue interference with the relationship between doctor and patient. Dunkin v Syntex Laboratories, Inc, 443 F. Supp. 121, 123 (WD Tenn, 1977); Carmichael, supra, p 988.
"Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative." Reyes v Wyeth Laboratories, 498 F.2d 1264, 1276 (CA 5, 1974) [cert den 419 U.S. 1096 (1974). 419 Mich. p 707.]
The "learned intermediary" doctrine has been adopted by many other jurisdictions, where it has almost unanimously been applied for all prescription drugs, including oral contraceptives. Justice BOYLE concluded that while the "learned intermediary" doctrine should not apply to oral contraceptives because women may obtain a refill without repeated medical assessment, it should apply to cases involving prescription drugs.
See 419 Mich. pp 704-705 for a lengthy list of cases from other jurisdictions.
In such a context, it is true that the patient relies almost completely on the skill and judgment of the physician in selecting an appropriate drug for the treatment of the patient's illness or injury. A warning to the patient under these circumstances could potentially cause undue interference with the doctor-patient relationship, cause patient confusion, and result in a hampering of the healing process. To this extent, the rationale for the learned intermediary doctrine supports a duty to warn only the prescribing physician." 419 Mich. pp 709-710.]
This panel's declination to "close the gap" or otherwise change the law regarding a drug manufacturer's duty to warn in accordance with plaintiffs' request is posited on two grounds. First, since the Supreme Court has ruled that this is a matter for the Legislature rather than the courts, we decline at this time to act contra to the Supreme Court and make this a judicial matter. While we may not agree with Supreme Court decisions, we must respect and follow them. Schwartz v City of Flint (After Remand), 120 Mich. App. 449, 462; 329 N.W.2d 26 (1982); Ratliff v General Motors Corp, 127 Mich. App. 410, 416; 339 N.W.2d 196 (1983).
Second, public policy supports the result reached below. Phospholine Iodide, unlike the contraceptive pills in In re Certified Questions, supra, or Odgers v Ortho Pharmaceutical Corp, 609 F. Supp. 867 (ED Mich, 1985), is not a "consumer demand" of "mass consumption" type drug. It is purchasable legally in the United States only with a valid prescription issued by a doctor. To expect the average citizen to know if he or she should take the drug or when to stop taking it, or to understand the technical language so often necessary to explain the dangers of the drug, is unreasonable. This is the basis for the "learned intermediary" rule adopted by a majority of jurisdictions in cases involving therapeutic, diagnostic or curative drugs.
Accordingly, in the absence of a clear legal duty imposed on defendant manufacturers to directly warn plaintiffs, plaintiffs have failed to state a claim upon which they may recover, GCR 1963, 117.2(1), now MCR 2.116(C)(8).
It was also plaintiffs' theory of liability that defendants failed to adequately test the drug and, because of such inadequate testing, defendants were unable to sufficiently warn Dr. Malach of Phospholine Iodide's risks. On this issue, as noted earlier, the trial court found that even if defendants had completed adequate testing, enabling them to effectively warn Dr. Malach of the danger of retinal detachment, the lack of such a warning was not the proximate cause of plaintiff's injury. Dr. Malach testified that she was aware of the association of retinal detachment with this drug from reading the opthamologic literature. She informed plaintiffs of this risk. Despite her knowledge that this drug could cause retinal detachment, Dr. Malach chose to prescribe this drug for plaintiff. She stated that it was worth taking the "risks" to avoid repeated intraocular lens dislocation, endangering plaintiff's cornea.
Thus, it appears that even if Dr. Malach had been given additional warnings by defendants of the risk of retinal detachment, she would have chosen to prescribe Phospholine Iodide for plaintiff. There is no evidence that she would have done otherwise.
Plaintiffs also argue that further discovery may have allowed them to establish proof that Dr. Malach possibly would have made another drug choice or to raise any other question of fact. Two months before the second summary judgment motion was heard on the adequacy of defendant's testing of this product, plaintiffs' counsel deposed Dr. Malach and asked, inter alia, why she decided to use Phospholine Iodide with the knowledge that it could cause retinal detachment. Dr. Malach responded that she was warned of the specific risks of retinal detachment, but by sources other than the defendants. Based upon this testimony, we do not believe that further warnings would have led Dr. Malach to have prescribed any differently, even if defendants themselves had warned her of the risks about which she already knew. Accordingly, we find no error on this issue.