Case Name: Scott and Denise ADAMS, Appellants, v. G.D. SEARLE & CO., INC., Appellee
Court: Florida District Court of Appeal
Jurisdiction: Florida
Decision Date: 1991-01-18
Citations: 576 So. 2d 728
Docket Number: No. 89-02843
Parties: Scott and Denise ADAMS, Appellants, v. G.D. SEARLE & CO., INC., Appellee.
Judges: FRANK, A.C.J., concurs.
Reporter: Southern Reporter, Second Series
Volume: 576
Pages: 728–737

Head Matter:
Scott and Denise ADAMS, Appellants, v. G.D. SEARLE & CO., INC., Appellee.
No. 89-02843.
District Court of Appeal of Florida, Second District.
Jan. 18, 1991.
Rehearing Denied April 4, 1991.
Michael D. Eriksen of Wagner, Nugent, Johnson, Roth, Romano, Eriksen & Kupfer, P.A., West Palm Beach, for appellants.
A. Broaddus Livingston and Alan C. Sundberg of Carlton, Fields, Ward, Emmanuel, Smith & Cutler, P.A., Tampa, for appellee.

Opinion:
PATTERSON, Judge.
Scott and Denise Adams brought a product liability action against G.D. Searle & Co., Inc., the manufacturer of Denise's intrauterine contraceptive device (IUD), after Denise became pregnant and suffered a septic abortion. The Adamses alleged in four counts that the IUD was defective and Searle was strictly liable for damages; that Searle failed to test the IUD adequately; that Searle's product labeling inadequately warned physicians and patients of the dangers associated with the IUD; and that Searle fraudulently misrepresented the IUD as safe. The trial court granted summary judgment as to the entire complaint in favor of Searle. We reverse.
Because of unrelated medical difficulties, Denise Adams cannot use oral contracep tives. She selected an IUD as her method of contraception based on the recommendation of her physician, Dr. Helwig. On January 2, 1980, Dr. Helwig prescribed for her and inserted the "Copper 7" (Cu-7), a copper-containing IUD manufactured by Searle.
When Denise decided to try the Cu-7, Dr. Helwig gave her a patient brochure which Searle provided in accordance with FDA regulations. This brochure warned of specific dangers associated with IUD's in general and the Cu-7 in particular. It also identified adverse reactions that have been reported with the use of IUD's. Denise read the brochure and signed a card stating, "I received and have read the patient booklet, Cu-7."
Almost a year after Dr. Helwig inserted the Cu-7, Denise became pregnant. Dr. Helwig's normal procedure in such cases is to remove the IUD, because this reduces the risk that the patient will miscarry later in the pregnancy. However, in Denise's case, he found that the IUD's polypropylene removal string had retracted into her uterus. This limited Denise to three options: she could elect to have an abortion; Dr. Helwig could probe for the IUD, which in itself could cause an abortion; or Denise could risk trying to carry the infant to term with the IUD in place. Denise chose the latter, and the pregnancy proceeded.
When she was in the middle trimester, about twenty-four weeks along, Denise began to suffer flu-like symptoms, fever, and premature rupture of membranes. To safeguard her life, physicians induced labor and on April 14, 1981, she delivered a premature infant son who died within hours. The child's death certificate listed the cause of death as premature rupture of the membranes and uterine infection caused by the Cu-7.
On January 21, 1983, the Adamses filed this action against Searle. They sought damages for Denise's permanent injuries, wrongful death of the child, loss of consortium for Scott, mental anguish, loss of support from the child, and medical and burial expenses. In Count I, the strict liability count, they alleged the existence of specific defects in the Cu-7. In Count II, the "negligent failure to test" count, the Adamses alleged that Searle failed to perform tests necessary to discover the Cu-7's defects and dangers. In Count III, the failure-to-warn count, they alleged that Searle knowingly failed to warn either physicians or patients about the defects and dangers. And, in Count IV, the fraud count, they alleged that to induce physicians to prescribe the Cu-7, Searle knowingly withheld facts it knew were material.
Early in the litigation, the trial court dismissed the fraud claim for failure to state a cause of action. However, within the four corners of the complaint, see Geer v. Bennett, 237 So.2d 311 (Fla. 5th DCA 1970), the Adamses alleged that Searle misrepresented and omitted specific material facts about the Cu-7 to Dr. Hel-wig and Denise with the intention to induce them to rely on the misrepresentations and omissions; and that Dr. Helwig and Denise did so to Denise's detriment. These allegations state a cause of action for fraud, and we therefore reverse the dismissal of Count IV.
The remaining counts were disposed of by the trial court's order granting Searle's motions for summary judgment. In discussing whether summary judgment was appropriate as to each count, we address first the claim for negligent failure to test, next the question of failure to warn, and last the matter of strict liability for design defects.
The trial court correctly disposed of the claim for negligent failure to test. That count alleged that Searle negligently failed to perform tests upon the Cu-7 to discover its defects and dangers. We agree with Kociemba v. G.D. Searle & Co., Inc., 707 F.Supp. 1517 (D.Minn.1989), that a manufacturer's duty to inspect and test is not a separate cause of action. The duty to test, as that court concluded, is a subpart of a manufacturer's duty to design a product with reasonable care, and thus is subsumed in the plaintiffs' claims for defective design and failure to warn. 707 F.Supp. at 1527. We therefore affirm the summary judgment as to this claim.
The trial court, in granting final summary judgment for Searle, found as a matter of law that the Cu-7's product labeling was adequate. Although the adequacy of prescription drug warnings can become a question of law where the warning is accurate, clear, and unambiguous, it otherwise remains a question of fact. See Upjohn Co. v. MacMurdo, 562 So.2d 680, 681-2 (Fla.1990); Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 105 (Fla.1989). In this case, the Adamses produced evidence tending to show that the warnings were not accurate, clear, and unambiguous; therefore, the adequacy of the warnings was a question of fact for the jury, and the trial court erred in deciding it as a matter of law.
As to the defective design claim, we find that the summary judgment must be reversed. To grant the motion for summary judgment as to this issue, the trial court necessarily must have found that Searle could not be held responsible under strict liability for defects in the design of the Cu-7. It could have arrived at this conclusion only by applying comment k of the Restatement (Second) of Torts (1959) section 402A, to the Cu-7.
Comment k protects the manufacturers of certain products from strict liability for design defects. It states:
UNAVOIDABLY UNSAFE PRODUCTS. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warnings, is not defective nor is it unreasonably dangerous. The same is true of many other drugs, vaccines and the like, many of which, for this very reason, cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of the time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug, notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.
Restatement (Second) of Torts (1959) section 402A, comment k. Thus, by its terms comment k applies to products which current knowledge and technology cannot make safe for their ordinary use, but for which society has a need great enough to justify using the product despite its dangers. Comment k increases the standard a plaintiff must meet from that of strict liability to negligence. See Toner v. Lederle Laboratories, 112 Idaho 328, 336, 732 P.2d 297, 305 (1987).
Some courts apply comment k uniformly to all prescription drugs. See, e.g., Brown v. Superior Court, 44 Cal.3d 1049, 1061, 751 P.2d 470, 477, 245 Cal.Rptr. 412, 418 (1988); McKee v. Moore, 648 P.2d 21 (Okla. 1982); Terhune v. A.H. Robins Co., 90 Wash.2d 9, 577 P.2d 975 (1978). While we recognize that policy reasons exist to support such an approach, we are disinclined to adopt it for several reasons.
First, the language of comment k indicates that it was not intended to apply to all prescription drugs. It speaks of "some products," "especially common in the field of drugs," "many other drugs," and "many new and experimental drugs." By definition, "some" and "many" are less than all. See Toner, 112 Idaho at 339, 732 P.2d at 308; Kociemba v. G.D. Searle & Co., 680 F.Supp. 1293 at 1300 (D.Minn.1988).
Second, the comment itself adopts a risk/benefit analysis in using the Pasteur rabies vaccine as an "outstanding example" of a product which is protected by comment k. It notes that injecting the vaccine may lead to very serious consequences, but because the disease "invariably leads to a dreadful death," the vaccine's marketing and use are justified. Applying comment k uniformly to all prescription drugs therefore rejects the comment's own approach to determining its scope.
Third, we believe that the policy reasons supporting a blanket approach are countervailed by those supporting a more selective application of the comment. For example, courts which apply comment k to all prescription drugs frequently state that the public's interest in the development of prescription drug products requires the user to bear all costs of injury unless the drug product was negligently manufactured, negligently designed, or accompanied by inadequate product warnings; otherwise, drug manufacturers might be discouraged from developing new products. See, e.g., Brown, 44 Cal.3d 1049 at 1062, 751 P.2d 470 at 478, 245 Cal.Rptr. 412 at 420. We d.o not believe this policy has a sound foundation.
We believe that a more selective application will encourage, rather than discourage, improvements in prescription products. Comment k was designed in part to protect new and experimental drugs. As the Toner court noted:
Comment k states: "There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use." Obviously, for this to be true, the design must be as safe as the best available testing and research permits.
112 Idaho at 306, 732 P.2d at 306 (citations omitted). Thus, a product which is as safe as current testing and research permits should be protected. The reverse is also true; a product which is not as safe as current technology can make it should not be protected. See Toner, 112 Idaho at 337-8, 732 P.2d at 306-7; Belle Bonfils Memorial Blood Bank v. Hansen, 665 P.2d 118 at 123 (Colo.1983); Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775 (R.I.1988). In Castrignano, the Rhode Island Supreme Court stated that "[W]e believe the societal interest in the development and marketing of prescription drugs will be adequately served by extending comment k to prescription drugs on a case-by-case basis." 546 A.2d at 781.
The allegations in this case illustrate why we prefer this approach. The Adams-es allege that the Cu-7's polypropylene withdrawal string had a "memory" which caused it to tend to retract into the uterus; that Searle knew of this problem; that by 1978 it had identified polyethylene as a safer alternative; that it used polyethylene successfully in another IUD; and that despite its knowledge, Searle continued to use polypropylene for the Cu-7's string. Applying comment k to all prescription drugs does nothing to discourage such practices.
Under a selective application theory, if comment k protected the Cu-7 originally, then certainly that protection would have been withdrawn after Searle learned that polyethylene made the Cu-7 safer but did nothing. To keep the Cu-7 within the scope of comment k, Searle would have had to replace the polypropylene string as soon as possible. Thus, it appears that a selective application should encourage improvements in prescription products.
Another factor courts have cited as supporting the determination that comment k should apply to all prescription drugs is that the Federal Food and Drug Administration (FDA) approves such products and their warning label inserts. See, e.g., Leibowitz v. Ortho Pharmaceutical Corp., 224 Pa.Super. 418, 307 A.2d 449 (1973). However, it seems likely to us that a drug manufacturer is in a better position to monitor the current state of knowledge and technology, as applied to its products, than is the FDA. We hesitate to hold that a manufacturer is excused from making changes it knows will improve its product merely because an older, more dangerous version received FDA approval.
We therefore reject a blanket approach and decline to apply comment k to all prescription products. Instead, we follow those courts which hold that comment k is an affirmative defense to a strict liability claim. See, e.g., Ortho Pharmaceutical Corp. v. Heath, 722 P.2d 410 at 416 (Colo. 1986); Toner, 112 Idaho at 339, 732 P.2d at 308; Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374, 383 (1984); Belle Bonfils, 665 P.2d at 122-3, 125, n. 12; Senn v. Merrell-Dow Pharmaceuticals, Inc., 305 Or. 256, 751 P.2d 215 (1988); Cas-trignano, 546 A.2d at 782. These courts generally adopt a risk/benefit analysis in determining whether comment k applies to a given product. We believe such an approach better comports with the language of comment k and the policy underlying it.
We therefore hold that the seller has the burden to establish the application of comment k. We also hold that whether comment k applies is a mixed question of fact and law. If reasonable minds could reach only one conclusion, then the trial judge may rule; but if reasonable minds might differ, then the matter must be submitted to the jury. See Castrignano, 546 A.2d at 782.
Any weighing of a product's risk against its benefit should consider the value of the benefit, the seriousness of the risk, and the likelihood of both. For comment k to apply, the product's benefits must outweigh its known risks as of the date the product is distributed. Toner, 112 Idaho at 337, 732 P.2d at 306; Belle Bonfils, 665 P.2d at 122-3. In Toner, the court stated:
Comment k does not require sellers to be clairvoyant. When a product is "apparently useful and desirable," considering its benefits and risks, then it ought to be immune from strict liability. Such products can include new or experimental drugs for which "there can be no assurance of safety." Comment k only requires that the balance "apparently" tip toward the benefit of a product at the time of distribution.
If new information later tips the balance toward the risk of a product, or if new developments make possible a safer design, at that point further distributions of the product are not protected by comment k.
Toner, 112 Idaho at 338, 732 P.2d at 306-7 (citations omitted). Thus, it appears that extending comment k's protection to prescription drug products on a case-by-case basis will adequately serve the'public interest.
In this case, the trial court could not have granted summary judgment for Searle without finding as a matter of law that comment k protected Denise Adams's Cu-7. After reviewing the evidence, we conclude that reasonable minds might differ on this question. We therefore hold that the trial court erred in granting Searle's motions for summary judgment.
In conclusion, we reverse the order dismissing the Adamses' fraud claim for failure to state a cause of action. We also reverse the final summary judgment as to their claims for failure to warn and strict liability for design defects. We affirm the summary judgment as to the claim for "negligent failure to test," and remand the case for further proceedings consistent with this opinion.
FRANK, A.C.J., concurs.
PARKER, Judge, dissenting in part and specially concurring in part with opinion.
. Because the copper in the Cu-7 has effects on the user's body, the FDA classified this device as a prescription drug.
. One Florida federal district court, in reversing a summary judgment for Searle, has said: "Far from a model of clarity, the Cu-7 warning is the very example of a qualified warning, the adequacy of whch must be resolved through a highly intensive factual inquiry." Zanzuri v. G.D. Searle & Co., 748 F.Supp. 1511, 1516, (S.D.Fla.1990).
. Searle moved for summary judgment on this issue and noticed the motion for hearing, but it appears from the record that the parties ran out of time and were unable to argue the motion to the trial court.
. Comment k protects manufacturers from strict liability only for design defects. An injured party may seek strict liability for manufacturing defects or inadequate warnings even though comment k applies. See Toner, 112 Idaho at 336, 732 P.2d at 305.
. One court noted that, at the American Law Institute meeting where section 402A and comment k were adopted, the drafters of comment k entertained a proposal to include all prescription drugs within its scope. This proposal was defeated. Hill v. Searle Laboratories, 884 F.2d 1064, 1069 (8th Cir.1989).
. This court does not pass judgment upon whether the Cu-7 was entitled to the protection of comment k at any time.