Opinion
Civil Action No. 3:97-CV-740H
November 8, 1999
MEMORANDUM OPINION
Defendants, Royce Laboratories, Inc. ("Royce") has filed a motion for summary judgment on all of Plaintiff's claims. Royce argues that it should not be held liable because Judith Hardy's ("Hardy") death resulted from a hypersensitive reaction, liability is barred by the learned intermediary doctrine, Hardy misused Royce's product and Royce's manufacture was not the proximate cause of Hardy's injuries. Royce also contends that Plaintiff lacks privity as required for warranty and Consumer Protection Act claims and that Plaintiff cannot establish the elements of a fraud claim. Plaintiff concedes that Kentucky has required privity for warranty and Consumer Protection Act claims but contests all of Royce's other arguments.
In prior actions, the Court has dismissed Watson Pharmaceuticals, Inc. from the case and Plaintiffs have settled their claims against Columbia Laboratories, Schering-Plough Corp., Schering-Plough HealthCare Products and Wal-Mart. Other motions are pending, including Walgreen Company's motion for summary judgment. The Court will address these motions in a subsequent memorandum.
Royce contests that Hardy's death was even caused by the quinine, but for purposes of summary judgment, this argument is not relevant.
Summary judgment is appropriate when there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. See Fed.R.Civ.Proc. 56(c). For purposes of summary judgment, any factual dispute must be resolved in favor of the non-moving party, in this case Plaintiff. Summary judgment should be granted if there is insufficient evidence in support of one or more elements essential to Plaintiff's claims. See Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986).
I.
The facts of this case from Plaintiff's perspective are these. On August 22, 1994 the FDA banned over-the-counter sales of quinine labeled as treatment for leg cramps, effective February 1995. On January 23, 1995 the FDA issued a warning letter to all drug companies prohibiting marketing of quinine for leg cramps. The FDA's actions were in response to evidence of severe adverse reactions to the drug and concerns over its lack of efficacy.
On July 12, 1995 Judith Hardy took an over-the-counter quinine preparation known as Legatrin for leg cramps. The drug had been purchased by her husband at Wal-Mart sometime in the fall of 1994. Within hours of taking the recommended dosage, Mrs. Hardy was hospitalized and diagnosed with granulomatous hepatitis. Plaintiff suffered liver injury and eventual gall bladder surgery. Unaware that Mrs. Hardy had taken quinine, the attend physicians made no connection between the illness and drug at that time.
In 1996, Marion Merrell Dow stopped producing the 260 mg. leg cramp tablets of quinine and removed its listing of the drug from the Physician's Desk Reference. Columbia removed the quinine from Legatrin, but continued to manufacture and sell Legatrin as a remedy for leg cramps without quinine. Royce continued to sell 260 mg doses of quinine but changed the indicated use to "for malaria". Plaintiff contends that Royce's recommended dosage is consistent with treatment for leg cramps, not malaria, and that today quinine is only used to treat malaria if the strain of malaria is resistant to chloroquine. Royce did not include any information contraindicating quinine for leg cramps, nor did Royce inform physicians that the FDA had required that quinine labeled as a remedy for leg cramps be removed from the market. Royce knew, based on the quantities of quinine sold, that physicians were continuing to prescribe quinine for leg cramps and can be presumed to have known that the physicians were unaware of the FDA's actions.
On April 15, 1997 Mrs. Hardy's family physician, Dr. Michael Hess, prescribed quinine for her leg cramps. She purchased the 260 mg. quinine sulfate tablets from Walgreen that day. Walgreen gave her an information sheet on the prescription stating, "This drug is used to treat malaria. It may also be used to treat nocturnal leg cramps and other conditions as determined by your doctor". The quinine sulphate was manufactured by Royce. The product insert indicated that the drug was for treatment of malaria.
Immediately after taking the quinine, Mrs. Hardy again developed granulomatous hepatitis and other severe adverse reactions to quinine including platelet destruction (thrombocytopenia) and kidney failure. Mr. Hardy then realized the connection and brought the quinine box to the hospital to show the physicians. Unfortunately, Mrs. Hardy died from her reaction to quinine four days later at the age of forty-seven.
II.
Royce claims that Plaintiffs cannot recover against manufacturers for hypersensitive reactions to products under Kentucky law. To support this position, Royce cites Gordon v. Proctor Gamble Distributing Co., 789 F. Supp. 1384 (W.D. Ky. 1992). In Gordon, the court held that the plaintiff's rare idiosyncratic sensitivity did not provide a basis for a products liability suit. In that case the manufacturer had warned that the prescription dental wash at issue may cause temporary loss of taste; the plaintiff claimed to have suffered a permanent loss of taste. The Gordon plaintiff made no argument against the manufacturer's claim that hypersensitivity should bar recovery; therefore, the court dismissed the case on summary judgment. The court stated, however, that the hypersensitive plaintiff defense would not apply if the manufacturer had reason to know that even a "very few" users of the product might be injured. Id. at 1385 ( quoting Thomas v. Amway Corp., 488 A.2d 716, 722 (1985)). Treatises on products liability for prescription drugs reaffirm the position that manufacturers can be found liable if the manufacturer knew or should have known that the drug was dangerous to even a statistically insignificant number of hypersensitive users. See, e.g. American Law of Products Liability 3d, vol. 6, § 89:9 (1998). This Court is inclined to agree that hypersensitivity does not provide manufacturers a defense if they knew or should have known that some people would be injured by their product.
In this case, Plaintiff has offered sufficient evidence to survive summary judgment that Royce knew or should have known of the risks associated with quinine sulfate. While the number of reported deaths caused by quinine are very low, the FDA's determination that quinine is not safe and effective for treatment of leg cramps coupled with the medical journal articles written on the possible side effects of quinine are sufficient to convince a reasonable jury that Royce knew or should have known of quinine's risks.
II.
Royce also argues that the learned intermediary doctrine provides a complete defense. Kentucky has never formally recognized the learned intermediary doctrine, but this Court at least has opined that this state's courts would recognize some form of the doctrine. See Clark v. Danek Medical, Inc., 1999 WL 613316 (W.D.Ky.). To state this opinion, however, leaves much still unsaid about the scope and specifics of the doctrine in Kentucky. The Court will leave that for another time. For now it is enough to say that the learned intermediary doctrine would exempt drug manufacturers from a legal duty to warn consumers directly about their products as long as the manufacturers adequately warn the medical community of the risks. A warning to an intermediary would be adequate if it clearly conveys any risk or contraindication that the manufacturer knows or should know is associated with the use of the prescription drug.
In our case, Plaintiff has introduced evidence to attack application of the defense from two different angles. First, Plaintiff questions the adequacy of the warning itself. Specifically, Plaintiff argues that the insert should have warned against granulomatous hepatitis and should have contained a contra-indication for usage to treat leg cramps. It is undisputed that the insert contained no such warnings. The jury must decide if the absence of these warnings means that Royce failed to convey all the know risks and contraindications associated with quinine sulphate. Second, Plaintiff attacks Royce's distribution of warnings to the medical community. Hardy's physician, Dr. Hess, was unaware that quinine could cause granulomatous hepatitis and that the FDA had banned marketing quinine for treatment of leg cramps because of questions regarding its safety and efficacy. Dr. Hess has stated that he would not have prescribed quinine to Hardy if he had been aware of either of these facts. The Court agrees that all of these facts would prevent summary judgment for Royce. Too many facts material to the most fundamental aspects of the learned intermediary defense remain at issue.
III.
Royce also claims that summary judgment is appropriate on all claims because Hardy misused the drug. Royce argues, correctly, that manufacturers are not liable for the unforeseeable misuse of their products. In this case, however, Royce knew its quinine was being used to treat leg cramps. See Royce's 1/25/96 letter to FDA. Royce claims that it could not foresee that Hardy's physicians would mis-diagnose her 1995 condition (not realizing that it was a reaction to quinine) or that Dr Hess would prescribe their product to a patient with a history of hepatitis. In other words while Royce could foresee that its quinine would be used to treat leg cramps, Royce argues that it could not foresee that its quinine would be used to treat leg cramps for someone with hepatitis having a known sensitivity to quinine. To be sure Royce is entitled to make these arguments before a jury. Reasonable people will disagree, however, about whether or not these intervening facts make Hardy's use of Royce's quinine unforeseeable.
Royce also tries to argue that the chain of causation linking Hardy's actions to Royce are too remote. Royce claims that their actions were not a proximate cause of Hardy's death. This argument, like the misuse argument above, remains a factual dispute for the jury.
IV.
Plaintiff concedes that his warranty claims and Consumer Protection Act claim require contractual privity which is lacking in this case. Nevertheless, Plaintiff asks this Court to revisit the current state precedents and change the law. Under the circumstances, the Court is not inclined to do this. As a federal court sitting in diversity, the Court has an obligation to apply state substantive law. See Hanna v. Plumer, 380 U.S. 460, 464-65, 85 S.Ct. 1136, 1140 (1965). Williams v. Fulmer, 695 S.W.2d 411 (Ky. 1985) (breach of warranty claims require vertical privity) and Skilcraft Sheetmetal v. Kentucky Machinery, Inc., 836 S.W.2d 907, 909 (Ky.Ct.App. 1992) (Consumer Protection Act claims require contractual privity) unequivocally demonstrate that state law requires contractual privity for all warranty and protection act claims. Plaintiff provides no compelling reason for this Court to believe that the Kentucky Supreme Court has changed its mind regarding this issue.
V.
Plaintiff also asserts a fraud claim against Royce. Under Kentucky law, fraudulent misrepresentation requires that the defendant make a false material statement with the intent to induce reliance by the plaintiff who justifiably and detrimentally relies upon the statement. See Miller's Bottled Gas, Inc. v. Borg-Warner Corp., 955 F.2d 1043, 1051 (6th Cir. 1992). Plaintiff is never entirely clear exactly what fraudulent misrepresentation Royce made. Plaintiff seems to allege several distinct fraud claims. First, Plaintiff argues that Royce made a fraudulent misrepresentation by stating that its 260 mg dosage of quinine sulphate was "for malaria" when, in reality, the quinine was intended to be used for treatment of leg cramps. The "for malaria" indication may have been false, but it is quite clear that neither Dr. Hess nor Hardy relied on Royce's "for malaria" indication.
Plaintiff also asserts a claim against Royce for fraudulent concealment. To support this claim, Plaintiff points to the 1995 PDR listing of Quinnam, Royce's product insert and the lack of any press release on the FDA's actions. Obviously, Royce has no liability for any fraudulent misrepresentation or concealment based on Quinnam's PDR listing. Royce had nothing to do with that listing. Any claim based upon it must be directed to Marion Merrell Dow.
Plaintiff argues that Royce's product insert contains two fraudulent omissions. First, it fails to adequately describe the possible side effects of quinine, including granulomatous hepatitis. Second, it does not include a contra-indication for usage to treat leg cramps. While these actions could conceivably support a fraud claim under other circumstances, in this case there is simply no evidence that Dr. Hess or Hardy relied on the product insert. Dr. Hess has testified that he never read the insert. Therefore, he cannot be said to have relied upon it. Similarly, all evidence indicates that Hardy never read the insert but instead relied on Dr. Hess.
Finally, Plaintiff urges that the lack of any press release on the FDA's actions constitutes fraudulent concealment. This claim is the most difficult to unpack, but it too appears to fail the reliance test. While Royce may face products liability because it allegedly failed to adequately inform physicians of quinine's risks, it is not liable under any theory of fraud. Royce did not take any action to induce Dr. Hess to rely on its omission. In fact, there was never any relationship between Royce and Dr. Hess. Dr. Hess' prescription was for quinine. While Royce produces a generic version of quinine, it is not the only producer. Dr. Hess could have obtained information on quinine from the FDA, from the Federal Register, from other manufacturers, or from medical journals. The fact that Walgreen filled Dr. Hess' prescription with a Royce product was mere chance. Dr. Hess was not relying on Royce any more than the other manufacturers or the FDA for product information.
The Court will enter an order consistent with this Memorandum Opinion.
ORDER
Defendant, Royce Laboratories, has moved for summary judgment. Being otherwise sufficiently advised,
IT IS HEREBY ORDERED that Royce's motion is SUSTAINED IN PART and Plaintiff's claims against Royce based upon warranty, fraud, fraudulent concealment and the Consumer Protection Act are DISMISSED WITH PREJUDICE. The motion is DENIED as to the remainder of Plaintiff's claims against Royce.