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Vitanza v. Upjohn Co.
Citations: 257 Conn. 365; 778 A.2d 829; 2001 Conn. LEXIS 320Docket: SC 16343
Court: Supreme Court of Connecticut; August 7, 2001; Connecticut; State Supreme Court
The key issue in this case is whether the learned intermediary doctrine prevents Michele M. Vitanza from pursuing a product liability claim against The Upjohn Company after her husband died from ingesting a prescription drug sample provided by her physician. The learned intermediary doctrine posits that if a drug manufacturer adequately warns the prescribing physician, it is not obligated to warn end consumers. The case arose from the distribution of promotional drug samples by Upjohn, which included appropriate warnings to physicians but did not directly inform the ultimate consumers. The sample in question, Ansaid, was prescribed to Vitanza's husband, who was unwarned about its potential dangers. The plaintiff's claim, filed under the Connecticut Product Liability Act, was removed to federal court, where Upjohn asserted the learned intermediary doctrine as a defense and sought summary judgment. The court granted Upjohn's motion and denied Vitanza's cross-motion for partial summary judgment. The appellate court subsequently certified a legal question regarding the applicability of the learned intermediary doctrine to this case. The facts indicated that Upjohn was aware of the potential fatal reactions of Ansaid for individuals allergic to similar drugs and had provided samples to a qualified physician, which included necessary labeling and warnings. As a result, the court concluded that the learned intermediary doctrine does indeed bar Vitanza's action as a matter of law. Each box of Ansaid samples included a single eight-column package insert detailing critical information such as clinical pharmacology, indications, contraindications, warnings, adverse reactions, precautions, drug interactions, overdosage, and dosage instructions. The insert highlighted the risk of allergic reactions, specifically stating that Ansaid should not be administered to individuals with known sensitivities to aspirin or nonsteroidal anti-inflammatory drugs, as fatal reactions have been reported. While each sample box contained nine blister cards, only one insert was included, and the blister cards did not carry warnings. The packaging complied with federal and state regulations. The defendant reprinted the insert in the 1989 Supplement to the Physicians’ Desk Reference and continued this practice in subsequent editions until the decedent's death. In June 1992, the plaintiff received sample blister cards of Ansaid from her physician, Besser, but did not receive the package insert. The plaintiff consumed Ansaid for neck stiffness relief. In October 1994, the decedent, who had been advised against using aspirin and nonsteroidal anti-inflammatory drugs due to his allergies, found leftover Ansaid tablets and ingested one after consulting two medical reference books that failed to indicate Ansaid's classification as a nonsteroidal anti-inflammatory drug or the associated risks for allergic individuals. Following ingestion, the decedent experienced severe respiratory distress, leading to emergency medical treatment where he suffered respiratory and cardiac arrest, resulting in death from an anaphylactic reaction to Ansaid. The plaintiff subsequently filed a lawsuit, claiming that the defendant did not provide adequate warnings on the sample packets regarding potential adverse effects. The defendant removed the case to federal court, asserting the learned intermediary doctrine as a defense, claiming it had fulfilled its duty by warning the prescribing physician. The plaintiff countered with a motion to dismiss this defense, arguing that Connecticut law had not recognized the doctrine and should not treat it as an absolute defense. The court ultimately granted the defendant's summary judgment motion, denied the plaintiff's cross motion, and ruled in favor of the defendant. The Court of Appeals has certified a question regarding the applicability of the learned intermediary doctrine to the defendant's liability in this case. The court affirms that the learned intermediary doctrine is recognized in state law and applies here to bar the plaintiff's claim. Under Connecticut law, manufacturers are strictly liable for defective products according to § 402A of the Restatement (Second) of Torts, which establishes that products can be deemed defective due to manufacturing flaws, design defects, or insufficient warnings. A product is considered "defective" if it lacks adequate instructions or warnings, potentially rendering it unreasonably dangerous even without manufacturing or design flaws. Proper warnings can mitigate a product's dangerousness. Prescription drugs are often classified as "unavoidably unsafe" products, meaning they can pose risks despite careful manufacture, but manufacturers can avoid strict liability if they provide proper warnings and instructions. The learned intermediary doctrine allows manufacturers to fulfill their duty to warn through adequate warnings to prescribing physicians, who are deemed capable of assessing risks and benefits for patients. This principle acknowledges that physicians serve as intermediaries between manufacturers and consumers. A sufficient warning must inform a general practitioner about the dangerous propensities of a drug, as established in Brooks v. Medtronic, Inc., 750 F.2d 1227 (4th Cir. 1984). In ethical drug cases, the duty to warn is restricted to physicians, differing from the general duty of manufacturers to warn ultimate consumers in products liability cases, as noted in Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir. 1968). Typically, a warning to the prescribing physician suffices in prescription drug cases. Although Connecticut has embraced principles of strict liability from § 402A of the Restatement (Second) of Torts, it has not directly adopted comment (k) to § 402A. This court acknowledges the persuasive policy considerations in comment (k), which states that some products may be "unavoidably unsafe" yet beneficial to society despite their inherent risks. If a product is properly prepared with adequate warnings, it is not considered defective or unreasonably dangerous. Comment (k) indicates that manufacturers of such products should not be held strictly liable for unfortunate outcomes, provided they supply a useful product with known, reasonable risks. Products liability law holds manufacturers strictly liable for unreasonably dangerous products causing injury, but does not equate this liability with absolute responsibility, as clarified in Potter v. Chicago Pneumatic Tool Co., 241 Conn. 199 (1997). The court has also cited Basko v. Sterling Drug, Inc., 416 F.2d 417 (2d Cir. 1969), which applied the learned intermediary doctrine in Connecticut law. In Basko, the plaintiff suffered severe side effects from prescribed drugs, and the Second Circuit recognized Connecticut's adoption of the strict liability standard from § 402A. It stated that a product is not deemed defective or unreasonably dangerous if the manufacturer has provided adequate warnings. In cases involving prescription drugs, the duty to warn can be satisfied by informing the medical community of the drug's risks, as reiterated in Tomer v. American Home Products Corp., 170 Conn. 682. The central issue in *Tomer* revolves around whether the drug manufacturer neglected to inform the medical community about Halothane's dangers. The court noted that while the plaintiff did not assert a duty to warn her husband, it referenced *Basko* to emphasize that products can be deemed defective if a manufacturer fails to warn about their dangerous characteristics. In prescription drug cases, warnings must be directed to the prescribing physician, aligning with the learned intermediary doctrine recognized in multiple jurisdictions, including federal courts applying Connecticut law for over thirty years. The plaintiff contended that the Connecticut product liability act, General Statutes 52-572q, does not provide absolute defenses due to the absence of enumerated affirmative defenses, implying legislative intent to abolish them. However, the court disagreed, noting the act's intent to protect against harm from defective products and simplify legal pleadings. It emphasized that the learned intermediary doctrine does not conflict with these goals. The court asserted that any interpretation of statutes altering existing common law must be clear and unambiguous, and changes should not extend beyond the statute's explicit language. Legislative intent to abolish common law rights must be clearly articulated, as a presumption exists against such intentions. Alterations to the common law are only recognized if clearly expressed in statute, maintaining the traditional principles of justice. The strict construction of statutes that derogate from common law aligns with the policy of continuity, similar to the doctrine of stare decisis. The interpretation of the learned intermediary doctrine in relation to the act begins with its express language, as the legislature typically provides explicit limitations when intended. The act does not explicitly mention the abrogation of the learned intermediary doctrine, and absent such language, it cannot be presumed that the legislature intended to alter the common law. Subsection (d) of 52-572q, despite its poor drafting, effectively restates the doctrine by requiring product sellers to provide adequate warnings to those best positioned to advise on precautions against harm. The learned intermediary doctrine obligates drug manufacturers to warn prescribing physicians rather than consumers, with the existence of this duty being a legal question. It is unlikely the legislature intended to change this to a factual question without clear intent, which is absent here. Legislative history does not indicate an intention to abrogate the doctrine but rather aims to simplify pleading standards in product liability cases by merging causes of action into one statutory framework. An exchange in the Senate during the passage of Public Act 79-483 clarified that while the act alters certain aspects, it does not abolish all case law, but instead streamlines various product liability theories. The language of General Statutes 52-572q (d) and its legislative history affirm the relevance of the learned intermediary doctrine following the enactment of the statute. This section stipulates that a manufacturer is not deemed to have provided adequate warnings unless they are tailored to inform the individual best positioned to recommend precautions against potential harm. The learned intermediary doctrine posits that the prescribing physician is that individual for prescription drugs. This aligns with the intent of the act, which aims to protect injured parties from defective products while simplifying the legal process. Senator DePiano emphasized that adequate warnings must be understandable by those who can properly advise on precautions, which may include individuals other than the end user. Legislative discussions surrounding amendments to 52-572q further support the notion that the act did not eliminate the learned intermediary doctrine, as noted by Representative Balducci, who highlighted that the bill broadens the defense in product liability cases by acknowledging the role of intermediaries. This indicates that warnings can be effectively directed at those who advise third parties on precautions, rather than solely at end users. Additionally, a historical perspective reveals that a 1978 product liability act, which was vetoed, specifically excluded prescription drugs from failure to warn claims. This previous proposal, along with the differences between it and the current product liability act, suggests a deliberate legislative choice to include the learned intermediary doctrine in the current framework. The analysis concludes that there is no indication that the legislature intended to abolish the learned intermediary doctrine, and the current act is modeled after the Draft Uniform Product Liability Law, which similarly specifies that adequate warnings must be aimed at those best suited to advise on safety precautions. The legal analysis indicates that the act, modeled on section 104 (C) of a draft act, does not abrogate the learned intermediary doctrine, which protects manufacturers from liability when adequate warnings are provided to prescribing physicians rather than direct warnings to patients. The commentary on section 104 (C) suggests that warnings should be directed to those capable of taking precautions. There is no legislative history supporting any claim that the learned intermediary doctrine was intended to be removed. The plaintiff argues that the absence of warnings on product sample packets creates a factual issue regarding the adequacy of warnings under specific statutes (52-572q (b) and (d)). However, it is established that the existence of a duty to warn is a legal question, and only if such a duty exists can a jury assess whether it was violated. The plaintiff's assertion that there is no rational basis to distinguish between the learned intermediary and sophisticated user doctrines is rejected. While both doctrines allow manufacturers to rely on warnings to intermediaries, they are not equivalent; the learned intermediary doctrine specifically relieves manufacturers from the obligation to warn each patient if the physician has been adequately informed of the dangers. The learned intermediary doctrine is specifically applicable in the medical field, particularly concerning unavoidably unsafe products, where responsibility for conveying product risks falls to a prescribing physician rather than directly to the ultimate user. In contrast, the sophisticated user doctrine offers manufacturers liability protection under circumstances where an intermediary in the distribution chain is deemed responsible for warning ultimate users, and it can apply to any product type, not exclusively those that are unavoidably unsafe. The chain of distribution can be more extensive under the sophisticated user doctrine, as products may pass through various hands before reaching the injured user. Key distinctions between the two doctrines include the safeguards inherent in the learned intermediary doctrine, such as the direct doctor-patient relationship and the legal requirement for obtaining products through a physician, which are absent in industrial contexts. The rationale behind the learned intermediary doctrine does not extend to bulk chemical sellers, emphasizing that the medical context provides unique protections to users that are not found in industrial settings. The applicability of each doctrine is context-specific; thus, reliance on cases solely addressing the sophisticated user doctrine is inappropriate in the prescription drug context. In prescription drug cases, the anticipated awareness of users regarding product dangers is not a relevant issue because the expected user is the physician, who is responsible for providing adequate warnings. This mitigates concerns about warnings being overlooked, as the physician is positioned to communicate risks effectively due to their relationship with the patient. The court rejected the plaintiff's request to create a new exception to the learned intermediary doctrine, which traditionally holds that manufacturers are not required to provide warnings directly to consumers if adequate warnings are given to physicians. The plaintiff argued that manufacturers should warn consumers directly on promotional samples of drugs with known risks of fatal adverse reactions, suggesting that the doctrine is outdated due to shifts in healthcare delivery and patient autonomy. While acknowledging changes in the healthcare landscape since the doctrine's inception, the court noted that it has already recognized certain exceptions, such as those related to vaccines, contraceptives, and directly advertised drugs, but found that the circumstances of the current case did not warrant a new exception. The traditional doctor-patient relationship was intact, communication was effective, and adequate warnings were provided to the prescribing physician. Consequently, the court affirmed the validity of the learned intermediary doctrine as it applies to this case, concluding that no new exception is needed. The certified question was answered affirmatively, with no costs imposed on either party. The Supreme Court can respond to legal questions certified by the U.S. Supreme Court, a U.S. court of appeals, or a U.S. district court when these questions pertain to state law issues that are crucial to the pending case and lack controlling precedent from the state Supreme Court. The certification can be initiated by the certifying court or any party involved. The certification order must specify the legal questions and relevant facts about the controversy. It must be prepared by the certifying court, signed by the presiding judge, and submitted to the state Supreme Court, which may request additional records if necessary. Fees associated with this process mirror those for civil appeals and are typically shared between parties unless directed otherwise by the certifying court. Proceedings follow the established rules of the state Supreme Court, and the written opinion on the certified questions is sent to both the certifying court and the parties involved. This process aims to standardize legal interpretations among states adopting it. In the specific case referenced, the plaintiff, as executrix of Timothy E. Vitanza's estate, filed a wrongful death claim and a personal loss of consortium claim. The parties have submitted a joint statement of facts for summary judgment, acknowledging that the defendant accepts the plaintiff's assertion that the decedent ingested the drug Ansaid. The plaintiff contends that the drug's packaging was defective and did not adequately warn consumers of severe side effects, including death, which the defendant should have anticipated. In its defense, the defendant argues that the package insert was designed to inform physicians, as learned intermediaries, about the drug's risks and benefits. The relevant legal principle is outlined in Section 402A of the Restatement (Second) of Torts. Liability arises for sellers of products deemed defective and unreasonably dangerous to consumers or their property. Such liability requires that the seller is engaged in selling the product and that the product reaches the consumer without substantial alteration. Notably, even if the seller exercises utmost care, liability still exists if the product is defective. The rule applies only if the product's defect renders it more dangerous than would be expected by an ordinary consumer with common knowledge of the product's characteristics. Sellers may need to provide warnings or instructions, particularly for hazardous products like drugs. However, products that cannot be made entirely safe, when properly prepared and accompanied by appropriate warnings, are not considered defective or unreasonably dangerous. The learned intermediary doctrine has been recognized in 44 jurisdictions, which emphasizes the role of physicians in the distribution of certain products, especially drugs, and shields sellers from strict liability when proper precautions are taken. In the case of **Violette v. Smith Nephew Dyonics, Inc.**, the court addresses liability for product defects, specifically focusing on the absence of adequate warnings or instructions. The relevant legal framework under **General Statutes § 52-572q** outlines that a product seller may be held liable if the claimant proves by a preponderance of the evidence that the product lacked adequate warnings or instructions. Several factors are considered when determining the necessity and adequacy of such warnings: 1. The likelihood of the product causing harm. 2. The seller's ability to foresee whether users would be aware of risks and the nature of potential harm. 3. The technological feasibility and cost of providing warnings. Furthermore, the claimant must demonstrate that adequate warnings would have prevented their harm. Adequate warnings must effectively communicate with those capable of taking preventive measures against the identified risks. This legal principle has been reinforced and referenced in multiple case law across various jurisdictions, including the cited cases from Maine, Maryland, Massachusetts, and others. The document also references important amendments to the statute, highlighting the evolution of legal standards regarding product liability and consumer safety. A product seller's warnings or instructions are deemed adequate only if they effectively communicate with individuals capable of taking necessary precautions against potential harm. Warnings must alert users of ordinary skill and judgment to material risks associated with the product, with no obligation to warn about risks that are open, obvious, or generally known. Specific precautions need only be detailed when they are not reasonably apparent to users. Instructions must offer reasonable information regarding the product's use, application, administration, or limitations, with any warnings about risks stemming from improper usage evaluated based on established standards. In products liability cases concerning inadequate warnings or instructions, the plaintiff must prove by a preponderance of evidence that: (1) the product caused the claimed injury or damage; (2) for manufacturers, either they failed to provide adequate warnings or instructions at the time of parting with the product, or they neglected to inform users of newly recognized material risks after relinquishing control; for non-manufacturing sellers, they failed to pass on received warnings or instructions or did not make reasonable efforts to share new warnings after relinquishing control; and (3) had adequate warnings and instructions been provided, the user would have altered their usage of the product. Damages recoverable are limited to those that would not have occurred if adequate warnings or instructions had been given. Proof of any element in subsection (c) does not establish any presumption regarding other elements of a plaintiff's cause of action. The section excludes prescription products. According to Section 104 of the draft act, a product seller may be liable if the claimant proves, by a preponderance of evidence, that the product was defective in construction, design, or lacked adequate warnings or instructions. The determination of adequate warnings involves considering the likelihood of harm, severity, the seller's ability to foresee user awareness of risks, and the feasibility of providing such warnings. In claims under Section 104(C), the claimant must demonstrate that proper warnings would have prevented harm to a reasonably prudent person. Warnings must be directed to individuals best positioned to take precautions against potential harm. The draft act is modeled after a 1979 draft, which incorporated the learned intermediary doctrine, clarifying that the manufacturer must warn the actual user unless adequate warnings are given to a responsible intermediary. The model act specifies that warnings can be directed to those able to ensure the safety of the actual user, particularly in cases involving expert supervision, such as prescription drugs. The plaintiff does not contest the adequacy of the warnings provided to the medical community regarding the specific risk at issue, nor could she, as the defendant had issued appropriate warnings. Factors under subsection (b) of 52-572q relate to warning content and are assessed by the trier of fact, distinct from the duty owed as outlined in subsection (d), making the plaintiff's reliance on subsection (b) inappropriate.