Opinion
108901/01.
Decided November 22, 2004.
Michael E. Pederson, Esq. Weitz Luxenberg, PC New York, NY, Plaintiff's Attorneys.
John D. Winter, Esq., Patterson, Belknap, Webb Tyler LLP, New York, NY, Defendant's Attorneys.
This is a products liability action concerning the prescription drug Propulsid that was manufactured by the defendants until it was withdrawn from the market in July 2000. Defendants now move for summary judgment. For the reasons that follow, defendants' motion shall be denied.
The plaintiff is Kenneth Smith, individually and as administrator of the estate of his deceased daughter Kristin Smith (the "decedent"). The complaint alleges that the decedent was prescribed and ingested Propulsid and that defendants' negligence in the design, manufacture and marketing of the product resulted in decedent's death.
Decedent, who was born on June 7, 1979, suffered from diabetes and complications related thereto from the time she was a 17-month-old infant. She was legally blind in the left eye and was admitted to the hospital on several occasions during the course of her childhood for diabetes-related complications. The parties' competing medical experts conflict as to the impact of the decedent's condition upon her ability to live a "normal" daily life.
In early May 1997, decedent was admitted and hospitalized for a few days for a condition known as diabetic ketoacidosis or DKA. DKA is described as a condition of insulin deficiency aggravated by ensuing hyperglycemia (elevated blood sugars), dehydration, acidemia (where the pH of the blood becomes dangerously altered), and hypokalemia (high potassium levels.) According to defendants' expert when a patient does not have sufficient insulin, wherein the body loses the ability to effectively break down glucose, resultant electrolyte disturbances in the body can affect the ability of the heart to pump normally. The decedent was again hospitalized for DKA in August and September 1998. Again, the parties' competing medical experts disagree as to the severity of decedent's DKA at the time of these hospitalizations.
Decedent was first prescribed Propulsid on November 16, 1998, upon discharge from Staten Island University Hospital after decedent had another bout of DKA. The 1998 Physicians' Desk Reference states that Propulsid is prescribed for the treatment of nocturnal heartburn symptoms due to gastroesophageal reflux disease ("GERD".) GERD occurs when the stomach contents wash back or "reflux" into the esophagus. It is very often at night because stomach contents can easily wash backwards when the person is lying down. The decedent's physician wrote the prescription in response to decedent's complaints about feeling bloated and not digesting her meals appropriately. His initial prescription was for two 20 milligram pills to be taken twice daily. Pharmacy records show that the decedent's Propulsid prescription was refilled on March 27, July 10, September 27, and November 1, 1999.
On November 9, 1999, decedent was admitted into the emergency room of a hospital in Fredericksburg, Virginia while on a trip to a friend. The initial assessment of the hospital staff was that the decedent was alert, did not show signs of any trauma, and that she had a regular heart rhythm. Decedent did not relay to the hospital staff that she was or had been taking Propulsid at the time of her admission. About one-half hour after her admission, the attending physician diagnosed decedent as suffering from another episode of DKA and ordered a blood test and directed the administration of insulin to her. At that time the physician noted that the decedent did not appear to be in any major distress. However, approximately one and one-half hours after this examination the decedent was found unconscious and attempts to revive her failed. Decedent was declared dead approximately one-half hour later. Propulsid was found among decedent's personal effects in her bag at the hospital according to a hospital inventory.
Plaintiff alleges causes of action in (1) negligence, (2) strict product liability and failure to warn, (3) breach of implied and express warranty, (4) negligent and fraudulent misrepresentation and concealment, and (5) deceptive business practices under General Business Law § 349. The gravamen of plaintiff's complaint is that Propulsid was the proximate cause of the decedent's death and that the defendants knew of and failed to adequately warn of the risks of Propulsid use and that decedent died as a result of said risks.
Defendants move for summary judgment on the grounds that (I) there is no proof that the decedent took Propulsid in the days prior to her death; (ii) plaintiff cannot establish that Propulsid caused injury to decedent; (iii) defendants' warnings were adequate; (iv) plaintiff's claims are preempted; and (v) plaintiff's warranty claims are unsupportable because plaintiff is unable to establish the element of reliance.
It is well established that summary judgment may be granted only when it is clear that no triable issue of fact exists. The burden is upon the moving party to make a prima facie showing that he or she is entitled to summary judgment as a matter of law. A failure to make that showing requires the denial of the summary judgment motion, regardless of the adequacy of the opposing papers. If a prima facie showing has been made, the burden shifts to the opposing party to produce evidentiary proof sufficient to establish the existence of material issues of fact. Although the papers submitted in support of and in opposition to a summary judgment motion are examined in a light most favorable to the party opposing the motion, mere conclusions, unsubstantiated allegations, or expressions of hope are insufficient to defeat a summary judgment motion. ( Zuckerman v. City of New York, supra, 49 NY2d, at 562.) Upon the completion of the court's examination of all the documents submitted in connection with a summary judgment motion, the motion must be denied if there is any doubt as to the existence of a triable issue. Ramirez v. Wyeth Laboratories, Inc., 179 Misc 2d 764, 768-769 (Sup Ct, NY County, 1999) (citations omitted).
Defendants initially argue that plaintiff cannot establish that the decedent ingested Propulsid prior to her death. It is of course axiomatic that in a product liability action based upon exposure to substance the plaintiff must in fact establish that she was exposed to the allegedly defective instrumentality. See Enright v. Eli Lilly Co., 77 NY2d 377, 387 (1991) ("limiting liability to those who ingested the drug or were exposed".) Defendants argue that plaintiff presents no evidence that anyone saw decedent ingest Propulsid in the days leading up to her death, that there are no medical records establishing this fact, and that upon admittance to the hospital on November 9, 1999, when asked what prescriptions she was taking, decedent did not state that she was taking Propulsid. Defendants also cite the deposition testimony of decedent's friend Denise Green that she saw decedent take a "white pill" while the color of the Propulsid pill was blue.
However, the court agrees with plaintiff that he has adduced sufficient evidence on this motion to raise a triable issue of fact as to whether the decedent ingested Propulsid. The pharmacy records introduced by plaintiff, and uncontroverted by defendants, show that the decedent refilled her Propulsid prescription four times, at regular intervals, after the initial prescription. Furthermore, decedent refilled her Propulsid prescription only 8 days before her death and Propulsid was found in the very bag she took to the hospital on the day of her death. The defendants themselves cite the deposition testimony of Dr. Shahed A. Quyyumi, in which it is stated that the decedent asked for a prescription for Propulsid in July 1999 because it was helping her symptoms. The preceding evidence, while not by itself sufficient to grant summary judgment to plaintiff on the issue of decedent's use of Propulsid, is sufficient to raise a triable issue of fact for determination by the fact finder as to whether the decedent used Propulsid prior to her death since a reasonable jury could infer from such circumstantial evidence that plaintiff did in fact ingest Propulsid prior to her death. "The courts have held that in wrongful death cases where there are often no surviving eyewitnesses to the occurrence which resulted in the death, circumstantial evidence may be afforded a greater degree of weight than in cases where there are eyewitnesses who can testify to the occurrence in question", Horne v. Metropolitan Transit Authority, 82 AD2d 909 (1st Dept. 1981.)
Defendants' next argument that plaintiff cannot establish causation as a matter of law is unsupportable.
As defendants state in the own brief on this motion, "to demonstrate causation here, plaintiff must present expert proof, based on scientific principles, demonstrating that Propulsid `more likely than not' caused Ms. Smith's death." On this motion, however, it is the defendants' burden to demonstrate that Propulsid could not have, as a matter of law, caused decedent's death. In opposition to defendants' motion plaintiff submits the expert opinion of Dr. Bruce Charash, who states that "to a reasonable degree of medical and scientific certainty and probability that Ms. Smith death was caused by Propulsid." Dr. Charash opines that decedent's Propulsid use was a "substantially contributing factor in her death from cardiac arrest" based upon the fact that in spite of decedent's other aliments, decedent had no known history of cardiac disease or cardiac arrest.
Although defendants obviously dispute the opinion of plaintiff's experts as to causation and have their own experts with opposing opinions, the very fact that expert medical testimony is required to determine causation precludes summary judgment. See Forte v. Weiner, 200 AD2d 421 (1st Dept 1994) ("as the medical data require the interpretation of an expert, the issue of cause of death . . . must await resolution at trial").
Plaintiff's complaint sounding in strict products liability is founded on theories alleging defendants' failure to provide adequate warnings regarding the use of the product and defendants' defective design, as opposed to defective manufacture, of Propulsid. See Jones by Jones v. Lederle Laboratories, 695 F Supp 700, 706-708 (US Dist Ct, ED NY, 1988). With respect to plaintiff's failure to warn theory, defendants argue that as a matter of law they provided adequate warnings of the hazards of Propulsid.
With respect to failure to provide adequate warnings, the Court of Appeals has stated in the leading case on the application of products liability to prescription drugs,
Although a prescription drug is by its nature an inherently unsafe product and would in the usual case impute strict liability to its manufacturer, a defense is provided against such liability when the drug is properly prepared, and accompanied by proper directions and warning. . . . The manufacturer's duty is to warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist.
Warnings for prescription drugs are intended for the physician, whose duty it is to balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects. The physician acts as an" informed intermediary" between the manufacturer and the patient; and, thus, the manufacturer's duty to caution against a drug's side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.
* * *
A warning for a prescription drug may be held adequate as a matter of law if it provides specific detailed information on the risks of the drug. Whether a given warning is legally adequate or presents a factual question for resolution by a jury requires a careful analysis of the warning's language. The court must examine not only the meaning and informational content of the language but also its form and manner of expression. Always bearing in mind that the warning is to be read and understood by physicians, not laypersons, the factors to be considered in resolving this question include whether the warning is accurate, clear, consistent on its face, and whether it portrays with sufficient intensity the risk involved in taking the drug . . .
It is basic that a warning must be commensurate with the risk involved in the ordinary use of the product. Thus, analysis logically starts with an ascertainment of the seriousness of the involved risk. Seriousness depends on the consequences of the side effects. Here, there is no question that the level of the risk is the highest, death from suicide. Accordingly, the adequacy of the package insert for reserpine must be evaluated as a warning of a risk of the most serious degree.
Once the general level of risk is established, the court should evaluate the insert's language for its accuracy, clarity and relative consistency. For a warning to be accurate it must be correct, fully descriptive and complete, and it must convey updated information as to all of the drug's known side effects. In this case, no issue is raised with respect to the correctness or completeness of the reserpine warning.
Clarity in the context of a drug warning means that the language of the warning is direct, unequivocal and sufficiently forceful to convey the risk. A warning that is otherwise clear may be obscured by inconsistencies or contradictory statements made in different sections of the package insert regarding the same side effect or from language in a later section that dilutes the intensity of a caveat made in an earlier section. Such contradictions will not create a question of fact as to the warning's adequacy, if the language of a particular admonition against a side effect is precise, direct, and unequivocal and has sufficient force. The clarity of the over-all warning may in such instances offset inconsistencies elsewhere in an insert.
Finally, a court should consider the warning as a whole. While a meticulous examination and parsing of individual sentences in the insert may arguably reveal differing nuances in meaning or variations in emphasis as to the seriousness of a side effect, any resulting vagueness may be overcome if, when read as a whole, the warning conveys a meaning as to the consequences that is unmistakable.
Martin v. Hacker 83 NY2d 1, 8-12 (1993)
In this case, there is no dispute that prior to the prescribing of Propulsid for decedent, the defendants provided warnings to doctors about Propulsid. The "black box" section of the warning set forth in a June 26, 1998 "Dear Doctor" letter from defendants to physicians stated in part " Warning: Serious cardiac arrhythmia including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking Propulsid. Many of these patients also took drugs expected to increase cisapride blood levels . . . Some of these events have been fatal. Propulsid is contraindicated in patients taking any of these drugs. . . . QT prolongation, torsades de pointes (sometimes with syncope), cardiac arrest and sudden death have been reported in patients taking Propulsid without the above contraindicated drugs. Most patients had disorders that may have predisposed them to arrhythmias with cisapride." (Emphasis in original). The court notes that Propulsid is the marketing name for cisapride.
Though not quoted in defendants' Memorandum of Law, the June 26, 1998 letter in the section captioned "Contraindications" also stated "PROPULSID should not be used in patients with uncorrected hypokalemia or who might experience rapid reduction of plasma potassium such as those administered potassium-wasting diuretics and/or insulin in acute settings."
Defendants argue that this warning and others is sufficient to preclude plaintiff's action under the reasoning of Martin v. Hacker, supra. The court disagrees. In the Martin case the Court of Appeals considered a situation where the plaintiff presented no expert evidence as to the adequacy of the manufacturer's warning and therefore the court held the warning adequate based on its analysis. Martin, supra, 83 NY2d at 12-15.
On this motion, plaintiff presents the expert affidavit of Dr. Joel Morganroth who opines that the defendants knew of the risks of adverse cardiac effects of Propulsid and that the warnings they issued were insufficient to place physicians on notice of those risks. In particular, Dr. Morganroth states that the defendants warnings failed to place physicians on notice that Propulsid by itself, without the aggravating factors of other drugs or preexisting disorders, could raise the risks of adverse cardiac events such as that which plaintiff alleges caused decedent's death. Plaintiff further argues that the effects of any warning were diluted by other marketing materials distributed by defendants which touted Propulsid's efficacy. Plaintiff's submission of an expert opinion as to the inadequacy of defendants' warnings is sufficient to raise an issue of fact precluding summary judgment where the alleged deficiency in the warnings is related to the condition which is alleged to have caused the decedent's death. Forte v. Weiner, 200 AD2d 421, 422-423 (1st Dept 1994); Tenuto v. Lederle Laboratories, 276 AD2d 550, 551 (2nd Dept 2000).
With respect to plaintiff's theory of defective design, the Court of Appeals has stated that the factors to be considered may include:
(1) the utility of the product to the public as a whole and to the individual user; (2) the nature of the product — that is, the likelihood that it will cause injury; (3) the availability of a safer design; (4) the potential for designing and manufacturing the product so that it is safer but remains functional and reasonably priced; (5) the ability of the plaintiff to have avoided injury by careful use of the product; (6) the degree of awareness of the potential danger of the product which reasonably can be attributed to the plaintiff; and (7) the manufacturer's ability to spread any cost related to improving the safety of the design.
Pertinent factors in the individual case, when evaluated as to whether or not they are applicable, should form the basis for charging the jury as to how it should evaluate the evidence in order to decide whether a product is not reasonably safe. Voss v. Black Decker Mfg. Co., 59 NY2d 102, 109-110 (1983) (citations omitted).
Defendants argue that the plaintiff's claim of a defective product should be dismissed because plaintiff has failed to demonstrate that there was an alternative safer design that would not have caused the decedent's death.
There is a distinction between the definition of what constitutes a "defect" for the purposes of a strict products liability cause of action versus what constitutes a "defect" for the purposes of a breach of implied warranty cause of action. In Voss, the Court of Appeals stated that the balancing test applies to the strict products liability tort cause of action. In contrast, the contract-based breach of implied warranty claim measures whether a product is defective by analyzing "whether the product in question was `fit for the ordinary purposes for which such goods are used' (UCC 2-314 [c])." Denny v. Ford Motor Co., 87 NY2d 248, 257-259 (1995).
Therefore, contrary to defendants' argument, plaintiff is not required to show that there was an alternative design or formulation of Propulsid available in order to prove its strict liability cause of action. Instead, the Court of Appeals has said that the availability of an alternative design is merely one factor that the fact finder may consider in determining whether the product was defective as an element of a strict products liability cause of action. On the other hand, in Denny the Court of Appeals, while expounding on the high degree of overlap between the substantive aspects of breach of implied warranty and strict products liability, made clear that the availability of alternative design is not at all an element of an implied breach of warranty claim. Denny, supra, 255-264. Therefore, the court shall also deny defendants' summary judgment motion as to the issue of whether there was any alternative design for Propulsid as that issue is only one factor to be considered as an element of a strict products liability cause of action and there are factual issues remaining as to the other factors that must be considered.
Defendants' assertion that plaintiff is unable to assert breach of warranty claims because no warranty as to the safety and efficacy of Propulsid was made directly to the decedent is contrary to the law. See Randy Knitwear, Inc. v. American Cyanamid Company, 11 NY2d 5 (1962), which held that privity is no longer required in a breach of warranty action. The defendants may not use the "learned intermediary" doctrine as a sword against plaintiff's breach of warranty claims in this action. The role of such doctrine is as a shield against product liability where a drug manufacturer has given an adequate warning of the potential danger of a prescribed drug to a patient's physician. The court has already held that such defense raises issues of fact that must be resolved at trial.
Nevertheless, the court must dismiss plaintiff's claim of breach of express warranty because plaintiff has not come forward with evidence of any "statement of fact or promise" regarding Propulsid that defendants made to plaintiff through her physician or otherwise. Jones by Jones, supra, p. 709. The statements cited by plaintiff constitute the manufacturer's "opinion or commendation", which do not create a warranty under the Uniform Commercial Code § 2-313(2)."
Defendants have not come forward with evidence that supports their motion for summary judgment dismissing plaintiff's claims of fraudulent misrepresentation and concealment and violation of General Business Law §§ 349 and 345.
Finally, defendants' argument that plaintiff's state court claims are somehow preempted by the federal Food and Drug Administration (FDA) regulatory scheme is contrary to precedent. Defendants' citation to the Supreme Court's holding in Buckman Co. v. Plaintiffs' Legal Committee ( 531 US 341, 350) is inapposite as that decision concerned preemption of state-law "fraud-on-the-FDA" under the Medical Device Amendments of 1976 ( 21 USC § 301 et seq. as amended by PL 94-295, 90 US Stat 53) and only applies to medical devices, not prescription drugs. This court instead agrees with the Court's decision in Jones by Jones, supra, at 711, where the court held that the federal FDA prescription drug licensing scheme was not intended, expressly or impliedly, to preempt tort claims in state courts.
Therefore, in accordance with the foregoing, it is hereby
ORDERED and ADJUDGED that defendants' motion for summary judgment is GRANTED with respect to the fifth cause of action only and that cause of action is hereby DISMISSED;
ORDERED and ADJUDGED that defendants' motion for summary judgment is otherwise DENIED; and it is further
ORDERED that the parties are hereby directed to attend a pretrial conference on January 7, 2005, at 11:59 A.M., at the Courthouse, IAS Part 59, Room 1254, 111 Centre Street, New York 10013.
This is the decision and order of the court.