Hurley v. Heart Physicians, P.C.

• Decision Date: 23 May 2006
• Docket Number: No. 17463.,17463.
• Citation: 898 A.2d 777,278 Conn. 305
• Court: Connecticut Supreme Court
• Parties: Nicole HURLEY et al. v. The HEART PHYSICIANS, P.C., et al.

898 A.2d 777

278 Conn. 305

Nicole HURLEY et al. v. The HEART PHYSICIANS, P.C., et al.

No. 17463.

Supreme Court of Connecticut.

Argued March 14, 2006.

Decided May 23, 2006.

Antonio Ponvert III, with whom was James D. Horwitz, Bridgeport, for the appellants (plaintiffs).

Lori G. Cohen, pro hac vice, with whom were James H. Rotondo and Victoria Woodin Chavey, Hartford, for the appellee (defendant Medtronic, Inc.).

NORCOTT, KATZ, PALMER, VERTEFEUILLE and ZARELLA, Js.

KATZ, J.

The plaintiffs, Nicole Hurley (Nicole), who was permanently brain damaged by a cardiac event allegedly caused by a downward adjustment to the rate of her pacemaker, and her parents, Lucinda Hurley and Navarro Hurley, brought the underlying action against the defendant Medtronic, Inc. (defendant), maker of the pacemaker, pursuant to the Connecticut Product Liability Act, General Statutes § 52-572m et seq., and the Connecticut Unfair Trade Practices Act (CUTPA), General Statutes § 42-110a et seq., claiming, inter alia, that one of the defendant's representatives had made statements to Nicole's treating physician and had engaged in conduct that nullified the warnings contained in the defendant's technical manual for Nicole's pacemaker (manual).¹ The defendant asserted as a special defense that, under the learned intermediary doctrine, it had no duty as a matter of law to provide a warning directly to the ultimate consumer regarding the product. That doctrine, based on the principle that prescribing physicians act as "`learned intermediaries'" between a manufacturer and the consumer and, therefore, stand in the best position to evaluate a patient's needs and assess the risks and benefits of a particular course of treatment, provides, in general terms, that, "adequate warnings to prescribing physicians obviate the need for manufacturers . . . to warn ultimate consumers directly." (Internal quotation marks omitted.) Vitanza v. Upjohn Co., 257 Conn. 365, 376, 778 A.2d 829 (2001). The principal issue in this appeal is whether the trial court properly rendered summary judgment for the defendant based on the learned intermediary doctrine.² We conclude that the record reflects a material question of fact as to whether the warnings given by the defendant's representative were consistent with the manual and, therefore, the trial court improperly determined that the defendant was entitled to prevail under the learned intermediary doctrine as a matter of law. We further conclude that the trial court properly rendered summary judgment for the defendant on the plaintiffs' CUTPA claim. Accordingly, we reverse in part the trial court's judgment.

The record discloses the following undisputed facts. Nicole was born with a congenital complete heart block condition that interfered with her heart's capacity to produce a safe heart rhythm. When she was seven days old, her physicians implanted a cardiac pacemaker manufactured by the defendant. Every few years, Nicole received a new pacemaker manufactured by the defendant, allowing her to grow and live a normal life.

On September 14, 1998, when Nicole was fourteen years old, her pacemaker's elective replacement indicator signaled that the pacemaker battery was nearing the end of its life cycle and was wearing down. Nicole's cardiologist, Richard Landesman, asked Frank Kling, a representative of the defendant, to attend an examination of Nicole and to test the battery in her pacemaker. Kling often was called in by physicians to evaluate pacemakers, looking at the mode, rate, amplitude, pulse width and sensitivity of the device, and to make adjustments at the direction of the physicians.³ The intent of Kling's visit to Landesman's office, however, was for Kling to assess whether the plaintiff's pacemaker was at its end of life.

During the visit, based on information he had gathered from Kling, Landesman concluded that Nicole needed a new pacemaker. Because, however, according to Landesman, Lucinda Hurley had refused to have the pacemaker replaced, Landesman decided to adjust downward the rate of the pacemaker in an effort to evaluate Nicole's ability to function with the pacemaker operating at a lower rate. Landesman testified that, because Nicole's "heartbeat had been previously demonstrated in Yale-New Haven [Hospital] to be in the [fifty to sixty paces per minute]⁴ range without the pacemaker . . . [he] was actually trying to obtain some additional information which [he] hoped would eventually convince [Nicole's] mother that she needed to have the battery replaced." Landesman further explained that he hoped that by adjusting the rate, he could gather information about new symptoms that Nicole might experience in a further effort to convince her mother of the need for a replacement. Finally, Landesman was interested in obtaining information about a different type of pacemaker, one with two wires that Nicole's physicians at Yale-New Haven Hospital had suggested.

In his deposition, Kling confirmed that his "interrogation" or evaluation of Nicole's pacemaker indicated that the battery was low and that, although it "was still very much operating," he had relayed to Landesman that the pacemaker battery needed to be replaced as soon as possible. Kling testified, however, that Lucinda Hurley had been adamant about wanting her daughter's pacemaker removed altogether. In exploring the possible responses to the situation, Kling stated that his role was to present options and that, in "trying to understand and assess" Nicole's condition, he had presented to Landesman the option of lowering the rate.⁵ Kling explained that, "[b]y taking the rate from [sixty to forty paces per minute], just like you take amplitude from eight volts to four volts, you are also giving yourself more time before a device would, you know, hit that end point. So you know, in this whole realm of consideration, it's giving us more time to work this situation and maybe [Lucinda] Hurley would come around and wake up and say jeez, I've got to get this done. Leaving it at [sixty] would keep it on its present course" but lowering the rate from sixty paces per minute would "buy us more time, just as it would changing the other three parameters." According to Kling's testimony, "[t]he only other option which was there from the beginning to the end was that this pacemaker needs to be replaced. And that was impressed over and over and over again." In light of what he understood Lucinda Hurley's position to be on the matter, Kling adjusted the pacemaker down from sixty paces per minute to forty.

In addition to the deposition testimony regarding Nicole's care and treatment, the trial court had an abundance of documentary evidence regarding the defendant's pacemaker. According to the pacemaker's Food and Drug Administration (FDA) approved warnings and the device's technical manual, the "[e]lective [r]eplacement [i]ndicator . . . signals when battery voltage is [less than] 2.5 [volts]. The physician should schedule an immediate replacement of the pacemaker once the [elective replacement indicator] signal is exhibited." The manual further provides that, "[i]f the battery voltage should temporarily fall to or below 2.5 [volts], the pacemaker paces at a 10 [percent] decrease from the programmed rate . . . ." It was undisputed, and, indeed the trial court expressly found, that these warnings had been "specified by the FDA's prescription device labeling regulations and . . . reviewed and approved by [the] FDA in the course of its review of the [defendant's] . . . [premarket approval] submissions." Additionally, as the trial court noted, it was undisputed that "failure to comply with the conditions of approval invalidates [the FDA's] approval order and that [c]ommercial distribution of a device that is not in compliance with these conditions is a violation of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 301 et seq.]." (Internal quotation marks omitted.) Finally, the trial court also noted the defendant's concession that the FDA's "Conditions of Approval . . . prohibited [the defendant] from making any changes to the . . . labeling affecting the safety or effectiveness of the device without supplementing the . . . [premarket approval application]." (Internal quotation marks omitted.) See Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1370 (11th Cir.1999) ("The manufacturer may not change the approved labeling . . . in any way that would affect the safety or effectiveness of the device. See 21 C.F.R. § 814.80.").

In addition to its findings that the "pacemaker was accompanied by adequate warnings in the [manual] . . . [and that the manual] warned of the need for replacement when the battery voltage fell below 2.5 volts," the trial court also found that Landesman "knew the battery to [Nicole's] pacemaker was nearing end of life, knew the pacemaker `absolutely' needed to be replaced soon, and knew the consequences of not replacing the pacemaker were potentially very serious, even life-threatening. This is precisely what the labeling accompanying the . . . pacemaker warned about and what Kling confirmed with . . . Landesman." Landesman and Kling also testified that they believed that Lucinda Hurley would not authorize the procedure to replace the pacemaker, and it was only when they reached that conclusion that they explored the other options.⁶ In reliance on a section in the manual that allows for rate reduction below forty paces per minute for diagnostic purposes,⁷ the trial court rejected the plaintiffs' claim that Kling's statement that the rate could be slowed down, along with his adjustment, nullified the warnings in the manual. Furthermore, the trial court concluded that, because Landesman, who was a learned intermediary, knew of the need for pacemaker replacement, the plaintiffs could not, as a matter of law, prove that inadequate warnings had caused Nicole's injuries.⁸ Finally, based on the exclusivity provisions of § 52-572m (b) of the Connecticut...