Opinion
No. X05 CV-00-0177475-S
January 4, 2005
MEMORANDUM OF DECISION REGARDING MOTION FOR SUMMARY JUDGMENT
The defendant, Medtronic, Inc. ["Medtronic"], has moved for summary judgment to dismiss the plaintiffs' Complaint contending that the pleadings, affidavits and other proof submitted demonstrate that there is no genuine issue as to any material fact and that Medtronic is entitled to judgment as a matter of law. More specifically, Medtronic claims that:
(1) All of the plaintiffs' claims are preempted by federal law, specifically the preemption clause of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360c, et seq.
(2) All of the plaintiffs' "failure to warn" claims are also barred by the learned intermediary doctrine.
(3) All of the plaintiffs' failure to warn claims are also barred because the plaintiffs had actual knowledge of the hazard of which they now claim Medtronic failed to warn them.
Because the court finds that the defendant is entitled to summary judgment based on the learned intermediary doctrine it will not address the other theories advanced by plaintiffs. The court also finds that the plaintiffs' CUTPA claim is barred by the exclusivity provision of the Products Liability Act.
I. FACTUAL FINDINGS
The following findings are based on undisputed facts in the record. The plaintiff, Nicole Hurley, was born with a congenital complete heart block condition that interfered with the capacity of her heart to produce a safe heart rhythm. Shortly after her birth, doctors at Yale implanted a cardiac pacemaker. This pacemaker, and other replacement pacemakers periodically implanted, allowed Nicole to grow and live a normal life.
The pacemaker's Technical Manual provided that:
Elective Replacement Indicator (ERI) signals when battery voltage is £2.5 V. The physician should schedule an immediate replacement of the pacemaker once the ERI signal is exhibited.
The Technical Manual also stated that "[i]f the battery voltage should temporarily fall to or below 2.5V, the pacemaker paces at a 10% decrease from the programmed rate . . ."
These pacemaker replacement warnings were specified by FDA's prescription device labeling regulations and were reviewed and approved by FDA in the course of its review of the company's PMA [pre-market approval] submissions. The defendant admits 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." The defendant also admits that these FDA "Conditions of Approval . . . prohibited Medtronic from making any changes to the . . . labeling affecting the safety or effectiveness of the device without supplementing the PMA [pre-market approval application]." Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1370 (11th Cir. 1999).
On September 14, 1998, Nicole's pacemaker's "Elective Replacement Indicator" signaled that the pacemaker battery was nearing the end of its life cycle and was wearing down. At the request of Nicole's cardiologist, Dr. Richard Landesman, a manufacturer's representative from Medtronic, the company that manufactured Nicole's pacemaker, attended an examination of Nicole in Landesman's office and tested Nicole's pacemaker battery. The Medtronic representative, Frank Kling, confirmed with Dr. Landesman that the battery was nearing the end of its safe life. "[I]t needed to be replaced . . . The assessment of that day was that this battery needs to be changed out . . . [A]s soon as possible."
There is no genuine issue of material fact that Dr. Landesman, Nicole's treating cardiologist, knew the battery to her 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 Model 8427 pacemaker warned about and what Kling confirmed with Dr. Landesman.
It was also Dr. Landesman's undisputed testimony that he believed Mrs. Hurley would not authorize the procedure to replace the battery. Dr. Landesman testified, "It became apparent that Nicole's pacemaker battery needed to be replaced. Nicole and her mother emphatically refused to consider that as a possible treatment."
Regardless of Mrs. Hurley's recollection of her position as to whether she wanted the battery replaced, Dr. Landesman's uncontroverted understanding and belief was that she did not and therefore he began to consider options for the patient. Accordingly, plaintiffs have not raised a genuine issue of material fact by claiming that Mrs. Hurley was not adamant that she would not authorize a battery replacement. It is undisputed that Dr. Landesman looked to alternative options because he believed rightly or wrongly that she would not allow the replacement.
Additionally, it is undisputed that Mr. Kling also believed that Mrs. Hurley would not authorize the procedure.
Based on Dr. Landesman's understanding that Mrs. Hurley refused to authorize replacement, he asked Mr. Kling about the functional capabilities of Nicole's pacemaker, in an effort to explore diagnostic options. For example, when asked why he reduced the pacing rate, Dr. Landesman testified:
In an effort to evaluate several things. Number one, Nicole's ability to function at a slower heart rate, if that would be the case. I didn't know that for sure because her own heartbeat had been previously demonstrated in Yale-New Haven to be in the 50 to 60 range without the pacemaker, to see how Nicole did. And I was actually trying to obtain some additional information which I hoped would eventually convince her mother that she needed to have the battery replaced.
. . .
Because Nicole needed — it was my impression based on the experiences that have happened to her on two different occasions in Yale-New Haven when they've replaced her battery that she needed to have a new battery. Her mother was emphatically refusing. I was obtaining some additional information.
. . .
There was another issue that was involved. The last time she was seen at Yale-New Haven, they recommended that this pacemaker be upgraded to a, what's called a physiologic pacemaker, a pacemaker that has two wires instead of one, to optimize the function of her heart. And I was interested in obtaining some information in reference to that decision.
Mr. Kling's testimony is consistent. As he explained: "[I]n assessing a pacemaker and assessing the pacemaker and the patient, I can present a list of options. Rate was one of them." Plaintiffs' own expert agreed that Mr. Kling discussed with Dr. Landesman reprogramming Nicole's pacemaker as a diagnostic tool. Dr. Landesman then had the rate of Nicole's pacemaker set down to a rate of 40 beats per minute from the 60 it had been set at. On October 26, 1998, Nicole suffered a cardiac event which resulted in permanent brain damage.
Mr. Kling also observed that reducing the pacing rate would prolong battery life and give Dr. Landesman more time to respond to Mrs. Hurley's concerns. Such observation is consistent with his and Dr. Landesman's testimony that they were discussing diagnostic programming options. There is no evidence to support plaintiffs' assertion that Mr. Kling ever told Dr. Landesman that it was not necessary to replace Nicole's pacemaker or that the warnings should be ignored.
II. PLAINTIFFS' CLAIMS ARE BARRED BY THE LEARNED INTERMEDIARY RULE A. Medtronic Provided Adequate Warnings to Nicole Hurley's Physician
The undisputed facts in this case establish that the Medtronic pacemaker implanted in Nicole Hurley was not defectively designed or manufactured and was accompanied by adequate warnings in the Technical Manual, which was approved by the Food and Drug Administration ("FDA"). Plaintiffs concede these points in their memorandum in opposition to summary judgment. However, plaintiffs seek to impose liability upon Medtronic based upon responses by a Medtronic representative to questions from Nicole's physician regarding the functional capabilities of her pacemaker. Plaintiffs claim that the information given by the representative was inconsistent with the warnings provided in the Technical Manual and therefore the adequate warnings contained in the manual were nullified.
The learned intermediary doctrine provides that "adequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly." Vitanza v. Upjohn Co., 257 Conn. 365, 376, 778 A.2d 829 (2001). As the court explained, "The learned intermediary doctrine stands for the proposition that, as a matter of law, the prescribing physician of a prescription drug is the person best able to take or recommend precautions against harm." Id., 384. The learned intermediary doctrine also extends to prescription medical devices. In Vitanza, the Connecticut Supreme Court favorably cited a federal case applying the learned intermediary rule to a prescription medical device in support of the proposition that Connecticut has recognized the learned intermediary rule for years. Id., 378 (citing Desmarais v. Dow Corning Corp., 712 F.Sup. 13 (D.Conn. 1989)). See Brooks v. Medtronic, Inc., 750 F.2d 1227, 1232 (4th Cir. 1984) ("[T]he decision to prescribe a cardiac pacemaker involves precisely the sort of individualized medical balancing contemplated by the drug exception.").
As the Fourth Circuit Court of Appeals explained, a physician, as a learned intermediary, "is in the best position to understand the patient's needs and assess the risks and benefits of a particular course of treatment." Brooks, 750 F.2d at 1231. Specifically discussing a cardiac pacemaker, the court further noted:
[T]he decision to prescribe a cardiac pacemaker involves precisely the sort of individualized medical balancing contemplated by the drug exception. Unlike polio vaccines, pacemakers are not dispensed indiscriminately in mass clinics, but instead are prescribed only after a physician balances the individual's needs against the known risks. Indeed, expert testimony in the present case indicated that each pacemaker candidate presents different problems requiring individualized professional judgments about lead models and generator units.
Brooks, 750 F.2d at 1232.
Plaintiffs admit that the Medtronic pacemaker was accompanied by adequate warnings in the Technical Manual. It is undisputed that Medtronic warned of the need for replacement when the battery voltage fell below 2.5 volts. The Technical Manual specifically states: "Elective Replacement Indicator (ERI) signals when battery voltage is £2.5 V. The physician should schedule an immediate replacement of the pacemaker once the ERI signal is exhibited." Indeed, plaintiffs do not even challenge the adequacy of the warnings contained in the Technical Manual. There is also no dispute that the Manual's statement regarding pacemaker replacement upon ERI was reiterated by Mr. Kling to Dr. Landesman. And there is no dispute that Dr. Landesman fully appreciated the need to replace Nicole's pacemaker. As Dr. Landesman testified:
A. . . . I was uncomfortable taking care of Nicole Hurley because her mother refused to have what I felt was the appropriate care rendered.
Q. And the appropriate care rendered was the replacement of the battery?
A. Yes.
Q. And can you tell me exactly what you told Nicole Hurley's mother in order to convey to her the necessity of replacing the battery?
A. I told her that it was absolutely necessary that Nicole have the pacemaker battery replaced.
Q. Did you tell her anything else?
A. I told her that it was potentially dangerous for Nicole to not have that pacemaker battery replaced.
Plaintiffs argue, however, that the Medtronic representative's statement that the rate of the pacemaker could be slowed down nullified the warnings in the Manual. This argument is inconsistent with the uncontroverted facts that Kling communicated the need to replace Nicole's pacemaker due to battery depletion and Nicole's physician fully understood the need to replace Nicole's pacemaker.
On the undisputed facts of this case, there simply can be no claim that Dr. Landesman — the learned intermediary between Medtronic and Nicole Hurley — was not fully aware of the substance of Medtronic's warnings and instructions pertaining to expected battery life and depletion, and the urgency of replacing the pacemaker.
It was only when Dr. Landesman believed that Nicole's mother would not authorize the surgery that he discussed with Medtronic's representative other programming options for Nicole's pacemaker. The technical information provided by Mr. Kling in response to this inquiry regarding lowering the pacemaker rate was consistent with the FDA-approved Technical Manual.
The issue before the court is narrow. Was the oral advice provided by the technician for Medtronic consistent with the written Technical Manual? After reviewing all of the record the court finds that there is no genuine issue of material fact that the technician's advice regarding the rate reduction was consistent with the Technical Manual and that plaintiffs' product liability claims are barred by the learned intermediary doctrine.
Landesman's undisputed testimony regarding his conversation with Kling makes clear that Kling was being asked about diagnostic programming options and the functional capabilities of the pacemaker. Discussing a rate reduction with Dr. Landesman was consistent with the Technical Manual section regarding diagnostic options. First, the Technical Manual makes clear that programming is a medical decision to be made by the physician based on the individual circumstances of the patient. The technical manual at section 3-6 specifically provides:
"Lower and upper rates, however, should be tailored to individual patient needs."
In addition, the Technical Manual states clearly that "[r]ates less than 40 ppm are intended primarily for diagnostic purposes."
Plaintiffs argue that the effective pacing rate of Nicole's pacemaker programmed at 40 ppm was actually 36 ppm. This argument does not support plaintiffs' theory of the case. The FDA-approved Technical Manual indicates that rates less than 40 ppm may be used for diagnostic purposes.
Further, Dr. Landesman's undisputed testimony that he was aware of the need for pacemaker replacement makes it impossible, as a matter of law, for plaintiffs to establish that alleged inadequate warnings caused Nicole's injuries. As courts have noted, where a physician is aware of the risks of a drug or medical device, no proximate cause exists based upon an alleged failure to warn. See Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1016 (8th Cir. 2004). Accord Eck v. Parke, Davis Co., 256 F.3d 1013, 1024 (10th Cir. 2001); Plummer v. Lederle Labs., 819 F.2d 349, 358-59 (2d Cir. 1987); see also Wooten v. Johnson Johnson Prods. Inc., 635 F.Sup. 799, 803 (N.D.Ill. 1986) ("Courts have consistently held that a drug manufacturer is entitled to summary judgment where the prescribing physician is aware of the risks associated with a drug").
The Connecticut Product Liability Act states that the adequacy of the warning is a question for the trier of fact. However, the rule in Connecticut is that questions for the trier of fact can be decided as a matter of law where a reasonable trier of fact could reach only one conclusion. See, e.g., Morrissey v. Yale Univ., 268 Conn. 426, 428, 844 A.2d 853, 854 (2004). There is no indication that the legislature intended the Act to eviscerate this common-law rule. See Vitanza, 257 Conn. at 381-82, 778 A.2d at 840.
There is also no indication that anything Mr. Kling said dissuaded Dr. Landesman from replacing Nicole's pacemaker. To the contrary, Dr. Landesman testified repeatedly that replacement was his preferred course of action. "[W]hen a particular adverse effect is clearly and unambiguously mentioned in a warning label and the prescribing physician unequivocally states that he or she was adequately informed of that risk by the warning, the manufacturer has satisfied its duty to warn under the learned intermediary doctrine." Stahl v. Novartis Pharms. Corp., 283 F.3d 254, 268 (5th Cir. 2002); see also id. at 264 n. 3 (rejecting argument that manufacturer sales representatives diluted warnings in light of physician testimony). Here, the uncontroverted evidence demonstrates that Dr. Landesman was aware of the need to replace the pacemaker.
Finally, the fundamental flaw in plaintiffs' argument that the learned intermediary doctrine should not apply in this case is that they incorrectly assert that Kling told Dr. Landesman that the pacemaker could be safely turned down to prolong the battery's life thereby nullifying the adequate warnings. First, there is no evidence that Kling ever said the battery could be safely turned down. It was Dr. Landesman's decision as a doctor whether the pacemaker rate could be safely turned down without jeopardizing Nicole's life. Dr. Landesman had responsibility for all medical decisions and the treatment he then rendered. Dr. Landesman conceded this in his deposition:
Q. . . . Did Mr. Kling also say that it might also cause some symptoms in Nicole Hurley that might help convince Mrs. Hurley to undergo the battery replacement?
A. No, no. He's not a physician, and I'm the physician.
B. Dr. Landesman Was a Learned Intermediary
Under Connecticut law, a physician-patient relationship is "created when the professional services of a physician are rendered to or accepted by another for the purposes of medical or surgical treatment." Rumbin v. Baez, No. CV 950378968S, 1997 WL 791483, at *2 (Conn.Super.Ct. Dec. 11, 1997), aff'd, 52 Conn.App. 487, 727 A.2d 744 (1999). Dr. Landesman is a licensed physician, board certified in cardiology, who has been practicing cardiology in Connecticut since 1973. Plaintiffs admit in their complaint that Dr. Landesman "cared for[,] treated, diagnosed, monitored and supervised the cardiac care of [Nicole Hurley]." Dr. Landesman admitted that he was one of Nicole's treating physicians. Dr. Landesman also insisted that the decision to reprogram Nicole's pacemaker was a medical decision that he made, not Mr. Kling. Accordingly, it is clear that Dr. Landesman was a learned intermediary.
Plaintiffs' assertion that there can be no traditional doctor-patient relationship between a doctor and a minor is not supported by any cited case law and is not persuasive. Clearly a doctor-patient relationship can be formed in this situation. See, e.g., Hurley v. Lederle Labs. Div. Of Am. Cyanamid, Co., No. 87-2578, 1989 U.S.App. LEXIS 2118, at *3 (5th Cir. Jan 5, 1989).
C. No Exceptions to the Learned Intermediary Rule Are Applicable
The Connecticut Supreme Court declined to decide whether it recognized any exceptions to the learned intermediary rule in Vitanza. In Vitanza, the court did note certain exceptions that had been recognized by other jurisdictions, but did not specifically adopt any of them. See 257 Conn. at 394, 778 A.2d at 847. In addition, the court declined to adopt a wholly new exception that would require a manufacturer to place consumer warnings on product samples. See Id. As in Vitanza, plaintiffs here advocate an exception that has not been recognized by other jurisdictions. Plaintiffs argue there should be a broad miscommunication exception to the learned intermediary doctrine. Plaintiffs have not identified any other court that has adopted such an exception to the learned intermediary rule.
The exceptions to the learned intermediary doctrine that have been recognized in some jurisdictions have been narrowly drawn so as to limit them to situations where a manufacturer has reason to know that the "individualized medical judgment" of a learned intermediary will not intervene, such as in cases involving mass vaccine inoculations. See, e.g., Reys v. Wyeth Labs., 498 F.2d 1264, 1276 (5ffi Cir. 1974). That is not the case here.
See also Pumphrey v. C.R. Bard, Inc., 906 F.Sup. 334, 337 (N.D.W.Va. 1995) (stating that the exceptions to the learned intermediary doctrine are "narrow and specific"); Mazur v. Merck Co., 767 F.Sup. 697, 711 n. 19 (E.D.Pa. 1991), aff'd, 964 F.2d 1348 (3d Cir. 1992) (stating that defendant need not show that the learned intermediary "actually made an individualized medical judgment" concerning plaintiff, but rather that she "was a qualified learned intermediary, that is, capable of making an individualized medical judgment, and was present at the time of her inoculation"); Taurino v. Ellen, 579 A.2d 925, 928 (Pa.Super.Ct 1990) (stating that where the manufacturer had no reason to know that a learned intermediary would not intervene, whether she actually intervened is "legally irrelevant").
Moreover, the recognized exceptions do not require a manufacturer to conduct a qualitative assessment of individual physician/patient relationships. Instead, it is the doctors who are best equipped to determine the needs of individual patients, and manufacturers should not be intervening in the physician-patient relationship.
Here, Medtronic had no reason to know that Nicole Hurley's treating physician would not make a proper "individualized medical judgment" concerning the care of Nicole Hurley and, therefore, there is no basis for not applying the learned intermediary doctrine.
Finally, plaintiffs' attempt to analogize this case to "over-promotion" cases is likewise unavailing. Over-promotion, as a theory of recovery, has been limited to situations in which aggressive marketing campaigns have diluted the effect of written warnings. See Motus v. Pfizer, Inc., 196 F.Sup.2d 984, 999 (C.D.Cal. 2001), aff'd 358 F.3d 659 (9th Cir. 2004). The instant case, however, does not involve any promotion of the product at all. Mr. Kling was not acting as a salesman on the dates in question. Mr. Kling was at Dr. Landesman's office in September and October of 1998 to interrogate Nicole's pacemaker for battery life and to answer Dr. Landesman's technical questions about the device.
III. THE CONNECTICUT UNFAIR TRADE PRACTICES CLAIMS ACT ARE BARRED BY THE CONNECTICUT PRODUCT LIABILITY STATUTE.
"The exclusivity provision makes the product liability act the exclusive means by which a party may secure a remedy for an injury caused by a defective product." Gerrity v. R.J. Reynolds Tobacco Co., 263 Conn. 120, 125 (2003). Accordingly, this court must decide whether plaintiffs' claim falls within the scope of the product liability act. Gerrity, supra at 126. Gerrity provides in relevant part
. . . the legislature defined a product liability claim to include all claims or actions brought for personal injury, death or property damage caused by the allegedly defective product. General Statutes § 52-572m(b). The legislature also provided that the damages are caused by the defective product if they arise from the "manufacture, construction, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging or labeling of any product." General Statutes § 52-572m(b). In addition, a product liability claim is defined broadly to include, but not be limited to, all actions based on "[s]trict liability in tort; negligence; breach of warranty, express or implied; breach of or failure to discharge a duty to warn or instruct, whether negligent or innocent; misrepresentation or nondisclosure, whether negligent or innocent." General Statutes 52-572m(b).
The court has carefully reviewed all of the allegations contained in plaintiff's CUTPA count. All of the paragraphs allege that the product was defectively designed or the defendant failed to properly warn about the functioning of the pacemaker in an alleged deceptive manner. Failure to warn falls within the definition of a product liability claim. Additionally, the injuries being claimed under the product liability count and the CUTPA count in this case are exactly the same. Unlike the plaintiff in Gerrity, the plaintiffs in this action are seeking a remedy for personal injury which falls squarely within the legislature's definition of a product liability claim. Based on the reasoning contained in Gerrity, the court finds that the CUTPA claim in this case is an action for personal injuries caused by the defective product. Accordingly, the Product Liability Act bars the concurrent prosecution of the plaintiffs' Connecticut Unfair Trade Practices claim.
CHASE T. ROGERS SUPERIOR COURT JUDGE CT Page 182