Opinion
CPLHHDCV166069413S
10-02-2017
Robert Laczek v. Boehringer Ingelheim Pharmaceuticals, Inc. et al
UNPUBLISHED OPINION
MEMORANDUM OF DECISION RE DEFENDANTS' MOTION FOR SUMMARY JUDGMENT REGARDING STATUTE OF LIMITATIONS (#105.00)
Ingrid L. Moll, Superior Court Judge.
Before the court is the motion for summary judgment regarding statute of limitations dated April 28, 2017 (motion), filed by defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim GmbH (defendants) (#105.00). Specifically, the defendants claim that the plaintiff Robert Laczek's (plaintiff) claims are time-barred under Connecticut's three-year statute of limitations for product liability claims, set forth in General Statutes § 52-577a(a). For the reasons stated below, the motion is denied.
I
BACKGROUND
The complaint alleges the following facts. Pradaxa is an anticoagulant that is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. At all relevant times, the defendants, directly or through their agents, apparent agents, servants, or employees, designed, manufactured, marketed, advertised, distributed, promoted, labeled, tested, and sold Pradaxa. On or about September 14, 2012, the plaintiff began taking Pradaxa, as prescribed by his physician, for treatment of atrial fibrillation. On November 26, 2012, the plaintiff presented to a hospital in Monroeville, Pennsylvania. He was diagnosed with gastrointestinal bleeding and was treated with blood transfusions. His Pradaxa use was immediately discontinued. The plaintiff experienced pain and suffering during his hospitalization and was discharged on November 28, 2012. The complaint alleges that, as a direct and proximate result of using Pradaxa, the plaintiff suffered an uncontrollable bleeding injury and other injuries.
In support of their motion, the defendants rely on a document entitled " Medication Guide--PRADAXA" (medication guide), which, according to the defendants, is written for patients and by law given to patients every time a Pradaxa prescription is filled. The medication guide includes the following information, inter alia :
What is the most important information I should know about PRADAXA?
PRADAXA can cause bleeding which can be serious, and sometimes lead to death.
You may have a higher risk of bleeding if you take PRADAXA and:
are over 75 years old
have kidney problems . . .(Emphasis in original.) The defendants also rely on the so-called " physician labeling" for Pradaxa (physician labeling). The first page references " WARNINGS AND PRECAUTIONS" and includes " Risk of bleeding: PRADAXA can cause serious and, sometimes, fatal bleeding." Section 2.2, entitled " Dosing Adjustments, " provides: " Assess renal function prior to initiation of treatment with PRADAXA. Periodically assess renal function as clinically indicated . . ." Section 5.1, entitled " Risk of Bleeding, " provides: " PRADAXA increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding." The physician labeling includes other references to bleeding risk and bleeding rates. (See, e.g., Sections 8.5 (Geriatric Use), 8.6 (Renal Impairment), and 17.2 (Bleeding).)
On June 29, 2016, the plaintiff commenced this action against the defendants. The complaint contains two counts against both defendants, as follows: (1) violation of Connecticut Product Liability Act; and (2) punitive damages for conduct in violation of General Statutes § 52-240b. Distilled to its essence, the complaint alleges that the defendants: (1) failed to warn patients, prescribing physicians, and/or critical care medical professionals that there was no agent to reverse the anticoagulation effects of Pradaxa and that such irreversibility could have permanently disabling, life-threatening, and fatal consequences; (2) failed to adequately investigate, research, and study patient weight in establishing recommended dosages; (3) failed to adequately investigate, research, and study the safety profile of Pradaxa; and (4) failed to provide adequate warnings. The complaint further alleges that Pradaxa is defective in design or formulation in various ways.
The court does not suggest that this is a comprehensive summary of the complaint. The court refers the reader to the 27-page complaint for a full recitation of the plaintiff's allegations.
The parties agreed to use the instant case as a test case for statute of limitations purposes for other cases on the Consolidated Pradaxa Litigation (CPL) docket that present similar fact patterns. On April 28, 2017, the defendants filed the instant motion, a supporting memorandum, and accompanying materials. (##105.00-106.00.) On May 19, 2017, the plaintiff filed his objection to the motion, as well as the declaration of Neal L. Moskow, Esq., and accompanying materials. (##108.00, 109.00 (re-filed at #112.00).) On June 9, 2017, the defendants filed their reply brief. (#111.00.) The court heard oral argument on June 19, 2017. At the parties' request, the court accepted post-hearing supplemental briefs on July 14, 2017. (##113.00, 114.00.)
As of September 26, 2017, the CPL docket comprised approximately 980 cases.
II
STANDARD OF REVIEW
" The motion for summary judgment is designed to eliminate the delay and expense of litigating an issue when there is no real issue to be tried." Wilson v. New Haven, 213 Conn. 277, 279, 567 A.2d 829 (1989). Practice Book § 17-49 provides that summary judgment " shall be rendered forthwith if the pleadings, affidavits and any other proof submitted show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." " In deciding a motion for summary judgment, the trial court must view the evidence in the light most favorable to the nonmoving party . . . The party seeking summary judgment has the burden of showing the absence of any genuine issue of material facts which, under applicable principles of substantive law, entitle him to a judgment as a matter of law . . . and the party opposing such a motion must provide an evidentiary foundation to demonstrate the existence of a genuine issue of material fact." (Internal quotation marks omitted.) Liberty Mut. Ins. Co. v. Lone Star Indus., Inc., 290 Conn. 767, 787, 967 A.2d 1 (2009).
" It is not enough, however, for the opposing party merely to assert the existence of such a disputed issue. Mere assertions of fact . . . are insufficient to establish the existence of a material fact and, therefore, cannot refute evidence properly presented to the court in support of a motion for summary judgment." (Internal quotation marks omitted.) Home Ins. Co. v. Aetna Life & Cas. Co., 235 Conn. 185, 202, 663 A.2d 1001 (1995). " A party may not rely on mere speculation or conjecture as to the true nature of the facts to overcome a motion for summary judgment." Buell Indus., Inc. v. Greater New York Mut. Ins. Co., 259 Conn. 527, 558, 791 A.2d 489 (2002). " A party opposing a motion for summary judgment must provide an evidentiary foundation to demonstrate the existence of a genuine issue of material fact." (Emphasis added.) Barlow v. Palmer, 96 Conn.App. 88, 92, 898 A.2d 835 (2006). " [O]nly evidence that would be admissible at trial may be used to support or oppose a motion for summary judgment." (Internal quotation marks omitted.) Taylor v. Barberino, 136 Conn.App. 283, 289, 44 A.3d 875 (2012) (affirming summary judgment in favor of defendant where plaintiffs failed to satisfy burden, following burden shift, to demonstrate existence of issue of material fact).
" The existence of the genuine issue of material fact must be demonstrated by counteraffidavits and concrete evidence. Kasowitz v. Mutual Construction Co., 154 Conn. 607, 613, 228 A.2d 149 (1967). A material issue of fact is one that will affect the outcome of the case. United Oil Co. v. Urban Redevelopment Commission, 158 Conn. 364, 379, 260 A.2d 596 (1969)." 2830 Whitney Ave. Corp. v. Heritage Canal Dev. Assocs., Inc., 33 Conn.App. 563, 567, 636 A.2d 1377 (1994). " Supporting and opposing affidavits shall be made on personal knowledge, shall set forth such facts as would be admissible in evidence, and shall show affirmatively that the affiant is competent to testify to the matters stated therein. Sworn or certified copies of all papers or parts thereof referred to in an affidavit shall be attached thereto." Practice Book § 17-46.
III
DISCUSSION
The defendants move for summary judgment on statute of limitations grounds under General Statutes § 52-577a(a), which contains a three-year limitation period. The defendants essentially argue that, because the plaintiff and his doctors received, prior to the plaintiff's use of Pradaxa, the defendants' prominent and unequivocal warnings that Pradaxa can cause serious and sometimes fatal bleeding, the three-year limitation period began to run on or about November 26, 2012, when he experienced an " observable bleeding event." Thus, the defendants contend, the plaintiff's claims are barred because they were brought outside the three-year limitation period (i.e., on June 29, 2016). According to the defendants, it is sufficient, for purposes of establishing a time bar, that the plaintiff (1) was prescribed Pradaxa, (2) experienced a gastrointestinal bleed a couple months later, (3) went to the hospital and immediately discontinued Pradaxa use, (4) has not used Pradaxa since that hospitalization, and (5) filed suit more than three years later. The court disagrees.
The parties do not dispute that § 52-577a(a) is the applicable statute of limitations.
The instant motion requires the court to apply the limitation period set forth in § 52-577a, which provides in relevant part:
(a) No product liability claim, as defined in section 52-572m, shall be brought but within three years from the date when the injury, death or property damage is first sustained or discovered or in the exercise of reasonable care should have been discovered, except that, subject to the provisions of subsections (c), (d) and (e) of this section, no such action may be brought against any party nor may any party be impleaded pursuant to subsection (b) of this section later than ten years from the date that the party last parted with possession or control of the product.(Emphasis added.) General Statutes § 52-577a(a). The cornerstones of § 52-577a(a) are the three-year limitation period, the presence of the discovery rule, and a ten-year statute of repose. To resolve the instant motion, the court must construe the term " injury" and the phrase " in the exercise of reasonable care should have been discovered."
As an initial matter, the court is unaware of any controlling appellate authority expressly adopting the " legal injury" (i.e., " actionable harm") construction of the term " injury, " as used in the limitation period under § 52-577a(a). In Peerless Ins. Co. v. Tucciarone, 48 Conn.App. 160, 708 A.2d 611 (1998), the Appellate Court assumed, without deciding, that " our Supreme Court would give the discovery language of § 52-577a(a) the same judicial gloss it gives to § 52-584." Id. at 165; see also Gnazzo v. G.D. Searle & Co., 973 F.2d 136, 138 (2d Cir. 1992) (applying " actionable harm" construction to § 52-577a(a)). Indeed, our Supreme Court has interpreted this exact language--i.e., the term " injury" and the phrase " in the exercise of reasonable care should have been discovered" --in the context of at least two other materially similar statutes, namely, General Statutes § § 4-148(a) and 52-584. In Lagassey v. State, 268 Conn. 723, 846 A.2d 831 (2004), the trial court had granted the defendant's motion to dismiss, having concluded, among other things, that the plaintiff's medical malpractice claim against the state was untimely as a matter of law under § 4-148(a). Id. at 730, 731. Section 4-148(a), governing claims presented under chapter 53, provided at the time: " Except as provided in subsection (b) of this section, no claim shall be presented under this chapter but within one year after it accrues. Claims for injury to person or damage to property shall be deemed to accrue on the date when the damage or injury is sustained or discovered or in the exercise of reasonable care should have been discovered, provided no claim shall be presented more than three years from the date of the act or event complained of." The Court noted the material similarities between § § 4-148(a) and 52-584 (applicable to actions seeking damages for personal injury generally), namely, that " [b]oth statutes provide that the limitation period begins to run when a plaintiff either sustains or discovers the injury or, in the exercise of reasonable care, should have discovered the injury . . ." Lagassey, 268 Conn. at 738. After engaging in a thorough analysis of its prior application of § 52-584 in Burns v. Hartford Hospital, 192 Conn. 451, 472 A.2d 1257 (1984), Catz v. Rubenstein, 201 Conn. 39, 513 A.2d 98 (1986), Merly v. State, 211 Conn. 199, 558 A.2d 977 (1989), and Taylor v. Winsted Memorial Hospital, 262 Conn. 797, 817 A.2d 619 (2003), the Court took the " opportunity to restate the correct legal standard by which to evaluate the timeliness of causes of action in negligence, " as follows:
Indeed, as stated by the Appellate Court, " [t]here is no relevant distinction, except for a difference in the stated limitation periods, between the discovery language contained in § § 52-577a and 52-584." Tarnowsky v. Socci, 75 Conn.App. 560, 569, 816 A.2d 728 (2003), aff'd, 271 Conn. 284, 856 A.2d 408 (2004).
General Statutes § 52-584 provides: " No action to recover damages for injury to the person, or to real or personal property, caused by negligence, or by reckless or wanton misconduct, or by malpractice of a physician, surgeon, dentist, podiatrist, chiropractor, hospital or sanatorium, shall be brought but within two years from the date when the injury is first sustained or discovered or in the exercise of reasonable care should have been discovered, and except that no such action may be brought more than three years from the date of the act or omission complained of, except that a counterclaim may be interposed in any such action any time before the pleadings in such action are finally closed."
The limitation period for actions in negligence begins to run on the date when the injury is first discovered or in the exercise of reasonable care should have been discovered. See General Statutes § § 4-148(a) and 52-584. In this regard, the term " injury" is synonymous with " legal injury" or " actionable harm." " Actionable harm " occurs when the plaintiff discovers, or in the exercise of reasonable care, should have discovered the essential elements of a cause of action . Catz v. Rubenstein, supra, 201 Conn. at 44. A breach of duty by the defendant and a causal connection between the defendant's breach of duty and the resulting harm to the plaintiff are essential elements of a cause of action in negligence; they are therefore necessary ingredients for " actionable harm." Id. Furthermore, " actionable harm" may occur when the plaintiff has knowledge of facts that would put a reasonable person on notice of the nature and extent of an injury, and that the injury was caused by the negligent conduct of another. Id., 47. In this regard, the harm complained of need not have reached its fullest manifestation in order for the limitation period to begin to run; a party need only have suffered some form of " actionable harm." Id., 43, 45. Finally, the determination of when a plaintiff in the exercise of reasonable care should have discovered " actionable harm" is ordinarily a question reserved for the trier of fact. Taylor v. Winsted Memorial Hospital, supra, 262 Conn. at 810.(Emphasis added.) Lagassey, 268 Conn. at 748-49. The Court concluded:
[O]n the basis of our holdings in Taylor v. Winsted Memorial Hospital, 262 Conn. 797, 805, 817 A.2d 619 (2003) (plaintiff has no duty to investigate potential malpractice claim), and Catz v. Rubenstein, 201 Conn. 39, 44, 49, 513 A.2d 98 (1986) (limitation period accrues on date plaintiff discovers or should have discovered " causal nexus" between alleged negligence and subsequent injury), the trial court improperly concluded that the plaintiff's claim was untimely as a matter of law.Lagassey, 268 Conn. at 731.
In light of § 52-577a(a)'s use of the identical language construed by the Supreme Court in Lagassey --i.e., the term " injury" and the language " in the exercise of reasonable care should have been discovered" --the court adopts the same " legal injury" (i.e., " actionable harm") construction of the word " injury, " as explained in Lagassey, and applies it here. Accordingly, in the present case, " actionable harm" may occur when the plaintiff has knowledge of facts (1) that would put a reasonable person on notice of the nature and extent of an injury, and (2) that the injury was caused by the conduct of another. Lagassey, 268 Conn. at 748-49. Although the parties appear to agree that application of the " legal injury" or " actionable harm" construction to the term " injury" is proper, the court is left in the unusual position of agreeing with neither side's position as to its application in the present case. That is, the defendants advocate for a conclusion as a matter of law that the limitation period begins to accrue when a plaintiff has an observable bleeding event while taking Pradaxa and discontinues use upon such event, regardless of any showing of actual knowledge on the part of the plaintiff. In contrast, aspiring to be limited only by the ten-year statute of repose, the plaintiff makes (although not consistently) the novel argument that the applicable limitation period still has not yet begun to run because " to this very day the Pradaxa label does not specifically warn identifiable patient populations that they are at significantly increased risk of bleeding." (Pl. Opp. at 17.) The court adopts neither position.
Plaintiff's counsel seemed to concede, however, that the date on which a plaintiff spoke with an attorney or saw an advertisement on television relating to his or her claims could trigger the limitation period. Meanwhile, plaintiff's counsel appear to have abandoned their prior suggestion made earlier in this litigation that it was possible that the limitation period began to run upon the announcement of the May 2014 Pradaxa master settlement agreement and/or a couple months later upon the publication of certain Pradaxa-related articles in the British Medical Journal .
With respect to the first prong of the actionable harm test, the parties do not dispute, and the court so finds, that the plaintiff learned of the nature and extent of his injury during his hospitalization period of November 26-28, 2012; that is, the plaintiff had knowledge of facts that would put a reasonable person on notice of the nature and extent of an injury. With regard to the second prong of the actionable harm test, however, the parties disagree as to when the plaintiff had knowledge of facts that such injury was caused by the conduct of another. On this point, the defendants contend that, at the time of his observable bleeding event, the plaintiff " possessed all of the relevant facts supporting his claim that Pradaxa might be responsible." The plaintiff argues, in contrast, that " [t]he Defendants' continuing failure to convey . . . relevant information on bleeding risks to the Plaintiffs and their health care providers in the Pradaxa label-- to this very day --renders it impossible to identify any date certain for the discovery of an actionable claim." (Pl. Opp. at 14 [emphasis in original].) The court finds that there is no evidence on this record as to when the plaintiff learned of a causal connection between his injury and his Pradaxa use, let alone any allegedly tortious conduct of the defendants. Although the defendants rely on the force of the medication guide and the physician labeling, there is no evidence in the current record regarding whether the plaintiff read or was made aware of any warnings regarding Pradaxa prior to his bleeding event. Similarly, there is no evidence in the record regarding why the plaintiff stopped taking Pradaxa, and it would be pure speculation to assume that he stopped taking Pradaxa because he knew that his bleeding event was caused by his use of Pradaxa or any tortious conduct by the defendants. Moreover, there is no evidence in the record regarding when the plaintiff ascertained or otherwise obtained information from a healthcare professional, attorney, and/or any other source (e.g., an advertisement on television regarding Pradaxa litigation) regarding a connection between his use of Pradaxa and his bleeding event. Notably, the complaint is silent on these facts. Although the court agrees with the defendants that a plaintiff need not know all applicable legal theories for his limitation period to begin to run, Catz, 201 Conn. at 47, the court is unable to establish a bar date based solely on the facts available on this scant record.
The court notes that the plaintiff has not been deposed.
Although the defendants' moving papers contain representations such as " [the plaintiff] discontinued his use of Pradaxa with the knowledge that it may have contributed to his bleeding " (Reply at 3), such representations are made without citation to the record, and the court is unaware of any evidence on this current record to support a finding that this plaintiff had knowledge in November 2012 of a possible causal connection between his bleeding event and the defendants.
The defendants rely on, among others, the decisions in Avoletta v. State, 152 Conn.App. 177, 98 A.3d 839 (2014), and Gnazzo, 973 F.2d at 136. The court finds those cases to be readily distinguishable because in each of those cases, there was evidence in the record to support a finding as to when the plaintiffs learned of a link between their injuries and the defendants' causal connection to them. In Avoletta, the plaintiffs, two minor students and their mother, brought suit against the state for its alleged failure in providing the students a free appropriate public education in an environmentally safe setting in violation of the federal and state constitutions, as well as certain state statutes. Avoletta, 152 Conn.App. at 179. The boys suffered physical ailments that the plaintiffs linked to the conditions of their respective public schools. At issue was whether the plaintiffs' claims were time-barred pursuant to § 4-148(a), which requires a claimant seeking monetary damages against the state to present a claim to the claims commissioner for authorization to bring suit within one year after the claim accrues. The trial court found the claims to be time-barred because the plaintiffs " undisputedly discovered a harm by the time [the boys] were taken out of the Torrington public schools, " which occurred in 2003, " far more than a year before the May 2, 2007 filing with the Claims Commissioner." Id. at 189, 190.
In addition, in Gnazzo, the federal district court granted the defendant manufacturer's motion for summary judgment on the ground that the plaintiff's product liability action, which was commenced in 1990, was time-barred by the three-year limitation period in § 52-577a(a). Gnazzo, 973 F.2d at 137. On appeal, the United States Court of Appeals for the Second Circuit " determined that Gnazzo's cause of action commenced in 1981, " id. at 139, because that is when, according to a questionnaire completed by the plaintiff, she first suspected that the intrauterine device at issue had caused her some harm. Id. at 137; see also id. at 138 (" she suspected 'sometime in 1981' that the IUD had caused her harm because she had been experiencing trouble becoming pregnant and had 'started hearing [and] reading about how damaging IUD's [sic] could be . . . [and had] figured that was [the] problem . . ." [alterations in original]). The Court stated: " [B]y her own admission, Gnazzo had recognized, or should have recognized, the critical link between her injury and the defendant's causal connection to it." Id. at 138.
In contrast, the current record does not permit a finding that, by a particular date prior to the commencement of suit, the plaintiff had knowledge of facts that his injury was possibly caused by the conduct of the defendants. Thus, the court cannot find on this record that the defendants are entitled to judgment as a matter of law on statute of limitations grounds. This conclusion is consistent with the oft-repeated principle that " the point at which a plaintiff discovered or in the exercise of reasonable care should have discovered an injury is generally a question of fact . . ." Lagassey, 268 Conn. at 739; Taylor, 262 Conn. at 810 (" determination of reasonable care is a question of fact"); Catz, 201 Conn. at 49 (when injury should have been discovered is question of fact).
IV
CONCLUSION
Based on the foregoing, the court denies the defendants' motion for summary judgment (#105.00).