Opinion
Civ. No. 07cv12370-NG.
December 23, 2009
MEMORANDUM AND ORDER RE: DEFENDANT'S MOTION FOR SUMMARY JUDGMENT
I. INTRODUCTION
Kelly A. Laspesa and Stephen Laspesa ("the Laspesas") bring this products liability action against Arrow International, Inc. ("Arrow"), the manufacturer of a medical device called an epidural catheter. An anesthesiologist administered a sedative through this device during the birth of the plaintiffs' first child. After delivery, part of the catheter became lodged in Ms. Laspesa's back. Although doctors were unable to remove the catheter immediately after delivery, a surgeon successfully did so in a separate surgery a few weeks later. Ms. Laspesa reports that she experienced considerable pain after removal of the catheter.
An epidural catheter is a thin tube used to inject a steady stream of anesthesia into the spinal canal. See Herrington v. Hiller, 883 F.2d 411, 413 n. 4 (5th Cir. 1989). A doctor first inserts a hollow hypodermic needle called a Touhy needle, then threads the catheter through the needle, and finally withdraws the needle over the catheter, leaving the catheter in place. See Brian R. Banwell et al., Decreased Incidence of Complications in Patients with the Arrow (FlexTip Plus) Epidural Catheter, 45 Can. J. of Anesthesia 370, 370 (1998) (document #15-3).
The plaintiffs present claims for negligence based on a design, manufacturing, or warning defect, breach of express warranties, breach of the implied warranty of merchantability, breach of the implied warranty of fitness for a particular purpose, and loss of consortium. Arrow moves for summary judgment on all claims because the plaintiffs have not disclosed any experts, which Arrow argues would be necessary to prove elements of each cause of action.
I find that the evidence plaintiffs present is insufficient to establish any of the particular product defects alleged in the complaint, but that they may proceed under a theory of res ipsa loquitur. On the record in this case, only an expert could explain whether the design was unreasonably dangerous compared to alternatives, whether this particular device deviated from its design, and whether the physicians treating Ms. Laspesa were warned about the risks of using Arrow's catheter, critical elements of Ms. Laspesa's claims. However, Massachusetts' expansive treatment of the res ipsa loquitur doctrine allows the plaintiffs to prove the existence of an unspecified type of defect based on the occurrence of the catheter incident.
At the same time, the absence of an expert has a direct impact on the scope of plaintiffs' claims for damages. Plaintiffs cannot prove that any defect caused Ms. Laspesa's later pain, apart from the pain of the surgery to remove the catheter, because they have not presented any evidence to controvert defendant's expert.
The Court GRANTS IN PART Defendant's Motion for Summary Judgment (document #12) to the extent that it refers to damages for Ms. Laspesa's pain subsequent to her recovery from surgeries for removal of the epidural catheter, and asks for dismissal of her claim for breach of an implied warranty of fitness for a particular purpose (Count IV). The Court DENIES IN PART the motion with regard to damages directly attributable to the surgeries and all other counts in the plaintiff's complaint.
II. SUMMARY JUDGMENT STANDARD
In a motion for summary judgment, all facts must be considered in the light most favorable to the nonmoving party. Fed.R.Civ.P. 56(c); Mariasch v. Gillette Co., 521 F.3d 68, 70 (1st Cir. 2008). The movant bears the burden of showing that there is no genuine issue regarding any material fact in the pleadings, discovery materials, and affidavits, and that the movant is entitled to judgment as a matter of law. Fed R. Civ. P. 56(c);Rogers v. Fair, 902 F.2d 140, 143 (1st Cir. 1990) ("To succeed, the moving party must show that there is an absence of evidence to support the nonmoving party's position."). If the moving party meets its burden, the burden shifts to the nonmovant to demonstrate a genuine, triable issue. Celotex Corp. v. Catrett, 477 U.S. 317, 324 (1986). A summary judgment motion "cannot be defeated by relying on improbable inferences, conclusory allegations, or rank speculation." Ingrams v. Brink's, Inc., 414 F.3d 222, 228-29 (1st Cir. 2005).
III. FACTUAL BACKGROUND
According to the medical records and other documents submitted by the plaintiffs, Ms. Laspesa gave birth to her first child at Beverly Hospital, in Beverly, Massachusetts, on March 20, 2009. During delivery, doctors administered a sedative via a FlexTip Plus epidural catheter designed and manufactured by Arrow. (Charles Ho, Operative Report at 1 (Mar. 21, 2006)) (document #18-2); (Letter from Barbara McCarthy to Joseph G. Abromovitz, (Oct. 2, 2007)) (document #18-3). Ms. Laspesa's anesthesiologist, Dr. Charles Ho, had difficulty removing the catheter from her lumbar region, and tried again by placing her in different positions. (Charles Ho, Operative Report at 1 (Mar. 21, 2006)) (document #18-2). During one of these attempts at removal, the catheter broke into two pieces. One piece, consisting of the catheter tip and fractured wire, remained in Ms. Laspesa's lumbar region. (Michael Medlock, Operative Report (Apr. 3, 2006)) (document #18-4).
The defendant's expert acknowledges, based on his own review of Ms. Laspesa's medical records, that Dr. Ho followed the recommendations in the literature for removing epidural catheters. (Letter from Michael V. DiTullio, to James E. Kruzer at 17 (Feb. 24, 2009)) (document #15-2)
The doctors attempted surgery immediately after delivery, but could not find the catheter fragment. (Charles Ho, Operative Report at 1 (Mar. 21, 2006)) (document #18-2). They then performed a series of x-rays to locate the fragment. Id. at 2. On April 3, 2006, a subsequent surgery succeeded in removing the remainder of the catheter. (Michael Medlock, Operative Report (Apr. 3, 2006)) (document #18-4). Ms. Laspesa reports that she experienced severe back pain during the week after the second surgery, and continued to have pain thereafter. (Pl.'s Answers to Interrogatories at 4-6) (document #13-4).
The Food and Drug Administration (FDA) has catalogued four other incidents in which a FlexTip Plus catheter split and became partially lodged in a patient. (FDA Adverse Event Reports) (document #18-5). Beverly Hospital also reported the broken catheter incident at issue in this lawsuit to the FDA. (Letter from Barbara McCarthy to Joseph G. Abromovitz (Oct. 2, 2007)) (document #18-3). On October 10, 2007, the FDA sent a letter to Arrow describing quality management problems for devices manufactured by the firm, including epidural catheters. (Corporate Warning Letter from Thomas D. Gardine and Timothy A. Ulatowski to Philip B. Fleck at 1 (Oct. 10, 2007)) (document #18-6). Those problems included failure to implement necessary quality controls and failure to address past manufacturing defects. Id. at 2.
The plaintiffs did not disclose any experts who could explain the cause of her pain, nor have they moved to extend discovery so that an expert could be disclosed. In contrast, the defendant has proposed an expert, Dr. Michael DiTullio, a neurologist, who provided an extended discussion of Ms. Laspesa's back problems. He concluded that "Ms. Laspesa's subsequent complaints were unrelated either to the . . . retained fragment or the operative procedures of either Dr. Ho or Dr. Medlock." (Letter from Michael V. DiTullio, to James E. Kruzer (Feb. 24, 2009), at 19) (document #15-2). Ditullio described Ms. Laspesa's surgeries as minor compared to many spinal procedures, and stated that any discomfort from the catheter or its removal would have been "transient and self-limited." Id. at 20. He attributed her pain to a preexisting lumbar disk condition caused by a fall in 2000 and exacerbated by her pregnancy. Id. at 21. In his medical opinion, the catheter was "physically incapable of causing an underlying disc injury" and the location of a herniated disc in her back was too far removed from the site of the surgeries to be causally related. Id.
IV. ANALYSIS
A. Causes of Action
A plaintiff in a product liability case generally must prove at least two elements: (1) the defendant had a defective product, and (2) the product caused plaintiff's injury. See Colter v. Barber-Greene Co., 403 Mass. 50, 63-64 (1988). In this case, Ms. Laspesa alleges that the epidural catheter Dr. Ho used during delivery of her child had a design defect, manufacturing defect, or warning defect. (Compl. ¶ 11). She contends that these defects subject the defendant to liability for negligence and three types of warranty breaches. Id. ¶¶ 9, 11-12, 16-17, 21-22, 26-27.
Under Massachusetts law, product defect claims can be brought either as negligence actions or breach of warranty actions. See generally 37 Mass. Prac., Tort Law §§ 16-17 (3d ed. 2005). The negligence actions require an additional element, that the defendant failed to exercise reasonable care to avoid foreseeable risks that the product could cause harm. Morrell v. Precise Engineering, Inc., 36 Mass. App. Ct. 935, 936 (Mass. App. Ct. 1994). Ms. Laspesa argues that the defendant was negligent in producing a defective epidural catheter. (Count I) The breach of warranty actions, in contrast, are similar to strict liability actions in other states. Back v. Wickes Corp., 375 Mass. 633, 639 (1978).
Ms. Laspesa alleges three types of warranty breaches: Breach of express warranty, breach of the implied warranty of merchantability, and breach of the implied warranty of fitness for a particular purpose. Mass Gen. Laws ch. 106, §§ 2-213 to 2-315. When a defendant makes an affirmative statement as to the fitness of a product, that is considered an express warranty under Mass Gen. Laws ch. 106, § 2-213. In this case, the complaint alleges that the product was not fit for the purpose expressly warranted because it was defective. (Count II) (Compl. ¶ 16). A seller breaches the implied warranty of merchantability when a product is not fit for its normal, ordinary use, see Mass Gen. Laws ch. 106, § 2-214, as the plaintiffs contend here. (Count III) (Compl. ¶ 21). The implied warranty of fitness for a particular purpose applies only when a product is inappropriate for a specific purpose that the buyer informs the seller of at the time of contracting. See Mass Gen. Laws ch. 106, § 2-315. The plaintiffs argue that Arrow presented the catheter as appropriate for administering a sedative, but that it was defective. (Count IV) (Compl. ¶ 26).
The types of defects at issue in this case — design, manufacturing, and warning — have distinct standards for liability, which apply in both the negligence and warranty contexts. A design defect exists when the product, as designed, is "unreasonably dangerous" for its "ordinary purposes." Haglund v. Philip Morris, Inc., 446 Mass. 741, 746-47 (2006). Claims for design defect generally must be accompanied by evidence of the feasibility of an alternative design. See Back, 375 Mass. at 642. A manufacturing defect exists when a product deviates in its construction or quality from specifications or planned output in a manner that renders it "unreasonably dangerous." Id. at 641. A warning defect exists when the marketing of a dangerous product does not adequately inform a user of the foreseeable risks associated with its ordinary use. See Simmons v. Monarch Machine Tool Company, 413 Mass. 205, 207 n. 3 (1992); Hayes v. Ariens Co., 391 Mass. 407, 413 (1984). In cases involving medical products, "the warning runs to the physician not the patient."Knowlton v. Deseret Medical, Inc., 930 F.2d 116, 120 n. 2 (1st Cir. 1991). The plaintiffs only need to be able to prove one of these types of flaws to establish that the product is defective.See Mendes v. Medtronic, 18 F.3d 13, 17 (1st Cir. 1994).
B. Implied Warranty of Fitness for a Particular Purpose
As a preliminary matter, Arrow is entitled to summary judgment with regard to the plaintiff's claim of breach of the implied warranty of fitness for a particular purpose. (Count IV.) That warranty applies only when the buyer envisages a specific use for the product "which is peculiar to the nature of his business." Mass Gen. Laws ch. 106, § 2-315 cmt. 2; see Fernandes v. Union Bookbinding Co., 400 Mass. 27, 35-36 (1987). When the buyer plans to use the product for its ordinary purpose, the only implied warranty is the warranty of merchantability alleged in Count III.See Mass.Gen. Laws ch. 106, § 2-314; Hannon v. Original Gunite Aquatech Pools, Inc., 385 Mass. 813, 821 (1982) (holding that a manufacturer could not be liable under § 2-315 when the buyer did not use his swimming pool for any purpose other than its normal one). In the present case, doctors used Arrow's catheter for one of its most common purposes, the administration of an epidural sedative. As such, the plaintiffs are foreclosed from pursuing Count IV of the complaint.
C. Expert Testimony and Product Defects
The defendant contends that the plaintiffs cannot prove the epidural catheter was defective, an essential element of all counts, without expert testimony. In diversity actions in the First Circuit, state law determines whether expert testimony is necessary. See Beaudette v. Louisville Ladder, Inc., 462 F.3d 22, 27 (1st Cir. 2006); Hochen v. Bobst Group, Inc., 290 F.3d 446, 451 (1st Cir. 2002). Under Massachusetts law, expert testimony must be presented in negligence and breach of warranty actions when "the nature of the defect or breach of warranty" is complex,Hochen, 290 F.3d at 451, but the requirements are slightly different for each type of defect alleged. There is no dispute that the plaintiffs do not have an expert who could testify at trial.
The defects that plaintiffs must prove for Arrow's catheter are complex, and the general information that plaintiffs present — about previous incidents, the fact that the hospital reported this event, and Arrow's quality management problems — does not come close to meeting the legal standards for particular types of defects. For a design defect, the question of whether a product's design is "unreasonably dangerous" depends on a certain base of knowledge about the normal dangers of delivering anesthesia and the relative risks of this design. Likewise, plaintiffs would need to prove an "unreasonably dangerous" deviation from the intended design to prevail on a theory of manufacturing defect, which entails both an understanding of baseline risks and this particular catheter's deviations from Arrow's design. The warning theory would require a showing that doctors received inadequate information about foreseeable dangers; comprehension of this issue presupposes knowledge about both anesthesiologists' training and specific information about the particular risks this product creates. Considering the evidence provided in this case, lay jurors would not be sufficiently familiar with the anesthesiological and engineering principles necessary to make judgments about these specific types of defects in the absence of expert testimony. I will now discuss each of these defects in more detail.
1. Design Defect
Plaintiffs must provide expert testimony to prove a design defect when the product's mechanisms are technical and complex. For example, the First Circuit has held that plaintiffs could not succeed on a theory of design defect without expert testimony regarding a printing press that exploded. Id. Similarly, a Massachusetts appeals court ruled that a suit against the manufacturer of an escalator required expert testimony because the "determination of the dimensions essential to its safe operation is generally beyond the scope of an average person's knowledge." Esturban v. Mass Bay Transp. Auth., 68 Mass. App. Ct. 911, 911 (Mass. App. Ct. 2007). Plaintiffs have also been required to present expert testimony for the design of a car door latch and windshield. Goffredo v. Mercedes-Benz Truck Co., 402 Mass. 97, 104 (1988); Wiska v. St. Stanislaus Social Club, Inc., 7 Mass. App. Ct. 813, 821 (Mass. App. Ct. 1979).
In some instances, Massachusetts courts have ruled that expert testimony is not required, such as when a design defect is simple and easy to understand. The Massachusetts Supreme Judicial Court stated that it was permissible for a jury to rely on lay knowledge to determine whether "unshielded metal protrusions on the handlebar of a snowmobile constitute a defect in design which creates an unreasonable risk of injury." Smith v. Ariens Co., 375 Mass. 620, 625 (1978). That court has also permitted a jury to reach the question of negligent design of an ironing machine that pulled an operator's hand into the machine. DoCanto v. Ametek, Inc., 367 Mass. 776, 782 (1975).
The FlexTip Plus epidural catheter's design may be straightforward relative to many other medical devices, but it nevertheless requires expert testimony. Unlike the snowmobile with metal protrusions in Smith, any design defect would not be apparent to a layperson from mere observation; there is no allegation that the device had a visible defect. See 375 Mass. at 625. The defect also could not be understood from lay testimony about the part of the machine that malfunctioned, as was the case with the ironing machine in DoCanto, because, as explained above, the risks of anesthesia delivery devices are outside the scope of common knowledge. See 367 Mass. at 782; Esturban, 68 Mass. App. Ct. at 912. Without expert testimony, the plaintiffs could not inform the jury about the normal dangers of delivering anesthesia through a catheter and the relative risks of Arrow's design, considerations which are necessary to determine whether the product is unreasonably dangerous. The plaintiffs, therefore, cannot prevail on a theory of design defect.
The plaintiff also has not proposed testimony to demonstrate the feasibility of an alternative design. The articles submitted by the defendant, however, contain a description of the prevailing catheter design before Arrow's current design, and state that they may be less likely to break. Takashi Asai et al., Letter to the Editor, More Difficulty in Removing an Arrow Epidural Catheter, 102 Anesthesia Analgesia 1595, 1596 (2006) (document #15-3) ("[T]he Arrow FlexTip epidural catheter is more likely to stretch and break than conventional catheters. . . ."). With this article in the record, there would have been enough evidence for the alternative design issue to reach the jury, if the design defect claims were not otherwise foreclosed.
2. Manufacturing Defect
Some manufacturing defect claims also require expert testimony.Hochen required expert testimony for a manufacturing defect theory regarding the printing press. 290 F.3d at 451. In contrast, a court in this district has concluded that an expert would not be necessary to prove a claim that a sandal had a manufacturing defect. Hofer v. The Gap, Inc., 516 F. Supp. 2d 161, 173 n. 13 (D. Mass. 2007). These cases are best interpreted to mean that courts should consider whether a lay jury would have sufficient information to determine that the particular catheter at issue deviated from its intended design. A jury would not have such information for a printing press because the operation of that machine is not commonly known; a sandal, on the other hand, is a simple product that laypeople use regularly.
In this case, the plaintiffs have not provided sufficient evidence to reach a jury on a general theory of manufacturing defect. The only evidence offered on this issue is the letter from the FDA about general manufacturing problems, reports of other catheters that broke during removal, and the fact that Beverly Hospital reported the broken catheter to the FDA. None of this evidence could establish that the manufacturing of the particular catheter at issue deviated from its intended design in a way that would be unreasonably dangerous. See Back, 375 Mass. at 341. This information merely shows that other catheters have broken, which could be the result of a design defect or even reasonable risk. Without a base of knowledge regarding catheters in general and the Arrow catheter in particular, the jury would need to hear testimony regarding the proper functioning of this catheter and the likelihood that it would break in order to find a manufacturing defect in the catheter at issue in this case. In the absence of such testimony, it is impossible for the jury to determine that the catheter deviated from its intended design.
3. Warning Defect
Expert testimony is not always necessary to establish the existence of a warning defect. A jury may be able to determine, based on lay knowledge, that a warning is needed to make a product reasonably safe. MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 140 (1985). Courts have allowed juries to consider, based on lay knowledge, such issues as whether a warning was necessary for the risks of using oral contraceptives, and the dangers of tire overinflation. Id.; Marchant v. Dayton Tire Rubber Co., 836 F.2d 695, 701 (1st Cir. 1998). In other cases, such as when the product requires technical knowledge, juries may need expert guidance regarding whether a warning would have been appropriate. See Wiska, 7 Mass. App. Ct. at 819-21. The appeals court in Wiska said that expert testimony would be necessary for a jury to decide whether a car manufacturer should have warned about the dangers of a windshield breaking. Id. Courts in other jurisdictions have said that expert testimony is particularly appropriate when the manufacturer does provide some warning, in order to determine the adequacy of that warning. See, e.g., Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 691 (Miss. 1988). The Mississippi Supreme Court has reasoned that warnings directed at doctors require expert testimony because they are "so distinctively related to some science, profession, business or occupation as to be beyond the ken of the average layman." Id. at 692 (quoting Dion v. Graduate Hosp. of the Univ. of Pennsylvania, 360 Pa. Super. 416, 425 (Pa. Super. Ct. 1987)).
The plaintiffs include a failure to warn theory in their complaint, but they have not supplied the text of any warnings. Dr. Ho did state in his deposition that Arrow provided instructions or manuals regarding the removal of epidural catheters. (Deposition of Charles C. Ho at 77) (document #18-7). In any case, since the workings of a FlexTip Plus epidural catheter are outside the scope of common knowledge, expert guidance as to the necessity and adequacy of Arrow's warnings, in light of the information that anesthesiologists already know, would be required. Otherwise, jurors would have to speculate regarding the appropriateness of the warnings provided and any additional dangers that should have been warned against. Without an expert witness, therefore, the plaintiffs cannot prove a failure to warn.
D. Res Ipsa Loquitur
Although the plaintiffs do not have sufficient evidence to present claims based on any of the typical types of defect, they argue that they may pursue their claims under res ipsa loquitur. This doctrine traditionally permits juries to infer negligence when an unusual event occurs that would not occur absent negligence. Coyne v. John S. Tilley Co., 368 Mass. 230, 235 (1975) (citing Evangelio v. Metropolitan Bottling Co., 339 Mass. 177, 180 (1959)). Although res ipsa loquitur traditionally focuses on negligence, it also precludes the Court from granting summary judgment on the remaining breach of warranty claims. See White v. W.W. Grainger Co., No. 85-0933-C, 1988 WL 290663, at *1 (D. Mass. Feb. 16, 1988). In effect, juries in a products liability action may infer under certain circumstances that some unspecified type of defect existed without direct evidence of any particular defect. Cases brought on a res ipsa loquitur theory sometimes require expert testimony, but may not "in the case of a brand-new device that has not been mishandled in any way." Smith v. Robertshaw Controls Co., No. 00-11239, 2003 U.S. Dist. LEXIS 23639, at *11 (D. Mass. Dec. 31, 2003).
Since the implied warranty of merchantability in Massachusetts is a form of strict liability, a manufacturer that is liable under a theory of negligence has necessarily breached its warranties. Hayes, 391 Mass. at 410 ("A defendant cannot be found to have been negligent without having breached the warranty of merchantability."). The express warranty claim also would not be foreclosed because it is based on the same defect as the implied warranty.
In a res ipsa loquitur negligence action, plaintiffs may prove the duty and breach elements of a negligence claim if they show by a preponderance of the evidence that "(1) the instrumentality causing the accident was in the sole and exclusive control and management of the defendant; and (2) the accident is of the type or kind that would not happen in the ordinary course of things unless there was negligence by the defendant." Wilson v. Honeywell, Inc., 409 Mass. 803, 805 (1991). Courts applying Massachusetts law have interpreted the first requirement broadly, and required plaintiffs to show only "that the instrumentality has not been misused or tampered with after leaving the hands of the defendant." White, 1988 WL 290663, at *3 (citing Coyne, 368 Mass. at 237; Calvanese v. W.W. Babcock Co., 10 Mass. App. Ct. 726, 732 (Mass. App. Ct. 1980)). For the second element, that the accident ordinarily would not happen without negligence, the plaintiff must show only that the accident more likely than not was a result of defendant's conduct. Id. at *3 (citing Evangelio, 339 Mass. at 180); see also Woronka v. Sewall, 320 Mass. 362, 365 (1946). The plaintiff need not eliminate all possible alternative causes to be entitled to such an inference. Woronka, 320 Mass. at 365.
The requirements for res ipsa loquitur in breach of warranty actions are similar to those in negligence actions. The first element is the same, so plaintiffs must only show that the instrumentality was not misused or modified. White, 1988 WL 290663, at *1. For the second element, the plaintiff need not show that the accident would not occur absent negligence, because negligence is not an element of the claim. See Hayes, 391 Mass. at 410. Instead, the plaintiffs need only present evidence that the accident would not ordinarily happen unless the product was defective. White, 1988 WL 290663, at *1; see also Smith, 2003 U.S. Dist. LEXIS 23639, at *11. In other words, the plaintiffs must provide circumstantial evidence that the accident most likely occurred because the product was defective. See White, 1988 WL 290663, at *2.
The plaintiffs in this case may pursue a res ipsa loquitur theory. With regard to the first element, Dr. Ho testified in his deposition that the catheter was "out of the box." (Deposition of Charles C. Ho at 77) (document #18-7). It was new, as was the light dimmer switch at issue in White. 1988 WL 290663, at *2. This evidence is sufficient for a jury to infer that any defect in the product existed before it left the defendant's control. See id. The plaintiff does not need an expert to prove this element. See Smith, 2003 U.S. Dist. LEXIS 23639, at *11.
There is also sufficient evidence for a jury to infer that the accident would not have occurred absent negligence or a defective product. The plaintiffs presented FDA documentation characterizing this incident, as well as four other incidents in which an Arrow catheter broke, as "adverse event[s]." This evidence alone is not enough, because the incidents may have occurred without a defective product if someone else was negligent, such as the doctor who administered the sedative. In this case, however, the defendant's expert admits that the medical records show "Dr. Ho appropriately and adequately" followed the recommendations in the literature for removing epidural catheters. (Letter from Michael V. DiTullio to James E. Kruzer at 17 (Feb. 24, 2009)) (document #15-2). Moreover, an article the defendant provided describes epidural catheter separation as an unusual event. See Robert Fischer, Epidural Conduction Device Fractures and Complications of Retained Fragments, 76 Am. Ass'n of Nurse Anesthetists J. 37, 39 (2008) (document #15-3). Under these circumstances, where the hospital reported the event to the FDA, the incident is unusual, and there is evidence that the patient's doctor was not negligent, it is appropriate to allow a jury to consider whether catheter separation was more likely than not the result of defendant's conduct.
E. Experts and Causation
Although plaintiffs may be able to establish that Arrow had a defective product and was negligent based on res ipsa loquitur, they still must show that Arrow's conduct caused Ms. Laspesa's injuries. See Colter, 403 Mass. at 63-64. Causation in negligence and warranty cases involves the familiar elements of cause in fact and proximate cause. Id. at 61, 63; see also Exxon Co. v. Sofec, 517 U.S. 830, 839-40 (1996) ("Although the principles of legal causation sometimes receive labels in contract analysis different from the 'proximate causation' label most frequently employed in tort analysis, these principles nevertheless exist to restrict liability in contract as well."). Cause in fact may be shown when an injury would not have occurred but for the product defect or when the product defect was a substantial contributing factor in causing the injury. See Matsuyama v. Birnbaum, 452 Mass. 1, 30-31 (2008). Proximate cause involves primarily the question of the harm's foreseeability. Kent v. Commonwealth, 437 Mass. 312, 320 (2002).
Expert testimony is generally necessary for questions of causation in medical cases, and one Massachusetts appeals court noted specifically that such testimony would be required for "injury causation and enhancement of injury to the spine," the precise issue in this case. Lally v. Volkswagen Aktiengesellschaft, 45 Mass. App. Ct. 317, 324-325 (Mass. App. Ct. 1998) (citing Look's Case, 345 Mass. 112, 115 (1962); Casey's Case, 348 Mass. 572, 574 (1965); Held v. Bail, 28 Mass. App. Ct. 919, 921 (Mass. App. Ct. 1989)). Similarly, Casey's Case involved an insurance claim by an employee who experienced back pain after returning to construction work following surgery. 348 Mass. at 572-73. The court held that the employee needed to present expert testimony to show the causal relationship between his work and later incapacity. Id. at 574. As in these cases, expert testimony is necessary here for a jury to assess whether the catheter incident had a causal connection with Ms. Laspesa's subsequent pain.
While the plaintiffs have presented no expert testimony regarding injury causation, the defendant's expert provided a detailed discussion of Ms. Laspesa's medical history to establish that her later pain could not have been caused by the catheter incident. In other words, the defendant has shown an absence of support for the plaintiffs' position, and as such, the plaintiffs have not met their burden of demonstrating a genuine, triable issue with regard to the later pain. Celotex Corp. v. Catrett, 477 U.S. at 324. This absence of expert testimony precludes the plaintiffs from pursuing their claims for damages based on Ms. Laspesa's subsequent pain.
Nevertheless, the failure to provide expert testimony does not end the case. It may be possible for Ms. Laspesa to show that the catheter caused a portion of her injuries, as long as she prevails on the res ipsa loquitur theory. The surgeries themselves constitute an independent harm for which Ms. Laspesa can recover. See Creech v. Roberts, 908 F.2d 75, 82 (6th Cir. 1990). There is no evidence that the surgeries were not caused by the epidural catheter. In fact, the defendant's expert acknowledges that they occurred only because the catheter broke. (Letter from Michael V. DiTullio, to James E. Kruzer 4, 6 (Feb. 24, 2009)) (document #15-2). Although the expert ultimately concludes that there was no need to remove the catheter — which calls into question the foreseeability of the surgeries — the doctors who operated on Ms. Laspesa may be able to present enough information regarding this decision to allow the issue to reach the jury. Ms. Laspesa, therefore, may pursue damages in this case, but only for a three-week period from the birth of her child to her recovery from the second surgery, not any later pain.
Since Ms. Laspesa can pursue her claims for breach of warranty and negligence, Mr. Laspesa's loss of consortium claim (Count V) also is not foreclosed. See Sena v. Commonwealth, 417 Mass. 250, 264-65 (1994).
V. CONCLUSION
For the foregoing reasons, the Court GRANTS IN PART Defendant's Motion for Summary Judgment (document #12) to the extent that it refers to Count IV and damages for Ms. Laspesa's pain after her recovery from surgeries for removal of the epidural catheter. The Court DENIES IN PART the motion with regard to all other counts in the plaintiff's complaint and damages directly attributable to the surgeries.