Fertik v. Stevenson

Citations: 186 F. Supp. 3d 98; 2016 U.S. Dist. LEXIS 63539; 2016 WL 2851315Docket: Civil Action No. 12-10795-PBS

Court: District Court, D. Massachusetts; May 13, 2016; Federal District Court

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William and Greta Fertik initiated legal action against Abbott Vascular, Inc. and two physicians after a surgical guide wire broke during cardiac surgery and was left inside William Fertik's heart. The plaintiffs allege that Abbott's negligence in manufacturing the Hi-Torque Balanced Heavyweight cardiac guide wire caused its failure. Abbott moved for summary judgment, arguing that the Fertiks did not provide reliable evidence linking the wire's breakage to its negligent manufacturing. The Fertiks countered with the res ipsa loquitur doctrine, which they believe undermines the summary judgment claim. The court found no negligence on the part of the physicians regarding wire placement. Following a hearing, the court denied Abbott's motion for summary judgment.

The factual background indicates that on May 6, 2009, William Fertik underwent a cardiac ablation procedure performed by Dr. William Stevenson and Dr. Melanie Maytin at Brigham Women’s Hospital. Dr. Stevenson noted no damage to the guide wire upon its removal from sterile packaging. During the procedure, a portion of the wire broke inside Fertik's body without the physicians’ awareness. After discharge, Fertik exhibited stroke symptoms, leading to the discovery of the wire remnant in his heart, which was later removed by Dr. Eisenhauer. There is some dispute regarding the handling of the wire remnant post-removal, but it ultimately ended up discarded due to an error unrelated to Abbott or Mr. Fertik.

The court clarified the standard for summary judgment, stating that it requires evaluating all facts and reasonable inferences in favor of the non-moving party. Summary judgment is appropriate only when there are no genuine disputes over material facts, and a reasonable jury could not return a verdict for the non-moving party. The requirement for genuine issues of material fact is that they must be based on solid evidentiary foundations.

A plaintiff in a product liability case must establish two key elements: the defendant produced or sold a defective product, and this product caused the plaintiff's injury. A manufacturing defect is defined as a product that deviates from its specifications or planned output, rendering it unreasonably dangerous. The case at hand involves a manufacturing defect claim against Abbott, invoking the doctrine of res ipsa loquitur, which infers negligence when the injury-causing incident typically does not occur without some negligence. The defendant argues that res ipsa loquitur is not applicable due to a lack of exclusive control over the guide wire, its 'off-label' use, and inherent risks of breakage. In contrast, the plaintiff contends that the absence of evidence of wire damage pre-surgery and no claims of physician negligence support the application of the doctrine. Under Massachusetts law, for res ipsa loquitur to apply, the jury must find that the instrument causing the accident was under the defendant's sole control and that the accident would not ordinarily occur without negligence. Even without absolute exclusivity, sufficient control can lead to an inference of the defendant’s responsibility. The plaintiff is not required to eliminate all other possible causes but must present a case from which a jury could reasonably conclude that the defendant's negligence was likely the cause of the incident.

Laspesa v. Arrow International, Inc. is a products liability case involving a broken epidural catheter during childbirth. In this case, the court determined that the element of exclusive control was satisfied because the catheter was new and unopened prior to surgery. The court also found that res ipsa loquitur was applicable due to unusual circumstances surrounding the incident, including the hospital's report to the FDA and the absence of negligence from the patient's doctor. 

The case references Parkinson v. Guidant Corp., where summary judgment was denied under similar circumstances involving a guide wire that broke inside a patient. No evidence suggested mishandling of the wire from the manufacturer to the surgical team, supporting the claim of exclusive control. Testimonies indicated that the guide wire was undamaged when opened during surgery, and the doctors had extensive experience without similar failures, suggesting that the break was likely due to manufacturer negligence.

Abbott, the defendant, cited FDA information indicating that guide wire breakage is often due to handling errors. However, all parties agreed there was no negligence during handling in this case. Abbott’s argument included that the wire is delicate and may break under normal use. Ultimately, the court noted that a jury could reasonably find the breakage resulted from a defect rather than normal circumstances.

Abbott also contended that the physicians used the guide wire in an 'off-label' manner, arguing that it was manufactured adequately for FDA-approved uses. The plaintiff countered that Abbott misrepresented the FDA's scrutiny, the guide wire's approved uses, and that the manufacturer is not shielded from liability simply because the product was used off-label.

The Medical Device Amendments of 1976 categorize medical devices into three classes based on risk. Class III devices are subject to a rigorous Premarket Approval Process (PMA), requiring extensive safety and efficacy data, with the FDA spending about 1,200 hours on each submission. Class II devices, like the guide wire in this case, undergo a less intensive 510(k) review, averaging only 20 hours, allowing for marketing without further regulatory scrutiny if deemed substantially equivalent to existing devices. The 510(k) process involves minimal information and rarely results in negative feedback from the FDA. Devices entering the market through this pathway have not undergone formal safety or efficacy reviews.

Off-label use of medical devices, while common, is not regulated by the FDA, which acknowledges its necessity in medical practice. Manufacturers must consider foreseeable product uses but are not liable for unforeseeable misuse. Whether misuse is foreseeable is a factual matter for the jury. In this context, the plaintiff disputes Abbott's assertion that the guide wire was used off-label during a cardiac ablation procedure. Abbott identifies four FDA-cleared uses for the guide wire but admits in an affidavit that its use in this procedure was off-label. The plaintiff argues that, while not explicitly listed as an approved use, the broader classification submitted to the FDA allows for its use in various therapeutic procedures, including the placement of a transseptal needle during cardiac ablation.

The plaintiff's use of the Abbott guide wire in a cardiac ablation procedure, deemed 'off-label,' is supported by evidence showing that leading surgeons at a prominent Harvard teaching hospital have used it this way thousands of times, and Abbott has not shown that this use was unforeseeable or constituted a misuse. There is no indication that the stress on the guide wire during this 'off-label' use exceeded that of 'on-label' uses. Abbott claims it is not liable for manufacturing defect claims related to 'off-label' uses, referencing cases primarily involving surgical screws. Courts have established that a manufacturer is not liable for a physician's 'off-label' use unless a defect exists in the product. Notably, the manufacturer cannot be held liable even if they are aware of the 'off-label' use unless a defect is proven. There is no controlling authority that would exempt Abbott from a product defect claim based on foreseeable 'off-label' use, leading to the denial of Abbott’s motion for summary judgment.

Additionally, Abbott seeks to exclude the testimony of the plaintiff's expert, Dr. Dana J. Medlin, arguing that his theory regarding the guide wire's breakage does not align with a pathologist’s measurement of the wire remnant. Dr. Medlin attributes the wire's failure to potential defects and asserts the break likely occurred at the hypotube junction. The pathologist reported the remnant length as 39.5 centimeters (15.55 inches), but the plaintiff disputes this measurement's accuracy, noting it was for gross diagnosis only. The wire consists of a longer Elastinite wire and a shorter steel wire bonded at the hypotube junction, which raises questions about potential defects in that area. The record currently lacks alternative measurements due to the wire being discarded and the pathologist being unavailable for deposition.

The report inaccurately labels the wire as a 'pacemaker wire' and provides only an approximate measurement of its diameter. Dr. Eager, the defendant's expert, interpreted the wire remnant to be between 39 and 40 centimeters (15.35 to 15.75 inches). If the measurement is at least 15.7 inches, Dr. Medlin's opinion regarding its separation at the hypotube junction is deemed reliable. The Court finds the plaintiff's res ipsa loquitur theory sufficient to survive summary judgment, indicating that wire fractures are not common in similar medical procedures, independent of Dr. Medlin’s testimony. The Court allows both parties until June 30, 2016, to submit additional evidence about the wire's measurement and will address the Daubert motion separately. The Court denies the defendant’s summary judgment motion. Following the filing of a suggestion of death for Greta Fertik, her estate, represented by William Fertik, becomes a plaintiff. William Fertik has waived his negligent design claim against Abbott Laboratories, Inc. The plaintiff's negligence claim focuses on the physicians' failure to recognize the wire's breakage rather than causing its failure. The plaintiff's motions to strike affidavits from Ms. Benson and Dr. Stevenson are denied, although the plaintiff challenges their qualifications as experts on device labeling and legal conclusions.