Thanks for visiting! Welcome to a new way to research case law. You are viewing a free summary from Descrybe.ai. For citation and good law / bad law checking, legal issue analysis, and other advanced tools, explore our Legal Research Toolkit — not free, but close.
Dorothy L. Payne, App. v. Medtronic Inc. Medtronic Xomed, Inc., Res.
Citation: Not availableDocket: 71411-2
Court: Court of Appeals of Washington; September 28, 2015; Washington; State Appellate Court
Original Court Document: View Document
Becky S. Anderson suffered serious injuries during elective throat surgery, leading her to file a negligence lawsuit against otolaryngologist Dr. Donald Paugh, anesthesiologist Dr. Linda Schatz, Wenatchee Valley Medical Center, Wenatchee Anesthesia Associates, Central Washington Hospital, and medical device manufacturers Medtronic, Inc. and Medtronic Xomed, Inc. After a seven-week trial, the jury ruled that Dr. Paugh, Wenatchee Valley Medical Center, Dr. Schatz, and Wenatchee Anesthesia Associates were negligent, attributing 42.5% of the negligence to Dr. Paugh and the medical center, 52.5% to Dr. Schatz and her associates, and 5% to Central Washington Hospital. Conversely, the jury found Medtronic not negligent and awarded Anderson $18 million in damages. Anderson appealed the jury's decision regarding Medtronic, arguing that the court erred by not providing a supplemental jury instruction related to strict liability for design defects under Restatement (Second) of Torts section 402A comment k. The court affirmed the jury verdict. The surgery occurred on February 3, 2012, after Dr. Paugh diagnosed Anderson with a benign vocal cord polyp. Miscommunication led the operating room staff to inform Dr. Paugh and Dr. Schatz that only the single-cuff 'Laser-Shield II' endotracheal tube from Medtronic was available. While this tube is designed for laser surgeries, its instructions warned that the inflatable cuff is not laser-resistant and could lead to combustion if struck by a laser. The instructions also advised the use of wet cotton gauze around the cuff to prevent damage and indicated that a blue methylene dye would signal a punctured cuff by staining the gauze. Additionally, the instructions cautioned against the risk of fire from elevated oxygen levels or flammable gases, recommending specific gas mixtures for safety. Dr. Paugh and Dr. Schatz, both inexperienced with the Laser-Shield II, opted to use it during surgery without reviewing its Instructions for Use. Dr. Schatz incorrectly administered 100 percent oxygen instead of the recommended 30 percent. During the procedure, Dr. Paugh inadvertently perforated the cuff of the endotracheal tube with the laser, leading to an airway fire that severely burned Anderson's trachea and lungs. Anderson subsequently filed a lawsuit against Central Washington Hospital, Dr. Paugh, Wenatchee Valley Medical Center, Dr. Schatz, and Wenatchee Anesthesia Associates for medical negligence, along with product liability claims against Medtronic Inc. and Medtronic Xomed Inc. Anderson alleged that Dr. Paugh and Dr. Schatz violated the standard of care, resulting in her injuries, and claimed Medtronic was liable under the Washington Products Liability Act for defects in production or construction. A motion for partial summary judgment filed by Anderson highlighted Dr. Schatz's negligence in administering 100 percent oxygen, which the court granted, determining Dr. Schatz and Wenatchee Anesthesia Associates were negligent as a matter of law. Medtronic later moved for summary judgment to dismiss claims regarding design defect, failure to warn, and production defect, arguing the Laser-Shield II was a prescription device governed by a specific negligence standard, with no evidence of defective design. They contended that the warnings were adequate and that Anderson could not demonstrate causation linking the device’s warnings to her injuries. Medtronic presented depositions from Dr. Paugh and Dr. Schatz acknowledging they had not read the Instructions for Use. In response, Anderson did not contest the application of the negligence standard but argued that there were factual disputes regarding Medtronic's breach of duty to design a reasonably safe product and issues related to inadequate warnings. At the summary judgment hearing, Anderson’s attorney confirmed the application of the negligence standard and withdrew claims regarding breach of warranty and manufacturing defects. The court partially granted and partially denied Medtronic's motion for summary judgment. It dismissed the failure to warn claim with prejudice, while allowing the negligent design claim to proceed. The Medtronic defendants’ motion was thus granted regarding failure to warn but denied concerning negligent design. The plaintiff withdrew claims for breach of warranty and unsafe construction or manufacturing defect. Prior to trial, Central Washington Hospital settled for $12 million, and the court allowed the hospital to be identified as a nonparty defendant for fault allocation purposes. During the seven-week jury trial, the court provided the jury with several legal instructions, including a Pre-Instruction on negligent design based on the manufacturer's duty under comment k of the Restatement (Second) of Torts section 402A. The instruction emphasized the manufacturer's obligation to exercise reasonable care in designing safe medical products, which includes proper testing and staying informed about scientific advancements. In her opening statement, the plaintiff, Anderson, alleged that Dr. Paugh breached the standard of care by inadequately protecting the Laser-Shield II cuff and failing to ensure safe oxygen levels, while Dr. Schatz was accused of administering 100 percent oxygen during the procedure. Additionally, both doctors were criticized for not familiarizing themselves with the Laser-Shield II, neglecting to read the Instructions for Use, and lacking a fire response plan. Anderson also claimed Medtronic was negligent for opting for a single-cuff design instead of a double-cuff design for the Laser-Shield II. Anderson contended that Medtronic was aware of safety issues with the Laser-Shield II, particularly incidents of airway fires, and failed to enhance the device's safety. The negligence of all defendants was claimed to be a proximate cause of Anderson's injury. Over 30 witnesses, including several experts, testified during a seven-week jury trial. Anderson's experts asserted that the fire resulted from Dr. Paugh perforating the cuff with a laser, allowing 100 percent oxygen, administered by Dr. Schatz, to ignite in the surgical field. They argued that using a lower oxygen concentration or properly protecting the cuff could have prevented the fire. Dr. James Reibel testified that Dr. Paugh breached the standard of care by not informing Anderson of fire risks before surgery, proceeding without familiarity with the Laser-Shield II, failing to communicate oxygen levels with Dr. Schatz, and not adequately protecting the cuff. Dr. Barry Swerdlow and Dr. Vladimir Nekhedzy criticized Dr. Schatz for administering 100 percent oxygen without notifying Dr. Paugh of the high levels. Medical device expert Dr. George Samaras claimed Medtronic was negligent for not employing a double-cuff design for the Laser-Shield II, stating that a double-cuff design provides an additional safety mechanism, preventing oxygen leaks in case of cuff puncture. Dr. Samaras reported eight airway fires linked to the Laser-Shield II since 2000, compared to only one with a double-cuff tube by Mallinckrodt. Dr. Jonathan Benumof testified that the fire could have been avoided with a double-cuff tube, but acknowledged the Laser-Shield II could be used safely, noting its prior successful applications in his hospital. Dr. Paugh defended his choice of the Laser-Shield II, claiming it was a reasonable substitute and that he believed he had adequately protected the cuff during surgery, despite not reading the device's instructions. He denied perforating the cuff and suggested that a double-cuff tube might have made the fire unlikely. Dr. Barry Wenig, testifying for Dr. Paugh, opined that he met the standard of care, attributing the fire to the presence of oxygen in the area between the cuff and the vocal cords. Dr. Wenig testified that he has exclusively used the Laser-Shield II since 2003 without safety concerns. Dr. Schatz acknowledged she did not consult the device's Instructions for Use, mistakenly operated with 100 percent oxygen instead of the recommended 30 percent, but believed she achieved an adequate cuff seal to prevent oxygen leakage. The first indication of a problem during surgery was a popping sound, followed by a request for saline; however, she could not determine the fire's cause. Medtronic presented witnesses, including James Hissong, who managed the Laser-Shield II's design, and experts Dr. Samsun Lampotang and Dr. Paul Flint. Hissong noted that a double-cuff design, initially considered in 1989, could create a false sense of security regarding punctures and damage detection. In 1999, Medtronic modified the Laser-Shield II to enhance its laser resistance. Hissong stated that investigations into airway fire reports indicated that in seven of eight cases, the medical personnel were at fault. Dr. Lampotang opined that Medtronic exercised reasonable care in the device's design and testing, and he disagreed with the notion that a double-cuff design was a necessary safety feature, highlighting that the Laser-Shield II's single cuff provided a better seal and was easier for leak detection compared to double-cuff tubes. Dr. Flint, an experienced otolaryngologist, supported the Laser-Shield II's superior laser resistance compared to the Mallinckrodt double-cuff endotracheal tube. Dr. Flint testified regarding a 1994 study by Dr. Mitchell Sosis, highlighting that it was the sole study comparing the Mallinckrodt double-cuff and the single-cuff Laser-Shield II endotracheal tubes. The study indicated that the Mallinckrodt tube combusted under extreme conditions while the Laser-Shield II did not. Flint noted that Medtronic's investigation of eight adverse events involving the Laser-Shield II concluded that user error by the surgeon or anesthesiologist was a factor in seven of these incidents. Timothy Ulatowski, a vice president at a consulting firm for medical device manufacturers, testified that the Laser-Shield II's design adhered to FDA regulations and was deemed reasonably safe and effective by both himself and the FDA. The evidentiary portion of the trial concluded on November 27, just before Thanksgiving, with closing arguments scheduled for December 3. Anderson submitted 'Amended Proposed Instructions' to the court, which included a jury instruction on the manufacturer’s duty of care for unavoidably unsafe medical devices. The court compared the proposed instructions with its pre-instructions to ensure consistency and found the duty of care instruction aligned with the agreed Pre-Instruction. On December 2, Anderson filed 'Supplemental Amended Proposed Instructions,' which included additional jury instructions regarding adherence to governmental standards and the absence of a patent claim against incorporating a double-cuff design. Anderson later filed 'Objections and Exceptions to Jury Instructions,' arguing that while the negligence instruction defined the manufacturer's duty to ensure reasonable safety, it did not clarify what 'reasonably safe' entails. The court declined to give Anderson's proposed supplemental instruction based on WPI 110.02 and opted to use the Amended Proposed Instructions from November 27 for the jury's instruction on negligent design defect claims against Medtronic. In closing arguments, Anderson contended that the hospital was negligent in providing the incorrect tube, and that Dr. Paugh breached the standard of care by deflating the cuff with a laser, which contributed to an airway fire. Additionally, Anderson claimed that Dr. Paugh failed to secure informed consent for the use of the Laser-Shield II, while asserting that Dr. Schatz also breached the standard of care by administering 100% oxygen, resulting in the airway fire. Anderson contended that Medtronic failed to design the Laser-Shield II as the safest device for foreseeable circumstances and did not adequately test or analyze it for safety improvements. He argued that Medtronic was aware of issues with the device but neglected to implement a safer double-cuff design. Key questions posed included what efforts Medtronic made to enhance product safety since the device's launch in September 2000, particularly in light of ten reported adverse events, four of which were life-threatening prior to Anderson's incident. Anderson emphasized that Medtronic had not conducted any testing or planned future studies, instead shifting blame to medical professionals and users. The standard of reasonable care was referenced, indicating that Medtronic had a duty to design safe medical devices and act prudently. The burden of proof was placed on Medtronic to demonstrate compliance with safety standards, which Anderson argued they did not meet due to inadequate testing and the absence of a known safety feature. Expert testimonies were presented, with Dr. Paugh attributing the fire to oxygen leakage around the cuff and disputing the necessity to warn of the risk of airway fire, while Dr. Schatz argued against the idea that high oxygen levels were a direct cause of the fire, suggesting alternative ignition sources. Medtronic defended its position by asserting that the expert witnesses called by Anderson were unqualified and that their own witnesses demonstrated the device's safety and compliance with standard care. They highlighted that existing regulations only required the use of cuffed endotracheal tubes, without specifying the number of cuffs, and claimed that the Laser-Shield II fulfilled this requirement. Medtronic also referenced peer-reviewed studies, including those by Dr. Sosis and Dr. Flint, suggesting that single-cuff lasers could be considered safer. Immediate combustion occurred in all four Mallinckrodt LaserFlex tubes, leading to the conclusion that the Xomed Laser Shield II endotracheal tubes possess a reasonably safe design, supported by standards, regulations, and witness testimony. Medtronic demonstrated adherence to the standard of care in testing, analyzing, and inspecting products, as well as staying updated on scientific advancements. Testimonies from Mr. Hissong, Mr. Ulatowski, Dr. Lampotang, and Dr. Flint confirmed extensive testing procedures, including FDA evaluations that did not necessitate additional tests. Each cuff undergoes final testing, with worst-case scenario assessments included. The manufacturer’s commitment to remaining informed on scientific developments was illustrated through regular attendance at conferences, thorough data reviews, and monitoring of adverse events via a customer service line. The jury found Dr. Schatz and Wenatchee Anesthesia Associates, Dr. Paugh and Wenatchee Valley Medical Center, and nonparty Central Washington Hospital negligent, awarding Anderson $18 million in damages. However, the jury determined Dr. Paugh had not failed to obtain informed consent, and Medtronic was not found negligent. Fault was attributed as follows: 52.5% to Dr. Schatz and Wenatchee Anesthesia Associates, 42.5% to Dr. Paugh and Wenatchee Valley Medical Center, and 5% to the hospital. The court subsequently reduced the judgment by $900,000 for the hospital's fault, resulting in a $17.1 million judgment against the two physician entities. Dr. Paugh, Wenatchee Valley Medical Center, Dr. Schatz, and Wenatchee Anesthesia Associates appealed the judgment, while Anderson appealed the summary judgment favoring Medtronic on the failure to warn issue, the jury’s verdict in favor of Medtronic, and the awarded costs. In July 2014, Dr. Schatz and Wenatchee Anesthesia Associates, along with Dr. Paugh and Wenatchee Valley Medical Center, filed a motion to withdraw their appeals, which was granted. Subsequently, in September 2014, Anderson withdrew her assignment of error regarding the summary judgment dismissal of her failure to warn claim against Medtronic. On September 17, the court granted a motion to substitute Dorothy L. Payne as the personal representative of the deceased Becky S. Anderson and amended the case caption. Anderson claimed the court erred by refusing to give a proposed jury instruction concerning the standard for 'reasonably safe' in a strict liability design defect claim against Medtronic. The standard of review for jury instructions is abuse of discretion, and the trial court has latitude in determining their language, provided they inform the jury adequately and are not misleading. Here, the court's instructions were deemed appropriate and allowed Anderson to argue her theory that Medtronic failed to design reasonably safe medical devices. Alleged legal errors in jury instructions are reviewed de novo. An erroneous instruction is considered reversible only if prejudicial. If it misstates the law, prejudice is presumed unless shown harmless. The burden of showing prejudice rests with the challenging party. The Restatement (Second) of Torts section 402A governs design defect claims, stating that a seller is liable for products in a defective condition that are unreasonably dangerous to users. Washington courts have adopted this standard, indicating that if a product is deemed unreasonably dangerous, it is inherently defective, and plaintiffs are not required to prove defectiveness separately. The consumer expectations standard defines 'unreasonably dangerous' as 'reasonably safe,' as established in prior case law. Strict liability for defective products centers on the product itself rather than the seller's actions, with liability arising when a product is deemed "unsafe to an extent beyond that which would be reasonably contemplated by the ordinary consumer." Factors influencing this assessment include the product's cost, potential harm from defects, and the feasibility of risk mitigation. The Restatement (Second) of Torts Section 402A Comment K introduces an exception for "unavoidably unsafe products," such as prescription drugs and medical devices, which may pose significant risks yet are deemed necessary for use. Examples include vaccines, like the rabies treatment, which, despite potential serious side effects, are justified due to the dire consequences of the diseases they prevent. Proper preparation, marketing, and warnings mitigate strict liability for sellers of these products, as the societal benefit of their availability outweighs the associated risks. Comment k establishes an exception to strict liability by emphasizing the societal value of certain products, which may be essential for users despite inherent risks. The Washington Product Liability Act (WPLA), enacted in 1981, holds manufacturers liable if a product causes harm due to negligence, specifically if it is not reasonably safe as designed or lacks adequate warnings. Under RCW 7.72.030(1), a product is deemed "not reasonably safe" if the potential for harm outweighs the burden of implementing safer designs. The determination of safety considers whether the product is unsafe beyond what an ordinary consumer would expect. The Washington Supreme Court in Falk clarified that ordinary negligence does not apply to design defect claims under the WPLA, retaining elements of the consumer-oriented approach predating the 1981 tort reform. Section (2) of RCW 7.72.030 asserts strict liability for products that are not reasonably safe in construction or violate warranties, without requiring a risk-utility balancing test. The Legislature's intention was to uphold consumer rights to recover for injuries from unsafe products, ensuring that the focus remains on the product's reasonable safety while still considering consumer expectations. The court determined that under the Washington Product Liability Act (WPLA), a plaintiff can demonstrate a product is "not reasonably safe as designed" using either a risk-utility test or a consumer expectations test. The risk-utility test evaluates whether the likelihood and seriousness of potential injury or damage outweigh the burden on the manufacturer to design a safer product, considering the feasibility of alternatives. The consumer expectations test assesses if the product is unsafe beyond what an ordinary consumer would expect, factoring in aspects such as the product's cost, potential harm, and the feasibility of risk mitigation. The WPI 110.02 instruction emphasizes that these tests are used to assess a manufacturer's duty to design reasonably safe products, explicitly stating that negligence is not included in this strict liability context. A product may be deemed "not reasonably safe" even if the manufacturer did not foresee the risk at the time of production. If the plaintiff proves the product's unreasonable safety contributed to their injury or damage, the manufacturer can be held liable. Additionally, the court acknowledged the applicability of the comment k exception, which protects manufacturers from liability for unavoidably unsafe products, even in negligent design claims, as established in prior case law. The court clarifies that the "comment k" exception to strict liability, although not explicitly included in the Washington Product Liability Act (WPLA), implies that "unavoidably unsafe" products cannot be designed to be "reasonably safe." This exception acknowledges the protective role of prescribing physicians and pharmacists. Consequently, for design defect claims involving such products, a negligence standard is applied instead of strict liability. The relevant jury instruction, WPI 110.02.01, emphasizes that manufacturers must exercise reasonable care in designing medical devices that are reasonably safe. The standard of reasonable care is based on what the manufacturer knew or should have known at the time of the plaintiff's injury. This includes a duty to test, analyze, and inspect products, as well as to stay informed about scientific advancements. The court utilized Anderson's proposed jury instruction, affirming that a medical device manufacturer must demonstrate reasonable care in its design processes. However, Anderson contends that the court erred by not allowing a supplemental jury instruction on risk utility and consumer expectations to determine the reasonableness of a medical device's safety. The proposed supplemental instruction removes inapplicable language from the Strict Liability Instruction regarding a manufacturer’s duty to design reasonably safe products, while retaining the risk utility and consumer expectations tests for strict liability design defect claims. Under the Washington Product Liability Act (WPLA) and relevant case law, a plaintiff can demonstrate that a product is not reasonably safe through these two tests. Anderson argues that the Comment K Negligence Instruction lacks a definition for "reasonably safe," necessitating jury instruction on these tests. However, it is clarified that these tests apply to strict liability claims and not to negligence claims under Comment K. The Comment K Negligence Instruction outlines factors for determining reasonable care by a medical device manufacturer, emphasizing the importance of testing and understanding scientific advancements. The court correctly refused Anderson's supplemental jury instruction, asserting that the existing jury instructions accurately reflect the manufacturer's duty regarding unavoidably unsafe products as per Comment K of the Restatement (Second) of Torts section 402A. Additionally, Anderson contests the court's award of costs to Medtronic for eight depositions, claiming they were not necessary for the trial's success and that Medtronic failed to demonstrate pro rata costs under RCW 4.84.010(7). The review of cost awards is subject to an abuse of discretion standard. A prevailing party is entitled to recover the costs of depositions used as substantive evidence or for impeachment at trial. Under RCW 4.84.010, the prevailing party is allowed certain sums for expenses incurred in the action, including reasonable transcription costs for depositions used during trial or mandatory arbitration, with allowances made on a pro rata basis for portions introduced into evidence. A party successful on a summary judgment motion can also recover costs for depositions specifically reviewed by the trial court. In this case, costs for eight depositions were justified; two were presented in full at trial, while others were utilized during cross-examination and impeachment. The court acknowledged its consideration of several depositions in its ruling on summary judgment, affirming that the award of costs for these depositions was within its discretion. The jury verdict was upheld.