SUPERIOR COURT OF WASHINGTON FOR KING COUNTY. Defendant OLYMPUS AMERICA INC. ( OAI ) answers and asserts its affirmative

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1 FILED JUN 01 PM :1 The Honorable Ronald Kessler KING COUNTY SUPERIOR COURT CLERK E-FILED CASE NUMBER: --0- SEA 1 1 THERESA BIGLER, individually and as Personal Representative of the Estate of Richard Bigler, v. Plaintiff, OLYMPUS AMERICA INC. and VIRGINIA MASON MEDICAL CENTER, Defendants. SUPERIOR COURT OF WASHINGTON FOR KING COUNTY Case No SEA DEFENDANT OLYMPUS AMERICA INC. S ANSWER, AFFIRMATIVE DEFENSES, AND CROSS-CLAIM TO VIRGINIA MASON MEDICAL CENTER S CROSS-CLAIMS Defendant OLYMPUS AMERICA INC. ( OAI ) answers and asserts its affirmative defenses and cross-claims to Defendant Virginia Mason Medical Center s ( VMMC ) crossclaims as follows: PARTIES 1. OAI is without knowledge and information sufficient to form a belief as to the truth of the allegations contained in this paragraph and therefore denies the same.. OAI admits it is incorporated in New York, it has its principal place of business in Pennsylvania, and it transacts business in Washington. AFFIRMATIVE DEFENSES, AND CROSS-CLAIM TO VIRGINIA MASON MEDICAL CENTER S CROSS-CLAIMS - 1

2 1 1 JURISDICTION. OAI admits it marketed and sold certain TJF-Q0V duodenoscopes in King County, Washington.. OAI admits it marketed and sold certain TJF-Q0V duodenoscopes to VMMC. OAI is without knowledge or information sufficient to form a belief as to the truth of the remaining allegations contained in this paragraph and therefore denies the same. FACTS. OAI restates and reasserts its answers to all preceding paragraphs as if expressly set forth herein.. OAI admits it markets and sells the TJF-Q0V for use in endoscopic retrograde cholangiopancreatography procedures. OAI denies all remaining allegations contained in this paragraph.. OAI admits it marketed duodenoscopes to VMMC. OAI is without knowledge and information sufficient to form a belief as to the truth of the remaining allegations contained in this paragraph and therefore denies the same.. OAI admits it represented to VMMC that TJF-Q0V duodenoscopes were effective and safe. OAI denies all remaining allegations contained in this paragraph. OAI denies all allegations contained in this paragraph.. OAI denies all allegations contained in this paragraph.. OAI denies all allegations contained in this paragraph. 1. OAI denies all allegations contained in this paragraph. 1. OAI denies all allegations contained in this paragraph.. OAI denies all allegations contained in this paragraph.. OAI denies all allegations contained in this paragraph.. OAI is without knowledge and information sufficient to form a belief as to the truth of the allegations contained in this paragraph and therefore denies the same. MASON MEDICAL CENTER S CROSS-CLAIMS -

3 1 1. OAI is without knowledge and information sufficient to form a belief as to the truth of the allegations contained in this paragraph and therefore denies the same.. OAI is without knowledge and information sufficient to form a belief as to the truth of the allegations contained in this paragraph and therefore denies the same.. OAI is without knowledge and information sufficient to form a belief as to the truth of the allegations contained in this paragraph and therefore denies the same.. OAI denies all allegations contained in this paragraph.. OAI denies all allegations contained in this paragraph.. OAI admits it visited VMMC to examine VMMC s reprocessing procedures. OAI denies all remaining allegations contained in this paragraph.. OAI denies all allegations contained in this paragraph.. OAI is without knowledge and information sufficient to form a belief as to the truth of the allegations contained in this paragraph and therefore denies the same.. OAI denies all allegations contained in this paragraph. CLAIMS AGAINST OLYMPUS AMERICA INC.. OAI denies all allegations contained in this paragraph and denies it is liable to VMMC in any manner or for any amount whatsoever.. OAI denies all allegations contained in this paragraph and denies it is liable to VMMC in any manner or for any amount whatsoever.. OAI denies all allegations contained in this paragraph and denies it is liable to VMMC in any manner or for any amount whatsoever.. OAI denies all allegations contained in this paragraph and denies it is liable to VMMC in any manner or for any amount whatsoever. 0. OAI denies all allegations contained in this paragraph and denies it is liable to VMMC in any manner or for any amount whatsoever. MASON MEDICAL CENTER S CROSS-CLAIMS -

4 OAI denies all allegations contained in this paragraph and denies it is liable to VMMC in any manner or for any amount whatsoever. PRAYER FOR RELIEF In answering the WHEREFORE paragraph following paragraph 1, OAI denies all allegations contained in this paragraph (including all subparagraphs), and specifically denies it is liable to VMMC in any manner or for any amount whatsoever. OAI S AFFIRMATIVE DEFENSES TO VMMC S CROSS-CLAIMS 1. VMMC s cross-claims, in whole or in part, fail to state a claim upon which relief may be granted.. VMMC s cross-claims, in whole or in part, may be barred by the learned intermediary doctrine.. OAI asserts all affirmative defenses it asserted to plaintiffs claims against it in the underlying action to all cross-claims asserted against it by VMMC.. All of the alleged injuries, losses, damages and expenses, if any, may have been the result of unforeseeable circumstances and reasons beyond the control of OAI, including, but not limited to, plaintiffs clinical condition, pre-existing conditions, the state of health of plaintiffs, idiosyncratic reactions of plaintiffs, unknown bodily processes unique to plaintiffs, diseases of known or unknown etiology and/or environmental exposure, which are not due to any alleged negligence and/or any cause of action alleged by VMMC.. VMMC s alleged injuries or damages may have been caused by an unforeseeable intervening cause. If so, VMMC is not entitled to recover from OAI in this action.. VMMC s alleged damages may have been caused by the acts and/or omissions of third-parties over whom OAI has no control and/or right of control and is in no way liable. Alternatively, any amount which VMMC might be entitled to recover against OAI must be reduced by the amount of damages attributable to the intervening acts and/or omissions of such MASON MEDICAL CENTER S CROSS-CLAIMS -

5 1 1 third persons. OAI further reserves any actions for contribution or indemnity against such third parties and reserves its right to remedies.. VMMC s alleged damages may have been caused by an unforeseeable change or alteration in the product. If so, VMMC is not entitled to recover from OAI in this action.. If VMMC sustained any of the injuries and damages alleged in its cross-claims, then these alleged injuries and damages may have been caused directly and proximately by VMMC s failure to exercise due care to avoid or mitigate injury. Accordingly, OAI hereby asserts that VMMC is barred from recovery to the extent that VMMC was comparatively negligent.. VMMC s fault for failure to mitigate damages are a bar or reduction to VMMC s recovery.. If plaintiffs sustained any of the injuries or damages alleged in its cross-claims, and it is proved that any such injuries and damages were attributable to a product, then these alleged injuries and damages may have been caused by an inherent characteristic of the product that would be recognized by an ordinary person with ordinary knowledge common to the community that uses or consumes the product and/or a learned intermediary for whose use the product was intended.. VMMC s claims are barred, in whole or in part, by the applicable statutes of limitation and/or repose. 1. VMMC s claims are barred by lack of personal jurisdiction and/or the failure to properly assert personal jurisdiction. 1. VMMC was fully aware of and informed about the risks and possible adverse effects pertaining to the procedures to be performed, and all alleged injuries, damages, expenses or losses, if any, arose from and/or were caused by risks of which plaintiffs and/or decedent may have been aware. As such, VMMC accepted, confronted and assumed all such MASON MEDICAL CENTER S CROSS-CLAIMS -

6 1 1 risks. Accordingly, VMMC s claims may be barred in whole or in part by principles of assumption of the risks, informed consent, estoppel, and waiver.. VMMC s claims are barred under the sophisticated user doctrine.. VMMC s claims are barred under the in pari delicto doctrine.. The product at issue reflected the state of the art of scientific and technological knowledge available to the manufacturer or supplier at the time the product was placed on the market.. The product at issue reflected the customary designs, methods, standards, and techniques of manufacturing, inspecting, and testing by other manufacturers or sellers of similar products.. The product at issue was in compliance with all federal or state statute or administrative regulation existing at the time the product was manufactured and was in conformance with prescribing standards of design, inspection, testing, manufacture, labeling, warning, or instructions for use.. OAI cannot be liable for any alleged defect connected to the product at issue, and cannot be liable under strict liability, because OAI did not design or manufacture the product.. OAI cannot be liable for any alleged inadequacy in connection with the warnings or instructions for use related to the product at issue, including any failure to warn, because OAI did not design or manufacture the product or develop any warnings or instructions for use relating to the product.. OAI denies that it violated any statute, ordinance, rule, regulation, or statutory standard of care under Washington law. Additionally, OAI conducted itself as a reasonably prudent supplier would have done, acting under similar circumstances, in desiring to obey the law. MASON MEDICAL CENTER S CROSS-CLAIMS -

7 1 1. At the time the product left the control of the manufacturer, there was not a practical and technically feasible alternative design that would have prevented the harm without substantially impairing the reasonably anticipated or intended function of the product.. VMMC s claims may be barred because of spoliation of the evidence and/or destruction of or tampering with evidence.. OAI asserts and relies upon all affirmative defenses found in the Washington and federal statutes or common law relevant to product liability and negligence actions, including Sections..0 et seq. and..00 et seq., RCW.. OAI asserts and relies upon all affirmative defenses found in the Washington and federal statutes or common law relevant to consumer protection actions, including Section. et seq., RCW.. OAI asserts and relies upon all affirmative defenses found in the Washington and federal statutes or common law relevant to actions under Washington s Uniform Commercial Code, including Section A. et seq., RCW.. OAI asserts and relies upon all affirmative defenses found in the Washington or federal statutes or common law relevant to fraud and misrepresentation claims and further states that VMMC failed plead its fraud claims with the specificity and particularity required under Washington law.. Should this Court find that VMMC sustained damages for which OAI is responsible, which is expressly denied, OAI is entitled to a set-off for any collateral source payments paid or payable to VMMC, and for any settlements reach with persons or parties other than OAI for the damages alleged in VMMC s cross-claims.. The product was approved by the United States Food and Drug Administration as reasonably safe and effective for use, and all claims asserted in the cross-claims are thus preempted. MASON MEDICAL CENTER S CROSS-CLAIMS -

8 The imposition of punitive or exemplary damages against OAI would violate OAI s constitutional rights in the Due Process Clauses of the Fifth and Fourteenth Amendments to the United States Constitution, the Excessive Fines Clause of the Eighth Amendment to the United States Constitution, the Double Jeopardy Clause of the Fifth Amendment to the United States Constitution and comparable provisions in the Washington Constitution, applicable statutes, common law, and court rules. 1. Any claim for punitive damages is barred and/or limited on the grounds that the facts and circumstances allegedly giving rise to VMMC s cross-claims do not warrant the imposition of an award for aggravated, exemplary or punitive damages.. All allegations in VMMC s cross-claims that have not been admitted or denied are hereby denied generally as if specifically denied.. OAI reserves the right to amend this answer and assert at trial any and all properly provable defenses it may have to this action. DEFENDANT OLYMPUS AMERICA INC. S CROSS-CLAIMS AGAINST DEFENDANT VIRGINIA MASON MEDICAL CENTER Defendant Olympus America Inc. ( OAI ) asserts its cross-claims against Defendant Virginia Mason Medical Center ( VMMC ) as follows: PARTIES 1. VMMC is a Washington corporation with its principal place of business in King County, Washington. Pennsylvania.. OAI is a New York corporation with its principal place of business in JURISDICTION. VMMC is subject to the jurisdiction of this court because it is a citizen of King County, Washington. MASON MEDICAL CENTER S CROSS-CLAIMS -

9 1 1 FACTS. VMMC purchased duodenoscopes from OAI, including the TJF-Q0V. OAI made available to VMMC instructions for use of the TJF-Q0V. OAI made available to VMMC instructions for reprocessing of the TJF-Q0V. OAI made available to VMMC warnings for use of the TJF-Q0V. OAI made available to VMMC training for use of the TJF-Q0V. OAI made available to VMMC training for reprocessing of the TJF-Q0V. OAI made available to VMMC training for warnings for use of the TJF-Q0V. VMMC failed to properly use the TJF-Q0V 1. VMMC failed to properly reprocess the TJF-Q0V 1. VMMC produced a publication by writing allegations OAI or its products caused physical injuries to Richard Bigler and/or was liable to Teresa Bigler.. VMMC produced a publication by printing allegations that OAI or its products caused physical injuries to Richard Bigler and/or was liable to Teresa Bigler.. VMMC willfully stated, delivered, or transmitted to an employee of a publisher of a newspaper, magazine, or publication a statement alleging OAI or its products caused physical injuries to Richard Bigler and/or was liable to Teresa Bigler.. The statements above are false, as OAI and its products were not responsible for physical injuries to Richard Bigler. MASON MEDICAL CENTER S CROSS-CLAIMS -

10 1 1. The statements above are false, as OAI is not liable to Teresa Bigler in any manner or for any amount whatsoever.. OAI is not liable to VMMC in any manner or for any amount whatsoever. COUNT I: NEGLIGENCE. OAI re-alleges and affirmatively asserts all paragraphs admitted in response to VMMC s Complaint and all paragraphs asserted in OAI s cross-claim.. VMMC negligently failed to follow the instructions, training, and warnings for the use and reprocessing of the TJF-Q0V. VMMC owed a duty to its patients, including Richard Bigler, to provide the accepted level of care in its treatment.. VMMC breached that duty by failing to provide the accepted level of care to Richard Bigler.. VMMC s failure to provide the accepted level of care to Richard Bigler caused the injuries alleged by plaintiffs in their Complaint.. VMMC negligently failed to follow the instructions, training, and warnings for the use and reprocessing of the TJF-Q0V. Due to VMMC s negligence, OAI has suffered damages. COUNT II: CONTRIBUTORY FAULT UNDER RCW. et seq.. OAI re-alleges and affirmatively asserts all paragraphs admitted in response to VMMC s Complaint and all paragraphs asserted in OAI s cross-claim.. VMMC is entirely at fault for plaintiffs injuries.. VMMC is entirely at fault for Richard Bigler s death.. VMMC contributed to plaintiffs injuries. 0. Due to VMMC s contributory fault, the amount awarded as compensatory damages to VMMC is diminished pursuant to RCW. et seq. MASON MEDICAL CENTER S CROSS-CLAIMS -

11 1 1 COUNT III: LIBEL AND SLANDER 1. OAI re-alleges and affirmatively asserts all paragraphs admitted in response to VMMC s Complaint and all paragraphs asserted in OAI s cross-claim.. VMMC produced a malicious publication by writing that injured OAI s business.. VMMC produced a malicious publication by printing that injured OAI s business.. VMMC produced a malicious publication by writing that exposed OAI to hatred, contempt, ridicule or obloquy.. VMMC produced a malicious publication by printing that exposed OAI to hatred, contempt, ridicule or obloquy.. VMMC produced a malicious publication by writing that deprived OAI of the benefit of public confidence.. VMMC produced a malicious publication by printing that deprived OAI of the benefit of public confidence.. VMMC furnished libelous information by willfully stating, delivering, or transmitting to an employee of a publisher of a newspaper, magazine, or publication a statement concerning OAI s liability to plaintiffs.. VMMC s malicious publications were not justified. 0. VMMC s malicious publications were not excused. 1. VMMC s malicious publications were not privileged.. Due to VMMC s malicious publications, OAI has suffered damages. WHEREFORE, OAI requests judgment against VMMC: 1. For damages suffered by OAI due to VMMC s negligence;. For damages suffered by OAI due to VMMC s contributory fault; MASON MEDICAL CENTER S CROSS-CLAIMS -

12 1 1. For damages suffered by OAI due to VMMC s acts of libel or slander;. For all costs and attorney s fees incurred in defense and prosecution of this action, including those incurred in defense of Plaintiffs Complaint; and. For all other damages permitted under the laws of Washington. Dated this 1st day of June,. DLA PIPER LLP (US) /s/ Katherine A. Heaton Katherine A. Heaton, WSBA No. 0 katherine.heaton@dlapiper.com Christopher M. Young, Admitted Pro Hac Vice Ryan T. Hansen, Admitted Pro Hac Vice 01 B Street, Suite 00 San Diego, California 01- Tel: christopher.young@dlapiper.com ryan.hansen@dlapiper.com CARROLL & WEISS LLP Jameson B. Carroll, Motion to Admit Pro Hac Vice Forthcoming Michael Weiss, Motion to Admit Pro Hac Vice Forthcoming Peachtree Road, Suite Atlanta, Georgia 00 Tel: jcarroll@carrollweiss.com mweiss@carrollweiss.com Attorneys for Defendant Olympus America Inc. MASON MEDICAL CENTER S CROSS-CLAIMS - 1

13 CERTIFICATE OF SERVICE I hereby certify that on June 1,, I caused the foregoing DEFENDANT OLYMPUS AMERICA INC. S ANSWER, AFFIRMATIVE DEFENSES, AND CROSS- CLAIM TO VIRGINIA MASON MEDICAL CENTER S CROSS-CLAIMS to be served on the following by the method/s indicated: 1 1 Joel D. Cunningham, WSBA No. Andrew Hoyal, WSBA No. LUVERA LAW FIRM 01 Fifth Avenue, Suite 00 Seattle, Washington joel@luveralawfirm.com andy@luveralawfirm.com deedee@luveralawfirm.com Attorneys for Plaintiff Rando Berry Wick, WSBA No. 1 Miranda K. Aye, WSBA No. 0 JOHNSON, GRAFFE, KEAY, MONIZ & WICK, LLP Fourth Avenue, Suite 00 Seattle, Washington WickR@jgkmw.com AyeM@jgkmw.com Attorneys for Defendant Virginia Mason Medical Center [ ] Via Hand Delivery [ ] Via U.S. Mail [ X ] Via per agreement of counsel [ X ] Via Hand Delivery [ ] Via U.S. Mail [ X ] Via WEST\.1 Dated this 1st day of June,. /s/ Katherine A. Heaton Katherine A. Heaton MASON MEDICAL CENTER S CROSS-CLAIMS - 1