Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 1 of 23
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`
`Steve H. Patience
`State Bar No. 009537
`SKOUSEN, GULBRANDSEN
`& PATIENCE, PLC
`414 East Southern Avenue
`Mesa, AZ 85204
`Telephone: 480-833-8800
`Email: shp@sgplaw.com
`Attorneys for Plaintiffs
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`
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF ARIZONA
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`
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`/ Case Number:
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`MICHAEL JANISKY and
`/
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`SUSAN JANISKY,
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`/
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`/
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` Plaintiffs,
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` COMPLAINT AND
`/
`v.
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`/ DEMAND FOR JURY TRIAL
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`/
`ZIMMER US, INC.,
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`/
`d/b/a Zimmer Biomet,
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`ZIMMER, INC., and
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`ZIMMER BIOMET HOLDINGS, INC., /
`f/k/a ZIMMER HOLDINGS, INC.
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`/
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`/
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` Defendants.
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`____________________________________/
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`COMPLAINT AND JURY DEMAND
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`COME NOW THE PLAINTIFFS, Michael Janisky and Susan Janisky (hereinafter
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`“Plaintiffs”), by and through their counsel, Steve H. Patience, Skousen, Gulbrandsen & Patience,
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`PLC, and file their Complaint for damages and Jury Demand against Defendants, Zimmer US,
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`Inc., d/b/a Zimmer Biomet, Zimmer, Inc., and Zimmer Biomet Holdings, Inc., formerally known
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`as Zimmer Holdings, Inc., and allege and state the following:
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 2 of 23
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`
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`The Parties
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`1.
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`Plaintiff Michael Janisky at all times relevant hereto was and is a citizen of the State
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`of Arizona, residing in Camp Verde, Yavapai County, Arizona.
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`2.
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`Plaintiff Susan Janisky at all times relevant hereto was and is a citizen of the State
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`of Arizona, residing in Camp Verde, Yavapai County, Arizona.
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`3.
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`At all times relevant hereto Plaintiff Michael Janisky and Plaintiff Susan Janisky
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`were and are married to each other.
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`4.
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`Zimmer US, Inc., is a Delaware Corporation, with its principle place of business
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`located in Warsaw, Indiana. As such Zimmer US, Inc., is a citizen of the State of Delaware and/or
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`the State of Indiana.
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`5.
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`Zimmer US, Inc., is registered with the Arizona Secretary of State as doing business
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`as Zimmer Biomet in the State of Arizona.
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`6.
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`Zimmer, Inc., is a Delaware Corporation, with its principle place of business
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`located in Warsaw, Indiana. As such Zimmer, Inc., is a citizen of the State of Delaware and/or
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`the State of Indiana.
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`7.
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`Zimmer Biomet Holdings, Inc., formerly known as Zimmer Holdings, Inc., is a
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`Delaware Corporation, with its principle place of business in the United States located in Warsaw,
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`Indiana. As such Zimmer Biomet Holdings, Inc., is a citizen of the State of Delaware and/or the
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`State of Indiana.
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`8.
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`At all relevant times, Zimmer US, Inc. was a wholly owned subsidiary of Defendant
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`Zimmer Biomet Holdings, Inc.
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`9.
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`At all relevant times, Zimmer, Inc., was a wholly owned subsidiary of Defendant
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`Zimmer Biomet Holdings, Inc.
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 3 of 23
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`10. Zimmer GmbH is not a named party to this civil action but is a predecessor,
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`affiliate, alter ego, or alternative name, of one or more or all of the Zimmer Defendants named as
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`parties to this action.
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`11. Defendant, Zimmer, Inc., designed, manufactured, labeled, marketed, supplied,
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`distributed and/or sold the subject Durom Cup and the related implant system to physicians,
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`hospitals, and clinics to be surgically implanted in patients in the State of Arizona.
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`12. Defendant, Zimmer Biomet Holdings, Inc., designed, manufactured, labeled,
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`marketed, supplied, distributed and/or sold the subject Durom Cup and the related implant system
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`to physicians, hospitals, and clinics to be surgically implanted in patients in the State of Arizona.
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`13. Defendant, Zimmer US, Inc., designed, manufactured, labeled, marketed, supplied,
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`distributed, and/or sold the subject Durom Cup and the related implant system to physicians,
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`hospitals, and clinics to be surgically implanted in patients in the State of Arizona.
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`Jurisdiction & Venue
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`14.
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`This Court has subject matter jurisdiction over this civil action pursuant to 28
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`U.S.C. §1332(a), as the parties are citizens of different states, and the amount in controversy
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`exceeds the sum or value of $75,000, exclusive of interest and costs.
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`15.
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`At all relevant times, Zimmer US, Inc., did business in the State of Arizona, or had
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`substantial contacts with the State of Arizona.
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`16.
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`At all relevant times, Zimmer, Inc., did business in the State of Arizona, or had
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`substantial contacts with the State of Arizona.
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`17.
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`At all relevant times, Zimmer Biomet Holdings, Inc., did business in the State of
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`Arizona, or had substantial contacts with the State of Arizona.
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 4 of 23
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`18.
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`Said Defendants actions stated herein and the relevant and material events,
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`incidents, and actions, involving the parties to this action, including the incident which resulted
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`in the damages sustained by Plaintiffs, took place within the State of Arizona.
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`19.
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`The Court has personal jurisdiction over the Defendants as Plaintiffs’ claims arise
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`out of Defendants’ commission of tortious acts or the transaction of business and within the State
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`of Arizona.
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`20.
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`Venue is proper in this Court pursuant to 28 U.S.C. §1391(a) and (c).
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`General Allegations
`The Zimmer Durom® Cup
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`21.
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`On or about December 19, 2005, Zimmer GmbH sent to the United States Food and
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`Drug Administration [FDA] what is known as a Section 510(k) premarket notification of intent
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`to market a device that Zimmer GmbH identified by the Trade/Device Name as the Durom®
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`Acetabular Component and Metasul® LDHTM Large Diameter Heads.
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`22.
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`On March 16, 2006 the FDA issues its clearance for Zimmer GmbH to distribute in
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`the United States the Durom® Acetabular Component and Metasul® LDHTM Large Diameter
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`Heads.
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`23.
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`The FDA clearance for Zimmer GmbH to distribute in the United States the
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`Durom® Acetabular Component and Metasul® LDHTM Large Diameter Heads was given the
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`designation of 510(k) Number K053536.
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`24.
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`The Durom® Acetabular component that was cleared for distribution in the United
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`States as 510(k) Number K053536 came to be generally known as the Zimmer “Durom® Cup”.
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`25.
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`The Durom® Acetabular component is a metal monoblock CoCrMo alloy [cobalt
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`chromium molybdenum] cup with a coating of titanium plasma spray. It was available in sizes
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`from 44 to 66 mm, and was intended for press-fit fixation in the acetabulum.
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 5 of 23
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`26.
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`The Metasul® LDHTM femoral heads are made of CoCrMo alloy and were available
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`in diameters ranging from 38 to 60mm. They were modular in design and were for use with four
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`head/neck length adaptors (-4 to +8mm), also manufactured from CoCrMo alloy. The femoral
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`heads and neck adapters were compatible with 12/14 taper femoral stems.
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`27.
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`The Metasul® LDHTM large diameter head system consists of large diameter
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`femoral heads, Durom® acetabular components and neck adapters for neck length variation.
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`[Hereinafter this combination of devices will at times be referred to as the “Durom® Cup hip
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`system.”]
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`28.
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`The Metasul® LDHTM large diameter head system, consisting of large diameter
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`femoral heads made of a CoCrMo alloy, combined with Durom® acetabular component also made
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`of a CoCrMo alloy, is what is generally known in the field of orthopaedic surgery as a Metal-on-
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`Metal bearing surface artificial hip.
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`29.
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`The Zimmer Durom® Cup was a medical device intended to be surgically implanted
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`in patients as the acetabular component of a hip replacement surgery.
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`30.
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`The Zimmer Durom® Cup hip system was a combination of various medical
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`devices intended to be surgically implanted in patients as total hip arthroplasty, the complete
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`replacement of the hip joint.
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`31.
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`One or more, or all, of the Zimmer Defendants, or their predecessors in interest,
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`designed, manufactured, marketed, distributed and sold in the United States, including in the state
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`of Arizona, the Metasul® LDHTM large diameter head system including the Durom® acetabular
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`component, a/k/a the Durom® Cup, and neck adaptors.
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`32.
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`The Durom® Cup has proven to be a device that is defective in its design and in its
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`manufacture.
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 6 of 23
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`33.
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`The Durom® Cup hip system has proven to be a device that is defective in its design
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`and in its manufacture.
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`34.
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`On September 26, 2008, the FDA issued a Class 2 Recall of the Zimmer Durom
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`Cup.
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`35.
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`Zimmer stated the reason for the Class 2 Recall was because the instructions for
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`use and the surgical technique instructions were determined to be inadequate.
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`36.
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`The FDA’s stated cause for the Class 2 Recall was “MISBRANDING: Labeling
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`False and Misleading”.
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`37.
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`The implantation of the Zimmer Durom® Cup, and the Durom® Cup hip system, in
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`patients has resulted in premature failure, metal poisoning and the need for surgery for the removal
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`and replacement (revision) of the Durom® Cup and other related artificial hip devices used with
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`it.
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`38.
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`The Durom® Cup, and the Durom® Cup hip system, designed, manufactured,
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`labeled, distributed, sold and/or supplied by defendants were placed into the stream of commerce
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`in a defective and unreasonably dangerous condition as designed, taking into account the utility
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`of the product and the risk involved in its use.
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`39.
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`Zimmer’s Durom® Cup, and the Durom® Cup hip system, designed, manufactured,
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`labeled, marketed, distributed, sold and/or supplied by Defendants was defective and
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`unreasonably dangerous due to its marketing and inadequate warnings or instructions needed for
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`the reasonably safe use of the device, independently and when coupled with its aggressive
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`marketing campaign.
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`40.
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`Zimmer failed to recognize the deficiencies of various components of the Durom®
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`Cup hip system due to poor and inadequate quality assurance procedures, including failure of
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 7 of 23
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`Zimmer to implement appropriate physical, manual, x-ray, microscopic and other inspections of
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`the Durom® Cup.
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`41.
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`During the time Zimmer manufactured the various components of the Durom® Cup
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`hip system, inadequate design, manufacturing and labeling processes led to material flaws in the
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`quality systems at its manufacturing facilities.
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`42.
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`During the course of designing, manufacturing and labeling the various
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`components of the Durom® Cup hip system, Zimmer failed in several ways, including, without
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`limitation, by:
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`a. failing to conduct adequate mechanical testing on components, subassemblies
`and/or finished Durom® Cup and/or the related components of the Durom® Cup
`hip system;
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`b. failing to test an adequate number of sample devices on an ongoing basis;
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`c. failing to take adequate steps to specifically identify modes with clarity and
`suggest methods to monitor, avoid, and/or prevent further failure of the Durom®
`Cup and/or the related components of the Durom® Cup hip system;
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`d. failing to identify and/or not the significance of any testing that resulted in
`failures of the Durom® Cup and/or the related components of the Durom® Cup
`hip system;
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`e. failing to take corrective actions to eliminate or minimize further failures of the
`Durom® Cup and/or the related components of the Durom® Cup hip system;
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`f. failing to adequately explain performance specifications for the components,
`subassemblies, and finished Durom® Cup and/or the related finished
`components of the Durom® Cup hip system;
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`g. failing to adequately explain or justify all test conditions and acceptance criteria
`for the Durom® Cup and/or the related components of the Durom® Cup hip
`system;
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`h. failing to perform adequate testing in an environment that adequately simulated
`in vivo conditions; and, by,
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`failing to perform adequate assurance testing before and after sterilization.
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`i.
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 8 of 23
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`j. Failing to provide adequate warnings for reasonable safe use.
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`Plaintiff Michael Janisky’s Durom® Cup
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`43.
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`Prior to 2007 Plaintiff Michael Janisky suffered from bilateral hip osteoarthritis of
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`his hip joints.
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`44.
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`Following a left total hip replacement in 2007, Plaintiff Michael Janisky started
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`increasing his activity. With the increased activity, Mr. Janisky’s right hip started bothering him.
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`He had discomfort along with significant arthritic changes on x-ray. He had been advised that he
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`was a candidate for and upon medical advice should submit to right total hip arthroplasty
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`replacement surgery to relieve his hip pain, regain his quality of life, and maintain his lifestyle.
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`45.
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`In consultation with Plaintiff Michael Janisky’s orthopedic surgeon, Theodore P.
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`Firestone, M.D., Dr. Firestone proposed to Plaintiff to implant in him the Zimmer Metasul® LDH
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`54 mm head, in conjunction with the 60 mm Metasul Durom® Acetabular Component.
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`46.
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`Literature and marketing information published by Zimmer included the following
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`statements and information:
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`a. “The combination of a Metasul LDH and, the Durom acetabular component and
`one of Zimmer’s clinically proven stems provides a hip system which retains
`the key aspects of Durability and Range of Motion.”
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`b. “This product is particularly suited to patients who are at risk of requiring
`multiple hip replacements over their lifetimes since it preserves more of the
`patient’s healthy bone stock. A primary objective of this system is to allow the
`patient to return to an active lifestyle.”
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`c. “A Metasul LDH large diameter head, used in conjunction with the Durom®
`Acetabular Component is designed to be a solution for active patients.”
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`d. “The combination of a Metasul LDH large diameter head and a Durom
`acetabular component makes it possible to increase the maximum range of
`motion without sacrificing prosthesis stability.”
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 9 of 23
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`47.
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`Based on the information provided by Dr. Firestone, Plaintiff Michael Janisky made
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`the decision to have the Zimmer modular system implanted, including the Metasul LDH head and
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`a Durom acetabular component, instead of any other artificial hip devices or systems that were
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`available on the market.
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`48.
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`On November 26, 2008, Dr. Firestone performed a total hip arthroplasty on Plaintiff
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`Michael Janisky’s right hip at Scottsdale Healthcare Shea Hospital in Scottsdale, Arizona.
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`Plaintiff Michael Janisky was 61years of age.
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`49.
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`The Zimmer Metasul® LDHTM head and other Zimmer artificial hip devices
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`implanted in Plaintiff Michael Janisky’s right hip on November 26, 2008 included, but were not
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`limited to, the following:
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`a. Metasul® Durom® Acetabular Component
`Code T
`Uncemented 60/54
`REF: 01.00214.160; LOT: 2409336
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`b. Metasul® LDHTM Head
`54 Code T Taper 15/20
`REF: 01.00181.540; LOT: 2428777
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`c. Zimmer® Fitmore Hip Stem uncemented B / 6. Taper12/14
`REF: 01.00551.206; LOT: 2374123DL
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`d. Metasul® LDHTM Head Adaptor
`REF: 01.00185.146; LOT: 2429329
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`50.
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`On September 26, 2008, approximately two months before Plaintiff Michael
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`Janisky was implanted with his Zimmer Durom cup, the FDA issued a Class 2 Recall of the
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`Durom Cup.
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`51.
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`Zimmer stated the reason for the Class 2 Recall was because the instructions for
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`use and surgical technique instructions were inadequate.
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 10 of 23
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`52.
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`The FDA stated the cause for the Class 2 Recall was “MISBRANDING: Labeling
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`False and Misleading”.
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`Plaintiff Michael Janisky’s Durom® Cup Failure
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`53.
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`Over time the right Zimmer Metasul® - Durom® Cup artificial hip of Plaintiff
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`Michael Janisky failed.
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`54.
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`The progressive failure of the right Zimmer Metasul® - Durom® Cup artificial hip
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`of Plaintiff Michael Janisky caused him pain, suffering, disability and physical impairment.
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`55.
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`In mid-December of 2019 Plaintiff Michael Janisky, first sought medical advice
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`concerning pain he had recently begun to experience in his right hip. At that time he was first
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`told that he may be in need of a revision surgery for the removal and the replacement of his right
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`Zimmer Metasul® - Durom® Cup artificial hip.
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`56.
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`On January 16, 2019, Dr. Firestone performed hip revision surgery to replace the
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`failed right Zimmer Metasul® - Durom® Cup artificial hip of Plaintiff Michael Janisky.
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`57.
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`The operative note for the revision of the right hip includes the following
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`observations by Dr. Firestone:
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`… I made a capsulectomy there with the electrocautery. Underneath, there
`was a large creamy effusion. The effusion was the consistency of pea soup.
`This was aspirated and sent for culture. It was consistent with pseudotumor
`and significant bone destruction. A complete excision of all the very
`thickened granuloma was then undertaken. This probably took about 45
`minutes in itself, excising all the thickened scar tissue, which was in the
`form of caseous necrosis. This was, unfortunately, a significant amount of
`the acetabular bone as well as the proximal femur, which had undergone
`significant resorption. At this point, it was evident that there was significant
`corrosion at the femoral head of the well-fixed short stem. It was still well
`fixed. I disimpacted the large cobalt chrome head, first while it was in the
`socket, and then externally rotated the stem and removed the femoral head.
`This allowed for further acetabular exposure and I did a further
`debridement. . . . I was able to easily remove the Durom shell, which
`measured 60 mm. There was only fibrous fixation at best.
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 11 of 23
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`Plaintiffs’ Damages
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`58.
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`As a direct and proximate result of the said defects of the Durom® Cup, and the
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`conduct of the Defendants, the Plaintiff Michael Janisky has suffered personal injuries.
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`59.
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`As a direct and proximate result of these defective implants, and the revision
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`surgery, Plaintiff Michael Janisky is at an increased risk for having future revision surgeries.
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`60.
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`As a direct and proximate result of these defective implants, and the revision
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`surgery, Plaintiff Michael Janisky has suffered personal injury, and has endured pain, suffering,
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`discomfort, disability, illness, physical impairment in the past and will continue to suffer and
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`endure these injuries and damages in the future.
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`61.
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`As a direct and proximate result of these defective implants, Plaintiff Michael
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`Janisky has suffered disability, physical impairment, and illnesses that are the direct and
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`proximate result of the defective Zimmer Metasul® - Durom® Cup artificial hips that had been
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`implanted in him.
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`62.
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`As a direct and proximate result of these defective implants, and the revision
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`surgery, Plaintiff Michael Janisky has incurred reasonable and necessary medical care and
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`expenses in excess of $75,000 in the past and will continue to incur medical expenses in the future.
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`63.
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`As a direct and proximate result of these defective implants, Plaintiff Michael
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`Janisky also suffered mental anguish, anxiety, and emotional distress as one would be expected
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`to have suffered and will reasonably probably suffer in the future due to his medical condition
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`caused by the defective and failed Zimmer Metasul® - Durom® Cup artificial hips that had been
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`implanted in him, and the revision surgery that he has endured.
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`64.
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`As a direct and proximate result of these defective implants, Plaintiff Susan Janisky
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`has suffered the loss of the consortium of her husband Michael Janisky.
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 12 of 23
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`65.
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`As a direct and proximate result of the actions of the Defendants, Plaintiffs suffered
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`severe and permanent physical injury, loss of enjoyment of life and other damages as set forth
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`elsewhere in this Complaint.
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`FIRST CAUSE OF ACTION
`STRICT PRODUCT LIABILITY
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`66.
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`The allegations contained in all prior paragraphs are incorporated herein by
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`reference.
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`67.
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`In and prior to November 2008, Defendants were engaged in the business of
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`designing, manufacturing, marketing, distributing, labeling, and selling orthopedic hip implants
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`and did design, manufacture, distribute, market, label and sell the artificial hip devices implanted
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`in Plaintiff Michael Janisky on November 26, 2008.
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`68.
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`Defendants had a duty to place into the stream of commerce, design, manufacture,
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`distribute, market, promote, label and sell the Durom® Cup hip system so that it was neither
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`defective or unreasonably dangerous when put to the use for which it was designed, manufactured,
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`distributed, marketed, and sold.
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`69.
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`Defendants did in fact design, manufacture, label, sell, distribute, supply, and/or
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`promote the Durom® Cup to Plaintiff Michael Janisky and his implanting physician, Theodore P.
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`Firestone, M.D.
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`70.
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`Defendants expected the Durom® Cup hip system they designed and were selling,
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`distributing, supplying, manufacturing, labeling, marketing and/or promoting to reach, and which
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`did in fact reach, implanting physicians and consumers in the State of Arizona, including Plaintiff
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`and his implanting physician, without substantial change in its condition.
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`71.
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`The Durom® Cup hip system implanted in the Plaintiff Michael Janisky was
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`designed, manufactured, labeled, marketed, distributed, sold and/or supplied by defendants and
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 13 of 23
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`placed into the stream of commerce in a defective and unreasonably dangerous condition as
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`designed, taking into account the utility of the product and the risk involved in its use. The
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`harmful characteristics or consequences of its design outweighed the benefits of the design.
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`72.
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`The Durom® Cup hip system implanted in Plaintiff Michael Janisky, as designed,
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`manufactured, labeled, marketed, distributed, sold and/or supplied by Defendants was defective
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`and unreasonably dangerous due to its marketing and inadequate warnings or instructions needed
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`for the reasonably safe use of the device, independently and when coupled with its aggressive
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`marketing campaign.
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`73.
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`The Durom® Cup hip system implanted in Plaintiff Michael Janisky, as designed,
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`manufactured, labeled, marketed, distributed, sold and/or supplied by Defendants was defective
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`and unreasonably dangerous because of its marketing due to misbranding, including false and
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`misleading labeling, independently and when coupled with its aggressive marketing campaign.
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`74.
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`Defendants were engaged in the design, manufacture, labeling, marketing,
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`distribution, dispensing, and sale of the Durom® Cup, and the Durom® Cup hip systems
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`throughout the United States, including in the State of Arizona and this jurisdiction. Defendants
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`are also strictly liable to Plaintiffs for the following reasons, including, but not limited to:
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`a. The Durom® Cup and/or the Durom® Cup hip system was defective, unsafe and
`unreasonably dangerous for its intended and/or foreseeable uses, and was
`defective, unsafe and unreasonably dangerous at the time it was placed into the
`stream of commerce by Defendants and at the time it was prescribed, provided,
`implanted and distributed to Plaintiff;
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`b. Defendants designed, manufactured, labeled, distributed, provided, dispensed,
`and sold the Durom® Cup and/or the Durom® Cup hip system in such a
`defective and unreasonably dangerous condition that it was likely to cause harm
`to Plaintiff when being used for its intended use;
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`c. Defendants labeled, distributed, dispensed, and sold the Durom® Cup and/or
`the Durom® Cup hip system in a defective and unreasonably dangerous
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 14 of 23
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`condition due to the product’s design and failure to warn of the dangers
`presented by it;
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`d. Defendants’ failure to warn of the dangers, rendered the Durom® Cup and/or
`the Durom® Cup hip system extremely hazardous and potentially lethal;
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`e. The instructions for use and surgical technique instructions were inadequate;
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`f. Defendants failed to provide timely and adequate warnings or instructions after
`it knew of the risk of injury;
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`g. Defendants failed to advise patients like Michael Janisky that monitoring of the
`cup was necessary to avoid a long and painful period, where the device failure
`would go undetected as it did here;
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`h. Defendants knew that Plaintiff would use the Durom® Cup and the Durom®
`Cup hip system without inspection for defects therein;
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`i. Defendants expected and knew that the Durom® Cup and the Durom® Cup hip
`system would reach Plaintiff, and was in fact received by Plaintiff, without
`change in the condition in which it was first manufactured, distributed,
`provided, prescribed, dispensed and sold; and
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`j. The said products failed to perform as safely as an ordinary consumer would
`expect when used in a reasonably foreseeable manner.
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`75.
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`Plaintiff was a foreseeable user and used the Durom® Cup and the Durom® Cup hip
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`system in their intended manner, and Plaintiff suffered serious harm because of said use.
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`76.
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`As the proximate cause and legal result of the defective condition of the Durom®
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`Cup and/or the Durom® Cup hip system and a failure to warn or inadequate warnings, Plaintiff
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`has been injured, suffered illness and was damaged physically, emotionally and economically;
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`has required health care and treatment; and has incurred the costs and expense of such health care
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`and treatment as a direct and indirect result of his implant.
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`77.
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`Defendants actually knew of the defective nature of the Durom® Cup and the
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`Durom® Cup hip system but continued to design, manufacture, label, distribute, dispense, and sell
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`the Durom® Cup and the Durom® Cup hip system in order to maximize sales and profits at the
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 15 of 23
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`expense of the public health and safety, in conscious disregard of the foreseeable harm. The
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`defective manner of the Durom® Cup and the Durom® Cup hip system is a contributing cause of
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`Plaintiffs’ injuries and Plaintiffs’ economic and non-economic loss.
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`78.
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`As a direct and proximate result of Defendants’ conduct Plaintiffs are entitled to an
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`award of compensatory damages.
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`79.
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`Defendants’ conduct is attended by circumstances of intentional concealment of
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`material facts, malice, and willful, wanton and reckless conduct exhibiting disregard for the safety
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`of others, entitling the plaintiffs to all other damages recoverable under Arizona law.
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`SECOND CAUSE OF ACTION
`NEGLIGENCE
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`The allegations contained in all prior paragraphs are incorporated herein by
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`80.
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`reference.
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`81.
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`Defendants had and continue to have a duty to exercise reasonable care in the
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`design, testing, manufacture, sale, labeling, distribution, marketing and sale, of said hip implants
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`into the stream of commerce, including a duty to assure that the product did not cause users to
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`suffer from unreasonably dangerous side effects.
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`82.
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`Defendants violated this standard of care and failed to exercise due care.
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`Defendants did so by committing acts and omissions that they knew or should have known were
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`reckless, careless, and done without taking reasonable care and includes, but not limited to, the
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`following:
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`a. By negligently and carelessly designing, manufacturing, testing, labeling,
`distributing, marketing, examining, selling, dispensing, and/or preparing said
`implants in such a manner that they were likely to injure Plaintiff;
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`b. By negligently and carelessly designing, manufacturing, testing, labeling,
`distributing, marketing, examining, selling, dispensing, and/or preparing said
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 16 of 23
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`implants such that the products were unsafe when they reached the hands of the
`consuming public, including Plaintiff Michael Janisky;
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`c. By negligently and carelessly designing, manufacturing, testing, labeling,
`distributing, marketing, examining, selling, dispensing, and/or preparing said
`implants prior to placing the same into the general stream of commerce; and,
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`d. Were otherwise negligent as may be shown in discovery or at the trial of this
`matter.
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`83.
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`As a proximate cause and legal result of the defective condition of the said implant
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`system; a failure to warn or adequately warn; and otherwise negligent acts and omissions of
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`Defendants, that they knew or should have known about, Plaintiff Michael Janisky has been
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`injured and damaged physically, emotionally and economically; has required health care and
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`treatment; and has incurred the costs and expense of such health care and treatment as a direct
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`and indirect result of the defective hip implants.
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`84.
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`As a direct and proximate result of the negligence of Defendants, Plaintiff Michael
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`Janisky was injured and is entitled to an award of compensatory damages as stated herein.
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`85.
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`86.
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`Defendants are liable to Plaintiffs for their negligence.
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`Upon information and belief, Defendants’ negligent conduct is attended by
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`circumstances of intentional concealment of material facts, malice, willful wanton and reckless
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`conduct exhibiting disregard for the safety of others.
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`THIRD CAUSE OF ACTION
`NEGLIGENT MISREPRESENTATION AND FRAUD
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`87.
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`The allegations contained in all prior paragraphs are incorporated herein by
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`reference.
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`88.
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`Defendants fraudulently, intentionally and/or negligently misrepresented to
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`Plaintiff Michael Janisky, his surgeon, and the orthopedic surgery community, the safety and
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`effectiveness of the Durom® Cup and the Durom® Cup hip system and/or fraudulently,
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`Case 3:20-cv-08310-DLR Document 1 Filed 11/23/20 Page 17 of 23
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`intentionally or negligently concealed material, adverse information regarding the safety and
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`effectiveness of that system.
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`89.
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`90.
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`Defendants knew or should have known that these representations were false.
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`Defendants made representations and/or actively concealed from Plaintiff Michael
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`Janisky, his sur