Case 2:21-cv-QOO85-KS-MTP Document 1 Filed 06/04/21 Page 1 of 38
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` IN THE UNITED STATES DISTRICT COURT
`
`FOR THE SOUTHERN DISTRICT OF MISSISSIPPI
`EASTERN DIVISION
`
`PHILIP A. BROWN
`
`AND CYNTHIA D. BROWN
`
`PLAINTIFFS
`
`v.
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`7
`
`CIVIL ACTION NO. 3219, \ mag -\L§NWT?
`
`DEPUY SYNTHES SALES, INS. d/b/a
`DEPUY SYNTHES JOINT RECONSTRUCTION;
`DEPUT ORTHOPAEDICS, INC.;
`DEPUY INTERNATIONAL LIMITED;
`JOHNSON & JOHNSON;
`JOHNSON & JOHNSON SERVICES, INC. ;
`JOHNSON & JOHNSON INTERNATIONAL;
`MEDICAL DEVICE BUSINESS SERVICES, INC.;
`DEPUY, INC.;
`DEPUY SYNTHES PRODUCTS, INC. ;
`DEPUY SYNTHES, INC.;
`DEPUY IRELAND UNLIMITED COMPANY;
`DEPUY SYNTHES JOHNSON & JOHNSON IRELAND LTD.
`
`.
`
`DEFENDANTS
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`COMPLAINT AND DEMAND FOR JURY TRIAL
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`COME NOW, Plaintiffs Philip A. Brown and Cynthia D. Brown, by and through their
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`undersigned counsel, and bring this Complaint against Defendants DePuy Synthes Sales, Ins.
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`D/B/A DePuy Synthes Joint Reconstruction; DePuy Orthopaedics, Inc; DePuy International
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`Limited; Johnson & Johnson; Johnson & Johnson Services,Inc.; Johnson & Johnson International;
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`Medical Device Business Services, 1110.; DePuy, Inc.; DePuy Synthes Products, Inc.; DePuy
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`Synthes, Inc.; DePuy Ireland Unlimited Company; DePuy Synthes Johnson & Johnson Ireland
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`Ltd. (collectively “Defendants”) and alleges as folloWs:
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`NATURE OF THE ACTION
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`1.
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`The action involves Plaintiff Philip A. Brown and the personal injuries he has
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`suffered as a result of a defective Attune® Knee System (hereinafter “ATTUNE or “ATTUNE
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`Device(s)”). Mr. Brown, and countless others, have or will be required tO undergo revision surgery
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`Case 2:21-cv-00085-KS-MTP Document 1 Filed 06/04/21 Page 2 of 38
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`to replace defective ATTUNE Systems. Specifically, the ATTUNE’S tibial baseplate de-bonds,
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`or comes loose, causing severe pain, instability, and swelling; and requires extensive surgery to
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`remove and replace the defective component.
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`2.
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`Defendants designed, tested, manufactured, labeled, distributed/placed into the
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`stream of commerce and marketed the ATTUNE Device.
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`3.
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`Failure rates for the ATTUNE Devices have been much higher than reasonably
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`expected for such devices, necessitating premature surgery, rehabilitation and disability sueh as
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`that suffered by Mr. Brown.
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`4.
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`Defendants knew about
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`the defective nature of the ATTUNE Devices, yet
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`continued to tout their safety and efficacy.
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`JURISDICTION AND VENUE
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`5.
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`This Court has jurisdiction over this matter pursuant to 28 U.S.C. § 1332 in that the
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`.
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`amount in controversy exceeds $75,000.00, exclusive of interest and costs, and this is an action by
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`individual Plaintiffs against Defendants who are citizens of different states and jurisdictions.
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`6.
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`Venue in the Southern District of Mississippi is proper pursuant to 28 U.S.C. §
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`1391(a) because a substantial part of the events giving rise to Plaintiffs’ claims occurred in the
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`Southern District of Mississippi, including the original surgery implanting the defective ATTUNE
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`Device in Mr. Brown and the failure of the ATTUNE Device and resulting injuries and damages.
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`Upon information and belief, Defendants regularly conducted business in the Southern District of
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`Mississippi. Defendants’ commercial activities in the Southern District ofMississippi include, but
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`are not limited to, the advertising, promoting, marketing and sale of ATTUNE Devices.
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`Case 2:21-cv-OOO85-KS-MTP Document 1 Filed 06/04/21 Page 3 of 38
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`THE PARTIES
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`7.
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`Plaintiff Philip A. Brown is an adult resident of Forrest County, Mississippi.
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`Plaintiff was implanted with a defective ATTUNE Device on June 14, 2016. The device came
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`loose and required a revision surgery on June 10, 2019.
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`8.
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`Plaintiff Cynthia D. Brown is the wife of Philip A. Brown an adult resident of
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`Forrest County, Mississippi.
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`9.
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`Defendant DePuy Synthes Sales, Inc. d/b/a DePuy Synthes Joint Reconstruction
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`(“DSS”) is and, at all times relevant, was a corporation organized and existing under the laws of
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`the State of Massachusetts, with its principal place of business located at 325 Paramount Drive,
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`Raynham, Massachusetts 02767, and regularly conducted business in the State of Mississippi by
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`selling and distributing its products in Mississippi. Upon information and belief, DSS is a division
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`and/or subsidiary of DePuy Orthopaedics, Inc. (“D01”). DSS is a wholly owned subsidiary of
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`Johnson & Johnson, a publicly traded company.
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`10.
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`DSS designs, manufactures, makes, imports, distributes, sells and/or offers for sale
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`total knee replacement prostheses, including the ATTUNE Device. DSS was engaged in the
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`business of designing,
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`licensing, manufacturing, distributing,
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`selling, marketing, and/or
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`introducing into interstate commerce, either directly or indirectly through third parties or related
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`entities, numerous orthopedic products, including the ATTUNE Device, as well as monitoring and
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`reporting adverse events related to the ATTUNE Device.
`
`1].
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`Defendant Medical Device Business Services, Inc. (“Device Business Services”) is
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`and, at all times relevant, was a corporation organized and existing under the laws of the State of
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`Indiana, with its headquarters and principal place of business located at 700 Orthopaedic Drive,
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`Warsaw, Indiana 46582, and regularly conducted business in the State of Mississippi by selling
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`Case 2:21-cv-OOO85-KS-MTP Document 1 Filed 06/04/21 Page 4 of 38
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`and distributing its products in Mississippi, with a registered office and principal place of business
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`in Mississippi. Device Business Services is a wholly-owned subsidiary of Johnson & Johnson, a
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`publicly traded company.
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`12.
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`Defendant DePuy 0thopaedics, Inc. (“D01”) is and, at all times relevant, was a
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`corporation organized and existing under the laws of the State of Indiana, with its headquarters
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`and principal place of business located at 700 Orthopaedic Drive, Warsaw, Indiana 46582, and
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`regularly conducted business in the State of Mississippi by selling and distributing its products in
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`Mississippi, with a registered office and principal place of business in Mississippi. D01 is a
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`wholly-owned subsidiary of Johnson & Johnson, a publicly traded company.
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`13.
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`At all times, relevant, D01 and Device Business Services were engaged in the
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`business of designing,
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`licensing, manufacturing, distributing, selling, marketing, packaging,
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`labeling and/or introducing into interstate commerce, either directly or indirectly through third
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`parties or related entitles, numerous orthopedic products, including the ATTUNE Device, as well
`
`as monitoring and reporting adverse events associated with ATTUNE. D01 and Device Business
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`Services participated in the decision making process and response ofthe Defendants, if any, related
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`to ATTUNE adverse events and/or MAUDE reports.
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`14.
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`Defendant DePuy Synthes Products, Inc. (“DSP”) is and, at all times relevant, was
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`a corporation organized and existing under the laws of the State of Delaware with its principal
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`place of business located at 325 Paramount Drive, Raynham, Massachusetts 02767, and regularly
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`conducted business in the State of Mississippi by selling and distributing its products in
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`Mississippi. DSP is division of D01. DSP is a wholly-owned subsidiary of Johnson & Johnson, a
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`publicly traded company.
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`Case 2:21-cv-OOO85-KS-MTP Document 1 Filed 06/04/21 Page 5 of 38
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`15.
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`Defendant DePuy Synthes, Inc.
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`(“DS”) is and, at all
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`times relevant, was a
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`corporation organized and existing under the law of the State of Delaware with its principal place
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`of business located at 700 Orthopaedic Drive, Warsaw, Indiana 46581, and at all relevant times
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`was doing business in the State of Mississippi by selling and distributing its products in
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`Mississippi.
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`16.
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`DSP and DS design, manufacture, test, package, label, distribute, sell and/or offer
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`for sale certain total knee replacement protheses, including the ATTUNE Device.
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`17.
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`Defendant DuPuy, Inc. is and, at all times relevant, was a corporation organized
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`and existing under the laws of the State of Delaware, with its headquarters and principal place of
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`business at Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801. At all
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`relevant times, DePuy, Inc. conducted regular and sustained business in Mississippi by selling and
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`distributing its products in Mississippi.
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`18.
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`As DOI’s parent company, DePuy, Inc. was, at all relevant times, involved in the
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`business of designing, licensing, manufacturing, distributing, selling, marketing, and introducing
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`into interstate commerce, either directly or indirectly through third parties or related entities,
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`numerous orthopedic products,
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`including the ATTUNE Device, as well as monitoring and
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`reporting adverse events associated with ATTUNE. Upon information and belief, DePuy, Inc.
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`participated in reviewing , investigating and/or responding to FDA adverse events and/or MAUDE
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`reports related to the ATTUNE Device, and in the decision of whether to submit reports of
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`ATTUNE failures to the FDA.
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`19.
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`Defendant DePuy International, Ltd. (“DIL”) is a public entity or corporation
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`organized and existing under the law of the United Kingdom, with its principal place of business
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`at St. Anthony’s Road, Beeston, Leeds, West Yorkshire, L811 8DT, United Kingdom, and at all
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`Case 2:21-cv-OOO85-KS-MTP Document 1 Filed 06/04/21 Page 6 of 38
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`times relevant was doing business with the United States. At all relevant times, DePuy
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`International, Ltd. Conducted regular and sustained business in Mississippi by selling and
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`distributing its products in Mississippi.
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`20.
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`DIL makes, designs, imports, distributes, labels, sells and/or offers for sale certain
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`total knee replacement prostheses, including the ATTUNE Device.
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`21.
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`DePuy Ireland Unlimited Company (“DePuy Ireland”) is a company and a citizen
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`of Ireland with its principal place of business located at Loughbeg Industrial Estate, Loughbeg
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`Ringaskiddy, County Cork, Ireland, and at all relevant times was doing business with the United
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`States. At all relevant times, DePuy Ireland Unlimited Company conducted regular and sustained
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`business in Mississippi by selling and distributing its products in Mississippi.
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`22.
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`At all times relevant, DePuy Ireland was involved in the business of designing,
`
`manufacturing, distributing, selling, marketing and introducing into interstate commerce, either
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`directly or indirectly, through third parties or related entities, numerous orthopedic products,
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`including the ATTUNE Device, as well as monitoring and reporting adverse events associated
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`with ATTUNE. DePuy Ireland had a role in the decision—making process and response of the
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`Defendants, if any, related to the handling of adverse events and MAUDE reports concerning
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`ATTUNE Device failures.
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`23.
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`DePuy Synthes Johnson & Johnson Ireland Ltd. (“Synthes Ireland”) is an entity
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`doing business and organized in Ireland with its principal place of business located at Unit 2, Block
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`10, Blanchardstown Corporate Park, Dublin 15, Ireland, and at all relevant times was doing
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`business within the United States.
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`.At all relevant times, DePuy Synthes Johnson & Johnson
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`Ireland Ltd. Conducted regular and sustained business in Mississippi by selling and distributing
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`its products in Mississippi.
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`Case 2:21-cv-00085-KS-MTP Document 1 Filed 06/04/21 Page 7 of 38
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`24.
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`At all times relevant, Synthes Ireland was involved in the business of designing,
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`manufacturing, distributing, selling, marketing and introducing into interstate commerce, either
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`directly or indirectly, through third parties or related entities, numerous orthopedic products,
`
`including the ATTUNE Device, as well as monitoring and reporting adverse events associated
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`with ATTUNE. Synthes Ireland had a role in the decision-making process and response of the
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`Defendants, if any, related to the handling of adverse events and/or MAUDE reports concerning
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`ATTUNE Device failures.
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`25.
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`Defendants DSS, DOT, DIL, DSP, DS, DePuy, Inc., Device Business Services,
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`DePuy Ireland and Synthes Ireland are collectively referred to as “DePuy” and the “DePuy Synthes I
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`Companies.” The DePuy Synthes Companies are part of the Johnson & Johnson Family of
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`Companies. The DePuy Synthes Companies are a group of functionally-integrated companies
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`with shared management, administrativeand general functions, including human resources, legal,
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`quality control, customer service, sales administration,
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`logistics,
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`information technology,
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`compliance, regulatory, finance and accounting and are considered a single business enterprise.
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`26.
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`Defendant Johnson & Johnson International is and, at all times relevant, was a
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`corporation organized and existing under the laws of the State of New Jersey with its principal
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`place of business at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, and
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`regularly conducted business in the State of Mississippi by selling and distributing its products in
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`Mississippi.
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`27.
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`As one of DePuy’s parent companies, Johnson & Johnson International is and, at
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`all relevant
`
`times, was involved in the business of designing,
`
`licensing, manufacturing,
`
`distributing, selling, marketing, and introducing into interstate commerce, either directly or
`
`indirectly through third parties or related entities, numerous orthopedic products, including the
`
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`Case 2:21-cv-OOO85-KS-MTP Document 1 Filed 06/04/21 Page 8 of 38
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`ATTUNE Device, as well as monitoring and reporting adverse events associated with ATTUNE.
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`Johnson & Johnson International participated in the decision—making process and response, if any,
`
`related to adverse events and/or MAUDE reports concerning the ATTUNE Device.
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`28.
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`At all times material hereto, Defendant Johnson & Johnson (“J&J”) is and was a
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`public entity or corporation organized and existing under the laws of the State of New Jersey, with
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`a principal place of business at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933,
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`and at all relevant times was doing business in the State of Mississippi by selling and distributing
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`its products in Mississippi.
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`29.
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`As DePuy’s most senior parent company, Johnson & Johnson is and, at all relevant
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`times, was involved in the business of designing, licensing, manufacturing, distributing, selling,
`
`marketing, and introducing into interstate commerce, either directly or indirectly through third
`
`parties or related entities, numerous orthopedic products, including the ATTUNE Device, as well
`
`as mentoring and reporting adverse events associated with ATTUNE.
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`Johnson & Johnson
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`participated in the decision—making process and response, if any, related to adverse events and/or
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`MAUDE reports related to ATTUNE Device failures.
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`30.
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`At all
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`times material hereto, Defendant Johnson & Johnson Services (“J&J
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`Services”) was a public entity or corporation organized and existing under the law of the State of
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`New Jersey, with a principal place of business at One Johnson & Johnson Plaza, New Brunswick,
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`New Jersey 08933, and regularly conducted business in the State of Mississippi by selling and
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`distributing its products in Mississippi.
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`31.
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`J&J Services is and, at all relevant times, was involved in the business of designing,
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`licensing, manufacturing, distributing,
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`selling, marketing, and introducing into interstate
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`commerce, either directly or indirectly through third parties or related entities, numerous
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`orthopedic products, including the ATTUNE Device, as well as mentoring and reporting adverse
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`events associated with ATTUNE. Johnson & Johnson participated in the decision-making process
`
`and response, if any, related to adverse events and/or MAUDE reports related to ATTUNE Device
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`failures.
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`32.
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`The Browns have suffered personal injuries as a direct and proximate result of
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`DePuy Synthes Sales, Inc. d/b/a DePuy Synthes Joint Reconstruction; Medical Device Business
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`Services, Ines, DePuy Orthopaedics, Inc; DePuy Sythes Products, Inc.; DePuy Synthes, Inc.;
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`DePuy, Inc. DePuy International, Ltd.,; DePuy Ireland Unlimited Company; DePuy Synthes
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`Johnson & Johnson Ireland Ltd.; Johnson & Johnson International; Johnson & Johnson; and
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`Johnson & Johnson Services, Inc. (collectively “Defendants”) conduct and misconduct, as
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`described herein, in connection with the design, development, manufacturing, testing, packaging,
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`advertising, marketing, distributing, labeling, warning and sale of the ATTUNE Device.
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`33.
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`Defendant Johnson & Johnson is the parent company of Defendant DePuy
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`International Limited, DePuy Ireland Unlimited Company and DePuy Synthes Johnson & Johnson
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`Ireland, Ltd.
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`34.
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`Defendant Johnson & Johnson is the alter ego of wholly owned subsidiaries
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`Defendants, DePuy International Limited; DePuy Ireland Unlimited Company and DePuy Synthes
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`Johnson & Johnson Ireland Ltd. (“subsidiary Defendants”). Defendant Johnson & Johnson has
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`used these named subsidiary Defendants as its agents; and/or Defendant Johnson & Johnson and
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`the named subsidiary Defendants are one single integrated enterprise.
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`3S.
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`Defendants DePuy Ireland Unlimited Company and DePuy Synthes Johnson &
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`Johnson Ireland Ltd. (hereinafter referred to as the “Ireland Defendants”), in addition to designing
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`and manufacturing the ATTUNE Devices, were identified by the FD as the manufacturer of failed
`4,
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`ATTUNE Devices reported through the FDA’s MAUDE system. Upon information and belief,
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`the Ireland Defendants reported, and made decisions about whether or not to report, failures of the
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`ATTUNE Devices, which occurred within the United States, to the FDA.
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`36.
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`Defendants DePuy International Limited; DePuy Ireland Unlimited Company and
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`DePuy Synthes Johnson & Johnson Ireland Ltd. produced and disseminated misleading marketing
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`publications throughout the United States, including Mississippi, touting the safety and efficiency
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`of the ATTUNE Device to consumers, hospitals and surgeons.
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`37.
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`Defendants DePuy International Limited; DePuy Ireland Unlimited Company and
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`DePuy Synthes Johnson & Johnson Ireland Ltd. engaged in substantial business within the United
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`States related to the ATTUNE Device, availed themselves of the benefits of conducting business
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`in the United State and derived benefits from the business within the United States.
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`38.
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`At all
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`times relevant, each of the Defendants was the representative, agent,
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`employee, co-conspirator, servant, employee, partner, joint—venturer, franchisee, or alter ego ofthe
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`other Defendants and was acting within the scopeof such authority in such conspiracy, service,
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`agency, employment, partnership, joint venture and/or franchise.
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`BACKGROUND AND FACTUAL ALLEGATIONS
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`39.
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`The knee joint is the largest joint in the human body. Knee replacement, or knee
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`arthroplasty, is a surgical procedure to replace the weight-bearing surfaces of the knee joint to
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`relieve pain and disability. The most common reason for such surgery is osteoarthritis, but can
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`also be appropriate in numerous other cases of damage to the knee joint.
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`40.
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`A normal knee functions as a hinge joint between the femur (upper leg bone) and
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`tibia and fibula (lower leg bones). The surfaces where these bones meet can become worn out
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`over time and can cause pain and swelling. During a total knee replacement, or total knee
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`arthroplasty (hereinafter “TKA”), parts of the knee joint are replaced with artificial parts. The
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`prosthesis is generally comprised of three (3) components: the tibial component, the femoral
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`component and the patellar component. Typically,
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`the tibial and femoral components are
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`cemented into the respective bones. The goal of TKA is to relieve pain, improve quality of life
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`and maintain or improve knee function.
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`41.
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`The procedure is performed in adults of all ages. Approximately 700,000 TKA
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`procedures are performed annually in the United States with a projected increase to 3.48 million
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`procedures per year by 2030 (with our increasingly aging population). For most people, a TKA
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`provides pain relief, improved mobility and a better quality of life and can be expected to last more
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`than 15 years.
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`THE ATTUNE KNEE DEVICE
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`42.
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`The DePuy Synthes Companies, party of the Johnson & Johnson Family of
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`Companies, claims the world’s most comprehensive portfolio of orthopedic products.
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`43.
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`DePuy Orthopaedics, Inc. has been designing and manufacturing knee replacement
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`devices for many years — starting with the LCS Complete Knee System, following be the RFC.
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`Total Knee System and finally the REC. Sigma System. Each became increasingly successful
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`both medically and commercially. The Sigma in particular was popular worldwide, with DePuy
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`claiming a 7-year survivorship of 99.6%.
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`44.
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`The ATTUNE was an effort to improve upon these prior products — at a purported
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`cost of some $200 million.
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`45.
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`In its marketing materials, DePuy claims that the ATTUNE allows patients to
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`achieve the best possible range of motion with more stability and less down time.
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`46.
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`The purported improved design elements include: a gradually reducing femoral
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`radius, a proprietary s-curve design of the posteriorly stabilized earn, a tibial base that can be
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`upsized or downsized two (2) sizes versus the insert, novel patella tracking and a new polyethylene
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`formulation.
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`47.
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`To gain approval from the FDA to market and sell the ATTUNE, DePuy relied on
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`Premarket Notification 510(k). Companies seeking to market medical devices in the United States
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`intended to human use can avoid a full Premarket Approval review by the FDA if the subject
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`device is “substantially equivalent” to a device or devices already on the market.
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`If a company
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`can demonstrate substantial equivalence with a legally marketed device, or predicate device, a
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`company need not establish that the device is safe and effective in its own right.
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`48.
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`The FDA granted clearance of the ATTUNE in December of2010; based on several
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`predicate devices that included the P.F.C. Sigma Knee System and Sigma components.
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`In its
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`Summary of Safety of Effective for the ATTUNE, DePuy notes that no clinical testing was
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`provided to the FDA because, “it was not necessary to determine substantial equivalence between
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`the Attune Knee System and the predicate devices.”
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`49.
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`The ATTUNE Knee System includes the Attune Tibial Base (510K Number
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`K101433)(“ATTUNE tibial baseplate”), also called tibial tray, which, as compared to the SIGMA,
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`included a design change to the keel, the surface texture and/or finish of the tibial baseplate and,
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`“combined with new technology to treat the underside of the implant,” amount other changes.
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`50.
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`The FDA cleared the following specific medical device components as part of the
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`DePuy AttuneTM Knee Total System.
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`A. The AttuneTM Cruciate Retaining (CR) Femoral Component;
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`B. The AttuneTM Fixed Bearing (FB) Tibial Insert;
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`C. The AttuneTM Tibial Base, which is available in 10 sizes; and
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`D. The AttuneTM Patellae.
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`51.
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`In August 2011, DePuy Orthopaedics, Inc. received 510K clearance for the DePuy
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`Attune Posterior Stabilized (PS) Femoral Components and PS Fixed Bearing inserts, which were
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`additions to the existing DePuy AttuneTM Knee System. These components are compatible with
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`the ATTUNE fixed tibial bases. This product was referred to as the DePuy AttuneTM PS Knee
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`System.
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`52.
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`The claims in this Complaint focus only on the ATTUNE Device as defined herein,
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`which includes the DePuy AttuneTM Knee System (including its component parts) and the DePuy
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`AttuneTM PS Knee System (including its component parts)(collectively referred to as “ATTUNE”
`
`and “ATTUNE Device” herein). The design and composition of the ATTUNE Device, especially
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`the tibial baseplate, is defective and failed resulting in harm to Plaintiff Philip A Brown and a loss
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`of consortium and household services to Cynthia Brown.
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`53.
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`The ATITUNE Device was launched onto the market in March, 2013, including
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`procedures for implantations, to surgeons and consumers.
`54.
`In its marketing materials, DePuy claimed that the ATTUNE Device could help
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`patients, “achieve the best possible range of motion while giving the confidence of a stable knee
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`replacement.” Additionally, DePuy noted “that ATTUNE Knee patients required significantly less
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`time to meet the necessary criteria to leave the hospital.”
`
`I
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`55.
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`DePuy touted multiple “new” technologies and claimed the project as one of the
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`largest research and development projects in the history of the DePuy Synthes Companies, costing
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`approximately $200 million.
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`56.
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`The most notable improvement Defendants purported to make between the SIGMA
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`and ATTUNE is the patented S-curve design of the femoral component. This feature, according
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`to Defendants, conferred greater mid-flexion stability as the implanted knee moves from extension
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`to flexion because of the more gradual change in the femoral component radius of curvature. This
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`design feature was also proposed to offer greater functional benefits and a greater range of
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`movement as compared to other implants.
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`57.
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`However, in reality, the ATTUNE Device did not deliver on its promises, resulting
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`in significantly higher failure rates than previous DePuy knee counterparts due to the de-bonding
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`of the tibial baseplate. As a result, thousands of knee replacement patients implanted with
`
`ATTUNE Devices have had more expensive, more dangerous and less effective TKA surgeries,
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`and many have required or will require expensive and dangerous knee revision surgery to remove
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`and replace the defective ATTUNE Device.
`
`5 8.
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`Despite learning of these issues, Defendants have continued to aggressively market
`
`the ATTUNE Device.
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`59.
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`The main mechanism failure of the ATTUNE Device involves mechanical
`
`loosening. This is caused by a failure of the tibial baseplate to bond at the implant/cement interface
`
`— essentially the attachment between the artificial knee and the existing bone becomes loose,
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`resulting in failure of the device. Mechanical loosening has occurred at an unprecedented rate in
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`patients implanted with an ATTUNE Device.
`
`60.
`
`A loose artificial knee generally causes pain and wearing away of the bone. It can
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`severely restrict a patient’s daily activities as it can involve severe physical impairment and pain.
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`Case 2:21-cv-00085-KS-MTP Document 1 Filed 06/04/21 Page 15 of 38
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`61.
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`There is no simple procedure to fix loose tibial component and repair requires
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`another surgery to remove the knee implant and replace it with a new one.
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`In some cases, bone
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`loss or damage will also need repair.
`
`62.
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`The success rate of a revision surgery is much lower than that of the initial total
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`knee replacement and the risks and complications are higher, including limitations in range of
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`motion, the ability to walk, and even death.
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`63.
`
`Beginning in 2013 and 2014, Defendants became aware of safety issues with the
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`ATTUNE Device. These concerns were evidenced through failure reports submitted to and kept
`
`in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which
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`houses medical device reports submitted to the FDA by reporters such as manufacturers, importers
`
`and device user facilities. Most related reports concern failures cause by ATTUNE Device design
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`elements which caused loosening and/or de-bonding at the tibial baseplate cement/implant
`
`interface. These MAUDE reports detail an extremely high incidence of aseptic loosening at the
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`tibial baseplate of the ATTUNE Device requiring subsequent revision surgeries.
`
`64.
`
`Upon information and belief,
`
`the FDA MAUDE database, as of June, 2017,
`
`included approximately 1,400 reports of failures. Approximately 633 of these reports resulting in
`
`revision surgeries. By comparison, the Persona knee replacement system, manufactured by
`
`Defendants, approximately 384,000 devices have been implanted, and the MAUDE database has
`
`a collection of only 183 reports of device failures with 64 of these resulting in revision surgeries.
`
`65.
`
`Interestingly, on March 16, 2016, DePuy Orthopaedis, Inc. submitted a 510(k)
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`premarket notice of intent to market a “new Cemented Tibial Base component to the ATTUNE
`
`Knee System.” The submission was approved in June 15, 2017.
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`15
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`Case 2:21-cv-00085-KS-MTP Document 1 Filed 06/04/21 Page 16 of 38
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`66.
`
`Upon information and belief, this new tibial component (ATTUNE 8+) has quietly
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`replaced the original ATTUNE tibial baseplate. Defendants have not recalled the defective tibial
`
`baseplate or informed consumers and surgeons about the dangers of its use.
`
`67.
`
`The “Summary of Technologies” portion of the 510(k) application for the
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`ATTUNE S+ tibial baseplate includes to following:
`
`The ATTUNE Cemented Tibial Base, FB provides a macro geometric feature
`and an optimized micro-blast finish which are both intended to aid in fixation
`of the tibial implant to the bone cement. The ATTUNE Cemented Tibial Base,
`FB is designed to enhance fixation by improving resistance (relative to the
`industry) to intra—operative factors which can result in a reduction in cement to
`implant bond.
`
`68.
`
`Defendants knew about the design defects and resulting failures with the original
`
`ATTUNE tibial baseplate long before the newly designed tibial baseplate (ATTUNE S+) was
`
`cleared in June of 2017, yet they failed to share this information with orthopedic surgeons using
`
`the original ATTUNE devices.
`
`In fact, the application for approval for the ATTUNNE 8+ was
`
`submitted by DePuy to the FDA on March 16, 2016, and many surgeons are still in the dark about
`
`the new and improved Attune design.
`
`69.
`
`Although Defendants obviously knew about the high number of ATTUNE failures
`
`resulting in revision surgeries, it failed to warn surgeons, consumers, patients, and allowed the
`
`original, defective design to continue to be implanted by unsuspecting surgeons into unsuspecting
`
`patients, including the Plaintiff and the Plaintiff’s physicians.
`
`70.
`
`It was not until surgeons themselves started raising the alarm in published studies
`
`and papers that information about the true nature of the defects in the ATTUNE came to light.
`
`71.
`
`Defendants designed, manufactured,
`
`tested,
`
`labeled, packaged, distributed,
`
`supplied, marketed, advertised, and/or otherwise engaged in all activities that are part of the sale
`
`16
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`Case 2:21-cv-00085-KS-MTP Document 1 Filed 06/04/21 Page 17 of 38
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`and distribution of medical devices, and by these activities, caused ATTUNE Devices to be placed
`
`into the stream of commerce through the United States and within Mississippi.
`
`72.
`
`Defendants actively and aggressively marketed to doctors and the public that the
`
`ATTUNE Devices were safe and effective total knee prostheses.
`
`73.
`
`From the time that Defendants first began selling ATTUNE Devices, the product
`
`labeling and product information for the ATTUNE Device failed to contain adequate information,
`
`instructions, and warnings concerning the increased risk that the ATTUNE Device fails at an
`
`extremely high rate.
`
`74.
`
`Despite Defendants’ knowledge of the serious injuries associated with the use of
`
`the ATTUNE Device, Defendants continue to engage in marketing and advertising programs
`
`which falsely and deceptively create the perception that the ATTUNE Device is safe.
`
`75.
`
`Upon information and belief, Defendants downplayed the health risks associated
`
`with the ATTUNE Device through promotional literature and communications with orthopedic
`
`surgeons. Defendants deceived doctors, including the Plaintiff’s surgeons, and potential users of
`
`the ATTUNE Device by relaying positive information, which concealing the nature and extent of
`
`the known adverse and serious health effects of the ATTUNE.
`
`76.
`
`Based on the design changes made to the original ATTUNE tibial baseplate before
`
`it was put on the market, and the number of failures reported since it was launched, Defendants,
`
`through their pre-marketing and post-marketing analysis, knew or should have known that the
`
`ATTUNE Device was prone to fail. Plaintiffs allege that the ATTUNE Device is defective and
`
`unreasonably dangerous.
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`l7
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`Case 2:21-cv-00085-KS-MTP Document 1 Filed 06/04/21 Page 18 of 38
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`CASE SPECIFIC FACUTAL ALLEGATIONS
`
`77.
`
`On or about June 14, 2016 Plaintiff Philip A. Brown underwent a right-sided total
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`knee replacement surgery at Forrest General Hospital in Hattiesburg, Mississippi. His surgeon
`
`was Dr. Elliot Nipper. Mr. Brown w