united states district court in re: depuy …...united states district court northern district of...

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1 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS DALLAS DIVISION IN RE: DEPUY ORTHOPAEDICS, INC. PINNACLE HIP IMPLANT PRODUCT LIABILITY LITIGATION ) ) MDL No. XXXX ) ) ) This Document Relates To: ALL CASES ) Honorable Ed Kinkeade ) ) ) ) PLAINTIFF FACT SHEET Please provide the following information for each individual on whose behalf a claim is being made. Whether you are completing this Plaintiff Fact Sheet for yourself or for someone else, please assume that "You" means the person who had the Pinnacle hip implant on which the lawsuit is based (the Device”) implanted. In filling out this form, please use the following definition: "healthcare provider" means any hospital, clinic, center, physician's office, infirmary, medical or diagnostic laboratory, or other facility that provides medical care or advice, and any pharmacy, x-ray department, radiology department, laboratory, physical therapist or physical therapy department, rehabilitation specialist, or other persons or entities involved in the diagnosis, care and/or treatment of you. In filling out any section or sub-section of this form, please submit additional sheets as necessary to provide complete information. In addition, if you learn that any of your responses are incomplete or incorrect at any time, please supplement your responses to provide that information as soon as you become aware of this information. This form requests information and documents about your medical condition for a specified period of time. However, defendants reserve the right to request additional information and information for a time period dating further back on a case-by-case basis, at which time the parties will meet and confer as the issue arises. In completing this Plaintiff Fact Sheet, you are under oath and must provide information that is true and correct to the best of your knowledge, information and belief. If the response to any question is that the person completing this Plaintiff Fact Sheet does not know or does not recall the information requested that response should be entered in the appropriate location.

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Page 1: UNITED STATES DISTRICT COURT IN RE: DEPUY …...UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF TEXAS DALLAS DIVISION IN RE: DEPUY ORTHOPAEDICS, INC. PINNACLE HIP IMPLANT PRODUCT

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UNITED STATES DISTRICT COURTNORTHERN DISTRICT OF TEXAS

DALLAS DIVISION

IN RE: DEPUY ORTHOPAEDICS, INC.PINNACLE HIP IMPLANT PRODUCTLIABILITY LITIGATION

)

) MDL No. XXXX)))

This Document Relates To:

ALL CASES

) Honorable Ed Kinkeade))))

PLAINTIFF FACT SHEET

Please provide the following information for each individual on whose behalf a claim is beingmade. Whether you are completing this Plaintiff Fact Sheet for yourself or for someone else, pleaseassume that "You" means the person who had the Pinnacle hip implant on which the lawsuit is based(the “Device”) implanted. In filling out this form, please use the following definition: "healthcareprovider" means any hospital, clinic, center, physician's office, infirmary, medical or diagnosticlaboratory, or other facility that provides medical care or advice, and any pharmacy, x-ray department,radiology department, laboratory, physical therapist or physical therapy department, rehabilitationspecialist, or other persons or entities involved in the diagnosis, care and/or treatment of you.

In filling out any section or sub-section of this form, please submit additional sheets as necessaryto provide complete information. In addition, if you learn that any of your responses are incomplete orincorrect at any time, please supplement your responses to provide that information as soon as youbecome aware of this information. This form requests information and documents about your medicalcondition for a specified period of time. However, defendants reserve the right to request additionalinformation and information for a time period dating further back on a case-by-case basis, at which timethe parties will meet and confer as the issue arises.

In completing this Plaintiff Fact Sheet, you are under oath and must provide information that istrue and correct to the best of your knowledge, information and belief. If the response to any question isthat the person completing this Plaintiff Fact Sheet does not know or does not recall the informationrequested that response should be entered in the appropriate location.

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You may and should consult with your attorney if you have any questions regarding thecompletion of this form.1

I. CASE INFORMATION

1. Name of person on whose behalf a claim is being made (first, middle name or initial, last),including maiden or other names used: XXXX Johnson

2. Name of person signing this form, if different than above: N/A

3. Please state the following for the civil action that you filed: N/A

a. Case caption:_______

b. Docket Number:______

c. Name, address, telephone number, fax number and e-mail address of principal attorneyrepresenting you:

Name: _______________Firm: ________________Address: ______________Telephone Number: _________Fax Number: ___________E-mail Address: ________

THE REST OF THIS PLAINTIFF FACT SHEET REQUESTS INFORMATION ABOUT THEPERSON WHO WAS IMPLANTED WITH THE DEVICE

II. CORE MEDICAL INFORMATION

1. Implant Date(s): 12/11/YYYY – Left total hip arthroplasty

2. Revision Date(s) (if applicable):

05/30/YYYY - First stage revision left hip arthroplasty

1 This Plaintiff Fact Sheet constitutes discovery responses subject to the Federal Rules of Civil Procedure.

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08/13/YYYY - Second stage revision left hip arthroplasty

3. If you have had a Device revised, please state the location of the revised components of theDevice, if known. 08/13/YYYY - Modular stem, acetabular shell, femoral head, and acetabularliner

4. Please attach a copy of: (1) the operative report(s) for the implant of the Pinnacle products atissue in this case, including the product identification information/stickers where available, and,if the plaintiff has undergone one or more revision surgeries, (2) the operative report(s) from thesurgery (ies) to remove the Pinnacle products at issue in this case.

5. Identify the following healthcare providers:2

a. Each doctor or healthcare provider (including, but not limited to, family/primary carephysicians, orthopedic surgeons, physical therapists, chiropractors and practitioners of thehealing arts) whom you have seen for medical care and treatment for any condition,including, but not limited to, any condition related to your hip, for the period five yearsbefore your first hip surgery to the present.

b. Each hospital, clinic, surgery center, healthcare facility, physical therapy or rehabilitationcenters where you have received medical treatment (in-patient, out-patient, or emergencyroom visit) for any condition, including, but not limited to, any condition related to yourhip, for the period five years before your first hip surgery to the present

c. Each facility at which radiographs (x-rays, ultrasounds, MRIs, CT scans) was taken ofyour hips, pelvis or legs for the period five years before your first hip surgery to thepresent.

d. Each laboratory at which your blood was tested blood levels of any metals, includingcobalt and chromium for the period five years before your first hip surgery to the present.

Name Address Nature and approximate dates of visit(s),treatment(s) or test(s)

XXXXX Medical Center XXXXX 03/31/YYYY, 05/13/YYYY – Visit for soresall over body, skin infection

12/11/YYYY–06/03/YYYY - Left total hip

2 Men are not asked to identify healthcare providers who treated prostate conditions and women are not asked to identifyhealthcare providers related to birth control or reproductive issues, unless they claim they are related to their hip replacement,and then the healthcare providers need to be identified.

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arthroplasty, first stage revision left hiparthroplasty, and inpatient Physical Therapystatus post first stage revision left hiparthroplasty

07/31/YYYY – Left hip aspiration

08/13/YYYY-08/17/YYYY – Second stagerevision left hip arthroplasty, and inpatientPhysical Therapy status post second stagerevision left hip arthroplasty

XXXXX Hospital XXXXX 06/12/YYYY, 10/21/YYYY - Visit for skininfections

XXXXX Hospital XXXXX 12/17/2012 - Visit for abdominal problem

XXXXX Orthopedics andSports Medicine - Provo

XXXXX 03/27/YYYY, 04/29/YYYY, 07/25/YYYY –Follow-up visits for left hip pain status postleft hip arthroplasty, order for left hipaspiration

XXXXX Clinic XXXXX 05/14/YYYY - Consultation for skin infection

06/14/YYYY, 06/21/YYYY, 06/28/YYYY,07/05/YYYY, 07/12/YYYY, 08/07/YYYY -Follow-up visits status post first stage revisionleft hip arthroplasty

XXXXX Homecare XXXXX 05/05/YYYY - Home Health Nursing prior tofirst stage revision left total hip arthroplasty

06/04/YYYY-06/29/YYYY - Home HealthNursing for intravenous antibiotics forinfection status post left hip arthroplasty

XXXXX Johnson, M.D. -Anesthesiologist

XXXXX 08/13/YYYY – Anesthesia for second stagerevision left hip arthroplasty

Craig XXXXX. – XXXXXl Medical 03/31/YYYY – Visit for sores all over body

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Emergency Medicine Center - XXXXX

Jeffrey XXXXX, M.D. -Orthopedic Surgery

Utah ValleyOrthopedics and SportsMedicine – Provo -XXXXX

12/11/YYYY – 08/17/YYYY - Left total hiparthroplasty, follow-up visits for left hip painstatus post left hip arthroplasty, first stagerevision left hip arthroplasty, order for left hipaspiration, second stage revision left hiparthroplasty

Todd XXXXX, M.D. –(Anesthesiologist)

XXXXXl MedicalCenter - XXXXX

12/11/YYYY - Left total hip arthroplasty

Devon XXXXX, M.D. –Infectious DiseaseMedicine

XXXXX Hospital -XXXXX

10/21/YYYY- Visit for skin infections

Douglas XXXXX, M.D. –Emergency Medicine

XXXXX 12/17/2012 - Visit for abdominal problems

Cindy XXXXX, R.N. XXXXX 05/05/YYYY – Assisted Living Facilityassessment for hip pain and ambulation

Larry XXXXX, M.D. –Infectious Disease

XXXXX ClinicXXXXX

05/14/YYYY - Consultation for skin infection

Igor XXXXX - InfectiousDisease

XXXXX Clinic -XXXXX

05/31/YYYY - Consultation for skin infection

06/14/YYYY, 06/21/YYYY, 06/28/YYYY,07/05/YYYY, 07/12/YYYY, 08/07/YYYY-Follow-up visits status post first stage revisionleft hip arthroplasty

Christian XXXXX, M.D. –Anesthesiologist

XXXXXl MedicalCenter - XXXXX

05/30/YYYY - First stage revision left hiparthroplasty

Genevieve XXXXX –Physical Therapy

XXXXX 05/31/YYYY-06/03/YYYY - InpatientPhysical Therapy status post first stagerevision left hip arthroplasty

08/14/YYYY-08/17/YYYY – InpatientPhysical Therapy status post second stage

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revision left hip arthroplasty

Sofarelli XXXXX, PA-C –Physician Assistant

XXXXX Hospital - 06/12/YYYY - Visit for skin infections

Carma XXXXX, R.N. XXXXX 06/04/YYYY-06/29/YYYY - Home HealthNursing for intravenous antibiotics forinfection status post left hip arthroplasty

Matthew XXXXX, M.D. –Vascular and InterventionalRadiology

XXXXX Clinic -XXXXX

07/31/YYYY – Left hip aspiration

Val XXXXX, M.D. –Diagnostic Radiology

XXXXX XXXXX 12/11/YYYY - Left total hip arthroplasty

Kimball XXXXX, M.D. -Diagnostic Radiology

XXXXX AmericanFork, UT 84003 (Websearch)

04/04/YYYY - Three phase bone scan of lefthip for left hip pain status post first stagerevision left hip arthroplasty

05/30/YYYY - Post operative X -ray of lefthip

Roy XXXXX, M.D. -Diagnostic Radiology

XXXXX St AmericanFork, UT 84003 (Websearch)

04/04/YYYY – MRI of left hip for left hippain status post first stage revision left hiparthroplasty

XXXXX Healthcare 36 S State St, Salt LakeCity, UT (Web search)

04/12/YYYY – Cobalt and chromium testing

III. PERSONAL INFORMATION

1. Current address and date when you began living at this address: Lives at Salina, UT (As on05/31/YYYY); Date when he began living at this address - Unknown

2. Social Security Number: 528-06-3725

3. Date and place of birth: Date of birth – 11/15/YYYY; Place of birth - Salina, UT

4. Current marital status: Divorced (As on 06/05/YYYY)

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5. Has your present or former spouse filed a loss of consortium or other claim in this action?Unknown

Yes: _____ No: _____

6. For the period of time from five years before your had your first hip surgery, until the present,please identify all of your employers, with name, address and telephone number, youremployment dates, your position there, and your reason for leaving if no longer employed there:

Name ofEmployer

Address andTelephoneNumber

Dates ofEmployment

Describe YourPosition or Dutiesand Specify if JobRequired Manual

Labor

Reason forLeaving

Unknown Unknown Unknown Coalminer Unknown

XXXXX Towing XXXXX, Salina,UT 84654

Unknown Towing (As on03/31/YYYY to07/19/YYYY)

Unknown

*Reviewer’s comment: As on 07/31/YYYY, he was unemployed

If you have you ever served in the military, please state the branch and dates of service: Unknown

7. If you have Medicare, please state your HICN number: N/A

8. Have you been on or applied for workers' compensation, Social Security, and/or state or federaldisability benefits? Unknown

Yes _____ No _____

If Yes, as to each application, separately state the following and attach any documents you havewhich relate to the application and/or award of benefits:

a. Date (or year) of application: ________

b. Type of benefits: _____________

c. Nature of claimed injury/disability: ______

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d. Period of disability: ______

e. To what agency or company did you submit your application: __________

f. Claim/docket number, if applicable:____________

g. Was claim granted?Yes _____ No _____

h. Amount awarded: ________________

9. Have you ever been involved in an accident or other event as a result of which you suffered anypersonal injuries to your legs, hips or pelvic area?

Yes X No___

If Yes, please provide the following information and attach copies of any accident reports:

Place and Dateof Accident

Circumstances, Nature,Location, and Extent of

Injury

Nature of Activityat Time of Injury

Names and Addresses ofTreating Physician(s)

Coalmine Fall Unknown Unknown

10. Have you ever filed a lawsuit or made a claim against anyone related to any injury to your hip,pelvis or legs, other than the present lawsuit? Unknown

Yes _______ No _______

If yes, please provide the following information and attach copies of all pleadings, releases orsettlement agreements and deposition transcripts you have:

Party YouSued/Made Claim

Against

Court in Which SuitFiled/Claim Made

Case/ClaimNumber

Attorney WhoRepresented You

Nature ofClaim and

Injury

11. Other than your retention agreement with your attorney, or any lien or repayment obligationsrelated to medical expenses, have you entered into a transaction, contract or other agreement that

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creates an obligation to pay or repay money that is contingent on the outcome of your case?Unknown

Yes _______ No _______

If yes, please attach any contracts or other documentation regarding the agreement.

IV. MEDICAL BACKGROUND

1. Current Height: 175.30 cm (As on 08/14/YYYY)

2. Please state your weight at the following times

a. Current: 117.94 kg (As on 08/14/YYYY)

b. Time of implant:253 pounds (As on 12/11/YYYY)

3. Time of revision surgery (if any):

05/30/YYYY - First stage revision left hip arthroplasty – Weight: 114 kg

08/13/YYYY - Second stage revision left hip arthroplasty – Weight: 265.4 pounds

4. Allergies and Allergic Reactions

a. Have you ever experienced an allergic reaction to any jewelry or metal? N/A

Yes _____ No ___

b. If Yes, please state the following:

Type of Jewelry orMetal

When AllergyDiagnosed

Symptoms ofAllergy

Name & Address of HealthCare Provider WhoDiagnosed Allergy

TreatmentReceived, if

any

V. IMPLANT

1. Did you see, read or rely upon any documents or other information from DePuy in making yourdecision to have the Device implanted? Unknown

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Yes ___ No ___

If Yes, please:

a. Identify each document/source of information: ___

b. State when you read the document/received the information:

c. State how you obtained the document or information:

d. Do you have the document or written information in your possession? If so, pleaseproduce a copy of it together with your answers to the Plaintiff Fact Sheet.

Yes No I don't knowIf you no longer have the document or written information in your possession, pleasedescribe the information that you received to the best of your ability:

2. Were you given any other written instructions, warnings or other information regarding theimplantation of the Device? Unknown

Yes___ No ___ I don't know ___

a. If yes, when did you receive the information?

b. Who gave you the information?

c. Do you have the written information in your possession? If so, please produce a copy ofit together with your answers to the Plaintiff Fact Sheet.

Yes No I don't know

d. If you no longer have the written information, please describe the information that youreceived to the best of your ability.

VI. UNREVISED PLAINTIFFS – TO BE ANSWERED ONLY IF YOU HAVE NOT HAD AREVISION SURGERY

1. Has any doctor recommended that you undergo revision surgery for your Pinnacle implant? N/A

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Yes No _______

If Yes, please respond to questions 2 – 6, below. If No, please proceed to Section VII.

2. Please provide the name and address of each doctor who has ever told you that you need to haveany components of your Device(s) removed, and the date you were told this: _______

3. Please explain what your doctor told you about why he or she recommended a revisionsurgery._________

4. Has any doctor told you that your medical condition prevents you from having a revision surgeryor from having any components of your Device removed?

Yes No ____

If Yes, please provide name and address of each such doctor, the date you were told this, andwhat the medical condition is:

5. Do you presently plan to have any of the components currently in your body removed? Unknown

Yes No Undecided

6. If Yes, please state:

a. The date scheduled for the surgery to remove/replace the Devices:

b. The name of the surgeon:

c. The name and address of the hospital where the surgery will be performed: ______

VII. INJURIES & DAMAGES

1. Are you claiming any physical injuries or illness as a result of the Device?

Yes X No _____

If yes, please describe in detail the following:

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a. The physical injuries or illness claimed and when the symptoms began: ________

03/27/YYYY-04/29/YYYY: Left hip pain – Prescribed Diclofenac gel, cryotherapy anduse of cane for pain or limp

05/16/YYYY: Numbness of both feet, unable to sit comfortably, persisting left hip pain -Diagnosed with greater trochanteric bursitis - Planned first stage revision left hiparthroplasty with Biomet components on 05/30/YYYY

05/30/YYYY: Underwent first stage revision left hip arthroplasty with removal of allcomponents and placement of antibiotic PMMA spacer, EquivaBone and cerclage cables

06/13/YYYY-07/05/YYYY: Was treated with Rocephin for left hip infection

08/12/YYYY: Planned for second stage revision left hip arthroplasty as infectionsubsided

08/13/YYYY: Underwent second stage revision left hip arthroplasty using Biometcomponents

b. Are those injuries or illnesses continuing?

Yes _____ No X

If Yes, state your current condition and describe any on-going limitations and/orsymptoms that you claim were caused by or are related to your Pinnacle implant.*Reviewer’s comment: As per last available record on 08/17/YYYY, he was discharged toHome Health in stable condition. Further records are not available.

2. Are you making a claim for lost wages or lost earning capacity? Unknown

Yes _____ No _____

If yes, describe your claim. Your description should include the problems that limited orprevented you from working, any permanent limitation on the types of jobs you can perform, thetotal amount of time (and amount of income) you have lost or will lose from work as a result ofany condition that you claim or believe was caused by the Device, and an explanation of howthose amounts were calculated:

___________________

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3. Please produce all documents related to the medical expenses (whether paid by you, insurers,Medicare or other third parties) for which you seek recovery in this lawsuit:

4. If you are filling this out on behalf of an individual who is deceased and on whom an autopsywas performed, please attach a copy of the death certificate and any autopsy report. - N/A

VIII. DOCUMENT DEMANDS

Please produce the following documents:

1. For the surgery in which the Pinnacle Device was implanted, (1) copies of the productidentification information/sticker for your Device; (2) the pre-operative history and physicalreport; (3) the implant operative report; and (4) the discharge summary.

2. For each revision surgery: (1) copies of the product identification information/sticker for anyprosthetic components or other hardware that was implanted; (2) the pre-operative history andphysical report; (3) the implant operative report; and (4) the discharge summary.

3. Any x-rays of your hip(s).

4. Documents that relate in any way to your application for, or award of, workers' compensationbenefits for any injury or condition related to your hip during the period from five years beforeyour first hip surgery to the present.

5. Copies of any accident report(s) related to any accident or event, in which or as a result of whichyou suffered any personal injuries to your legs, hips or pelvic area.

6. Copies of all pleadings, releases or settlement agreements and deposition transcripts related toany lawsuit or claim against anyone related to any injury to your hip, pelvis or legs.

7. Documentation of any agreement you have entered into, other than your retention agreementwith your attorney or any lien or repayment obligations related to medical expenses, whichcreates an obligation to pay or repay money that is contingent on the outcome of your case.

8. Copies of any documents from DePuy that you read or relied on in making your decision to havethe Device implanted.

9. Copies of any written instructions, warnings or other information received from any sourceregarding the implantation of the Device, including any informed consent form.

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10. Copies of any communications with any present or former employee of DePuy, Johnson &Johnson or any DePuy distributor or sales representative concerning the Device or matters in anyway related to this lawsuit.

11. If you are filling out this Plaintiff Fact Sheet on behalf of an individual who is deceased, providea copy of the letter of administration and a copy of the death certificate.

12. If you are filling out this Plaintiff Fact Sheet on behalf of an individual who is deceased, providea copy of any autopsy report.

IX. AUTHORIZATIONS

Complete and sign the attached Authorizations.

X. VERIFICATION

I declare under penalty of perjury that all of the information provided in this Plaintiff Fact Sheet is trueand correct to the best of my knowledge upon information and belief, that I have supplied all thedocuments requested in this Plaintiff Fact Sheet, to the extent that such documents are in my possession,custody, or control, or in the possession, custody, or control of my lawyers, and that I have supplied theauthorizations attached to this declaration.

Date:

Signature

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EXHIBIT B

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LIMITED AUTHORIZATION TO DISCLOSE HEALTH INFORMATION

(Pursuant to the Health Insurance Portability and Accountability Act "HIPAA" of 4/14/03)

TO:Patient Name:DOB:SSN:

I, ________________________________, hereby authorize you to release and furnish to:XXXX LLP, and/or RecordTrak copies of the following information:

All medical records, including inpatient, outpatient, and emergency room treatment,all clinical charts, reports, documents, correspondence, test results, statements,questionnaires/histories, office and doctors' handwritten notes, and records receivedby other physicians. Said medical records shall include all information regardingAIDS and HIV status.

All autopsy, laboratory, histology, cytology, pathology, radiology, CT Scan, MRI,echocardiogram and cardiac catheterization reports.

All radiology films, mammograms, myelograms, CT scans, photographs, bone scans,pathology/cytology/histology/autopsy/immunohistochemistry specimens, cardiaccatheterization videos/CDs/films/reels, and echocardiogram videos.

All pharmacy/prescription records, including NDC numbers and drug informationhandouts/monographs.

All billing records including all statements, itemized bills, and insurance records.

1. To my medical provider: this authorization is being forwarded by, or on behalf of,attorneys for the defendants for the purpose of litigation. You are not authorized to discussany aspect of the above-named person's medical history, care, treatment, diagnosis,prognosis, information revealed by or in the medical records, or any other matter bearingon his or her medical or physical condition, unless you receive an additional authorizationpermitting such discussion. Subject to all applicable legal objections, this restriction doesnot apply to discussing my medical history, care, treatment, diagnosis, prognosis,information revealed by or in the medical records, or any other matter bearing on mymedical or physical condition at a deposition or trial.

2. I understand that the information in my health record may include information relating tosexually transmitted disease, acquired immunodeficiency syndrome (AIDS), or humanimmunodeficiency virus (HIV). It may also include information about behavioral or mentalhealth services, and treatment for alcohol and drug abuse.

3. I understand that I have the right to revoke this authorization at any time. I understand that if Irevoke this authorization, I must do so in writing and present my written revocation to the healthinformation management department. I understand the revocation will not apply to information

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that has already been released in response to this authorization. I understand the revocation willnot apply to my insurance company when the law provides my insurer with the right to contest aclaim under my policy. Unless otherwise revoked, this authorization will expire in one year.

4. I understand that authorizing the disclosure of this health information is voluntary. I can refuseto sign this authorization. I need not sign this form in order to assure treatment. I understand Imay inspect or copy the information to be used or disclosed as provided in CFR 164.524. Iunderstand that any disclosure of information carries with it the potential for an unauthorized re-disclosure and the information may not be protected by federal confidentiality rules. If I havequestions about disclosure of my health information, I can contact the releaser indicate above.

5. A notarized signature is not required. CFR 164.508. A copy of this authorization may be usedin place of an original.

Print Name: ______________________________________ (plaintiff/representative)

Signature: _____________________________________ Date_________________