Opinion
Mdl Docket No. 1396
October 15, 2001
PRETRIAL ORDER NO. 2
The Court finds that the parties have met and conferred with regard to an initial scheduling and discovery order.
As a preliminary matter, the parties have agreed that the initial discovery should focus primarily on the class action matters, and that merits discovery should proceed after the ruling on class certification, recognizing that some limited merits discovery may be necessary. If a dispute arises with respect to whether a particular discovery request relates to a "class" issue or a "merits" issue, the parties agree to immediately submit such dispute for resolution by the Court or by the Court's designee. The Court or the Court's designee shall endeavor, to the extent possible, to issue a contemporaneous ruling on this issue.
The Court also finds that St. Jude Medical is desirous of evaluating the individual injury cases as soon as possible with a view toward possible resolution through the mediation process. In that regard, the Court will authorize St. Jude Medical to obtain medical records and, in certain instances, depose individual injury plaintiffs, during the class action discovery period.
Individual injury cases are defined as all of the cases in these proceedings, except those filed by the class action plaintiffs listed in footnotes 2 and 3.
The parties have agreed to the following initial schedule:
1. Non-injury class plaintiffs shall file and serve via overnight mail a consolidated amended class action complaint on or before October 21, 2001.
Non-injury class plaintiffs are Beatrice Bailey, Lester Grovatt, Evelyn Fox, James Macolly, Patricia Maronen, John McFadden, Jr., Irwin Fabre and Joseph Sanchez.
2. The injury class plaintiff shall file and serve via overnight mail a consolidated amended class action complaint on or before October 21, 2001.
The injury class plaintiff is Bonnie Sliger.
3. St. Jude Medical shall have until November 20, 2001 to file and serve an answer to the consolidated amended class action complaints.
4. Class plaintiffs (both injury and non-injury) and St. Jude Medical will exchange Rule 26(f) disclosures on or before October 21, 2001, unless previously provided.
5. Individual injury plaintiffs and St. Jude Medical will exchange Rule 26(f) disclosures on or before November 14, 2001, unless previously provided.
6. Unless previously provided, on or before October 21, 2001, class plaintiffs (both injury and non-injury) will provide (a) hard copies of all documents identified in the Rule 26(f) disclosure and (b) a completed Plaintiff's Initial Disclosure in the form attached hereto as Exhibit 1.
7. Individual injury plaintiffs will provide (a) hard copies of all documents identified in the Rule 26(f) disclosure and (b) a completed Plaintiff's Initial Disclosure in the form attached hereto as Exhibit 1 on or before November 14, 2001.
8. On or before October 21, 2001, St. Jude Medical will provide the documents identified in its Rule 26(f) disclosure in electronic form. The Rule 26(f) production by St. Jude Medical is conditioned upon the entry of a protective order signed by the parties and entered by the Court. If an agreement cannot be reached on a protective order prior to the time St. Jude Medical is required to produce such documents, St. Jude Medical will agree to produce such documents to parties who have executed an Interim Confidentiality Agreement in the form attached hereto as Exhibit 2.
9. Beginning on November 5, 2001, St. Jude Medical and the class plaintiffs may begin to exchange Interrogatories, Requests for Admissions or Requests for Documents. This initial written discovery shall be limited to class issues.
10. Depositions can commence after the exchange of Rule 26 disclosures and are to be completed on or before February 28, 2002, subject to having received complete answers and responses to written discovery. In the event objections are lodged that must be resolved by the Court, then all depositions are to be completed within forty-five (45) days of receipt of revised answers and/or responses pursuant to the Court s Order. Except for the depositions of individual injury plaintiffs, depositions shall be limited to class issues. If St. Jude Medical takes individual plaintiffs depositions for use at mediation, then limited merits discovery of St. Jude Medical shall be permitted. The parties are ordered to meet and confer prior to the initiation of any such merits discovery.
11. Except for the discovery set forth above, all other discovery is stayed pending further order of this Court.
12. Pursuant to Rule 16(f), joinder of any additional parties shall occur on or before March 4, 2002.
13. Plaintiffs' Motion for Class Certification will be filed and served via overnight mail on or before March 18, 2002.
14. St. Jude Medical's response to the Class Certification Motion will be filed and served via overnight mail on or before May 2, 2002.
15. Plaintiffs' reply will be filed and served on or before May 22, 2002.
16. A hearing on Plaintiffs' Class Certification Motion will take place at 9:30 a.m. on June 11, 2002.
17. The parties are ordered to meet and confer on or before March 1, 2002 with regard to a schedule for merits discovery. The parties are ordered to jointly submit a proposed merits discovery schedule on or before March 15, 2002.
18. The next Status Conference will take place at 9:30 a.m. on December 10, 2002.
IT IS SO ORDERED:
PLAINTIFF'S INITIAL DISCLOSURE
This Initial Disclosure and the attached List of Medical Providers and Other Sources of Information must be completed by each plaintiff in JCCP-1396.
I. CASE INFORMATION
A. Please state the following for the civil action which you filed:
1. Case Caption: __________________________________
2. JCCP Civil Action No.: ___________________________
3. Court in which action originally brought (transferor district): _______________________________________________
4. Original civil action number in the transferor court. Civil Action No.: ________________________________
B. If you are completing this questionnaire in a representative capacity (e.g., on behalf of the estate of a deceased person or a minor), please complete the following:
1. ____________________________________________ Your Name
2. _____________________________________________ Street Address
3. ______________________________________________ City, State and Zip Code
4. In what capacity are you representing the individual: ___________________________________ _____________
5. If you were appointed by a court, state the: _____________________________ Court Date of Appointment
6. Your relationship to deceased or represented person: _______________________________________ __________
7. If you represent a decedent's estate, state the date of death of the decedent. _______________________________________________ __
[If you are completing this questionnaire in a representative capacity, please respond to the remaining questions with respect to the person who received a St. Jude Medical mechanical heart valve. Those questions using the term "You' refer to the person who received a mechanical heart valve. If the individual is deceased, please respond as of the time immediately prior to his or her death unless a different time period is specified.]
C. Claim Information
1. Do you claim that you have suffered a bodily injury as the result of the use of a St. Jude Medical mechanical heart valve?
Yes ________ No _________
2. If the answer to the foregoing questions is "Yes", state the nature of the injury or injuries which you claim. _______________________________________________ _______________________________________________ _______________________________________________ _________________
3. If you do not claim you have suffered a bodily injury as the result of the use of a St. Jude Medical mechanical heart valve, state how you have been injured. _______________________________________________ _______________________________________________ _______________________________________________ ____________________
II. PERSONAL INFORMATION
A. Last Name: ____________________________________________ First Name: ____________________________________________ Middle Name or Initial: __________________________________
B. Maiden or other names used or by which you have been known: _____________________________________ ______________________
C. Present Street Address: ___________________________________ ___________________________________________________________ City State Zip Code
D. Current or last employer: __________________________________________________ _____ Name _______________________________________ _______________ Address __________________________________________________ _____ Dates of Employment __________________________________________________ _____ Occupation
E. Social Security Number: __________________________________
F. Date of Birth: ___________________________________________
G. Sex: Male ___ Female ___
Answer questions H-J only if you claim that you have suffered a bodily injury as the result of the use of a St. Jude Medical mechanical heart valve.
H. Have you ever filed a worker's compensation claim? Yes ___ No ___
If yes, please state
1. Year claim was filed: _____________________
2. Where claim was filed: ____________________
3. Claim/docket number, if applicable: ___________
4. Nature of disability: _________________________
5. Period of disability: _________________________
6. Address of claims office: _____________________
[Attach additional sheets if necessary to describe more than one claim]
I. Have you ever filed a social security disability claim? Yes ___ No ___
If yes, please state
1. Year claim was filed: _________________
2. Where claim was file: _________________
3. Nature of disability: _________________
4. Period of disability: _________________
5. Address of claims office: _____________
[Attach additional sheets if necessary to describe more than one claim)
J. Have you ever filed a lawsuit or made a claim, other than in the present suit, relating to any bodily injury? Yes ___ No ___
If so, state the court in which such action was filed and the civil action or docket number assigned to each such claim. action or suit. ____________________________________________________ ____________________________________________________ _______
III. MARITAL STATUS
A. Are you currently married? Yes ___ No ___
B. Has your spouse filed a loss of consortium claim? Yes ___ No ___
C. Spouse's name: _____________________
D. Spouse's date of birth: ______________
E. Spouse's occupation: _________________
IV. IMPLANT/EXPLANT INFORMATION
A. If you received a St. Jude Medical mechanical heart valve with Silzone on the sewing cuff, please state:
1. The date of implantation: ________________
2. The name and address of the implanting surgeon: ________________
B. If you had your St. Jude Medical mechanical heart valve with Silzone on the sewing cuff explanted, please state:
1. The date of explant: _________________
2. The reason for the explant: _________________
3. The name and address of the explanting surgeon: ___________________
V. OTHER MEDICAL INFORMATION
A. To the best of your knowledge, have you ever been told by a doctor or any other health care provider, that you have, may have or had any of the following:
1. Hypertension or high blood pressure Yes ___ No ___
2. Heart valve problems Yes ___ No ___
3. Heart attack Yes ___ No ___
4. Stroke Yes ___ No ___
5. Any kind of blood clot Yes ___ No ___
6. Pulmonary embolism Yes ___ No ___
7. Congenital abnormality of heart Yes ___ No ___
8. Immune system disease or dysfunction (including Aids or HIV) Yes ___ No ___
9. Rheumatic fever Yes ___ No ___
10. Cirrhosis, hepatitis or other liver disease Yes ___ No ___
11. Alcoholism Yes ___ No ___
12. Cancer(s) Yes ___ No ___ If yes, specify: ____________________________
13. Pulmonary hypertension Yes ___ No ___
14. Neurological problem Yes ___ No ___ If yes, specify: ___________________________
15. Cardiac arrhythmias Yes ___ No ___
16. Endocarditis Yes ___ No ___
17. Any cholesterol problem Yes ___ No ___
18. Diabetes mellitus or other form of diabetes Yes ___ No ___ If yes, specify the type: ___________________
19. Kidney disease Yes ___ No ___
20. Any connective tissue disease Yes ___ No ___ (e.g. Marfan's, Lupus or Arthritis)
21. Other autoimmune disease Yes ___ No ___ If Yes, specify: ___________________________
22. Thyroid disorder Yes ___ No ___
23. Coronary artery disease Yes ___ No ___
24. Other heart or lung disease Yes ___ No ___
25. Gum disease, tooth infection or abscess Yes ___ No ___
26. Transient ischemic attack (TIA) Yes ___ No ___
27. Hypotension (low blood pressure) Yes ___ No ___
28. Carotid artery disease Yes ___ No ___
29. Aortic aneurysm Yes ___ No ___
30. urinary infection Yes ___ No ___
B. If you responded yes to any of the above, please identify the condition, the date of onset and state the name of the physician or other person and, if not provided in the accompanying list, the address of the physician who made the diagnosis or informed you of the condition.
1. Condition: ____________________________________ _____ Onset: __________________________________ __________ Name and address of diagnosing physician or other person: _______________________________________________ ___
2. Condition: ____________________________________ _____ Onset: __________________________________ __________ Name and address of diagnosing physician or other person: _______________________________________________ ___
3. Condition: ____________________________________ _____ Onset: __________________________________ __________ Name and address of diagnosing physician or other person: _______________________________________________ ___
4. Condition: ____________________________________ _____ Onset: __________________________________ __________ Name and address of diagnosing physician or other person: _______________________________________________ ___
5. Condition: ____________________________________ _____ Onset: __________________________________ __________ Name and address of diagnosing physician or other person: _______________________________________________ ___
C. State the name and address of your current family/primary care physician: _________________________________________________ _________________________________________________ _______________________ _________________________________________________ ___________
D. State the name and address of each of your family/ primary care physicians going back 10 years. __________________________________________ ___________________ _________________________________________________ _________________________________________________ _________________________
E. State the name and address of each cardiologist, cardiac surgeon and/or thoracic surgeon that has ever seen or treated you. _________________________________________________ _________________________________________________ _______________________ _________________________________________________ ___________
F. State the name and address of each hospital or surgery center where you have ever received treatment in the last 10 years. _________________________________________________ _________________________________________________ _____________________ _________________________________________________ __________
G. State the name and address of each other physician or healthcare provider from whom you ever received treatment in the last 10 years. _________________________________________________ _________________________________________________ _____________________ _________________________________________________ __________
H. State the name and address of each pharmacy, drugstore or any other facility where you ever received any prescription medication in the last ten years. ______________________________________ _________________________ _________________________________________________ _________________________________________________ _____________________________
VI. LOSS OF INCOME
A. If you claim or expect to claim that you lost earnings or impairment of earning capacity as a result of any condition which you believe was caused by your St. Jude Medical mechanical heart valve:
1. Complete the following information with respect to your employment for the past ten years.
Employers for Past Address Position Dates of Employment Ten Years ___________________________________________________ __________________________ ___________________________________________________ __________________________ ___________________________________________________ __________________________ ___________________________________________________ __________________________
2. State the total amount of time which you have lost from work as a result of any condition which you claim or believe was caused by your St. Jude Medical mechanical heart valve and the amount of income which you lost.
3. State your earned income for each of the last five years. Year Income $_______________ $_______________ $_______________ $_______________ $_______________
B. State the amount of medical expenses you have you paid or incurred, including amounts billed or paid by insurers and other third party payors, which are related to any condition which you claim or believe was caused by your use of a St. Jude Medical mechanical heart valve for which you seek recovery in this action. $________________
DOCUMENT REQUEST
Attach the following documents to this declaration, to the extent that such documents are currently in your possession or in the possession of your lawyers:1. All press releases or other public statements made by you relating to this litigation or to your illness, injury, or medical condition that forms the basis of your Complaint.
2. All tissue specimens, pathology material, slides or tissue blocks obtained from your heart or heart valves.
3. All documents referring or relating to your claimed damages.
4. Each informed consent form signed by you in connection with treatment by a health care professional and/or institution relating to any St. Jude Medical heart valve with Silzone coating on the sewing cuff.
5. All documents, including but not limited to, literature and/or warnings, received by you relating to any St. Jude Medical heart valve with Silzone coating on the sewing cuff from any source.
6. All documents referring or relating to your medical history, including, but not limited to, medical records.
7. All documents relating to your insurance coverage that are applicable to the illness, injury or medical condition which forms the basis of your Complaint, including any application to any insurer for coverage whether insurance was obtained or not.
8. All written, recorded or transcribed statements concerning this action made by any parties or witnesses, or their respective agents, servants or employees.
9. If you claim that you have suffered a bodily injury as the result of the use of a St. Jude Medical mechanical heart valve, all documents submitted to or received from the Social Security Administration, any workers' compensation agency, or any disability insurer concerning any disability claim you have made.
10. If you are making a claim for loss of earnings or loss of earnings impairment, your state and federal tax returns for the last five years.
11. Authorizations for the release of release of medical, employment, insurance and disability records for those entities identified in the above responses.
DECLARATION
I declare under penalty of perjury under the laws of the United States of America that all of the information provided in this Initial Disclosure is true and correct to the best of my knowledge. I further declare that I have supplied all the documents requested in part VII of this declaration, to the extent that such documents are in my possession or in the possession of my lawyers, and that I have supplied authorizations for the release of medical, employment, insurance and disability records for those entities identified in these responses. _____________________ Signature Date
AUTHORIZATION FOR RELEASE OF MEDICAL RECORDS{PRIVATE }
TO: _________________________________ _________________________________ _________________________________
Identifying Information
Patient Name:Patient Date of Birth:
Patient SSN:
This authorization is being provided to you to authorize you to give CROSBY, HEAFEY, ROACH MAY or their representative(s), copies of all files or documents including information stored in electronic form, videotape, audio tape, photographs, or any other computerized data storage, imaging system or pathology material in deponent s possession, custody or control, regarding __________________________(PATIENT NAME), including but not limited to:
(1) WRITTEN MEDICAL RECORDS: any and all medical records, all impatient and out patient charts and records, hospital charts and records, doctor and nurse notes, emergency room records, correspondence, memoranda, physical therapy and rehabilitation records, patient questionnaire forms, patient history forms, laboratory reports, diagnostic reports
(2) DIAGNOSTIC TESTS OR IMAGING: any and all written reports, videotapes, transcripts/tracings, operative photographs, slides, x-ray films, audio tapes, computer disk/storage films of, including, but not limited to the following:
a. echocardiograms (transthoractic (EEG) and transesophageal (TEE))
b. electrocardiograms (EKG)
c. pulmonary function tests
d. stress tests
e. angiograms
f. catheterizations
g. cardiac catherization tapes (CINE films)
(3) PATHOLOGY: any and all pathology records including:
a. written reports
b. materials
c. microscopic slides
d. wet tissues
e. special stains
f. unstained tissue paraffin
g. epoxy or plastic blocks
h. sputum reports
i. recuts of cardiac pathology
(4) RADIOLOGY: any and all radiology, x-rays, cat scans, MRI films, SPECT scans, CAT scans, brain scans, EEG and EKG tracings in all forms including original films, copy of computer storage of the data on disk or tape and a copy of the reports.
(5) PRESCRIPTION RECORDS: any and all prescription records, the issuance of sale of prescription drugs, original doctor's prescription forms, refill records and pharmacy records.
(6) PROTOCOL: any and all documents describing the protocol and criteria for administration and interpretation of diagnostic tests or imaging.
(7) BILLING: any and all billing records, including itemized statements of charges, payments, all insurance records, including all claims, claim forms, correspondence, payments and reports.
This authorization shall remain valid for one (1) year from the date of my signature. A photostatic copy of this authorization with my photostatic signature shall have the same binding effect as an original authorization with an original signature.
DATED: _________ SIGNED: _______ PATIENT SIGNATURE
INTERIM CONFIDENTIALITY AGREEMENT
WHEREAS St. Jude Medical has agreed to disclose documents pursuant to Federal Rules of Civil Procedure, Rule 26(f); andWHEREAS, St. Jude Medical believes that certain documents and other information which it has agreed to produce may consist of or contain confidential and sensitive financial data, technical information, trade secrets, proprietary or nonpublic commercial information, information involving privacy interests, and other commercially and/or competitively sensitive information of a nonpublic nature, or received on a confidential basis; and
WHEREAS, the undersigned are attempting to reach agreement on a Stipulated Protective Order and/or a motion to the Court to enter a Protective Order, but in the interim want to begin the production of documents;
IT IS HEREBY AGREED by the undersigned that:
1. All documents produced by St. Jude Medical during the pendency of efforts to obtain an agreed-upon or court-ordered Protective Order shall be deemed "confidential" and shall not be disclosed by the undersigned Plaintiff[s] or their counsel of record to anyone whatsoever until such time that the Court has entered a Protective Order.
2. All documents produced by St. Jude Medical pursuant to this Interim Confidentiality Agreement shall immediately become subject to the terms and conditions of any Stipulated Protective Confidentiality Agreement and/or Protective Order entered by the Court.
3. The undersigned agree that by entering into this Agreement, neither party is agreeing that the documents produced pursuant hereto either are or are not entitled to protection pursuant to a Protective Order under applicable law, and are entering into this Agreement only for the purpose of facilitating the production of these documents while the Protective Order issue is being resolved.
4. The phrase counsel of record as set forth herein shall include the undersigned, and their partners, associate attorneys, paralegals, and clerical employees assigned to assist the undersigned in the prosecution or settlement of this case.
5. Unless otherwise agreed to by the parties, in writing, any documents produced by St. Jude Medical pursuant to this Interim Confidentiality Agreement shall not be filed with the Court unless the parties agree, in good faith, to a Consent Order pursuant to which the confidentiality of the documents shall remain protected in connection with the Court filing.