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IN RE REZULIN PRODUCTS LIABILITY LITIGATION

United States District Court, Southern District of New York


September 3, 2003

IN RE: REZULIN PRODUCTS LIABILITY LITIGATION (MDL NO. 1348) THIS DOCUMENT RELATES TO: ALL CASES

The opinion of the court was delivered by: Lewis Kaplan, District Judge

PRETRIAL ORDER NO. 172 (HIPAA Compliant Medical Authorization Forms)
On December 5, 2000, this Court entered Pretrial Order No. 4 (Plaintiff's Fact Sheet), which adopted a form, agreed upon by the Plaintiff's Executive Committee ("PEC") and defendants, for a plaintiff's questionnaire, including requests for medical, employment and insurance authorizations and other pertinent documents. It has come to the Court's attention that, in light of regulations recently implemented pursuant to the Health Insurance Portability and Accountability Act ("HIPAA"), the authorizations to be provided with the Plaintiff's Fact Sheet adopted in Pretrial Order No. 4 require amendment. Upon review of the proposed amendments agreed to by both the PEC and the defendants, it is hereby: ORDERED, as follows:

1. Adoption of Amended Authorizations. The attached amended medical authorizations are to be completed under oath by all plaintiffs in newly transferred cases pursuant to the schedule and procedures previously Ordered in Pretrial Orders No. 2 (Pretrial Schedule) and No. 4 (Plaintiff's Fact Sheet). From the date of this Page 2 order, the PEC shall provide to the plaintiff in each case transferred to this Court, a Plaintiff's Fact Sheet incorporating the attached amended authorizations.
2. Authorizations for Each Provider. Prior to the enactment of HIPAA, it may have been sufficient for a plaintiff to execute in blank one original medical authorization form to be used by defendants for all health care providers. HIPAA prohibits the execution of a single blank form, and therefor, each plaintiff must complete a separate, original and fully completed form for each doctor and medical facility from which records may be obtained.
3. Previously Transferred Cases. Pretrial Order No. 4 provides that any authorizations shall remain valid for the duration of the litigation. Recognizing that additional requests for medical records and other documents may become necessary in cases where plaintiff has already completed a fact sheet, any plaintiff shall be required, on defendant's request, to complete amended HIPAA-compliant authorizations. Defendants' request for such additional authorizations shall not be unreasonable. Page 3
4. Except as amended herein, all other provisions of Pretrial Order No. 4 shall remain in effect.
HIPAA COMPLIANT AUTHORIZATION FORM PURSUANT TO 45 C.F.R. § 164.508 (No psychological injury claimed)
To: Custodian or other person(s) in possession, custody, or control of the records at:
_____________________________________________

Name _____________________________________________
Address _____________________________________________
City, State and Zip Code _____________________________________________
Patient Name: ____________ AKA:_____________

Date of Birth: ___ Social Security Number:___

1) I authorize the disclosure of all protected medical information, including the following, for the purpose of review and evaluation in connection with a litigation relating to Rezulin:
• All medical records, including inpatient, outpatient and emergency room treatment, all clinical charts, reports, documents, correspondence, test results, statements, questionnaires/histories, office and doctor's notes, and records received from other physicians.
• All autopsy, laboratory, histology, cytology, pathology, radiology, CT Scan, MRI, ultrasound, echocardiogram and cardiac catheterization reports.
• Copies of all radiology films, ultrasounds, CT scans, MRI films, photographs, bone scans, cardiac catheterization videos/CDs/films/reels, echocardiogram videos, cuts and recuts of pathology/cytology/histology/autopsy/ immunohistochemistry specimens/slides.
• All pharmacy/prescription records including NDC numbers and drug information handouts/monographs.
• All billing records including all statements, itemized bills, and insurance records.
• All employment records, wage records, and disability records.
2) I authorize you to release the protected health information to:
RecordTrak, 501 Allendale Road, King of Prussia, Pennsylvania 19406.
I expressly request that full and complete medical information be released.
3) This authorization does not apply to disclosure of medical information for treatment of psychological, psychiatric, or emotional problems.
4) This authorization specifically authorizes the production and copying of records for alcohol and substance abuse, as provided by 42 C.F.R. § 2.1, et seq. Page 2
5) I acknowledge the right to revoke this authorization by writing to the ROA Agent at Recordtrak at the above referenced address. However, I understand that any actions already taken in reliance on this authorization cannot be reversed, and my revocation will not affect those actions. I acknowledge the potential for information disclosed pursuant to this authorization to be subject to redisclosure by the recipient and no longer be protected under 45 C.F.R. § 164.508.
6) I understand that the covered entity to whom this authorization is directed may not condition treatment, payment, enrollment or eligibility benefits on whether or not I sign the authorization.
7) This authorization expires at the conclusion of the above-referenced litigation by or on behalf of the above-named patient.
8) Any facsimile, copy or photocopy of the authorization shall authorize you to release the records herein.
Signature: ____________ Date:_____________

Relationship to the person who is the subject of the records:
Self:_________ Other:_____________________

Describe authority Page 2

HIPAA COMPLIANT AUTHORIZATION FORM FOR THE RELEASE OF PSYCHOLOGICAL RECORDS PURSUANT TO 45 C.F.R. § 164.5089(a) (2)
To: Custodian or other person(s) in possession, custody, or control of the records at: ______________________________________________
Name

______________________________________________

Address

______________________________________________

City, State and Zip Code

Patient Name: ________________________________

AKA:________________________

Date of Birth: ___________ Social Security

Number:______________________

1) I authorize the disclosure of all protected medical information, including the disclosure of all psychiatric, psychological, or other confidential records relating to my emotional or other psychiatric/psychological condition, including substance abuse (including drug and alcohol information) for the purpose of review and evaluation in connection with a litigation relating to Rezulin.
2) I expressly request that full and complete medical information, including but not limited to, all psychiatric/psychological records, including inpatient, outpatient and emergency room treatment, all clinical charts, reports, documents, correspondence, test results, statements, questionnaires/histories, therapy notes, office and doctor's notes, records received from other physicians, pharmacy and prescription records, and billing records, be released in accordance with this authorization.
3) I authorize you to release the protected health information to: RecordTrak, 501 Allendale Road, King of Prussia, Pennsylvania 19406. I expressly request that full and complete medical information be released.
4) This authorization is given in compliance with 42 C.F.R. § 2.31, the restrictions of which have been specifically considered and expressly waived.
5) I acknowledge the right to revoke this authorization by writing to the ROA Agent at Recordtrak at the above referenced address. However, I understand that any actions already taken in reliance on this authorization cannot be reversed, and my revocation will not affect those actions. I Page 2 acknowledge the potential for information disclosed pursuant to this authorization to be subject to re-disclosure by the recipient and no longer be protected under 45 C.F.R. § 164.508.
6) I understand that the covered entity to whom this authorization is directed may not condition treatment, payment, enrollment or eligibility benefits on whether or not I sign the authorization.
7) This authorization expires at the conclusion of the above-referenced litigation initiated by or on behalf of the above-named patient.
8) Any facsimile, copy, or photocopy of this authorization shall authorize you to release the records of the above-named patient.
Signature: ________________________

Date:_____________________

Relationship to the person who is the subject of the records:
Self: _________

Other:______________________________________

Describe authority

_______________________________________________________

_______________________________________________________

_______________________________________________________

Page 1

20030903

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