IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
:
:
: / MDL NO. 2342
12-MD-2342
HON. CYNTHIA M. RUFE
THIS DOCUMENT RELATES TO:
MDL Case No.:
Case Name: / :
:
:
:
:
PLAINTIFF COMPREHENSIVE FACT SHEET
INSTRUCTIONS
- Each Plaintiff family whose case has been selected as part of the Initial Discovery Group and who has filed a lawsuit against Pfizer Inc., Greenstone LLC, or any other entity, alleging congenital malformations, persistent pulmonary hypertension of the newborn (“PPHN”), or other conditions purportedly caused by the ingestion of Zoloft or sertraline hydrochloride during pregnancy must complete this separate form.
- All the responses in this Fact Sheet or an amendment thereto are binding upon Plaintiffs as if they were contained in answers to interrogatories.
- In completing this form, you are under oath and must provide information that is true and correct. You must answer every question as specifically as possible. If you cannot recall all of the details requested, please provide as much information as you can. For example, if a question asks for a date and the exact date is not known or capable of being ascertained, an approximate date should be provided (i.e., “approximately mid-2001”). You may and should consult records in your possession that contain responsive information to assist you in responding. You may be requested to provide copies of such documentation that are in your possession.
- You must supplement your responses if you learn that they are incomplete or incorrect in any material respect. Each question herein shall be deemed continuing in nature so as to require supplemental answers if you obtain further information between the time of answering and the trial.
- Each question herein should be construed independently, unless otherwise noted. No question should be construed by reference to any other question if the result is a limitation of the scope of the answer to such question.
- The questions herein do not seek the discoveryof information protected by the attorney-client privilege.
- Your lawyer has an electronic version of this Fact Sheet that can expand to accommodate as much information as is necessary to fully answer any of these questions. If you are filling out a paper copy of this Fact Sheet, you may photocopy and submit as many copies of any page of this Fact Sheet as is necessary to fully answer any question.
DEFINITIONS
Minor Plaintiff: The Child who allegedly sustained a congenital malformation, PPHN, or other similar condition caused by his/her mother’s ingestion of Zoloft or sertraline hydrochloride and for whom this Fact Sheet is being completed. This definition shall include Minor Plaintiffs who are deceased.
Mother Plaintiff: The biological mother of the Minor Plaintiff and the person whose ingestion of Zoloft or sertraline hydrochloride during pregnancy allegedly caused the Minor Plaintiff to sustain a congenital malformation, PPHN, or other condition. This person may or may not be named as a plaintiff in the filed-lawsuit pending in this Court.
Father: The biological father of the Minor Plaintiff (who may also be named as a plaintiff in the filed-lawsuit pending in this Court).
Healthcare Provider: Any provider of healthcare, including physicians, osteopaths, medical doctors, psychologists, psychiatrists, nurses, nurse practitioners, physician’s assistants, school nurse practitioners, lay therapists, rehabilitation specialists, counselors, physical therapists, pharmacists, mental health specialists., and substance abuse treatment personnel.
Healthcare Facility: All hospitals, clinics, outpatient facilities, health departments, medical offices, laboratories, substance abuse treatment centers, and all other locations at which medical care, treatment, or medication is provided by any Healthcare Provider.
Mental Health Issue: Any diagnosed disease or condition affecting or influencing the way a person thinks, feels, behaves, and/or relates to others and to his or her surroundings. Such conditions include but are not limited to those which are biological, psychodynamic, cognitive, behavioral, interpersonal, familial, psychological, psychiatric, or environmental in nature and/or any other stressors or trauma that influence or trigger such conditions in a person susceptible to such factors. Examples of Mental Health Issues include but are not limited to: depression, anxiety, aggression, agitation, hallucinations, violence tendencies, suicidal thoughts, suicidal plans, suicidal acts or gestures, completed suicide, akathisia, panic or panic disorder, bipolar disorder, manic depressive illness, schizophrenia, personality disorder, phobia, physical dependence, psychological dependence addiction, substance abuse, and/or any other condition that affects the health or well-being of a person.
Complaint: The operative complaint filed in your case, whether an original, amended or subsequent complaint.
PLAINTIFF COMPREHENSIVE FACT SHEET
- A. CASE INFORMATION
1. / Case caption:
2. / MDL Case Number:
3 / Mother Plaintiff’s Name: / Minor Plaintiff’s Name:
4. / Principal Attorney name:
Firm:
Telephone number: / Fax number:
E-mail address:
- B. PERSONAL INFORMATION FOR MOTHER PLAINTIFF
1. / Representative. If this Fact Sheet is being completed in a representative capacity (e.g., on behalf of the Estate of a deceased minor or person), list the following for the Decedent:
Name of Decedent / Street Address of Decedent
(at Time of Decedent’s Death) / In What Capacity are You Representing the Decedent?
2. / Representative Information.
Name and Current Address / Your Relationship to
the Deceased / If Appointed by a Court, Give the State, Court, Case Number, and Date of Appointment
3. / Mother Plaintiff’s full legal name (first/middle/last):
4. / Mother Plaintiff’s Social Security Number:
5. / Mother Plaintiff’s Date and Place of Birth:
6. / Mother Plaintiff’s Date, Place, and Cause of Death (if applicable):
7. / Mother Plaintiff’s Residence(s). Identify each address at which the Mother Plaintiff has resided for the period ten (10) years prior to birth of the Minor Plaintiff and continuing to the present:
Address / Dates of Residence / All Other Persons Who Resided There (and Relation)
8. / Current Marital Status (choose one). Never married; Legally married and living together; Married but separated; Common Law Union; Divorced; Widowed
9. / Marital History. If Mother Plaintiff has ever been married, whether legally or as a common law marriage, please provide the following for each marriage:
Spouse’s Name and Any Other Name Used / Spouse’s Date of Birth and, if applicable, Date of Death / Spouse’s Current or Last Known Address / Dates of Marriage and Any Legal Separation, Divorce, or Annulment
10. / Educational History. Identify each high school, vocational school, college, university, or other post-secondary educational institution the Mother Plaintiff has attended, the dates of attendance, and diplomas or degrees awarded:
Name of School, Address,
Telephone Number / Dates of Attendance / Degree Awarded / Major or Primary Field
11. / Employment History. Please provide the following information for Mother Plaintiff’s employment, including self-employment, military service, and volunteer work for the period beginning ten (10) years prior to birth of the Minor Plaintiff though the present. If you are making a claim for lost wages in this case, also list, for each position, your salary and/or other compensation received, include your employment history two years prior to the claimed loss thought two years after the claimed loss.
Employer’s Name, Supervisor, Address, Telephone Number / Dates of
Employment / Occupation/
Job Title / Reason for Leaving / Salary/Annual
Gross Income
12. / Has Mother Plaintiff ever been out of work for more than 30 days for reasons related to health? / Answer yes or no:
If yes, please identify the dates, employer, and health condition(s) at issue:
13. / Obstetrician/Gynecologist. Identify each Obstetrician/Gynecologist with whom the Mother Plaintiff consulted or who examined the Mother Plaintiff for any routine physical examination or for any mental or physical illness, condition, or disability, for the period five (5) years prior to birth through the birth of the Minor Plaintiff and for any other pregnancy of the Mother Plaintiff at any time.
Ob/Gyn, Healthcare Facility, Address / Dates of Care or Treatment
14. / General Practitioner. Identify each General Practitioner with whom the Mother Plaintiff consulted or who examined the Mother Plaintiff for any routine physical examination or for any mental or physical illness, condition, or disability, for the period five (5) years prior to birth through the birth of the Minor Plaintiff,
Name of Provider, Healthcare Facility, Address / Specialty / Illness, Injury, Condition, Disability for Which Care was Sought / Dates of Care
or Treatment
15. / Mental Healthcare Providers. Identify each Mental Healthcare Provider, including but not limited to psychiatrists, psychologists, primary care physicians, general practitioners, other physicians, social workers, and counselors with whom the Mother Plaintiff consulted, sought, or received treatment or counseling for any Mental Health Issue from the age of 18 through the birth of the Minor Plaintiff. If the birth of the Minor Plaintiff occurred before age 18, for the period five (3) years prior to birth through the birth of the Minor Plaintiff.
Name of Provider, Mental Healthcare Facility, Address / Specialty / Mental Health Issue for Which Treatment or Counseling was Sought / Dates of Care or Treatment
16. / Zoloft/Sertraline Prescribing Healthcare Providers. Identify each Healthcare Provider who ever prescribed (or provided samples of) Zoloft or sertraline hydrochloride to the Mother Plaintiff:
Name of Provider, Healthcare Facility, Address / Specialty / Medical Diagnosis Leading to Prescription / Dates of Prescription
17. / Other Healthcare Providers. Identify each Healthcare Provider with whom the Mother Plaintiff consulted or who examined the Mother Plaintiff for any routine physical examination or for any mental or physical illness, injury, condition, or disability during the pregnancy at issue who is not already identified above:
Name of Provider, Healthcare Facility, Address / Specialty / Illness, Injury, Condition, Disability for Which Care was Sought / Dates of Care
or Treatment
18. / Zoloft/Sertraline Use History. Provide the following information regarding the Mother Plaintiff’s Zoloft/sertraline hydrochloride use history. Please enter a separate line for every change in dosing regimen. Attach additional pages as necessary:
Start and End Dates / Dosage and Frequency (per day) / Prescribing Healthcare Provider / Manufacturer, Seller, Distributor or Drug Co., and NDC No.
19. / Pharmacies. Provide the following information for all pharmacies at which the Mother Plaintiff filled prescriptions for medications, specifically including but not limited to those pharmacies at which the Mother Plaintiff filled prescriptions for Zoloft or sertraline hydrochloride, for the period for the period five (5) years prior to birth through the birth of the Minor Plaintiff. This includes all drug stores, supermarkets, hospital pharmacies, or any other location from which medications were purchased or obtained.
Name of Pharmacy, Address / Approximate
Dates Used / Used for Zoloft or sertraline?
20. / Mental Health Issues. Please identify each Mental Health Issue Mother Plaintiff experienced, was diagnosed with, and/or was treated for prior to ingestion of Zoloft/sertraline hydrochloride:
Mental Health Issue or Condition / Date First Diagnosed or Treated / Is Issue Ongoing?
21. / Pregnancies.Identify each and every pregnancy that Mother Plaintiff has ever had, regardless of whether the pregnancy resulted in birth, and provide the following:
Live Birth? / Date of Birth or Loss / Weeks at Birth/Loss
Were there any complications in pregnancy or birth? (Describe)
Was assisted reproductive technology used? (Describe)
Was termination due to medical reasons? (Describe)
Were any congenital or chromosomal defects diagnosed or suspected in fetus or child? (Describe)
Live Birth? / Date of Birth or Loss / Weeks at Birth/Loss
Were there any complications in pregnancy or birth? (Describe)
Was assisted reproductive technology used? (Describe)
Was termination due to medical reasons? (Describe)
Were any congenital or chromosomal defects diagnosed or suspected in fetus or child? (Describe)
22. / Other Health Information. Please provide the following information:
Height:
Highest weight during the period one (1) year prior to conception of the Minor Plaintiff:
Was the Mother Plaintiff ever diagnosed with or treated for obesity during the period one (1) year prior to birth through the birth of the Minor Plaintiff? / Answer yes or no:
If yes, please complete the rest of this section.
Date of diagnosis or treatment:
Healthcare Provider who made the diagnosis or provided diagnosis or treatment for obesity:
Alcohol use. Please check the box that describes your highest alcohol use over an extended period of time (more than three months) during the period one (1) year prior to conception of the Minor Plaintiff: / Never
Social
1-5 drinks per week
6-10 drinks per week
Did the Mother Plaintiff use alcohol during her pregnancy with the Minor Plaintiff, including those times when she was unaware that she was pregnant? / Answer yes or no:
If yes, please complete the rest of this section.
Dates of consumption during pregnancy (include gestation when quit, if applicable):
Type of alcohol consumed during pregnancy:
Number of drinks per week during pregnancy (include weaning schedule until quitting, if applicable):
Number of days per week alcohol consumed during pregnancy (include weaning schedule until quitting, if applicable):
Tobacco use. Did the Mother Plaintiff use tobacco products during the period one (1) year prior to conception through the birth of the Minor Plaintiff? / Never
Social
1-5 times per week
Other (Describe)
Type of tobacco consumed:
Did the Mother Plaintiff use tobacco during her pregnancy with the Minor Plaintiff, including those times when she was unaware that she was pregnant? / Answer yes or no:
If yes, please complete the rest of this section.
Dates of consumption during pregnancy (include gestation when quit, if applicable):
Type of tobacco consumed during pregnancy:
Number of times per day during pregnancy (include weaning schedule until quitting, if applicable):
Did the Mother Plaintiff take any prescription medication not prescribed to her, misuse any prescription medication, or use LSD, opiates, cocaine, or marijuana (“other drugs”) during the period one (1) year prior to conception through the birth of the Minor Plaintiff? / Never
1-2 times per week
3-5 times per week
Other (Describe)
Did the Mother Plaintiff ever use any such other drugs during pregnancy with the Minor Plaintiff, including those times when she was unaware that she was pregnant? / Answer yes or no:
If yes, please complete the rest of this section.
Dates of consumption of other drugs during pregnancy (include gestation when quit, if applicable):
Type of other drugs consumed during pregnancy:
Amount of other drugs consumed per day or week during pregnancy:
Number of days per week other drugs were consumed during pregnancy (include weaning schedule until quitting, if applicable):
23. / Substance Abuse Treatment Providers. Identify each Substance Abuse Treatment Provider with whom the Mother Plaintiff consulted, sought or received treatment or counseling from for drug or alcohol abuse, addiction, or dependency for the period one (1) year prior to conception through the birth of the Minor Plaintiff:
Name of Provider, Facility, Address / Drug/Substance Involved / Dates of Care or Treatment
24. / Social Security Disability. Has Mother Plaintiff ever made a Social Security disability claim for the period of five (5) years prior to the birth of the Minor Plaintiff though the birth of the Minor Plaintiff, or during any time when the Mother Plaintiff was pregnant? Answer yes or no: If yes, please provide:
Year Filed / Where Filed / Nature of Disability / Period of Disability / Action Number
25. / Criminal History. Has Mother Plaintiff ever been convicted of or pled guilty to a felony or a crime involving truthfulness? Answer yes or no: If yes, please provide:
Crime or Offense / County and State / Court / Outcome / Date of Conviction or Guilty Plea
26. / Civil Litigation. Has Mother Plaintiff ever been a party to an arbitration or civil lawsuit relating to any of the injuries or claims alleged in this lawsuit other than the present action? Answer yes or no: If yes, please provide:
Caption and Case Number / When and Where Filed / Nature of Claims, Including Any Personal Injury Claims / Attorney Representing Mother Plaintiff / Outcome, Including Damages or Compensation Received
27. / Health Insurance. For each insurance company that issued a health, disability, or life insurance policy to Mother Plaintiff five (5) years before the birth of the Minor Plaintiff, through the birth of the Minor Plaintiff, please provide:
Name of Insurance Company / Type of Insurance Sought / Who was Named Insured? / Policy Number / Effective Dates of Policy
28. /
Computer and Internet Use.
At any time prior to the birth of the Minor Plaintiff, did Mother Plaintiff ever visit any website containing information regarding Zoloft, sertraline hydrochloride, or the claims or allegations in this lawsuit? / Answer yes or no:If yes, please list the website(s) visited, the location of the computer used, and the dates or approximate dates visited:
Has Mother Plaintiff ever had a Facebook, MySpace, LinkedIn, Google Plus, Windows Live, YouTube, Twitter, or other personal social networking account? / Answer yes or no:
If yes, please list the type of account and the timeframe of use:
Did Mother Plaintiff ever communicate via e-mail, chat room, listserv, or social networking site regarding Zoloft or sertraline hydrochloride, this lawsuit, or the claims or allegations in this lawsuit? / Answer yes or no:
29. / Bankruptcy. Has Mother Plaintiff ever filed for bankruptcy? Answer yes or no: If yes, please provide:
Court / Date Filed / Case Docket Number / How Resolved
- C. INSTRUCTIONS AND WARNINGS
1. /
If the Mother Plaintiff’s prescribing doctor or other prescribing health care provider discussed with her the risks and benefits of using Zoloft or sertraline hydrochloride or gave her any instructions or warnings regarding use of Zoloft or sertraline hydrochloride, state:
Who had these discussions with the Mother Plaintiff or gave her any instructions/ warnings?On what date(s) did this occur?
What, if anything, did he or she tell the Mother Plaintiff about possible side-effects that might be associated with Zoloft or sertraline hydrochloride, including specifically any side effects associated with congenital birth defects, congenital heart disease, spina bifida, hydrocephalus, severe asthma, PPHN, or other serious congenital/pregnancy issues?
Identify all individuals who have knowledge regarding such discussions and include their addresses and phone numbers.
2. / If the Mother Plaintiff’s prescribing doctor or other Prescribing Health Care Provider gave her any written instructions or warnings regarding the use of Zoloft or sertraline hydrochloride, state:
Who gave the Mother Plaintiff the written instructions or warnings?
On what date(s) did this occur?
Identify the author(s) or publisher(s) of any written information the Mother Plaintiff received from her prescribing doctor or other prescribing health care provider:
Did the Mother Plaintiff read the written instructions or warnings?
On what date(s) did this occur?
Does the Mother Plaintiff currently have the written instructions or warnings, or a copy thereof? (If so, provide a copy of the written instructions or warnings with your responses.) / Answer yes or no:
If no, describe what the written information looked like (e.g., number of pages, whether it had pharmacy name, doctor’s name, identity of who wrote it) and what, if anything, it said about possible side-effects that might be associated with Zoloft or sertraline hydrochloride, including any side effects associated with use in pregnancy or congenital birth defects:
Identify all individuals who have knowledge regarding the Mother Plaintiff’s receipt or use of any such written instructions or warnings and include their addresses and phone numbers.
3. / If the Mother Plaintiff’s pharmacy or pharmacist discussed with her any instructions or warnings regarding use of Zoloft or sertraline hydrochloride, state:
Who had these discussions with the Mother Plaintiff or gave her any instructions/ warnings?
On what date(s) did this occur?
What, if anything, did he or she tell the Mother Plaintiff about possible side-effects that might be associated with Zoloft or sertraline hydrochloride, including specifically any side effects associated with congenital birth defects, congenital heart disease, spina bifida, hydrocephalus, severe asthma, PPHN, or other serious congenital/pregnancy issues?
Identify all individuals who have knowledge regarding such discussions with the Mother Plaintiff and include their addresses and phone numbers.
4. /
If the Mother Plaintiff’s pharmacy or pharmacist gave her any written instructions or warnings regarding the use of Zoloft or sertraline hydrochloride, state:
Who gave the Mother Plaintiff the written instructions or warnings?On what date(s) did this occur?
Identify the author(s) or publisher(s) of any written information the Mother Plaintiff received from pharmacy or pharmacist:
Did the Mother Plaintiff read the written instructions or warnings?
On what date(s) did this occur?
Does the Mother Plaintiff currently have the written instructions or warnings, or a copy thereof? (If so, provide a copy of the written instructions or warnings with your responses.) / Answer yes or no:
If not, describe what the written information looked like (e.g. how many pages was it, did it have the name of the Mother Plaintiff or the name of the pharmacy on it, did it identify who wrote it) and what, if anything, it said about possible side-effects that might be associated with Zoloft or sertraline hydrochloride, including specifically any side effects associated with congenital birth defects, congenital heart disease, spina bifida, hydrocephalus, severe asthma, PPHN, or other serious congenital/pregnancy issues?
Identify all individuals who have knowledge regarding the receipt or use of any such written instructions or warnings by the Mother Plaintiff and include their addresses and phone numbers.
5. Medications – Please indicate whether Mother Plaintiff took any of the Medications listed below during the period of five (5) years prior to conception through the birth of the Minor Plaintiff.. For each “Yes,” please fill out the information requested for that Medication in Section (below). Attach additional pages as necessary.