If you are considering filing a complaint to the Minnesota Board of Social Work about Jean Kenney and the CAFÉ or CATIE studies, here is a guide to how you might proceed, based on Mike Howard’s successful complaint.
Start by gathering records from Fairview Hospital and/or the Ambulatory research Center. If past experience is an indicator, however, chances are that they will refuse your request. Don’t be bullied; you have a right to these records. Contact the Minnesota Attorney General’s office and have them send a letter ordering the release of the records to you.
You should ask for all records pertaining to your or your family member’s medical care and the study in which they were enrolled, but here are some special requests that you should specifically include:
- Jean Kenney’s handwritten case notes
- All CAFÉ or CATIE study visit logs
- Signed consent forms for the CAFÉ or CATIE study
- Medical records from Fairview Hospital if the patient was hospitalized
- Records from any outside caseworker or therapist who may have been involved
- Records of any interaction with Stephen Olson, with special attention to how often the patient was seen by Olson
- Records of any family meeting with the study team
- Records of Kenney’s phone logs and any emails involving the CAFÉ or CATIE study between Kenney or Olson and AstraZeneca, Quintiles, the University of North Carolina or the National Institutes of Mental Health
Second, read the depositions by Jean Kenney and Stephen Olson from the lawsuit by Mary Weiss. Many of the things that are discussed in those depositions may be relevant to your case.
Third, look at the Minnesota statutes governing social work and see if any of them were violated in your case. If they were, cite the statutes in your letter. Statutes that might be especially relevant include the following:
In addition, see this:
When you begin writing the complaint, here are some general areas you might cover.
Topic 1: Medical competence
Mike Howard’s complaint successfully challenged Kenney’s competence. The “corrective action” found that Kenney was medical unqualified to do many of the tasks she was assigned as study coordinator, such as dispensing study drugs and assessing their side effects. You should start by looking through the records with an eye towards answering these questions.
Did Kenney dispense a study drug to you or your family member?
Did Kenney take a medical history or sign off on any medical history forms?
Did Kenney sign off on any “adverse event” forms? (The phrase “adverse event” is medical jargon for anything that goes medically wrong for a subject in a research study, such as a side-effect from a drug or an abnormal laboratory finding.)
Did Kenney sign off on any “rating scales” for psychiatric symptoms or drug side-effects? Examples might include the Barnes Akathisia Rating Scale, the Simpson-Angus Scale, the Positive and Negative Syndrome Scale (PANSS), or the Clinical Global Impressions (CGI) scale.
Did Kenney make any mistakes about your or your family member’s medical diagnoses, medications or dosage?
Topic 2: Informed consent
All of the atypical antipsychotics used in the CAFÉ and CATIE studies have been linked to hyperglycemia, diabetes, and weight gain. During the period when the CAFÉ and CATIE studies were in progress, the drugmakers issued warnings about these problems to doctors and clinical investigators. All subjects in the CAFÉ and CATIE studies should have been told about these new risks and offered the opportunity to drop out of the study or continue. If they decided to continue, the subjects should have been asked to sign a new consent form which included the risks of hyperglycemia, diabetes and weight gain.
So look carefully at the informed consent form. Note whether it includes these risks. If it doesn’t -- and if it is the only consent form in the chart -- this suggests that you or your family member was never informed of the new risks. This is a serious ethical breach. As the Board of Social Work “corrective action” points out, the failure to inform subjects of these risks would effectively invalidate their consent.
Topic 3: Privacy
The sponsors of the CAFÉ and CATIE studies did not have a legal right to see the medical records of anyone they planned to recruit into a research study unless that person gave them authorization by signing a HIPAA form. (HIPAA, or the Health Information and Accountability Act, is a federal law protecting the privacy of health information.) But the depositions from Olson and Kenney in the lawsuit brought by Mary Weiss suggest that Olson and Kenney may not have always asked subjects for authorization.
So be sure to look through the medical records for a signed HIPAA form. Examine the signature carefully and make sure that it matches that of your family member. If there are irregularities, make a note of this in your complaint.
Topic 4: Falsified study entries and fraudulent initials and/or signatures.
The “corrective action” noted that Kenney had signed clinical documents with the initials of a physician, presumably Stephen Olson. Look carefully through the records of study visits and any other relevant documents to see if there is evidence of falsification. Look at any documents that your family member should have signed (informed consent form, HIPAA authorization, etc.) and make sure that his or her signature is genuine. Be sure that the records of any study visits, family meetings, etc. match up with your own records or recollections of what happened.
Topic 5: Standard of practice for a clinical social worker
The “corrective action” for Kenney noted a number of instances where Kenney failed to meet minimal standards of practice for a social worker, such as failing to respond to warnings by family members, and the failure to document any treatment goals. Look carefully through the study records for anything that strikes you as inadequate medical care and make a note of them in your complaint.