Frequently Asked Questions
Stephen Barrett, MD
Robert S. Baratz, MD, DDS, PhD
- How do you select which documents to post?
- Most cases involving regulatory action involve quackery and/or fraud, but some do not. Why have you posted them?
- In some cases, the offense looks trivial and/or the penalties appear to be very light. Why have you posted them?
- In some cases, you report that a suit has been filed but fail to report the outcome. Why?
- If a company complies with an FDA warning letter, why do you still post the warning letter?
- I like what you are doing. Is there a way I can help?
Many of the materials we collect are difficult to know about and to find elsewhere. We highlight government investigations, regulatory actions, and civil lawsuits that we believe will help consumers make intelligent decisions. The site also provides—in one place—useful material for regulators, attorneys, and anyone else seeking background information about the people and companies presented.
In such cases, based on other information we have collected, we believe that the people involved are also involved in questionable health-related activities.
The stated problem and size of the penalty are not always related to the severity of the problem. In many cases, regulatory agencies enter consent agreements in order to avoid expending limited resources on what might be a protracted legal battle. State boards, for example, may be satisfied with an agreement under which a practitioner agrees to be disciplined for inadequate recordkeeping even though the real problem was gross mismanagement of patients. The resulting settlement agreements may look benign, but most contain language that will allow the case to be reopened and efficiently pursued if the agreement is violated.
Keeping track of what happens can be very difficult. Federal cases are relatively easy to follow because the documents are posted to PACER. But we do not have sufficient staff to systematically follow all of them. Some attorneys regularly send documents, but most do not. In some cases, they are afraid that ongoing publicity might antagonize the judge. Attorneys may also fear that publicity will make it harder to settle their case. Cases that are settled usually contain a nondisclosure agreement that bars further discussion.
Most warning letters are posted on the FDA site, but there is no assurance that they will remain there. In addition, older letters are posted in PDF image format, which makes them less accessible to search engines. Posting them on Casewatch serves two purposes. The first is to increase their visibility to search engines. The second is to assure that they will be permanently posted. Many of the products cited in warning letter are useless for any purpose. Many companies comply with the FDA's order to modify their claims but continue to market the products and/or make misleading claims for other products. Although FDA warnings are major regulatory events, they often understate the agency's concerns about the recipient. Keeping the warning letters posted may help consumers judge whether the recipients are trustworthy.
Anyone can help by telling others about our Web sites, asking the administrators of other sites to link to us, and making donations to support our research.
This page was revised on August 3, 2012.