November 8, 2011
Managing News from Post-Approval Studies, Medical Device Reports, Complaints, Product Recalls and Disclosures to Shareholders (and Investors)
Friday, November 11, 2011
Click here to register for this free seminar
After medical device manufacturers have brought their product(s) to market, they may be required to undertake 522 post-marketing surveillance studies. They are also subject to filing Medical Device Reports under appropriate circumstances. Manufacturers may receive complaints about the product(s) from patients, physicians, hospitals or other providers. All of this information held by the manufacturer may trigger various reporting responsibilities to, or other actions concerning, various constituents including the FDA, medical community, and shareholders or investors.
In this session the panel will discuss with the attendees:
- How does the information derived from these different sources interrelate?
- How should a manufacturer manage signals from the field such as the frequency of adverse events reported from 522s, MDRs or complaints, and what level(s) of adverse events should act as triggers for a manufacturer to consider a recall, or disclosure to its shareholders or investors?
- Is the trigger for reporting to shareholders (investors) the same as that for disclosing to the government?
- How do you manage investors who have direct access to physicians through “expert networks” and may have access to information you have not disclosed publicly?
- What should a manufacturer do to manage this flow of information, especially since the whistleblower provisions of Dodd-Frank have given employees serious incentives to disclose perceived potential problems that someone might believe should have been disclosed to the SEC?
- How does the Supreme Court’s decision in Matrixx, dealing with disclosure to shareholders, affect a manufacturer’s consideration of these issues?
Brian Halak, Domain Associates
Mark Klausner, Westwicke Partners
John Reiss, Saul Ewing
Marta Villarraga, Exponent, Inc.
For more information, see our Medical Device Seminar webpage