From: Kuckelman, John (SHB) [mailto:Jxxxxxxx@xxx.com]
Sent: Wednesday, March 14, 2007 3:43 PM
To: Susan Chana Lask
Cc: laurie.polinsky@xxxxxxxxxxx; Kaplan, Harvey L. (SHB)
Subject: Makinen v sanofi-aventis
 

Dear Susan:

On Friday, March 9, 2007, we received the questionnaires and other materials you sent via overnight mail regarding people you represent who believe they experienced an adverse event while taking AmbienŽ.  We sent those materials, via Federal Express, to Laurie H. Polinsky, Associate General Counsel at sanofi-aventis US. She has sent these materials to the US Pharmacovigilance group of her company.

As you noted in your letter to me, it is the obligation of sanofi-aventis to conduct post-marketing safety follow-up where appropriate and, in accordance with the expectations expressed in your letter, the US Pharmacovigilance group will undertake that effort. Accordingly, they will need to contact your clients directly regarding their use of AmbienŽ.

Sanofi-aventis treats matters of patient health and safety with the highest priority. Please notify your clients (for whom you have submitted information regarding their use of AmbienŽ and alleged adverse events) that the US Pharmacovigilance group of sanofi-aventis US will contact them in the near future to obtain additional information, including medical records. Please ask your clients to cooperate in this process.

Very truly yours,

John F. Kuckelman

John F. Kuckelman
Shook, Hardy & Bacon L.L.P.
2555 Grand Blvd.
Kansas City, Missouri 64108
Telephone: (816) 474-xxxx
Facsimile: (816)xxx-xxxx
E-mail: jxxxxxxxxxxx