Last week, a jury in the United States District Court for the Middle District of Florida found that the manufacturer of the intravenous bisphosphonate Zometa failed to adequately warn of the risk of osteonecrosis of the jaw (“ONJ”) resulting from use of the drug. The jury also concluded that Zometa caused J.
Attorney Tim O'Brien of the Levin Papantonio law firm secures decisive jury verdict in a jawbone injury trial.
Levin, Papantonio shareholder Tim O'Brien informs the Fosamax Examiner that closing arguments are set for Tuesday, April 17, in the New Jersey Fosamax bellwether trial in the case of Jo Ann Sessner vs. Merck & Co.. The case involves the claim of a Florida Fosamax patient who developed Stage 3 bisphosphonate-related osteonecrosis of the jaw after more than six years of Fosamax use.
A New England Journal of Medicine study recently published indicates that less than 10% of women with normal, mild, or moderate T-scores will develop osteoporosis over a fifteen year period. This study calls into question the currently Medicare DEXA-scan screening protocol of every two years for postmenopausal women. Further, because most osteopenic women never would develop osteoporosis, the study refutes marketing positions adopted by Merck & Co. relating to its prescription drug Fosamax which Merck touted would help osteopenic women prevent osteoporosis.
In September 2011, Chief Judge Garrett Brown of the United States District Court for the District of New Jersey announced his upcoming retirement from the federal bench. Chief Judge Brown was the judge assigned by the Judicial Panel on Multidistrict Litigation ("JPML") to oversee the Fosamax Femur MDL pending in the District of New Jersey. As a result of Judge Brown's announced retirement, the JPML reassigned the Fosamax Femur MDL to District Judge Joel Pisano, effective November 22, 2011. Like Chief Judge Brown, Judge Pisano sits in Trenton, NJ. (
The Wall Street Journal reports that Merck & Co. has been issued a criminal investigation subpoena by the U.S. Department of Justice regarding how Merck marketed its brain tumor medication, Temodar; its hepatitis C drug, PegIntron; and its cancer treatment, Intron A. In an August 2011 filing with the Securities and Exchange Commission, Merck disclosed the subpoena as part of a “federal health-care investigation under criminal statutes”.
At today's FDA Panel conference on the long term use of osteoporosis drugs like Fosamax, presenter Arthur C. Santora MD, PhD, speaking for Merck, the drug manufacturer, attempted to convince the panel that limits on the duration of the drugs use were not necessary. However, Dr. Santora did admit that drug "holiday" (meaning a temporary interruption in usage) may be considered for patients who are no longer considered to have a sufficiently high fracture risk.
In the early morning session of today's FDA Panel conference on the long term use of bisphosphonates, like the drug Fosamax, the FDA's Lead Medical Officer Fatmatta Kuyateh, M.D. indicated that radiographic findings consistent with atypical femur fractures case have been associated with bisphosphonate use.