Merck Barred From Contacting Plaintiff Doctors in Fosamax Fracture Suits

Citing physician-patient privilege, a federal judge has barred Merck from directly contacting the doctors of patients who have filed a lawsuit after suffering bone fractures allegedly caused by the osteoporosis drug Fosamax. 

In a court order (PDF) issued on May 2, U.S. District Judge Joel A. Pisano sided with plaintiffs, saying that it would be inappropriate for Merck’s attorneys to directly contact prescribing or treating physicians in any way outside the presence of plaintiffs’ attorneys.

The order came after Merck sought permission to directly initiate and participate in “ex parte” communication with physicians in states where such communications are permitted. The drug maker also sought to limit Plaintiffs’ counsel to discussing only certain documents and topics during any “ex parte” communications they have with those physicians outside of the presence of Merck’s counsel.

Judge Pisano is overseeing all federal Fosamax lawsuits over bone fractures, which have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the District of New Jersey.

Hundreds of Fosamax fracture suits have been filed against Merck, alleging that the drug maker failed to adequately research their medication or warn about the potential increased risk of femur breaks from Fosamax side effects, which typically occur with little or no trauma.

In his order, Judge Pisano cited the protected relationship between doctors and their patients as a primary reason for denying Merck’s requests and barring direct contact in any state between the drug maker and plaintiffs’ physicians without involvement of plaintiffs’ counsel, stating that any violation shall result in sanctions.

Judge Pisano indicated that while the decision may, on its face, appear one-sided and unfair, it is not. He noted that Merck “still has access to the information it seeks by way of a variety of mechanisms” such as depositions and plaintiff profile forms.

Fosamax (alendronate sodium) is the most commonly used bisphosphonate medication in the United States, which was introduced by Merck in 1995.  The medication generated over $3 billion in annual sales before it became available as a generic in 2008.

Long-term use of Fosamax has been linked to an increased risk of atypical femur fractures, which can occur with falls from standing height or less, which would not usually cause a complete break of the femur bone.

In October 2010, following an investigation by the FDA, Merck was required to add new warnings to the Fosamax label about the risk of bone fractures from Fosamax and other bisphosphonate medications. Earlier this week FDA researchers published a review noting that they found no long-term benefits in taking Fosamax or other bisphosphonates, like Actonel and Boniva.