Judge Seeks Proof of Fosamax Jaw Injury in Lawsuits Not Involving ONJ

The judge presiding over all federal Fosamax lawsuits involving osteonecrosis of the jaw (ONJ) or other jaw bone injuries, has issued an order calling for plaintiffs in many of the cases to provide evidence supporting that their problems were caused by side effects of the osteoporosis drug.

For the past six years, all product liability lawsuits filed against Merck that involve allegations of a jaw injury from Fosamax side effects have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, before U.S. District Judge John F. Keenan in the Southern District of New York.

Some 1,000 Fosamax lawsuits have been included in the MDL, including allegations that former users developed osteonecrosis of the jaw (ONJ), osteomyellitis and other jaw-bone injuries that they claim were caused by the long-term use of Fosamax.

Osteonecrosis of the jaw (ONJ) is a rare and debilitating condition in which the jaw bone actually decays, often resulting in exposed bone within the mouth, infection and possibly the need for surgery to remove portions of the jaw.

While about 40% of the complaints have involved allegations of ONJ or osteomyellitis, a number of lawsuits involve other jaw-related injuries allegedly caused by Fosamax, such as sore and swollen gums, lost and broken teeth, and jaw pain.

On November 20, Judge Keenan issued what is known as a “Lone Pine” order (PDF), which requires all plaintiffs who are not claiming to have ONJ or osteomyellitis to submit expert reports showing that their other jaw injuries were caused by Fosamax.

The name Lone Pine comes from a 1986 decision known as Lore v. Lone Pine Corp. which resulted in a similar requirement. The decision does not affect plaintiffs claiming ONJ injuries.

Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, which are prescribed for treatment of osteoporosis. Fosamax was approved by FDA in October 1995, and has been used by more than 20 million people. The drug generated over $3 billion in annual sales for Merck before it became available as a generic last year.

Since the Fosamax jaw litigation was consolidated before Judge Keenan, the parties have exchanged millions of pages of documents, deposed dozens of executives of the pharmaceutical company and held a number of “bellwether” trials in the MDL, which are designed to help gauge how juries are likely to respond to certain evidence and testimony.

Merck has successfully defended their drug at trial in all of the bellwether cases except for one, which resulted in an $8 million damage award. That case is currently pending on appeal, but the parties reached a confidential stipulation on damages to avoid a retrial earlier this year.

Judge Keenan previously indicated that at least two more “bellwether” trials will be held in the Fosamax jaw damage MDL, with the next case scheduled to begin on January 14 involving a lawsuit (PDF) filed by Rhoda Scheinberg, who alleges that she was diagnosed with osteonecrosis of the jaw after using Fosamax from October 2000 through September 2006.

The Fosamax lone pine order is designed to identify the cases that may not have sufficient evidence to bring to trial, and may ultimately help promote settlement agreements between the parties in other cases.

Following the remaining bellwether trials, barring any Fosamax settlement agreements, it is expected that Judge Keenan will consider remanding cases back to the U.S. District Courts where they were originally filed for individual trial dates throughout the country.

In addition to claims involving jaw damage, Merck also faces an even greater number of Fosamax lawsuits over atypical femur fractures, which occur with little or no trauma at all.  In the federal court system, those cases are consolidated as part of a different MDL, which is centralized in the U.S. District Court for the District of New Jersey.