Judge Rules Fosamax Generics Liable for Failure-to-Warn

Fosamax lawyers at Pintas & Mullins Law Firm report that a New York federal judge recently ruled that manufacturers of generic Fosamax can be held liable for not updating labels within a reasonable time after the brand-name did.

Platiniffs claimed that the generic companies long-delayed updating their warning labels to match the brand-name version, manufactured by Merck & Co. Fosamax’s labels were changed in March 2010 to relay information about the risk of osteonecrosis (bone death) of the jaw. This condition, along with Fosamax femur fractures, is at the center of recent litigation.

There are currently more than 900 lawsuits pending in federal court, the first of which were filed in 2006. Most lawsuits have similar claims, namely that Fosamax, a drug prescribed to treat osteoporosis and bone loss, caused osteonecrosis of the jaw.

The responsibilities, liabilities, and specific legal obligations of generic drug manufacturers have been subject to much contention recently. In June 2013, the U.S. Supreme Court ruled that a generic manufacturer, Mutual Pharmaceuticals, could not be held liable for the injuries caused by one of its painkillers. The suit was filed by Karen Bartlett, who suffered a severe, life-changing reaction from the generic painkiller sundilac.

She developed Steven-Johnson Sydrome, which caused two-thirds of her skin to slough off, left her permanently disfigured and legally blind. Nearly a decade after her hospitalization (her doctor described her experience as “hell on earth” in his testimony), she is still suffering from permanent injuries to her lungs, eyes and esophagus.

Generic companies are required to use the exact same labels as the brand-name versions, however, they may not include any additional warnings. If a generic changes their labeling in any way, as Merck did in 2010, generics are required to reflect those changes.

This requirement was the basis for the Mutual vs Bartlett ruling, and also for a previous SCOTUS case, Pliva vs Mensing. In their majority decision, five out of four justices asserted that generic manufacturers could not be sued for improper labeling or design defects because they are legally required to be identical to brands.

In this Fosamax decision, however, the presiding judge ruled that generic companies’ liability does extend to their failure to update the drug’s labeling within a reasonable time after brand names. The judge further stated that plaintiffs can now only argue that the generic’s warning was inadequate because it did not include the same language as the updated Merck labels.

The generic Fosamax companies at the center of this suit include Teva Pharmaceuticals, Barr Pharmaceuticals, Mylan Inc., and Watson Pharmaceuticals. At least 20 million people have been prescribed Fosamax and its generics since it was introduced in 1995. Unfortunately, a growing body of evidence suggests that that the drug, instead of strengthening bone density, may actually have the opposite effect, making bones weaker over time.

Besides jaw necrosis, other dangerous side effects have been reported in alarmingly high numbers. Among them include femur fractures, esophageal ulcers, problems with vision, and skin rashes. The femur is one of the strongest bones in the body, and is not typically prone to breaks or fractures from low-impact activity. Fosamax users, however, have been experiencing spontaneous fracture while going about their daily activities, such as when they are walking. The risk of such fractures increases the longer patients take Fosamax. Surgery to repair such a major break is extremely complex, and often results in painful recoveries and years of medical treatments.

Fosamax lawyers at Pintas & Mullins Law Firm have extensive knowledge about Fosamax drug litigation, and will continue to report on any and all legal, medical, and scientific updates regarding this dangerous drug. We are currently investigating and accepting Fosamax claims, so if you or a loved one experienced a femur fracture or jaw necrosis due to Fosamax, contact our office immediately for a free, no-obligation consultation.


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