Fosamax Litigation and ONJ

Fosamax lawsuits claim the osteoporosis drug causes ONJ, or 'jaw death,' and other bone injuries.

Fosamax, also known as alendronate sodium, is a prescription drug that is used to treat osteoporosis. Since 2006, over a thousand product liability lawsuits have been filed in state and federal courts against Merck, the maker of Fosamax. The plaintiffs (the people filing the lawsuits)  in these cases make a variety of allegations -- including claims that Fosamax causes osteonecrosis of the jaw (ONJ), or jaw death, that Fosamax increases the risk of certain hip and femur fractures, and that Merck overstated the benefits of the drug while minimizing its risks. Over 700 federal Fosamax cases have been consolidated in multidistrict litigation (MDL) in New York to establish common legal issues and help lead the way to possible out-of-court settlements (more on this below).

Read on to learn more about Fosamax, the claims made in these product liability lawsuits, and the status of Fosamax litigation. (For answers to basic questions about defective product claims, see Nolo's Product Liability FAQ.)

What Is Fosamax?

Fosamax, or alendronate sodium, is a prescription drug manufactured by Merck. A type of bisphosphonate drug, Fosamax limits bone loss by inhibiting the breakdown of old or damaged bones. In 1995, the U.S. Food and Drug Administration (FDA) approved the use of Fosamax to treat and prevent:

  • osteoporosis in post-menopausal women
  • osteoporosis in men
  • steroid-induced osteoporosis, and
  • Paget's disease of bone.

Since its introduction, Fosamax has been used by more than 20 million people around the world, generating billions of dollars in sales for its manufacturers and marketers.

Side Effects of Fosamax

The most common complaint about Fosamax (in lawsuits filed against Merck) is that the medication causes osteonecrosis of the jaw (ONJ), also called jaw death. Symptoms of ONJ include loosening of teeth, gum lesions, osteomyelitis (infection of jaw bone marrow), and sequestration (splintering of jaw bone). ONJ appears to particularly affect Fosamax users who undergo dental surgery or treatment.

Other serious potential side effects of Fosamax include:

  • irritation, inflammation, or ulceration of the esophagus
  • severe bone, joint, or muscle pain
  • atrial fibrillation, or abnormal heart rhythm, and
  • femur fractures and other problems with the bones in the hips, shoulders, and knees.

Legal Claims Against Merck

Typically, people who feel that they were injured by a pharmaceutical drug (like Fosamax) bring a defective product liability claim against the drug's manufacturers and marketers. In these cases, the plaintiffs claim that their injuries were a result of one or more of the following factors:

  • the drug was manufactured improperly
  • the drug caused unreasonably dangerous or unexpected side effects, or
  • the manufacturer, doctor, or pharmacy did not adequately warn the consumer or prescribing physician of the dangers of the drug. (To learn more about inadequate warnings in defective product claims involving pharmaceutical drugs, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)

The majority of Fosamax lawsuits fall into one of two camps: lawsuits alleging a link between Fosamax and ONJ, and lawsuits claiming that Fosamax causes other bone problems. Here's a look at both kinds of cases.

Lawsuits alleging that Fosamax causes ONJ. Most plaintiffs in lawsuits filed against Merck allege that Fosamax causes a dangerous side effect -- ONJ, or jaw death. In these lawsuits, many plaintiffs also claim that Merck knew or should have known that Fosamax causes ONJ, but that it failed to warn doctors of this possible side effect.

Lawsuits alleging that Fosamax causes other bone problems. A small minority of plaintiffs allege that Fosamax leads to femur fractures and problems with bones in the hips, shoulders, and knees. According to the FDA, scientific data does not show a clear connection between Fosamax use and the risk of femur fractures. However, the FDA's investigation into the issue is ongoing.

Legal Defenses in Fosamax Cases

Drug manufacturers almost always mount a vigorous defense when they get sued under product liability laws. Often, they challenge plaintiffs' claims by arguing that either the drug is not dangerous or the plaintiffs' injuries were caused by something other than the drug.

In the Fosamax cases that have gone to trial, Merck has argued that:

  • Fosamax does not cause ONJ
  • plaintiffs' dental problems are not caused by Fosamax but instead by other health problems, and
  • Merck warned doctors of Fosamax's known side effects.

Status of Fosamax Litigation, Multidistrict Litigation, and "Bellwether" Cases

More than 1,000 Fosamax lawsuits -- some including multiple plaintiffs -- have been filed against Merck and are pending in either federal or state court.

Over 700 federal lawsuits have been consolidated in multidistrict litigation in a New York court. In multidistrict litigation (MDL), cases involving similar issues of fact are transferred to one court for pretrial and discovery proceedings (the process where each side finds out everything they can about the other side's case). Once that process is finished, attorneys try the cases in the court where the case was originally filed or sometimes in the MDL courtroom. (To learn more about multidistrict litigation, see Nolo's article Multidistrict Litigation (MDL) for Drug Lawsuits and Other Cases.)

The judge in the Fosamax MDL selected three "bellwether" cases. These cases -- set to be tried before the other MDL cases -- will help each side evaluate the strengths and weaknesses of their arguments and point the way to possible out-of-court settlements.

The jurors in the first bellwether Fosamax trial to reach a verdict found that the plaintiff did not have ONJ. In the second case to reach a verdict, the jury found that Fosamax did cause plaintiff's injuries, and awarded $8 million in compensatory damages. (To learn about the types of damages you can get in defective product liability claims, see Nolo's article Damages in Defective Products Cases.) The third MDL bellwether case is scheduled for trial in September 2010.

Getting Help

The legal and medical issues in Fosamax cases are sophisticated and complex. Depending on your case, you may want to hire a lawyer who specializes in products liability litigation (or, even better, one who has experience with cases involving Fosamax). You may also consider joining an existing class action lawsuit, if there is one. (To learn more about class actions, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.)

For help in choosing a good personal injury attorney, read Nolo's article Finding a Personal Injury Lawyer. Or go straight to Nolo's Lawyer Directory for a list of personal injury attorneys in your geographical area.

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