Fosamax Lawsuit

From Pharmacy Drug Guide

More than 1,600 individuals have filed litigation against Fosamax manufacturer Merck, stating the the drug has caused debilitating "jawbone death," which in some cases requires multiple painful surgeries. Lawsuit verdicts have been mixed, with some judges dismissing the patient's complaints and one judge awarding $8 million dollars to a single plaintiff (though the amount was later reduced to $1.5 million).^[1]

The FDA initially approved the use of prescription Fosamax in 1995 to prevent and treat osteoporosis or bone loss in postmenopausal women.^[2] Over the next decade, Fosamax became one of the most-prescribed drugs in the world and was taken by millions.

In 2001, the FDA issued warnings regarding the risk of esophageal damage and other possible dangers including cancer, the potential for leg fractures without high activity levels, and jawbone tissue death or osteonecrosis of the jaw. It was noted that Merck, the manufacturer of Fosamax, was not adequately informing patients of the full risks involved with the drug. The company was forced to change its consumer information materials to more accurately caution users of serious adverse reactions.^[3]

The list of Fosamax side effects also includes esophageal damage, heartburn, constipation, nausea, upset stomach, and joint or muscular pain.

Contents 1 Fosamax Side Effects 2 Fosamax Warnings 3 Fosamax Class Action Lawsuit 4 Prescription Drugs 5 Fosamax Lawsuit Settlements 6 References

Fosamax Side Effects

Common Fosamax side effects include heartburn and other gastrointestinal discomfort, necessitating precise instructions for administration. Fosamax is to be taken in the morning upon arising, before consuming any food or drink other than plain water. Patients are instructed not lie down for at least 30 minutes after taking the pill and after eating their first food of the day.^[2] Other possible side effects include:

• bone and joint pain
• low blood calcium levels
• muscle pain

Fosamax Warnings

Children should not take Fosamax, nor should those with serious renal illness.^[2] The FDA issued warnings regarding Fosamax's risk of femur (leg) fractures that patients experience without high activity level or severe trauma. The U.S. government also warned of the potential for a serious degeneration of the jawbone, called osteonecrosis of the jaw. This rare condition is most common among patients who have received radiation to the area but a number of cases have been reported among those who took Fosamax over a period of time.^[6]

Fosamax Class Action Lawsuit

In May 2011, a number of federal lawsuits were combined in a New Jersey class action.^[7] Many other lawsuits are pending in federal and state courts. In August, 2011, the "bellweather" case of patient Linda Secrest, who experienced severe osteonecrosis from the drug, was thrown out by New York District Judge John Keenan. Secrest claimed that the warning label was not thorough enough, but the judge stated that even if the Merck had labelled its product more accurately it was still likely that Secrest's doctor would have continued to prescribe Fosamax to her.^[1]

Prescription Drugs

Fosamax Lawsuit Settlements

While Merck prevailed in some lawsuits, a Florida jury awarded $8 million in compensatory damages to a woman who alleged her dental and jaw problems were caused by taking Fosamax for about 10 years.^[8] Merck challenged the verdict and a New York court found the settlement to be excessive.^[9] Merck has set aside millions to defend Fosamax against claims from lawsuits in federal and state courts.^[10]

Also See: Fosamax Coupons, Fosamax Side Effects, Boniva Side Effects, Actonel Side Effects, Merck Patient Assistance Programs

References

1. ↑ ^{1.0 1.1} http://www.reuters.com/article/2011/08/30/us-merck-fosamax-idUSTRE77T4N520110830
2. ↑ ^{2.0 2.1 2.2} http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020560s060,021575s020MedG.pdf
3. ↑ http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM166451.pdf
4. ↑ http://www.consumerinjurylawyers.com/dangerous-product-alerts/Fosamax/index.html
5. ↑ http://articles.latimes.com/2006/apr/11/business/fi-fosamax11
6. ↑ http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm208690.htm
7. ↑ http://fosamaxwarning.org/?_vsrefdom=core
8. ↑ http://www.reuters.com/article/2010/06/25/us-merck-fosamax-verdict-idUSTRE65O5HG20100625
9. ↑ Daily Record (Rochester, NY), October 7, 2010
10. ↑ "High Stakes for Merck in Litigation on Fosamax." New York Times (September 3, 2009), p. B1 (L)