The debate over how long women should use bone density drugs, known as bisphosphonates, for osteoporosis continues especially after the Food & Drug Administration published an analysis of the safety of long term use of bisposphonates, such as Fosamax. The analysis published in the New England Journal of Medicine, reveals the FDA is concerned that the use of bisphosphonates actually contributes to rare but serious adverse events associated with bisphosphonates, such as atypical femur fractures,

Baldness drug Propecia and enlarged prostate drug Proscar, both manufactured by Merck & Company, will now both carry a new warning linking the two drugs to sexual dysfunction after treatment this according to the Food and Drug Administration.  The warning for Propecia will include a warning regarding libido disorders, ejaculation disorders, and orgasm disorders that continue after discontinuation of the drug.  A revision to the Proscar label will include a warning about decreased libido that

A panel of the Pennsylvania Supreme Court ruled that “There was sufficient evidence of gross negligence and willful and wanton misconduct to support imposition of punitive damages,” against Pfizer and units Wyeth and Pharmacia & Upjohn. As a result, Pfizer must pay more than $45 million in damages to Connie Barton and Donna Kendall.  The court noted that while the amount of punitive damages was large, it “correlated with the enormity of the defendants’ wrongs,

Pfizer and its Wyeth and Pharmacia & Upjohn units have resolved about 46 percent of suits that claimed the companies’ hormone-replacement medicines, including Prempro, Prempro and Provera, caused breast cancer, according to the Securities and Exchange Commission filing. Pfizer said it added $68 million to the $772 million it already reserved for the cases according to Bloomberg. The latest revelation comes after a $72.6 million dollar jury verdict against Pfizer and its units Wyeth and

In a closely watched trial in Philadelphia, a jury has awarded three women $ 72.6 million for developing breast cancer after using menopausal drugs made by Pfizer’s units Wyeth and Pharmacia Upjohn this according to Bloomberg. Plaintiff Judy Mulderig used Premarin and Provera for more than 11 years and was awarded $24.75. Plaintiff Bernadette Kalenkoski used Prempro for 4 years and was awarded $27.85 million while Susan Elfont was awarded $20 million. It is estimated

The Vancouver Sun reports that a class action has been certified in Canada for Canadian women who took Prempro and developed breast cancer.  B.C. Supreme Court Justice Miriam Gropper found that the case met the criteria for class-certification. This ruling is the exact opposite of how Judge William R. Wilson ruled in MDL 1506, In re Prempro Products Liability Litigation. Judge Wilson ruled that there exists no commonality of interest among the claimants. http://www.vancouversun.com/health/Judge+certifies+class+action+lawsuit+involving+hormone+therapy+drug/5213703/story.html

Bloomberg reports that Pfizer has won another lawsuit involving Prempro.  The federal jury in West Virginia ruled that Leah Royce Hines’ breast cancer was not caused by her use of the hormone drug – Prempro. Mrs. Hine’s lawyer, Harry F. Bell Jr. of The Bell Law Firm, said “the verdict is not surprising given the defense’s resources and how restricted the evidence in the case was.”  Mr. Bell went on to state: The defense’s resources

On July 8, 2011, Pfizer filed a pleading in the MDL Proceedings (4:03-cv-1507) asserting that there may be no reason for core discovery to take place in the MDL proceedings thereby permitting many cases to be remanded to the trial court for scheduling orders with trial dates.  This development may be significant for the thousands of cases in the MDL proceeding. Cases ripe for remand will involve those cases where only Wyeth/Upjohn are named as

On June 23, 2011, the United States Supreme Court ruled that lawsuits against generic drug manufacturers are preempted by federal drug regulations which require a generic drug label to match the brand warning label word for word regardless of mounting evidence that a generic drug carries a risk far greater than what is disclosed in the label. The case is Pliva v. Mesing. Writing for the Court, Justice Thomas noted that if Mesing and Demahy

The FDA has issued a warning to women with breast implants alerting them to the likely need for additional surgery within eight to ten years of implant.  According to FDA spokesperson  “breast implants are not lifetime devices. Breast implants have been controversial and have resulted in substantial litigation over their safety.  Earlier in 2011, the FDA warned of a small correlation between breast implants and anaplastic large-cell lymphoma (ALCL). Helpful links: FDA Chicago Tribune, You