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

William Maisel, deputy director of the FDA Center for Devices, stated “The clinical effectiveness of surgical mesh for transvaginal repair of pelvic organ prolapse has not been demonstrated,” this according to Bloomberg. In response Johnson & Johnson, and other manufactures of vaginal mesh products have agreed to more safety studies as well as further labeling changes to properly inform potential recipients of the true risks and the alleged benefits of vaginal mesh products. Besides Johnson

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

Once again the issue of how implant devices are selected for insertion into patients is analyzed in a recent New York Times article, Sales Tactics on Implants Raises Doubts.  The article focused on how Biotronick, a manufacturer of pacemakers and defibrillators, created sham medical studies and consultancy arrangements as a means to funnel money to doctors to increase sales of Biotronick medical devices. According to the New York Times article, Biotronick developed financial relationship with

Bloomberg reports that Pfizer has set aside $772 million to settle all remaining claims related to the drug Prempro, which Pfizer acquired in the acquisition of Wyeth in 2009.  Pfizer acknowledges that the final amount could go higher. “The decision to settle cases reflects a business decision by the company to avoid the cost and distraction of prolonged litigation,” Chris Loder, a Pfizer spokesman, said in an e-mailed statement. This development could be good news

H.R. 5 would impose a limit of $250,000.00 on non-economic damages passed through the U.S. House Energy and Commerce Committee on May 10, 2011, in a 30-20 vote.  The vote was mostly along party lines.  A full House vote has not been scheduled and the bill will likely face opposition in the United States Senate. The American Bar Association opposed the bill while the American Medical Association and the American Hospital Association supported the bill.