Parilman & Associates

Fosamax (Alendronate Sodium) is a type of drug, known as biphosphonates, used to treat osteoporosis, paget’s disease, and other bone loss disorders. Since the FDA approval of Fosamax in 1995, Merck, the drug’s creator, has been under serious scrutiny from the FDA for their marketing of Fosamax. In 1997, a letter was sent by the Division of Drug Marketing, Advertising and Communications (DDMAC) of the FDA to Merck stating that marketing material for Fosamax lacked balance and only outlined the benefits of the drug, but failed to list the warnings and risks. Merck was sent another letter from the DDMAC in 1999, this time stating that advertisements for Fosamax violated the Federal Food, Drug, and Cosmetic Act by not providing enough information. Merck received yet another FDA Fosamax warning letter in 2001; this time the letter was in response to the drug’s website, which according to the letter, overstated the benefits of Fosamax while minimizing the serious side effects.

By 2001, oral surgeons and dentists had already begun to notice a link between use of bisphosphonates like Fosamax and the onset of osteonecrosis of the jaw (ONJ), otherwise known as “dead jaw”. ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue.

Avandia is a type II diabetes controller drug that first hit the market in 1999. It was designed to help type II diabetes patients increase their insulin levels by increasing the sensitivity of insulin receptors. For several years, Avandia generated billions of dollars annually for its Manufacturer, GlaxoSmithKline.

By 2007, many reports of serious and sometimes fatal side effects had already begun to surface. After a study was published showing that Avandia raises its users' risk of heart attack by 43% and their risk of death from heart problems by 64%; the FDA issued a Black Box warning, the FDA's most significant action short of a recall.
Emerging evidence shows that the FDA may have known about Avandia's cardiac risks long before the 2007 study.

DePuy Orthopaedics, the subsidiary of Johnson & Johnson, has been coping with an ominous black cloud ever since the recall of its ASR hip replacement system in August 2010. Now, a DePuy Pinnacle recall seems imminent after medical warnings report that these metal-on-metal devices have abnormally high failure rates among patients. So as the storm rolls in, DePuy can only wait patiently while the flood of litigation pends on the horizon.

Hydroxycut®, the group of dietary supplements which claim to be fitness and weight loss aids, have recently been linked to severe, and sometimes life threatening injuries. Recent reports state that these injuries include damage to the liver, kidneys and other internal organs, rhabdomyolysis (severe muscle damage), cardiovascular disorders and even death. On May 1, 2009, the United States Food and Drug Administration (FDA) issued a warning urging consumers to discontinue the use of the supplements due to the severe health dangers associated with Hydroxycut®. Following the warning from the FDA, the makers of Hydroxycut® issued a voluntary recall of the supplements.

The makers of Zicam Cold Remedy products blamed for causing nearly 1,000 people to lose their senses of smell have officially begun the process of recalling the products from store shelves. If you have experienced loss of smell due to use of Zicam products, call Parilman & Associates for information on your rights.

A week after the Food and Drug Administration announced it has received 130 reports since 1999 of Zicam users losing their ability to smell, Matrixx Initiatives of Scottsdale, Ariz. has now notified retail stores, wholesalers, and distributors of the recall of Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Gel Swabs products. The stores are being asked to stop selling the products.