When the U.S. Food and Drug Administration (FDA) approves a new drug for sales to consumers, it gives hope to those suffering from the condition that drug is purporting to alleviate. Most of the time, the results are overwhelmingly positive. There are those times, however, when a harmful product makes it to the market and causes serious harm to the very people it purported to help. In the case of Fosamax, a drug designed by Merck & Co. to strengthen bones, several serious side effects of the medication have emerged since its introduction. As these Fosamax problems have gained public attention, thousands of lawsuits have been filed in response against Merck.
Problems with Fosamax
When Fosamax (alendronate) was first introduced to the U.S. market in 1995, it was hailed as a miracle treatment for the 40 million Americans who either already have osteoporosis or are at risk for developing the disease. The class of drugs to which Fosamax belongs, bisphosphonates, work by slowing the body’s natural bone breakdown process. By inhibiting bone turnover, bisphosphonates can help keep the skeletal system strong. In some cases, however, they can begin to interfere with bone metabolism and actually cause bones to weaken.
This may be why some patients taking Fosamax for osteoporosis or Paget’s disease experience bone problems. One of these is osteonecrosis (literally “bone death”), a condition that interrupts the blood supply to bone tissue, causing the tissue to die.
In the late 1990’s bisphosphonate users began reporting to the FDA that they had developed osteonecrosis of the jaw (ONJ). By the end of 2006 more than 100 Fosamax ONJ lawsuits had been filed against Merck. To date, 1,000 such lawsuits have been consolidated in a New York federal court.
The results of a study published in 2008 concluded that people who took drugs like Fosamax were up to three times more likely to develop osteonecrosis. These findings followed closely an FDA warning about the ability of Fosamax and other bisphosphonates to cause severe musculoskeletal pain.
Since the beginning of 2011, two reports linking Fosamax to atypical femur fractures, rare injuries that can occur after little or no impact, have been featured in prominent medical journals. Their publication has led to additional lawsuits against Merck, which now faces dozens of centralized femur fracture lawsuits in New Jersey.
And most recently, it has been brought to the public’s attention that Fosamax may cause esophageal cancer. Two U.K. studies on the side effect were published in 2010, with one finding a positive association between bisphosphonates and esophageal cancer and the other finding no link between them. In hope of settling the debate, the FDA announced its own investigation into the matter in July 2011.
Why Dangerous Drugs Make it to Market
One reason why harmful drugs make it to market lies in the process by which they are approved. The FDA leaves the testing and the funding of studies to determine the safety of new drugs to the manufacturing companies. This creates the potential for individual actors within such companies to put the bottom line ahead of the health of their consumers.
With billions of dollars at stake in the pharmaceuticals industry, the lure of the dollar sometimes causes these people to see past the risks and prematurely bring the product to market, or else keep it on the market despite evidence pointing to adverse effects. In many of the ONJ and femur fracture lawsuits against Merck, plaintiffs claim that the company was aware of Fosamax side effects, but failed to warn of them.
Less insidious, though no less dangerous to consumers, is the fact that clinical trials are often poor indicators of a drug’s actual safety. For example, despite the fact that Merck performed clinical trials on around 8,000 patients, this number is nowhere near the millions of people who have received Fosamax prescriptions since its approval. Furthermore, clinical trials often only last two or three years, while subsequent scientific studies suggest that Fosamax problems have a much longer incubation period.
Once dangerous drugs do make it to market, their manufacturers may also engage in deceptive marketing to maximize profits, resulting in large numbers of people unnecessarily exposed to harmful side effects. In 1997, the FDA rebuked Merck for falsely connecting menopause and osteoporosis in an attempt to recruit menopausal woman to take Fosamax. A similar incident occurred in 2001 when Merck was again reprimanded by the FDA, this time for overstating the benefits of Fosamax while downplaying its health risks.
Contact the Rottenstein Law Group For Lawsuit Help
If you have suffered harm from any of the Fosamax problems described above, then you should contact a legal professional to evaluate the facts of your case. Only then can you be sure whether or not you have a worthwhile Fosamax lawsuit to pursue.
The attorneys at the Rottenstein Law Group have the experience and the know-how to help you determine the strength of your potential claim. For a free consultation with RLG, please fill out this brief contact form.