Darvon and Darvocet, which have been on the market for over fifty years, have already been banned in the U.K. The FDA was first pressured to closely scrutinize the effectiveness and safety of the drugs in 2006. The FDA will render a final decision about whether to pull the drugs from the market within the next ninety days.
Daytona Beach, Florida (JusticeNewsFlash.com) — In late January of this year, an advisory panel of medical experts narrowly recommended by a 14-12 margin for Darvon and Darvocet to be pulled from the market due to general lack of effectiveness and the potential for deadly side effects including addiction, suicide and heart failure. Darvon and Darvocet, which have been on the market for over fifty years, have already been banned in the U.K. The FDA was first pressured to closely scrutinize the effectiveness and safety of the drugs in 2006. The FDA will render a final decision about whether to pull the drugs from the market within the next ninety days.
Both Darvon and Darvocet are among the most often prescribed painkilling medications. Propoxyphene, the exclusive medication in Darvon and one of the two medications used in Darvocet, has been linked to over 7,000 deaths in the 1980’s and 90’s. In 2007 alone, approximately 500 deaths were connected to propoxyphene, causing medical professionals to criticize the medication for having one of the most unfavorable benefit-to-risk ratios ever observed. Evidence was presented to the FDA which indicated that propoxyphene metabolites accumulate in the heart, leading to toxicity which is exacerbated when combined with alcohol and/or other drugs.
It has also been alleged that propoxyphene is relatively ineffective at reducing and eliminating pain. For example, over-the-counter drug ibuprophen is hailed as being more effective than prescription propoxyphene. It is suspected that the ineffectiveness of the drug is one of the leading causes of the extraordinarily high frequency of addiction and overdose among people who are prescribed propoxyphene. When people do not achieve any noticeable physical relief from pain and discomfort when using the drug, they naturally have a tendency to exceed the prescribed dosage. Unsurprisingly, this behavior leads to a much increased propensity for users to develop addictions and to suffer other personal detriment, such as entertaining suicide and overdosing.
Also of public concern is the fact that the drug is being prescribed at unusually high rates to elderly patients. Over fifteen percent of institutionalized elderly Medicare beneficiaries are being prescribed a drug that contains propoxyphene. Since this drug is a narcotic, it has a tendency to affect people’s balance, making it increasingly likely that elderly users will lose their balance and sustain physical injury, such as breaking a hip.
One of the obstacles plaintiffs’ attorneys will have to surmount is the fact that these drugs have a fifty year history of helping many people. Of course, though, because the drug has been marketed to users for this lengthy period of time, it will be extremely difficult for defense attorneys to claim that their drug manufacturer clients did not detect or notice a risk until the drug was being distributed to consumers. Accordingly, lawsuits will most likely be very fact-specific. This may make it more difficult for class actions to succeed against the manufacturers. Further complicating the picture is the possibility of a preemption argument.
Specifically, the United States Supreme Court is contemplating the issue of whether the manufacturer(s) of a drug that was approved by the FDA can be sued in tort due to adverse affects of consuming that drug. Naturally, if the High Court answers that issue in the negative, this would provide defense counsel their first and very effective line of defense.
Visit the Rue & Ziffra website at http://www.rueziffra.com for more information on the possible termination of the manufacturing and distribution of Darvon and Darvocet. The attorneys at Rue & Ziffra, P.A., will help you bring a claim against the manufacturers of dangerous and defective drugs. Contact our law offices today at (386) 788-7700 or at 1-800-526-4711.