Articles Posted in Darvon & Darvocet Recall

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Recently the American Association for Justice (AAJ) issued a letter explaining the latest developments in a case with implications for all those working on matters involving defective medical devices. The issue of preemption is invovled in the case related to state and federal rules for off-label promotion of the devices. In other words, this is a matter of a company violating rules in order to get its products used in ways that were not approved by regulators.

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The AAJ letter explains that the case, Sandager v. Medtronic, Inc. stems from complaints by a plaintiff that she was harmed by a bone-graft product as a result of that product’s illegal promotion. The device was not approved by the U.S. FDA for the use in the way that the plaintiff received it. These illegal marketing issues are quite common in many settings, including medical devices and pharmaceuticals.

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The Darvon and Darvocet recall continues to make headlines as experts weigh in on its impact around the world.

Lawyers and Settlements published a story this week in which one well known physician explained that the danger of the now-recalled drugs was very clear early on. The results of the delay in banning the drug have been catastrophic. Calls for the ban began decades ago, but nothing was done. Now the doctor explains, “There could have been hundreds of thousands of deaths due to Darvon and Darvocet over the past 25 years.”

Medical researchers informed the FDA of their findings regarding the dangers of the drugs decades ago. However, the department was extremely slow in investigating the true risks of the medication-only pulling it from shelves this November.

Some experts believe that the trials related to Darvon and Darvocet will prove to be larger than many other mass medication cases. For example, Vioxx maker Merck provided a $4.85 billion settlement fund to be used to families of those injured by the painkiller’s effect on heat attacks.

The upcoming lawsuits will be of a similar magnitude.

One expert shared, “I think the Darvon trials will become bigger than Vioxx because it has been going on for so long, but some people are just now realizing how catastrophic Darvon is.”
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This blog has recently shared information about the growing number of lawsuits filed on behalf of patients who suffered because of complications from the medications Darvocet and Darvon.

News published in About Lawsuits now suggests that the manufacturer of those dangerous drugs, Xanodyne Pharmaceuticals, is attempting to block all efforts that would consolidate and centralize those lawsuits. Multidistrict litigation, or MDL, is common when product liability cases like this one occur. It is designed to avoid the wasteful repeated efforts of discovery and avoid inconsistent rulings on the various claims across the country. Thousands of victims are expected to file lawsuits in all parts of the country following the recall of these products.

The medication became one of the country’s most popular prescriptions in the late 1970s as a pain medication. Concerns were raised about the drug’s safety as early as 1978. However, it wasn’t until 2006 that an FDA advisory panel began investigating the safety of the medication following public advocacy claims regarding the skyrocketing death toll linked to the drugs. Two year later Public Citizen, a consumer rights organization, filed a lawsuit against the FDA for its failure to properly take action against the drug.

The FDA finally changed course from previous pronouncements in late November of last year, asking the drug makers to pull the medication from the market.
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Few medical miscalculations have the potential to harm more people than mass medication errors. When unsafe drugs are continually given to patients, the consequences are often catastrophic. That is exactly what happened with two drugs that were recently pulled from the market for the unacceptable health risks that they caused. However this was not before the medication was given to patients for more than half a century, even though concerns about its safety had been made clear for decades.

Darvocet and Darvon, also known as propoxyphene, was finally pulled from shelves by the FDA in November. The recall was spurred by evidence of the drugs’ causing dangerous disturbances in heart rhythm. An unusually high number of patients were found to exhibit the heart problem after 18 months on the medication.

The Darvon and Darvocet recall is only the latest in a series of FDA actions that have been questioned, mostly for their delay. On many occasions the decision to recall a drug is a battle of risks, financial investment, and patient safety. Millions and millions of dollars are spent investing in new medications and pharmaceutical companies always exert pressure to keep the drugs on the market.
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In late November last year we posted on the large medication Darvon and Darvocet recall announced by the FDA. The recall was initiated following medical studies which showed that the drugs caused serious, unacceptable side effects. Particularly troubling was indications that patients who took the medication were at risk for fatal heart rhythm abnormalities as well as risks of suicide, addiction, and overdose.

The medication became one of the country’s most popular prescriptions in the late 1970s as a pain medication, according to reports at Lawyers and Settlements. Concerns were raised about the drug’s safety as early as 1978. However, it wasn’t until 2006 that an FDA advisory panel began investigating the safety of the medication following public advocacy claims regarding the skyrocketing death toll linked to the drugs. Two year later Public Citizen, a consumer rights organization, filed a lawsuit against the FDA for its failure to properly take action against the drug.

In early 2009 that advisory committee recommended recall of both drugs. However, a few months later the FDA as a whole rejected the committee’s urging, instead only claiming that some changes should be made on the label. The FDA finally changed course in late November of last year, asking the drug makers to pull the medication from the market.

Several lawsuits have been filed on behalf of the victims and their families seeking redress for the problems with the drug and its recall. With the mounting evidence pointing to a link between potentially deadly side-effects and the use of the medication, it is vital for all patients who have taken the drug to receive a health assessment.
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