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Increasing numbers of Darvocet lawsuits pile up in US courts and experts continue to compare the tremendous scope of the Darvocet litigation to the mess of litigation that followed the damage down by the popular diet pill Fen-phen.
There are obvious similarities between Darvocet and Fen-phen. Both were linked to serious heart problems resulting in their removal from the market. Fen-phen was pulled from the market in 1997. But prior to its being pulled…6 million Americans had already taken the diet pill. And thousands experienced the dangerous Fen-phen side effects: pulmonary hypertension and valvular heart disease.

Wyeth, the Fen-phen manufacturer, has paid out substantial monies in compensatory damages to thousands of plaintiffs totaling over $13 million.

Experts are indicating that the similarities between the two drugs will most likely reach to similar monetary compensation totals for Darvocet lawsuits as those seen in response to Fen-Phen cases.

Darvocet was a popular and accepted mild painkiller for more than 50 years prior to being recalled for dangerous side effects. In 2009 along the prescription was filled over 10 million times.

Darvocet side effects are serious. And they have been evident for a long time. For decades consumer advocacy groups have petitioned the FDA to remove the drug. These same groups estimate that the FDAs refusal to remove the drug from the market has resulted in approximately 1,000 to 2,000 American deaths in the last 5 years. They also predict that these deaths will be the source of a high number of Darvocet lawsuits in the future. The FDA repeatedly, study after study, concluded that the benefits of Darvocet as a pain killer outweighed the risks from potential side effects. They changed their conclusion to one where the risks outweighed the benefits in 2010.

Last November the FDA ordered that Xanodyne Pharmaceuticals (who purchased the Darvocet patent from AAI Pharmaceuticals in 2005) pull Darvocet from US pharmacy shelves. Xanodyne immediately pulled the drug without contesting the order.
But now that the lawsuits are piling up Xanodyne is definitely complaining and contesting the FDAs claims of risk outweighing benefit of Darvocet. They are currently fighting the efforts being made on behalf of plaintiffs to consolidate litigation into a central federal court. Xanodyne’s main complaint regarding litigation consolidation is that they are not the sole manufacturers of the drug; several companies actively made and sold generic forms of Darvocet.

In spite of the company’s objections to Multidistrict Litigation legal experts fully expect the Judicial Panel on Multidistrict Litigation to approve the centralization of Darvocet lawsuits. The panel is expected to make their decision in late March.

Legal experts also expect that once the Multidistrict Litigation is approved that Xanodyne will then raise new objections; specifically bringing up their doubt of the causative link between cardiac issues and Darvocet.

It has been brought to the attention of the public that Darvocet manufactures will most likely attempt to raise a “Daubert motion” during the upcoming trial. A “Daubert motion” is a motion to exclude certain testimony on the grounds that the “expert” testifying has an inadequate knowledge of the material being discussed. In the case of Darvocet the drug manufacturers will most likely attempt to claim that the chosen expert has an inadequate expertise of the chemical mechanism through which Darvocet damages the individual’s heart.

When Fen-phen was pulled from the market in 1997 several clinical studies had already linked it to both pulmonary hypertension and valvular disease. In the case of Darvocet…evidence is still mounting continuing to point towards a causal connection between Darvocet and heart problems even when the drug is taken as prescribed.

The FDA finally found evidence that was “conclusive” after half a century. Most experts feel it is very likely that the judge will find similar evidence concluding that the drug is a danger.

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22-year-old Kara Nicole Gilbert of Ohio suffered a torn ligament in her knee and her doctors prescribed Darvocet as part of her treatment to help with the pain of the injury. Like all Darvocet prescription, risks associated with the medication were listed on both the bottle and the insert that came with the drug. Reading these warnings gave Kara and her parents, Tammy and John Gilbert, peace of mind and assured them the drug would be safe. At the time, which was in 2009, Darvocet was still a commonly prescribed painkiller and routinely given to patients for mild to moderate pain.

However, eight days after she began taking the medication, Kara was found dead in her apartment. She was young and healthy – no history of heart conditions. Her cause of death was acute cardiac failure with evidence of pulmonary edema. Darvocet was the only factor that could have rationally caused her death – an especially tragic incident since there has been speculation regarding the safety of Darvocet for decades. In fact, the first petition for the product’s recall came from the consumer advocacy group Public Citizen in the 1970s.

Darvocet and other propoxyphene-based painkillers were banned in the United Kingdom in 2005, and regulations were in place in the United States that prohibited the Food and Drug Administration from requiring drug monitoring once medications were approved for the pharmaceuticals market. It was for this reason that Darvocet was allowed to remain on the market, largely unchecked, for as long as it did. However, they had the power to request clinical trials to be done by manufacturers of Darvocet – which is what happened in 2007, when Xanodyne Pharmaceuticals Inc. conducted their own study and determined that the benefits of their product did not outweigh the risks. They recalled Darvocet voluntarily shortly afterwards.

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Many refer to the most serious of the Darvon side effects as Darvocet heart arrhythmia or irregular heartbeat. More than 850,000 people in the US alone are admitted to the hospital each year with some form of irregular heartbeat.

Most pharmaceutical drugs come with a list of potential side effects and Darvon was no different. Darvon side effects listed included: general weakness, lightheadedness, skin rashes, minor visual disturbance, euphoria, hallucinations, headache, dysphoria, abdominal pain, constipation, vomiting, nausea, sedation and dizziness.

Most pharmaceutical drugs also release a much “longer” list of potential side effects that are reported after the drug is released to the public. Darvon was also not an exception to this common rule. Darvon’s “long” list of potential side effects was much longer and much more serious. The potential side effects of Darvon and Darvocet that were discovered after the drug was released included: kidney disorders, liver disorders, rash and itch, psychiatric disorders, nervous system disorders, disorders of metabolism and nutrition, elevated heart rate, immune system disorders such as hypersensitivity, stomach disorders, symptoms of drug withdrawal, heart and respiratory arrest (cardiac arrest), respiratory arrest, drug dependence, heart attack, coma, dizziness, vomiting, convulsion, liver disorders, lowered blood pressure, eye disorders, heart rhythm disorders, diarrhea, accidental death, confusional state, accidental and intentional overdose and suicide.

The active ingredient in Darvon and Darvocet, propoxyphene, was shown to interfere with the electrical activity of an otherwise healthy heart according to independent studies. This interference causes heart arrhythmia in some instances as well as heart rate abnormalities, irregular heart rates, and other cardiac issues that can result in fatal heart attack. Experts on the subject estimate that Darvocet related deaths totals are in the thousands.

Darvocet (and related drugs) were recalled by the FDA after 53 years on the US market. The recall was due to the seriousness of the Darvocet side effects (Darvocet heart arrhythmia and other potentially fatal Darvon/Darvocet side effects).

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Although Darvocet settlements have not yet been paid out to patients, the drugmaker Xanodyne is expected to be responsible for millions – perhaps even billions – of dollars paid to consumers in compensation for side effects they may have endured due to the popular painkiller. Time will tell what kind of settlement plaintiffs will get – and since Darvon and Darvocet, along with other propoxyphene products, were pulled from U.S. and Canadian shelves a mere two months ago, there is plenty of time for victims of the side effects associated with the product to receive their settlement.

Unfortunately, drug settlements often take years – and the first trials may not even begin for a long time. Many plaintiffs have filed suit since the product was recalled, but only a few of these cases have been made public, with many plaintiffs wishing to remain anonymous. Linda Gallagher is one of the exceptions to this – her suit after she suffered a heart attack related to Darvocet was filed in a New Orleans court in December. This is said to be the first Darvocet suit filed in a federal court since the recall of the drug on the 19th of November.

Drug settlements are often very large – for example, a plaintiff won $25 million after filing a lawsuit related to the acne medication Accutane, and this kind of money is not uncommon when it comes to lawsuits against major companies who have the means to pay large amounts. These kinds of settlements are usually reached in a jury trial and not when the company settles out-of-court with a plaintiff, although out-of-court settlements are still often significant and could be in the millions for some patients, depending on the case and the amount of money that the plaintiff is requesting.

It is only a matter of time before more trials get underway and decisions are made regarding not if but when plaintiffs will receive compensation.

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In November 2010, the Food and Drug Administration mandated a recall for prescription painkillers Darvon, Darvocet, and all other analgesics that contain propoxyphene. Such drugs have been proven to pose a significant risk to users and have been linked to serious side effects such as Darvocet heart problems and arrhythmia.

Medical experts and consumer watchdog groups had been warning for years that Darvon (propoxyphene) and Darvocet (propoxyphene with acetaminophen) tended to interfere with the electrical activity of the heart. The FDA published a report in 2009 that gave credence to these concerns.

Researchers determined that even in recommended doses, both Darvon and Darvocet were capable of causing negative inotropic effects, meaning that the medications can make the heart’s muscular contractions weaker. When the contractions of the heart are thus weakened, this can result in dangerous changes to the regular intervals of heartbeat.

The FDA has stated that these kinds of changes include a lengthened PR interval, a prolonged QT interval, as well as a widened QRS complex (see image). Such changes are symptoms of Darvocet heart arrhythmia, an irregular heartbeat caused by Darvocet, which is a dangerous disorder that can end in sudden and possibly deadly heart attack. One consumer advocacy group known as Public Citizen has repeatedly asked the FDA to ban Darvocet for decades. This same group has estimated that Darvon and Darvocet heart problems have led to the deaths of between 1,000 to 2,000 Americans over the past five years.

Symptoms and Treatment of Darvocet Heart Arrhythmia

While certain types of heart arrhythmia are harmless, others can be lethal. All kinds of heart arrhythmia can be detected by a physician using an ECG (electrocardiogram). Symptoms of a dangerous Darvocet heart arrhythmia include signs such as fatigue, dizziness, shortness of breath, or the feeling of the heart fluttering or experiencing other agitation.

In some cases, no treatment is called for when a heart arrhythmia is detected. In other cases, there are anti-arrhythmia drugs that may be prescribed. In the most serious cases, surgery is needed to remedy the condition.

If you have used Darvon or Darvocet and you have reason to believe you may be experiencing Darvon or Darvocet heart problems, please cease consuming the medicine right away. It is important that you consult a physician as soon as possible. In addition, you should know that you may be eligible for compensation for your medical expenses by means of a Darvocet lawsuit. If you believe this may be the case, it is recommended that you speak to a Darvocet lawyer at your earliest convenience.

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Multidistrict litigation, a legal process with some similarities to a class action lawsuit, may soon be applied to a growing number of Darvocet lawsuits. Almost three months after the Food and Drug Administration banned Darvocet in the U.S., increasing numbers of lawsuits related to this dangerous painkiller are pressing the court system for the creation of a Darvocet class action lawsuit.

So far fewer than one dozen Darvocet lawsuits have been filed in state and federal courts, however Darvocet lawyers expects that Darvocet plaintiffs will soon number in the thousands. If that happens, these thousands of claims could then be consolidated under multidistrict litigation (MDL) which in many ways resembles the proceedings that would be undertaken by a Darvocet class action lawsuit.

One of the very first plaintiffs to file a Darvocet lawsuit is Kristin Esposito. In December 2010 she filed a motion requesting MDL for herself and similar plaintiffs who also filed a Darvocet lawsuit in a federal court. Her request, which has been seconded by two additional plaintiffs, is currently pending approval. The decision is expected at the earliest on March 30, the next meeting date of the Judicial Panel on Multidistrict Litigation.

The manufacturer of Darvon (propoxyphene) and the very popular Darvocet (propoxyphene and acetaminophen) is Xanodyne Pharmaceuticals. This company is in opposition to the request for MDL for all Darvon and Darvocet lawsuits. Xanodyne insists that the majority of Darvocet lawsuits do not have enough similarities to qualify for this type of centralization of cases. Furthermore, the defendant’s lawyers claim, some of the plaintiffs of these lawsuits used generic propoxyphene medications that were not produced by Xanodyne.

In addition, the defendant does not agree with the specific court and judge Esposito has requested to oversee her proposed multidistrict litigation. Esposito requested that Judge Jack B. Weinstein of the U.S. District Court for the Eastern District of New York be put in charge of the centralized Darvocet and Darvon lawsuits. But Xanodyne claims that if the Judicial Panel on MDL does decide to consolidate these Darvocet lawsuits, the cases ought to be processed in the Eastern District of Kentucky, near the bulk of witnesses, evidence, and Xanodyne headquarters.

If the panel decides to move forward with the proposed MDL consolidation, all future Darvocet lawsuits filed in a federal court will then be sent directly to the judge presiding over the proceedings. In multidistrict litigation, unlike class action lawsuits, each case is considered an independent claim once the MDL process has been completed. This process includes such pretrial proceedings as evidence gathering and witness testimony, which are all organized by the presiding MDL judge. Afterwards, the individual claims can be sent back to the districts where each was first filed.

Since propoxyphene was approved by the FDA in 1957, more than 22 million individuals have consumed Darvocet and other drugs that contain propoxyphene. It has been estimated that over the past five years, the drug has been responsible for the deaths of thousands of Americans, leaving thousands more with serious permanent heart troubles.

If you have used Darvocet or Darvon and experienced side effects as a result, speak to a Darvocet attorney as soon as possible.

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Since the Food and Drug Administration’s November 2010 ban on popular propoxyphene-based painkillers such as Darvon and Darvocet, patients have been trying to determine their eligibility for a lawsuit against the makers of the medication. Although propoxyphene products, most commonly sold under the brand names, have been on the market since the 1950s, they have been plagued with health and safety issues from the very beginning, and a consumer advocacy group called Public Citizen first petitioned the FDA for a recall of the drug more than 30 years before the ban was actually instated. Because of this, many more lives were put at risk than should have been.

The 2010 ban on Darvocet unfortunately comes after many warning signs that should have alerted both consumers and the Food and Drug Administration about the very real risks surrounding the medication, including the ban on propoxyphene in the United Kingdom six years ago and in Europe a year and a half ago. An advisory committee recommended a ban on the drug in 2009, but this voting was overruled. In addition, studies have been conducted that have linked the use of Darvon and Darvocet to heart related problems in otherwise healthy people, even at normal doses of the medication.

When the ban was announced, about 10 million people were taking propoxyphene-based painkillers. These patients were urged to discard their drugs – but also issued a contradictory warning that told them to consult their doctors before discontinuation of treatment, due to withdrawal concerns. Those who are eligible for Darvocet lawsuits include those who have suffered negative side effects due to propoxyphene use and family members of people who have died as a result of the medication, but certain restrictions may apply – potential plaintiffs need to know about their state’s statue of limitations, and sufficient evidence must be provided that the patient suffered side effects as a result of their Darvon or Darvocet prescription.

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Since the Food and Drug Administration’s November 2010 ban on popular propoxyphene-based painkillers such as Darvon and Darvocet, patients have been trying to determine their eligibility for a lawsuit against the makers of the medication. Although propoxyphene products, most commonly sold under the brand names, have been on the market since the 1950s, they have been plagued with health and safety issues from the very beginning, and a consumer advocacy group called Public Citizen first petitioned the FDA for a recall of the drug more than 30 years before the ban was actually instated. Because of this, many more lives were put at risk than should have been.

The 2010 ban on Darvocet unfortunately comes after many warning signs that should have alerted both consumers and the Food and Drug Administration about the very real risks surrounding the medication, including the ban on propoxyphene in the United Kingdom six years ago and in Europe a year and a half ago. An advisory committee recommended a ban on the drug in 2009, but this voting was overruled. In addition, studies have been conducted that have linked the use of Darvon and Darvocet to heart related problems in otherwise healthy people, even at normal doses of the medication.

When the ban was announced, about 10 million people were taking propoxyphene-based painkillers. These patients were urged to discard their drugs – but also issued a contradictory warning that told them to consult their doctors before discontinuation of treatment, due to withdrawal concerns. Those who are eligible for Darvocet lawsuits include those who have suffered negative side effects due to propoxyphene use and family members of people who have died as a result of the medication, but certain restrictions may apply – potential plaintiffs need to know about their state’s statue of limitations, and sufficient evidence must be provided that the patient suffered side effects as a result of their Darvon or Darvocet prescription.

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How any given lawsuit will fare once it reaches trial is heavily influenced by the legacy of similar litigation that came before. There are multiple Darvon and Darvocet lawsuits scheduled to reach trial in the coming months, and they may be affected by an important ruling on a generic drug that was made last January.

In the generic drug lawsuit, Gaeta v. Perrigo, a woman in California claimed that the manufacturer of a generic form of ibuprofen should be held responsible for her child’s liver failure. Her child had, prior to consuming the generic ibuprofen, taken an anesthetic which interacted with the ibuprofen resulting in liver complications.

There was no warning of this type of drug interaction on the label of the generic ibuprofen because the brand name version of the drug doesn’t have such a warning. Under current federal law, manufacturers of generic forms of drugs are not required to add this information to their labels if the brand name doesn’t include it and they are thereby immune. This idea is usually called “generic preemption.”

A lower court ruled in favor of the defendant, Perrigo Pharmaceuticals, in 2005. Gaeta’s lawsuit was considered temporarily defeated, but the plaintiff was not finished fighting. A court decision in 2009 involving the anti-nausea medication Phenergan made it possible for Margarita Gaeta to appeal the decision made on her case to a higher court.

Then on Januray 14, 2011, a new ruling was made by Judge David R. Thompson of the United State Court of Appeals of the 9th Circuit. He overturned Gaeta’s first ruling, stating that the duty to provide a warning was mandated by state law and could not be preempted by a federal law. His decision is a landmark for cases such as Gaeta’s lawsuit and will undoubtedly have an effect on any legal proceedings undertaken by the generic pharmaceutical industry in the future.

How Decision Will Affect Darvocet Lawsuits

As a result of this landmark decision, it is understood that companies such as Perrigo Pharmaceuticals, as well as the companies that manufacture generic versions of Darvon and Darvocet, are now to be held responsible for keeping their warning labels updated and complete, regardless of what the brand-name drugmaker has on their own label.

Xanodyne Pharmaceuticals is the manufacturer of brand-name medicines Darvon (propoxyphene) and the well-known Darvocet (propoxyphene with acetaminophen). Xanodyne didn’t change the warning label on these drugs in the months leading up to the November 2010 recall of both, even though it had been established that there were serious cardiac side effects which merited additional warning information. There are several generic versions of these prescription painkillers, and their labels matched those of the brand-name medicines up until the recall.

Following the recent overturn of the Gaeta v. Perrigo case, plaintiffs with lawsuits against generic makers of propoxyphene now have increased hope that these manufacturers will be held responsible for the inadequate warning labels as Darvon litigation proceeds. A defense strategy claiming that they were simply ‘following the leader’ will no longer hold water in court.

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Darvocet, before its ban by the Food and Drug Administration at the end of last year, was one of the most-prescribed painkillers in the country. Used for mild to moderate pain, the propoxyphene-based product was prescribed to millions of users across the country for over half a century. The ban, surrounding allegations of severe side effects and complications related to the medication, prompted thousands of victims to consider whether or not they had a lawsuit against the manufacturers of the medication.

Darvon, Darvocet, and generic forms of propoxyphene have been found to cause arrhythmia, heart attacks, accidental death, and overdose – even in small doses. The more recent research showed that more people were affected by these serious side effects than originally thought, and out of the millions of patients who had been prescribed the drug since its introduction to the market, thousands of them suffered from any of the many side effects of the medication. As a result, Darvocet lawyers across the country have filed lawsuits on behalf of those who have suffered.

Prior to the FDA ban on propoxyphene, it was linked to suicides and accidental deaths across the country, with an estimated 2,500 deaths in the United States alone. Most doctors were unaware of the side effects, or at least the seriousness of the side effects, that the drug caused – despite the fact that the first petition for the ban of the drug was in 1978. In addition, an advisory board voted to ban recall the drug in 2009, but the ban was not enacted until November of 2010 – putting countless more lives at risk. Since these conditions are becoming more well known to patients who may have suffered one of the Darvocet or Darvon side effects, more and more patients are filing lawsuits – which will likely be consolidated in a multidistrict litigation case.