Darvocet Lawsuit FAQs

Posted on May 3, 2011

Since the opioid pain reliever propoxyphene was recalled last November, the number of Darvon and Darvocet lawsuits filed in U.S. courts has continued to pile up. And while injured Darvocet users understand that their cardiac injuries may make them eligible for compensation from distributor Xanodyne Pharmaceuticals, Inc., they still often have questions about the particulars of a product liability claim. Below are the answers to some frequently asked Darvocet lawsuit questions. If you still are unsure about some aspect of your case, don’t hesitate to get in touch with the Rottenstein Law Group for more information.

Am I eligible for a Darvocet lawsuit?

If you have taken Darvon, Darvocet, or another form of propoxyphene and suffered a cardiac side effect such as a heart attack, stroke, ventricular fibrillation, or arrhythmia, or if a loved one suffered a fatal Darvocet overdose, then it may be possible to sue Xanodyne and/or drug manufacturers. Of course, you will have to substantiate your claims through evidence, and only a lawyer can determine whether you have a valid case.

How much time do I have to file a Darvocet lawsuit?

Although the exact amount of time you have to initiate a claim against a drug manufacturer depends on a number of factors, you must understand that it is finite. Statutes of limitations exist so that lawsuits are filed a reasonable amount of time after the events that gave rise to them occurred. Otherwise, important evidence, recollections, and witnesses can be lost or rendered inaccurate. You must therefore file a lawsuit before the statutes of limitations expires, which could be as little as one year or as many as several years after your injury occurred. Again, because every situation is different, you should speak with an attorney to determine how much time you have to sue Xanodyne and/or another manufacturer.

How long will it take to resolve my Darvocet lawsuit?

This is one of the questions most commonly asked by plaintiffs, and also one of the most difficult to answer. As a guideline, most lawsuits take around 2 years from the time they are filed until they reach trial, but a number of factors can make this period longer or shorter. And because some of them, such as the docket schedule, lie beyond the control of even an attorney, not even he or she can give you a completely accurate answer about the amount of time needed to resolve a lawsuit. The bottom line is that you need to be patient and trust that your attorney is doing everything possible to make the legal process as efficient as possible.

How much money can I recover from a Darvocet lawsuit?

None of the cases against Xanodyne and other propoxyphene manufacturers/distributors have yet to be settled, and with the recent ruling by the Judicial Panel on Multidistrict Litigation (JPML) to delay a decision on Darvocet lawsuit consolidation until July, it could be many months before any cases actually go to trial. The most important thing to understand about a Darvocet settlement amount is that it depends on the extent of your injuries and losses. Both monetary damages such as medical bills and non-monetary damages such as physical pain are compensable, however, and some clients’ recoveries could be significant.

How much does it cost to hire RLG to represent me in a Darvocet lawsuit?

Generally, the Darvocet lawyers of the Rottenstein Law Group work on a contingency basis, meaning there are no up-front fees. In the event that RLG is able to secure compensation on your behalf, whether through a trial verdict or a pre-trial settlement, you will be charged a percentage of the total recovery amount.

The Rottenstein Law Group is offering free case evaluations to prospective Darvocet lawsuit clients. You have nothing to lose by submitting the details of your case to one of our experienced attorneys, but you must act quickly to avoid the expiration of the statute of limitations. You can be confident knowing that RLG is handling your propoxyphene injury claim. Our lawyers have a total of more than 25 years of experience standing up for the rights of clients who have been harmed due to the negligence of powerful corporations like Xanodyne. For your complimentary claim evaluation, fill out this form or call 1 (888) 736-7262.

Despite Darvocet Recall, Lawsuits, Drug Still a Public Health Concern

Posted on April 26, 2011

In an effort to preserve the public health, the Food and Drug Administration issued a propoxyphene recall last November, which sparked a wave of Darvon and Darvocet lawsuits against the distributor of the two drugs, Xanodyne Pharmaceutical, Inc. But while the FDA may have prevented drug companies from manufacturing and marketing Darvon and Darvocet, frequent reports of illicit activity involving the pain medications shows that they are still available on the black market at perhaps a greater risk to users.

A simple Google search query for “Darvocet” turns up numerous reports of individuals being arrested in possession of the drug, including:

  • On March 2011 in Genesee Country, New York, a man was arrested and charged with possession of controlled substances that included Darvocet.
  • Earlier this month Shreveport, Louisiana police seized hundreds of pills, including 100 Darvocet tablets, from a suspect and charged him with possession with intent to distribute.
  • On April 15 police in Polk Country, Florida arrested and charged a woman with illegal sale of prescription drugs. She possessed Hydrocodone, Oxycodone, Morphine, and Darvocet.

Literally dozens of such accounts involving illegal Darvocet possession and/or distribution can be found in police blotters across the nation, and they underscore an important point about the drug. Propoxyphene is an opioid and like other controlled substances in this class, carries risks of abuse and dependence. In fact, the U.S. Drug Enforcement Agency (DEA) names Darvon as one of the nation’s ten most abused drugs. And while the FDA’s recall of Darvon and Darvocet means the medications are no longer available by prescription, black market buyers still have access to them, as demonstrated by crime reports.

Propoxyphene was recalled due to its cardiac toxicity, which can cause abnormal heart rhythm, heart attack, and stroke. In explaining its decision to ban the drug, the FDA cited the fact that it can cause heart complications at prescribed dosages in healthy patients. This supports the contention of longtime critics of the drug, who pushed for its ban in large part because research suggested it is toxic at doses only slightly above the recommended dose. If this is true among a population taking the drug under close medical supervision, then imagine the consequences when propoxyphene is consumed by a group of people who are taking it for recreational purposes. Such individuals stand a strong chance of abusing the drug and overdosing, not to mention any contraindications, such as the use of depressants, that could make the use of Darvon or Darvocet even more dangerous.

Darvon and Darvocet were bestselling drugs for decades, and hundreds of millions of prescriptions were written for the pain relievers. This means that untold quantities of them can still be found in homes and storage facilities across the country and that it could take years before supplies are exhausted. Until they are, propoxyphene remains a significant health threat to many, despite the government’s action to restrict its availability.

If you were prescribed a form of propoxyphene for pain and suffered a cardiac injury, the Rottentstein Law Group wants to hear about it. We are in the process of reviewing claims on behalf of clients nationwide, and are committed to defending the rights of those injured by this dangerous drug. We believe that Xanodyne provided insufficient warning of Darvon and Darvocet, and that this negligence entitles injured users of the drugs to compensation. To receive a free review of your Darvon/Darvocet lawsuit claim, fill out this form or call 1 (888) 620-0259.

JPML Defers Decision on Darvocet Lawsuit Centralization Until July

Posted on April 19, 2011

The Judicial Panel on Multidistrict Litigation (JPML), which met on March 30 to decide whether to grant consolidation of all federal Darvon/Darvocet lawsuits before a single judge, has postponed a decision on the matter until the Panel’s July 2011 hearing session.

A motion to centralize all federal litigation related to the recalled pain reliever propoxyphene, best known as the brand name drugs Darvon and Darvocet, was filed by Kristine Esposito of New York last December. Esposito, who claims that Darvocet caused her to suffer a life-threatening cardiac arrhythmia, proposed that the centralization of all pending and future propoxyphene litigation take place in the Eastern District of New York. Additional plaintiffs have also sought multidistrict litigation (MDL) status for Darvocet lawsuits, but suggested alternative transferee districts, including the Eastern District of Louisiana and the Southern District of Ohio.

The JPML, a panel of federal judges responsible for granting MDL status for a group of similar lawsuits, decided after reviewing filed papers and hearing oral arguments from plaintiffs and defendants for and against centralization to defer its decision until its next hearing session in July, when further arguments will be made. In a court document filed on April 11, the JPML provides as the reason for its deferral the growing complexity of the proposed MDL. Specifically, the panel notes that Esposito’s December motion for centralization encompassed a total of four actions against a single defendant (Xanodyne Pharmaceuticals, maker of Darvon and Darvocet), while there are currently 18 known actions involving more than a dozen different defendants.

In the document the Panel writes, “Consideration of this Section 1407 motion so soon after a handful of actions were filed, where the contours of the litigation are in flux, leaves the Panel with less than ideal information to make the best possible decision. This is a potentially complex case. Our desire to make the most informed possible decision counsels further deliberation.”

The surge in Darvocet lawsuits came after the U.S. Food and Drug Administration (FDA) ordered that all products containing propoxyphene be removed from the United States Market in November 2010 due to a high risk of cardiac injury. Initially, Xanodyne Pharmaceutical was targeted by plaintiffs who suffered injuries such as heart attacks, strokes, and arrhythmia, but a number of generic propoxyphene manufactures and even original Darvon/Darvocet patent holder Eli Lilly and Company have been sued for damages. Although Xanodyne and Eli Lilly oppose centralization, they suggest it take place in the Eastern District of Kentucky if their objections do not hold up.

The Rottenstein Law Group will continue to follow this story as it develops and provide regular updates. And even if the Panel ultimately decides to disallow Darvocet lawsuit MDL, this does not mean you cannot sue a drug manufacturer for the injuries propoxyphene has caused you. If you suffered a cardiac injury after taking Darvon, Darvocet, or a chemically similar product, RLG wants to help you hold the blameworthy party liable. RLG’s lawyers have a total of more than 25 years of experience defending the rights of clients who have suffered harm due to the negligence of powerful corporations like Xanodyne. To receive a free case review, just fill out this form or call 1(888) 620-0259.

Two Generic Darvocet Lawsuits Filed in Maryland Last Month

Posted on April 12, 2011

Since the Food and Drug Administration (FDA) ordered a propoxyphene recall last November, hundreds of people have filed Darvon and Darvocet lawsuits against Xanodyne Pharmaceuticals in an attempt to hold the company liable for their cardiac injuries. But while Xanodyne has been the company most often targeted in Darvocet litigation, two cases filed last month demonstrate that it is also possible to sue a company that makes a generic version of the drug available to the public.

Xanodyne Pharmaceuticals, Inc. owns the rights to Darvon and Darvocet, which are brand name versions of the painkiller propoxyphene (Darvocet additionally contains acetaminophen, the active ingredient in Tylenol). Generic forms of Darvon and Darvocet, however, are made and distributed by a number of companies, including Mylan Pharmaceuticals, Inc., Teva Biopharmaceuticals USA, Inc., Propst Distribution, Inc., and Vintage Pharmaceuticals, LLC. The primary accusation against Xanodyne in Darvocet litigation is that the company failed to properly warn of the drug’s cardiac side effects. The established federal law is that generic drugmakers are not responsible for independently altering product labels, a concept known as “generic preemption.” In other words, according to the law, if the brand name version of a drug does not have warning information, then a generic manufacturer of that drug cannot be held liable for omitting a comparable warning from its products’ labels.

But a decision reached in a United States Court of Appeals in January could change this. In the case Gaeta v. Perrigo, a California woman sought to hold a generic ibuprofen manufacturer liable for her daughter’s liver due to the company’s failure to warn of dangerous side effects. The courts ruled in favor of the drugmaker, Perrigo Pharmaceuticals, in 1995, but Gaeta appealed the decision to a higher court and this time, Judge David R. Thompson overturned the previous ruling on the ground that state law duty to warn consumers could not be preempted by federal law.

This groundbreaking decision is expected to have a major effect on the liability of generic manufacturers in disputes related to product labeling. Some experts are now stating that in the upcoming Darvon/Darvocet litigation, there is a strong possibility that makers of off-brand propoxyphene can be held liable for plaintiffs’ injuries and losses. Perhaps spurred by this like likelihood, two generic Darvocet lawsuits were filed last month in Maryland District Court. One action involves plaintiffs Paul Neil Smith, Norma Sue Gibson Lanning and Jimmy D. Blanton against defendants Mylan, Teva, Propst, and Vintage, and in another case, David Cole is suing Mylan.

Whether or not generic manufacturers of propoxyphene can be found liable though a Darvocet lawsuit is a matter to be decided by the courts. The Rottenstein Law Group is following this development closely and will provide updates when they become available. And if you are interested in taking legal action against a propoxyphene manufacturer, RLG will review your claim for free. RLG’s lawyers have a total of more than 25 years of experience standing up for the rights of clients who have suffered harm due to the negligence of powerful corporations like Xanodyne. To receive your complimentary case review, fill out this form or call 1 (877) 620-0259.

On Eve of JPML Decision, a Closer Look at Darvocet Lawsuit MDL

Posted on April 5, 2011

With an announcement due any day now about whether multidistrict litigation (MDL) will be granted for all federal Darvon and Darvocet lawsuits, it is worth taking a closer look at the MDL procedure and the panel of judges that oversees it.

As the Rottenstein Law Group has previously written, MDL is a mechanism that allows the pretrial litigation of numerous similar cases to be centralized and consolidated before a single judge in a single court. This provides several benefits, including preventing inconsistent pretrial judicial rulings, avoiding duplicative discovery (the process in which the lawyers representing the plaintiffs and the defense gather and share evidence), and conserving the resources of the parties, witnesses, and courts. It can also provide a strategic advantage for plaintiffs, as their attorneys can work together to coordinate ideas and strategies.

The group that has the authority to transfer multiple, similar cases to one federal judge for coordination and consolidation is the Judicial Panel on Multidistrict Litigation (JPML). The JPML consists of seven federal judges appointed by the Chief Justice of the United States. Aside from determining which cases are appropriate for MDL, the Panel also must decide to which federal court each case approved for MDL should be transferred. The JPML may initiate proceedings for transfer itself or in response to a motion filed with it. In the case of Darvon/Davocet lawsuit MDL, the request for consolidation came from lawyers for plaintiff Kristine Esposito, who is suing Darvon’s and Darvocet’s maker, Xanodyne Pharmaceuticals, over her alleged cardiac injury.

Whoever initiates the proceedings for transfer, the decision to grant MDL for a group of cases comes down to the JPML’s determination of whether the cases share at least one “question of fact.” A question of fact is a legal term that refers to a factual dispute between the parties in a lawsuit that will be resolved at trial by the judge or jury. It is not up the JPML to answer questions of fact, merely to decide whether at least one exists among all the cases for which MDL is being sought. An example of a question of fact in Darvocet litigation could be, “Did Darvocet’s manufacturer fail to warn consumers of the drug’s potential side effects?” In this example, if the JPML determines that this question of fact is central to the outcome of all of the lawsuits being considered for multidistrict litigation, then it would likely grant them MDL status.

As soon as the JPML makes a decision regarding the proposed Darvon/Darvocet MDL, the Rottenstein Law Group will provide the details of this important development. Before that happens, however, feel free to contact RLG with any questions you have about Darvocet lawsuits. And if you’re ready to take the next step and file a lawsuit against Xanodyne or another manufacturer, RLG will review the details of your case for free. For more than 25 years, consumers injured by dangerous products have counted on RLG’s lawyers to protect their rights and obtain maximum compensation for them. To get started with your complimentary claim evaluation, fill out this form or call the number below.

Darvocet Lawsuit MDL Hearing Set to Begin Wednesday, March 30

Posted on March 29, 2011

On Wednesday, March 30, the Judicial Panel on Multidistrict Litigation (JPML) will hear arguments about whether all Darvon and Darvocet lawsuits should be centralized for pretrial litigation before a single federal judge.

Last December, the attorneys representing Queens, New York resident Kristine Esposito filed a petition requesting multi district litigation (MDL) for all federal lawsuits related to the recalled drug propoxyphene, the main active ingredient in a number of popular painkillers, including Darvon and Darvocet. Esposito claims to have suffered a near-fatal cardiac arrhythmia after taking Darvocet, and seeks compensation for her resulting losses, including a number of cardiac procedures she underwent. Her case was filed in the U.S. District Court for the Eastern District of New York, which is also where her attorneys are proposing that the Darvocet multidistrict litigation take place. Since Esposito’s MDL request was entered, two other Darvocet plaintiffs have proposed that MDL be held in either the Eastern District of Louisiana or the Western District of Louisiana.

MDL is a mechanism that allows the pretrial litigation of a number of similar cases to be consolidated before a single judge, with the intended results of avoiding inconsistent rulings and discovery and conserving the resources of the parties involved. Product liability cases are often good candidates for MDL because they involve a large number of plaintiffs similarly injured by a particular product. But Xanodyne Pharmaceuticals, Inc., the company that distributes Darvon and Darvocet and has been targeted in a number of lawsuits, argues that Darvon/Darvocet MDL is not appropriate due to the availability of numerous forms of generic propoxyphene and the importance of individual claimants’ health.

The Food and Drug Administration (FDA) ordered a market-wide withdrawal of all propoxyphene products last November after a Xanodyne clinical study revealed the drug’s potential to disturb cardiac electrical activity. Since that time, many people have taken legal action against propoxyphene manufacturers, accusing the companies of failing to adequately research the drug’s health risks and provide warnings of its side effects. Esposito’s was one of the first claims to be filed, and some attorneys are predicting that thousands of cases, and billions of dollars in settlements, could eventually arise. If Xanodyne is unable to convince the JPML that Darvocet MDL is not proper, it at least hopes to have the centralized litigation take place in the Eastern District of Kentucky, where the company is headquartered.

The moment that a decision is reached concerning Darvocet lawsuit consolidation, the Rottenstein Law Group will provide details of the results. RLG is currently evaluating claims by those who believe that Darvon, Darvocet, or another product containing propoxyphene caused them to suffer a heart attack, stroke, arrhythmia, or other cardiac injury. RLG’s attorneys have been assisting clients with product liability claims for more than 25 years, ensuring that those injured through no fault of their own are fairly compensated. To receive a free review of your case, just fill out this form or call the number below.

What Propoxyphene Manufacturers Knew… and the Effect on Darvocet Lawsuits

Posted on March 22, 2011

Darvon and Darvocet lawsuits are one of the biggest legal stories of the day, with some attorneys expecting settlements to be even larger than the record-setting $4.85 billion paid to settle Vioxx cases in 2007. But ever since the U.S. Food and Drug Administration (FDA) ordered the withdrawal of all products containing propoxyphene (the drug contained in Darvon and Darvocet) last November, a secondary debate has emerged over whether the FDA’s recall was too late.

The FDA has taken some heat for not taking action sooner to bar a substance that many consider to be one of the deadliest in U.S. history. Propoxyphene’s manufacturers, including original formulator Eli Lilly and current distributor Xanodyne Pharmaceutials, have also been criticized for not voluntary including stronger warnings on packages of Darvon and Darvocet about the risks of cardiac death. Presupposing for a moment that Xanodyne and other manufacturers knew about propoxyphene’s dangers but ignored them and refused to warn consumers, a plaintiff might wonder whether this would increase their chances of succeeding in a Darvocet lawsuit.

The FDA recall of propoxyphene was prompted by new research that showed it could cause potentially fatal heart rhythm abnormalities in healthy patients at prescribed doses. But some critics contend that this news was hardly groundbreaking, and there are studies to back up their assertion. The consumer advocacy group Public Citizen, in its 2006 petition to ban propoxyphene, presented data indicating that between 1981 and 2002, the drug caused more than 7,000 deaths in the United States alone. The group further argues that a large portion of these deaths were accidental and caused by propoxyphene’s cardiac toxicity.

And even before that there was evidence to suggest propoxyphene was deadly. A study published in 1975, just three years after Darvocet gained FDA approval, showed that 1,002 autopsies found traces of the drug. In more than 65 percent of the cases, propoxyphene was named as the cause of death or a contributor to it.

Such statistics clearly indicate that propoxyphene’s deadly side effects have been documented for decades, and that calls for an earlier recall of the drug are justified. As the Rottenstein Law Group has previously reported, however, the FDA cannot be held legally responsible for any injuries Darvon or Davocet cause. The question that remains, then, is whether a pharmaceutical manufacturer’s failure to recognize propoxyphene’s health risks and warn of them has any bearing on its liability in a Darvon/Darvocet lawsuit.

Companies that make drugs available to the public are responsible for ensuring they are safe. Drug safety, though, at least in the eyes of the FDA, is relative, taken to mean that a drug is more effective than it is dangerous. As long as the public is warned of a drug’s potential risks, which is typically done through product labeling, a manufacturer cannot be held liable for harm that drug causes.

In the cases against Xanodyne and other manufacturers, plaintiffs are claiming that insufficient warning was provided about the dangers of propoxyphene to the heart and that this caused them to be injured. Whether or not a manufacturer knew about the cardiac health risks of the drug is secondary to the fact of whether they provided proper warning of them. In other words, ignorance of propoxyphene’s cardiac toxicity is irrelevant in the eyes of the law in determining liability.

Of course, were it to come out that Xanodyne or another company knowingly ignored data on Darvon’s and Darvocet’s side effects, this would likely hurt their chances of defending the charges against them. But from a strictly legal standpoint, propoxyphene manufacturers will be judged by what they should have done, not by what they might have known.

Important news on Darvon and Darvocet lawsuits is forthcoming, as a hearing that will determine how these cases are to be litigated is set to take place on March 30. The Rottenstein Law Group will provide an update on the results of the Darvocet multidistrict litigation (MDL) hearing as soon as they become available, so check back in soon to find out more. Currently, RLG is providing complimentary case evaluations for anyone who believes their or a loved one’s cardiac injury was caused by propoxyphene. To have your claim reviewed for free by an attorney with more than 25 years of experience, fill out this form or call the number below.

Cardiac Injuries Prompt Louisiana Residents to File Darvocet Lawsuit

Posted on March 15, 2011

Three Louisiana residents filed a Darvocet lawsuit recently against several drug manufacturers, claiming that the painkiller caused them to suffer cardiac injuries.

On March 4, Billy Lambert, Gladys Delaune, and Margaret Seagraves filed suit in U.S. District Court for the Eastern District of Louisiana. The complaint names several defendants that either currently manufacture or previously manufactured Darvocet, including Xanodyne Pharmaceuticals, AAIPharma Services, Eli Lilly and Company, Teva Pharmaceuticals USA, and Qualitest Pharmaceuticals. The lawsuit alleges that Darvocet caused the plaintiffs to develop serious, life-threatening heart conditions, including wide complex tachycardia, a type of cardiac rhythm abnormality. The principal charge against the defendants is that they knew or reasonably should have known about Darvocet’s potential health risks and failed to warn the public about them.

By taking legal action against the pharmaceutical companies that make or previously made Darvocet available to the public, the Louisiana plaintiffs join dozens of others nationwide who similarly accuse drugmakers of producing and failing to warn about a dangerous product. Darvocet, along with Darvon and a host of generic pain relievers containing the drug propoxyphene, were recalled last year by the U.S. Food and Drug Administration (FDA). Eli Lilly and Company originally developed Darvon (in 1957) and Darvocet (in 1972) before selling the drugs to AAIPharma in 2002. Current distributor Xanodyne Pharmaceuticals acquired the rights to Darvon and Darvocet in 2005 after AAI became insolvent. Propoxyphene is generically manufactured by a number of companies, including Teva and Qualitest.

A hearing is scheduled for the end of this month to determine whether all Darvon and Darvocet lawsuits should be consolidated under a single judge for pretrial proceedings. So-called Multidistrict Litigation (MDL) would allow all the parties involved with propoxyphene litigation to save significant time and resources.

Following the March 30 MDL hearing in San Diego, the Rottenstein Law Group will provide all the details of this important development. Until then, you can contact RLG about any question you have concerning the recalled drug propoxyphene, or to initiate a Darvon/Darvocet lawsuit. You have limited time to file a claim, so it is important that you act quickly. RLG’s lawyers have more than 25 years of experience in product liability law. By choosing us to handle your case, you are selecting legal professionals who are dedicated to obtaining the best possible results. To receive a free evaluation of your claim, fill out this form or call the number below.

Supreme Court Decision, Obama Policies Affect Darvocet Lawsuits

Posted on March 11, 2011

The decision by the U.S. Food and Drug Administration (FDA) last November to recall all products containing the drug propoxyphene has led to numerous Darvon and Darvocet lawsuits being filed in state and federal courts. As they are currently interpreted under President Obama, state tort laws allow an individual harmed by corporate irresponsibility to sue for damages. But during the Bush Administration, there was a push for federal preemption, or the precedence of federal law over state law, in regards to a citizen’s right to sue a company that caused him or her harm.

The United States constitution says that federal law trumps state law whenever there is a conflict of the two. Under President George W. Bush, however, several federal agencies attempted to extend this principle to include not only federal law, but federal regulations, such as those implemented by the FDA.

The argument basically went that if a product had won FDA (a federal agency) approval, this carried the same weight as federal law, effectively preempting state tort law. In one Supreme Court decision, the Bush Administration argued that a patient injured by an exploding balloon catheter could not sue the manufacturer under state law because the device had been approved by the FDA. The Supreme Court ruled in favor of the manufacturer.

But in 2009, The Supreme Court largely reversed directions. In Wyeth v. Levine, a Vermont woman who took the drug Phenergan sued its manufacturer, the pharmaceutical company Wyeth, after her arm was amputated due to tissue damage. She accused the drugmaker of failing to warn about Phenergan’s dangers, a charge that Wyeth argued was preempted by the fact that the drug was FDA-approved. The Supreme Court ruled that just because a drug obtains FDA approval does not mean its manufacturer is absolved of the duty to sufficiently warn of its risk. And Obama, upon entering office, acted to further reverse Bush-era preemption policy by issuing a memorandum to the heads of executive departments and agencies that recognized the important of state law for safeguarding the public.

The same “failure to warn” charges in Wyeth v. Levine can be found in the numerous lawsuits against Xanodyne Pharmaceuticals, the company that distributes Darvon and Darvocet. Claimants are accusing the company of insufficiently warning of the drugs’ cardiac dangers. Thanks to the shift in the way federal preemption is interpreted, plaintiffs with a legitimate claim against Xanodyne can rest assured they will receive their “day in court.”

If you suffered cardiac complications after taking Darvon, Darvocet, or another product containing propoxyphene, the Rottenstein Law Group wants to make sure that your voice is heard and your rights are protected. For more than 25 years, the lawyers of RLG have been helping those injured by a blameworthy corporation recover the financial compensation they are entitled to. To receive a complimentary review of your Darvon/Darvocet lawsuit by an experienced RLG attorney, fill out this form or call the number below.

Can I File a Darvocet Lawsuit Against an Acetaminophen Manufacturer?

Posted on March 8, 2011

Ever since the FDA recalled the painkiller propoxyphene last November, Darvon and Darvocet lawsuits have continued to pile up against Xanodyne Pharmaceuticals, Inc., the company that distributes the two products. While the sole active ingredient in Darvon is propoxyphene, Darvocet additionally contains acetaminophen (better known by its brand name, Tylenol). Because of this, some individuals injured by Darvocet may be wondering whether they can sue an acetaminophen manufacturer for harm suffered.

While acetaminophen has the potential to cause liver damage and is a dangerous drug in its own right, this does not constitute grounds for a Darvocet lawsuit. The reason that dozens of legal claims have been filed against Xanodyne is that a study conducted by the company at the request of the U.S. Food and Drug Administration (FDA) discovered that propoxyphene can disrupt the heart’s normal rhythm, potentially causing a heart attack, stroke, or other cardiac complication. Upon learning about the results of the Xanodyne clinical trials, the FDA issued a market withdrawal of all propoxyphene products (which includes numerous generics in addition to the brand-name Darvon and Darvocet).

Some attorneys are expecting claims against Xanodyne and other propoxyphene manufacturers to eventually number in the thousands and surmise that recoveries from such lawsuits could be in the billions of dollars. If this turns out to be true, it could make Darvon and Darvocet lawsuit settlements one of the biggest pharmaceutical settlements of all time.

Darvon (FDA approved in 1957) and Darvocet (FDA approved in 1972), used by tens of millions of Americans over the years for pain relief, have been as controversial as they have been widely prescribed. The group Public Citizen filed petitions seeking a ban of propoxyphene in 1978 and 2006, citing data on the drug’s cardiac dangers. Both were unsuccessful, although the consumer advocacy organization’s most recent attempt did lead to the FDA’s order that Xanodyne perform clinical testing on the drug.

But just because a drug can cause injury does not necessarily mean that its manufacturer can be targeted in a lawsuit. The FDA, in determining whether to permit the marketing of a pharmaceutical product, measures a drug’s safety against its benefits. As long as a drug benefits outweighs its risks, it will generally be permitted for sale to the public. This means that dangerous drugs can be (and are) approved by the FDA.

The catch, however, is that the companies that manufacture and distribute dangerous drugs must warn of the products’ potentially hazardous side effects. In the lawsuits against Xanodyne, claimants allege that the company knew or reasonably should have known but failed to warn of Darvon and Darvocet side effects. Although the FDA ordered revised product labeling of all propoxyphene products in 2009, this action fails to take into account the many Darvon and Darvocet users who were harmed by the drugs before then.

An important decision on Darvon/Darvocet lawsuits should come later this month, when the Judicial Panel on Multidistrict litigation meets in California. The Rottenstein Law Group will provide up to date information on Darvocet MDL when it becomes available, so be sure to check back. And if you believe that your (or a loved one’s) cardiac injury was caused by Darvon, Darvocet, or another product containing propoxyphene, submit the details of your case to RLG for a free claim evaluation. For more than 25 years, the lawyers of RLG have been protecting injured consumers against corporate wrongdoing. For a complimentary case review, fill out this form or call the number below to get started.