Drug Injury Attorney Blog

In a decision that affects nearly every home in the United States, the U.S. Food and Drug Administration required stronger warnings Tuesday for labels on several common over-the-counter painkillers. According to Forbes magazine, the rules require pharmaceutical companies to display the chemical name of the product prominently on its label and warn of any potential interactions with other drugs or common consumables like alcohol. Products containing acetaminophen must also warn about the risk of severe liver damage, and products containing non-steroidal anti-inflammatory drugs must warn about the risk of stomach bleeding. Manufacturers have one year to change their labeling to comply.

The labeling change affects multiple common over-the-counter pain relievers, including Advil, Tylenol, Bayer, Aleve, Excedrin and Motrin. The generic names of the affected products include aspirin, acetaminophen, ibuprofen, naproxen and ketoprofen. All of those drugs but acetaminophen are in a category of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are associated with an increased risk of bleeding in the stomach, particularly in people over 60, those who are taking blood thinners or steroids or people with ulcers or other stomach problems. Heavy use of NSAIDs also contributes. Labels will soon warn consumers about the potential for stomach problems and common risk factors.

Acetaminophen, which is in a category of drugs by itself, does not carry a risk of stomach bleeding. Rather, the new FDA rule will warn consumers of the increase risk of severe liver damage from taking acetaminophen, especially for exceeding the maximum recommended does. According to an FDA press release, research shows that some people take more acetaminophen than the label recommends, while others may take several acetaminophen-containing products at once without realizing the risk. Having three or more alcoholic drinks on the same day can also increase the risk of liver damage. In addition, taking acetaminophen with the blood thinner warfarin may increase the chances of serious bleeding problems. An FDA advisory committee plans to meet in late June to discuss

As an dangerous drug injury attorney, I am pleased at the FDA’s announcement. The problems with both kinds of medicines have been understood for decades, and in fact, acetaminophen overdose is the most common cause of acute liver failure in the United States. Unfortunately, many consumers don’t realize this, so they feel free to take another dose if the first does not work to relieve their pain. As the FDA press release notes, manufacturers have voluntarily added some amount of safety labeling to address the issues, but not as many as the agency now requires. With literally millions of Americans of all backgrounds and states of health taking these medications every day (at a cost of billions of dollars annually), we need clear safety information on their labels.

The pharmaceutical liability lawyers at The Lowe Law Firm represent people who have suffered serious illnesses or injuries because they took a dangerous over-the-counter or prescription medication. In a defective drug lawsuit you can win back the cost of the drug and all of the treatment it necessitated, as well as compensation for a serious injury, permanent disability or the loss of someone you love. If this sounds like your situation and you’re ready to take the next step, you can learn more about your rights and your options at a free, confidential consultation. To set one up, please contact our main St. Louis office or call toll-free at 1-877-678-3400.

A court has ordered Neligen Pharmaceuticals and its parent company, Advent Pharmaceuticals, to immediately cease distributing more than 50 of its drugs. According to an April 10 Associated Press story, the U.S. Food and Drug Administration has a permanent injunction against the companies, barring them from manufacturing and distributing drugs that are adulterated, misbranded or not approved by the FDA. The drugs are mainly prescription cough and cold medicines -- but none have gone through the FDA approval process, so their safety, labeling and effectiveness are all in doubt.

According to the FDA press release, the companies (which also do business as Unigen Pharmaceuticals Inc.) agreed to a consent decree that requires them to destroy all of the drugs they currently have and stop manufacturing any new medications without FDA approval. They must hire outside experts to advise them on complying with regulatory standards, and may not resume operations until they have written permission from the FDA. After they do, the FDA may order them to stop their operations at any time if it finds a regulatory violation. The agency may fine the companies $1,000 per violation and up to $5,000 per day for any continuing legal violations.

As a defective prescription drug attorney, I am pleased to see the FDA cracking down on drug companies that abuse the public’s trust. Most of us assume that a drug wouldn’t even be on the market without FDA approval, so we trust that prescription medications are safe to use and adequately labeled. Companies that illegally bypass the FDA approval process betray that trust and expose consumers to potential serious injury from defective drugs or unannounced drug interactions. As a dangerous prescription medication lawyer, I have seen too many pharmaceutical companies’ cynical marketing tactics to believe that they would all be immune from the temptation to cut costs if they were not held accountable.

Based in St. Louis, The Lowe Law Firm represents people in Missouri, southern Illinois and throughout the United States. Our pharmaceutical liability lawyers sue on behalf of people who have lost a loved one or been seriously harmed because of a prescription or over-the-counter medication they thought they could trust. In these defective drug lawsuits, victims can win the money they need to pay for medical care or other bills related to the tainted medication; replace lost wages while they are out of work; and compensate them for a serious injury or illness, permanent disability or loss of a loved one. To learn more at a free, confidential consultation, please contact the Lowe Law Firm today.

Last year’s Supreme Court ruling in Riegel v. Medtronic took away patients’ right to sue makers of defective medical devices that seriously harmed them or their loved ones. The court said in the 2008 ruling that patients may not file these legal claims because they are explicitly preempted by language in federal law. In response, Congress introduced the Medical Device Safety Act of 2009, which would correct that decision with language that explicitly says federal law does not preempt state-court lawsuits against makers of dangerous medical devices. On April 9, the New England Journal of Medicine published an editorial supporting the legislation, on the belief that it would make patients safer.

The editorial noted that thousands of medical device lawsuits have been thrown out of court since Riegel, regardless of how deserving the injured patients might be. In particular, it cited dismissal of more than 1,000 lawsuits filed by victims of the defective Medtronic Sprint Fidelis defibrillator, which is surgically implanted directly into the patient’s chest. The device has a defective wire that’s unreasonably likely to break, causing it to stop working or shock the patient internally at random times until it can be surgically removed. As the New York Times noted April 7, that surgery is very risky and should ideally be performed by a doctor who specializes in removing the wires. Medtronic itself notes that there have been 13 related deaths so far -- but thanks to Riegel, victims and their families have no legal recourse.

The editorial called for the Medical Device Safety Act’s passage for two major reasons, most importantly, patient safety. The decision shielded medical device makers from the potential consequences of not disclosing risks -- and as a defective medical device lawyer, I know all too well that some pharmaceutical companies are willing to hide risks in order to protect their profits. Restoring the right to sue would remove that risk and improve safety. It would also bring the law on dangerous medical devices in line with the law on defective drugs, the editorial said. The Supreme Court recently ruled in Wyeth v. Levine that federal law does not preempt state-court claims that a medication is defective, a decision the writers find inconsistent with Riegel. The proposed bill would level the playing field between drugs and devices, they wrote.

I strongly agree, and not just because this issue affects my practice as a defective drug and medical device attorney. Medical device safety, effectiveness and disclosure are literally life-or-death situations for many patients. The high-profile cases of drugs like Vioxx and Seroquel make it clear that not all manufacturers are putting safety ahead of profits, and mistakes or lax regulation by the FDA show that we can’t rely on that agency as our only safeguard. Allowing litigation in the cases that slip through the regulatory cracks would give medical device companies the accountability that American patients deserve. As the editorial said, “lawsuits by injured patients... have been an important part of the regulatory framework and very effective in keeping medical devices safe.”

Based in St. Louis, the Lowe Law Firm represents clients throughout the United States who have been seriously harmed or lost a loved one because of a defective prescription drug or medical device. If you or a loved one was hurt after taking a drug, and you believe the manufacturer failed to disclose important safety information about it, our Missouri defective pharmaceutical lawyers can help. To speak to us about your situation and your legal rights, please contact us online as soon as possible or call toll-free from anywhere in America at 1-877-678-3400.

Pharmaceutical company Genentech announced April 8 that it would remove its drug Raptiva (efalizumab) from the market for safety reasons. Raptiva is an injectable medication given weekly to patients who have psoriasis, a chronic skin condition. According to Forbes magazine, the move came almost two months after the U.S. Food and Drug Administration confirmed the medication’s link to a rare but deadly disease called progressive multifocal leukoencephalopathy, a viral infection of the brain. Patients using Raptiva are strongly encouraged to contact their doctors right away to discuss alternative treatments.

Ironically, the problems with Raptiva may stem from its effectiveness. Psoriasis is a chronic, lifelong condition that produces raised patches of scaly or inflamed skin. Doctors are not sure what causes it, but many believe it’s an autoimmune disorder in which an overactive immune system produces too many skin cells. Raptiva addresses the problem by partially suppressing the immune system -- stopping white blood cells from reaching tissues. Because of the suppressed immune system, Raptiva carries a risk of side effects including infection with viral meningitis and fungal disease.

Most recently, the FDA has discovered that it also raises the risk of progressive multifocal leukoencephalopathy (PML), a disease caused by infection with a common virus. Authorities believe most people have this virus, but it is latent in people with healthy immune systems. The most likely victims are people with immune problems, such as AIDS, or who are on immunosuppressant drugs after a transplant. PML inflames the white matter of the brain, destroying the myelin sheath on nerve cells and causing weakness, paralysis, blindness, speech impairments and eventually death. It resembles multiple sclerosis, but progresses much more quickly. There is no known cure.

Thus far, the FDA has identified two confirmed cases of deaths from PML in Raptiva patients, and suspects PML in a third death. A fourth patient has PML but has not died. Since October of 2008, the agency has revised the drug’s labeling twice and issued a public advisory once on the risk of PML. During that time, the European Union’s equivalent to the FDA has suspended all sales of the drug. Genentech is working with other regulatory agencies to inform them about Raptiva’s withdrawal from the U.S. market, but it has not stopped worldwide sales. According to Forbes, 46,000 people around the world have used Raptiva since 2003.

I applaud Genentech for doing the right thing and withdrawing this potentially deadly medication from the market. But as a dangerous prescription drug attorney, I wonder how long the company has known about this risk and what measures it took to detect it. Accidents happen, but I know that some drug companies are willing to suppress unfavorable safety information or manipulate scientific studies to ensure that their sales stay high. If investigation shows that Genentech knew about the risk, or even failed to do adequate testing, the manufacturer would be legally liable for all of the deaths and deadly illnesses that resulted. That could mean millions of dollars’ worth of defective prescription drug lawsuits.

Based in St. Louis, the Lowe Law Firm handles dangerous pharmaceutical legal claims throughout the United States. Our defective drug lawyers represent people who have lost a loved one or been seriously hurt because they trusted the wrong prescription drugs. If you are in this situation and you’d like to learn more about your options, we offer free, confidential consultations. To set one up, please contact the Lowe Law Firm online today or call 1-877-678-3400.

Political lobbying may have trumped FDA scientists’ opinions during the approval process for the medical device Menaflex, the Wall Street Journal reported March 6. According to the newspaper, internal documents and emails show that FDA scientists twice rejected an application for controversial “fast-track” approval by Menaflex maker ReGenBiologics Inc. before the agency later approved the device. Agency emails show that officials later removed language from a draft letter because it documented special treatment for ReGen.

Menaflex is an implant used to treat tears to the meniscus, the most commonly injured part of the knee. Millions of people undergo surgery to correct a torn meniscus every year, and some need to repeat the surgery later. This device is unique, according to Dr. Jay Mabrey, an orthopedic surgeon who chaired the FDA advisory committee that considered Menaflex. For that reason, Mabrey told the Wall Street Journal, he believes it should not have been fast-tracked. Mabrey said he now suspects that the FDA packed the committee with friendly members to secure approval for Menaflex.

The ordinary approval process was not working out well for Menaflex. According to the article, ReGen started a clinical trial required under the conventional approval process, only to be rebuked by the FDA for recordkeeping violations and a conflict of interests on its independent oversight panel. ReGen then applies fast-track approval process -- which doesn’t require a clinical trial -- even though devices must be substantially similar to an approved device to qualify. After the FDA rejected its request twice, ReGen enlisted lobbying help from elected officials and sent letters pressuring the FDA to remove officials who had rejected their requests before. The agency did what ReGen asked, even after FDA scientists disputed ReGen’s favorable analysis of the results in its clinical trial.

The agency is already under fire for its handling of medical device approvals. An anonymous group of FDA staffers wrote to the Obama transition team in January calling for the removal of top medical device officials, saying the process was “corrupted and distorted by current FDA managers.” Also in January, the watchdog General Accountability Office said the FDA was too quick to allow fast-track approval. If all of these allegations are true, they point to severe corruption of the regulatory process -- and the science behind that regulation. And that would put patients who use and trust Menaflex in potential danger from an untested, unproven device.

As a defective medical device lawyer practicing in Missouri and around the nation, I have seen multiple cases of medical devices with serious flaws that cause real harm to patients. If improper pressure from ReGen contributes to another, victims could have a strong case against the company for knowingly bypassing safety regulations and selling an untested, unproven product. In a dangerous medical device claim, patients can win back all of the costs related to the injury, plus compensation for physical pain, emotional suffering and any permanent disability. The Lowe Law Firm handles these claims throughout the United States for a variety of unsafe medical devices, along with defective prescription drugs.

If you or someone you love has been hurt by Menaflex or any other flawed medical device and you’d like to learn more about your legal options, please contact the Lowe Law Firm online or call us at 1-877-678-3400.