Posted On: February 25, 2009

FDA to Study Effects of TV Ads for Prescription Drugs on Consumers -- Missouri Pharmaceutical Liability Law Firm

The FDA plans to study how well consumers absorb information and respond to television advertisements for prescription drugs, American Medical News reported Feb. 2. The agency is interested in how well consumers learn about the risks and benefits of drugs they see on television, the article says, with the goal of setting standards for the ads. To study this, the FDA will produce television ads for a fictional blood pressure medication and recruit 2,400 people to watch them and tell researchers what they've learned. The study's start date was not announced, but the FDA was taking public comments until the end of January.

Television ads that market directly to consumers -- rather than to the doctors responsible for prescribing drugs -- have been controversial throughout their 12-year lifespan. The ads were not allowed on the air or in print at all until 1997, and only one other country, New Zealand, allows them on television. Since TV pharmaceutical ads were introduced in the U.S., doctors and consumer activists have repeatedly complained that the ads encourage patients to ask for drugs that they don't really need, wasting doctors' time and raising the risk of over-medication. Another concern is that direct-to-consumer ads gloss over the risks of a drug and spend more time on their benefits, presenting a biased view. And one study showed that the ads aren't very effective, raising concerns about wasted millions that are built into the cost of the drugs.

In response, the American Medical Association has called for drug makers to submit to mandatory FDA review of the ads; allow doctors to learn about a drug before advertising it to consumers; and make a more balanced presentation of drug risks and benefits. Congress is also concerned about the safety of drug ads, which is why it asked the FDA to set drug advertising standards in the FDA Amendments Act of 2007. The FDA's advertising study was launched in response to that legislation, in hope of eventually devising standards.

As a Missouri drug injury attorney, I am concerned about the possible over-medication effect of prescription drug advertising. Statistics show that prescription drug errors are already responsible for more deaths each year than illegal drugs, so we hardly need to create more unnecessary prescriptions. Furthermore, the drugs that are most likely to be advertised on television are the newer drugs, which means we still have relatively limited information on their safety and efficacy. Among recent heavily advertised drugs that turned out to have serious problems are Vioxx, a painkiller now withdrawn from the market after strong links to heart attacks and strokes, and Zyprexa, a psychiatric medication that may cause diabetes and was allegedly illegally marketed for off-label uses.

The Lowe Law Firm has active pharmaceutical liability practices for victims of both Vioxx and Zyprexa. If you or someone you love developed serious health problems after taking these drugs -- or other dangerous pharmaceuticals -- we would like to hear from you. Based in St. Louis, we help clients in the Midwest and throughout the United States. To schedule a free consultation, please contact us online or call us at 1-877-678-3400 as soon as possible.

Posted On: February 20, 2009

FDA Panel Recommends Davron and Darvocet Be Removed From Market -- St. Louis Defective Prescription Drug Lawyer

An FDA panel, citing safety risks, voted Jan. 30 to remove a pair of painkillers from pharmacy shelves. According to the Associated Press, the panel of outside experts voted to end sales of Davron and Davrocet because of concerns that their safety risks outweigh their benefits. The FDA is not bound by the decision, but it frequently follows the recommendations of its outside panels.

Davron (propoxyphene) is a opioid painkiller used for mild to moderate pain. Davrocet is a combination of Davron and acetaminophen, the active ingredient in Tylenol, and is now more frequently prescribed then Davron alone. Like all opioids, both drugs carry a high potential for addiction and abuse and are not safe when combined with alcohol. They have also been linked with serious health problems, including heart problems, respiratory disorders and kidney and liver problems. And in the 1970s, studies linked the drug with suicide, prompting an unsuccessful drug recall campaign from watchdog group Public Citizen. Complaints from the same group spurred the current review.

Davron has been on the market since the 1950s and is now among the 25 most commonly prescribed drugs in America, with 20 million prescriptions written in 2007. However, because it is a relatively weak painkiller competing in a field that includes newer, stronger drugs, experts are concerned that its risks are now greater than its benefits. A limited federal study showed about 500 Davron-related deaths in 2007; 20% of these were suicides. In Florida, medical examiners found Davron in the bodies of 341 people who died of any cause and cited it as the cause of death in 85 cases (about a quarter of the total). The British version of the drug was banned outright in 2005.

The FDA may not take such a drastic step; it could choose to strengthen the warnings on Davron's label or further restrict its use. However, the controversy over this drug dates back more than 30 years -- making its risks older than some of the patients taking it. As a Missouri defective drug lawyer, I know that the FDA is currently very reluctant to recall prescription medications, sometimes even when there's strong evidence that they have serious defects. However, when the doubts about a drug have persisted for so long, it may be time for serious action. Thanks to advancements in medical science, doctors now have a variety of safer or more effective drugs to replace it with.

If it turns out that Davron has been putting patients at serious risk of suicide, heart problems and other serious side effects for decades, its manufacturers could be legally liable to thousands or even millions of families in a defective prescription drug lawsuit. If you believe you or someone you love was hurt by Davron, Davrocet or another potentially dangerous medication, The Lowe Law Firm can help. Based in St. Louis, we help clients in Missouri and throughout the nation who have lost a loved one or sustained permanent injuries because of a drug company's carelessness.

To learn more about your rights at a free consultation, please contact the Lowe Law Firm online today or call toll-free at 1-877-678-3400.

Posted On: February 17, 2009

FDA Recalls Dietary Supplement Containing Undeclared Controlled Substance -- St. Louis Dangerous Drug Attorney

An over-the-counter weight-loss drug was recalled by the FDA due to serious safety risks, the Miami Herald reported Jan. 29. Venom Hyperdrive 3.0 was recalled after it tested positive in FDA laboratories for substantial amounts of sibutramine, a Schedule IV controlled substance not listed on the drug's label. The FDA is warning consumers to stop taking the drug immediately and contact their doctors for further medical instructions. They can also contact the manufacturer, Applied Lifescience Research Industries, at legal@alrindustries.com for instructions on returning the product for a refund.

As a controlled substance, sibutramine is illegal to dispense without a doctor's prescription. More importantly, the lack of warning makes the recalled supplement dangerous for people with heart disease, arrhythmia or a history of heart failure or stroke, because sibutramine increases blood pressure and heart rate. It's also contraindicated for people with several common conditions, including depression, eating disorders, a history of alcohol abuse or glaucoma. And it's not safe to mix sibutramine with certain other kinds of drugs, including opioid painkillers and a class of antidepressants called monoamine oxidase inhibitors.

This recall comes on the heels of a wider FDA recall of 69 weight-loss supplements that contain undeclared active ingredients, including drugs that are carcinogenic, controlled or not approved for use in the United States. Under these circumstances, selling a substance without telling consumers what it is may well be prosecuted as a crime. Even if it's not, this illegal and irresponsible behavior could kill many patients or cause them to develop serious or permanent health conditions. And that would expose manufacturers to hundreds or even thousands of drug injury lawsuits from people who have developed serious health conditions or lost a loved one to side effects of the supplements.

A defective drug lawsuit holds manufacturers legally responsible for their actions, but it also helps victims of unsafe prescription drugs recover some of the high financial costs of a sudden and serious health problem. An emergency room visit even for a minor problem can easily reach five figures; lifetime medical care for someone with a serious chronic condition can exceed the multi-million-dollar lifetime caps on health insurance plans. And of course, no price is high enough to compensate people who suddenly lose a loved one.

If you're facing these issues after you or someone you love took a defective prescription drug, the Lowe Law Firm can help. Our experienced defective prescription drug lawyers help people in Missouri and throughout the United States hold drug makers responsible for their carelessness. And we offer free consultations, so there's no risk in speaking to us about your case. To set up a free consultation today, contact the Lowe Law Firm online or call us at 1-877-678-3400.

Posted On: February 11, 2009

Troubled Missouri Drug Manufacturer Pulls Almost All Products From Market -- Southern Illinois Drug Injury Law Firm

Because I'm a drug injury attorney in St. Louis, I have been following the news about KV Pharmaceuticals, a troubled St. Louis generic drug manufacturer. The most recent news, reported Jan. 26 by Fierce Pharma, is that KV has recalled all of the products that it manufactures itself, which is more than 100 drugs and the majority of its products. It's the fifth drug recall for KV Pharmaceuticals in a year, following closely after November and December recalls of specific products.

As I've blogged here before, the December recall was of oversized pills of hydromorphone, a morphine-related painkiller, which raised concerns about possible overdoses. In fact, the same oversized pill problem prompted all of the 2008 recalls, although different drugs (including morphine and dextroamphetamine) were involved. The company already faces lawsuits from patients, as well as lawsuits over corporate governance matters that led the company to replace its president and CEO in December. The article says KV is being investigated by both the FDA and the SEC.

The FDA has not yet announced the newest recall, although KV's press release suggests that it eventually will. The release does not specify why the company recalled its entire line of drugs, but given the serious financial problems KV is facing, they must have had a very good reason. And given the oversized pill problems it had throughout 2008, more manufacturing defects could be the culprit. While the drugs involved are different, any drug with an oversized pill presents a risk of an overdose, and an overdose of a powerful prescription drug is a serious matter. Depending on the drug, patients could risk death, heart attacks, hallucinations and other very serious side effects.

Patients who have suffered these effects after taking defective drugs from KV Pharmaceuticals -- or any other company -- have the right to hold the careless manufacturer legally responsible for the results. Based in St. Louis, the Lowe Law Firm handles these pharmaceutical liability cases for clients in Missouri and throughout the United States. To speak with our experienced defective drug lawyers at a free consultation, please contact us online or call 1-877-678-3400 today.

Posted On: February 6, 2009

Prescription Painkiller Recalled Due to Potential for Dangerous Overdose -- St. Louis Dangerous Medication Law Firm

A St. Louis-based drug maker has recalled some lots of generic Hydromorphone HCl and suspended shipments of other drugs because of manufacturing problems. According to an FDA press release, Ethex Corporation, a division of KV Pharmaceutical, recalled the painkiller Dec. 23 because the manufactured pills were larger than intended. This could cause an overdose of the drug, a morphine product with addiction potential and a federal Schedule II classification, leading to low blood pressure, breathing problems and sedation. People who think they might have the recalled drug (Lot #90219) should visit KV's Web site for more information on how to identify and return it.

This is the fourth recall by Ethex and KV over the last few months, according to an article by the St. Louis Post-Dispatch. Like this one, at least some of the past recalls involved oversized pills. At least two of them also involved morphine products that had the potential to addict patients or cause a fatal overdose. KV fired its longtime CEO for cause in December, has lost value on the stock market and doesn't expect to resume manufacturing its products until spring.

Morphine products are both useful and potentially dangerous because they are derived from opium. In addition to being highly addictive, they can slow the heartbeat and breathing, sometimes dangerously so. Oversized pills like the ones that were recalled could potentially give patients more of the drug than intended or marked on the packaging. In addition to raising the potential for a fatal overdose, this could also sedate patients more than intended, causing problems with driving or other everyday activities and raising the potential for a harmful drug interaction.

The article doesn't say how the corporate problems with this company may have affected its drug safety problems. But if a drug manufacturer or its decision-makers have suppressed important information about a drug's safety, the company is liable for a dangerous prescription drug lawsuit. In this case, that could mean multiple morphine overdose lawsuits filed by families who have lost a loved one to dangerously oversized pills. The Lowe Law Firm represents clients throughout the Midwest and the United States who have been seriously injured by a pharmaceutical company's failure to warn patients of their products' defects. If you or someone you love has been seriously hurt in this way and you’d like to learn more, please contact us online for a free evaluation of your case.

Posted On: February 5, 2009

Defibrillator Lawsuits Against Medtronic Dismissed--Missouri Medical Device Attorney

A federal judge has dismissed with prejudice lawsuits filed over lead wires to an implantable defibrillator made by Medtronic, the Associated Press reports.

The court concluded that the Food and Drug Administration’s approval of the device protected Medtronic from lawsuits under the legal doctrine of preemption. The lawsuit involved the Sprint Fidelis defibrillator wires. In 2007, the wires were pulled off the market after it was discovered that broken wires may have played a role in several patient deaths.

Last year, the U.S. Supreme Court ruled that Medtronic was protected from a similar lawsuit involving FDA approval of a balloon catheter that could burst during angioplasty.

With the democrats controlling the United States House, Senate and Presidency, this protection of medical device manufactures under the guise of preemption may be overturned legislatively.

If you believe you have been injured by a defective medical product, we can help. Contact The Lowe Law Firm headquartered in St. Louis, Missouri to discuss your case.

Posted On: February 2, 2009

Missouri to Receive $18 Million in Zyprexa Lawsuit -- St. Louis Defective Drugs Attorney

The Lowe Law Firm has actively investigated cases of serious injuries and diseases stemming from the use of Zyprexa (olanzapine) in Missouri and throughout the United States. So we were pleased to see in the St. Louis Business Journal that Zyprexa's maker, Eli Lilly & Co., has agreed to an $800 million settlement with the U.S. Department of Justice over Zyprexa marketing practices. The settlement covers civil claims by federal and state Medicare and Medicaid agencies, as well as a $615 million fine for violating the federal Food, Drug and Cosmetic Act. Missouri's Medicaid agency will receive nearly $18 million as part of the settlement and Illinois will receive a combined $44 million for Medicaid and the state itself.

The claims stemmed from Eli Lilly's choice to market Zyprexa for off-label uses. The drug was approved by the FDA as an anti-psychotic for use with patients who have schizophrenia or bipolar disorder, but the company marketed it for a variety of maladies, including anxiety, age-related dementia and addiction to gambling. Marketing a drug for uses not approved by the FDA is illegal under the Food, Drug and Cosmetic Act. Unfortunately, Zyprexa has also been linked by research to serious blood-sugar and pancreas disorders, including diabetes, hypoglycemia and pancreatitis.

These are serious, chronic medical conditions that generally must be managed over the patient's entire lifetime. If they aren't detected and treated in time, they can lead to other serious medical problems, including diabetic comas, amputations and loss of eyesight. Just like other companies, drug makers like Eli Lilly have a responsibility to take reasonable care to avoid harming their customers. In this case, that could mean complete honesty about any information they may have had about Zyprexa and blood sugar disorders. It could also mean not encouraging primary care doctors to prescribe the medication for uses that weren't approved or intended by regulators.

When drug makers deliberately break laws and fail to warn the public about the risks of their products, they are legally liable for any harm they cause to their customers. In a defective drug lawsuit, consumers can win reimbursement for the cost of treating the side effects of dangerous medications; replace any income they lost; win compensation for the loss of their good health or a loved one; and ensure that the drug maker is forced to stop its deceptive and abusive practices. The Lowe Law Firm handles Zyprexa injury lawsuits and claims over many other defective prescription drugs, in Missouri and throughout the United States. If you believe you have a claim and would like to know more, please contact us today for a free consultation.