January 17, 2012

Vaccines Recalled Due to Inclusion of Glass Particles

It sounds like something out of a horror movie, but it’s actually the subject of the FDA’s latest recall.

Bedford Laboratories, a pharmaceutical- and medical device-manufacturing corporation has just recalled two vaccines after it was found that vials of the injections contained glass particles.

Bedford Laboratories is an American manufacturer that supplies an extensive selection of critical-care and medically necessary multisource and specialty injectable products to the healthcare marketplace. This is the second recall for the same product; according to the FDA’s report, the recalls were first initiated in August of 2011 after visible glass particles were found in a limited number of vials in the affected lots.

The first vaccine retracted from the market was for Vecuronium, a muscle relaxant that is generally used during surgery in conjunction with general anesthesia, to facilitate intubation and mechanical ventilation. The other recalled injection was Polymyxin B, an antibiotic used primarily to treat infections by causing cells to become more permeable, at which point the increase in water-uptake leads to the cell’s death. Polymyxin B, in its natural form, is also commonly used in the topical first-aid preparation ointment Neosporin.

Nevertheless, despite the enormous benefits these medications may have, the glass particles make them potentially deadly. According to the U.S. Food and Drug Administration, particulate matter in injections – such as the glass in this particular case – can be harmful when introduced into the bloodstream. Potential adverse effects may include such things as vein irritation and inflammation, tissue death, obstruction of capillaries and arteries, and in more serious cases, anaphylactic shock, and death.

Although to date there have been no injuries reported from the affected lots, the potential for hazard is enormous.

Illinois product liability law is an area of personal injury law that focuses on dangerous and defective products; it is the area of law in which manufacturers, distributors, retailers, and others who manufacture and disseminate goods to the public are held responsible for the injuries caused by those products. "Products" in this instance covers a wide range of categories, including medical devices and pharmaceuticals.

In cases in which Illinois product liability lawsuits arise, the claims most commonly asserted are negligence, strict liability, breach of warranty, and various other consumer protection claims. This particular situation involves strict liability. Under strict liability, the manufacturer of the product is liable for injuries caused if the product harms consumers, even if the manufacturer was not directly negligent in making that product defective.

Our Chicago personal injury lawyers represent victims across Illinois in matters against companies that have sold or manufactured unsafe products to consumers. In fact, our attorneys brought a case against Orion Research Inc. and Baxter Health Care Corporation for a flawed test for the genetic disease cystic fibrosis. The failures of the test led a set of parents to have a second cystic child. While recovering a substantial settlement for the family, the firm and the family were more concerned with the discontinuation of the test. As a result of our efforts, the test was eliminated.

If you've had an incident with a product that caused an injury, or are the survivor of someone who may have died from the use or exposure to a dangerous or defective product, contact an attorney to better understand your rights under the law. You may be entitled to compensation for your suffering.

January 10, 2012

Over-The-Counter Medications Recalled Because of Accidental Inclusion of Prescription Pharmaceuticals

Novartis International AG, the second-most lucrative pharmaceutical company in the world, has just recalled a number of over-the-counter medications because packages of pills may have accidentally included doses of powerful prescription medications.

Although the U.S. Food and Drug Administration is not recalling all containers of these medications because they may be otherwise medically necessary, the FDA has released a public warning, cautioning consumers about the potential mix-up.

According to reports by the Associated Press, the problem arose at an American Novartis production facility, which has subsequently been shut down. In 2010, Novartis International AG, a major manufacturer of generic prescription drugs, recorded sales of $46.806 billion. A number of the prescription drugs inadvertently included in the over-the-counter medications were opioids (drugs used in the treatment and management of pain) that are otherwise sold under the labels Percocet, Endocet, Opana, and Zydone. Pieces of the prescription drugs made their way into containers of the over-the-counter remedies, which is what caused the concern and the resulting recall.

This past Sunday, Novartis AG issued a nationwide retraction of certain bottled versions of Excedrin (a headache pain-reliever), Bufferin (an anti-inflammatory medication for minor aches and pains), Gas-X (a pill intended to relieve pain caused by excess gas in the stomach), and No-Doz (a caffeine stimulant), saying that they may contain stray, broken, or chipped parts of prescription tablets of drugs which were manufactured at the same plant.

This situation is a prime example of Illinois product liability law; product liability is an area of Chicago personal injury law that focuses on dangerous and defective products. Although no injuries have yet been reported as a result of the mistake, because Novartis AG’s negligence led to the prescription medications’ inclusion in over-the-counter products, Novartis could be liable for damages if injuries do arise.

Said the FDA’s recall report, mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength pain-reliever drug than otherwise intended, or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a customer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.

Although the Consumer Health division of Novartis has publicly stated that the recall is a precautionary measure, the tainted over-the-counter packages were distributed to wholesale and retail stores across the country. With such widespread dissemination, the risk to consumers is enormous.

Novartis AG plans to notify distributers and customers, and is urging customers to return potentially hazardous packages. Our Chicago personal injury lawyers have handled numerous cases in which customers have been injured by dangerous, defective, or diseased products. If you or a loved one have suffered as a result of using an unsafe product, contact an attorney to be apprised of your rights under the law.

Continue reading "Over-The-Counter Medications Recalled Because of Accidental Inclusion of Prescription Pharmaceuticals" »

December 15, 2011

Fentanyl Pain Patches: Risk of Lethal Overdose from Manufacturing Mistake Leads to Recall

The Food and Drug Administration has just released another medication recall, this time for Fentanyl pan-relieving patches, after manufacturers discovered that the patches were releasing medicine into the bloodstream faster than intended.

Fentanyl is a synesthetic opiod that acts quickly to treat pain, but has a short duration of relief. It is commonly used both as an anesthetic and a pain-reliever, and it is estimated to be more than 100 times more powerful than heroin, per dose. Fentanyl patches are prescribed to patients suffering from chronic, severe pain. When the patch is designed correctly, it slowly releases a very small dose of medication. However, if too much of the medication is delivered or the fentanyl from the patch comes into direct contact with the skin and too much fentanyl is released into the bloodstream, there is a risk of fatal overdose.

There have been a number of problems with fentanyl patches since they were first put on the market in 1994 as a result of manufacturing issues, and several Illinois wrongful death lawsuits have arisen as a result of problems with the patch’s design.

This particular patch, the Actavis Fentanyl Transdermal system is the generic version of Johnson & Johnson’s Duragesic patch. The FDA stated that this particular patch may release lethal amounts of the painkiller into the bloodstream. Although no [Illinois wrongful death cases] have yet been brought against this particular manufacturer, a number of users have reported excessive sedation, respiratory depression, and difficulty breathing.

As the manufacturer of a drug that is available to consumers, Avtavis is responsible for ensuring the safety of their product. When a company manufactures a product to be marketed to the public, the company is responsible for ensuring the safety of those products. There are three main types of Illinois product liability claims:

1. A manufacturing defect, which generally occurs when an otherwise safe product is assembled carelessly;
2. A design defect, which occurs when, no matter how well the product is put together, its intent or layout is inherently dangerous;
3. A failure to warn, which can occur when a product markets a product that they know to be potentially hazardous, and fails to warn consumers of the latent danger.

In this case, when the manufacturing defects lead to injuries or death of consumers, Actavis may be held legally responsible for damages arising from those injuries. This may lead to an Illinois personal injury lawsuit which would serve to compensate the victim for hospital and medical bills, or, in more serious cases, the death of a loved one.

The recall affects lots of the Actavis Fentanyl Transdermal System 25 mcg/hour C-II patches at the wholesale and retail level. They are boxed in packages of 5, and marked with one of the following lot numbers: 30041, 30049 and 30066 with an expiration date of 12/2011; 30096 and 30123 with an expiration date of 01/2012; 30097, 30241, and 30256 with an expiration date of 02/2012; 30257, 30258, 30349 and 30350 with an expiration date of 03/2012; 30391, 30392, 30429, 30430, 30431 and 30517 with an expiration date of 04/2012.

Consumers are advised to throw away the packages or return them to a retail store for a full refund. Additionally, if users note adverse reactions, contact a physician immediately. Additionally, report symptoms to the FDA. Individuals may also want to contact an attorney to be advised of their rights under the law.

November 16, 2011

Popular Birth Control Yaz May Have Serious Risks

A recent report released by MSNBC and the Associated Press details the fact that the popular contraceptive pill, Yaz, may not be as safe as drug manufacturers originally thought.

Concerns arose with Yaz and other, newer forms of birth control when federal health scientists discovered that more recent forms of birth control treatments appear to increase the risk of potentially fatal blood clots. The study compared the latest birth control medications and their effects to symptoms and side effects associated with older forms of contraceptive drugs. The FDA’s report showed that on average, women taking Yaz had a 75% higher risk of developing a blood clot than women taking older types of contraceptive pills. A related study published earlier this week in the British Medical Journal also found that women taking Yaz and other newer medications had twice the risk of blood clots as women taking the older hormone levonorgestrel.

Bayer, a major chemical and pharmaceutical producer in the United States that is a branch of the German pharmaceutical conglomerate, manufactures Yaz. Yaz, Yasmin, and related pills containing the same hormones as found in Yaz, were Bayer’s second-most successful line of products last year, and brought in almost $1.6 billion in sales, worldwide.

Yaz, as well as a number of the newer birth control pills on the market, contains estrogen along with a next-generation synthetic hormone called drospirenone, which is known to increase potassium levels in the blood, reports MSNBC. The Food and Drug Administration’s report also expressed concern over the Ortho Evra contraceptive patch (produced by Johnson & Johnson), and the Nuvaring vaginal contraceptive ring (manufactured by Merck & Co. Inc.). All of these newer birth control medications contain synthetic hormones that have been developed in the last decade.

In fact, this isn’t the first problem the FDA has cited regarding Yaz. In 2009, the FDA required Bayer to run corrective TV commercials for Yaz, with the purpose of saying that the original marketing campaign overstated Yaz’s ability to prevent acne and premenstrual syndrome. It is very rare occurrence for the FDA to necessitate remedial advertisements, and it is a testament to the seriousness of the misinformation that the FDA demanded that Bayer take such action.

"At a certain point we have to ask why the FDA continues to approve drugs that are less safe and have no benefit compared to drugs already on the market," said Dr. Diana Zuckerman, president of the National Center for Women and Families, a consumer group for women's health issues.

When corporations manufacture a product, they have the responsibility for testing that product to ensure its safety before the product is put on the market and sold to consumers. This is especially true for pharmaceutical companies whose products must undergo extensive testing before they are distributed to consumers. When a company makes a product that is defective or dangerous and that product harms the person using that product, the company may be held legally responsible for the customer’s injuries. This type of situation would give rise to an Illinois product liability lawsuit.

As it applies in this case, if it is found that the use of Yaz or other types of birth control has caused a blood clot in a consumer, and the blood clot causes serious personal injury or death, the manufacturer of the drug may be liable for damages from the product’s hazardous effects. In Illinois wrongful death cases a victim’s family members and loved ones may sometimes recover for the loss of companionship and the loss of future wages caused by the early death.

Although the FDA’s report didn’t state a final conclusion on the safety of Yaz, the Agency plans to hold a meeting with scientific advisers on December 8 of this year to evaluate the potential danger of the drug.

November 9, 2011

Concern Over Cardiovascular Risks Leads to Avandia Recall

Our Illinois personal injury lawyers are concerned about the FDA’s recall of Avandia, a pharmaceutical intended to treat diabetes.

Avandia is one of the most popular drugs used in the treatment of patients with diabetes. It works by binding to receptors in human fat cells, and making those cells more responsive to insulin. Nevertheless, recent reports have shown a strong link to major health problems, including the risk of death.

Avandia is manufactured by London, United Kingdom-based GlaxoSmithKline, which is the third-largest pharmaceutical company in the world, after Johnson & Johnson and Pfizer. Complaints and concerns about the drug started around the year 2000, and the FDA has recently undertaken extensive testing to determine potential health and safety hazards associated with Avandia. In response to these tests, the FDA has approved further restrictions on the sale and prescription of this drug.

There has been an enormous amount of research showing that Avandia is associated with potentially-fatal cardiovascular problems. In February of 2007, GlaxoSmithKline disseminated a warning that use of Avandia was potentially associated with the risk of bone fractures, especially in female users. In November of 2008, the consumer group Citizen Watchdog issued a statement that warned consumers of the potential link to liver failure, cardiovascular issues, vision problems, and anemia. In response, GlaxoSmithKline denied the reports.

The New England Journal of Medicine published an article in June of 2010 that exposed the fact that Avandia use increased the risk of heart attacks by 43% and the risk of cardiovascular-related death by 64%. GlaxoSmithKline has since recalled Avandia from European countries, and the FDA ordered a restriction on the use and prescription of Avandia because of the enormous risks of cardiovascular issues.

This type of situation is one that is absolutely covered under Products Liability Law. Products Liability is an area of Illinois personal injury law that focuses on dangerous and defective products; when a corporation manufactures and/or distributes a product to the public, that company is responsible for testing the merchandise for safety before putting it on the market. When a dangerous or defective product causes injury to consumers, the company may be liable for the damages caused by those injuries.

Many Avandia consumers who have suffered side-effects as a result of using the drug have since filed personal injury lawsuits against GlaxoSmithKline. Currently there are thousands of pending lawsuits against GlaxoSmithKline. As of July 2010, GlaxoSmithKline had agree to settle more than 11,500 of the more than 13,000 pending lawsuits.

Our Chicago personal injury attorneys understand the dangers associated with defective medications. In fact, our attorneys brought a case against Orion Research Inc. and Baxter Health Care Corporation for a flawed test for the genetic disease cystic fibrosis. The failures of the test led a set of parents to have second child born with cystic-fibrosis. In addition to winning a substantial settlement for the family, our attorneys and the family were more concerned with the discontinuation of the test. As a result of our efforts, the test was eliminated.

If you or a loved on have taken a prescription for Avandia and have suffered injury as a result of the negative side effects, talk to your doctor about finding an alternative medication, and contact an attorney to learn whether you are entitled to compensation under the law.

March 21, 2011

FDA orders cold drugs pulled from the market

Earlier this month, the FDA ordered a product recall of nearly 500 prescription medications used for treating colds, coughs, and allergies from the United States market. The reason, according to the Food and Drug Administration (FDA), is that the drugs contain ingredients that have not been approved by federal regulators. These products had not been formally evaluated by federal regulators and is being referred to as the latest in a series of actions by the FDA to stop the sale of products sold without government authorization. The FDA stated that the agency was unsure if the drugs were safe or effective and believe that their existence on the market poses an untenable risk to US consumers. Hence, removing these unapproved products will reduce potential risks to consumers.

The unapproved drugs have been linked to some minor problems, such as drowsiness and irritability. However, the agency is concerned that medical problems associated with the drugs may be significantly underreported. Some of the products are labeled as suitable for children, but contain ingredients covered by a 2008 FDA advisory that warned against over-the-counter medications in children under the age of 2. Some of the drugs combine two varieties of the same ingredient that could cause excessive drowsiness. Agency officials do not know how many patients are taking the drugs that would be removed from the market. Over-the-counter medications, which are used more frequently than prescription drugs, are not affected by the FDA’s order. Many questioned whether physicians were aware that they prescribed a drug that was never approved by the FDA.

Visit the New York Times to read more about the FDA cold drug product recall.

January 14, 2011

Darvocet recall proves that FDA needs better drug safeguards

The United States Food and Drug Administration (FDA) issued a massive request last month when it requested that the manufacturers of propoxyphene, known as PXP, a pain reliever, to stop selling drugs that contain PXP. PXP was introduced in 1957 under the trade name of Darvon. Derivatives of Darvon, including Darvon Compound and Darvocet, quickly followed and added other analgesics to the parent drug. When the product recall occurred, an estimated 10 million Americans took drugs containing PXP. Alone, PXP was not very effective in pain-relief and seemed to have an addictive risk.

The Darvocet product recall came after reports that PXP could cause dangerous disturbances in heart rhythm. Individuals critical of PXP have argued for over 20 years that the recalled drug was unsafe for many reasons. The FDA vote was 14-12, reflecting the controversy surrounding the issue. The United Kingdom and the European Union had already banned PXP sales several years prior to the recall. PXP is not the only recently recalled drug with suspected cardiac side effects. In September 2004, Vioxx was recalled based upon heart problems that appeared after 18 or more months of use of the drug. This product recall was despite a spirited defense by its manufacture that the drug was safe. And since that, the FDA has issued new warnings of cardiac risks associated with diabetes drug Avandia. Again, the panel reviewing the dangers of Avandia was deeply divided over whether to withdraw or restrict use of the agent.

While the FDA conducts extensive review of all laboratory and clinical studies to assess the safety of new drugs, the agency depends on the integrity of scientists who conducted the original studies. The FDA unfortunately does not have the capacity to test new drugs independently. The agency must consider other options to review drugs and avoid subsequent product recalls.

Read more about the need for better product safeguards by following the link.

January 7, 2011

Product liability victim files shareholder proxy for drug company’s meeting

One man is trying to get to the heart of the problem of Floxin, a drug that caused him serious side effects. The product liability victim suffered permanent tendon and nerve damage from Floxin and has since acted as an advocate for a complete Levaquin withdrawal. To accomplish this, the product liability victim filed a shareholder proxy for Johnson & Johnson’s, the drug manufacturer’s, next annual meeting. He bought a share of Johnson & Johnson’s stock so that he would be able to attend its annual shareholder meeting and ask the shareholder to: (1) discontinue the sales incentive program for selling Levaquin and Floxin so that they can tell the truth about its toxicity and (2) add to the Levaquin label that side effects include permanent delayed reactions can lead to chronic pain and that medication should be stopped at the slightest sign of reaction.

The product liability victim bought additional Johnson & Johnson shares in order to file a Shareholder Proxy for the next Annual Meeting for shareholders. He stated that he wants them to vote on forcing the company to put a warning on the Levaquin label, stating that it may cause permanent tendon and nerve damage with permanent pain.

Continue reading "Product liability victim files shareholder proxy for drug company’s meeting" »

December 27, 2010

Early warnings on Januvia drug

The U.S. Food and Drug Administration (FDA) urged a change to the product labeling for Januvia, an oral Type 2 diabetes drug, over a year ago regarding various Januvia side effects. Many are arguing that the FDA was slow to urge this change regarding the drug side effects, given reports of adverse reactions that had been coming in since Januvia had been approved. On the other hand, Public Citizen had posted Januvia to its Worstpills.org website in June 2007, advising that Januvia should not be used until seven years after its introduction on the market – no earlier than 2014.

In October 2006, Januvia was approved by the FDA and the adverse reactions began rolling in shortly thereafter with the FDA receiving reports of pancreatitis with Januvia starting the very month that the drug was approved. Of 88 reports of pancreatitis reported from October 2006 to February 2009, 19 patients suffered the onset of pancreatitis within a mere 30 days of starting the Januvia drug. Public Citizen noted that even in clinical studies, trial participants were found to experience an increased level of creatinine in their bodies, which is often an early indicator of kidney problems. Anyone considering a Januvia product liability lawsuit may consider the lag time between October 2006 – when the first negative side effect reports were received by the FDA – and September 2009 – when the agency revised the drug’s warning label. This time should have spent to prevent further suffering by those who take Januvia.

Public Citizen is a well-established and trustworthy consumer advocate group, who has an enviable track record of raising concerns about potentially problematic drugs and remains ahead of the curve.

Visit Public Citizen for more information on their early warning against Januvia.

December 17, 2010

FDA targets tainted supplements manufacturers

The Associated Press is reporting that the Food and Drug Administration (“FDA”) is cracking down on manufacturers of certain weight loss, body building, and sexual supplements that contain potentially dangerous ingredients. The FDA said last week that some manufacturers are deceptively labeling products to hide that they contain ingredients known to cause adverse health effects. Further, other supplements contain ingredients that should only be available by prescription. Dietary supplements can slip through regulatory cracks because, unlike drugs, they do not have to be approved by the FDA before they are marketed. Such “slipping through the cracks” is dangerous! Some of the weight-loss supplements contained the active ingredient in the recalled diet drug Meridia, which was pulled off of the market a couple of months ago due to heart risks.

Continue reading "FDA targets tainted supplements manufacturers" »

October 13, 2010

Illinois-based company pulls weight loss drug from market

The United States Food and Drug Administration (FDA) announced last week that Illinois-based pharmaceutical company Abbott Laboratories has agreed to remove its obesity drug Meridia off of the market. The Illinois company voluntarily withdrew the drug because trial studies showed an increased risk of heart attacks and strokes in individuals who used the drug. Nearly 8 million people worldwide have been taking the weight loss drug, including 100,000 Americans who use the recalled product. The drug had projected sales of $30 million in the U.S. this year.

The director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research announced that the drug’s continued availability is not justified when one compares the very modest weight loss gained with the product liability risks of heart attack or stroke. The original data on the drug showed that individuals who took the drug lost at least 5 percent more of their body weight than those who were on a placebo and relied on diet and exercise alone.

The FDA requested that the Illinois company withdraw the dangerous drug adfter reviewing data from a follow-up study. It showed a 16 percent increase in the risk of many serious product liability side effects, including non-fatal heart attacks, non-fatal strokes, and death. The FDA could not find one person whose benefit from the drug outweighed its risk.

Read more about the drug pulled from the market at CNN.

August 25, 2010

FDA cautions about heart risk with Parkinson’s drug

In the latest update regarding product liability and harmful pharmaceutical interactions, the Food and Drug Administration (FDA) warned that it is investigating the possibility that the combination Parkinson’s drug called Stalevo may increase the risk of heart attack, stroke, and death in elderly patients who are taking the drug. Stalevo is an anti-parkinsonian dopaminergic combination medication, combined of carbidopa, levodopa, and entacapone, that treats Parkinson’s disease. The drug is manufactured by Finnish drugmaker Orion Corporation and is marked by Swiss-based Novartis Pharmaceuticals. Stalevo is currently used to treat adult patients with idiopathic Parkinson’s disease in two scenarios: to substitute with equivalent strength of each of the three components or to replace immediate-release therapy when patients experience the signs and symptoms of end-of-dose “wearing off.”

FDA urged patients not to stop taking the drug, but warned patients to let their physicians know if the patients have risk factors for cardiovascular disease. The first indication of product liability risk for Stalevo came from a clinical trial called STRIDE-PD, according to LA Times. The average age of the patient was 60 years of age and the trial that exposed the risks lasted an average of 2.7 years. The study’s results found seven heart attacks and one death.

The results of the clinical trial were combined by the FDA with results from fourteen other trials totaling about 4800 patients. With the wider patient pool, the analysis showed twenty-seven adverse product reactions of heart attacks, strokes, or deaths for a statistically significant increased risk of 146%. When the data from the trial was not included, the increased risk was only 67% and it was not statistically significant. The FDA is continuing to look into the significance of the clinical trial results.

Click the link to the LA Times to read more about the FDA product liability warnings.

August 11, 2010

Pharmaceutical company reaches $198 million settlement of 17,500 Seroquel lawsuits

Pharmaceutical company AstraZeneca Plc is set to pay roughly $198 million dollars to settle about 17,500 product liability lawsuits. The product liability lawsuits alleged that AstraZeneca’s antipsychotic drug Seroquel causes some users to develop diabetes. AstraZeneca had previously agreed to pay at least $55 million dollars to resolve more than 5,500 lawsuits alleging that the company knew that Seroquel could cause diabetes and failed to adequately warn patients. The earlier agreements to settle are part of the 17,500 product liability settlements. The Financial Times reported that the product liability settlement stems from court ordered mediation. And, the Wall Street Journal reported that analysts have described the settlement figure as relatively small.

Seroquel is an antipsychotic drug used in the treatment of schizophrenia, bipolar disorder, insomnia, and anxiety disorders. Annual sales of Seroquel are approximately $4.7 billion worldwide and $2.9 billion in the U.S. The most common side effect of the drug is sedation and other side effects include tachycardia, abnormal liver tests, dizziness, upset stomach, substantial weight gain, a stuffy nose, akathisia, and increased paranoia. The rare, but life-threatening, neuroleptic malignant syndrome may also result from use of the drug.

In October 2009, AstraZeneca reported reaching a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of Seroquel. One of the investigations related to certain physicians who participated in clinical trials and the other involved off-label promotion of the drug. Aggressive marketing resulted in Seroquel being increasingly used for children and elderly people for uses not approved by the Food and Drug Administration. Physicians are permitted to prescribe any approved drug for off-label uses.

Read more about the product liability settlement by visiting the Wall Street Journal.

July 16, 2010

Product liability complaints filed in Chicago against health products company

Several U.S. consumers have filed suit against Johnson & Johnson, the world’s largest health-products company in federal court in Chicago. The racketeering lawsuits stem from Johnson & Johnson’s product recalls from earlier this year and accuse the company of fraud and racketeering and demands cash refunds for recalled children’s cold and allergy medicines. Five complaints have been filed, seeking class-action status, expressing their rejection of the offer by Johnson & Johnson’s McNeil Consumer Healthcare and McNeil-PPC Inc. units for refund coupons and demanded cash. The complaints allege that the coupons are worthless because McNeil has ceased making the medicines and assumes – wrongfully – that all consumers will want to purchase the company’s children’s products at some uncertain future date.

In late April, the companies issued a product recall for over 40 types of pediatric allergy medications and pain relief medications, stating that the quality and potency of those drugs for children did not meet the company’s internal requirements. The Chicago product liability attorneys at Levin & Perconti think that what was remarkable about this wide reaching product recall was how many popular products were recalled – recalled products included children’s formulations of liquid Tylenol, Motrin, and Benadryl.

These racketeering cases related to product liability and recalls were filed in the Federal Court located in Chicago, Illinois, which is known as the “Dirksen” federal courthouse, named after Everett McKinley Dirksen. It’s located in downtown Chicago, not too far from the offices of the Illinois personal injury lawyers at Levin & Perconti.

Click the weblink to read the entire article on the lawsuit filed in Chicago.


June 14, 2010

Study finds blood pressure drugs may raise cancer risk

CNN.com is reporting that a possible medical product liability study published in a British medical journal found that certain blood pressure medications may be linked to an increased risk of cancer. While researchers cannot say the exact risk of cancer for each drug, they are calling for more research to be sure of the risks. The blood pressure drugs are called angiotensin-receptor blockers and they block the chemical angiotensin II from having any effect on the heart and blood vessels, which prevents blood pressure from going up. The study is especially worrisome because the drugs are often prescribed to individuals with hypertension (high blood pressure), heart failure or disease, and diabetes-related kidney disease.

One heart failure expert told CNN.com that these studies have found a 1.2 percent increased cancer risk for taking these high blood pressure drugs over a four year span. The current data suggests an overall 10 percent increase in the risk of cancer diagnosis in patients on these drugs compared to placebo. The study concluded that the risk for lung cancer was the highest, but the study authors could not explain why these drugs may be causing cancer. Some experts question the study – one expert stated that these data raise a question regarding the drugs and the risk of cancer. But, the data showed only non-small cell lung cancer was statistically increased and the extent of the increase was quite modest. He compared this study’s data to a “hint” rather than a “signal.” The experts recommend that any patients currently taking the drugs to continue taking the drugs and talk to their doctors about any concerns.

More information is available about the blood pressure drug interaction study on CNN.com.

May 17, 2010

Tylenol plant conditions called “shocking”

Recent findings are showing that the safety and quality violations that led to the Tylenol plant shutdown were extremely serious and can lead to extremely tough action by United States regulators on drugmaker Johnson & Johnson. Last week, the Food and Drug Administration (“FDA”) released an inspection report on the facility in Pennsylvania where the product recall stems from, which a professor of pharmaceutical manufacturer called “absolutely shocking.” According to the professor at Temple University, the inspection report “is pretty close to being the worst [he’s] seen. It suggests that basically the FDA found an issue with almost every system at the plant.”

Earlier this month, a division of Johnson & Johnson recalled nearly fifty children’s versions of non-prescription (over-the-counter) drugs, including Tylenol, Motrin, and Benadryl. Since then, Johnson & Johnson has suspended all production at the plant. The FDA report listed twenty violations, including dozens of consumer complaints on the products recalled. However, Johnson & Johnson has not revealed details of those complaints. Congress has opened a product liability investigation into the product recall and lawmakers gave Johnson & Johnson and the FDA a deadline of today (May 17) to hand over details about consumer complaints. The Illinois product liability attorneys will keep our readers posted as the details of this product recall involving millions of consumers unfolds.

Chicago injury attorneys at Levin & Perconti want to remind you that you can dispose of pharmaceuticals. The City of Chicago and the Chicago Police Department have partnered to provide a place for the safe and proper disposal of unused or expired prescription and over-the-counter medications.

Where to dispose of recalled and expired prescription and over-the-counter medications.

To read about the shocking conditions at the product facility.

May 5, 2010

Lawmakers launch Tylenol recall investigation

The Chicago product liability attorneys at Levin & Perconti have blogged frequently about the recent Tylenol and other over-the-counter drug recalls from Johnson & Johnson’s drug manufacturing division. Now, CNN.com is reporting that lawmakers have announced that began an investigation into the recent product recall of Children’s Tylenol, Motrin, Benadryl, and other over-the-counter drugs. The House Committee on Oversight and Government Reform is asking the Food and Drug Administration (FDA) and Johnson & Johnson’s drug manufacturing division to disclose information on the drug recall and tell what prompted the recall. Important to potential injuries to minors and children, the House is also requesting that they disclose the severity of the impact would be to children who may have taken the recalled over-the-counter drugs.

The Illinois product liability attorneys think this a good action – especially considering that this recent product recall is the third to include Tylenol products this year. Lawmakers are hoping that the investigation will shed light on whether FDA’s inspection procedures are effective. Additionally, the investigation will also determine whether the division neglected to explore consumer complaints about the problem.

Chicago injury attorneys at Levin & Perconti also came across a helpful Chicago link regarding where you can find a location to dispose of pharmaceuticals. With all of the recent recalls of popular products that consumers use, the link will undoubtedly be helpful. The City of Chicago and the Chicago Police Department are partnering to provide a place for the safe and proper disposal of unused or expired prescription and over-the-counter medications.

To read more about the federal investigation into the recent drug recalls.

Click the link to determine where to dispose of recalled products, including expired prescription and over-the-counter medications.

March 15, 2010

Boxed warning added to blood thinner drug

The Food and Drug Administration (FDA) is adding its strongest product liability warning to the label for the drug Plavix. The warning will caution that some patients do not respond to the blockbuster blood thinner. The Los Angeles Times reported that the boxed warning indicates that the drug is dangerous only in the sense that it does not work in certain patients and may leave them vulnerable to heart attacks and strokes. Last year, the FDA warned that popular drugs like Prilosec or Nexium can weaken the effect of Plavix. Plavix is used for prevention of vascular ischaemic events, acute coronary syndrome, and for the prevention of thrombosis after placement of a stent. Plavix is marketed worldwide in nearly 110 countries, with sales in the United States of $6.6 billion in 2009. It has been the 2nd top selling drug in the world for a few years as of 2007.

The FDA regulates almost every facet of prescription drugs – testing, manufacturing, labeling, advertising, marketing, efficacy, and safety. A drug that is approved by the FDA is said to be “safe and effective when used as directed.” The product liability attorneys at Levin & Perconti try to keep our Chicago attorneys updated on drug safety or recalls. Earlier this year, the FDA added new product liability health warnings to Meridia, a popular diet and weight loss drug. Although European Medicines Agency advised physicians and pharmacists in Europe to stop using the drug altogether, the FDA added a warning stating that the drug is associated with an increased risk of heart attack and stroke in people who use the drug and have a history of heart problems.

To read more about the added boxed warning to Plavix, click here.

January 29, 2010

FDA’s controversial Meridia decision

As the attorneys at Levin & Perconti recently blogged about, European and American drug regulators reacted to data on weightloss/obesity drug Meridia recently. Now, the FDA’s decision is causing controversy as it starkly differs from European regulator’s decision. The New York Times addressed that raw data from the drug study indicated that people with certain health problems who took the prescription diet drug Meridia experienced more heart attacks, strokes, and other cardiovascular problems.

Last week, the European regulating body advised physicians and pharmacists to cease prescribing and dispensing the European equivalent of Meridia. In contrast, the Food and Drug Administration took a less forceful step and just asked the maker of Meridia to put a stronger warning on its label. The significantly different actions by two health authorities is stirring debate among drug makers and consumer advocates.

Click here to read more about the controversy surrounding the Meridia decision.

January 24, 2010

Heart attack warning added to diet pill

Last week, regulators from the Food and Drug Administration (FDA) added new product liability health warnings to a diet and weight loss drug called Meridia. The new warning states that there is an increased risk of heart attack and stroke in people who use the diet drug and have a history of heart problems. The attorneys at Levin & Perconti want our readers to know that this labeling announcement from the FDA came on the same day that European Medicines Agency advised physicians and pharmacists in Europe to stop using the diet drug Meridia altogether. The European Medicines Agency has to be adopted by a Commission in order to take effect, but it should act as a product warning to potential users of the drug. Similarly, the FDA has urged patients to talk to their physicians about whether they should or should not continue taking the diet drug.

To read more about the diet drug warnings.