Illinois Injury Lawyer Blog

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.

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.

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.

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.

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.

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.

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.

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.

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.

The Chicago Tribune this week addressed the Tylenol product recall, that many of you were likely concerned with, and focused on how the Food and Drug Administration (FDA) has accused Johnson & Johnson of dragging its feet in recall of tainted Tylenol, Motrin, and other over the counter medications. Last week, Johnson & Johnson expanded its product recall of various batches of the over-the-counter products tainted by a chemical in wooden shipping pallets.

Consumes had complained of moldy-smelling bottles and some have been temporarily sickened nausea, vomiting, diarrhea, or other stomach distress and personal injuries stemming from the product defects. According to the Chicago Tribune article, the FDA cannot order product recalls on its own. So, last week it sent the company a warning letter seeking improvements in the company’s manufacturing operations. The company has linked the illness to a chemical used in the tainted products. It is believed that the chemical leaked into the packaging material.

Click here to read the Chicago Tribune’s full article on the Tylenol recall.

Many medications, including antibiotics, are prescribed to people based on dosage recommendations that do not account for individual body mass. According to a recent editorial, this pharmaceutical system is outdated. Children’s dosages are generally calculated according to body mass. However, for adults, there is no such system in place. One expert pointed out that under current practices a 200 pound, 6 foot 2 inches man receives the same antibiotics as a 124 pound, 5 foot woman with the same condition.

Check out the blog here on Time to read more about this interesting issue.

Last week, three personal injury lawsuits were filed against drugmaker Pfizer, Inc. The injury lawsuits allege that Pfizer’s smoking cessation drug Chantix caused people who took the drug to attempt suicide – and some succeeded. Two of the lawsuits allege that the plaintiffs tried to kill themselves as a result of the drug and the third, a wrongful death lawsuit, claims that the decedent committed suicide after using Chantix. The lawsuits contend that at the time that the individuals took Chantix, Pfizer did not inform physicians or patients about dangers it knew were related to the drug. Some dangers that the lawsuit alleges were related to the drug were depression and thoughts of suicide. Pfizer did subsequently add warnings to its package insert; however, the injury and wrongful death lawsuits allege that the drug’s label is still inadequate.

As background info, the Chantix drug hit the market about 3-4 years ago. Chantix was supposed to be a huge multibillion dollar product and revive profits. But, the drug’s sales fell off as concerns about the product’s serious side effects increased. The lawsuits seek punitive and compensatory damages in addition to medical and legal expenses. The wrongful death lawsuit also seeks funeral expenses.

Click here to read more about the Chantix injury lawsuits.

A series of products manufactured by a medical device manufacturer named Sybaritic Inc. have come under scrutiny after reports alleging that they were not cleared for approval by the U.S. Food and Drug Administration (FDA). Sybaritic makes medical products for skin and spa treatments and has agreed to stop production of the product in the United States until they are in compliance with FDA quality standards. While the company did not agree with the FDA allegations, they stated that they are cooperating with the FDA to resolve the issues raised in its complaint. The stop production agreement came after a consent decree reached between the U.S. Department of Justice and three of the medical device manufacturer’s top executives. The U.S. Department of Justice filed for an injunction last year and has said that companies need to comply with laws that are in place to protect consumer health from dangerous products.

Click here to read more about the FDA issues with some medical devices.

A product liability lawsuit has been filed against a drug maker and a treatment facility by the family of a man who allegedly died after being given contaminated blood thinner. The wrongful death lawsuit contends that the victim was given Heparin during treatment. After a month of treatments, the wrongful death victim had an adverse reaction to the medication and died. The product liability lawsuit alleges that the facilities in China where the drug was manufactured did not meet U.S. regulations. The wrongful death lawsuit seeks damages for medical and hospital expenses, loss of income, physical and mental pain and suffering, loss of enjoyment of life, funeral and burial expenses, pecuniary losses, loss of advice and counsel, loss of services, loss of inheritance, and loss of companionship and society.

Click here to read more about the product liability lawsuit against the drug maker.

In cooperation with the Food and Drug Administration (FDA), McNeil Consumer Healthcare has expanded their product recall of Tylenol Arthritis Pain Caplet 100 count bottles with the red easy-open cap. The pharmaceutical company had initially recalled the product in November 2009 due to consumer reports of an unusual moldy smell of the pharmaceuticals that made reported consumers queasy, have stomach pain, caused vomiting, and diarrhea. All consumers are advised to stop using the pain caplets and contact McNeil to receive a refund or replacement bottle at 1-888-222-6036.

Click here for more information on the Tylenol recall.

For many years, people have been advised to purchase generic pharmaceuticals, especially with the rising costs of drugs. So, when the attorneys at Levin & Perconti saw this article in the New York Times, we wanted to ensure that our readers were aware. Obviously, despite what the article suggests, generic pharmaceuticals save Americans billions of dollars yearly and provides injured or ill people with access to drugs at affordable prices.

The New York Times recently suggested, however, that there is a growing concern among doctors and researchers that some prescription generic drugs may not be as effective as their brand-name counterparts. Luckily, the drug effectiveness problem is not pervasive. Nonetheless, it is an issue that consumers should be aware of, especially when insurers sometimes insist that patients take generic medications when they are available.

Continue reading "Are generics as good as name brands?" »

The New York Times recently reported about a new report that the Centers for Disease Control and Prevention (CDC) did a poor job of screening medical experts for financial conflicts when it hired them to advise the agency on vaccine safety. The report stated that most of the experts who served on advisory panels in 2007 to evaluate vaccines for flu and cervical cancer had potential conflicts of interest that were never resolved. The issue was so problematic that some advisers were legally prohibited from considering the vaccine issues, but did so anyway! As many unsafe medicines have been pulled from the market in recent years, worries have intensified that experts may be recommending medical products in part because manufacturers are paying them.

Continue reading "Conflicts abound for advisers on vaccines" »

The Food and Drug Administration (FDA) have issued a warning to physicians about eleven recalled lots of an intravenous (IV) hypertension drug. The pharmaceutical drug, manufactured by the Medicines Co. are contaminated with bits of steel pieces in it. The company issued a product recall of the affected lots of the Celviprex drug after detecting tiny particles of steel during a routine inspection. The hypertension drug is used to lower excessively high blood pressure in patients who cannot take pills. The recalled drug is distributed to doctors for injection in patients who are undergoing surgery.

Continue reading "FDA warns doctors about tainted hypertension drugs" »

The Food and Drug Administration (FDA) and Bayer have issued a voluntary recall for gel capsules of Alka Seltzer that have the wrong labeling. The product recall affects the combination package of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels. The product recall was initiated when the company found out that the labeling was printed reversed last week.

Continue reading "FDA and Bayer issue product recall for Alka-Seltzer capsules with wrong label" »

New drug safety warnings have been added to the Norpramin label. Norpramin is an antidepressant drug. The new label describes potentially fatal side effects in patients with a family history of certain cardiac health conditions. The drug’s manufacturer is Sanofi-Aventis and they said that the new label also includes new language on overdosage.

Continue reading "Antidepressant drug gets new warnings " »