Articles Posted in Pharmaceutical Litigation

by

The U.S. Department of Justice completed a deal with pharmaceutical company AstraZeneca where the drug company agreed to pay $520 million to settle a federal investigation into questionable marketing practices for its anti-psychotic drug, Seroquel.

The government had accused AstraZeneca of violating anti-kickback laws through its practice of paying doctors to refer Seroquel to patients while it also brought in additional money from government health care programs like Medicare and Medicaid. The pharmaceutical company was also accused of promoting favorable research on Seroquel’s effects which misled doctors and patients alike, while at the same time failing to disclose studies that showed Seroquel increased the risk of diabetes.

Currently there are over 25,000 pharmaceutical litigation claims against AstraZeneca alleging that Seroquel caused increased incidences of diabetes and weight gain. AstraZeneca’s aggressive marketing and promoting of Seroquel helped increase the prescription of the anti-psychotic drug among children and the elderly, oftentimes for indications or uses not approved by the Food and Drug Administration (FDA).

Continue reading

by

An Illinois prescription drug case that originally had been dismissed due to issues of federal preemption, has been reinstated by the 7th Circuit Court of Appeals in Chicago. This case, Mason v. SmithKline Beecham Corp. d/b/a Glaxo SmithKline, No. 08-2265,___F.3d___, 2010 WL 605922 (7th Cir. Feb. 23, 2010) may be the first decision that addresses preemption with respect to prescription drugs.

The original Illinois prescription drug lawsuit was brought by the parents of 23 year-old Tricia Mason after she committed suicide just two days after being started on the prescription drug Paxil. The Illinois prescription drug lawsuit alleged that Paxil increases the risk in suicide in children and young adult, which the manufacturer should have known and therefore had a duty to warn its users.

The lawsuit alleged that GSK violated Illinois law by choosing not to warn Tricia Mason on its label that Paxil increases the risk of suicide for children and young adults. Two years after the decedent’s suicide, Paxil added a label warning of an increased risk of suicide among children taking the drug.

Continue reading

by

The Illinois Supreme Court recently clarified the scope of the Illinois Consumer Fraud Act in its decision in the pharmaceutical litigation case of De Bouse v. Bayer AG, et al., No. 107528. The Supreme Court ruled that a consumer could not bring an action claiming fraud under the Act if the consumer had not received deceptive information indirectly or directly from the defendant drug manufacturer.

In De Bouse, the plaintiff was claiming economic damages against Bayer AG, the manufacturer of the drug Baycol. The plaintiff had purchased and taken Baycol on three occasions prior to the drugs withdrawal from the market for its potential harmful side effects. It is important to note that the plaintiff was not alleging any damages due to the drug’s side effects.

The plaintiff’s case was brought under the Illinois Consumer Fraud and Deceptive Businesses Practices Act along with several other class action plaintiffs. The claim alleged that the plaintiff was harmed by the Bayer’s concealment of Baycol’s negative side effects because the drug manufacturer was able to inflate prices for Baycol as a result of its deceptive omissions regarding the drug’s potential side effects.

Continue reading

by

Since this May, when the U.S. Food and Drug Administration (FDA) reported that Hydroxycut product users could suffer from adverse liver disease, numerous lawsuits have been filed around the country, including several in the Chicago area.

On May 1, 2009, the FDA announced that it had been made aware of 23 reports of adverse liver effects that occurred in the course of normal Hydroxycut usage. The reports included injuries that ranged from general liver damage, the need for a liver transplant, and to death. At that time the FDA warned consumers to immediately cease using Hydroxycut products.

Signs and symptoms of liver damage from Hydroxycut usage can include fatigue, malaise/ tiredness, loss of appetite, nausea, jaundice, blurry vision, abdominal itching, abdominal pain, and/or dark colored urine. Hydroxycut has also been known to cause drug-induced hepatitis and liver failure.

In response to the FDA’s warning, Iovate, the owner and distributor of Hydroxycut products, agreed to recall its remaining product from store shelves. Hydroxycut was generally sold throughout the United States and Illinois at stores such as Wal-Mart, Walgreens, and CVS Pharmacy, among others.

Continue reading

by

Increased reports of medical problems associated with certain nutritional supplements has prompted The Food and Drug Administration (FDA) to issue a public health advisory on body building supplements. These supplements may contain steroids or steroid-like substances and may be associated with kidney failure and liver failure in men.

While the FDA has not specified exactly how many products fall into this category, it advised that consumers not to purchase and use products labeled with words such as “anabolic” or “tren” or phrases like “blocks estrogen” and “minimizes gyno”. In addition, the FDA cautions consumers to be wary of body-building products claiming to enhance or diminish the effects of hormones like testosterone, estrogen or progestin.

Of those products that the FDA did specifically name, those included MASS Xtreme, TREN-Xtreme, ESTRO Xtreme, HMG Xtreme, AH-89-Xtreme, MMA-3 Xtreme, TT-40-Xtreme, and VNS-9 Xtreme, all of which contained hidden and potentially dangerous steroids. The FDA has taken action in the form of sending a warning letter to these drugs’ manufacturer, Americell-Labs, stating that the company should produce products that are in compliance with federal regulations.

Continue reading

by

The U.S. Food and Drug Administration (FDA) advised consumers that products sold under the Hydroxycut branded name could cause liver and heart problems. The FDA Hydroxycut advisory stated that “although liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risks.” The results were that its products were recalled.

Chicago and Illinois residents have reported symptoms of adverse affects from taking Hydroxycut, which range from stomach and abdominal pain, excessive fatigue, recurring headaches, excessive weakness, vomiting, loss of appetite, to kidney failure and liver damage severe enough to require a liver transplant.

Hydroxycut products are dietary supplements that were marketed for weight loss as fat burners, energy-enhancers, low carbohydrate diet aides, and for water loss. The brand names are marketed by Iovate Health Sciences, Inc., Iovate Health Sciences USA, Inc., Muscle Tech, among other brand names.

The FDA has asked that healthcare professionals and consumers report any serious adverse or side effects from the taking of these products.

Continue reading

by

The Food and Drug Administration (FDA) has reported that it has received 23 reports of adverse health effects in persons who have used the weight-loss product, Hydroxycut. Reported complications from using Hydroxycut include heart problems and a kind of muscle damage that could lead to kidney failure. One person suffering from severe side effects of Hydroxycut even required a liver transplant.

On May 1, 2009 the FDA issued a warning to consumers to stop using Hydroxycut. According to the FDA warning the manufacturer, Iovate Health Scientists of Oakville, Ontario, Canada and its American distributor, are recalling Hydroxycut. All in all, lovate is recalling 14 of its product line. This recall will not affect its products Hydroxycut Cleanse and Hoodia, which have different ingredients than the other products.

The Hydroxycut brand has been widely sold at national stores including Vitamin Shoppe and GNC. The product is sold in a form of pills, drinks and powders which is designed to increase energy, burn calories and fat, and control appetite. According to the FDA about nine millions units of the product were sold in 2008. Vitamin Shoppe and GNC reportedly are removing Hydroxycut products from their websites and stores.

Continue reading

by

I recently came across a case where a Chicago jury returned a verdict of $3.4 million for the plaintiff who had been prescribed Fleet Phospho-Soda Buffered Saline Laxative for a colonoscopy procedure.

The case centered on the physician who had prescribed Fleet Phospho-Soda, an over-the-counter oral laxative used to cleanse the system pre-colonoscopy. Recent studies of Fleet Phospho-Soda have shown that the drug can pose a risk of kidney damage in patients with kidney disease.

Prior to being prescribed the oral laxative the plaintiff had blood work done that showed chronic kidney disease. During the trial the plaintiff alleged that the physician should have instead prescribed an alternative drug that posed no risk to the kidneys. The plaintiff ended up suffering from renal failure and required dialysis for two and half years.

Fleet Phospho-Soda has been the subject of multiple pharmaceutical lawsuits connected to its use, including those in Illinois. It is found to cause kidney damage, renal failure and other kinds of kidney ailments.

Continue reading

by

Thousands of Americans across the country, Illinois, and in the Chicago area have suffered life-threatening kidney injuries after taking Fleet Phospho-Soda in preparation of colonoscopies and other surgeries. Fleet Laboratories is the principal manufacturer of Phospho-soda and has been promoting the product without warning of its drug side effects, which can include kidney damage and renal failure.

Studies have revealed that the link between Fleet Phospho-Soda and these side affects could be the result of calcium phosphate tubules that form in a kidney, which can lead to acute renal failure.

As far back as April 2002 a Health Canada advisory first warned the medical community that oral sodium phosphate solutions like Fleet Phospho-Soda can affect heart and kidney function. A later article published by the New England Journal of Medicine in September 2003 warned that this product could result in serious side effects, such as seizures and acute renal failure.

In December 2008 the U.S. Food and Drug Administration (FDA) issued a patient saftey alert which advised that oral sodium phosphates solutions should be available by prescription only. Immediately following that warning Fleet issued a recall of Phospho-Soda, which had been sold as an over-the-counter medication. In their statement regarding the recall, Fleet advised doctors to no longer directed patients to use this product for bowel cleansing.

Continue reading

by

My brother is a physician and psychiatrist who frequently lectures on the benefits of certain drugs for prescription by family practice physicians, or other practicing physicians. At a recent gathering he reported that he played on the absurdity of drug companies distributing products carrying their name and logo by starting his speech by raving about his stay at the local chain hotel near Chicago’s O’Hare airport because they gave him a pen and notepad.

While my brother dismisses drug company’s efforts to win doctors over with pens and notepads, there is a lot of skepticism raised by watch groups about the impropriety of doctors promoting pharmaceuticals especially given the rise of pharmaceutical lawsuits. Recently, drug companies have been prevented from distributing pens, cups, and notepads with its insignia names or drug products. And while my brother and others in the medical field feel these types of freebies are harmless, there are other ways that pharmaceutical companies exert their influence that are much more serious.

The American Medical Students Association (AMSA) is now objecting to the influence of drug companies in medical schools’ educational curriculum. The case of a professor at the Harvard Medical School illustrates this point. In his class the professor promoted the benefits of a cholesterol drug and seemed to belittle a student asking about its side effects. It turns out that this particular lecturer, also a physician, was not only a full time member of the Harvard Medical School faculty, but a paid consultant to ten drug companies, including five makers of cholesterol treatments.

Continue reading