FDA Inspects Specialty Compounding Pharmacies

As reported by The Washington Post, federal regulators are in the process of conducting unannounced inspections of specialty pharmacies.  Those pharmacies have been in the spotlight since a fall 2012 outbreak of meningitis had been linked to tainted drugs. Two manufacturing-style compounding pharmacies already inspected were a part of a prior Washington Post investigation.  The investigation uncovered unsanitary conditions, substandard practices and lapses in safety at a Massachusetts compounding pharmacy. That pharmacy had shipped contaminated steroid shots to 23 states. The report concluded that this was not an isolated incident.  Federal and state officials did not regularly inspect compounding pharmacies, so hazards went uncorrected.  Even when mistakes caused deadly consequences, they were infrequently punished. So far 48 people have died from the meningitis outbreak caused by the tainted steroid shots, and more than 600 have become ill. Ongoing inspections, according to director of compliance for the FDA Center for Drug Evaluation and Research Howard Sklamberg, are focusing on pharmacies where sterile injectable products are compounded—products much like the steroids that caused the outbreak of meningitis last fall. The surprise inspections, which began in mid-February, 2013, and are scheduled to continue over a two-month period, have already discovered 39 safety deviances[…..]

Arguments Heard Regarding Formation of MDL on Pradaxa Lawsuits

As reported by The Legal Examiner, the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguments on July 26 regarding the formation of the Pradaxa MDL, or multidistrict litigation. The hearing was held at Carl B. Stokes U.S. Courthouse in Cleveland, OH. Multidistrict litigation is common in complex pharmaceutical litigation where a large number of cases are brought forward involving similar allegations of facts. Essentially, an MDL is a consolidation, or grouping of, injury cases, and the cases would be handled in a coordinated manner but each lawsuit remains an individual case. Once an MDL is approved, federal courts with cases will transfer their cases automatically to the MDL court before one judge who will manage all cases as one case. The coordinated portion of pretrial proceedings is designed to reduce duplicate discovery, avoid inconsistent pretrial ruling from various judges, and to serve the convenience of the parties involved and the courts. As part of the Pradaxa MDL consolidation, 48 Pradaxa side effect lawsuits have been filed in federal courts across the U.S. Pradaxa was introduced in October 2010 by Boehringer Ingelheim as an alternative to Coumadin used for the prevention of stroke in patients with non valvular atrial[…..]

Drug Maker GlaxoSmithKline to Pay $3 Billion in Health Fraud Case

British drug manufacturer GlaxoSmithKline (GSK) has been ordered to pay $3 billion for criminal and civil violations involving ten drugs, as reported by Fox News. The $3 billion marks the largest health care fraud settlement in U.S. history, and GlaxoSmithKline has pled guilty to promoting Paxil and Wellbutrin, two popular antidepressants, for unapproved uses. According to government officials, the original complaint alleged that GSK promoted Paxil as safe for children and adolescents, though the U.S. Food and Drug Administration (FDA) had not approved it for these younger patients and the company’s clinical trials raised concerns about an increased suicide risk. In addition, prosecutors in the case charged that the British drug maker promoted Wellbutrin for unapproved uses, including the treatment of obesity, attention deficit disorder (ADD), bipolar disorder, anxiety, and sexual dysfunction. However, the drug was not shown to be safe or effective for these uses. The company also admitted to failing to report to the government problems with the diabetes drug Avandia. The drug was restricted in the U.S. and banned in Europe in 2010 after it was found to significantly increase the risk of congestive heart failure and heart attacks in users. The large $3 billion settlement includes[…..]

Diabetes Drug Avandia Could Be Pulled from Market

On June 28, a study was released which showed a connection between Avandia, a diabetes drug made by GlaxoSmithKline, and increased risks of heart problems, strokes and deaths in older adults. According to FoxNews.com, the study conducted a comprehensive review of over 200,000 Medicare patients who took Avandia. The study followed the patients, who were an average age of 74, for three years. The study showed that 100,000 deaths, strokes, heart attacks and cases of heart failure may be due to Avandia side effects. GlaxoSmithKline maintains that the drug is safe and claimed there were limits on the study which led to an improper result. The study found that patients who used Avandia were 27 percent more likely to have a stroke, 14 percent more likely to die, and 25 percent more likely to have heart failure than individuals on Actos, a competitor to Avandia. The FDA plans to hold a hearing on Avandia, where it will hear testimony about the safety of the drug and decide what should be done. The drug could be pulled from the market or be required to display more warning labels. Some dangerous prescription drugs can have deadly side effects, if not leave a[…..]

Zicam Defective Drug Recall Begins

Matrixx Initiatives is issuing a product recall of several Zicam intranasal cold remedies a week after federal regulators told the company to stop selling its products that were apparently causing consumers to lose their sense of smell. According to a Reuters news report, the U.S. Food and Drug Administration (FDA) recently issued a warning to consumers that several Matrixx Zicam cold remedies, such as sprays and gels, were not safe to use because they contained zinc, which has the potential to damage a nerve that affects the sense of smell. On June 16, 2009, the FDA warned Matrixx to stop selling these defective drugs after more than 130 reports of people losing their sense of smell after using the products. The FDA also urged consumers to stop taking the over-the-counter products. There are a variety of state and federal laws, which govern the manufacture, production, labeling and distribution of pharmaceutical products. Drug makers are expected to exercise a certain standard of care that includes safe labeling, appropriate manufacturing conditions, and informing doctors about the risks of their drugs. However, brief testing periods and unsafe manufacturing conditions can lead to massive drug recalls, which can affect a drug company’s reputation and[…..]

Maryland Patients Can Sue Drug Makers: Supreme Court Ruling

The Baltimore Sun reports in a story that a Supreme Court ruling upholds the right for patients to sue drug manufacturers. According to the Sun, the Bush administration made a push in its final days to shield drug manufacturers from personal injury claims. The pro-manufacturer strategy claimed that FDA approval of a given drug removed the ability of juries to decide whether that drug had dangerous effects. In its 6-3 ruling, the Supreme Court disagreed with this argument and sent a clear message to consumers and drug manufacturers that product liability lawsuits and dangerous drug lawsuits are legitimate means of protecting the interests of consumers. The case that brought this matter to the attention of the Supreme Court involved a Vermont musician, Diane Levine, who developed gangrene in one of her arms after an injection of an anti-nausea drug. Her case against pharmaceutical giant Wyeth resulted in a jury award of $6.7 million, which the drug manufacturer appealed on the grounds that the drug carried an FDA warning. An experienced Maryland defective products and drugs attorney like Steven H. Heisler will protect your rights, work hard on your behalf, and help you navigate the legal course to justice. Mr. Heisler[…..]