Drug company slammed with $70 million judgment in Risperdal drug injury case

  Earlier this month, a jury in Pennsylvania delivered the largest verdict yet against the maker of Risperdal, an antipsychotic medication. A jury awarded a family $70 million as compensation for devastating drug side effects suffered by their son. According to media reports, this is the fifth such lawsuit… Read More


Food and Drug Administration Tracks Recalls and Safety Alerts Regarding Potentially Dangerous Products

 According to the Centers for Disease Control and Prevention, about half of all Americans take at least one prescription medication. Many also take over-the-counter medications - such as pain relievers, vitamins, and antihistamines - on a regular basis. It is, therefore, very important that pharmaceutical products be carefully monitored. Patients who are harmed by unreasonably dangerous or defective medications may be able to obtain compensation for their injuries via a product liability lawsuit. Such suits often allege multiple theories of liability, including negligence, strict liability, failure to warn, and breach of warranty. The United States Food and Drug Administration (FDA) is the federal agency charged with protecting and promoting the health of Americans through the regulation and supervision of prescription drugs, over-the-counter medications, dietary supplements, and related products. Read More


Johnson and Johnson’s push for Risperdal sales overrode its public duty

The Huffington Post is in the midst of publishing a 15-part series that details Johnson & Johnson’s push of the anti-psychotic drug Risperdal. The drug was approved for sale in 1994 for patients with psychosis, but was not approved for use in adolescent or elderly patients. Skirting the Food & Drug Administration and the law became the crux of Johnson & Johnson’s aggressive marketing plan, which was designed to make Risperdal the best-selling anti-psychotic drug on the market. The series is a bombshell. Three chapters of the 15-chapter series have been published by The Huffington Post so far. Every day brings a new chapter – and more tales of how one of the world’s largest pharmaceutical companies pursued sales at all costs. Selling the drug to approved patient groups for FDA-approved uses wasn’t enough for Johnson & Johnson. Drug sales representatives pushed the drug onto doctors who dealt with psychiatric illnesses in children and elderly, and pushed them to prescribed the drug for symptoms such as agitation in the elderly, which is not an approved use. Read More


FDA makes it clear: drug side effects must be disclosed in social media posts

Recently, the U.S. Food and Drug Administration sent a not-so-friendly letter to to a drug manufacturer concerning a certain reality star's social media post about a medication she is allegedly taking to help her deal with morning sickness during her pregnancy. While it may seem like just another nugget of celebrity gossip, the FDA's letter is important because it brings to light the influence that so-called "celebrity endorsers" can have on their massive fan base.  The FDA calls the celebrity endorsers and the drugs' manufacturers to task for not mentioning drug side effects as required by federal law. Read More


Kentucky Federal Court dismisses woman’s medical device product liability lawsuit

In Babich-Zacharias v. Bayer Healthcare Pharmaceuticals, Inc., a woman filed a product liability lawsuit against a pharmaceutical company in the U.S. District Court for the Western District of Kentucky after she allegedly suffered a number of adverse health effects from using the company’s intrauterine contraceptive device (“IUD”). According to her complaint, the woman developed idiopathic intracranial hypertension as a result of her use of the device that was designed to stay in the body for up to five years. If not properly treated, the condition can result in severe headaches and temporary blindness. The woman claimed the patient pamphlet provided to her when the IUD was inserted failed to warn her of the link between her condition and use of the product. Despite this, the woman admitted the information stated further research regarding the medical product was needed. The woman also claimed that the medical device manufacturer failed to conduct sufficient clinical testing and intentionally concealed known risks associated with use of the device from patients and medical professionals in the company’s marketing products. Read More


FDA regulations regarding generic drug warnings need an update

For people who take a medication, the warnings that comes along with it are the most important protection they have from harmful side effects. New information emerges every day about drugs and its potential side effects. Under the current Food and Drug Administration regulations, getting a proper warning included with drug information is harder than it should be for makers of generic drugs, and the Food and Drug Administration is considering steps to fix that. Since November 2013, the FDA has been considering new rules for generic drugs that would allow manufacturers to expedite the process of revising labels to add warnings or information that is critical for consumers taking these drugs. This can include updating dosage amounts, safety and efficacy information. Under the current rules, generic drug manufacturers must follow the warning labels provided by the brand name drug.  The proposed changes would allow generic drug manufacturers to change the warning labels on drugs if new information is discovered regarding dangerous side effects of the drug. The FDA plan is called Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. The FDA recently accepted public comments about this change and held a public hearing on it. The American Association for Justice supports this change to allow generic drug manufacturers to update information packaged with their products. AAJ's comments to FDA are available here. Read More


Risperdal case brings $2.5 million verdict against Johnson and Johnson

Risperdal Plaintiffs seeking a judgment against Johnson & Johnson, the makers of the drug Risperdal, saw a big victory this week out of Philadelphia. A jury sided with the family of an autistic boy who grew size 44 DD breasts after taking Risperdal in 2002. The Wall Street Journal, along with many other publications, wrote about the verdict, which was handed down on February 24, 2015. Growing breasts was one of several risks that Johnson & Johnson knew about but hid from the Food and Drug Administration, lawyers said. The condition is called gynecomastia. Some patients have been forced to undergo surgery to remove the breasts. Due to the widespread use of this drug, our firm believes there are many patients who have taken Risperdal and may very well have suffered similar problems, or other side effects. ELPO is accepting cases against Johnson & Johnson, the maker of Risperdal, representing children and their families who have been harmed by Risperdal. The drug treats the symptoms of psychiatric disorders. In addition to gynecomastia, there is an increased risk of stroke and diabetes for patients taking Risperdal. We want to help patients protect their rights, and encourage anyone who has taken Risperdal or who has a family member who has done so to contact us as soon as possible. Read More


Breach of Warranty and Fraud Claims Will be Litigated in Kentucky Pharmaceutical Injury Case

The Western District of Kentucky has ordered portions of a pharmaceutical injury case to trial. In Vanden Bosch v. Bayer Healthcare Pharmaceuticals, Inc., two women filed a lawsuit against the drug manufacturer Bayer over health consequences they allegedly sustained after the women used the Mirena contraceptive product. According to the complaint, a Florida woman suffered a chronic health condition following the use of the device after it was implanted into her body in Kentucky. Additionally, a Kentucky woman purportedly became pregnant despite her use of the contraceptive product. Her child allegedly suffered an abnormal chromosome disorder as a result of her exposure to Mirena. In response to the lawsuit, Bayer filed a Rule 12(b)(6) motion asking the federal court to dismiss the case. When such a motion is filed, the defendant in a civil lawsuit is essentially stating that, even if everything a plaintiff alleged in his or her lawsuit were true, the plaintiff did not assert sufficient information to show that he or she is entitled to a legal remedy. After determining that Kentucky law applied to the case, the federal court addressed Bayer’s motion to dismiss the lawsuit. Since Kentucky has a one-year statute of limitations for products liability claims, and the Florida woman filed her lawsuit more than one year after her purported injury, the Western District of Kentucky dismissed the woman’s negligence and other products liability causes of action against the drug company. The federal court also dismissed many of the Kentucky woman’s claims against Bayer because pregnancy “is not a legally cognizable injury” in the state. Next, the Western District of Kentucky dismissed the plaintiffs’ breach of implied warranty claims because there was no “privity of contract” between the parties. Bayer argued that the plaintiffs’ breach of express warranty and Kentucky Consumer Protection Act claims should be dismissed as well, since the women did not purchase Mirena directly from the drug company, but the court disagreed. The federal court stated that the plaintiffs’ express breach of warranty claims required further evidence and should be fleshed out at trial. Also, Kentucky case law provides an exception to the Consumer Protection Act’s privity requirement when a manufacturer makes “valid express warranties for the benefit of consumers.” According to the federal court, the exception applied to the plaintiffs’ case. Read More