This is an Advertisement

Articles Posted in Pharmaceutical Injury

Published on:

shots with bottlesEarlier this week, the Food and Drug Administration announced it is requiring the manufacturers of low testosterone drugs to change the labels of their products and to conduct further studies about the drugs. The FDA says some studies have indicated there is an increased risk of heart attack, stroke and even death while taking supplemental testosterone, while other studies have not. This has led the FDA to say that more research is needed by the manufacturers of the drugs as well as to require more warning labels on Low Testosterone drugs to better prepare doctors and patients for discussions about taking “Low T” drugs.

The FDA specifically called out clinics offering to treat the “signs of aging” in men which are often believed to be linked to gradually decreasing testosterone in the body. While decreasing testosterone may seem to be the culprit of fatigue or other similar problems, there’s not been enough research of the side effects of taking Low T drugs simply to fight the signs of aging. The FDA says the drugs should only be used in men who are suffering from low testosterone as a result of “disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism.”

Health care providers should make patients aware of the risk of possible cardiovascular events and even death due to taking testosterone, the FDA says.

Continue reading

Published on:

Risperdal

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.

Continue reading

Published on:

The U.S. District Court for the Eastern District of Kentucky recently ruled in favor of a medical device manufacturer in a products liability case in which the plaintiff did not participate in written discovery. In Johnson v. Zimmer Holdings, Inc., a man had four medical devices implanted into his body when he underwent hip surgery in 2010. Unfortunately, the man’s hip dislocated at least six times between 2010 and 2012. About two years after his initial surgery, the man underwent a second procedure to replace three of the four medical products. Following the second surgery, the man filed a products liability lawsuit in a Kentucky federal court against the manufacturer of the medical devices that were initially implanted into his body. According to his complaint, the man experienced pain, suffering, emotional distress, and unnecessary surgery as a result of the medical device manufacturer’s defective products.

Pursuant to the Eastern District of Kentucky’s scheduling order, the parties entered into the discovery stage of the lawsuit. This is a pre-trial phase of a case in which each party is entitled to request certain relevant information from the opposing side. Discovery may include depositions, interrogatory and document requests, and more. Although the medical device manufacturer served the allegedly harmed man with written discovery requests, he failed to submit any discovery requests prior to the deadline that was imposed by the court. As a result, the medical device manufacturer filed a motion for summary judgment in the case.

Continue reading

Published on:

In Putnam v. Medtronic, Inc., an Indiana woman filed a medical product injury lawsuit asserting 15 state-law causes of action in Jefferson County Circuit Court against her Kentucky doctor, the manufacturer of a medical product, and the Kentucky hospital where she underwent spinal fusion surgery. According to the woman’s complaint, the physician used the medical product to treat her in an off-label manner that was not approved by the Food and Drug Administration. In addition, she accused the manufacturer of the product of intentionally and illegally promoting it for off-label use. The woman claimed she suffered harm as a result of this unapproved use and asked the Circuit Court to award her both compensatory and punitive damages.

The manufacturer of the medical product immediately removed the woman’s case to the Western District of Kentucky in Louisville based on diversity of citizenship. The manufacturer also asserted that removal was appropriate because the case involved questions of federal law. In response, the woman filed a motion to remand the lawsuit back to state court.

In considering the woman’s motion, the U.S. District Court examined the two sources of federal jurisdiction alleged in the case. Diversity jurisdiction is proper when the amount in controversy exceeds $75,000 and the parties hail from different states. Federal question jurisdiction exists only when a lawsuit arises from the United States Constitution, federal statutes, or a treaty the nation is a party to. The U.S. District Court continued by stating the burden of establishing federal jurisdiction is on the party that seeks removal, and the case must be remanded if jurisdiction is not proper.

Continue reading

Published on:

In Waltenburg v. St. Jude Medical, Inc., a man received an implantable cardioverter defibrillator (“ICD”) that was manufactured by St. Jude Medical, Inc. The electrical ICD device was inserted into the man’s body through a vein and then attached to his heart in an effort to correct irregular heart rhythms. Not long after the device was implanted into the man’s chest, he apparently began experiencing unexpected and unnecessary electrical shocks. Several years later, the man’s physicians reportedly told him that the ICD device implanted into his body was faulty, but it was too risky to remove it. The man filed a products liability lawsuit seeking damages for physical injury and emotional distress from the manufacturer of the ICD in the Western District of Kentucky.

In his complaint, the man claimed the medical device manufacturer was strictly liable for the allegedly defective ICD. He also claimed the company manufactured the product in a negligent fashion, negligently failed to warn him about the product defect, and alternately should be held accountable through the doctrine of negligence per se. A negligence per se cause of action normally arises when someone is injured after another party violates a law that was designed to protect the public or a specific class of individuals from the type of harm that the injured person sustained. In general, negligence per se is easier to prove than other types of negligence because the reasonableness of an at-fault actor’s conduct is not at issue.

The medical device manufacturer countered by alleging the man’s claims were preempted by the Medical Device Amendments (“MDA”) to the federal Food, Drug, and Cosmetic Act and argued the lawsuit should be dismissed because the man failed to state a claim on which relief may be granted. Preemption occurs when a state law conflicts with a federal law in such a way that the purpose of the federal law is thwarted. According to the Supremacy Clause of the United States Constitution, federal law controls in such cases.

Continue reading

Published on:

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.

Continue reading

Published on:

A “Daubert hearing” takes its name from a United States Supreme Court case titled Daubert v. Merrell Dow Pharmaceuticals, Inc. It refers to a hearing in which the trial judge evaluates whether testimony or evidence from a particular expert is admissible. The hearing occurs outside of a jury’s presence before trial. This type of hearing is often necessary in a pharmaceutical injury case where the plaintiff alleges the drugs prescribed caused serious harm.

In Kentucky, a trial judge must determine whether the expert will be testifying to (1) technical, scientific, or specialized knowledge that (2) will help the trier of fact understand a fact at issue in the trial. A hearing is not always required, but a trial judge can only rule without a hearing if the record before the court is complete enough to measure the proposed evidence against the standards of reliability and relevance. Evidence must be both reliable and relevant to be admitted.

A 2008 pharmaceutical injury case involving, among other issues, a Daubert hearing arose when a woman gave birth to her second child by cesarean section. She didn’t want to breastfeed, so her obstetrician prescribed the drug Parlodel to stop her lactation. She started the drug and was discharged from the hospital. A few days later, she experienced a headache and pain between her shoulders. The next morning, her mother found her dead. Continue reading