Category: Pharmaceutical Litigation

A significant number of Americans rely on medications to control current illnesses and prevent future health conditions. Sometimes these drugs do more harm than healing, resulting in adverse side effects and developing a need for more treatments along with greater medical costs to address the new symptoms. Raizner Slania knows the manufacturers of these pharmaceuticals need to be held liable for the harmful side effects of the drugs they put on the market. The attorneys at our law firm fight for injured patients to receive their owed financial compensation.


risperdal trial

Risperdal Trial Recap

The antipsychotic drug Risperdal can cause devastating side effects in children, most notably gynecomastia in boys or the growth of breast tissue. In some cases, breast growth is so severe that patients must undergo invasive surgery to remove excess tissue. Risperdal manufacturer, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), faces thousands of lawsuits alleging it failed to warn patients of the risk of developing gynecomastia; and, several notable trials have paved the way for the Risperdal litigation.

What Is Risperdal?

Risperdal is an atypical antipsychotic drug used to treat bipolar disorder and schizophrenia in adults and adolescents. Risperdal affects the levels of dopamine and serotonin in the brain, neurotransmitters known to impact mood and behavior.

Risperdal Trials

By the time a Philadelphia jury decided the first Risperdal trial, Janssen and J&J had already paid out massive amounts to the both the government and individuals to settle claims of illegal marketing and that the company minimized the risk of gynecomastia. The plaintiff in that first trial began taking Risperdal when he was eight years old to treat symptoms of autism and developed substantial breast tissue as a result. In February 2015, the jury awarded him $2.5 million for J&J and Janssen’s negligence.

The second Risperdal trial occurred just one month later, and again a jury found J&J and Janssen guilty of illegally marketing Risperdal to children.

The third and fourth Risperdal trials were significant because both plaintiffs had taken Risperdal after it was approved for use in children. In both trials, the juries found J&J and Janssen were negligent in failing to warn patients of the risk of gynecomastia and awarded the third plaintiff $500,000 in December 2015 and the fourth plaintiff $1.75 million in November 2015.

The fifth and most recent Risperdal trial saw the largest damage award so far in the litigation. The trial, which concluded this past July, awarded the plaintiff $70 million.

Raizner Slania: Risperdal Attorneys

Raizner Slania is experienced in handling pharmaceutical lawsuits from start to finish, and will work with you each step of the way. Our pharmaceutical attorneys have been leaders in important nationwide litigation against large and powerful drug companies. If someone in your family has experienced physical and emotional trauma from taking Risperdal, please contact the attorneys at Raizner Slania LLP today for a free and confidential consultation to discuss your case.

Drug Injury Pradaxa

The Pradaxa Antidote Came Too Late To Save Lives

When Pradaxa received FDA approval in 2010, it was the first oral anticoagulant approved by the FDA in more than 50 years. This newcomer to the blood thinner market quickly gained traction, but only a year after its release, the FDA issued a safety announcement about its adverse effects.

What is Pradaxa?

Pradaxa was designed to stop strokes and blood clots in patients with non-valvular atrial fibrillation, or an abnormal heart rhythm. The drug was promising because it had fewer drug and food interactions than its competitors and did not require routine blood monitoring. By 2012, more than 3.7 million patients in the US were prescribed the blood thinning medication, contributing to worldwide sales of $209 million in the first quarter of that year alone. As Pradaxa’s popularity rose, patients quickly began suffering from its life-threatening complications.

Complications from Pradaxa

While Pradaxa is designed to thin the blood for the prevention of blood clots, it can also cause uncontrollable bleeding. A bump on the head could cause massive intracranial hemorrhaging, and unlike its competitor, Warfarin, Pradaxa had no antidote to reverse its effects. With no reliable way to truly control Pradaxa bleeding, doctors were only able to administer supportive care.

Just a year after it hit the market, the FDA had received 817 reports of adverse events involving Pradaxa. While uncontrollable bleeding is a risk of any blood thinner, patients taking Pradaxa were at a heightened risk because there was no reversal agent available.

Too Late for a Pradaxa Antidote

In 2015, the FDA granted an accelerated approval for Praxbind, the first public attempt at an antidote for Pradaxa. Praxbind can effectively reverse the effects of Pradaxa in as little as four hours, but this does little for the patients who had already experienced uncontrollable bleeding from Pradaxa in the preceding three years. With over 500 deaths and 3,700 life-threatening incidents of excessive bleeding, Pradaxa has caused devastating damage to a largely elderly and frail consumer segment.

Contact Raizner Slania Today for Your Pradaxa Claim

Raizner Slania is experienced in handling pharmaceutical lawsuits from start to finish, and will work with you each step of the way. Our pharmaceutical attorneys have been leaders in important nationwide litigation against large and powerful drug companies, and some of our lawyers have even represented pharmaceutical giants in the past, giving us valuable insight into their tactics. If you or a loved one has suffered excessive bleeding from the use of Pradaxa, contact the attorneys at Raizner Slania to get the compensation you deserve.

Sources:
http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm

Bard IVC Filters

Bard IVC Filters – Problems With The FDA

Inferior vena cava (IVC) filters are medical devices implanted to eliminate or catch blood clots before they travel through the bloodstream to the lungs or the heart. The Food and Drug Administration (FDA) issued a safety communication in 2010 after receiving nearly 1,000 reports of significant complications caused by implanted IVC filters.

An IVC filter should be removed after a set period of time; however, in many cases, the devices stay in the vein for too long and dangerous side effects occur.

If an IVC filter is left in place for too long, the following can happen:

  • IVC filters may move, migrate, and/or change position, causing damage to internal organs
  • IVC filters may perforate or erode into other veins, damaging them
  • Parts of IVC filters can break off, travel through the bloodstream and damage the heart or lungs
  • IVC filters can become clogged with clots that impede blood flow to the heart
  • A doctor may be unable to remove IVC filters at all

Medical Research and The FDA Find Fault With Bard IVC Filters

In one study that took place between 2004 and 2009, 80 people who had been implanted with Bard IVC filters were given a fluoroscopy check up on the status of their filters. The fracture rates for the filters were found to be 25 percent with first generation devices, and 12 percent with second-generation devices.

The FDA sent a warning letter to C.R. Bard, one of the most prolific manufacturers of IVC filters, because the company did not address or correct violations found at its facilities. The FDA had previously cited Bard for the issues. Questions arose as to the level of adherence to Quality System Regulations, notably this misclassification of serious IVC filter injuries and deaths as “device malfunctions.”

NBC News investigated Bard IVC filters, and questioned Bard’s internal process to clear its IVC filters for market. A company insider revealed that the FDA failed to approve one application for the device. After that misfire, Bard recruited a regulation specialist to help it gain the necessary clearance with the federal agency. The specialist ultimately was concerned about the safety of the IVC filters and refused to sign the application paperwork. An allegation of the forgery of her signature on the documents was later levied.

Raizner Slania, Handling Bard IVC Filter Injury and Death Claims Nationally

If you or somebody you know had an IVC filter implanted, you may have a legal claim and can potentially reach an IVC filter lawsuit settlement. Contact the experienced defective medical device lawyers of Raizner Slania for a free and confidential consultation about your concerns.

Invokana Bone Fracture

FDA Strengthens Invokana Risk Warnings

Earlier this month, the Food and Drug Administration (FDA) announced that it will now require Johnson & Johnson to add new warnings regarding the potential risk of side effects for users related to Type 2 diabetes drugs Invokana and Invokamet (canagliflozin) after newer, updated data demonstrated a far greater risk than previously thought.

Invokana Bone Fracture Lawsuits

In the FDA statement announcing the increased warnings, the agency noted that they had concerns that side effects of the two drugs may include a risk of bone density loss even before they approved the drug and it was introduced in March 2013, but there were no warnings about bone fracture in either the “Highlights of Prescribing Information” or in the “Warnings and Precautions” sections; there was simply a small mention in the “adverse reactions” section of the drug label, saying that bone fractures were possible. Since then, however, updated clinical trial data demonstrates a far more certain link between Invokana and bone fractures, which is why they’re requiring Johnson & Johnson to strengthen the warnings.

Data from several recent studies suggest that fractures occur more frequently with canagliflozin than a placebo, and that the increased risk of fracture can occur as little as 12 weeks after starting treatment with the drug. The clinical trials demonstrated that even minor trauma can cause a fracture, including simply falling from a standing height. In addition to the clinical trials, the FDA also received additional information about the nature of the bone density loss related to Invokana and Invokamet, when a study of 714 elderly patients demonstrated that those taking Invokana and Invokamet saw loss of bone density in the hip and lower spine that was not present in those patients who were given a placebo.

The FDA will now require that the label for Invokana contain much stronger bone fracture warnings and that those warnings be placed prominently in the “warnings and precautions” section of the label. They are continuing research, but they have not yet named any other drugs that will be required to carry these warnings, because they have not yet determined whether the risk of bone fracture and bone density loss is also present in other Type 2 diabetes medications in the same class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, a group which includes drugs like Farxiga, Xigduo XR, Jardiance and Glyxambi.

A number of lawsuits are being considered with regard to Invokana, because there seems to be evidence that the drug manufacturer, Johnson & Johnson, appears to have been aware of the potential bone fracture side effects of the drug even before they asked the FDA for approval. It’s entirely possible that, instead of providing accurate information for the medical community and consumers, the drug maker may have placed their quest for profits ahead of patient safety by minimizing the risk and providing everyone with warnings that were potentially misleading.

Invokana Side Effects Lawyers

The drug defect lawyers at Raizner Slania are evaluating potential claims for those users of Invokana and Invokamet who perhaps suffered a bone fracture, which could include spinal fractures, as a side effect of their treatment using this medication. If you have taken one of these drugs, please contact the firm so that we can take a look at the circumstances and see if there is a potential claim to be made.

Invokana

How Does Invokana Cause Ketoacidosis?

In May 2015, the Food and Drug Administration (FDA) has warned that a new class of Type 2 diabetes drugs, including Johnson & Johnson’s blockbuster Invokana, may cause a serious condition called ketoacidosis. Many patients experiencing this condition took the drug for about 2 weeks before symptoms showed up.

Invokana causes a diabetic’s blood sugar to leave his or her body through urine and is among the most popular SGLT2 inhibitors, a class of Type 2 diabetes drugs. The drug can cause a condition called ketoacidosis that happens when the body produces too many acids called ketones.

Diabetic ketoacidosis (DKA) is a life-threatening condition that comes about when cells cannot get the glucose they need due to a lack of insulin. Instead, the body breaks down fat and muscle for energy. When this happens, fatty acids (ketones) are produced and cause a chemical imbalance called diabetic ketoacidosis.

Ketoacidosis Symptoms

  • Abdominal pain
  • Confusion
  • Difficulty breathing
  • Dizziness or fainting
  • Fruity breath
  • Increased thirst
  • Increased urination
  • Nausea
  • Unconsciousness
  • Unusual fatigue or sleepiness.
  • Vomiting
  • Weakness

A very similar medication that may cause the same dangerous side effects is Invokamet. J&J also combines the active ingredient in Invokana with metformin and markets it as Invokamet.

J&J and its Janssen Pharmaceuticals unit made $278 million on Invokana in the first quarter of 2015 alone. With more people being diagnosed with Type 2 diabetes than ever before, many expect that claims of ketoacidosis and other serious side effects will only continue to grow.

Raizner Slania Accepting Invokana Ketoacidosis Cases

Injuries caused by an antidiabetic medication may require hospitalization and long-term medical care.  Patients who are injured by medications may be eligible for financial compensation for medical expenses, lost wages, and more. Loved ones of patients who die due to drug injury may be eligible to file a wrongful death lawsuit. If you developed Ketoacidosis after taking Invokana or another type 2 diabetes drug, you may have legal options. Contact us today.

Class Action

What is the Difference Between a Class Action and a Mass Tort?

Class actions and mass torts are both types of lawsuits involving a large number of plaintiffs wanting to sue for injuries from a defendant’s conduct. Because those affected by the defendant’s alleged wrongdoing are large in number, these lawsuits join them all in an action against the defendant. Although a class action and mass tort ultimately have the same purpose, the two are handled much differently.

What is a Class Action Lawsuit?

A class action lawsuit allows a number of individuals who have experienced common damages to assert their claims in one lawsuit together. In a class action lawsuit, a large number of people join together in a representative action naming only one or a few individual plaintiffs in the complaint. These “class representatives” sue on behalf of the defined class against one or more defendants.

In federal court, Federal Rule of Civil Procedure 23 governs certifying a class and the requisite elements for certification. But, a class action lawsuit can also be brought in state court. Each state has its own laws regarding class actions, and most states use rules similar to the federal rules.

How is a Class Action Different Than a Mass Tort?

The main difference between a mass tort and a class action lawsuit has to do with how the courts treat the group of plaintiffs.

In a mass tort, each plaintiff files his or her own lawsuit individually, but all in the same court. Even though the plaintiff is part of a large group, he or she is still treated as an individual. In a class action, a class representative is the only named party in the actual lawsuit. The class representative alone represents everyone in a large group of plaintiffs, and no individual lawsuits are filed. Many mass tort cases are combined into what is called Multi-District Litigation, or MDL. In an MDL, a single judge is appointed to oversee many cases in order to handle them efficiently and in the same manner.

How Much Do Class Actions and Mass Torts Cost?

A potential claimant will pay no money out-of-pocket as a class action lawsuit class member or a mass tort client, regardless of the outcome. In class actions and mass torts at Raizner Slania, our attorneys work on a contingent fee basis, where the firm pays all costs and expenses. We are only paid if we are successful in obtaining a recovery on your behalf.