Abilify Passes Daubert Test

Judge's gavel

Judge Finds Testimony of Plaintiffs’ Experts Reliable

On January 22, Chief Judge M. Casey Rodgers ruled that plaintiffs’ experts’ opinions that use of Abilify can cause uncontrollable behaviors are “scientifically reliable” and admissible (with very minor exceptions) in the MDL trials scheduled for later this year. Specifically, Judge Rodgers found that plaintiffs’ experts’ argument that “Abilify can cause impulse control problems through its effects on dopamine neurotransmission in the brain” was consistent with findings by the FDA and even Bristol-Myers Squibb’s own studies on the drug’s mechanism of action. Judge Rodgers also denied the Defendants’ motion for summary judgment as to general causation issues.

Defendants’ Challenge to Plaintiffs’ Experts’ Opinions

Defendants challenged the admissibility of plaintiffs’ experts’ testimony on general causation, claiming the expert opinions provided were unreliable under Federal Rule of Evidence 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993). Further, they contended that plaintiffs failed to provide “reliable scientific evidence” demonstrating a statistically significant association between Abilify and compulsive behaviors.

Scientifically Reliable Testimonies

In her order, Judge Rodgers found plaintiffs’ experts’ opinions sufficiently reliable under Daubert and concluded, “Plaintiffs have satisfied their burden to demonstrate that a genuine dispute of material fact exists as to whether Abilify can cause uncontrollable impulsive behaviors in individuals taking the drug.”

Judge Rodgers’ holding that plaintiffs’ experts’ opinions met the Daubert standard was based in large part on the fact that those opinions are supported by peer-reviewed, published scientific literature as well as sound scientific reasoning. In addition, the Plaintiffs’ experts’ opinions are consistent with the FDA’s assessment of Abilify.

Bellwether Trials start in June

Discovery is now ending, and the first Abilify bellwether trial will start in mid-June of this year.

Our Involvement

GoldnebergLaw Partner Marlene Goldenberg is a member of the Plaintiff’s Steering Committee and serves on the discovery committee for Abilify. Contact Marlene with questions about Abilify.

Limbrel Medication Linked to Potentially Life-Threatening Health Issues

The medication Limbrel is allegedly causing serious life-threatening issues for users. The FDA is investigating this drug, a prescription product to help meet nutritional requirements of patients with osteoarthritis. Among many serious adverse events, two severe injuries are drug-induced liver injury and hypersensitivity pneumonitis.

The FDA received 194 adverse event reports related to the use of Limbrel. Of these, 57 cases have sufficient information that the FDA will use to analyze whether Limbrel was the actual cause of the adverse event. 30 of the 194 cases have sufficient information to apply the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method. This method is used to determine the likelihood that there is an association between Limbrel and the reported adverse event.

GoldenbergLaw has over 30 years of experience handling dangerous drugs and is committed to holding drug manufacturers and suppliers responsible in these circumstances. Contact Senior Partner Stuart Goldenberg for any questions on Limbrel or other dangerous drugs and supplements.

FDA Warns of Dangers of Anesthesia to Developing Brains

An infographic about anesthesia and pregnancyThe Food and Drug Administration has issued a warning regarding the use of certain types of anesthesia in children and pregnant women. According to the release, “repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.”

To help protect woman and children who may be harmed by anesthesia, the FDA is now requiring warning labels be placed on general anesthesia and sedation medications, and instruction healthcare professionals to carefully monitor the use of these drugs. Sadly, this warning comes only after damage has occurred and may fail to fully prevent injury in the future.

When your child suffers injury due to dangerous drugs or medications, you may be entitled to compensation for medical expenses, home and lifestyle modifications, emotional suffering, and other related economic and noneconomic damages. Our dangerous medication lawyers have decades of combined experience and a proven track record holding pharmaceutical companies, doctors, nurses, and other healthcare professionals accountable for the injuries they cause. We are here to stand by your family’s side and take your case as far as needed to secure every penny you are due. Call us at 612-436-5026 to schedule a free consultation and learn more.

Anesthesia can be medically necessary – even for small children – and should be used when needed. However, use of sedatives must be carefully measured and administered in a way consistent with accepted standards of patient care. If you suspect improperly administered or excessive exposure to a dangerous medication has caused brain damage in your child, please contact GoldenbergLaw to schedule free case evaluation. We serve families living throughout the nation.