GoldenbergLaw Partner Marlene Goldenberg Appointed To Valsartan MDL Leadership

Partner Marlene Goldenberg
Marlene Goldenberg

On May 6, 2019, New Jersey Federal District Court Judge Robert B. Kugler appointed GoldenbergLaw Partner Marlene Goldenberg to the Executive Committee as part of the leadership structure for the Valsartan Multidistrict Litigation (MDL). Marlene has previously served as the head of the discovery committee for the Abilify MDL in the Northern District of Florida and helped lead discovery, science, and briefing on over 800 Medtronic Infuse Bone Graft cases. Marlene and GoldenbergLaw look forward to holding these Valsartan manufacturers accountable for their actions.

Valsartan and Cancer

Valsartan (and other Sartan drugs such as Losartan and Irbesartan) are used to help treat high blood pressure and other heart-related conditions. Millions of Americans take this generic drug. Certainly no person taking this drug would take it knowing it could cause cancer.

Many of these medications are manufactured for generic companies overseas in China by Zhejiang Huahai and in India by Hetero Labs, among others. It has now been reported that for at least four years, many brands of Valsartan contained carcinogenic substances, such as NDMA, NDEA, and NBMA. These contaminated products were then sold to many companies in the U.S. for use in their sartan drugs. The U.S. companies failed to properly monitor and test their products before selling them to consumers.

How Does Contaminated Valsartan Cause Cancer?

NDMA is N-nitrosodimethylamine. It has been classified as a probable carcinogen and is often given to rats in medical studies to cause cancer! NDMA is so toxic it is contained in rocket fuel and has no approved uses in the United States. NDEA and NBMA have similar carcinogenic properties.

After consulting with some of the finest toxicologists in the country, the dose and duration of the exposure will help to determine if a patient’s cancer can be attributed to contaminated Valsartan. Unfortunately, most people take Valsartan daily and in high doses. Many American patients will have consumed enough NDMA or other nitrosamines to trigger genetic mutations and cancer.

The cancers linked to contaminated NDMA (the contaminant found in Valsartan) are digestive tract cancers where these substances would have been processed by the body. This includes liver, kidney, stomach, and colorectal cancer.

FDA Recall

In July 2018 the FDA recalled the first Valsartan medications, but the recalls didn’t stop there. In October 2018, certain lots of Irbesartan began to be recalled. Then in December, 2018, certain batches of Losartan were recalled as well. And the recalls keep coming almost every month. Just last week, another batch of Losartan was recalled because of toxic contamination. The FDA is continuously updating the list of recalled medications.

Have You Received A Recall Letter?

Patients around the country have and continue to receive recall notices regarding their contaminated medications. If you or a loved one has received a letter, you should talk with your doctor right away about your options. If you or one of your loved ones developed liver, kidney, stomach, or colorectal cancer after taking Valsartan or Losartan over the past four years, please contact the Minnesota defective drug lawyers at GoldenbergLaw so we can discuss your legal rights.

Xeljanz Blood Clotting: Symptoms and Risks

A FDA-mandated study recently found that patients taking a twice daily 10mg dose of tofacitinib (known by its brand names Xeljanz and Xeljanz XR) may experience an increased risk of developing blood clots in the lungs. The FDA approved tofacitinib for 5mg twice daily use in 2012 and had only approved the drug for use in 10 mg doses for treatment of ulcerative colitis. However, the study’s results have now prompted the drug’s manufacturer, Pfizer, to recommend patients on the 10mg dose transition to the 5mg dose.

What is Xeljanz (tofacitinib)?

Xeljanz was initially approved by the FDA in 2012 to treat moderate-to-severe forms of rheumatoid arthritis, and has since been approved for treating psoriatic arthritis and ulcerative colitis. It is xeljanz boxan immunosuppressant that blocks the activity of Janus kinases enzymes that can affect inflammation in the joints. For sufferers of rheumatoid arthritis, it is prescribed to relieve pain in the joints.

What Has The Study Found?

The Xeljanz study was mandated as part of the FDA’s initial approval of tofacitinib to analyze the risk of cancer, heart-related issues, and infections among patients taking the drug. Participants in the study were all over 50 years old and each had at least one cardiovascular risk factor. The participants were on either the 5mg twice daily dose or the 10mg twice daily dose of Xeljanz and were being compared to a group of similar participants on a tumor necrosis factor (TNF) inhibitor.

Results showed that the use of a 10mg twice daily dose of Xeljanz increased the risk of blood clots in the lungs and death compared to participants on the 5mg twice daily dose and the TNF inhibitor. The study is ongoing, but the initial results were concerning enough to prompt the FDA to issue a Safety Announcement in February 2019 warning of blood clots in the lungs as a side effect of use of the 10mg twice daily dose.

How Do I Know if This May be Happening to Me?

Speak to your doctor immediately if you have been taking Xeljanz and experienced any of these blood clotting symptoms:

  • Sudden shortness of breath or difficulty breathing
  • Chest pain or pain in your back
  • Coughing up blood
  • Excessive sweating
  • Clammy or bluish colored skin

Is Xeljanz Safe?

That is ultimately a question you should discuss with your medical provider. The FDA announcement is not the first time a government agency has expressed concern over the potential side effects of Xeljanz. In 2013, the Committee for Medicinal Products for Human Use (CHMP) advised the European Medicines Agency (EMA) not to approve use of Xeljanz for treatment of rheumatoid arthritis.

In its refusal recommendation, the CHMP cited “significant and unresolved concerns about the risk and type of serious infections seen with tofacitinib, which are related to the immunosuppressant action of the medicine.” The CHMP also noted risks of additional Xeljanz side effects, including certain cancers, perforations in the gut, liver damage, and increased lipid levels in the blood.

Pfizer requested reconsideration on multiple occasions, and the EMA eventually approved Xeljanz for treatment of rheumatoid arthritis in 2017. EMA approval for treatment of psoriatic arthritis and ulcerative colitis came shortly after. However, the EMA announced its own review of Xeljanz in February 2019 after the FDA announced the findings of increased risk of blood clots among users of the twice daily 10mg dose. The results of the EMA review have yet to be released.

What Should I Do Next?

If you or someone you love has suffered blood clots in the lungs after taking Xeljanz, we want to help you. Contact the defective drug attorneys at GoldenbergLaw for a free evaluation of your case. We have over 30 years of experience litigating complex drug injury cases, let us deliver the Gold standard advocacy you deserve.

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.