Oklahoma Judge Issues $572 Million Verdict in First Opioid Trial

On August 26, 2019 Oklahoma District Court Judge Thad Blakman held healthcare giant Johnson & Johnson responsible for its role in the opioid epidemic in Oklahoma by delivering a $572 million verdict in favor the state. The judge cited the aggressive marketing strategies employed by Johnson & Johnson to increase opioid sales that involved minimizing the risks of addiction and dependence, a sales strategy also known as the “addiction ditch.”

What Happened in Oklahoma?

In the first opioid epidemic case to reach trial, Oklahoma Attorney General Mike Hunter claimed that opioid overdoses killed more than 4,600 people in the state from 2007 through 2017 with thousands more currently battling opioid addiction. The state estimates that it will cost $17.5 billion over 30 years to handle the crisis through opioid use disorder screenings, prevention and treatment, recovery services, medical education, and pain management programs.

What Did Johnson & Johnson Do?

The judge found that Johnson & Johnson engaged in deceptive marketing campaigns aimed at convincing Oklahoma doctors and the public that opioids are safe and effective for long-term use and treatment of chronic pain.

In addition, Johnson & Johnson sales representatives persuaded doctors that patients’ pain symptoms were under-treated and that patients were being harmed as a result. A technique known as “pseudoaddiction” was used to convince doctors that if patients were requesting higher doses they were not necessarily addicted to the opioid, but rather they needed the higher dose to treat their pain.

In trial, the co-director for the Opioid Policy Research Collaborative at Brandeis University, Dr. Andrew Kolodny, testified that Johnson & Johnson and their proxies downplayed the risks of opioid

opioid-pill

use, exaggerated the benefits, and saturated the market with opioids. For instance, Johnson & Johnson minimized the fact that when patients take opioids every day for as few as five days,

physiological dependence begins to set in and it becomes extremely difficult to discontinue opioid use. As a result, there are now more than 2 million opioid-addicted Americans who need treatment.

What are Prescription Opioids and Why are they Dangerous?

Prescription opioids are used for moderate to severe pain relief. To achieve relief, opioid receptors attach to brain cells and release signals to block pain receptors and boost feelings of pleasure. Opioids are intended to be used for a limited time to treat pain that does not respond to standard painkillers such as Aspirin, Ibuprofen, and Paracetamol.

However, opioids are extremely addictive and can be dangerous if abused. The feelings of pleasure resulting from opioids can be addictive. As a result, the patient develops a psychological dependence on the opioids in order to achieve the feelings of pleasure. Additionally, if opioids are consumed at too high of doses, breathing and heart beat are slowed which may lead to death.

A study on opioids conducted by the Center for Disease Control and Prevention revealed the severity of the drugs’ addictiveness. In a sample of opioid naïve, cancer-free adults who received opioid prescriptions, the likelihood of chronic opioid use increased with each additional day of treatment staring with day 3 and the most drastic increase in chronic opioid use occurred after the 5th and 31st day of treatment.

What is the Opioid Epidemic?

The Center for Disease Control and Prevention reported that almost 400,000 overdose deaths in the United States between 1999 and 2017 were tied to opioids.

Startling research from the Center for Disease Control and Prevention in 2006 revealed a stark increase in opioid overdose deaths paralleling a similar increase in opioid prescriptions. Before the opioid epidemic, unintentional drug poisoning mortality rates increased on average 5.3% per year. However, at the beginning of the opioid epidemic (1990-2002), unintentional drug poisoning mortality rates increased by 18.1% per year.

Between 1999 and 2002, the number of opioid-related poisonings listed on death certificates increased by 91.2%. By 2002, opioid-related poisoning was involved in 5,528 more deaths than other addictive drugs such as heroin or cocaine.

What is Happening with Other Opioid Manufacturing Companies?

When Oklahoma initially sued to combat the opioid epidemic plaguing the state, Purdue Pharma and Teva Pharmaceuticals were named as defendants in addition to Johnson & Johnson. However, Purdue Pharma and Israel’s Teva Pharmaceuticals settled with the state prior to trial. Purdue Pharma, the maker of the blockbuster drug OxyContin, agreed to pay $270 million. Teva Pharmaceuticals, one of the world’s leading providers of generic drugs, agreed to pay $85 million.

Since Purdue Pharma did not go to trial, their marketing strategies for OxyContin were not revealed in court; however, the American Public Health Association published an analysis of their manipulative marketing tactics.

Purdue Pharma introduced the opioid OxyContin to the market in 1996 through aggressive marketing and promotion. The high availability of OxyContin correlated with increased abuse, diversion, and addiction. As a result, by 2004 OxyContin became a leading drug of abuse in the United States.

Aggressive and deceptive marketing strategies included creating individual profiles of physicians based on their prescribing patterns and creating a national database to identify the highest and lowest prescribers of particular drugs in a single zip code, county, state, or the country as a whole. After the profiles were compiled, Purdue Pharma targeted physicians who were already the highest prescribers for opioids in the country due to their large numbers of chronic-pain patients.

Purdue Pharma also introduced a lucrative bonus system which incentivized representatives to increase OxyContin sales in their region. The representatives also created a patient coupon program for OxyContin which provided patients with a free, limited-time prescription for 7 to 30 days.

These manipulative marketing tactics disguised the risk of addiction associated with opioids for the treatment of chronic pain. As a result, sales representatives were told to relay the message that the risk of addiction was “less than one percent.”  However, the studies providing these claims proved to be defunct and resulted in Purdue Frederick Company Inc. (an affiliate of Purdue Pharma) pleading guilty to criminal misbranding charges in 2007.

Dangerous Drugs and Deceptive Marketing

The $572 million verdict in Oklahoma against Johnson & Johnson is only the beginning of justice in the opioid epidemic plaguing the country. Companies who fueled the opioid epidemic by predatory marketing techniques increased the presence and availability of dangerous and addictive products. However, cities, states, and municipalities across the United States are fighting to hold those companies responsible for the devastation and predation.

 

 

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, stomach, prostate, esophageal, and colorectal cancers. Some studies have also linked ingestion of the contaminated drugs to non-hodgkin’s Lymphoma, leukemia, and multiple myeloma.

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 cancer, stomach cancer, colorectal cancer, intestinal cancer, esophageal cancer, prostate cancer, pancreatic cancer, non-hodgkin’s lymphoma, leukemia, or multiple myeloma 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.