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.

 

 

Roundup Verdicts Find Strong Public Support

While the manufacturers of Roundup—Bayer AG—combat thousands of lawsuits regarding the safety of their product, they are also facing a trial in the court of public opinion. A recent wave of plaintiff victories in California has brought the safety of the popular herbicide Roundup into question and produced immense public scrutiny. Although Bayer AG claims that Roundup is safe, three juries have disagreed after being presented with evidence from both sides of the case. The plaintiffs claim that the active ingredient in Roundup—glyphosate—is a human carcinogen that can cause a blood cancer known as Non-Hodgkin Lymphoma (NHL).

What Juries are Saying

An extraordinary wave of juror advocacy has occurred after Bayer filed appeals to reduce the monetary damages awarded to the plaintiffs. Jurors from the Roundup trials have felt compelled to write letters to the judge voicing their profound concerns about Roundup’s safety.

Juror Robert Howard was one of nine jurors who concluded that glyphosate exposure likely caused former school groundskeeper Dewayne Johnson’s cancer and awarded him $289 million. After

gavel and law books
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attending a post-trial hearing that suggested the award would be reduced, Howard felt a “civic duty” to write a letter to California Superior Court Judge Suzanne Ramos Bolanos expressing his concerns regarding Roundup’s safety. Howard now contributes to an anti-Roundup blog called Glyphosate Girl. Johnson’s award was later reduced to $78 million.

In another case, Judge Vince Chhabria reduced the jury’s award from $80.27 million to $25.27 million for Edwin Hardeman who used Roundup for decades starting in the 1980s and was diagnosed with NHL in 2014. After the jury’s award was slashed, a juror wrote the judge asking him not to decrease the award because “based on the evidence provided, ‘reprehensible’ is much too kind a word to describe the actions of the Monsanto employees responsible for putting Roundup on the shelves of stores without a cancer warning on the label.”

Juror Robert Howard from the Johnson trial also wrote to the judge in the Hardeman case expressing his hope that the jury’s award will stand: “It is just what happens when jurors find evidence of such egregious behavior by a company that they feel it is their duty to speak out and support their verdicts in the hope the company will be compelled to change its behavior.”

Public Sentiment About Roundup

The recent scientific discoveries regarding the dangers of glyphosate and the subsequent Roundup cases have sparked public outcry over the safety of Roundup.

In 2015, the World Health Organization’s International Agency for Research on Cancer (IARC) classified glyphosate as a “probable carcinogen.” The announcement triggered lawsuits against Monsanto- the original manufacturer of Roundup. Plaintiffs alleged that Monsanto knew of the purported health risks of Roundup since the 1990s when a connection between glyphosate and lymphoma was uncovered. However, the company downplayed the results and did not put a warning label on products leading consumers to believe it was safe.

Trials produced internal emails from Monsanto and the plaintiffs argued that company scientists were asked to “ghostwrite” scientific papers downplaying the link between lymphoma and glyphosate in addition to trying to change a well-known toxicologist’s opinion that glyphosate could cause a gene mutation associated with cancer. These emails sparked public outrage and a sense of betrayal over the safety of Roundup products.

Public outcry only intensified when environmental groups conducted a study that purportedly found glyphosate in cereals such as Cheerio – a favorite of many children. In a report by Olga Naidenko, Ph.D. and Alexis Temkin, Ph.D., glyphosate was found in 21 oat-based cereal and snack products. The study by the Environmental Working Group found that all but four of the products contained levels of glyphosate higher than what EWG scientists consider protective for children’s health and safety.

The report claims that these products are exposed to glyphosate when Roundup is sprayed on oats to act as a drying agent and induce an earlier harvest while increasing the likelihood that glyphosate ends up in the products.

A Parent’s Concern

Farmer John Barton sprayed Roundup daily for several weeks every year for more than thirty years during his career as a farmer. He hoped that spraying thousands of gallons of Roundup would kill the weeds threatening his cotton crop.

However, in light of the recent concerns regarding Roundup’s safety, he is very concerned about his health and the health of his children: “I just think about the amount of Roundup that I used over the years, and then my sons started working for me when Monsanto claimed it was a safe product. I let my sons put those sprayers on their backs, and I’m worried. Now my biggest concern is as a parent.”

What Should I Do Now?

If you or a loved one has been diagnosed with non-Hodgkin Lymphoma after using Roundup, contact the Minnesota Cancer Attorneys at Goldenberg Law. With over 30 years of experience fighting corporate negligence, we deliver the Gold standard advocacy you deserve

Allergan Issues Worldwide Recall of Breast Implant Products Due To Cancer Link

The FDA requested that the pharmaceutical company Allergan recall its textured breast implant products after discovering a connection between Allergan’s implants and a rare form of cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). In response, Allergan issued a worldwide recall of all of its textured breast implants and implant-related products.

What Is A Textured Breast Implant?

Allergan manufactures BIOCELL breast implants which include a uniquely textured shell-like surface to prevent the implant from slipping and minimizes scar tissue around the implants.

What Is BIA-ALCL and How Does A Textured Breast Implant Cause It?

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is not breast cancer but actually non-Hodgkin’s lymphoma (cancer of the immune system) that grows within the scar tissue surrounding the implants and may spread throughout the body. BIA-ALCL grows slowly and can usually be treated with surgery to remove the implant and surrounding scar tissue. However, some patients may require chemotherapy and/or radiation therapy.

Textured breast implants have a rougher surface intended to reduce an implant’s movement, but may also lead to the development of cancer cells due to the rough surface causing inflation and irritation to the surrounding tissue.

How Do I know If I Have BIA-ALCL?

Symptoms of BIA-ALCL Include:

  • Pain
  • Lumps
  • Swelling
  • Breast asymmetry

What Is The FDA Saying?

As of May 2019, the FDA said that the risks of BIA-ALCL in textured breast implants did not warrant a national ban. However, as of July 24, 2019 the FDA has issued an updated statement explaining that new data shows a direct link between cancer and specifically textured breast implants manufactured by Allergan.

The data has concluded that more than 80% of 573 lymphoma cases have been linked to Allergan implants and 33 cases have resulted in the patient’s death. In addition, risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.

FDA Principal Deputy Commissioner, Dr. Amy Abernethy, M.D., Ph.D., said in a statement regarding the textured breast implants that, “Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health.”

How Common Is BIA-ALCL From Textured Breast Implants?

In countries such as France, Canada, and Australia BIA-ALCL from textured breast implants is common due to the products’ domination of the breast implant market by up to 80%. As a result, regulatory bodies similar to the FDA in these nations have already instituted bans on textured breast implants.

However, in the U.S., only 10% of all breast implants are textured breast implants. More specifically, macro-textured implants (the type Allergan manufacturers) are found in less than 5% of the breast implants marketed in the U.S.

Which Products Are Affected?

In response to the FDA uncovering cases of BIA-ALCL and BIA-ALCL-related deaths worldwide and the FDA’s request for a recall of all BIOCELL textured breast implants and tissue expanders marketed in the U.S., Allergan voluntarily issued a worldwide recall of their products.

Allergan’s textured breast implant recall includes:

  • Allergan Natrelle Saline-Filled Breast Implants
  • Allergan Natrelle Silicone-Filled Textured Breast Implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Allergan’s textured breast implant-related products include their tissue expander products used by patients prior to breast augmentation or reconstruction procedures:

  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

What Should I Do Now?

FDA Recommendations:

  • If you do not have symptoms from your breast implant, the FDA does not recommend having the implant removed due to low risk of cancer. However, speak to your health care provider about your concerns
  • Know the symptoms of BIA-ALCL and monitor the area around your breast implants
  • If you experience any symptoms, speak to your health care provider immediately to be evaluated
  • If your BIA-ALCL is confirmed by your health care provider, undergo implant and scar tissue removal surgery
  • Keep a record of the device manufacturer, device identifier, and implant model name (this information may be found on a patient device card from your surgeon or can be requested from your surgeon or the facility where your procedure was performed)
  • Know that most BIA-ALCL cases occur years after breast implant procedure
  • Talk with your surgeon regarding your risk of developing BIA-ALCL

What Should I Do If I Was Diagnosed With BIA-ALCL After Receiving Textured Breast Implants?  

If you or a loved one has been diagnosed with BIA-ALCL after using an Allergan textured breast implant, contact the Minnesota Cancer Attorneys at GoldenbergLaw. With over 30 years of experience fighting corporate negligence, we deliver the Gold standard advocacy you deserve.