Weekly Mass Torts Bulletin 2021-May-17

A Massachusetts attorney general has sued Publicis Health, LLC, alleging that the company helped Purdue Pharma in selling more OxyContin by deploying unfair and deceptive marketing schemes resulting in the opioid crisis.

The complaint is filed in Suffolk Superior Court alleged that Publicis partnered with Purdue to boost its opioids sales by recommending the doctors to prescribe Purdue’s opioids to more patients, in higher doses, for longer periods of time. Publicis garnered dozens of contracts with Purdue from 2010 to 2019 and collected more than $50 million for opioid marketing.

The attorney general explained Purdue fueled the opioid crisis in Massachusetts that resulted in death and overdose of the drug among the patients. She even stated that Publicis should also be equally blamed for the crisis, as it convinced the doctors to prescribe more OxyContin to more patients.

Publicis faces numerous allegations in the lawsuit, including deceptive marketing strategies and sending thousands of unfair emails to the prescribers along with the doctors to boost opioid use among the patients. Publicis even placed ads for OxyContin right in patients’ electronic medical records. The company even created stories to market the drugs and boost the sales of Purdue.

This lawsuit is a perfect way to combat the opioid epidemic and deal with the culprits who fueled the crisis. The attorney general will focus on dealing with the crisis through a multi-disciplinary approach that includes enforcement, policy, prevention, and education efforts. 

The attorney general even led a $573 million settlement along with 53 attorneys general against McKinsey & Company for helping Purdue to promote opioid sales. She even sued the Sackler family in June 2018 for creating the opioid crisis.

West Virginia Attorney General reached a multistate settlement against a pharmaceutical company over allegations of falsely and aggressively marketing and promoting opioids.

According to a news release, Indivior, a global pharmaceutical company, will pay more than $5.2 million to West Virginia. $1.36 million of the settlement amount will be kept by the state and the remaining amount will be paid to the federal Medicaid programs.

The attorney general said that deceptive marketing of the products claiming that it is safe to use can have dangerous outcomes.

From 2010 to 2015, Indivior promoted the sale and use of Suboxone by encouraging physicians to prescribe the drug to users without a medical prescription. The company purposely promoted the opioid sale, even after knowing that it is unsafe for use.

In September 2012, Indivior submitted a petition to federal regulators that stated discontinuation of Suboxone tablet to prevent generic competitors from entering the market. The petition was fraudulent and the agreement even resolves those allegations.
 

The first opioid crisis trial started in the federal court on May 3, 2021, where the communities of West Virginia claimed that narcotic painkiller manufacturers are responsible for numerous deaths across the country due to opioids.

West Virginia's Cabell County and its largest city, Huntington are the worst-hit areas due to the opioid epidemic. Cabell County's attorney summoned the principle of "Occam's razor" as it was the simplest and correct explanation for the trial.

The attorney even stated that though the MDL is the largest and most complex litigation in the history of the United States, the simple truth was that the manufacturer distributed the painkiller in huge quantity which resulted in the deaths of 1,100 people in Cabell County in the past decade.

According to a U.S census, the number of residents in the county has reduced from 96,000 a decade earlier to 92,000 in 2019.

The drug distributors, AmerisourceBergen Corp., Cardinal Health Inc., and McKesson Corp. are blaming the lawbreakers and regulators for the epidemic.

It is only the second settlement of Medicaid fraud allegations in West Virginia. In 2019, the first settlement of $700 million was announced against Reckitt Benckiser Group.

Lawyers of more than 70,000 former patients who sued Sanofi accused that the company has deleted email links related to a 2019 recall of the heartburn medication Zantac.

The mails deleted by Sanofi included some mails from the head of regulatory affairs for the company’s U.S. Consumer Healthcare division. It will be difficult for the consumers without the emails to prove that Zantac contains a suspected carcinogen.

The lawyers for the patients have requested the judge to give them some more time to prepare for their first trials, which will begin next year. The lawyers further explained that the deleted emails were very important and it will delay in getting the key Sanofi testimonies.

The authorities of Sanofi stated that the company will thoroughly investigate the email destruction and will also provide a detailed report to the judge overseeing the Zantac cases.

Although the company has already provided required documents of relevant discovery to the plaintiffs, it intentionally disclosed the mishandling of certain emails requested by the plaintiffs.

Zantac was first introduced in the 1980s and was most widely used as a medication for the treatment of heartburn and acid reflux. It was available as generic ranitidine and widely used by Americans.

It was discovered in late 2019, that the ranitidine-based medication contained high levels of a human carcinogen, N-nitrosodimethylamine (NDMA), which can get activated if the drug passes through the body or the pills are stored under certain conditions.

There are thousands of Zantac lawsuits filed by the consumers against Sanofi and other manufacturers of ranitidine-based drugs. All the defendants in the lawsuits allege that the exposure to NDMA produced by ranitidine caused them to develop breast cancer, prostate cancer, pancreatic cancer, stomach cancer and other injuries. Sanofi responded to the issue by stating the Zantac brand is not as toxic as the chemical that might have caused the problems for the consumers and still has some reputation in the market.

The spokesperson for Sanofi announced on April 28 that the company will launch a new product named Zantac 360. The company even notified that it will use famotidine, which is the active ingredient in Pepcid instead of ranitidine to manufacture the new product.

The company will release two versions of the new Zantac drug on the U.S. market in June 2021. The products include a 10 mg famotidine “Original Strength” version, and a 20 mg “Maximum Strength” version.

The spokesperson for Sanofi defending the company said that the data loss was not intentional and the company is making the necessary arrangements to gather as much as data possible from alternative sources. The company is confident about the safety of Zantac and this issue will not have any impact on Sanofi's strong defenses in the litigation.

Plaintiffs appeal alleging Pfizer Inc. of failing to warn that its cholesterol drug Lipitor caused their type 2 diabetes is denied by the Second Circuit

The reasons for the denial are still unclear and the three-judge panel stated that the decision has come after considering the substantial reasons provided by the district court.

As per a lawsuit filed by the plaintiffs in April 2019, Lipitor's label changed in 2012 claiming that it included drug statin which can increase glucose levels and hemoglobin A1c. The plaintiffs even alleged that the label did not warn that Lipitor caused Type 2 diabetes and the doctors prescribed the drug without knowing its side effects.

U.S. District Judge William H. Pauley III dismissed this case with prejudice in April 2020 by stating that Pfizer label change in 2012 complied with the Federal Food, Drug, and Cosmetic Act. He even said that the claims before April 2016 fall outside the three-year statute of limitations so the pleading cannot be considered.

Plaintiffs appealed to the Second Circuit in August as their claims were not acknowledged because the pharmaceutical company could have changed its label warning about diabetes without the U.S. Food and Drug Administration's approval.

The best-selling drug of all time, with sales of more than $130 billion since it hit the market in 1996, more than 29 million people in America have been prescribed Lipitor. Unsurprisingly, this number suggests that there is a vast pool of potential plaintiffs.

Lipitor (Atorvastatin calcium tablets) brought to market by Pfizer. Atorvastatin belongs to a class of drugs called statin, which is used to lower blood cholesterol levels. It also stabilizes the skin and prevents strokes using its anti-inflammatory and other methods.

Lipitor is given to patients with Dyslipidemia (an abnormal amount of lipids such as cholesterol and/or fat in the blood) and prevention of cardiovascular disease.

Lipitor was approved by FDA in the year 1996 as a preventive measure against cardiovascular disease that helps lowering cholesterol. Pfizer first presented the drug in February 2012 to treat patients with high blood sugar and who have higher chances to develop diabetes. After the FDA’s Division of Metabolism and Endocrinology Products request, the Lipitor maker had to update the warning label of the drug.

As per lawsuits, Pfizer promoted Lipitor as safe and effective, despite being aware of the risks associated with the increase in blood glucose levels and development of type 2 diabetes. Plaintiffs alleged that Pfizer engaged in misleading marketing where they aggressively made their products safe and superior to other drugs. However, they did not provide patients and their healthcare providers with warnings that could have avoided injuries.

Plaintiffs highlighted the fact that post-2012 FDA approval when the defendant received new information Lipitor's link to diabetes, it could have added the label or sought FDA approval to change the label based on these reports; however, it did not do anything to alert the users and doctors.

Pfizer argued that the post-2012 claims made by the plaintiffs are barred because the FDA approved the updated label, while any claims before 2016 fall outside New York's statute of limitations in October. The company also stated that the adverse event reports should not be considered as new evidence, based on which the label change was justified.