What Happened In The MassTorts World Last Week? 2021-Jan-04

The U.S. Department of Justice (DOJ) has sued Walmart over the illegal distribution of opioids that has fueled the opioid crisis throughout the nation.

The federal government filed a lawsuit against the retail giant, claiming that the company forced the pharmacists to fill the opioid prescriptions. The lawsuit even claims that Walmart failed to detect and report distrustful prescriptions to the U.S. Drug Enforcement Administration. Jason Dunn, the U.S. attorney for Colorado, informed that Walmart was aware of the inefficient system used by its distribution center, which failed to detect and report suspicious orders.

Opioids are a class of drugs that act on the nerve cells in the body and brain to relieve pain. There are different types of opioids like Buprenorphine, Butorphanol, Codeine, Fentanyl, Oxycodone. Hydrocodone, Hydromorphone, and Hydromorphone are opioids that are not commonly used.

Walmart is the biggest opioid distributor with over 5,000 pharmacies in its stores around the country. It is precisely positioned to prevent the illegal distribution of opioids, yet it failed in the process, resulting in a nationwide opioids rampage.

Walmart rejected all the allegations by saying that the federal claims are inaccurate and doctors should be blamed for giving the wrong prescriptions. The spokesperson for Walmart informed that the company always allowed the pharmacists to deny the uncertain opioids prescriptions, and the pharmacists have even denied filling hundreds of thousands of such prescriptions. The company has blocked many doctors from filling their opioid prescriptions at Walmart's pharmacies and also forwarded many investigative leads to Drug Enforcement Administration (DEA).

Earlier in October, Walmart filed a preemptive suit against the Justice Department, Attorney General William Barr, and the Drug Enforcement Administration. The lawsuit stated that the investigation launched in 2016 by the Justice Department identified many doctors who wrote problematic prescriptions, but nearly 70% of these doctors were still actively registered with DEA.

The company has urged the federal judge to overrule the government from seeking civil damages. It even claimed that the government's inefficiency is the main cause of the opioid crisis of the country.

On December 15, Health Canada, the department of the Government of Canada responsible for the country's federal health policy, released a report titled Dear Healthcare Professional Letter, indicating that the drug used for the treatment of interstitial cystitis (IC) should not be used by individuals with a history of macular disease.

Elmiron, also known by its generic name pentosan polysulfate sodium (PPS), is a medication prescribed to treat IC. Several cases of pigmentary maculopathy, which involves changes to the retina, causing vision loss and impairment, have been reported among its users, mostly by individuals who have been using it for three years or longer.

Several studies and a growing number of lawsuits filed in recent years claimed that long-term exposure to Elmiron has serious eye-related side effects and causes maculopathy, an eye disorder affecting the macula, central part of the retina, which is a major cause of blindness. Many experts have referred the retinal disease to “Elmiron maculopathy” or “PPS maculopathy.” It is also a weak blood thinner and, therefore, may increase the risk of bruising/bleeding.

According to the letter, along with the new contraindication information, the Canadian Product Monograph for the drug has also been updated to strengthen the information about the associated risks.

The key messages noted in the letter for healthcare professionals are:

• Assess the benefits and risks with the patients before initiating treatment with Elmiron and periodically thereafter.

• Obtain a detailed ophthalmologic history of all patients before starting treatment with Elmiron.

• Perform baseline and regular retinal examinations for early detection of macular pathology.

• Counsel patients to report changes in vision, such as difficulty reading, slow adjustment to low or reduced light, blurred vision, including blurry or wavy vision near or in the center of the field of vision.

The letter also asks healthcare professionals and consumers to report any case of pigmentary maculopathy or other serious or unexpected side effects associated with the drug to Janssen Inc. or Health Canada.

In the U.S., a couple of weeks ago, the United States Judicial Panel on Multidistrict Litigation (JPML) centralized the growing number of Elmiron lawsuits in the District of New Jersey for coordinated pretrial proceedings, which will be monitored by Honorable Brian R. Martinotti.

Currently, more than 100 product liability lawsuits are pending in the U.S. against Johnson & Johnson's (J&J) subsidiary Janssen Pharmaceuticals, Inc., each claiming that its users suffered severe retina damage and permanent vision problems, including difficulty adapting to the dark light, spots, or floaters in the vision and complete blindness.

On December 16, the New York Supreme Court for New York County awarded summary judgment to East Manufacturing Corp., a trailer manufacturer, after finding that the plaintiffs' counsel failed to establish that the plaintiff’s decedent was exposed to asbestos from materials manufactured by the company.

The case at issue now involves the estate of a decedent who alleged that her husband was exposed to asbestos while performing mechanical work, specifically brake work, on a fleet of delivery trailers and vehicles from 1974 to 1976. The man was diagnosed with lung cancer on August 2, 2019, and he died on November 19, 2019.

East Manufacturing was identified as one of the manufacturers of trailers, whereas other manufacturers of the old brakes or the new brakes were not identified by the plaintiffs.

The company moved for a summary judgment arguing that it never designed, manufactured, distributed, or sold brakes; and that it had no duty to warn about the risks associated with the composition of any third-party manufactured aftermarket replacement brakes installed onto its trailers.

In the motion, the company contended that it has made a prima facie case demonstrating a lack of duty, breach, or causation and to dismiss complaints and all cross-claims against it.

The company also demonstrated that the case was similar to a case from 1992 involving Goodyear in which a New York Court of Appeals concluded that the company had no duty to warn about defective rims manufactured by another company.

Referring to the mentioned case, the court held that defendant’s knowledge of potentially dangerous products manufactured by another company did not create a duty to warn about it. The court granted the motion for summary judgment and noted that the plaintiffs had failed to demonstrate that the company’s trailers could not be operated safely without asbestos brakes.

Recently, an analysis was also published in the journal Environmental Health Insights, stating that a lack of regulation and inadequate screening of talc-containing cosmetic products in the U.S. has resulted in asbestos contamination.

The lawsuits over talc-based products are also growing in numbers, each alleging that the users were exposed to talc and asbestos particles present in the products, which resulted in ovarian cancer and other injuries.

Last week, a study was published in the medical journal Cancers, which indicated that users of the recalled heartburn drug Zantac are three-times more at risk to develop gastrointestinal cancer due to the production of the cancer-causing chemical N-nitrosodimethylamine (NDMA) by the active ingredient ranitidine.

Ranitidine Hydrochloride is a drug sold under the name of Zantac, used to treat and prevent ulcers in the stomach and intestine. GlaxoSmithKline first received FDA approval for Zantac in 1983. Ranitidine belongs to a group of drugs called histamine-2 blockers and works by reducing the amount of acid the stomach produces, treating conditions such as Zollinger-Ellison syndrome. It is also used to treat gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Researchers from the University of Alabama conducted research to evaluate the link between ranitidine in Zantac and gastrointestinal cancer. The researchers examined the adverse events reported to the FDA about the use of different types of medications used to prevent or treat heartburn. The medications included proton pump inhibitors (PPIs), and H2 antagonists, which were compared according to their proportionate reporting ratios (PPR).

The research showed that the overall rates of gastrointestinal cancer for ranitidine had a PPR of 3.66. This ratio demonstrated that the rate of gastrointestinal cancer with ranitidine use tripled the risk among its users as compared to the users of other heartburn drugs.

It further noted that some specific types of cancers are strongly associated with Zantac side effects, which include:

• Colorectal cancer, affecting Zantac users 16 times more than those who used other heartburn drugs.

• Pharyngeal cancer, which is nine times more likely caused by Zantac use.

• Anal and gallbladder cancer, both of which are four times more likely to be caused by Zantac use.

The researchers concluded that the study provided direct support for the assertion that NDMA contaminated ranitidine is associated with the occurrence of gastrointestinal cancer.

Zantac manufacturer, GlaxoSmithKline, is facing hundreds of lawsuits, each claiming that the manufacturer failed to warn about the presence of carcinogen NDMA. The lawsuits are centralized under MDL No: 2924 in the Southern District of Florida, presided by U.S. District Judge Robin L. Rosenberg for coordinated discovery and pretrial proceedings.