What Happened In The MassTorts World Last Week? 2019-Apr-29

About 60 doctors, pharmacists, medical professionals, and others linked to the alleged opioid pushing were charged by federal prosecutors, according to a statement by the Justice Department last week.

The cases are a result of more than 350,000 prescriptions for controlled substances and more than 32 million opioid pills. Some of the doctors are accused of trading the prescription opioids for sex and prescribing the painkiller to their social media friends without medical screening. The statement by the Justice Department revealed charges against 31 doctors, 7 pharmacists, 8 nurse practitioners, and 7 other licensed medical professionals for being involved in the biggest health care fraud in West Virginia, Virginia, Ohio, Kentucky, Alabama, Tennessee, Pennsylvania, and Louisiana. Many doctors signed blank prescriptions that their employees used to fraudulently prescribe pills to patients, some of whom were already addicts. Another doctor allegedly prescribed dangerous combinations of opioids and benzodiazepines, in exchange for sexual favors. The department also indicated about charges put upon a doctor who prescribed pills for his own use, and a dentist who allegedly prescribed opioids for no valid reasons and removed teeth unnecessarily.

The opioid epidemic has disastrously affected the U.S., and as per reports, Appalachia has seen the worst consequences than any other region. Attorney General William Barr said the DOJ was taking measures to help communities put an end to the opioid crisis.

In a pretrial order issued on April 19, Judge Casey Rodgers, laid out the plaintiff leadership structure, asking product liability lawyers representing veterans in the 3M Earplug lawsuits to apply for various leadership roles in the recently formed multidistrict litigation (MDL).

The order calls for attorneys to apply for the position of lead counsel, liaison counsel, membership on an executive committee, steering committee, and a number of subcommittees. The attorneys appointed in these leadership roles will be responsible for certain actions during the trial proceedings that will be beneficial to all plaintiffs. These actions might include arguing motions before the court, taking depositions, reviewing discovery documents, among other actions. However, each veteran will still have their own attorney to represent the case-specific interests and assert claims that their hearing loss was caused due to faulty 3M Earplug. Any attorney who has his 3M Earplug case in the federal MDL will be allowed to apply for leadership roles, and the applications will be reviewed by May 3. Some attorneys will be called on May 20 and May 21, to make an oral presentation about their qualifications for the above-said positions.

The federal court system has more than 600 3M Earplug lawsuits with allegations that the device left veterans with tinnitus or hearing damage.

On the eve of trial, Johnson & Johnson's subsidiary Ethicon Inc. agreed to pay $9.9 million to settle the first lawsuit brought by Washington Attorney General Bob Ferguson accusing the company of downplaying the risks of its pelvic mesh products.

The New Jersey-based company was sued by the Attorney General in 2016, saying its Ethicon Inc. breached the state’s Consumer Protection Act by failing to warn patients and doctors about the dangers and irreversible complications of its defective products. According to claims filed by thousands of women, the surgical mesh intended to render extra support to damaged or weakened tissue caused urinary dysfunction, constipation, sexual problems, and severe pain. The defendants who were supposed to face the trial in King County Superior Court on Monday, April 22, did not admit wrongdoing. According to Ferguson’s office, about 14,000 Washington women were implanted with the company's pelvic mesh, and the settlement amount will be helpful for them. The Attorney General will declare a formal claims process for the affected women soon.

Ethicon pelvic mesh lawsuits are consolidated as a part of multidistrict litigation (MDL No. 2327; In Re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation) before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia.

On April 21, the FDA announced a recall for an Alvogen Fentanyl Transdermal System over mislabeling issues in some cartons. The agency indicated that some cartons labeled as having 12 mcg/h patched were actually containing 50 mcg/h patches.

Though Alvogen Inc. had not received any adverse event reports related to the recall, such misinformation could pose serious risks for individuals who were prescribed the lower dose. The patches indicated 50 mcg/h reading; however, if a patient purchased the 12 mcg/h carton and used the 50 mcg/h patch carried init, this could lead to serious and fatal respiratory depression. The company said that the first time users, children, and the elderly would be at risk because of this mislabeling. The recall affects Lot 180060 of Fentanyl Transdermal System 12 mcg/h, expiration date 05/2020; and Lot 180073 of Fentanyl 12 mcg/h, expiration date 06/2020. Alvogen has notified distributors and customers about the recall through a certified letter and made arrangements for the return and replacement of all recalled products. The company has also requested pharmacies to stop dispensing products from the recalled lots. Patients who discovered the carton with the wrong dosage must inform their doctors and replace any unused pain patches from the point of purchase. Any adverse effects linked to the recalled products must be reported to the FDA’s MedWatch Adverse Event Reporting System.

Fentanyl pain patches are powerful medications prescribed to reduce the pain by gradually releasing fentanyl, which gets absorbed through the skin. It is 50 to100 times more powerful than morphine and has been linked to more than half of all opioid overdose deaths recorded in recent years, making it the most dangerous drug in the U.S.

After detecting the third cancer-causing impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), the FDA and Torrent Pharmaceuticals have expanded the nationwide recall for generic losartan pills on April 18, 2019.

The company expanded its recall for 36 lots of Losartan Potassium Tablets USP and 68 lots of Losartan Potassium/hydrochlorothiazide tablets, to the consumer level as trace amounts of unforeseen impurity was detected in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. This recall applies only to those lots which have NMBA levels above the current acceptable daily intake levels. Torrent indicated that it had notified the distributors and customers over the phone as well as through a written letter requesting them to discontinue selling or using the recalled lots. Arrangements have been made by the company to return all affected tablets to Qualanex for disposal. The first recall for generic blood pressure drugs, valsartan, was announced in July 2018, when it was found that the U.S. supply of the drug distributed for years was contaminated with carcinogenic chemicals.

Previous recalls were the result of the presence of   N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in the blood pressure medications, which are known to increase the chances of cancer in humans. The recalls impacted different generic version of valsartan, losartan, irbesartan, and other products.

In a case management order issued on April 17, Judge Jane Triche Milazzo presiding over all Taxotere hair loss lawsuits announced a schedule for the first bellwether trial in the litigation scheduled for September 2019.

According to the announced schedule, all supplemental motions and briefs must be submitted by June 4, a final witness list by July 3, jury questionnaire by July 12, and motions in Limine to be filed by July 16. A final pretrial order has been scheduled for August 23, and a final pretrial conference will be held on August 30.

There are more than 12,000 product liability claims filed against Taxotere manufacturer, Sanofi-Aventis, each raising similar allegations that the chemotherapy drug causes permanent hair loss in several women, which was not the case with other equally effective breast cancer treatment methods. The lawsuits are centralized in the Eastern District of Louisiana, as part of a federal Multidistrict Litigation (MDL No. 2740; In Re: Taxotere (Docetaxel) Products Liability Litigation).

In a U.S. Securities and Exchange Commission filing, Bausch Health Companies Inc. (BHC) struck a deal with Johnson & Johnson to cover the costs of litigation involved in personal injury and product liability lawsuits linked to Shower to Shower product that Bausch acquired in 2012.

The deal covers suits filed before March 2020. J&J will compensate Bausch for any regulatory actions related to the production, use or sale of the talcum powder up to September 2012. The lawsuits against Bausch included several filed into the multidistrict litigation involving J&J's talcum products in New Jersey federal court and state courts. Some of the cases claimed that Shower to Shower powder cause ovarian cancer to women who used them for personal hygiene purposes. The company stated in the annual report that it was actively defending itself in suits that have not been dismissed yet.

J&J faces more than 14,000 claims linked to asbestos exposure from its talc-based products causing ovarian cancer or mesothelioma.

On Tuesday, April 23, Monsanto asked a California appeals court to reverse a $78.5 million verdict awarded in the first Roundup trial over the herbicide's alleged cancer risks.

In its appeal, Bayer asserted that there was no evidence that glyphosate detected in Roundup and Roundup Range Pro products could cause cancer. The company said the court must either flip the verdict in its favor or order a new trial, contending that the lower court was wrong in preventing jurors from hearing evidence that the U.S. Environmental Protection Agency and foreign regulators had marked glyphosate as non-carcinogenic to humans. The $78.5 million verdict was a reduced award granted to the plaintiff after Judge Suzanne Bolanos slashed the initially awarded $289 million sanctioned by a San Francisco jury in August 2018.

Bayer, which faces over 13,000 Roundup cancer lawsuits over glyphosate exposure continues to defend itself by proclaiming that decades of scientific research and real-world use have shown glyphosate as safe for humans. U.S. District Judge Vince Chhabria overlooks the federal multidistrict litigation (MDL No. 2741; In Re: Roundup Products Liability Litigation) in the Northern District of California.

On Wednesday, April 24, a Philadelphia jury awarded $120 million to a woman who claimed she suffered incontinence and chronic pain due to Ethicon Inc.'s defectively designed transvaginal mesh.

The trial involved claims filed by a Pennsylvania woman who was implanted with J&J and Ethicon’s TVT-O pelvic implant to treat her urinary stress incontinence. She complained that the negligent design of the mesh caused it to erode into the soft tissue in her pelvis and injured her vagina, she had to undergo multiple surgeries to remove broken pieces of the mesh, but some fragments still remained in her body. She alleged that the complications prevented her from having sex for the last 10 years. The trial began in September 2018 and left the jury deadlocked on whether the mesh actually caused her injuries. The retrial, which began in March, was halted for a month when an expert witness suffered a heart attack. Wednesday's verdict includes $20 million in compensatory damages and $100 million in punitive damages.

There are more than 48,000 lawsuits filed against various transvaginal mesh manufacturers over devastating injuries caused due to their faulty designs. The FDA recently ordered a halt on the sale and distribution of all transvaginal mesh in the U.S.

On April 19, a Los Angeles County jury awarded $4.4 million to the family of a former bowling alley owner on finding that asbestos supplier Honeywell International Inc. was responsible for his death.

The victim, who co-owned the bowling alley with his brother, developed pericardial mesothelioma in 2012 as a result of drilling holes into asbestos-containing bowling balls. He used to regularly drill ebonite balls in a small room, without any protection, for years. He was unaware that Ebonite balls contained asbestos. Asbestos, which was used as a filler in the bowling balls, was supplied by Honeywell in the form of discarded brake lining dust. The jury found that exposure to asbestos waste was hazardous to humans, and Honeywell was negligent in providing adequate warning about asbestos exposure risks. The victim died of mesothelioma in 2013, leaving behind two adult sons and a wife. The jury held Honeywell 40% liable for the man's death and awarded $4,397,716 to the family.

Recently, the Environmental Protection Agency (EPA) announced to put a complete ban on the use of asbestos in product categories in the automobile industry and building materials. Asbestos exposure has been reported to cause mesothelioma in several individuals, who were unaware of the risks or were not adequately protected.