What Happened In The MassTorts World Last Week? 2019-Nov-18
Jury Awards $13M To Mesothelioma Victim’s Family
Last week, a California appellate court declared the $13 million verdict made by a lower court jury in favor of a mesothelioma victim's family.
According to the court memorandum, the victim was affected by the rare and deadly asbestos-related disease while growing up in the company town of Betteravia, California. The victim's father, as well as grandfather, worked at Hillshire Brands, a Tyson Foods subsidiary, where they were exposed to asbestos.
The lawsuit alleges that the carcinogenic material was brought into the family's home on the hair, skin, and clothing of his father and grandfather as the company did not provide safety precautions to protect either workers or their families from asbestos. The victim died due to mesothelioma in 2015.
The lower court jury had awarded the victim's family $2 million in economic damages and $11 million in non-economic damages, which was appealed by the defendants for inadequate evidence. The assertion was later denied by the appellate court.
Asbestos is one of the main ingredients in baby powder, considered cosmetic when used in makeup and body powders, which require very little federal oversight. The U.S. Food and Drug Administration (FDA) is alerting consumers about certain cosmetic products due to the presence of asbestos. Despite several studies highlighting the cancer risk, the FDA does not require Baby Powder warnings on talc-based product labels to be updated. Moreover, J&J has also refused to add one, willingly.
MDL Court Frames Guidelines For Testing Asbestos In Talc
On November 1, Special Master Joel Pisano, appointed by the U.S. District Judge Freda L. Wolfson presiding over all federal talcum powder lawsuits, approved a supplemental order with regards to the testing procedures for Johnson & Johnson's (J&J) Baby Powder samples from the recalled lots.
The order indicates that J&J should notify plaintiffs that additional samples for independent testing will not be available, if the testing associated with recent recall uses up all the samples. It further states to preserve the samples and recalled bottles of baby powder returned by consumers and an appropriate protocol for dividing and selecting such samples should be raised with the court.
The last month's recall impacted 33,000 bottles after the FDA found evidence of asbestos in a sample tested. The lawsuits are consolidated under multidistrict litigation MDL No. 2738 ( In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices, and Products Liability Litigation). Lawsuits are also pending in a coordinated California proceeding under Judicial Council Coordinated Proceeding No. 4877.
Johnson's Baby Powder, one of the most popular products containing talcum powder, is linked to increasing a woman's risk of ovarian cancer if she uses it regularly in the genital area. In a few cases, the cancer tissue was studied using an electron microscope and was found to have talc in it, which supported the claim that the cancer was caused by the body powder and increases the talc-related cancer risk.
Lawsuit Filed Against Gilead Over HIV PrEP Patents
The U.S. government has sued Gilead Sciences over HIV PrEP patents claiming that the patents belong to the Department of Health and Human Services, and the manufacturers are using it without paying royalties.
According to a complaint, Gilead allegedly violated four government patents for Truvada (emtricitabine and tenofovir disoproxil fumarate) and Descovy (emtricitabine and tenofovir alafenamide), which are meant for pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV. The lawsuit states that the manufacturer relied on the U.S. Centers for Disease Control's (CDC) research for the approval of Truvada by the U.S. Food & Drug Administration (FDA) for Truvada approval. CDC, previously received patents for emtricitabine and tenofovir in 2006.
Gilead is facing Allegations including, that the manufacturer failed to warn about their tenofovir disoproxil fumarate HIV medication Truvada, Viread, Atripla, Complera, and Stribild led to kidney problems and bone loss. The lawsuits are consolidated under MDL-2881, IN RE: Tenofovir Disoproxil Fumarate Products Liability Litigation, filed on December 19, 2018, in the Judicial Panel on Multidistrict Litigation.
Tenofovir Disoproxil Fumarate (TDF) is an orally administered prodrug of tenofovir. Tenofovir is similar to Adefovir, which is used for the treatment of HIV and chronic hepatitis B virus infections. Gilead Sciences Inc. originally developed it under the brand name Viread, tenofovir disoproxil fumarate, or TDF. Gilead sells five different TDF brand name drugs in the United States, and the drug also comes in generic form.
Stryker Issues Warning On Total Ankle Replacements
On October 11, Stryker issued a safety notice concerning its STAR Total Ankle Replacements distributed before August 2014. The notice warns patients and doctors about the risks associated with ankle replacements, which could result in significant pain, loss of mobility, and require revision or replacement surgery.
Stryker Corporation of Kalamazoo, Michigan, manufactured the product and distributed it to hospitals and medical facilities across the nation. It is used to repair ankle joints that have been affected due to the development of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. The replacement helps to increase mobility and provide joint pain relief.
Currently, the U.S. Food and Drug Administration (FDA) has received more than 100 reported polyethylene fractures related to ankle replacement. According to a Post-Approval Study (PAS), there has been a 13.79% fracture rate in patients who got the replacements.
Stryker Orthopaedics is known for the development and manufacture of specialty surgical products and other medical supplies for health care around the world. The company has manufactured scores of medical devices and joint replacement products, most of which have been successful; however, some of the hip replacement devices have caused serious adverse events, injuring hundreds of patients.
The Stryker Rejuvenate Modular-Neck Stem and the ABG Modular-Neck Stem hip replacement devices were approved by the FDA in 2008 and 2009. These devices are not typical "metal-on-metal" (MoM) as the necks are built of Cobalt and Chromium and the neck stems are layered with Titanium. Though the intention was to make it corrosion resistant, the two metals rubbed on each other at the connection and released toxic metal ions and debris. Stryker permanently recalled the Rejuvenate Modular and ABG II Modular-Neck Hip Stems in 2012 and stopped all global sales and production of these components. Another hip stem model, the Accolade TMZF, also caused problems and was recalled in 2009, 2011, and 2013.
Stryker is also facing lawsuits over problems related to its hip replacement products, including the Stryker Rejuvenate and ABG II hip implants. The products were recalled in July 2012 following a rise in the number of allegations including failures caused by corrosion, fretting, and loosening of the modular-neck stem, which have led to hip revision surgery and have also resulted in permanent injuries.
J&J Fights Back Over Okla.'s Move On State’s Opioid Crisis
On Tuesday, Johnson & Johnson (J&J) asked the Oklahoma state court judge to limit the payouts concerning the state's opioid crisis for one year.
Oklahoma Governor Kevin Stitt, along with state’s two senior legislators, filed a proposed amicus brief on October 28, explaining that J&J should continue to fund abatement costs over several years, and the state’s taxpayers should not bear the costs. The move is a part of the $572 million court judgment issued on August 26, which was intended to wane the opioid crisis. During the August hearing by Cleveland County District Court Judge Thad Balkman, J&J stated that there were “gaps in the state’s evidence,” for the costs to go beyond a year.
The governor and senior legislators also intervened during the settlements with Purdue Pharma and Teva Pharmaceuticals to make sure that the funds went to Oklahoma’s treasury.
Opioids are on the market for ages and have been used basically for pain relief for post-surgical pain, cancer-related pain, chronic or persistent pain. Opioids when used in proper dosage and along with a combination of other pain treatments, work in relieving pain successfully, unless there is a misuse or abuse of the drug.
Companies manufacturing opioids convinced the medical community that these medications were not addictive and were purely beneficial. This belief raised the number of prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by the U.S. Food and Drug Administration (FDA) as a public issue and named it an opioid crisis.
Opioid Crisis: A Concern For Nearly 2 Million Children
A new analysis shows that approximately 2 million children are affected by the U.S. opioid crisis, and the numbers seem to be rising.
According to the analysis from the United Hospital Fund, a health policy nonprofit based in New York, the primary reason for children to get affected by the crisis is parents' use of opioids. A child separated from a drug addict parent, or a child whose parents died due to an overdose of opioids can also be affected by it. The analysis also asserts that an estimated 170,000 kids had opioid use disorder themselves or had accidentally taken the drugs in recent years.
The analysis suggests that these children are likely to incur higher expenses than others during childhood, which estimates to $117.5 billion in health care, special education, and child welfare, along with societal costs of $62.1 billion during adulthood. The analysis also concluded that even after a continual downward trend in opioid usage, there still could be 4.3 million children affected by the opioid crisis at $400 billion by 2030.
Opioids are on the market for ages and have been used basically for pain relief for post-surgical pain, cancer-related pain, chronic or persistent pain. Opioids when used in proper dosage and along with a combination of other pain treatments, work in relieving pain successfully, unless there is a misuse or abuse of the drug.
Companies manufacturing opioids convinced the medical community that these medications were not addictive and were purely beneficial. This belief raised the number of prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by the U.S. Food and Drug Administration (FDA) as a public issue and named it an opioid crisis.
There are more than 1,900 opioid lawsuits consolidated under MDL No. 2804 (In Re: National Prescription Opiate Litigation), presided by U.S. District Judge Dan Polster.