What Happened In The MassTorts World Last Week? 2021-Mar-08

Last month, a study was published in the medical journal The BMJ in which Harvard researchers highlighted the side effects of opioid use during pregnancy and indicated that the use increased the risk of a cleft palate, cleft lip, or other birth defects.

The data for research was collected from two sources, the Medicaid Analytic eXtract (MAX) from 2000 to 2014 and the MarketScan Research Database from 2003 to 2015, which included more than 1.6 million publicly insured pregnant women. The researchers had set the eligibility to at least three months before pregnancy to one month after delivery with infants’ eligibility for at least three months after birth.

The women with two or more prescription dispensations of an opioid painkiller, like Vicodin or OxyContin, during the first trimester of pregnancy, were considered by the researchers. Out of the total, nearly 70,000 publicly insured women and around 12,000 commercially insured pregnant women had two or more prescription dispensations.

The research revealed that in the MAX cohort the risk of abnormalities overall was 41 per 1,000 pregnancies as compared to 32 per 1,000 unexposed pregnancies and in the MarketScan cohort, the data revealed a risk of 42 per 1,000 exposed pregnancies as compared to 37 per 1,000 unexposed pregnancies. The researchers further noted that other birth defects, like heart malformations, club foot, or neural tube defects were comparatively lower.

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.

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'

In conclusion, the researchers stated that prescription opioids used in early pregnancy are not associated with a substantial increase in risk for most of the malformation types considered, although a small increase in the risk of oral clefts associated with their use is possible.

The same month, the U.S. Centers for Disease Control and Prevention issued the Morbidity and Mortality Weekly Report (MMWR) indicating that from 2013 to 2019 overdose deaths related to opioids, which involved fentanyl, and other synthetic versions of the addictive pain killers had skyrocketed.

On Tuesday, a three-judge appeals panel reversed two verdicts worth $83 million awarded to two women who alleged that they suffered severe complications from pelvic mesh medical devices.

The New Jersey appeals court panel had consolidated both the cases and overturned the verdicts based on one important issue, which was common to both cases. The verdicts were awarded by two separate Bergen County juries to the plaintiffs over their claims against Johnson & Johnson (J&J) and its subsidiaries and C.R. Bard, Inc. and its subsidiaries.

In the first case brought against Ethicon Inc., Ethicon Women's Health and Urology, Gynecare, and J&J, a Bergen County jury had awarded the woman and her husband $5 million in compensatory damages and $10 million in punitive damages. The jury held the defendants liable under independent theories of defective design and inadequate warning under New Jersey product liability laws.

The second case had resulted in $33 million in compensatory damages, along with stipulated medical expenses, and another $35 million in punitive damages. The jury held C.R. Bard, Inc., Bard Medical Division, and Bard Urological Division responsible for design and failure to warn defects claims.

The defendants appealed for their cases respectively and raised arguments over evidentiary and substantive parts. However, the panel rejected those arguments and concluded that the verdicts were misjudged by categorically excluding any proof that defendants had obtained what is known as 'Section 510(k)-clearance' from the U.S. Food and Drug Administration (FDA) for the devices.

Ethicon Physiomesh is a flexible, composite, macroporous, and partially absorbable mesh made of non-absorbable polypropylene by Johnson & Johnson. FDA approved the use of Ethicon Physiomesh in March 2010 for the repair of hernias and other fascial deficiencies that require the addition of strengthening or bridging material to obtain the desired surgical result. A hernia is a condition that occurs when an organ, intestine, and/or tissue squeezes through a hole or weak point in the surrounding muscle or connective tissue. The number of hernia repair operations performed every year in the USA is remarkable.

Despite the already existing mesh implants in the market, the sale of Ethicon Physiomesh increased after the FDA approval as it was promoted as a physiologically well-designed device, offering strong and comfortable healing and giving an exceptional intraoperative handling benefit. But within a few years, Ethicon globally recalled the Physiomesh after thoroughly considering the data which was revealed out of Hernia registries.

The appeals court further noted that although courts in other jurisdictions have excluded 510(k) evidence from jury trials involving the design and safety of mesh devices, there is sufficient probative value of such evidence under N.J.R.E. 401 to justify informing the jurors, without extensive elaboration, that the products were reviewed by the FDA under the 510(k)-clearance process before selling.

The panel reversed both jury decisions and remanded the cases for new trials over the Rule 104 hearings on the 510(k)-clearance evidence.

Johnson & Johnson (J&J) talc users have appealed to reverse California’s federal judge's decision which favored the company by dismissing a class action lawsuit. It was one of those few wins for the company in the litigations over its talcum powder products.

The lawsuit alleged that J&J misled the consumers with fraudulent advertising of the baby powder and other talc-based products. The company marketed the products as “safe and pure” to gain consumers' trust and increase sales. Contrary to the company's marketing, the lawsuit claims that the products are unsafe and contain multiple hazardous substances like asbestos, lead, asilica, and arsenic.

In January 2020, the judge dismissed the lawsuit by stating that the plaintiffs do not have enough evidence to support the claims.

Plaintiffs filed an appeal to the U.S. Court of Appeals to review and reconsider the lawsuit. Following the appeal, the plaintiffs are required to present the necessary arguments of the case before the court by June 1.

Currently, J&J faces more than 20,000 individual talcum powder lawsuits from women throughout the United States. The lawsuits claim that the regular use of the products resulted in the development of ovarian cancer and other injuries.

All the talcum powder cases are centralized before Judge Freda L. Wolfson in the District of New Jersey, for coordinated discovery and pretrial proceedings. Previously, J&J has been fined billions of dollars in the state court trials claiming that the company was aware that its products caused cancer.

On March 2, Johnson & Johnson (J&J) petitioned a Writ of Certiorari with the U.S. Supreme Court to review the $2.1 billion verdict, which was awarded to a group of women over allegations of ovarian cancer from the company's talcum powder.

The attempt was expected and is considered to be a final attempt to overturn the multi-billion-dollar verdict after the highest appeals court in Missouri upheld the judgment.

The company announced the filing in a press release and claimed that the trial was “fundamentally flawed” and yielded an “incorrect verdict and arbitrary and disproportionate damages.”

A Writ of Certiorari is only granted in about 3% of all civil lawsuit appeals filed with the highest court in the country. In this case, the essential point that the company focuses on appears to be the difficult causation questions, which were obscured in the trial.

The initial verdict favoring a group of 22 women was given in July 2018 by a state court jury. J&J appealed over the decision, following which the Missouri appeals court upheld the jury’s finding of liability but slashed the $4.69 billion damages award in June 2020.

Johnson & Johnson (J&J) talc users have also appealed to reverse California’s federal judge's decision which favored the company by dismissing a class action lawsuit. It was one of those few wins for the company in the litigation over its talcum powder products.

The lawsuit alleged that J&J misled the consumers with fraudulent advertising of the baby powder and other talc-based products. The company marketed the products as “safe and pure” to gain consumers' trust and increase sales. Contrary to the company's marketing, the lawsuit claims that the products are unsafe and contain multiple hazardous substances like asbestos, lead, silica, and arsenic.

In January 2020, the judge dismissed the lawsuit by stating that the plaintiffs do not have enough evidence to support the claims.

Plaintiffs filed an appeal to the U.S. Court of Appeals to review and reconsider the lawsuit. Following the appeal, the plaintiffs are required to present the necessary arguments of the case before the court by June 1.

Currently, the talcum powder giant is facing more than 25,000 Baby Powder and Shower-to-Shower lawsuits, each raising similar allegations about the presence of asbestos and the risk of cancer.

Recently, J&J filed an Annual Report Pursuant to Section 13 of the Securities Exchange Act of 1934, indicating that it has set aside $3.9 billion in litigation expenses in 2020, which is primarily associated with talc-related reserves and certain settlements.