What Happened In The MassTorts World Last Week? 2021-Feb-15

On Thursday, McKinsey & Co., the American worldwide management consulting firm, announced that it would pay $573 million to resolve a lawsuit filed over its role in fueling the opioid epidemic.

According to the settlement, which is yet to be approved by the court, the company will have to pay $478 million within 60 days, which will be distributed to opioid treatment, prevention, and recovery programs. The case was filed by 47 states, Washington, D.C., and five territories for turbocharging opioid sales for Purdue Pharma LP and earning profits from the crisis caused.

The allegations include that the company advised Purdue on how to boost sales by pushing on higher, more lucrative dosages and increased sales rep visits to high-volume opioid prescribers. The complaint states that McKinsey delivered OxyContin directly to patients through mail-order pharmacies to avoid suspicion.

The states also alleged that the company urged physicians to prescribe more OxyContin to more patients and encouraged drugmakers to band together to defend against strict treatment by the FDA on risk mitigation efforts that could have reduced high doses and saved lives.

As per the settlement deal, the company is also required to produce all the internal documents that report its work with Purdue. The company denied any wrongdoing and agreed to not take part in any opioid-related work moving forward.

Last month, Insys Therapeutics founder agreed to pay $5 million to New Jersey to resolve a lawsuit that claimed that the founder bribed doctors of the state to boost sales of its powerful Opioid, Subsys.

According to the settlement deal, the founder will pay a lump sum of $1 million first, which will be followed by another $4 million. The amount is intended to be used to fund the state's efforts to combat the opioid epidemic as well as pay for litigation expenses. The remaining funds will be given to agencies affected by the founder's alleged kickback scheme.

Purdue Pharma settlement

The deal is the settlement to come from the more than 3,000 lawsuits that have been brought against medicine manufacturers and other companies involved in opioid manufacturing.

The organization, which has denied wrongdoing, is blamed for using deceptive marketing and ignoring signs of abuse, unleashing an epidemic that drove millions to addiction and claimed the lives of an estimated 450,000 people through overdose deaths from 1999 to 2018.

In October, Oxycontin-maker Purdue admitted to enabling the supply of drugs "without legitimate medical purpose", paying doctors and others illegal kickbacks to prescribe the drugs, among other claims. It agreed to pay $8.3bn.

Thousands of lawsuits against pharmacies, drug distributors, and others are still pending.

The Kentucky Court of Appeals reversed a verdict that favored Johnson & Johnson (J&J) over a lawsuit claiming its baby powder for a deceased woman's cancer.

According to the opinion dated January 29, the appellate court reversed the verdict after finding that the trial court’s decision over allowing the defendant to elicit “irrelevant personal and family use testimony from its witness” prejudiced the plaintiff. The court also remanded the case for a new trial against the defendant.

The lawsuit was filed on behalf of a woman who was in her early 70s when she was diagnosed with mesothelioma in April 2016. She died in December 2016, and her family claimed that her disease was caused by asbestos-containing cosmetic talcum powder manufactured by J&J and Colgate-Palmolive.

In this trial, the defendant offered a witness, a toxicologist, who worked for various J&J units from the 1970s to the 1990s. The witness told the jurors about his personal use of the product to rebut the claims made by the family.

Earlier, U.S. District Judge Todd W. Robinson of the Southern District of California favored Johnson & Johnson (J&J) Consumer Inc. and Bausch Health US LLC over a lawsuit that claimed the defendants for misleading representations in advertising and marketing of the talcum products.

The lawsuit was brought by two plaintiffs seeking damages on behalf of all purchasers of the talcum powder products in the state of California. The plaintiffs contended that the products contained contaminants like asbestos, lead, silica, and arsenic that can cause cellular inflammation and oxidative stress.

J&J and the co-defendant were alleged of engaging in deceptive advertising practices for its baby powder and other talc-based products as an effort to obtain consumers' trust and increase sales.

The defendants filed a motion to dismiss, arguing that the plaintiffs failed to show that the alleged misrepresentations are in fact misleading and they have not satisfied Rule 9(b). Under Rule 9(b), the plaintiff must state with “particularity the circumstances constituting the fraud or mistake.”

According to the recent order, Judge Robinson stated that the plaintiffs failed to identify which particular advertisement they relied on and that they failed to show which specific statement they actually saw. Additionally, the judge said that the plaintiffs failed to show the products are unsafe and dismissed the case with prejudice.

Earlier this month, the Baby Powder giant argued over the Plaintiffs’ Steering Committee's (PSC) motion to add a spoliation of evidence claim to the First Amended Master Long Form Complaint, stating that it's untimely for the plaintiffs to add the claim four years after the first Master Complaint was filed.

J&J is currently facing more than 20,000 Baby Powder and Shower-to-Shower lawsuits and has been paying millions to resolve them.

Last year the company stopped selling its talcum-based products in the U.S. and Canada, stating a decline in consumer demand and misinformation about the safety of the products.

Last week, the 9th Circuit U.S. Court of Appeals upheld the dismissal of four lawsuits brought against Mentor Worldwide LLC’s MemoryGel silicone breast implants, stating that the claims are barred by federal law.

According to the memorandum dated February 5, the federal appeals court panel said that the four separate but similar claims were properly dismissed by a California federal judge as preempted under the 1976 Medical Device Amendment (MDA) to the Food, Drug, and Cosmetic Act.

The panel further discovered that the plaintiffs did not allege actual adverse events that the Johnson & Johnson (J&J) unit did not report to the Food and Drug Administration (FDA). According to the panel, state-law claims are preempted unless they are based on a parallel requirement under the MDA.

The lawsuits in which the women alleged fatigue, muscle pain, migraines, and the defects in the implants were tossed in August 2019 in separate orders by U.S. District Judge Andre Birotte Jr.

The panel stated that, in states like California that recognize failure to report claims, an allegation that a company failed to report adverse events could become the basis of a parallel claim that can escape preemption. The plaintiffs made conclusory and speculative allegations, which according to the panel, is insufficient to state a parallel failure to warn claim.

Currently, Allergan is also facing nearly 150 product liability lawsuits and class action lawsuits over its recalled “Biocell” textured breast implants, each claiming that the textured design was unreasonably dangerous and defective, and the manufacturer knew that it increased the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) yet failed to warn about those risks.

On Monday, the 8th Circuit U.S. Court of Appeals affirmed that Teva Pharmaceuticals, the manufacturer of ParaGard intrauterine contraceptive device (IUD), was not required to warn a woman directly over the risks associated with using the birth control device as the company warned her physician.

The lawsuit was filed by a Nebraska woman after her physicians discovered that the device had broken apart and a piece had become embedded in her uterus. The plaintiff in her lawsuit had cited a Massachusetts case and two cases from Michigan in which the consumers had to be directly warned about the risks for prescription contraceptives.

According to the opinion dated February 8, the decision was a split where the panel majority asserted that like any other state, Nebraska requires manufacturers to warn consumers directly about any design risks in their products. However, there is an exception called the learned-intermediary doctrine for prescription drugs, as per which the manufacturers are allowed to warn medical professionals of the risks, instead of the patients themselves.

The Nebraska Supreme Court did not state whether it would apply the doctrine to other medical products like ParaGard, but the panel said that the court would do it.

U.S. Circuit Judge Jane Kelly, in a dissent, stated that the panel should not venture into an uncertain area of tort law without seeking guidance from the Nebraska Supreme Court. She further added that the question of whether the learned-intermediary doctrine covers prescription contraceptives should be sent to the Nebraska Supreme Court.

In December, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order confirming centralization of all ParaGard IUD cases in the Northern District of Georgia. The cases will be presided by Honorable Leigh Martin May for coordinated or consolidated pretrial proceedings.

On Monday, a study was published in the medical journal JAMA Pediatrics in which Swedish researchers suggested that future breathing and respiratory risks are the potential adverse events that should be considered when prescribing proton-pump inhibitors (PPIs) to children.

The research, which was conducted with an objective to investigate the association between PPI use and risk of asthma in children included registry data collected in Sweden from January 1, 2007, to December 31, 2016.

An analysis was done from February 1 to September 1, 2020, on nearly 81,000 matched pairs of children and adolescents. The group included the ones who initiated PPI use and those who did not.

The findings revealed that the ones who started using the drug during the study period showed an asthma incidence rate of 21.8 events per 1,000 person-years as compared to just 4 events per 1,000 person-years among the ones who did not use the drug.

The drugs mentioned in the study that doubled the risk of asthma among child users was Protonix, which was followed by Nexium with a 64% increased risk of asthma. Prevacid and Prilosec were also found to increase the risk by just under 50%.

The researchers concluded that initiation of PPI use compared with nonuse was associated with an increased risk of asthma in children and the heartburn drugs should be prescribed to children only after weighing the potential benefit against potential harm.

Currently, more than 13,000 Nexium, Prilosec, Prevacid, and other PPI drug lawsuits are pending across the federal court system. The lawsuits, consolidated under MDL No. 2789, claim that the manufacturers failed to warn about the risk of acute kidney injury, chronic kidney disease, and end-stage renal failure associated with the heartburn medications.

U.S. District Judge Landya McCafferty of the United States District Court for the District of New Hampshire, overseeing all Atrium C-Qur hernia mesh lawsuits, rescheduled the first bellwether trial of the multidistrict litigation (MDL) to begin on July 7, 2021.

The proposal was sent in last week through a joint agenda by the parties involved in the litigation, indicating that they are optimistic that the case will proceed in-person before a jury. The parties also noted that they will revisit the logistics if the in-person trial becomes unmanageable.

The trial was initially scheduled for May 2020 but due to the on-going COVID-19 pandemic, the trial was delayed several times.

The result of this trial and other upcoming trials will not hold an obligation on other cases and will be closely monitored by the parties as it would influence settlements for the plaintiffs, helping avoid the need for individual trials nationwide in the coming years.

Currently, more than 2,500 hernia mesh lawsuits are pending against Atrium in the federal court system, each raising similar allegations that the C-Qur mesh has design defects and was unreasonably dangerous, and increased the need for additional corrective surgeries to remove or replace the patch.

Apart from Atrium C-Qur, other products, which include Ethicon Physiomesh, Bard Polypropylene Mesh, and Kugel Patches have also been alleged to cause similar complications.