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What Happened In The MassTorts World Last Week? 2020-Jul-06

Allergan Biocell Lawsuits: MCL Formed In New Jersey

On June 8, Acting Administrative Director of the Courts, Glenn A. Grant, issued a Notice To The Bar, stating that all Allergan Biocell breast implant lawsuits filed in New Jersey will be consolidated as part of multicounty litigation (MCL) in the New Jersey Superior Court for Bergen County, where the claims will be presided by Judge Rachelle Harz for coordinated discovery and pretrial proceedings.

Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality).

Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received approval from the U.S Food & Drug Administration (FDA) on 11/17/2006.

The popular product, its textured implants, is linked to a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The disease is a type of non-Hodgkin lymphoma. 

The consolidation of the cases is designed to reduce duplicative discovery into common issues in the cases, avoid conflicting pretrial schedules from different judges, and serve the convenience of the common parties, witnesses, and the judicial system.

The MCL works similarly to the federal multidistrict litigation (MDL) but at the state-court level. The cases will continue as individual lawsuits, where the judge would schedule a series of early test trials known as bellwether cases. If no settlement is reached through the bellwether process, then the cases will eventually be tried as individual claims in the New Jersey state court system.

Last year, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated the Allergan Biocell lawsuits in the Federal court system before U.S. District Judge Brian R. Martinotti in the District of New Jersey under MDL No. 2921.

Lawsuits against Allergan Biocell breast implants are rising in numbers, following the nationwide recall. Each lawsuit has a similar allegation that the textured surface of the implant may increase the risk of a rare type of cancer in the tissue surrounding it, which is now known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Recently, the parent company of Allergan, AbbVie Inc., announced to launch a new awareness campaign to inform women implanted with their recalled Allergan Natrelle Biocell breast implants, who might be unaware of the risks associated.

 

MDL Judge To Consider $1.1B Roundup Class Settlement Motion

A hearing has been scheduled for late July, by U.S District Judge Vince Chhabria to consider a motion for approval of a class action settlement, which includes funding of more than $1.1 billion to help former users of Roundup, who have not yet been diagnosed with cancer.

The June 24th motion to approve the settlement was filed by attorneys involved in the litigation, on which Judge Chhabria issued a pretrial order on June 27, announcing a hearing to consider the preliminary approval of the class action settlement for July 23.

According to the pretrial order, a July 13 deadline has been set to file any opposition or objections over the motion, along with a proposal to submit a consolidated reply to the pretrial order by July 17. The order also indicated that the hearing could be scheduled for August 6 if the July 23 date seems soon.

The class-action settlement also proposes to form an independent Science Panel, to help provide a conclusive and necessary decision about the link between the weedkiller and non-Hodgkin lymphoma. Grant programs would also be set to help diagnose non-Hodgkin lymphoma, to compensate for delays in the litigation, and to fund medical and scientific research of the diagnosis and treatment of non-Hodgkin lymphoma.

In exchange for the deal, the class members would be agreeing to pause the litigation for four years to give time for the completion of scientific research, and consent to issue claims for medical review and punitive damages. The class members would still have the right to proceed with individual injury lawsuits in the future, subject to the Science Panels decision about general causation, which would be binding for both parties.

Last week, Bayer indicated that it would pay more than $10 billion to settle about 75% of the lawsuits claiming that its herbicide was the cause of non-Hodgkin lymphoma.

IARC, considered to be the apex in the field of cancer research, classified glyphosate as a “probable human carcinogen.” According to IARC, Roundup is made up of other ingredients that are toxic in themselves, and are also known to increase the toxicity of glyphosate. Monsanto has known this for many years but still refuses to study the link between cancer and Roundup.

Monsanto has a brief history of legal troubles and Glyphosate is just another herbicide of the company to attract lawsuits. Plaintiffs across the U.S. have filed numerous lawsuits. A plaintiff from one of the Roundup lawsuits claims that she worked as a grower’s assistant on a crop field in New York from 1994 to 1998 where Roundup was regularly sprayed indoors and outdoors resulting in chronic lymphocytic leukemia in 2012. She eventually quit the job and is currently seeking reasonable compensation and punitive damages in court.

Currently, Bayer is facing more than 125,000 Roundup lawsuits, and the company has acknowledged the filing of 52,500 lawsuits. The lawsuits are consolidated under MDL No. 2741 in the U.S. District Court for the Northern District of California.

 

Illicit Dispensing Of Opioids Costs Andover Drug Co. $11M

Injured Workers Pharmacy (IWP), a national mail-order pharmacy based in Andover, Massachusetts, has agreed to pay $11 million over a lawsuit brought by the state alleging that the company illegally dispensed thousands of prescriptions for dangerous drugs, including opioids like fentanyl.

According to the federal Drug Enforcement Agency (DEA), the pharmacy marketed a large number of opioids in Massachusetts between 2006 and 2012, which included 34.2 million oxycodone and hydrocodone pills. Last year, Attorney General Maura Healey's office announced an investigation against the company, which sells the drugs to workers' compensation patients.

The investigation revealed that the pharmacy violated Massachusetts consumer protection laws as it did not have proper policies to determine if the prescriptions were valid, and practiced unlawful marketing methods like paying law firms for patient referrals.

The settlement agreement also specified conditions to change the pharmacy's business practices, which include:

  • Hiring a full-time compliance officer to help identify red-flag prescription behavior.

  • Having a data analyst and software to help identify at-risk prescribers and patients.

  • Establishing measures to help at-risk patients, including hiring pain management specialists, to help review patients' treatment plans with their doctors.

  • Providing an offer to dispense naloxone, a drug used to treat overdoses, at no out-of-pocket cost to the patient.

  • Taking precautions to identify problematic prescribers, including using data and dispensing software that allows pharmacists to see a prescriber's entire history.

  • Disincentivizing filling prescriptions of controlled substances by eliminating compensation based on volume and stopping payments for referrals.

Congresswoman Lori Trahan, D-Westford, appreciated Healey's work and stated that she introduced the Medication Access and Training Expansion Act, in the House, where the legislation has similar goals to the settlement agreement.

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.'

 

JPML To Consider Profemur Hip Implant MDL Consolidation

An oral argument has been scheduled for this month by a panel of federal judges over the proposal of the centralization of Wright Profemur hip implant lawsuits for coordinated pretrial proceedings.

On June 26, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a notice of hearing session indicating that it will hear oral arguments on the proposed centralization on July 30. Due to the ongoing COVID-19 pandemic, the hearing will be conducted via videoconference or teleconference at the Thurgood Marshall Federal Judiciary Building in Washington, D.C.

The proposal for consideration was filed on May 18, by the plaintiffs involved in the hip replacement lawsuits to help avoid duplicative discovery, prevent contradictory rulings from different judges, and serve the convenience of the parties, witnesses, and the courts.

The Wright Profemur hip stem features two modular pieces, allowing the implant to be adjusted for leg length, which makes it different from traditional hip replacement systems. But, many problems associated with the modular hip design have caused trouble for the Wright Profemur system. Due to the design defects, as the metal pieces rub against each other during normal daily activities, reports of corrosion have been indicated.

Around 42 cases are pending in 25 different U.S. District Courts against Wright Medical Technology and MicroPort Orthopedics, Inc., each having similar allegation that plaintiffs suffered complications after the Profemur Modular necks and Profemur femoral stems were used together in a total hip replacement system.

Other manufacturers, including DePuy Synthes Companies, Zimmer Biomet, and Stryker Corporation, are also facing similar lawsuits against their hip implants. Several hip implants have been recalled due to their design defects and rising number of lawsuits.

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