What Happened In The MassTorts World Last Week? 2020-Jun-08
Zantac-Cancer Link To Be Considered For Bellwether Selection
The U.S. District Judge Robin L. Rosenberg, presiding over all Zantac litigation, indicated that the court would weigh on the admissibility of expert witness testimony concerning the link between Zantac and cancer before moving forward with bellwether trials.
Last week two orders were issued by the court, one establishing deadlines for the proceeding’s Initial Census and another laying out a path for moving the cases forward.
According to an Order issued on May 27, the deadlines for submission of Census Plus Forms are set as follows:
Plaintiffs whose case is filed on or before May 31, 2020 (whether filed in the MDL or transferred or removed to the MDL), must file his/her Census Plus Form no later than July 21, 2020. For any Plaintiff whose case is filed on or after June 1, 2020, the Census Plus Form shall be due 60 days from the date of such filing.
Individuals who retain counsel on or before June 30, 2020, and seek to participate voluntarily in the Registry as a claimant must file his/her Census Plus Form no later than August 17, 2020. For any individual who retains counsel on or after July 1, 2020, the Census Plus Form shall be due either 30 days from the end of the calendar-year quarter in which he/she retained counsel, or 45 days from the date of retention, whichever is later.
According to another Order issued on May 28, an initial phase of discovery centered on general causation issues about the link between Zantac and cancer will be completed over the next 18 months, post which the parties will file Daubert challenges to the admissibility of expert witness testimony.
In September 2019, public concerns about the Zantac cancer risk emerged when an independent on-line pharmacy Valisure discovered that each pill may expose users to NDMA levels higher than the permissible daily intake limits set by the FDA. The pharmacy found that some 150 mg pills contained more than 3,000,000 nanograms (ng) of NDMA, while the daily limit deemed safe by the FDA is only 96 ng.
In April 2021, Sanofi informed the investors that it was planning to bring back Zantac with the generic pharmaceutical ingredient found in Pepcid; famotidine. The spokesperson for Sanofi announced on April 28, 2021, that the company will launch a new product named Zantac 360. The company even notified that it will use famotidine, which is the active ingredient in Pepcid instead of ranitidine to manufacture the new product. The company announced it will release two versions of the new Zantac drug on the U.S. market in June 2021. The products include a 10 mg famotidine “Original Strength” version, and a 20 mg “Maximum Strength” version.
More than 230 Zantac lawsuits are pending in the Southern District of Florida, and it is estimated that the numbers would rise in the coming years. Each lawsuit claims that ranitidine, an active ingredient in Zantac, produces high levels of the known human carcinogen Nitrosodimethylamine (NDMA), which leads to various types of cancers, including breast cancer, bladder cancer, stomach cancer, testicular cancer, and other injuries.
Allergan Launches Campaign Over Breast Implant Recalls
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.
The recall was a result of the link between Biocell textured surface design of the implants and BIA-ALCL, a type of non-Hodgkins lymphoma that may develop in the tissue surrounding the implant. Dozens of women nationwide have filed claims against the manufacturer, alleging that it intentionally covered up the problems and misled patients and the medical community.
According to a press release issued on June 1, the goal of the “dedicated multi-channel campaign” is to directly contact patients with Natrelle Biocell textured breast implants via digital and social media advertisements, which will lead those with the implants to visit www.BIOCELLinformation.com. The company states that this will help the consumers identify which implants they have and register them, which will, in return, help Allergan track the devices.
The announcement of the campaign will also be included on FDA's Biocell recall website. The federal agency also indicated that it will regularly monitor and assess the effectiveness of breast implants and will inform the public whenever new information becomes available.
On May 14, 2020, the FDA notified Allergan and Ideal Implant that the companies were unsuccessful to comply with the post-approval study requirements and procedures for reporting its user. Since the recall of the Biocell implant in July 2019, Allergan has faced hurdles in collecting data to track information of affected patients. Allergan revealed on June 1, 2020, that they failed to track the information of approximately 52,000 patients.
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 FDA on 11/17/2006.
Last year, all the breast implant products that featured the macro textured design used in Natrelle implants were recalled by Allergan as ordered by the federal regulators in the United States. The recall was announced by the FDA as all the reported cases of BIA-ALCL were linked to the design of the product.
The warning letter issued by the FDA indicated that the company agreed to conduct the study in October 2006 but failed to achieve it in the coming years. The company even failed to collect crucial data on safety endpoints such as long-term complications, connective tissue diseases, neurological effects, reproductive issues, lactation, suicide, and other issues, including cancer. Allergan was even supposed to collect complication data from physician evaluations on the product's completion of 1, 4, and 10 years.
As per the June 2020 Fortune article, women discovered about the breast implant device via news or social media. There were only a few who heard about the recall from Allergan or FDA.
Senior VP of AbbVie and President of Global Allergan Aesthetics stated in the latest press release that they will leave no stone unturned to inform every woman about Biocell voluntary recall. Allergan will also educate women to know about their implant type and the level of risk associated with it. Allergan has partnered with the American Society of Aesthetic Plastic Surgery to work on major initiatives and raise awareness of breast implants.
Allergan Biocell Textured Breast Implant products liability lawsuits are consolidated under MDL No. 2921. The litigation is presided by the U.S. District Judge for the District of New Jersey Brian Martinotti and the U.S. Magistrate Judge for the District of New Jersey Joseph A. Dickson.
Grande Prairie Signs $10 Billion Class Action Opioid Lawsuit
A $10 billion class-action opioid lawsuit has been signed by the city of Grande Prairie to become a representative plaintiff against more than 40 pharmaceutical companies. The city is seeking compensation for the damages caused by the opioids to its communities, and the strain it has put on municipalities resources responding to the opioid crisis.
Grande Prairie Mayor Bill Given said the opioid crisis had impacted nearly every individual of the city, and the city's response by participating in the class-action lawsuit was a logical continuation to deal with the crisis. The Mayor further said that the crisis had affected the city financially by increasing costs for local governments in terms of policing and arranging emergency response services along with awareness programs.
The Mayor informed that the lawsuit would allow the city to deal effectively against the opioid crisis on behalf of all municipalities and hold companies responsible for the costs incurred in Grande Prairie, instead of local taxpayers.
The lawsuits filed state that a total of 19 people died due to the opioids crisis in Grande Prairie. Furthermore, more than 100 people have registered for local methadone treatment. Also, compared to the previous quarter, there is a 30 percent increase in supervised consumption sites.
The opioid crisis has also put a toll on the city’s budget indirectly. The real estate market in Grande Prairie has gone down along with the decrease in citizenry productivity. This has led to eroding of the tax base and income in the city. The lawsuit has been filed against reputed pharmaceutical companies like Apotex and Johnson & Johnson, who are opioid manufacturers. The defendant list also includes Shoppers Drug Mart and Jean Coutu.
On May 28, 2020, the U.S. Attorney for Colorado, Jason R. Dunn, announced that Omnicare Inc., a subsidiary of CVS Health, has agreed to compensate $15.3 million in penalties to settle allegations of dispensing opioids and other drugs without a valid prescription.
Omnicare owns two pharmacies in Colorado, one in Pueblo and the other in Grand Junction. The company supplied medications daily to the patients of long-term care facilities and also organized the kits for emergency drug dispensations.
The authorities claimed that Omnicare violated the Controlled Substances Act while delivering prescription medications to facilities. The company allowed the employees of the care facilities to remove opioids and other controlled substances from emergency kits before obtaining prescriptions from doctors, and the medications did not contain necessary documentation.
Along with the monetary settlement, the company will also increase its auditing and monitoring of the emergency kits. The Drug Enforcement Administration’s Denver field division was also involved in the investigation along with the attorney.
The Calgary law firm representing plaintiffs of Grande Prairie city has stated that separate claims will be filed against Purdue Pharmaceuticals, who are makers of OxyContin. The law firm also mentioned in its statement that opioid manufacturers were engaged in a deceptive promotional campaign that misguided the people and make them addicted to these pain-killer drugs. Also, both manufacturers and distributors will be liable to pay out the settlement on refusal to monitor and put restrictions on the distribution of these pain-killer drugs.
Guardian Law Group, a U.S. firm with a track record of successful lawsuits against pharmaceutical companies, represents Grande Prairie.