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A Utah Mom’s Case Could Break Through a Wall of Legal Immunity Surrounding Vaccine Makers
A Utah woman is part of a first-of-its-kind lawsuit against an industry that has been given rare immunity regardless of any mistakes it makes. Vaccines work to immunize us from a variety of diseases, but some complain the government has given immunity from accountability to powerful medical companies.
“I feel like I’m being electrocuted from head to toe,” said Brianne Dressen in describing what is her constant experience.
As the COVID pandemic raged in 2020, she felt a chance to be part of a clinical trial for a COVID vaccine was an opportunity and a duty. Almost immediately she said she felt disturbing symptoms. “Within an hour my reaction started. It started with pins and needles down the same arm as my injection,” she said. “Some days it’s a 10 out of 10 on pain and I can’t even think straight. Some days it’s a 4 or a 5.”
With local doctors unsure of what was happening, she went to the National Institutes of Health where she was diagnosed with Post Vaccine Neuropathy. Doctors said tests showed nerves across her body slowly withering and dying.
For most who have been potentially hurt by a medication, their recourse would be the courts — but during the pandemic Congress passed something called the PREP Act. The summary of the PREP acts spells out that it “provides liability immunity for activities related to medical countermeasures against COVID-19.” It essentially banned almost all lawsuits for those who claim they were harmed.
Johnson & Johnson Reaches $700 Million Talc Settlement With U.S. States
Johnson & Johnson (JNJ.N) has agreed to pay $700 million to settle an investigation by 42 U.S. states and Washington, DC, into its marketing of baby powder and other talc-based products blamed for allegedly causing cancer. The settlement resolves charges that Johnson & Johnson misled consumers into believing its talc products, which it sold for more than a century before stopping, were safe.
J&J did not admit wrongdoing in settling with the states, which were led by Florida, North Carolina and Texas, and has said its talc products are safe and do not cause cancer. The company announced a settlement in principle in January.
J&J still faces tens of thousands of talc lawsuits, and a class action accusing the New Brunswick, New Jersey-based company of fraudulently hiding their dangers from shareholders.
As of March 31, about 61,490 people were still suing J&J over talc. Most were women with ovarian cancer, while a smaller number had mesothelioma, a type of cancer linked to asbestos.
Talc Plaintiffs File for Restraining Order to Block Johnson & Johnson’s 3rd Bankruptcy Attempt
As Johnson & Johnson has tried to resolve talcum powder lawsuits that have been consolidated in a multidistrict litigation in New Jersey, the company has had to deal with two groups of plaintiffs—one that wants to accept a settlement and another that doesn’t.
Wednesday, lawyers representing the latter group announced they had filed a motion asking a New Jersey federal court to issue a restraining order that would block a J&J subsidiary from filing for bankruptcy, which would facilitate a new settlement offer of $6.48 billion.
The filing states that the ovarian cancer victims who have sued J&J will suffer “irreparable harm” if the bankruptcy is allowed to proceed.
Drug-Resistant ‘Dual Mutant’ Flu Strains Now Being Tracked in U.S., CDC Says
At least two human cases of the new so-called “dual mutant” strains of H1N1 influenza have been detected in U.S. patients, the Centers for Disease Control and Prevention said Wednesday, with genetic changes that could cut the effectiveness of the main flu antiviral that hospitals rely on.
An analysis of the new H1N1 flu viruses with these two concerning mutations — which scientists call I223V and S247N, describing changes to key surface proteins of the virus — was published this week in the agency’s Emerging Infectious Diseases journal.
It follows a report by scientists from Hong Kong who first tested the mutations. Their lab experiments, published in March, found the two mutations appeared to raise H1N1’s resistance to the flu treatment oseltamivir, commonly sold under the brand Tamiflu by drugmaker Roche.
“These mutated viruses retained sensitivity to other anti-influenza medications, including a newer one, baloxavir marboxil. There are no immediate implications to change decisions for clinical care,” a CDC spokesperson said in an emailed statement. The spokesperson said that flu vaccination can still offer protection against viruses with these mutations.
High-Risk Health Workers Can Get Routine Ebola Vaccine, Says Gavi
A global stockpile of Ebola vaccines can be used to protect frontline health workers in high-risk countries routinely, rather than just as an emergency measure during outbreaks, international vaccine group Gavi said on Thursday.
A stockpile of half a million Ebola vaccine doses was established by Gavi and other global health partners in 2019 for use in outbreaks of hemorrhagic fever, which has an average fatality rate of roughly 60%. Around 11,000 people died in a 2014-16 outbreak in West Africa, the largest ever.
But while highly deadly, outbreaks of Ebola are relatively rare. Around 208,000 doses of the stockpiled Ervebo vaccine, made by Merck, are set to expire this year if unused.
Some countries have already had doses shipped to them for preventative campaigns, including the Democratic Republic of Congo and Uganda. Now Gavi says it will fund this use routinely for high-risk countries, including transport and vaccination costs after the World Health Organization last month recommended using Ervebo in this way.
Pfizer, Flagship Name First Target for Multibillion-Dollar Collaboration: Obesity
Pfizer and Flagship Pioneering have settled on the first target for their billion-dollar, multiprogram collaboration, and it’s not exactly a surprise: The New York Big Pharma giant will work with the venture creation firm’s ProFound Therapeutics to develop new obesity drugs.
No financial details of the collaboration were released. However, previously the companies committed $50 million each for the opportunity to develop 10 programs. Each successful drug from the partnership could be worth as much as $700 million in various milestones and payments.
ProFound will use its ProFoundry Platform along with Flagship’s Pioneering Medicines to find new proteins and determine if they can be used for therapeutics, specifically obesity, the new market with megablockbuster potential.
Pfizer is in a come-from-behind battle in the competitive obesity market that is well-led by Novo Nordisk and Eli Lilly. Early efforts to find a lead obesity candidate have been slow for Pfizer, although Chief Scientific Officer Mikael Dolsten, M.D., Ph.D., told Fierce Biotech in February that the company is hoping to use its expertise in small molecules to break through.
Michigan’s Largest Insurer to Drop Weight-Loss Drug Coverage
Weight-loss drugs from Novo Nordisk A/S and Eli Lilly & Co. will lose coverage under many plans run by Michigan’s largest health insurer as companies grapple with whether the drugs are worth the cost.
Blue Cross Blue Shield of Michigan will drop coverage of GLP-1 obesity drugs in fully insured large group commercial plans starting in January, a spokesperson said, a move that will affect nearly 10,000 people on the medications. The insurer’s spokesperson cited consideration of the drugs’ effectiveness, safety and cost in reaching this decision, but did not respond to a question about what the safety concerns were.
