Feds Approved $11 Million in Vaccine Injury, Death Claims: Report + More
The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments.
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The federal Vaccine Injury Support Program processes claims in which “the injury is serious and permanent or has resulted in death,” the report said. Of the 2,233 claims filed at the time, 1,825 were approved for processing. A total of 138 were approved for payment by a medical review board and payouts as of Dec. 31 totaled $11,236,314.
“A total of $75 million in funding has been earmarked for the first five years of the program,” the Health Department wrote in a 2021 memo. “The program ensures all people in Canada who have experienced a serious and permanent injury as a result of receiving a Health Canada-authorized vaccine administered in Canada on or after Dec. 8, 2020, have access to fair and timely financial support,” said the memo.
Dr. Supriya Sharma, the senior medical adviser for the Health Department, said the long-term effects of COVID vaccines were not known.
Washington State Reaches a Nearly $150 Million Settlement With Johnson & Johnson Over Opioid Crisis
The Washington state attorney general announced a $149.5 million settlement Wednesday with drugmaker Johnson & Johnson, more than four years after the state sued the company over its role in the opioid addiction crisis.
“They knew what the harm was. They did it anyway,” Attorney General Bob Ferguson told reporters Wednesday.
The attorney general’s announcement came as opioid overdose deaths more than doubled from 2019 to 2022, with 2,048 deaths recorded in 2022, according to the most recent numbers from the Washington State Department of Health.
The settlement agreement still requires approval from a judge. If approved, the deal would send over $20 million more to respond to the opioid crisis than if the state had signed onto a national settlement in 2021 involving Johnson & Johnson, the attorney general’s office said.
Since the 2000s, drugmakers, wholesalers, pharmacy chains and consultants have agreed to pay more than $50 billion to state and local governments to settle claims that they played a part in creating the opioid crisis.
Robitussin Products Recalled Nationwide Due to Microbial Contamination
Robitussin manufacturer, Haleon, is voluntarily recalling eight lots of its cough syrup due to microbial contamination, the manufacturer announced Wednesday. There have been no reports of adverse events related to this recall, Haleon said in its statement.
The recall includes six lots of Robitussin Honey CF Max Day Adult, 4 oz. and 8 oz., and two lots of Robitussin Honey CF Max Adult, in 8 oz.
One lot of daytime cough syrup in 4 oz. was recalled, T10810, which expires on Oct. 31, 2025. Five lots of daytime cough syrups in 8 oz. were recalled, including T08730, T08731, T08732 and T08733, all of which expire on May 31, 2025; lot number T10808 expires on Sept. 30, 2025.
The two lots of nighttime cough syrup recalled, T08740 and T08742, both expire on June 30, 2026.
The potential effects from ingesting the contaminated product would be especially severe for immunocompromised individuals, for whom “the use of the affected product could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection.”
‘The Response Defies Belief’: Year of Inaction Leaves Children at Risk From Bad Cancer Drugs
A year after an investigation revealed widespread use of a substandard cancer drug, the World Health Organization and national drug regulators around the world have come under fire for failing to protect children from the dangerous chemotherapy.
The WHO plays a major role in protecting people worldwide from bad medicines. One of the fastest ways it is able to warn governments about a dangerous or ineffective drug is by issuing a medical product alert. This prompts governments to take action such as recalling the drugs or investigating the manufacturers. But the WHO has issued no alert about the problematic cancer drug.
Last January, the Bureau of Investigative Journalism (TBIJ), in partnership with STAT, revealed that at least a dozen brands of asparaginase, a key childhood chemotherapy drug, had failed quality tests. In some cases, they fell well below the standard needed to treat cancer and many contained contaminants such as bacteria. It put an estimated 70,000 children — mostly in low- and middle-income countries — at risk.
One year on, neither national governments nor the WHO has taken meaningful action, with both sides claiming communication breakdowns and a lack of evidence. And doctors are frustrated that these brands are still for sale.
Exclusive: Suspected Fake Ozempic Linked to Three U.S. Cases of Hypoglycemia
Three people sought medical treatment for dangerously low blood sugar in the U.S. last year after taking suspected fake versions of Novo Nordisk‘s (NOVOb.CO) diabetes drug Ozempic, America’s Poison Centers told Reuters.
One person also experienced hypoglycemia in 2023 after injecting a compounded version of Ozempic, said the organization, which represents 55 regional poison centers across the country and works with the U.S. Food and Drug Administration to identify public health risks.
Ozempic and similar diabetes medicines have been increasingly used off-label for weight loss. Explosive demand for Ozempic and other drugs approved for weight loss, including Eli Lilly‘s (LLY.N) Zepbound and Novo’s Wegovy, has fueled a burgeoning global market for counterfeit versions.
America’s Poison Centers, formerly known as the American Association of Poison Control Centers, said all three U.S. cases of suspected fake Ozempic were reported by the same regional poison control center, and that the FDA was investigating, without providing further details.
What You Need To Know About Measles After WHO Sounds Alarm Over Killer Virus In Europe
Health officials around the world are scrambling to combat a rising tide of measles as falling vaccination rates and increased travel after the COVID-19 pandemic help the dangerous virus stage an alarming comeback, with countries in Europe declaring national emergencies as U.S. experts monitor growing cases at risk of spiraling into bigger outbreaks.
There has been an “alarming resurgence of measles” in Europe over the past year, warned Hans Kluge, the World Health Organization’s lead for the region, which covers 53 countries across Europe, Israel and parts of Central Asia.
The U.K. Health Security Agency (UKHSA) declared a major incident on Friday amid the country’s alarming surge of measles cases, with health officials now scrambling to stem the tide with an emergency vaccination campaign.
Novo Strikes Another Obesity Drug Deal
EraCal Therapeutics tests compounds in larval zebrafish in a bid to trigger behavioral changes related to appetite while minimizing other effects in the body. The Swiss startup says it’s seen early success in mice and may be able to produce a drug that helps people lose weight without the side effects sometimes seen with current treatments.
As part of the deal announced Tuesday, EraCal is eligible for payments worth as much as 235 million euros, or about $256 million, as well as royalties if a product reaches the market. The total includes an unspecified amount of money upfront, as well as future payments tied to developmental and commercial milestones.
Motion to Consolidate Lawsuits Against Ozempic, Wegovy, Other GLP-1 Receptor Agonists Manufacturers to Be Reviewed by MDL Panel
With a growing number of Ozempic lawsuits and Wegovy lawsuits being filed throughout the federal court system, a panel of judges will hear oral arguments this week on a motion to centralize all pretrial proceedings and determine whether any multidistrict litigation (MDL) should also include similar claims against the makers of other glucagon-like peptide-1 (GLP-1) receptor agonist medications, including Mounjaro and Zepbound.
Originally approved for the treatment of type 2 diabetes, Ozempic, Wegovy, Mounjaro and other GLP-1 drugs have more recently been identified as breakthrough weight loss treatments. This has led them to quickly become blockbuster medications used by individuals throughout the United States.
However, evidence has emerged over the past year that certain users experience a painful and debilitating stomach paralysis, known as gastroparesis, which lawsuits allege was not fully disclosed on the drug labels.
Each of the complaints filed throughout the federal court system involves nearly identical allegations, indicating that drug manufacturers knew or should have known about the potential GLP-1 gastroparesis side effects, but withheld information from consumers and the medical community to increase profits.
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