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Information About Gardasil Vaccine Injury Claims to Be Outlined on Plaintiff Fact Sheets

AboutLawsuits.com reported:

The U.S. District Judge presiding over all federal Gardasil lawsuits is requiring each claimant to complete a Plaintiff Fact Sheet, providing information about the injuries they experienced after receiving the HPV vaccine, which will help guide the selection of potential bellwether lawsuits that will serve as early test cases in the growing litigation.

While it has been marketed as safe and effective, a growing number of Gardasil vaccine injury claims have been filed against Merck in recent months, alleging that the drug maker failed to adequately disclose the risk of permanent and debilitating side effects, including postural orthostatic tachycardia syndrome (POTS), neurological problems, premature ovarian failure and other complications.

Each of the lawsuits involves similar allegations, claiming that Merck knew about risks associated with the HPV vaccine and withheld important safety information from families and the medical community while promoting and pushing the wider use of their vaccine among children nationwide.

On March 10, U.S. District Judge Robert J. Conrad issued an order, calling for plaintiffs to complete a four-part form in each case. Every plaintiff, present and future, will be required to complete the fact sheets, which will include basic information about their Gardasil vaccine injury claim, relevant medical and pharmacy records, records pertaining to their vaccination and other documents with relevant details.

After Appeals Loss, Johnson & Johnson Will Take Texas Two-Step Case to the U.S. Supreme Court

Fierce Pharma reported:

Johnson & Johnson will do the two-step all the way to the U.S. Supreme Court. After an unsuccessful bid to get its appeal reheard in the Third Circuit Court on Wednesday, the company said it will make one last appeal to the Supreme Court to legitimize its strategy to funnel more than 38,000 talc lawsuits into a company it created with the intent to declare it bankrupt.

J&J faces claims that its talcum products — including its iconic baby powder — cause cancer. After assigning the lawsuits to a subsidiary called LTL Management and filing for bankruptcy protection, J&J earmarked corporate funds for LTL to resolve the claims en masse.

The legal ploy, known as the Texas two-step, has been used by companies to resolve asbestos lawsuits. J&J set up LTL in Texas in 2021 and moved it to North Carolina before making its bankruptcy claim. The tactic has frozen the lawsuits for 17 months.

In 2022, J&J made a $2 billion offer to resolve the cases, but a company lawyer at the time said the drugmaker could raise its offer.

Drug-Resistant Candida Auris Fungus Is Spreading at an ‘Alarming Rate’ in the U.S., CDC Says

Insider reported:

Compared to the deadly fungal outbreak of mutated Cordyceps in “The Last of Us,” the current fungal threat in the U.S. may seem relatively benign. But according to the U.S. Centers for Disease Control and Prevention, we also have a fungus spreading through the country at an “alarming rate.”

The fungus, Candida auris, won’t turn you into a zombie or a “clicker” like in the popular TV show. In fact, for most healthy people, a brush with Candida won’t end in illness. But C. auris poses a growing threat to sick people in healthcare facilities, and according to the latest update from the CDC, it appears to be evolving new levels of drug resistance as it spreads across the U.S.

A growing portion of C. auris infections have not responded to treatment with the top-recommended antifungal, a medicine called echinocandins. According to the CDC, the number of drug-resistant C. auris cases recorded in the U.S. tripled from 2020 to 2021.

The CDC’s findings suggest that the fungus thrived during the COVID-19 pandemic, spreading throughout critical care settings as hospitals were overwhelmed by COVID cases.

Rand Paul: ‘I Wouldn’t Vaccinate My Children’

The Hill reported:

Sen. Rand Paul (R-Ky.) in a Thursday interview on The Hill’s Rising said he wouldn’t vaccinate his own children for COVID-19 out of concerns about the risk of heart inflammation.

Paul, a vocal critic of pandemic policies who frequently battled with former White House adviser Anthony Fauci during the Trump and Biden administrations, said the risk of myocarditis — heart inflammation — is greater than the manufacturers of vaccines have said. He also argued the vaccine carries an unnecessary risk for young people.

“I, frankly, wouldn’t vaccinate my children for COVID,” he said. “I think the risks of the vaccine are greater than the risks of the disease. The risks of the disease are almost non-existent.”

Paul’s remarks to Rising follow a hearing on Wednesday where he accused Moderna CEO Stéphane Bancel of lying to the public about the risk of myocarditis to young men.

Outbreak Linked to Eyedrops Leaves 68 Infected, 8 Blind and 3 Dead, CDC Says

The Hill reported:

U.S. officials are reporting two more deaths and additional cases of vision loss linked to eyedrops tainted with a drug-resistant bacteria.

The outbreak has infected 68 people in 16 states, according to the latest update from the Centers for Disease Control and Prevention. The bacteria has now caused a total of three deaths and eight cases of people losing their vision, the Centers for Disease Control and Prevention reported on Tuesday. That’s up from one death and five cases of permanent vision loss reported last month.

The CDC said four people have undergone surgery to remove an eyeball due to the infections. The CDC said it is investigating the outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa. Health officials said the stain, called VIM-GES-CRPA, had never been reported in the United States prior to the outbreak.

Drug Shortages Are Rising and Pose a National Security Risk, New Report Warns

NBC News reported:

Children’s medication, antibiotics and treatment for ADHD are among a number of drugs that have been in short supply in recent months — and these shortages of critical medications are only rising, according to a new report released on Wednesday.

“These shortages, which reached a peak of 295 individual drugs in shortage at the end of 2022, have left healthcare professionals grappling with limited resources to treat patients in need,” committee Chairman Gary Peters, D-Mich., is expected to say in his opening remarks at a hearing highlighting the report’s findings on Wednesday.

Shortages have been caused by economic drivers, reliance on foreign sources and poor visibility of the pharmaceutical supply chain, the report said. In his opening remarks, Peters is expected to say that the U.S.’s overreliance on foreign suppliers, especially those in China, “remains an unacceptable national security risk.”

These drug shortages have led to delays in treatment for patients, providers resorting to substitute sometimes less effective treatments, and medication errors. Some patients, including those with cancer, have faced a lack of alternative drugs.

​​U.S. Declines to Force Lower Price on Cancer Drug Xtandi

Reuters reported:

The U.S. government will not force Pfizer Inc. (PFE.N) and Astellas Pharma Inc. (4503.T) to lower the price of their prostate cancer drug Xtandi using its emergency “march-in” authority, the National Institutes of Health (NIH) said on Tuesday.

March-in rights, which have never been used before, allow the government to grant additional licenses to third parties for products developed using federal funds if the original patent holder does not make them available to the public on reasonable terms.

Xtandi’s wholesale cost is between $160,000-$180,000 per patient a year.

Pfizer and Astellas were not immediately available for comment. The companies are expected to have combined revenue from Xtandi of more than $2 billion this calendar year, according to data from Refinitiv.

In a Surprise Approval, FDA Greenlights Incyte’s PD-1 Inhibitor to Treat Rare Cancer Type

Fierce Pharma reported:

Sometimes, the second time is the charm. After a 2021 complete response letter from the FDA for approval in a different indication, the agency has now greenlighted Incyte’s intravenous drug, Zynyz. The drug got the go-ahead through the FDA’s accelerated approval pathway for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

Zynyz is a checkpoint inhibitor immunotherapy that targets PD-1. Its approval marks the eighth checkpoint inhibitor to hit the market and the third indicated for metastatic MCC, joining Merck & Co.’s PD-1 inhibitor Keytruda and Pfizer and Merck KGaA’s PD-L1 directed Bavencio.

In the trial, serious adverse reactions occurred in 22% of patients, with 11% permanently discontinuing treatment due to adverse reactions.