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New data is out on COVID vaccine injury claims. What’s to make of it?

(Reuters) – The U.S. Centers for Disease Control and Prevention, facing a Freedom of Information Act lawsuit seeking a vast trove of data about the safety and side-effects of the COVID-19 vaccines, made a pledge in August.

The agency in court papers said that on or before Sept. 30, it would post on its website a “public use” set of data from about 10 million people who signed up for its “v-safe” program — a smartphone-based system that periodically sends people text messages and web surveys to monitor potential side effects from the Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines.

But the CDC missed its deadline. A spokesperson cited a delay in “the technical and administrative processes” necessary to post on the agency’s website, but said it hopes to have the information up by late November or early December.

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In the meantime, the CDC handed over the v-safe data (minus personal identifying information) to the plaintiff in the FOIA case, the Informed Consent Action Network, or ICAN, a Texas-based nonprofit that says it opposes “medical coercion” in favor of individual healthcare choices.

ICAN crunched the numbers on its own and came up with some statistics that its lawyer says appear to be “alarming.”

According to ICAN, 7.7% of the v-safe users — 782,913 people — reported seeking medical attention via a telehealth appointment, urgent care clinic, emergency room intervention or hospitalization following a COVID-19 vaccine.

About 25% of v-safe users said they experienced symptoms that required them to miss school or work or prevented them from doing other normal activities, according to ICAN’s “dashboard” that summarizes the results.

There’s no way, however, based on the information collected, to determine whether the COVID-19 vaccines actually caused the ailments. ICAN’s analysis included responses reported beyond the first seven days post-vaccine and it counted all reports of people seeking medical attention up to a year after receiving the shot. ICAN did not specify when after vaccination they received the care, nor did the data indicate what the care was for.

I asked a CDC spokesperson what the agency made of ICAN’s calculations. Are the numbers accurate?

The CDC “cannot comment on analyses conducted outside of the agency that we have not seen,” the spokesperson said via email, but added that v-safe data “have shown low rates of medical care after vaccination, particularly hospitalization.”

In the first week after getting the shot, the spokesperson continued, “reports of seeking any medical care (including telehealth appointments) range from 1-3% (depending on vaccine, age group and dose).”

She pointed me to a report looking at the first six months of v-safe data to back up the assertion. In addition, another CDC spokesperson said that agency personnel made follow-up calls to any v-safe users who reported seeking medical attention.

But ICAN counsel Aaron Siri of Siri & Glimstad, who led the FOIA litigation against the agency, said that because some vaccine-related adverse effects (chronic arthritis, thrombocytopenia, Guillain-Barré syndrome, myocarditis and more) can appear weeks after vaccination, it’s important to broaden the time frame beyond the one-week window in research the CDC cited.

“This is a large and concerning number of negative health impacts,” Siri said of ICAN’s conclusions, adding that he’s aware of no comparable public data for other vaccines.

A Pfizer media representative in an email said that the company’s vaccine has “a favorable safety profile and high level of protection against severe COVID-19 disease and hospitalization.”

Representatives from Moderna and Johnson & Johnson did not respond to requests for comment.

Until ICAN’s suit, the v-safe data was not public, though specific findings have been reported by the CDC and medical journals.

The data has its limits. The CDC asked v-safe users to self-report a range of post-vaccine symptoms such as headache, joint pain and fatigue, and (irrespective of whether they sought medical attention) to categorize the ailments as mild, moderate or severe. The agency queried v-safe users about their health every day for the first week following vaccine, and then at various points afterwards for the next 12 months, gathering a total of 146 million records.

In addition to the dashboard summary, ICAN on its website has made the underlying dataset available for public download. Reuters did not independently verify ICAN’s analysis of the information.

Siri, a 2004 University of California Berkeley School of Law grad who got his start at Latham & Watkins, is no stranger to FOIA fights. Last year, he sued the Food and Drug Administration to make public the data it relied on to license Pfizer-BioNTech’s COVID-19 vaccine. The agency unsuccessfully argued that it needed up to 76 years to review and release all the information.

Siri filed suit against the CDC on behalf of ICAN last year in Austin, Texas, federal court to get the v-safe data.

For concerned members of the public wondering about vaccine safety, it’s hard to know what to think.

The CDC — which should be the gold standard for accurate information — still hasn’t made the v-safe information publicly available itself, although it seems to have fulfilled a FOIA obligation by giving it to ICAN.

It’s notable that ICAN has a history of vaccine skepticism. Its founder, Del Bigtree, is known for producing the 2016 documentary “Vaxxed: From Cover-Up to Catastrophe,” which may be why the group’s findings have received scant media coverage.

Look. I believe vaccines save lives, and I eagerly received COVID-19 shots. I have no interest in being an anti-vax mouthpiece.

But I also believe in maximum government transparency.

Siri said that the v-safe information offers a unique window: millions of people, all “answering identical questions, making the data susceptible to calculating a rate for each harm reported.” He has point.

It indicates that, at a minimum, hundreds of thousands of people experienced health events that they considered “severe” following the shot and sought medical care.

Moreover, for those still struggling to recover and believe the vaccine is to blame, legal recourse is limited.

The COVID-19 vaccine makers are indemnified by the government, and all injury claims are adjudicated by an obscure tribunal, the Countermeasures Injury Compensation Program. Payouts are limited to unreimbursed medical expenses and up to $50,000 a year in lost wages.

As of Sept. 1, the forum had received 7,084 claims alleging injuries or death from the COVID-19 vaccines. Three claims have been deemed eligible for compensation and 42 have been rejected.

A spokesperson told me the compensation program is “actively bringing on additional administrative staff and claims reviewers to process these claims as quickly as possible.”

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Opinions expressed are those of the author. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias.

Jenna Greene

Thomson Reuters

Jenna Greene writes about legal business and culture, taking a broad look at trends in the profession, faces behind the cases, and quirky courtroom dramas. A longtime chronicler of the legal industry and high-profile litigation, she lives in Northern California. Reach Greene at jenna.greene@thomsonreuters.com

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Jurors weigh punitive damages in Alex Jones Sandy Hook defamation trial

Aug 5 (Reuters) – Jurors in Texas on Friday were deliberating on how much Alex Jones should pay in punitive damages to the parents of a child killed in the 2012 Sandy Hook mass shooting for falsely claiming that the massacre was staged.

The parents of slain 6-year-old Jesse Lewis are seeking $145.9 million in punitive damages for the broadcaster’s falsehoods about the killing of 20 children and six staff at Sandy Hook Elementary School in Newtown, Connecticut, on Dec. 14, 2012.

“We ask that you send a very, very simple message, and that is: stop Alex Jones. Stop the monetization of misinformation and lies,” Wesley Todd Ball, a lawyer for the parents, told jurors before they began deliberations.

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An attorney for Jones, Federico Andino Reynal, asked jurors to return a verdict of $270,000 based on the number of hours Infowars devoted to Sandy Hook coverage.

The 12-person jury on Thursday said Jones must pay the parents $4.1 million in compensatory damages for spreading conspiracy theories about the massacre. That verdict followed a two-week trial in Austin, Texas, where Jones’ radio show and webcast Infowars are based.

Earlier on Friday, forensic economist Bernard Pettingill testified on behalf of Lewis’ parents that Jones “promulgated some hate speech and some misinformation” and “made a lot of money.”

Jones and Infowars are worth between $135 million and $270 million combined, Pettingill said.

Neil Heslin and Scarlett Lewis testified that Jones’ followers harassed them for years in the false belief that the parents lied about their son’s death.

Jones sought to distance himself from the conspiracy theories during his testimony, apologizing to the parents and acknowledging that Sandy Hook was “100% real.”

Jones’ company, Free Speech Systems LLC, declared bankruptcy last week. Jones said during a Monday broadcast that the filing will help the company stay on the air while it appeals.

The bankruptcy declaration paused a similar defamation suit by Sandy Hook parents in Connecticut where, as in Texas, he has already been found liable.

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Reporting by Jack Queen; Editing by Howard Goller and Mark Porter

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Johnny Depp’s attorneys challenge Amber Heard on abuse claims

May 16 (Reuters) – Attorneys for actor Johnny Depp began their questioning of Amber Heard in the couple’s defamation trial on Monday and challenged the “Aquaman” star’s claims that she suffered physical abuse before and during their brief marriage.

Depp’s attorneys introduced photographs of Heard making public appearances on red carpets and “The James Corden Show” shortly after times that she said Depp had struck her with his hands, on which he usually wore heavy rings.

The pictures shown to jurors appeared to reveal no injuries. Heard said the harm, which included what she thought was a broken nose, was not severe enough to be visible or was covered up by makeup.

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Depp, 58, is suing Heard, 36, for $50 million, saying she defamed him when she claimed she was a victim of domestic abuse. Heard has countersued for $100 million, arguing that Depp smeared her by calling her a liar.

At the start of cross-examination of Heard, an attorney for Depp asked Heard if she had abused Depp and was further harming him with false allegations.

“I could never hurt Johnny,” Heard said.

Earlier, Heard told jurors that she filed for divorce from Depp in 2016 because she worried she would not survive physical abuse by him. She said she realized the relationship was beyond repair after he threw a cell phone that hit her in the face.

“I knew I had to leave him,” she said. “I knew I wouldn’t survive it if I didn’t.

“I made the decision to file for divorce,” she added. “It was hard because I loved Johnny so much.”

The pair wed in February 2015 and their divorce was finalized about two years later.

Depp has testified that he never hit Heard and argued that she was the abuser in their relationship. He said she threw a vodka bottle at him in early 2015, severing the top of his right middle finger.

Heard said she did not cause the finger injury and said she only hit him to defend herself or her sister.

She also denied Depp’s allegation that she had left feces in a bed at one of his homes following a fight on her birthday. A security guard had testified that Heard told him the feces were a “horrible practical joke.”

Heard said she did not commit any prank that day, adding that she was “not in a pranking mood.”

“I had just been attacked on my 30th birthday by my husband, with whom I was desperately in love and knew I needed to leave,” she said.

The legal case centers on a December 2018 opinion piece by Heard that appeared in the Washington Post. The article never mentioned Depp by name, but his lawyer told jurors it was clear Heard was referencing him. read more

Depp, once among Hollywood’s biggest stars, said Heard’s allegations cost him “everything.” A new “Pirates of the Caribbean” movie was put on hold, and Depp was replaced in the “Fantastic Beasts” film franchise, a “Harry Potter” spinoff.

Heard’s attorneys have argued that she told the truth and that her opinion was protected free speech under the U.S. Constitution’s First Amendment.

Closing arguments are scheduled for May 27.

Less than two years ago, Depp lost a libel case against the Sun, a British tabloid that labeled him a “wife beater.” A London High Court judge ruled that he had repeatedly assaulted Heard.

Depp’s lawyers filed the case in Fairfax County, Virginia, because the Washington Post is printed there. The newspaper is not a defendant.

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Reporting by Lisa Richwine in Los Angeles
Editing by Mark Porter, Jonathan Oatis and Matthew Lewis

Our Standards: The Thomson Reuters Trust Principles.

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