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FDA Finds Violations and Unsanitary Conditions at Emergent J&J Plant as Lawmakers Open Investigations

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  • The Food and Drug Administration said Wednesday that it found numerous safety violations at Emergent Biosolutions, the Baltimore manufacturing plant responsible for ruining more than 15 million Johnson & Johnson Vaccines.
  • The FDA said it watched security footage of employees ignoring cross-contamination protocols and improperly handling medical waste. It also found brown and black residue on the floors and walls of the plant, respectively. 
  • Separately, top House Democrats launched an investigation into how Emergent won contracts to manufacture two COVID-19 vaccines and whether or not those contracts were the result of an improper relationship between the plant and a former Trump administration official.
  • Democrats are also investigating Emergent’s role as the country’s only provider of the anthrax vaccine in the Strategic National Stockpile.

The FDA’s Unforgiving Report

The U.S. Food and Drug Administration released a damning inspection report Wednesday on Emergent Biosolutions, the Baltimore manufacturing plant that ruined 15 million Johnson & Johnson COVID-19 vaccines.

Among a multitude of violations, inspectors workers hadn’t been properly trained. They also found that medical waste had been improperly handled, saying “such waste was transported through the warehouse before disposal and has the potential to contaminate the warehouse and adjacent areas.”

For example, it found that employees had used their gloved hands to put waste into bags, that they drug the waste through hallways, and that they even allowed it to touch walls.

Made worse was the fact that the FDA found peeling paint on the walls of several sensitive work areas, with inspectors noting that they found paint flecks all along the floors around the walls. As the agency reported, that peeling — as well as additional wall damage — “impacts the firms’ ability to adequately clean and disinfect the area.”

Moreover, inspectors said they found an unknown brown residue attached to the walls, as well as a black residue on the floor.

Through reviewing security footage, inspectors said workers repeatedly failed to follow procedures that were meant to prevent vaccine cross-contamination.

Notably, that backs up information that had been previously reported, particularly that those 15 million Johnson & Johnson vaccines were ruined because of cross-contamination with AstraZeneca’s vaccine. That said, it’s important to note that none of those vaccines were ever distributed to the public because the FDA never gave the plant approval to do so.

It’s possible that the report also describes the event that specifically led to the vaccine cross-contamination, as it mentions that through security footage, it watched an employee travel from one area of the plant where one vaccine was being made, to another area of the plant where the other vaccine was being made — all without that employee changing their protective gear. 

With that finding, the FDA said Emergent didn’t properly investigate its workers’ movements as a potential cause of contamination. More broadly, it also noted that even after the plant was made aware of the contamination, it only performed routine cleaning and didn’t take further decontamination steps.

Congress Investigates Emergent’s Role in Winning Vaccine Contracts

Alongside the FDA’s recent report, top House Democrats have now launched an investigation into how Emergent won several multi-million dollar contracts.

Those lawmakers are specifically looking into what role Dr. Robert Kadlec played in helping the company obtain the contract and if it was influenced by Kadlec’s previous role as a consultant for Emergent. 

Kadlec was the assistant secretary for preparedness and response under former President Donald Trump, and as this group of Democrats alleges, Kadlec “appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.”

Those Democrats went on to say that after Kadlec’s confirmation, Emergent obtained millions in contracts from his agency — including some that “were awarded without competitive bidding.” In fact, the Trump administration ultimately awarded $628 million to the plant, even though it had fallen short on federal investigations.

Emergent also reportedly tried to encourage oversight of the stockpile to be shifted from the CDC to an office under Kadlec’s control. 

“We are concerned by the costs to taxpayers and the potential impact on our nation’s vaccination efforts caused by Emergent’s failed attempts to manufacture these vaccines,” the Democrats said. 

Congress Investigates Emergent’s Role as Sole Anthrax Provider

It doesn’t end there. Those lawmakers are also looking into Emergent’s role as the country’s sole provider of the anthrax vaccine in the Strategic National Stockpile.

“Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998,” they said. “As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine.” 

When Emergent acquired that anthrax vaccine license in 1998, the vaccine was selling for about $3.35 a dose. Today, it’s over $30.

See what others are saying: (The Washington Post) (Wall Street Journal) (CNBC)

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Derek Chauvin and 3 Others Ex-Officers Indicted on Civil Rights Charges Over George Floyd’s Death

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  • The Justice Department filed federal criminal charges Friday against Derek Chauvin and three other former Minneapolis police officers after a grand jury indicted them for violating the civil rights of George Floyd.
  • The indictment charges Chauvin, J. Alexander Kueng, and Tou Thao for violating Floyd’s right to be free from unreasonable seizure and unreasonable force. All three, as well as Thomas Lane, were also charged with failing to provide medical care to Floyd. 
  • Chauvin was additionally hit with two counts in a separate indictment, which claims he violated the civil rights of a 14-year-old boy who he allegedly held by the neck and repeatedly beat with a flashlight during a 2017 arrest.
  • Chauvin was already convicted last month of murder and manslaughter over Floyd’s death, which Kueng, Lane, and Thao were previously charged for allegedly aiding and abetting.

Former Minneapolis Officers Hit With Federal Charges

A federal grand jury indicted Derek Chauvin and three other former Minneapolis police officers for violating George Floyd’s civil rights during the arrest that lead to his death last summer, the Justice Department announced Friday.

Chauvin, specifically, was charged with violating Floyd’s right to be free from unreasonable seizure and unreasonable force by a police officer. Ex-officers J. Alexander Kueng and Tou Thao were indicted for willfully failing to intervene in Chauvin’s unreasonable use of force.

All three men, as well as former officer Thomas Lane, face charges for failing to provide medical care to Floyd, “thereby acting with deliberate indifference to a substantial risk of harm to Floyd,” according to the indictment.

In a second, separate indictment, Chauvin was hit with two counts of civil rights violations related to the arrest of a 14-year-old boy in September 2017. During that incident, Chauvin allegedly held the boy by the neck and hit him with a flashlight repeatedly.

The announcement, which follows a months-long investigation by the Justice Department’s Civil Rights Division, comes just over two weeks after Chauvin was found guilty of three state charges of murder and manslaughter in Floyd’s death.

He is currently awaiting his June 25 sentencing in a maximum-security prison.

State-Level Charges

Kueng, Lane, and Thao all face state charges of aiding and abetting second-degree murder and manslaughter.

Kueng and Lane were the first officers to responded to a call from a convenience store employee who claimed that Floyd used a counterfeit $20 bill. Body camera footage showed Floyd sitting in the car and Lane drawing his gun as the officers ordered him out and handcuffed him. 

Floyd can be heard pleading with the officers not to shoot him.

Shortly after, Chauvin and Thao arrived, and the footage shows Chauvin joining the other officers in their attempt to put Floyd into the back of a police car. In the struggle, the officers forced Floyd to the ground, with Chauvin kneeling on his neck while Kueng and Lane held his back and legs. 

Meanwhile, in cellphone footage taken at the scene, Thao can be seen ordering bystanders to stay away, and later preventing a Minneapolis firefighter from giving Floyd medical aid.

Their trial is set to begin in late August, and all three are free on bond. The new federal charges, however, will likely be more difficult to prove.

According to legal experts, prosecutors will have to show beyond reasonable doubt that the officers knew that they were depriving Floyd of his constitutional rights but continued to do so anyway.

The high legal standard is also hard to establish, as officers can easily claim they acted out of fear or even poor judgment.

See what others are saying: (The Washington Post) (The New York Times) (The Associated Press)

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Caitlyn Jenner Says Her Friends Are Fleeing California Because of the Homeless Population

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  • California gubernatorial candidate Caitlyn Jenner sparked outrage after an interview with Sean Hannity on Wednesday that was filmed from her Malibu airplane hangar. 
  • “My friends are leaving California,” she said. “My hangar, the guy right across, he was packing up his hangar and I said, ‘Where are you going?’ And he says, ‘I’m moving to Sedona, Arizona. I can’t take it anymore. I can’t walk down the streets and see the homeless.’”
  • Many criticized Jenner for sounding out of touch and unsympathetic to real issues in California and suggested that she prioritize helping the homeless population rather than incredibly wealthy state residents.

Caitlyn Jenner’s Remarks

California gubernatorial candidate Caitlyn Jenner sparked outrage on Wednesday after suggesting that wealthy people are fleeing the state because of its homeless population.

Jenner sat down for an interview in her Malibu airplane hangar with Fox News’ Sean Hannity. Jenner is one of the handful of Republicans aiming to unseat current Governor Gavin Newsom in a recall election in the fall. While polls show that most Californians do not support recalling Newsom, the conservative-led movement to do so gained enough signatures to land on the ballot.

“My friends are leaving California,” Jenner claimed during the interview. “My hangar, the guy right across, he was packing up his hangar and I said, ‘where are you going?’ And he says, ‘I’m moving to Sedona, Arizona, I can’t take it anymore. I can’t walk down the streets and see the homeless.’” 

“I don’t want to leave,” she continued. “Either I stay and fight, or I get out of here.”

Jenner’s Remarks Prompt Backlash

Her remarks were criticized online by people who thought Jenner sounded unsympathetic and out of touch to the real issues in the state. Many found it hypocritical that Jenner has slammed Newsom for being elite but was so concerned for wealthy people who don’t like having to see unhoused residents on the street.

Rep. Ted Lieu (D-Ca.) called Jenner out on Twitter for seemingly fighting for a small percentage of Californians. 

Unlike you, Dems are focused on the 99% of people who don’t own planes or hangars,” he wrote. “And you know what’s going to help reduce homelessness? The #AmericanRescuePlan, which your party opposed.”

Others suggested she prioritize directly addressing the homeless situation.

“If you don’t like the homeless situation, instead of hiding in your PRIVATE PLANE HANGAR, your campaign should be about helping them,” actress Merrin Dungey said. “They don’t like their situation either. Your lifelong privilege is showing. It’s not a good color.”

Jenner, an Olympic gold medalist and reality star, is one of the most prominent transgender Americans. Because homelessness is such a common issue within the trans community, some were frustrated she was not using her campaign to fix the situation, and rather used it to complain about how it impacted her wealthy friends. 

See what others are saying: (The Hill) (Politico) (Washington Post)

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Derek Chauvin Seeks New Trial In George Floyd Murder Case

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  • A lawyer for Derek Chauvin, the former Minneapolis police officer who was convicted of murdering George Floyd, filed a motion Tuesday for a new trial.
  • Among other complaints about Chauvin’s conviction, the attorney cited “prosecutorial and jury misconduct; errors of law at trial; and a verdict that is contrary to law.”
  • He also claimed the court “abused its discretion” by not granting a change of venue or sequestering the jury for the duration of the trial, arguing that publicity before and during it threatened its fairness. 
  • John Stiles, deputy chief of staff for Minnesota Attorney General Keith Ellison, told CNN, “The court has already rejected many of these arguments and the State will vigorously oppose them.”

Derek Chauvin’s Attorney Files Motion for New Trial

Former Minneapolis police officer Derek Chauvin is officially asking for a new trial, hoping to overturn his conviction for the murder of George Floyd.

His attorney, Eric Nelson, filed court paperwork Tuesday laying out a number of errors he believes were made during Chauvin’s legal proceedings that violated his constitutional rights to due process and a fair trial. Nelson cited alleged issues, including, “prosecutorial and jury misconduct; errors of law at trial; and a verdict that is contrary to law.”

The filing did not cite any specific examples of jury misconduct, but Nelson also argued that the court “abused its discretion” by not granting a change of venue or sequestering the jury for the duration of the trial.

The court proceedings took place in the same city where Floyd was killed and where protesters drew national attention by calling for justice in his name. As a result, Nelson claimed that publicity before and during the trial threatened its fairness. He also argued that a defense expert witness was intimidated after he testified, but before the jury deliberated.

His filing asks for a hearing to impeach the guilty verdict, in part, on the grounds that the 12 jurors “felt threatened or intimidated, felt race-based pressure during the proceedings, and/or failed to adhere to instructions during deliberations.”

It’s unclear exactly what will come of this request, but John Stiles, deputy chief of staff for Minnesota Attorney General Keith Ellison, told CNN, “The court has already rejected many of these arguments and the State will vigorously oppose them.”

For instance, a judge previously denied Chauvin’s request to move the trial in March, saying, “I don’t think there’s any place in the state of Minnesota that has not been subjected to extreme amounts of publicity on this case.”

See what others are saying: (CNN) (NPR) (CBS)

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