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by Mica Rosenberg

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In handwritten cursive, a Russian immigrant named Marina wrote out the story of the day U.S. Customs and Border Protection agents took away her 1-year-old baby while she was being held in a detention facility in southern California. “I cried and begged, kneeling, not to do this, that this was a mistake, not justice and not right,” she wrote. “She was so little that no one knew anything about her. I was very afraid for her and still am!”

This didn’t happen during the Trump administration, which separated more than 4,000 migrant children from their families under its controversial “zero tolerance” policy. Marina was separated from her baby in April of this year. The 40-year-old former restaurant manager came to the U.S.-Mexico border with her husband, mother-in-law and child to seek asylum. More than eight months later, she and her mother-in-law remain in federal immigration custody in Louisiana. Her husband is detained at a different Louisiana immigration facility. And Aleksandra is over a thousand miles away, being cared for by strangers in foster care in California.

Aleksandra is one of around 300 children the Biden administration has separated from their parents or legal guardians this year, according to two government sources who asked not to be identified because they hadn’t been authorized to speak about the separations. Most of the cases involved families crossing the southwestern border, the sources said. These numbers haven’t previously been reported.

Similarly, 298 children were separated from their parents in 2023, according to a government report to Congress published on Tuesday, even as overall migrant crossings have declined. According to the report, the average amount of time children separated between April 2018 and October 2024 have spent in federal custody before being released to a sponsor is 75 days.

The Department of Homeland Security, Customs and Border Protection, and Immigration and Customs Enforcement did not respond to multiple requests for comment on the numbers or on Marina’s case.

Those officials who did speak about the separations did so on the condition they not be identified. They said the current separations are not similar — in either character or scale — to what was happening during the Trump administration. Its zero tolerance policy directed authorities to detain and criminally prosecute all immigrants caught illegally crossing the border and to separate them from their children if they were travelling together. Biden administration officials say they have only separated families for reasons according to longstanding immigration practices, including when they have concerns about the parents or the safety of the children. Some of those concerns are related to suspicions about abuse, criminal histories or threats to national security.

The administration reports the numbers of separations to Congress and to lawyers at the American Civil Liberties Union who have been charged with providing oversight. However, those reports give few details about the reasons for the separations, especially in cases where parents have been flagged for national security reasons. Around 80 of the children separated between December 2023 and November 2024 were in that category, one of the government sources said, and some 50 of those were Russian, like Aleksandra. The second source said at least 10 of the Russian children who were separated this year are still in government custody.

In cases involving national security, the government can withhold its rationale even from the families themselves, making it hard for them and their lawyers to contest the separations or mount a defense. And some advocates have been reluctant to talk publicly about the current separations, much less call out President Joe Biden’s administration, as they press for the government to resolve their clients’ cases and fear the incoming Trump administration could apply the same standards more broadly to separate more families in the future.

Family separations at the border did not begin with the zero tolerance policy and didn’t end when it was lifted, said Talia Inlender, deputy director of the Center for Immigration Law and Policy at the University of California, Los Angeles School of Law, which wrote a report on family separations going back to the Obama years and before. She said that while Trump’s policy was unprecedented because of how expansive it was, the scant information that the government provides about separations at the border has been common practice across administrations.

“I think the lack of transparency creates a lack of accountability,” she said, “and that is by design.”

“Where there is room left for agency discretion,” Inlender said, “that’s really where we need to make sure that there are eyes on what is happening, so that these exceptions, or these grey areas, don’t become the rule.”

During telephone interviews with Marina and her husband, conducted through a translator, the couple said they hoped by breaking the silence on their case, they might get answers about why they were separated from their daughter and get her back. They asked to be identified only by their first names because of their pending deportation cases.

Marina said that she and her husband Maksim, who worked as a supplies manager at a construction company, had met at a restaurant where Marina worked in Moscow. They married in 2021 and tried for years to have a child before Alexsandra was born.

Maksim said he started going to antigovernment protests in support of opposition leader Alexei Navalny and later against Russia’s invasion of Ukraine. According to an affidavit Marina gave as part of her asylum case, she said Maksim had been detained, questioned and on one occasion beaten up by police after protests. ProPublica could not independently corroborate the accounts of his political activity. They both said Marina wasn’t involved in the protests and had asked him to stop attending them. Eventually the family decided to leave the country, fearing government reprisals.

After researching the best routes into the U.S. online, they said they bought tickets to Dubai, Mexico City and Tijuana, which sits on the border with California. Once in Tijuana, Marina said they waited for six months for an appointment after using a U.S. government app known as CBP One to apply for permission to approach the border and ask for asylum. They were finally granted a slot and allowed to cross in mid-April.

But instead of being released to pursue their asylum claim, Marina said she and Aleksandra were held in a cold cell at a Border Patrol detention facility. She said she was given only formula and vegetable purees for Aleksandra. She smashed up bread from her own sandwiches to give her daughter extra food. At the time Aleksandra was learning to walk and was always moving around; she had just started to talk.

Then, after several days, Marina said she and her baby were surrounded by border officials who told her the adults would be detained and Aleksandra would be taken away. She said one of the agents handed her a note that read: “CBP has made this decision for the following reason: You are being taken into custody for presenting a public safety or national security risk.”

Recalling the desperation she felt upon seeing the note, Marina wrote: “Why would that be? I didn’t even have an interview!!!”

She said she became catatonic after a Border Patrol agent took her daughter by the hand and led her away.

“I thought I died at that moment.”

Excerpts from a handwritten account by Marina, a Russian immigrant, about her separation from her 1-year-old at the U.S. border. She wrote and translated it in detention and shared it with ProPublica.

Her experience might sound familiar to anyone who followed the news about the thousands of separations carried out by the Trump administration. Its zero tolerance policy first began as a pilot program in 2017, but the administration denied its existence until spring 2018. Even then, authorities refused to make public the details of how the policy was being implemented, including where the children were being held, how many of them were in custody, or even how the separations were conducted.

In June of 2018, ProPublica obtained audio that had been recorded in a Border Patrol facility of wailing children who had been separated from their parents. Among them was a 6-year-old girl, pleading to make a phone call to her aunt. That audio triggered a bipartisan outcry that led the administration to announce the end of the policy 48 hours later. And a federal lawsuit brought by the ACLU forced the administration to reunify the children in its custody with their families.

That reunification effort continued even after Trump left office. Biden, who called zero tolerance a “a moral and national shame,” formed a task force to finish the reunifications shortly after taking office. It found that some parents had been deported without their children and remained separated years later. Biden promised going forward that his administration would not separate children from their parents “except in the most extreme circumstances where a separation is clearly necessary for the safety and well-being of the child or is required by law.”

Biden’s Justice Department negotiated a settlement with the ACLU allowing it to disperse assistance to the families that had been harmed by zero tolerance. Under the terms of the deal, signed last December, future family separations were only allowed in “limited” circumstances, including when parents are deemed a threat to the child, have an outstanding arrest warrant or need to be hospitalized.

The settlement also said separations were allowed when government officials found parents or legal guardians could pose “a public safety or national security risk to the United States,” including people suspected of terrorism or espionage. But in those cases the agreement says that the government is not required to provide documentation of the reason for its decision if it would mean disclosing sensitive information.

Such cases could include instances when migrants’ names come up on an international watch list, said a third government official, who, like the others, spoke on the condition of anonymity. In June of this year, the U.S. Treasury Department sanctioned two Uzbeks and one Russian national for alleged links to an ISIS-linked human smuggling network that the State Department said facilitated travelers coming to the United States.

“If they are looking into cases more deeply and then people are let go after they found out the information they had was not correct,” the official said, “it’s still pretty difficult to say we shouldn’t go ahead and make those checks if we need to pay extra security attention in these cases.” Sometimes, the official said, authorities are able to quickly resolve any security concerns and reunite the families.

Advocates do not disagree that sometimes separations are warranted, said Lee Gelernt, an ACLU attorney and the lead lawyer in the family separation lawsuit. And they said they understand the sensitivity of sharing information that could put the country at risk.

However, when asked whether the Russian cases highlight the potential pitfalls of the agreement the ACLU made with the administration, Gelernt said that the government “cannot create a loophole and place everything in the black box of national security.”

He added that if the exceptions become “an excuse to circumvent the bar on separations, we will return to court.”

With Biden leaving office soon, it’s the incoming Trump administration that most worries the advocates. Trump made stopping border crossings and mass deportations a centerpiece of his campaign and says they are part of his Day 1 plans for when he takes office, but when asked several times in an interview over the weekend if he would revive the zero tolerance policy, he said: “We’ll send the whole family, very humanely, back to the country where they came. That way the family’s not separated.”

Inlender wasn’t convinced that Trump wouldn’t ramp up family separations. “With any loopholes that exist in policies, any loopholes that exist in the settlement agreements, I think there is always a danger when you have an incoming administration that has already both shown itself willing, and in some cases able, to inflict cruelty to separate families, that they will use any tools at their disposal,” Inlender said.

The children who were separated from their parents for national security reasons in the past year came from a range of countries, including Romania, Turkey, Ukraine, Lebanon, Iran, Kyrgyzstan, Armenia, Colombia and Venezuela, the two government sources said. The majority, however, came from Russia. In fact, only one Russian child separated from their parents this year was listed as being separated for a reason other than national security, they said.

None of the officials interviewed could say whether Russian families had been flagged for special scrutiny. The 50 Russian children separated last year represent a very small share of the overall Russian border crossings. According to CBP data for the 2024 fiscal year, which began last October and ended in September, 7,137 Russian families crossed the southwestern border, almost all of them through legal ports of entry like Marina’s family.

The secrecy surrounding Marina’s case has meant the government has not told her or her lawyer any more specific reason for her detention and prolonged separation from Aleksandra. Marina’s New York-based attorney, Elena Denevich, said in an email that while she has filed a series of parole requests for Marina since May, “the requests were denied based on unspecified ‘national security concerns.’” Denevich said DHS “has provided no evidence or explanation to substantiate this allegation.”

The Office of Refugee Resettlement, which is part of the Department of Health and Human Services and oversees migrant children, said it could not comment on individual cases and referred questions about enforcement to DHS. ORR, which earlier this month had only published data on family separations through January 2024 on its website, updated its site with nine new reports from February through October this week.

In addition to interviews, Marina shared her four-page handwritten account of the separation after translating it herself into English using a tablet provided to her in detention. ProPublica reviewed court documents and spoke to Maksim’s stepfather, who crossed the border months earlier but was released to pursue an asylum claim.

Marina’s family has joined a class-action lawsuit brought by more than 150 detained Russian-speaking asylum seekers against the government claiming they are systematically being denied parole by ICE because of their nationalities. Maksim’s stepfather says he has been working nonstop as a long-haul truck driver to pay for legal fees as he fights for the release of his family. ICE said it could not comment on pending litigation.

After their separation, Marina, stuck in detention, said she had to wait three months before she was finally allowed to speak with her daughter on the phone in July. Beginning in August, they were allowed weekly video calls. Because the family Aleksandra is staying with doesn’t speak Russian, Marina has asked them to put on Russian YouTube videos from time to time so her daughter can listen to people speaking her native language. She says Aleksandra looks healthy and like she is being well taken care of, surrounded by toys and wearing new clothes. She is grateful for the foster family, who points to the screen and says “mama” when they talk to remind her who her mother is, but she breaks down crying when talking about how the separation has affected her.

“I’m just trying to take care of myself because my little daughter needs a healthy mom. But because she is so little, I feel really bad. I am starting to fall apart, both mentally and physically,” Marina said from detention. She said she is having trouble sleeping and experiencing a series of worsening health problems.

Not knowing the reason behind their family’s separation is agonizing.

“I don’t have the slightest clue why they did this to us.”

Andrey Babitskiy contributed reporting.

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by Patricia Callahan, Debbie Cenziper and Megan Rose

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up for Dispatches, a newsletter that spotlights wrongdoing around the country, to receive our stories in your inbox every week.

The drug potassium chloride has been on the market for decades, widely prescribed to help the nerves and muscles — including the heart — function properly in patients with low potassium. Too much of it, however, can kill you.

At high doses, it is so effective at stopping the heart that some states have used injections of it for executions.

So the danger was obvious in May, when Indian drugmaker Glenmark Pharmaceuticals recalled nearly 47 million capsules for a dire flaw: The extended-release medication wasn’t dissolving properly, a defect that could lead to a perilous spike in potassium. The U.S. Food and Drug Administration deemed it the most serious kind of recall, a defective drug that had the potential to kill people.

At the time of the recall, the FDA, which is charged with protecting Americans from unsafe drugs, was already on notice about troubles at Glenmark.

The Mumbai-based company had four recalls in the previous eight months and would have two more in following months, all for the same dangerous tendency for pills to dissolve improperly. All the faulty medications were made at the same Glenmark factory in central India, government records show.

Yet the FDA hasn’t stopped Glenmark from shipping pills from the factory to American patients. Nor did it send investigators to the Indian facility to figure out what had gone wrong. Its last inspection of the plant was more than four years ago, before the COVID-19 pandemic.

“They should have been camping out there,” said Patrick Stone, a former FDA inspector who now advises pharmaceutical companies.

Glenmark’s String of Recalls

In less than 12 months, Glenmark Pharmaceuticals had seven recalls for drugs that didn’t dissolve correctly. All were made at the same factory in central India, records show.

Oct. 20, 2023: Recall of deferasirox tablets for oral suspension, which treat iron overload from blood transfusions

Oct. 23, 2023: Recall of ranolazine extended-release tablets, which treat chest pain

March 26, 2024: Recall of diltiazem hydrochloride extended-release capsules, which treat high blood pressure

April 17, 2024: Another recall of diltiazem hydrochloride extended-release capsules

May 29, 2024: Recall of potassium chloride extended-release capsules, which treat low potassium. This recall was expanded on June 24, 2024, and announced by the FDA the next day.

June 28, 2024: Recall of pravastatin sodium tablets, which treat high cholesterol

July 31, 2024: Recall of indomethacin extended-release capsules, which treat rheumatoid arthritis

Since the May recall, Glenmark told regulators it has received reports of three deaths, three hospitalizations and four other serious problems in patients who took the recalled potassium chloride capsules, FDA records show. It’s unclear if the drug was the cause.

A federal lawsuit alleges that the pills were responsible for the death of Mary Louise Cormier, a 91-year-old woman in Maine. A letter informing her of the recall arrived three weeks after she died.

The FDA’s anemic response underscores longstanding weaknesses in the way the agency oversees the safety of generic medications manufactured in foreign factories. The agency failed to act on clear patterns of trouble, was slow to warn the public about the potentially deadly pills and never mentioned that millions of them had been sold to consumers.

From the day of the first recall in October 2023 through the next 12 months, the FDA oversaw 22 recalls for drugs that didn’t dissolve correctly and could cause harm, agency data shows. That single Glenmark factory was responsible for more than 30%, a ProPublica analysis found.

“The FDA is always late to respond,” Stone said. “This should have been dealt with immediately.”

The FDA has long said it polices foreign plants by prioritizing inspections based on risk. For routine inspections, the agency uses a computer model that weighs prior recalls, the date and results of the most recent inspection, and other factors. FDA employees decide when to send investigators for more urgent visits based on signs that something is amiss. But the agency would not explain why Glenmark’s string of recalls didn’t meet that threshold.

What’s more, federal regulators were aware of significant deficiencies at three of Glenmark’s four other factories that have made drugs for the U.S. market, FDA records show. The breakdowns were so grave at one plant that the FDA barred drugs made there from entering the country.

The FDA’s failings date back decades. In her book “Bottle of Lies,” journalist Katherine Eban exposed the agency’s struggles to identify and combat corruption in the global pharmaceutical industry amid a huge demand for cheap generic drugs in the U.S. The book detailed how a whistleblower in 2005 started feeding the FDA insider details about unsafe medications at a different Indian drugmaker, but it took federal officials almost nine years to wrap up a criminal case.

The majority of the factories making drugs for U.S. patients are in other countries, many of which churn out the generics that make up more than 90% of prescriptions filled here. Yet the investigative arm of Congress has repeatedly found that the FDA has too few inspectors to adequately oversee these plants.

The consequences of lax oversight were unmistakable when the U.S. Centers for Disease Control and Prevention reported in 2023 that four people died and others had to have their eyeballs removed after they used contaminated eyedrops made by a different Indian company. The FDA had never inspected that factory before people got sick.

Fed up with what they called “institutional weaknesses and dysfunction” in the oversight of foreign drugmakers, the House Committee on Energy and Commerce in June demanded that the head of the FDA turn over documents about inspections in India and China.

A spokesperson for the FDA declined to answer questions about the Glenmark recalls or inspection history, saying the agency could not publicly discuss potential or ongoing compliance matters. “When there are quality issues identified that could result in harm, patients should rest assured that the FDA does everything within our authority to work with firms to ensure a recall is conducted most effectively,” FDA spokesperson Amanda Hils wrote in an email. A recent reorganization, she added, “will ultimately help the agency be more efficient and cohesive in our inspection and investigation efforts.”

Officials with Glenmark also declined to answer detailed questions. In a court document, the company denied being responsible for the death of Cormier, the woman in Maine.

“Due to the ongoing litigation, we are unable to provide further information at this time but Glenmark is fully committed to maintaining the highest standards of quality and regulatory compliance in all our operations,” a Glenmark spokesperson wrote in an email. “We continue to work closely with the FDA to ensure compliance with manufacturing operations and quality systems.”

Overseas compliance with U.S. manufacturing standards is crucial in a drug market where foreign factories like the ones operated by Glenmark make a wide range of injections and pills that treat some of the most vulnerable patients in the U.S., including those with cancer, heart disease, epilepsy and kidney ailments. What happens in a factory a half a world away can have deadly consequences.

Glenmark’s major troubles with the FDA began in 2019 at a factory far from the one that made the potassium chloride.

That spring, FDA investigators went to the company’s Himachal Pradesh plant in northern India and reviewed more than 100 complaints about products made there: A steroid cream was gritty, a medication was watery, and tubes of medicines were cracked and punctured.

The inspectors found so many problems at the facility that the agency sent Glenmark what’s known as a warning letter, a disciplinary tool the FDA uses to lay out significant violations of federal requirements and demand changes. Too often, Glenmark didn’t identify the root causes of problems and failed to come up with plans to prevent the same defects in the future, the director of the FDA’s Office of Manufacturing Quality wrote to Glenmark’s chairman.

“Your quality system for investigations is inadequate and does not ensure consistent production of safe and effective products,” the FDA official wrote.

This became a recurrent theme for Glenmark in subsequent years as FDA investigators dinged one plant after another for failing to follow manufacturing processes that prevent defective drugs from winding up in American medicine cabinets.

FDA records show the problems stretched from India to the U.S., where Glenmark has a factory outside of Charlotte, North Carolina. In August 2021, Glenmark recalled every product it made at that plant. The recall notices said they failed to meet manufacturing standards.

In the spring of 2022, FDA investigators spent more than a month in that factory, documenting 17 violations that resulted in a warning letter for that plant as well.

The problems snowballed in the fall of 2022. The FDA sent Glenmark’s chairman yet another warning letter, this time about its factory in Goa, India, which the agency said failed to thoroughly investigate discrepancies among batches of drugs and lacked the procedures necessary to ensure that its products had the strength, quality and purity that Glenmark claimed. And FDA officials were so concerned after a subsequent inspection of Glenmark’s Himachal Pradesh factory that they placed it on the agency’s dreaded import alert list, which allowed federal regulators to prevent drugs made there from entering the U.S.

At that point, three of the five Glenmark factories that had made drugs for American consumers were in trouble with the FDA.

Get in Touch

Do you work at the FDA? Do you have information about generic drugs that we should know? We’re particularly interested in decisions made by the Center for Drug Evaluation and Research about drug shortages, foreign or U.S. manufacturing, and regulatory actions, such as warning letters and import alerts. What aren’t officials telling Americans about their drug supply? Email Megan Rose at megan@propublica.org or Debbie Cenziper at debbie.cenziper@propublica.org. If you prefer to reach out confidentially on Signal, Megan can be contacted at 202-805-4865, Debbie can be contacted at 301-222-3133, or get in touch with both reporters at 202-886-9594.

But one plant has escaped scrutiny in the last few years: the Glenmark facility that made the recalled potassium chloride.

The factory, in Madhya Pradesh, India, previously had a mixed record with the FDA. The agency had sent inspectors every year between 2015 and 2020, finding problems in half the visits.

In 2018, the FDA asked Glenmark to voluntarily make improvements after inspectors found evidence that drafts of internal investigations were shredded in the quality department, among other deficiencies.

Subsequent inspections in September 2019 and February 2020, though, went well.

Then the COVID-19 pandemic hit, and the FDA put all but the most urgent inspections on hold. An Associated Press analysis this September found that about 2,000 pharmaceutical plants had not been inspected by the FDA in five years.

The FDA doesn’t have enough experienced investigators to figure out what’s wrong at factories where there are signs of trouble, said Peter Baker, a former FDA inspector who consults on pharmaceutical quality.

“It’s really difficult to be proactive when you don’t have people,” Baker said.

People familiar with FDA enforcement say inspectors are often frustrated because they have little say on which facilities they inspect. That decision is made by another arm of the agency that doesn’t have the same sort of on-the-ground view of what’s going on in factories.

Those who have the most to lose — the patients who could be endangered by defective pills — rarely, if ever, learn about the conditions inside the manufacturing plants. The FDA doesn’t make it easy for people to know where a drug is made, let alone whether it was by a factory with a concerning safety record.

To determine that the recalled Glenmark drugs were all made at the Madhya Pradesh factory, ProPublica matched drug-labeling records from the U.S. National Library of Medicine with details in two FDA databases. Because the FDA doesn’t routinely post its inspection reports online, ProPublica obtained these and other records from Redica Systems, a data analytics company that receives this information from the FDA through public-records requests.

The first in the string of recalls from the plant came in October 2023 for a drug that treats iron overload from blood transfusions. Days later, the company announced a second recall, this time for a medication for chest pain. Then came two more for capsules that treat high blood pressure. The potassium chloride recall was Glenmark’s fifth. Two more came after that, for a cholesterol-lowering drug and a rheumatoid arthritis medicine.

The only one mentioned on the FDA’s recalls website was the potassium chloride. In that case, the agency followed its practice of posting a press release from the drug company rather than writing its own alert for the public.

“Public notification is generally issued when a product poses a serious health hazard or has been widely distributed,” the FDA spokesperson wrote in an email.

Records show the agency determined that potential harm from taking the other pills Glenmark recalled was likely to be temporary or reversible. But it never told the public what that harm might be.

Mary Louise Cormier never knew her potassium chloride pills had been recalled.

On June 27, the 91-year-old was taken to the emergency room from her nursing home in Brunswick, Maine. She was lethargic and could give only soft, monosyllabic answers to questions, according to the lawsuit filed by one of her daughters.

A blood test showed that her potassium level was alarmingly high — so high that an emergency room doctor had the lab run the test a second time to make sure the result wasn’t a mistake, according to the lawsuit. A level above 6 millimoles per liter is considered a medical emergency. The tests showed Cormier’s level was 6.9, the lawsuit says.

Cormier — who had raised five children, cared for babies in the foster care system and once ran a day care out of her home — suffered cardiac arrest and died, the suit says.

The lawsuit, filed in federal court in Newark, New Jersey, accuses Glenmark of a “systematic disregard for drug safety” and alleges the company sold pills “more suitable for an execution” than for the vulnerable patients they were supposed to help. Cormier’s pharmacy confirmed that her pills came from recalled batches, the lawsuit says. The suit is seeking class-action status.

In a court filing, Glenmark denied the allegations. The company’s attorneys listed dozens of defenses, including that the injuries claimed were the result of preexisting or unrelated medical conditions and that the product contained an adequate warning. There can be other reasons for a spike in potassium, and ProPublica was unable to independently verify key details in the suit. Cormier’s daughter referred a reporter to her attorney, Aaron Block, who declined to release Cormier’s medical records, citing the early stage of the litigation.

It’s not clear when Cormier’s pharmacy first learned the pills could be dangerous, but news of recalls can often take time to reach pharmacists — and longer to get to patients. The suit says Cormier’s pharmacy dispensed the pills on June 25. That was the day the FDA posted the recall on its website and three days before Cormier died. Medicines in the U.S. often pass through distributors. The manufacturer is responsible for notifying its distributors, who then have to notify their customers and so on down the supply chain.

News of the recall didn’t reach Cormier’s family until three weeks after her death. As her family was preparing for her memorial, a letter arrived. Cormier’s health insurance company was writing with “important drug recall information” about her potassium chloride: “Our records show that you may have recently filled a prescription for this product.” The letter made it clear that the pills may cause high potassium levels, potentially leading to cardiac arrest and death.

Glenmark knew there was a problem with its potassium chloride at least a month before Cormier died.

On May 29, a Glenmark executive wrote a letter to distributors saying a batch of potassium chloride had failed to dissolve correctly in a test, so the company was issuing a recall. The executive told the distributors that the recall was “being made with the knowledge of the Food and Drug Administration” and used red capital letters to mark the notice “URGENT.” The letter was sent via FedEx overnight. But the company and the FDA didn’t tell the public at the time.

In late June, Glenmark recalled dozens more batches, including the pills that the lawsuit says Cormier took.

On June 25, about four weeks after the Glenmark executive had written to distributors, the FDA finally alerted the public.

Glenmark and the FDA declined to say why the initial recall in May didn’t include all of the faulty pills or why they didn’t tell the public sooner. Speaking generally, Hils, the FDA spokesperson, said that the agency does not have the authority to mandate recalls of most drugs, with a limited exception for controlled substances. The agency’s role, she said, is “to oversee a company’s recall strategy, assess the adequacy of the company’s action, and classify the recall.”

Since then, Glenmark has told the FDA about reports it received of the deaths, hospitalizations and other serious health problems in patients who took the recalled potassium chloride. Companies are required to file reports to the FDA’s Adverse Event Reporting System so the agency can monitor the safety of drugs. The FDA’s online database includes only bare-bones details, so ProPublica was unable to independently verify what happened in each case. While the FDA would not comment on these complaints, the agency generally warns, “For any given report, there is no certainty that a suspected drug caused the reaction.”

A majority of the reports said the patients suffered from abnormal heart rhythms, while the second-most-common complaint was of muscle problems. Glenmark’s public alert said that the recalled pills could cause irregular heartbeats and severe muscle weakness.

Glenmark’s top executives have told financial analysts on earnings calls that the company has invested in improvements to its factories.

The company’s troubles with U.S. regulators are so well known to investors that its compliance officer notified the National Stock Exchange of India in September that FDA inspectors had found no problems at one of its other factories in India. As the news spread, Glenmark’s stock jumped 9%.

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