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☆ Explainer: U.S. Supreme Court presses pause on abortion pill case for 5 days, What happens next?
▼ + stars: | 2023-04-14 | by ( Brendan Pierson | Thomson Reuters | Brendan Pierson Reports On Product Liability Litigation | ) www.reuters.com time to read: +6 min

HOW DID IT REACH THE SUPREME COURT? Circuit Court of Appeals for an emergency stay putting his injunction on hold. Whether or not the Supreme Court decides to stay Kacsmaryk's order, it will not decide the merits of the case. WHAT HAPPENS AFTER THE SUPREME COURT RULES? Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.

[1/2] The sun sets on the U.S. Supreme Court building after a stormy day in Washington, U.S., November 11, 2022. REUTERS/Leah MillisApril 14 (Reuters) - New court-imposed restrictions on the abortion pill mifepristone could cut off access to the drug entirely for months, the Biden administration and the drug's distributor, Danco Laboratories, said in petitions asking the U.S. Supreme Court to lift the curbs. Circuit Court of Appeals on Wednesday will require a new approval from the U.S. Food and Drug Administration and new labeling, they said. Danco, whose sole product is the abortion pill, said that if the Supreme Court does not act, it may have to halt its operations. Some Democratic-led states have said that they have taken steps to stockpile mifepristone in case it becomes unavailable.

An appeals court put part of that decision on hold late Wednesday, preserving access to the pill for now, with significant restrictions the Justice Department will ask the Supreme Court to lift. Neither Kacsmaryk's order, known as a preliminary injunction, nor the 5th Circuit's emergency stay is a final ruling on the merits of the case. REUTERS/Evelyn HocksteinThe Biden administration said on Thursday it will appeal to the Supreme Court for an emergency stay of Kacsmaryk's order in full. If the FDA wins a stay from the Supreme Court blocking the injunction, mifepristone will remain available with no new restrictions. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.

[1/2] Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023. However, the appeals court declined to block portions of Kacsmaryk's order, effectively reinstating restrictions on the pill's distribution that had been lifted since 2016. The FDA and lawyers for the groups suing to block the drug could not immediately be reached for comment. The lawsuit before Kacsmaryk was filed against the FDA in November by four anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors. Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi, Bill Berkrot and William MallardOur Standards: The Thomson Reuters Trust Principles.

The deal, which also included Colorado, Illinois, Massachusetts and New Mexico, means that San Francisco-based Juul has now settled with 45 states for more than $1 billion. The various states had accused Juul of falsely marketing its e-cigarettes as less addictive than cigarettes and targeted minors with glamorous advertising campaigns. It previously reached a $439 million settlement with 34 states and territories, as well as settlements with several individual states. As of December, its share of Juul was valued at $250 million, down from $12.8 billion in 2018. The CDC also has said using nicotine in adolescence may raise the risk for future addiction to other drugs.

NEW YORK, April 12 (Reuters) - E-cigarette maker Juul Labs Inc has agreed to pay $462 million to settle claims by six U.S. states including New York and California that it unlawfully marketed its addictive products to minors, the states announced on Wednesday. With the deal, Juul has now settled with 45 states for more than $1 billion. The states had accused Juul of falsely marketing its e-cigarettes as less addictive than cigarettes and targeted minors with glamorous advertising campaigns. As of December, its share of Juul was valued at $250 million, down from $12.8 billion in 2018. The CDC also has said using nicotine in adolescence may raise the risk for future addiction to other drugs.

The Biden administration is seeking an emergency stay of Kacsmaryk's order from the New Orleans-based 5th U.S. The 5th Circuit has a conservative reputation, with 12 of its 16 active judges appointed by Republican presidents. The FDA could then petition the U.S. Supreme Court for an emergency stay. Regardless of whether it wins an emergency stay of the injunction, the FDA will continue its appeal of Kacsmaryk's preliminary injunction. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.

Adding to the volatile legal landscape around abortion, a federal judge in Washington state on Friday issued a seemingly conflicting injunction that prevented federal regulators from altering access to the same abortion drug. Kacsmaryk's ruling is a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues. By choosing to sue in Amarillo, the plaintiffs ensured that the case would go before Kacsmaryk, a conservative former Christian activist. Circuit Court of Appeals, which has a conservative reputation, with more than two-thirds of its judges appointed by Republican presidents. The FDA in January said that the government for the first time will allow mifepristone to be dispensed at retail pharmacies.

April 7 (Reuters) - A federal judge on Friday halted federal regulators' approval of the abortion pill mifepristone while a legal challenge proceeds, partially granting a request by anti-abortion groups and dealing another setback to abortion rights in the United States. A White House official said they are reviewing the abortion ruling. Kacsmaryk's ruling is a preliminary injunction that would essentially ban sales of mifepristone while the case before him continues. Some abortion providers have said that if mifepristone is unavailable, they would switch to a regimen using only misoprostol for a medication abortion. During the hearing in the case, the judge raised questions about the regulatory process used by the FDA.

April 5 (Reuters) - A Planned Parenthood affiliate and two doctors on Wednesday filed a lawsuit seeking to block Idaho authorities from punishing healthcare providers for referring patients to get abortions in other states. Idaho Attorney General Raul Labrador, a Republican, said in a legal opinion last week that the state's near-total abortion ban, enacted last August, "prohibits an Idaho medical provider from ... referring a woman across state lines to access abortion services." In their lawsuit, filed in federal court in Boise, Planned Parenthood and the doctors said Labrador's interpretation of the law violates the U.S. Constitution by prohibiting protected free speech and attempting to extend Idaho law beyond its borders. "Attorney General Labrador is violating the boundaries of our constitution to further deny Idahoans the freedom to decide what is best for their own bodies and futures," said Alexis McGill Johnson, president of Planned Parenthood Federation of America, in a statement. Reporting By Brendan Pierson in New York; Editing by Alexia Garamfalvi and Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

April 4 (Reuters) - Federal appeals court judges on Tuesday appeared skeptical of 3M's (MMM.N) bid to use the bankruptcy of its subsidiary Aearo Technologies to shield itself from nearly 260,000 lawsuits over allegedly defective military-issue earplugs. Circuit Court of Appeals in Chicago to reverse a bankruptcy court order allowing the lawsuits to move forward against 3M, even though Aearo is bankrupt. Aearo and 3M said the bankruptcy process would facilitate a fair and comprehensive settlement with the plaintiffs. David Frederick, representing the plaintiffs, told the panel that 3M "contrived this bankruptcy to help itself, not Aearo or its creditors." The next-largest MDL, the Johnson & Johnson talc litigation, has 38,000 cases.

REUTERS/Lawrence Bryant/File PhotoApril 3 (Reuters) - Planned Parenthood on Monday asked a state court judge in Utah to block a law set to take effect next month that would effectively ban abortion clinics from operating in the state. The case is before Judge Andrew Stone, who last year issued a preliminary order preventing the state from enforcing an earlier abortion ban while he hears a legal challenge by Planned Parenthood. Planned Parenthood argued that Stone should block the newer law for the same reason, saying it would ban 95% of abortions in the state if allowed to take effect on May 3. "As promised, Planned Parenthood Association of Utah is fighting back and doing everything in our power to make sure that Utahns can get the care they need to stay healthy," Sarah Stoez, interim president and CEO of Planned Parenthood Association of Utah, said in a statement. Twelve of the 50 U.S. states now ban abortion outright while many others prohibit it after a certain length of pregnancy, according to the Guttmacher Institute, a research organization that supports abortion rights.

The state's 21-year age minimum, enacted as part of a 2003 gun control law, had been challenged in a 2021 lawsuit by three gun rights groups - Minnesota Gun Owners Caucus, Firearms Policy Coalition and Second Amendment Foundation - and three individuals. The plaintiffs argued in their lawsuit that the age minimum violated the Second Amendment because 18- to 20-year-olds were permitted to possess guns at the time of the United States' founding. Menendez wrote that she had "reservations" about the historical analysis demanded by the Supreme Court, noting that "judges are not historians." Circuit Court of Appeals recently upheld a 21-year age minimum for handgun purchases in Florida, based on 19th-century laws, but said those laws only concerned gun sales, not the right to carry guns. Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Bill BerkrotOur Standards: The Thomson Reuters Trust Principles.

March 30 (Reuters) - A federal judge in Texas on Thursday blocked Obamacare's mandate that health insurance plans cover pre-exposure prophylaxis against HIV (PrEP) and other preventive care including cancer and diabetes screenings. U.S. District Judge Reed O'Connor in Fort Worth, Texas, said the PrEP mandate violated a federal religious freedom law and that the other preventive care mandates were based on recommendations by an illegally appointed task force. The ruling was a victory for conservative businesses and individuals that sued to challenge the mandates in 2020. The U.S. Department of Health and Human Services, which oversees Obamacare, did not immediately respond to a request for comment. Reporting By Brendan Pierson in New York; Editing by Mark PorterOur Standards: The Thomson Reuters Trust Principles.

☆ The government is cracking down on online prescriptions. Patients with addiction and the startups caring for them are caught up in the fight.
▼ + stars: | 2023-03-27 | by ( Blake Dodge | ) www.businessinsider.com time to read: +9 min

Proposed rules would limit online addiction treatmentIn February, the Drug Enforcement Administration, or DEA, published much-anticipated rules meant to set the record straight on online prescribing. The rules, if implemented, generally don't allow providers to prescribe controlled medications online if they don't see the patients in person. For buprenorphine and other drugs, there's an exception that would allow for initial 30-day prescriptions for online patients. Some patients are flights away from in-person careFor some patients, especially in rural areas, in-person appointments are hard to find. Last year, Alabama passed a new law prohibiting providers from prescribing controlled drugs to patients they hadn't seen in person within the past year.

March 27 (Reuters) - E-cigarette company Juul Labs Inc and its former largest investor, Marlboro maker Altria Group Inc (MO.N), will face their first U.S. trial this week over claims that they created a public nuisance by marketing addictive e-cigarettes to minors. It says Juul sold its e-cigarettes in sweet flavors and promoted them on social media to appeal to underage consumers. Juul and Altria have faced thousands of similar lawsuits around the country. The state also says Altria helped Juul market its products, including by providing it access to its sales force and including Juul advertisements in Marlboro products. Altria this month announced that it had given up its investment in Juul in exchange for some of Juul's intellectual property.

The trial will be the first test of how Zantac cancer claims will fare before a jury. GSK said in a statement it disagreed with the ruling and would defend the case at trial. Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer (PFE.N), Boehringer Ingelheim and finally Sanofi (SASY.PA). While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts. Analysts said it was not surprising that Grillo ruled differently from the federal court because California's courts are known to be friendlier to plaintiffs.

March 21 (Reuters) - Oklahoma's highest court on Tuesday ruled the state's constitution protects a right to an abortion to preserve the mother's life, and that a doctor does not need to wait until there is an immediate medical emergency to perform one. In a 5-4 ruling, the Oklahoma Supreme Court found that a law passed last year that allows life-saving abortion only when there is a "medical emergency" violates the "inherent right to life" under the state constitution. The court did not strike down a separate 1910 abortion ban with an exception for preserving the mother's life that does not require a medical emergency. It also did not address whether the state constitution includes a right to abortion under any other circumstances. Tuesday's decision comes amid widespread uncertainty in states with abortion bans about when doctors can perform the procedure if needed to preserve the mother's life or health.

[1/2] Customers view semi automatic guns on display at a gun shop in Los Angeles, California December 19, 2012. REUTERS/Gene BlevinsMarch 20 (Reuters) - A federal judge on Monday blocked California from enforcing a state law requiring new semiautomatic handguns to have certain safety features, finding it violates the right to bear arms under the Second Amendment of the U.S. Constitution. The ruling by U.S. District Judge Cormac Carney in Santa Anna, California is the latest in a line of decisions striking down state gun laws following a U.S. Supreme Court ruling last year expanding gun rights. The judge said it would not take effect for 14 days to give the state a chance to appeal. The California Rifle & Pistol Association and four individuals sued the state last year to challenge the law.

March 16 (Reuters) - North Dakota's Supreme Court on Thursday refused to revive a strict abortion ban previously blocked by a lower court, finding that the ban runs afoul of a right under the state constitution to abortion if it is needed to preserve the mother's life or health. North Dakota's near-total abortion ban would allow a doctor to be prosecuted for performing an abortion even in order to save the mother's life. A state court blocked the law last year, finding the providers were likely to succeed. The state Supreme Court agreed, rebuffing Wrigley's petition to revive the law, while the case proceeds on the merits in the lower court. Twelve states are currently enforcing abortion bans adopted since last year's Supreme Court reversal of Roe v. Wade, according to the Guttmacher Institute, a research organization that supports abortion rights.

March 15 (Reuters) - A U.S. judge in Texas is set to hear arguments on Wednesday in a bid by anti-abortion groups to ban sales of the abortion pill mifepristone across the country, even in states where abortion is legal, as they challenge regulatory approval granted more than two decades ago. Twelve of the 50 states now ban abortion outright while some others prohibit it after a certain length of pregnancy, according to the Guttmacher Institute, a research organization that supports abortion rights. The judge cited death threats and harassment directed at the court during the case and a wish to avoid disruption. After appealing to the 5th Circuit, the losing side could seek to take the matter to the U.S. Supreme Court. Reporting by Brendan Pierson in New York; Editing by Will Dunham and Alexia GaramfalviOur Standards: The Thomson Reuters Trust Principles.

☆ U.S., EU Try to Defuse Subsidies Dispute to Focus on Russia and China
▼ + stars: | 2023-03-10 | by ( Andrew Duehren | Kim Mackrael | ) www.wsj.com time to read: 1 min

WASHINGTON—President Biden and European Commission President Ursula von der Leyen will meet Friday as the U.S. and Europe try to move beyond a spat over subsidies for clean-energy technology and preserve a trans-Atlantic relationship that had strengthened following Russia’s invasion of Ukraine. Since Congress passed the climate and healthcare law called the Inflation Reduction Act last year, European officials have loudly complained about provisions that they fear disadvantage their own industries. They have taken aim at U.S. subsidies for electric vehicles that impose new requirements on the source of the materials used in the vehicles, as well as a wider range of tax incentives that officials believe could draw investment out of Europe and into the U.S.

March 9 (Reuters) - A U.S. appeals court on Thursday upheld a Florida law barring people under age 21 from buying a gun, rejecting a challenge by the National Rifle Association gun rights lobby group. Two Republican state lawmakers have introduced a measure to lower the age to 18, as it was previously. Federal law already imposes a 21-year age requirement for handguns. A federal judge in 2021 upheld the law, finding it was a kind of "longstanding" restriction that courts had upheld in the past. The 11th Circuit panel decided on Thursday that this one was, pointing to more than a dozen 19th century state laws barring people under 21 from buying guns.

REUTERS/Bing GuanNEW YORK, March 9 (Reuters) - A federal judge on Thursday blocked 10 companies from selling certain gun components in New York while the state pursues a lawsuit against them aimed at ending sales of illegal, untraceable "ghost guns." The preliminary order by U.S. District Judge Jesse Furman in Manhattan adopts an agreement reached between New York Attorney General Letitia James and the companies last month, court records show. "Today's court order will help protect New York communities and save New Yorkers' lives," James said in a statement. The lawsuits claimed that the companies were creating a public nuisance by selling gun frames and receivers without serial numbers to consumers. Three defendants have settled with New York City, agreeing to stop selling guns there.

Companies USU Software AG FollowMarch 7 (Reuters) - Five women who said they were denied abortions despite grave risk to their lives or fetuses sued Texas on Monday, in the first apparent case of pregnant women suing over curbs imposed after the U.S. Supreme Court overturned Roe v. Wade in June. Texas, like most of the 13 states with abortion bans, allows exceptions when a physician finds that there is a medical emergency. Texas banned abortion shortly after the U.S. Supreme Court overturned its landmark 1973 ruling in Roe v. Wade, which had guaranteed abortion rights nationwide. Four of the women in Monday's lawsuit had to travel out of state to obtain abortions in order to avoid serious medical complications. Reporting by Jonathan Stempel and Brendan Pierson in New York; Editing by Mark Porter and Alexia GaramfalviOur Standards: The Thomson Reuters Trust Principles.

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