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Column: A stem cell clinic and its doctor will pay a $3.65-million settlement to 1,100 ex-patients

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The story of StemGenex, a onetime stem cell clinic working out of shiny quarters in La Jolla, seems lastly to have reached its well-deserved finish.

A $3.65-million settlement with 1,063 former purchasers reached by the clinic and its former chief medical officer has simply received last approval from federal Choose Anthony Battaglia in San Diego.

The purchasers have been plaintiffs in a class-action lawsuit initially filed in 2016, alleging that they have been misled by StemGenex promoting and promotional materials.

In some unspecified time in the future insurance coverage corporations are most likely going to cease protecting this business.

Paul Knoepfler, UC Davis

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The clinic asserted that its therapy was efficient towards quite a few medical situations, together with the autoimmune illness lupus, diabetes, a number of sclerosis, Alzheimer’s illness and Parkinson’s illness.

Its web site claimed “100% client satisfaction,” though a small disclosure assertion revealed that the determine was based mostly on affected person exit interviews, performed earlier than the outcomes of their therapy could possibly be felt.

The category members will every obtain about $1,936 from the settlement fund, with a lot of the relaxation going to authorized charges and bills. That’s a fraction of the $14,900 price that StemGenex charged per therapy, in keeping with the lawsuit.

Of the overall settlement, $2.5 million might be paid by an insurance coverage provider for Andre Lallande, an osteopath who served because the agency’s chief medical officer, and $1.15 million by the insurance coverage provider for StemGenex.

Nonetheless, the settlement “highlights the large dangers to clinic corporations and particularly their physicians” for promoting unproven stem cell therapies, says Paul Knoepfler, a UC Davis biologist who has tracked the proliferation of unlicensed stem cell clinics for a number of years.

In November, New York Atty. Gen. Letitia James obtained a $5.1-million judgment towards a now-defunct New York Metropolis stem cell clinic for “scamming sufferers out of 1000’s of {dollars} every for unproven and probably dangerous medical therapies involving stem cells.”

Comparable lawsuits from regulators and sufferers may collectively yield tens of tens of millions of {dollars} in settlements and judgments, Knoepfler conjectures. “Given such monetary dangers, how can the a whole lot or 1000’s of clinic docs throughout the U.S. nonetheless maintain getting malpractice or enterprise insurance coverage that they should proceed? In some unspecified time in the future insurance coverage corporations are most likely going to cease protecting this business.”

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The StemGenex therapy concerned eradicating fats from the purchasers by liposuction, treating it purportedly to pay attention stem cells from the tissue and injecting the cells again into the purchasers. Not one of the plaintiffs “acquired any vital profit” from the therapy, in keeping with the lawsuit. The 5 named plaintiffs had sought therapy for lupus, a number of sclerosis, diabetes and a spinal wire harm.

There isn’t any scientifically legitimate proof that therapy of the type supplied by StemGenex works as claimed. The Meals and Drug Administration has permitted stem cell therapies just for sure blood-related situations, and in these circumstances solely with stem cells derived from umbilical wire blood.

The company cautions customers towards accepting every other claims for stem cell therapies. Unproven stem cell therapies are “unlawful and probably dangerous,” the FDA says.

StemGenex itself got here beneath FDA scrutiny. The agency acquired a prolonged warning letter in October 2018 from the FDA, asserting that it was in impact advertising and marketing an unlawful drug. The agency’s doubtful sanitary and sterilization procedures raised “potential vital security issues,” the letter stated.

Lallande didn’t reply to a message left at his workplace. Rita Alexander, who had been recognized because the proprietor of StemGenex, couldn’t be reached for remark. As a part of the settlement, neither StemGenex nor Lallande admitted to the allegations within the class motion lawsuit.

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“This was not an atypical client case,” Elizabeth Banham, an lawyer for the plaintiffs, instructed me. “The plaintiffs suffered from quite a lot of painful and sometimes degenerative situations for which they paid some huge cash for a stem cell therapy based mostly on the defendants’ advertising and marketing. We’re happy that justice has been obtained for them after 5 years of litigation.”

StemGenex filed for chapter in 2019, claiming belongings of about $156,000 and liabilities of greater than $1 million. The chapter submitting disclosed that the agency had acquired revenues of greater than $8.2 million courting again to the start of 2017.

Based mostly on the agency’s normal price, that advised that the clinic could have had as many as 550 prospects over that interval; some have stated they’d multiple therapy, for which they have been charged separate charges. When the chapter case was closed in January 2021, there was nearly nothing to be distributed to collectors.

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Supreme Court upsets $10-billion opioid settlement because it shields the Sacklers

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Supreme Court upsets $10-billion opioid settlement because it shields the Sacklers

The Supreme Court on Thursday rejected a mass settlement related to the nation’s opioid crisis that would have paid an estimated $10 billion to victims, hospitals, states and others, and shielded the Sackler family from further liability.

By a 5-4 vote, the justices ruled that a bankruptcy judge does not have broad power to arrange a mass settlement of thousands of claims that includes protections for people who are not bankrupt.

The justices were split in an unusual way. Justice Neil M. Gorsuch spoke for the majority, while Chief Justice John G. Roberts Jr. and Justices Sonia Sotomayor, Elena Kagan and Brett M. Kavanaugh dissented.

“We hold only that the bankruptcy code does not authorize a release and injunction that, as part of a plan of reorganization under Chapter 11, effectively seeks to discharge claims against a nondebtor without the consent of affected claimants,” Gorsuch said.

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“Today’s decision is wrong on the law and devastating for more than 100,000 opioid victims and their families,” Kavanaugh said in dissent. “The court’s decision rewrites the text of the U.S. Bankruptcy Code and restricts the long-established authority of bankruptcy courts to fashion fair and equitable relief for mass-tort victims.”

The Sacklers, owners of the Purdue Pharma company, had denied wrongdoing but agreed to contribute $6 billion to the settlement fund if they would be protected from future lawsuits.

The case has been closely followed not just because of the opioid settlement but also because of the use of bankruptcy laws to settle other mass lawsuits involving the Boy Scouts of America and some Catholic dioceses.

Purdue Pharma filed for bankruptcy in 2019 facing thousands of lawsuits alleging its marketing of OxyContin as a nonaddictive pain relief pill had triggered an opioid epidemic that led to more than a half-million deaths since the mid-1990s. In the decade prior to the bankruptcy, the company had distributed about $11 billion to members of the Sackler family and their offshore accounts.

Their lawyers maintained that more than half of this amount was paid in taxes.

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But the scale of the damage and the liability for OxyContin was extraordinary. A bankruptcy court later put a hold on new lawsuits, while the pending claims against Purdue Pharma and the Sacklers were estimated to seek in total more than $40 trillion.

A coalition of creditors, including victims, hospitals, local and state governments and tribal nations, negotiated a settlement that was that expected to pay out about $10 billion. Most of the funding — about $6 billion — came from the Sacklers.

In 2021, a bankruptcy judge approved the settlement and described it as the “only reasonably conceivable” way to fairly resolve the mass of lawsuits. Without the money from the Sacklers, he said the company would be liquidated, leaving most of the creditors with nothing.

While more than 95% of the creditors said they approved the deal, including all 50 states, the Biden administration’s bankruptcy trustee opposed it. He did so because the settlement shielded the Sacklers from any further or future liability.

In Harrington vs. Purdue Pharma, the trustee argued that the Sacklers were not bankrupt and therefore, cannot take advantage of the shield provided by a bankruptcy settlement.

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Last year, the Supreme Court put the settlement on hold to consider that argument.

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Inflation’s Wild Ride

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Inflation’s Wild Ride

“The signal that we’re taking is that it’s likely to take longer for us to gain confidence that we are on a sustainable path down to 2 percent inflation,” Mr. Powell said in May, after price increases had stalled for months. Inflation has recently cooled again, and policymakers are waiting to see if the trend lasts.

The question now is just how much continued progress on lowering inflation Fed officials will need to see to feel comfortable lowering interest rates.

Investors still think it is possible that the central bank will cut rates in September, based on market pricing. Fed officials themselves predicted one reduction this year and four in 2025, as of their June economic forecasts.

For politicians, that means that the November election will almost certainly happen against a backdrop of high interest rates that are making car leases, credit card borrowing and new mortgages pricey for consumers.

After years of elevated inflation, Americans are also still seeing much higher price levels at the grocery store, on car repair bills and at hotels than before the pandemic.

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Price increases have slowed, but getting used to new price levels could take time for consumers.

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Irvine-based EV maker Rivian gets $5-billion lifeline from Volkswagen

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Irvine-based EV maker Rivian gets $5-billion lifeline from Volkswagen

Irvine-based Rivian Automotive got a big financial boost on Tuesday, as Volkswagen agreed to invest up to $5 billion in a joint venture with the struggling manufacturer of electric trucks.

Under a partnership announced by the companies, the German automaker will provide $1 billion initially and as much as $4 billion more over time.

The infusion will give VW the ability to tap the company’s technology to develop “next generation” battery-powered vehicles and software.

The surprise investment comes during a tough time for the electric vehicle market, which has posed economic headwinds for Rivian and other EV makers.

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With their sleek design, Rivian trucks and sport utility vehicles initially drew plenty of interest among investors, fueling a massively successful initial public offering of stock in 2021; the company ended its first day of trading valued at nearly $88 billion. Amazon.com is Rivian’s largest shareholder.

But analysts said some car buyers were put off by the high price of Rivian’s latest offering of vehicles — the company’s R1T electric pickup truck starts at nearly $70,000, while its R1S SUV starts at almost $75,000.

Rivian reported a net loss of $1.52 billion for the three-month period that ended Dec. 31, compared with $1.72 billion during the same period a year earlier.

Signs of stress mounted. In March, Rivian postponed plans to build a new $5-billion manufacturing plant in Georgia to save money amid heavy losses.

A month earlier, Rivian announced a 10% cut to its workforce and lower production expectations.

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Last week another local EV manufacturer — Fisker Group Inc. of Manhattan Beach — filed for Chapter 11 bankruptcy protection after it failed to secure financing from undisclosed automakers.

Early this year, Apple pulled the plug on its self-driving electric vehicle program, reportedly after spending $10 billion over a decade.

And Lucid Motors, a maker of luxury electric vehicles in the Bay Area city of Newark, received a $1-billion infusion last month from an affiliate of the Saudi sovereign wealth fund — the kind of big backer that Fisker didn’t have.

Rivian’s shares, which were pummeled earlier this year, jumped 30% in extended trading on Tuesday. The shares closed at $11.96.

Tesla Inc., the biggest player in the business, also has been squeezed by weak sales and declining profits. The company said in April that it would lay off more than 10% of its workforce.

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Bloomberg News contributed to this report.

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