Grégoire Courtine, a French-born neuroscientist at École Polytechnique Fédérale de Lausanne in Switzerland, is the International Paraplegic Foundation chair in spinal cord repair at the Center for Neuroprosthetics and the Brain Mind Institute at the Swiss Federal Institute of Technology in Lausanne.

Courtine and Jocelyne Bloch of HBP partners EPFL and CHUV have created a device that allows patients with total spinal cord injuries to stand, walk, and even participate in recreational activities such as swimming, cycling, and canoeing. The device is called a “digital bridge.”

The “digital bridge” device is a breakthrough study that could represent a quantum leap in the treatment of certain brain and central nervous system injuries. The device uses artificial intelligence to decode brain signals that enable the patient to move around independently.

“When there’s a spinal cord injury, the brain is disconnected from the spinal cord, so the communication is interrupted,” said Courtine during a press call Tuesday. “And what we’ve been able to do here is to reestablish the communication between the brain and the region spinal cord that controls leg movement with a digital bridge.”

That so-called “digital bridge” can effectively turn thought into actions – or, as Courtine put it, it can “capture thoughts” and translate them into a stimulation of the spinal cord.

According to the study published in the Journal Nature, the experimental treatment has been tried just once. Gert-Jan Oskan is a 40-year-old Dutch man who suffered a spinal cord injury in a bicycle accident. For nearly 12 years, he was unable to walk, step or stand. Courtine’s team implanted two devices, one into Oskan’s brain, and another into his spinal cord. The two devices communicate wirelessly, hence the digital bridge, or as the paper calls it, the “brain-spine interface,” or BSI.

Now, Oskan, whom Courtine calls the first “test pilot” of the newly invented system, has regained function in his knees, hips and ankle joints. He can walk – slowly, with the help of crutches – for about 300 to 600 feet. He can stand, with support from his hands, for two to three minutes at a time. He can even climb a few stairs.

Perhaps most remarkably, the treatment appears to work even after the system is shut off.

The implant has been life-changing, says Oskam. “Last week, there was something that needed to be painted and there was nobody to help me. So I took the walker and the paint, and I did it myself while I was standing,” he says.

When Oskam thinks about walking, the skull implants detect electrical activity in the cortex, the outer layer of the brain. This signal is wirelessly transmitted and decoded by a computer that Oskam wears in a backpack, which then transmits the information to the spinal pulse generator.

After around 40 rehabilitation sessions using the brain-spine interface, Oskam had regained the ability to voluntarily move his legs and feet. That type of voluntary movement was not possible after spinal stimulation alone, and suggests that the training sessions with the new device prompted further recovery in nerve cells that were not completely severed during his injury. Oskam can also walk short distances without the device if he uses crutches.

Bruce Harland, a neuroscientist at the University of Auckland in New Zealand, says that this continued improvement in spinal function is great news for anyone with a spinal-cord injury, “because even if it’s a longer-term chronic injury, there’s still a few different ways that healing could happen”.

“It’s certainly a huge jump” towards improved function for people with spinal-cord injuries, says neuroscientist Anna Leonard at the University of Adelaide in Australia. And, she says, there is still room for other interventions – such as stem cells – to improve outcomes further. She adds that although the brain-spine interface restores walking, other functions such as bladder and bowel control are not targeted by the device. “So, there’s certainly still room for other areas of research that could help progress improvements in outcomes for these other sort of realms,” she says.

Antonio Lauto, a biomedical engineer at Western Sydney University, Australia, says that less-invasive devices would be ideal. One of Oskam’s skull implants was removed after about five months because of an infection. Nevertheless, Jocelyne Bloch, the neurosurgeon at the Swiss Federal Institute of Technology who implanted the device, says that the risks involved are small compared with the benefits. “There is always a bit of risk of infections or risk of haemorrhage, but they are so small that it’s worth the risk,” she says.

Courtine’s team is currently recruiting three people to see whether a similar device can restore arm movements.

Mulberri is a software company that provides a cloud-based platform for small and medium-sized businesses (SMBs) to purchase and manage insurance.The company was founded in 2016 by Hamesh Chawla and is headquartered in Sunnyvale, California.

Mulberri’s platform uses artificial intelligence (AI) to automate the insurance buying process, making it easier and faster for SMBs to find the right coverage at the best price. The company’s customers include businesses in a variety of industries, including retail, healthcare, and technology.

Mulberri just announced the launch of its Risk Engine, a first of its kind risk assessment offering for workers compensation underwriters. The Risk Engine, which is already being deployed by customers like Paychex’s PEO department, uses machine learning models to put the information underwriters need at their fingertips, making it possible to make fast, accurate decisions.

Workers’ comp is a multi-billion-dollar market, but most existing underwriting processes have not taken full advantage of the power of data, especially AI. Mulberri designed its Risk Engine to meet the needs of underwriters and their customers, extending Mulberri’s existing portfolio of insurance products for payroll businesses, HR providers, brokers and small-medium businesses.

“Our mission from day one has been to leverage technology to complement underwriters’ judgment so that the business insurance process can be simple, efficient, and transparent,” said Hamesh Chawla, CEO and cofounder of Mulberri. “The Risk Engine is a transformative step forward.”

Mulberri trained its Risk Engine to determine factors that impact claims based on millions of pieces of information including firmographic information, previous loss experience and workers compensation information. The cloud-based product allows intuitive access to predictions on demand from any SaaS application as well as easy deployment. It also enables users to analyze and score prospects one at a time or in bulk. All data is obfuscated, so PII remains safe.

It allows underwriters to make predictions for:

– – Claim Propensity – Likelihood of an insured filing a claim in twelve months
– – Claim Frequency – Claim repetition in twelve months
– – Claim Severity – Severity of the claim should it occur
– – Loss Ratio – Likelihood of the loss ratio getting worse than a profitable level

Mulberri has won the following awards from Insurtech:

– – 2023 Insurtech Innovation Award for Best Insurtech Solution for PEOs and Brokers
– – 2023 Insurtech Rising Star Award
– – 2023 Insurtech Best of Show Award

To learn more about the Mulberri Risk Engine and get a demo , sign up at mulberri.io

The Federal Trade Commission is seeking to block biopharmaceutical giant Amgen Inc. from acquiring Horizon Therapeutics plc, saying the deal would allow Amgen to leverage its portfolio of blockbuster drugs to entrench the monopoly positions of Horizon medications used to treat two serious conditions, thyroid eye disease and chronic refractory gout.

The FTC filed a lawsuit in federal court this month to block the transaction, saying it would enable Amgen to use rebates on its existing blockbuster drugs to pressure insurance companies and pharmacy benefit managers (PBMs) into favoring Horizon’s two monopoly products – Tepezza, used to treat thyroid eye disease, and Krystexxa, used to treat chronic refractory gout. Neither of these treatments have any competition in the pharmaceutical marketplace.

“Rampant consolidation in the pharmaceutical industry has given powerful companies a pass to exorbitantly hike prescription drug prices, deny patients access to more affordable generics, and hamstring innovation in life-saving markets,” said FTC Bureau of Competition Director Holly Vedova. “Today’s action – the FTC’s first challenge to a pharmaceutical merger in recent memory – sends a clear signal to the market: The FTC won’t hesitate to challenge mergers that enable pharmaceutical conglomerates to entrench their monopolies at the expense of consumers and fair competition.”

The proposed acquisition is the largest pharmaceutical transaction announced in 2022. Given how central protecting and growing Tepezza and Krystexxa monopoly revenues are to the deal valuation Amgen calculated for Horizon, Amgen has strong incentives post-acquisition to raise Tepezza and Krystexxa rivals’ barriers to entry or dissuade them from competing as aggressively if and when they gain FDA approval, the agency argues. Amgen said it “remains committed” to completing the Horizon acquisition.

This action dovetails with other ongoing work at the Commission in response to widespread complaints about rebates and fees paid by drug manufacturers to PBMs and other intermediaries to favor high-cost drugs at the expense of lower cost drugs. As the Commission explained in a policy statement issued in June 2022, these financial relationships create numerous conflicts of interest and can shift costs and misalign incentives in a way that stifles competition from lower-cost or higher-quality drugs, thereby harming patients, doctors, health plans, and competition. The FTC’s market inquiry examining the business practices of PBMs is also ongoing.

California-based Amgen is one of the world’s largest biopharmaceutical companies, with global sales of about $24.8 billion and a product portfolio of 27 approved drugs, including blockbuster drugs Enbrel (for rheumatoid arthritis), Otezla (psoriasis), and Prolia (osteoporosis). The FTC said that “Amgen has for years built its pharmaceutical portfolio through acquisitions, thereby increasing its leverage with the insurers and PBMs that negotiate reimbursement for its products.”

Horizon, based in Dublin, Ireland and Deerfield, Illinois, is a global biotechnology company with about $3.6 billion in sales that focuses on medicines treating rare, autoimmune, and severe inflammatory diseases. Horizon markets and distributes 11 drug products in the United States, including Tepezza and Krystexxa.

In securities filings, Horizon has boasted that its Tepezza “has no direct approved competition,” and that Krystexxa “faces limited direct competition.” Because of this, Horizon charges extremely high prices for those medications – approximately $350,000 for a six-month course of treatment of Tepezza and approximately $650,000 for an annual supply of Krystexxa.

The FTC claims that Amgen has a history of leveraging its broad portfolio of blockbuster drugs to gain advantages over potential rivals. In particular, the company has engaged in cross-market bundling, which involves conditioning rebates (or offering incremental rebates) on products such as Enbrel in exchange for giving Amgen drugs preferred placement on the insurers’ and PBMs’ lists of covered medications in different product markets.

The value of the rebates that Amgen can offer on its high-volume drugs as part of its cross-market bundles may make it difficult, if not impossible, for smaller rivals who are developing drugs to compete against Tepezza and Krystexxa to match the level of rebates that Amgen would be able to offer.

By substituting Amgen, with its portfolio of blockbuster drugs and significant contracting leverage, for Horizon, the FTC said the deal could give the merged firm the ability and incentive to entrench Tepezza’s and Krystexxa’s monopolies through its multi-product contracting strategies. This could effectively deprive patients, doctors, and health plans from the benefits of competition and access to critical new options for treatment of thyroid eye disease and chronic refractory gout.

The Commission vote to authorize staff to seek a temporary restraining order and preliminary injunction was 3-0.

Last year the FTC launched an inquiry into the prescription drug middleman industry, requiring the six largest pharmacy benefit managers to provide information and records regarding their business practices. The agency’s inquiry will scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of prescription drugs. As part of this inquiry, the FTC will send compulsory orders to CVS Caremark; Express Scripts, Inc.; OptumRx, Inc.; Humana Inc.; Prime Therapeutics LLC; and MedImpact Healthcare Systems, Inc.

Cedars-Sinai Medical Center operates a nonprofit academic medical center in Los Angeles. Its total workforce exceeds 15,000 employees, including approximately 2,100 doctors and 2,800 nurses. Together, these employees provide medical care to thousands of patients per day and perform related administrative and operational functions.

Deanna Hodges began working for Cedars in 2000. Throughout her tenure, she worked in an administrative role with no patient care responsibilities. Her office was in an administration building Cedars owned about a mile from the main Cedars medical campus, though she occasionally visited the main medical campus in her capacity as an employee. A shuttle bus ran continuously between the main medical campus and the administration building, and many Cedars employees traveled between the two sites on a daily basis.

In 2007, Hodges was diagnosed with stage III colorectal cancer. She stopped working for a year and a half to undergo treatment, which included chemotherapy. The treatment was effective to rid her of cancer but left her with lingering side effects. These included unspecified allergies, a weakened immune system, and neuropathy – damage to the nerves resulting in an ongoing “tingling sensation” in her fingers and toes. None of these side effects limited her ability to perform her job functions, and she successfully returned to work for Cedars in 2009.

As an administrative employee without direct patient contact, plaintiff was under no obligation to get a flu vaccine when she was hired or when she returned from cancer treatment in 2009. This changed in 2017. That September, Cedars announced a new policy requiring all employees, regardless of their role, to be vaccinated by the beginning of flu season. This was the latest expansion to Cedars’s longstanding efforts to limit employee transmission of flu, which had become more urgent in recent years following multiple patient deaths relating to flu.

The expanded 2017 policy aligned with the recommendation of the United States Department of Health and Human Services Centers for Disease Control and Prevention (CDC) “that all U.S. health care workers get vaccinated annually against influenza.”

Her doctor wrote a note recommending an exemption for various reasons, including her history of cancer and general allergies. None of the reasons was a medically recognized contraindication to getting the flu vaccine.

Cedars denied the exemption request. Hodges still refused to get the vaccine. Cedars terminated her. Hodges sued Cedars for disability discrimination. Her complaint contained six causes of action, each alleged as a violation of FEHA or the public policy it manifests.

The trial court granted Cedars’s motion for summary judgment. The court of appeal affirmed in the published case of Hodges v. Cedars-Sinai Medical Center – B297864 (May 2023).

In her appellate briefing she identifies the elements of her prima facie discrimination claim as being those of a claim for physical disability discrimination. Citing Arteaga v. Brink’s, Inc. (2008) 163 Cal.App.4th 327, 344-345, a physical disability case which recites the elements of her prima facie claim as follows: “that she (1) suffered from a disability, or was regarded as suffering from a disability; (2) could perform the essential duties of the job with or without reasonable accommodations[;] and (3) was subjected to an adverse employment action because of the disability or perceived disability.”

Plaintiff argues her cancer history and neuropathy amount to a physical disability because they “make it impossible for her to work as she cannot work as she cannot get vaccinated. Her disabilities limited her ability to safely receive the vaccine.” To be clear, plaintiff admits her cancer history and neuropathy in no way otherwise limited her ability to work in 2017.

In moving for summary judgment, Cedars introduced evidence that plaintiff was not disabled and could not prove she was disabled. It offered official guidance from the CDC and testimony from Dr. Grein that there were only two medically recognized contraindications for getting the flu vaccine. None of the conditions listed on her exemption form were recognized contraindications for getting the flu vaccine.

The court of appeal concluded that “Judgment was proper on plaintiff’s disability discrimination cause of action because she failed to produce evidence sufficient to create a fact issue concerning an essential element of her prima facie case, i.e., her claimed disability or the perception by Cedars of disability. We therefore need not address the other elements of plaintiff’s prima facie case.”

“Even if plaintiff had made a prima facie case for discrimination of any kind (e.g., physical disability, medical condition, or otherwise), summary adjudication of her disability discrimination cause of action would still have been proper because Cedars presented a legitimate, nondiscriminatory reason for her termination, and plaintiff fails to argue the reason was pretextual.”

Elizabeth Castelo was employed by Xceed as its Controller and Vice President of Accounting. In November 2018, Xceed informed Castelo her employment would be terminated effective December 31, 2018. On November 19, 2018, the parties entered into an agreement entitled “Separation and General Release Agreement”, in which Xceed agreed to pay Castelo a severance payment in consideration for a full release of all claims, including “a release of age discrimination claims that she has or may have under federal and state law, as applicable.”

The release extended to all claims known and unknown “arising directly or indirectly from Employee’s employment with [Xceed] [and] the termination of that employment” including (among many other listed claims) “wrongful discharge[;] violation of public policy[;] . . . [and] violation of the California Fair Employment and Housing Act.” The parties agreed to waive the protections of Civil Code section 1542.

Castelo and Xceed signed the Separation Agreement on November 19, 2018. Attached as Exhibit A to the Separation Agreement was a document entitled “Reaffirmation of Separation and General Release Agreement” which was to be signed on the date of her separation, which was December 31, 2018.

It was undisputed Xceed management intended that Castelo would sign the Reaffirmation on the date of her separation. However, Castelo signed it on the same date she signed the main Separation Agreement, on November 19, 2018, and Xceed did nothing to correct that error. She was paid $137,334 for her signing this agreement as of the date of her separation.

Nonetheless Castelo sued her former employer Xceed Financial Credit Union (Xceed) for wrongful termination and age discrimination in violation of the Fair Employment and Housing Act (FEHA)

On October 3, 2019, the parties stipulated the action would be submitted to binding arbitration pursuant to an arbitration agreement executed in 2013. The court then dismissed the action without prejudice but retained jurisdiction to enter judgment on any arbitration award.

The matter was submitted to binding arbitration before Hon. Enrique Romero (ret.). Xceed filed a response to Castelo’s complaint alleging, among other things, Castelo’s action was barred by the release. Xceed also filed a cross-complaint and first amended cross-complaint, asserting claims for (1) breach of the Separation Agreement and Reaffirmation; (2) unjust enrichment; (3) reformation; (4) declaratory relief; and (5) promissory estoppel.

The arbitrator rejected Castelo’s assertion that since the release was signed on November 18, and that she was not wrongfully terminated until December 31, the release violated Civil Code section 1668, which prohibits pre-dispute releases of liability in some circumstances. The arbitrator granted summary judgment in favor of Xceed on the ground Castelo’s claims were barred by a release in her separation agreement.

Castelo moved to vacate the arbitration award, arguing the arbitrator exceeded his powers by enforcing an illegal release. The trial court denied the motion to vacate and entered judgment confirming the arbitration award. The Court of Appeal affirmed in the published case of Castelo v. Xceed Financial Credit Union – B311573 (May 2023).

The parties disagreed as to the proper scope of the court of appeal’s review. “Where, as here, an arbitrator has issued an award, the decision is ordinarily final and thus ‘is not ordinarily reviewable for error by either the trial or appellate courts.’ [Citation.] The exceptions to this rule of finality are specified by statute.

As relevant here, the [California Arbitration Act (CAA)] provides that a court may vacate an arbitration award when “[t]he arbitrators exceeded their powers and the award cannot be corrected without affecting the merits of the decision upon the controversy submitted.”

Castelo contends on appeal that the release, as interpreted and applied by the arbitrator, violates Civil Code section 1668 because it purported to release claims that accrued after Castelo signed the document. Castelo claims that the arbitrator exceeded his authority in giving effect to the illegal release and that this court must review the arbitrator’s and trial court’s decisions de novo.

The court of appeal noted that “Castelo does not claim the entire Separation Agreement and Reaffirmation is illegal. She does not seek to rescind the agreement and does not propose she return the $137,334.00 she received as consideration. Rather, she seeks to invalidate only the release, and only to the extent the arbitrator applied the release to claims that accrued on or after the date of its execution. Castelo’s argument that the arbitrator’s decision is subject to judicial review simply because the release is alleged to be illegal thus fails.”

The arbitrator explained the basis for this conclusion at length. Among other things, the arbitrator reasoned: “[T]he objectively-manifested intent of the Agreement was for Castelo to release all claims as of the date of signature (defined as the ‘Effective Date’ in the Agreement) in exchange for the payment of $5,000.00, and then extend that release through the Separation Date, December 31, 2018, for an additional $132,334.00.”

When the arbitrator then turned to whether the release, as interpreted, violated Civil Code section 1668 because Castelo executed the release before the claim for wrongful termination had fully accrued. “[¶] Even assuming arguendo that Castelo’s claim for wrongful termination did not accrue until her termination on December 31 and that the release affects the ‘public interest,’ this argument gains no traction.”

“The Agreement did not have, as its purpose, the immunization of Xceed from liability for a future violation of law. Rather, it clearly intended to, on December 31, 2018, effect the release of claims which had accrued on or before that date (i.e., an accrued claim for wrongful termination, and any other employment-related claim Castelo could bring). The Arbitrator declines to permit Castelo – who accepted the benefits under the Reaffirmation – to use her mistakenly-premature execution of the Reaffirmation to leverage this statute as a weapon against Xceed.”

Here the court of appeal noted “Castelo has not cited a single case in which section 1668 was invoked to invalidate a release of a claim that was known to the releasor at the time the release was executed and after a dispute had already arisen between the parties, and our review has revealed none.“

The court of appeal concluded “the arbitrator did not commit clear legal error in enforcing the release and the trial court did not err in denying the motion to vacate. The arbitrator’s enforcement of the release did not violate section 1668 because Castelo signed the release after the allegedly discriminatory decision was made and after Castelo had already concluded that she was being wrongfully terminated because of age discrimination.”