Women Cancer Victims Opposed to Johnson & Johnson's 'Texas Two-Step' Bankruptcy Ploy Urge Passage of Reforms Introduced by Warren, Durbin, Nadler, Blumenthal, and Maloney

More than 30,000 women cancer victims would retain their constitutional right to have juries decide if talc in Johnson & Johnson's (NYSE:JNJ) baby products caused their ovarian cancer under bankruptcy reforms proposed Wednesday by key lawmakers in the U.S. Senate and House of Representatives.

The Nondebtor Release Prohibition Act of 2021 would close controversial bankruptcy loopholes, including non-consensual third-party releases and the so-called "Texas Two-Step." Recent media reports indicate that Johnson & Johnson – with a market cap of more than $400 billion – is contemplating bankruptcy to avoid paying claims and damages that would likely cost a fraction of that amount. In a quarterly earnings report issued this week, J&J announced sales of $23.31 billion , a 27 percent increase year over year, and upgraded its annual sales forecast to $94.6 billion .

"Many of us are shocked that Johnson & Johnson would consider abusing the bankruptcy process to avoid caring for the women and families they've harmed," says Deane Berg , whose 2013 trial resulted in the first jury verdict establishing a link between talcum powder and ovarian cancer. "Before we were harmed by J&J, we were loyal J&J customers. They've turned their back on all of us."

Dozens of studies published in peer-reviewed journals during the past 25 years have shown a statistically significant association between talc use and ovarian cancer and mesothelioma. Documents produced at trial show that the company was aware of the dangers as far back as the 1960s.

The bankruptcy reform proposal introduced by Sen. Elizabeth Warren (D-Mass.), Sen. Richard Durbin (D-Ill.) and Sen. Richard Blumenthal (D-Conn.) in the Senate, and Rep. Jerrold Nadler (D-N.Y.) and Rep. Carolyn Maloney (D-N.Y.) in the House, would address a growing trend in which a profitable company is able to quickly corral legal liabilities and debts into a separate corporate entity. Known as a "divisive merger" or the "Texas Two-Step," the liability-laden subsidiary is then reincorporated elsewhere and eventually declared bankrupt. The threat of bankruptcy is used to intimidate individuals who file lawsuits and to drive down the value of negotiated settlements.

"These conscientious and well-informed lawmakers recognize that allowing highly profitable companies to shirk their responsibilities to society is reprehensible and can't be tolerated," says Andy Birchfield , Mass Tort Section Head at the Beasley Allen Law Firm, which represents thousands of women diagnosed with ovarian cancer after exposure to Johnson & Johnson Baby Powder and other talc-based products. "The courts – not the federal bankruptcy system – are the proper forum for resolving disputes between wrongdoers and the people they injure."

The Nondebtor Release Prohibition Act would prohibit bankruptcy judges from allowing companies that are not a party to gain non-consensual releases of liability as part of the bankruptcy process. This tactic allows corporations to employ bankruptcy as a shield against liability. The legislation aligns with other proposed legislation – dubbed the SACKLER Act – introduced by Rep. Maloney.

In addition, bankruptcy filings often result in indefinite delays that freeze ongoing lawsuits in state and federal courts. Sen. Warren's bill would limit stays for a duration of only 90 days.

"These legislators should be applauded for recognizing the need to close the loopholes that allow powerful individuals and successful corporations to play blame-shifting with people's lives," says Michelle Parfitt , co-lead counsel in the federal talc MDL and a senior partner in the law firm Ashcraft & Gerel. "Whether it's a baby powder, a pharmaceutical or any other dangerous product, consumers need to be able to gain adequate compensation for any losses and injuries they've suffered. Without these proposals, that fundamental tenet of our justice system is at risk."

About the Beasley Allen Law Firm
Headquartered in Montgomery, Alabama , Beasley Allen is comprised of more than 70 attorneys and 200 support staff. One of the largest Plaintiffs law firms in the country, Beasley Allen is a national leader in civil litigation, with verdicts and settlements of more than $26 billion . For more information visit www.beasleyallen.com .

About the Ashcraft & Gerel Law Firm
Washington, D.C. -based Ashcraft & Gerel, LLP was first developed in 1953. The goal of the law firm is to help those who have been injured while on the job. Since its founding, this law firm has become one of the largest and most well-known personal injury firms in the U.S.

Contact:
Mark Annick
mark@androvett.com
800-559-4534

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SOURCE Beasley Allen Law Firm

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Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

  • FDA Breakthrough Device Designation Awarded to AVIM Therapy
  • FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline.

Q1 2025 Highlights:

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Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

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New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

Star Jones , award winning television personality & women's heart health advocate,   helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign

A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.

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Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

  • One-year clinical trial data for the next-generation, investigational, Sphere-360â„¢ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9â„¢ catheter demonstrates efficacy for linear ablation in persistent AFib
  • Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Afferaâ„¢ family of technologies, including the next-generation Sphere-360â„¢ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9â„¢ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelectâ„¢ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugoâ„¢ robotic-assisted surgery (RAS) system.

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Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success

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