Latest news with #FDA-regulated
Yahoo
21-05-2025
- Business
- Yahoo
J&J subsidiary ordered to pay $147M for violating antitrust rules
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. A California jury ruled on Friday that Biosense Webster, a subsidiary of Johnson & Johnson, broke antitrust rules by withholding clinical support to hospitals using reprocessed catheters. The lawsuit was filed by medical device reprocessing firm Innovative Health in 2019. The jury awarded Innovative Health more than $147 million in damages, according to court documents. Law360 first reported the verdict on Friday. The Association of Medical Device Reprocessors said in a Sunday statement that the decision is a 'victory for America's hospitals, providers, patients, and the environment.' A Johnson & Johnson spokesperson wrote in an emailed statement that the company disagrees with the jury's decision and is evaluating all legal options, including appeal. Trade group AMDR said the lawsuit brings 'potentially anticompetitive" tactics by original equipment manufacturers under closer examination. 'For too long, Johnson & Johnson has used tying arrangements and other tactics to interfere with fair competition from lower-cost, FDA-regulated, reprocessed 'single-use' devices,' AMDR CEO Daniel Vukelich said in a statement. Scottsdale, Arizona-based Innovative Health first filed the case against Biosense Webster in 2019, claiming the company has a monopoly on heart-mapping catheters. In the complaint, Innovative Health claimed that Biosense Webster tied clinical support to purchases of high-density mapping catheters and ultrasound catheters used with its Carto 3 cardiac mapping system. Biosense Webster accounts for more than half of cardiac mapping systems installed in the U.S., according to the complaint. Biosense Webster received FDA clearance to sell catheters for single use by hospitals, and Innovative Health received FDA clearance to reprocess and sell the catheters one to three additional times before disposal. Reprocessed devices are equipment that has been used in a procedure and have been disinfected or sterilized. A technician must operate the cardiac mapping system software when a physician performs a procedure. In the past, system manufacturers had provided training for hospital staff to provide their own case coverage, but Biosense Webster has run a program for more than 10 years where clinical account specialists provide case coverage free of charge, according to the complaint. Innovative Health alleges in the complaint that Biosense Webster had a written policy of refusing to provide case coverage by its account specialists for these catheters when reprocessed by competitors. Other medical device manufacturers, such as Abbott, provide clinical support for their mapping machines regardless of who provides the catheters used for the procedure, according to the complaint. Innovative Health sought damages and injunctive relief. J&J is reviewing the verdict. 'We continue to believe our actions are pro-competitive and meet our responsibility to ensure patient safety and product performance,' a J&J spokesperson wrote in a statement. Recommended Reading 4 PFA studies in the spotlight at Heart Rhythm 2025 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
American Military News
19-05-2025
- Health
- American Military News
Video: Major chemical to be removed from kids' drugs
The Food and Drug Administration (FDA) announced last week that the agency will be taking action to remove prescription drug products with ingestible fluoride for children from the market. In a Department of Health and Human Services press release last Tuesday, President Donald Trump's administration confirmed that the FDA would be taking action after studies have shown that ingestible fluoride can 'alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood.' The press release also noted that studies have indicated that there may be a connection between fluoride and weight gain, thyroid disorders, and a decreased IQ. The FDA explained that unlike fluoride's inclusion in toothpaste and mouth rinses, child drug products with ingestible fluoride, which have not been approved by the agency, are 'swallowed and ingested by infants and toddlers.' In a video statement highlighting the FDA's action against ingestible fluoride in children's prescription drugs, Makary warned that drugs containing fluoride are currently 'prescribed to infants as young as six months of age.' Today, the FDA is taking action to remove concentrated ingestible fluoride prescription drug products for children from the market. A growing body of research is demonstrating how ingested fluoride can alter the gut microbiome. This is especially concerning with young children… — Dr. Martin Makary (@DrMakaryFDA) May 13, 2025 'The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child's microbiome,' FDA Commissioner Marty Makary said. 'For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child's health.' READ MORE: Video: Trump order against 'Big Pharma' aims to reduce drug prices 'I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area,' Makary added. 'When it comes to children, we should err on the side of safety.' In last week's press release, the FDA announced that it would complete a safety review and public comment period by October 31 and that the agency would take 'appropriate action' regarding the removal of ingestible fluoride prescription drug products for children from the market. In a statement on X, formerly Twitter, Health and Human Services Secretary Robert F. Kennedy Jr. expressed his support for the FDA's action against ingestible fluoride in children's drugs. He explained that a recent review of 74 'high-quality studies' discovered a 'clear association between fluoride exposure and reduced IQ in children.' 'This isn't fringe science—this is mainstream, peer-reviewed data,' Kennedy tweeted. 'Yes, when it comes to children, we should always err on the side of safety.'
Yahoo
19-05-2025
- Business
- Yahoo
Innovative Health awarded $147m in antitrust lawsuit against J&J's Biosense Webster
Innovative Health has been awarded $147m in damages from a lawsuit against Biosense Webster relating to the Johnson & Johnson (J&J) business's policy to withhold cardiac mapping support services from hospitals that chose to purchase reprocessed catheters from Innovative instead of Biosense's new devices. Originally seeking $143m in damages, Innovative first filed its lawsuit in 2022, arguing that Biosense's policy unfairly restricted competition and violated both the Sherman Act and California's Cartwright Act that prohibit market monopolisation. Initially dismissed in 2022, the case was later revived by the Ninth Circuit in 2023, paving the way for a jury trial. Delivering a unanimous verdict in a California court, a federal jury found that J&J subsidiary Biosense Webster violated federal and state antitrust laws by withholding clinical support to hospitals using Innovative Health's FDA-regulated, reprocessed catheters. Daniel J Vukelich, president and CEO of the Association of Medical Device Reprocessors (AMDR), commented: 'For too long, J&J has used tying arrangements and other tactics to interfere with fair competition from lower-cost, FDA-regulated, reprocessed 'single-use' devices (SUD). 'We hope this jury's message will be heard loud and clear: hospitals want to reduce costs and greenhouse gas emissions by using more reprocessed SUDs without fear of retribution by their original equipment manufacturers (OEMs).' Accompanying Vukelich's remarks, AMDR advised hospitals to add guardrails to their processes and reminded them that OEMs cannot lawfully revoke support, void warranties, withdraw service, or otherwise retaliate for using FDA-regulated reprocessed SUDs. The AMDR said: "Make it a policy to document and escalate any such threat and remind sales reps this activity is illegal and will not be tolerated." Other AMDR advisements included tracking SKU pricing over time across vendors to skirt potential price-gouging practices on OEMs' re-processable equipment models and to 'explicitly deny' any equipment updates that "just happen" to block reprocessed devices or force obsolescence. The AMDR concluded: "Adopt these guardrails as formal policy, train staff to spot violations, and remind OEM partners that the rules of engagement have changed – hospitals will no longer put up with anti-reprocessing sabotage." Medical Device Network has reached out to Innovative Health and J&J for comment on the lawsuit. "Innovative Health awarded $147m in antitrust lawsuit against J&J's Biosense Webster" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
18-05-2025
- Business
- Yahoo
Statement On $147M Verdict for AMDR Member Innovative Health Against Johnson & Johnson's Biosense Webster Medical Technology Unit
WASHINGTON & BERLIN, May 18, 2025--(BUSINESS WIRE)--Association of Medical Device Reprocessors issued the following statement: Friday's unanimous verdict by a federal jury in Santa Ana, California for Innovative Health against Johnson & Johnson (NYSE: JNJ) is a victory for America's hospitals, providers, patients, and the environment. The jury found that Biosense Webster violated federal and state antitrust laws by withholding clinical support to hospitals using Innovative Health's FDA regulated, reprocessed catheters. "For too long, Johnson & Johnson has used tying arrangements and other tactics to interfere with fair competition from lower cost, FDA regulated, reprocessed 'single-use' devices (SUDs)," said Daniel J. Vukelich, President and CEO, Association of Medical Device Reprocessors. "We hope this jury's message will be heard loud and clear: hospitals want to reduce costs and greenhouse gas emissions by using more reprocessed SUDs without fear of retribution by their original equipment manufacturers (OEMs)." Reprocessed SUDs are domestic devices, and domestic devices make hospitals stronger By having the freedom to choose FDA regulated reprocessed SUDs, hospitals reduce costs, waste, and greenhouse gas emissions. When using reprocessed SUDs, hospitals also help address supply chain resilience issues that were illuminated by COVID and could be made worse by tariffs. How to Stop OEM Anti-Reprocessing Tactics: Proactive Steps for Hospitals For decades, AMDR and its member companies have reported potentially anticompetitive market manipulation tactics by some OEMs. This case brings these tactics under closer examination. Hospitals, particularly procurement staff, should pay close attention to these activities and take proactive steps to combat them. Threats to void warranties or case support OEMs cannot lawfully revoke support, void warranties, withdraw service, or otherwise retaliate for using FDA-regulated reprocessed SUDs. Make it policy to document and escalate any such threat and remind sales reps this activity is illegal and will not be tolerated. Unapproved software updates that disable reprocessed devices Protect your consoles and generators: require written hospital approval before any OEM software upgrade is installed. Explicitly deny updates that "just happen" to block reprocessed devices or force obsolescence, and audit firmware versions after service visits. "Chipping" or ePROMs that brick reprocessed devices Bar OEMs that use embedded chips or ePROM programming that disable reprocessed devices or shortens their life. Require advance disclosure of any device-identification or authentication features, make chip-based lock-outs a breach of contract, and reject products that rely on forced-obsolescence coding. Contract clauses that restrict reprocessing When negotiating contracts, particularly those including volume-based discounts, calculate the hidden cost of losing reprocessing savings. Refuse language that conditions "free" equipment or discounts on exclusive use of new SUDs and run all proposals past legal/procurement for anti-competitive red flags. Price gouging on the "reprocessable" model Track SKU pricing over time and across vendors. If an OEM inflates the price of its reprocessable version to steer you to a non-reprocessable device, document it consider switching suppliers. Interference with hospital assets Ban any practice that sabotages your inventory: replacing cables without permission, hiding or discarding reprocessed-device bins, rearranging stock to favor new SUDs, or instructing clinicians to destroy hospital property. Treat such actions as asset tampering and revoke vendor access privileges immediately. Publication or use of misleading "dirty device" studies If a rep circulates OEM-funded studies, especially any that have been retracted or flagged for bias, suspend their access pending a formal review, and share the incident with infection-control and value-analysis committees. Adopt these guardrails as formal policy, train staff to spot violations, and remind OEM partners that the rules of engagement have changed – hospitals will no longer put up with anti-reprocessing sabotage. AMDR is conferring with its members, and considering legal options, to push back forcefully against behaviors like those described above and identified in Innovative Health, LLC v. Biosense Webster, Inc. About AMDR The Association of Medical Device Reprocessors (AMDR) is the global trade association for the regulated, commercial "single-use" device reprocessing and remanufacturing industry. AMDR members serve over 9,400 hospitals and surgical centers in the U.S., Canada, Europe, Japan and Australia. Founded in 1997, AMDR advocates for reprocessing and remanufacturing as an important healthcare strategy that helps hospitals and healthcare providers to strengthen the supply chain while simultaneously reducing costs, waste, and emissions. AMDR protects the interests of its members in regulation, legislation, and standard-setting. AMDR protects the interests of its members in regulation, legislation, and standard-setting. AMDR members include Arjo ReNu Medical, Innovative Health, Medline Renewal, Stryker's Sustainability Solutions, Sustainable Technologies (a Cardinal Health Business), and Vanguard AG. Having played a key role in the establishment of the reprocessing industry, AMDR continues to push the global medical technology industry, leading the way for remanufacturing to play a defining role in the evolution of new device technologies. View source version on Contacts David SheonVP External Affairs202-422-6999dsheon@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18-05-2025
- Business
- Yahoo
Statement On $147M Verdict for AMDR Member Innovative Health Against Johnson & Johnson's Biosense Webster Medical Technology Unit
WASHINGTON & BERLIN, May 18, 2025--(BUSINESS WIRE)--Association of Medical Device Reprocessors issued the following statement: Friday's unanimous verdict by a federal jury in Santa Ana, California for Innovative Health against Johnson & Johnson (NYSE: JNJ) is a victory for America's hospitals, providers, patients, and the environment. The jury found that Biosense Webster violated federal and state antitrust laws by withholding clinical support to hospitals using Innovative Health's FDA regulated, reprocessed catheters. "For too long, Johnson & Johnson has used tying arrangements and other tactics to interfere with fair competition from lower cost, FDA regulated, reprocessed 'single-use' devices (SUDs)," said Daniel J. Vukelich, President and CEO, Association of Medical Device Reprocessors. "We hope this jury's message will be heard loud and clear: hospitals want to reduce costs and greenhouse gas emissions by using more reprocessed SUDs without fear of retribution by their original equipment manufacturers (OEMs)." Reprocessed SUDs are domestic devices, and domestic devices make hospitals stronger By having the freedom to choose FDA regulated reprocessed SUDs, hospitals reduce costs, waste, and greenhouse gas emissions. When using reprocessed SUDs, hospitals also help address supply chain resilience issues that were illuminated by COVID and could be made worse by tariffs. How to Stop OEM Anti-Reprocessing Tactics: Proactive Steps for Hospitals For decades, AMDR and its member companies have reported potentially anticompetitive market manipulation tactics by some OEMs. This case brings these tactics under closer examination. Hospitals, particularly procurement staff, should pay close attention to these activities and take proactive steps to combat them. Threats to void warranties or case support OEMs cannot lawfully revoke support, void warranties, withdraw service, or otherwise retaliate for using FDA-regulated reprocessed SUDs. Make it policy to document and escalate any such threat and remind sales reps this activity is illegal and will not be tolerated. Unapproved software updates that disable reprocessed devices Protect your consoles and generators: require written hospital approval before any OEM software upgrade is installed. Explicitly deny updates that "just happen" to block reprocessed devices or force obsolescence, and audit firmware versions after service visits. "Chipping" or ePROMs that brick reprocessed devices Bar OEMs that use embedded chips or ePROM programming that disable reprocessed devices or shortens their life. Require advance disclosure of any device-identification or authentication features, make chip-based lock-outs a breach of contract, and reject products that rely on forced-obsolescence coding. Contract clauses that restrict reprocessing When negotiating contracts, particularly those including volume-based discounts, calculate the hidden cost of losing reprocessing savings. Refuse language that conditions "free" equipment or discounts on exclusive use of new SUDs and run all proposals past legal/procurement for anti-competitive red flags. Price gouging on the "reprocessable" model Track SKU pricing over time and across vendors. If an OEM inflates the price of its reprocessable version to steer you to a non-reprocessable device, document it consider switching suppliers. Interference with hospital assets Ban any practice that sabotages your inventory: replacing cables without permission, hiding or discarding reprocessed-device bins, rearranging stock to favor new SUDs, or instructing clinicians to destroy hospital property. Treat such actions as asset tampering and revoke vendor access privileges immediately. Publication or use of misleading "dirty device" studies If a rep circulates OEM-funded studies, especially any that have been retracted or flagged for bias, suspend their access pending a formal review, and share the incident with infection-control and value-analysis committees. Adopt these guardrails as formal policy, train staff to spot violations, and remind OEM partners that the rules of engagement have changed – hospitals will no longer put up with anti-reprocessing sabotage. AMDR is conferring with its members, and considering legal options, to push back forcefully against behaviors like those described above and identified in Innovative Health, LLC v. Biosense Webster, Inc. About AMDR The Association of Medical Device Reprocessors (AMDR) is the global trade association for the regulated, commercial "single-use" device reprocessing and remanufacturing industry. AMDR members serve over 9,400 hospitals and surgical centers in the U.S., Canada, Europe, Japan and Australia. Founded in 1997, AMDR advocates for reprocessing and remanufacturing as an important healthcare strategy that helps hospitals and healthcare providers to strengthen the supply chain while simultaneously reducing costs, waste, and emissions. AMDR protects the interests of its members in regulation, legislation, and standard-setting. AMDR protects the interests of its members in regulation, legislation, and standard-setting. AMDR members include Arjo ReNu Medical, Innovative Health, Medline Renewal, Stryker's Sustainability Solutions, Sustainable Technologies (a Cardinal Health Business), and Vanguard AG. Having played a key role in the establishment of the reprocessing industry, AMDR continues to push the global medical technology industry, leading the way for remanufacturing to play a defining role in the evolution of new device technologies. View source version on Contacts David SheonVP External Affairs202-422-6999dsheon@ Sign in to access your portfolio
