FDA Warns 350 Deaths Linked To Philips CPAP Machines

FDA Warns 350 Deaths Linked To Philips CPAP Machines
Sun, 02/12/2023 - 20:55

According to a recent assessment by federal authorities, the disintegration of sound abatement foam in recalled Philips CPAP sleep apnea devices has been connected to roughly 350 fatalities and nearly 100,000 claims of health issues among former users.

Following widespread reports of small black particles being found in the tubing and face masks, which were released by a polyester-based polyurethane (PE-PUR) foam intended to reduce noise and vibrations while the sleep apnea machines were used at night, a Philips CPAP recall was issued in 2021, affecting millions of machines sold since 2009.

As a result of the potential CPAP foam health risks, federal health officials immediately advised all consumers to stop using the recalled machines, unless necessary for life-sustaining therapy, and reports of former users developing various cancers, lymphoma, lung damage, and other injuries linked to the toxic chemicals and gases released as the sound abatement foam degraded began to surface.

Thousands of Philips CPAP claims have been filed across the federal court system, and it is widely believed that the litigation will quickly become one of the greatest mass torts in the United States.

The US Food and Drug Administration published an update on the current number of medical device reports received by the agency that are associated with PE-PUR foam deterioration in recalled Philips CPAP equipment on February 9.

Since April 2021, the FDA has received more than 98,000 medical device reports related to exposure to recalled sleep apnea equipment, as well as recalled ventilators and BiPAP machines. This figure contains 346 instances of fatalities connected to foam particles.

According to the FDA update, the MDRs received comprised both mandated reports from Philips and voluntary reports from health professionals, customers, and patients. Cancer, pneumonia, asthma, other respiratory issues, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest discomfort have all been observed in these MDRs.

The information comes after Philips revealed in December that it had conducted its own evaluation of the recalled DreamStation CPAP devices, concluding that the health risks posed by PE-PUR foam are negligible. However, Philips recognised at the time that the FDA's interpretation of the evidence may differ.


Roughly $2M Opioid Settlement For Marinette County

Roughly $2M Opioid Settlement For Marinette County
Thu, 02/09/2023 - 18:59

Marinette County, as one of the plaintiffs in a case against a dozen pharmaceutical corporations, could collect a roughly $2 million opioid settlement over an 18-year period.

In his monthly report last week, County Administrator reminded supervisors that in 2017, the county, along with the Wisconsin Counties Association, entered a statewide lawsuit against seven pharmaceutical firms for their participation in the opioid crisis. Marinette County will get an anticipated total of $1.13 million over an 18-year period, according to him. He said that five additional corporations had settled, which may bring the county another $850,000 if the board votes to join that deal in roughly two months.

According to the administrator, the county is currently gathering information on how the cash may be used. He added that the county agencies that have been and will be entrusted with dealing with the opioid crisis will have a place at the table to determine how the settlement monies will be spent, and that whatever plan the county comes up with will evolve over the next 18 years.

An official from the Health and Human Services Department has been designated to attend discussions about how the cash can be used. Marinette County has already received $237,667.63 in settlement funds by 2022, according to the administrator. He stated that the city of Marinette is also a defendant in the case.


Vets Seek Dismissal Of 3M Bankruptcy Over Earplugs Suits

Vets Seek Dismissal Of 3M Bankruptcy Over Earplugs Suits
Mon, 02/06/2023 - 16:28

Soldiers who claim they lost a hearing because of malfunctioning 3M earplugs urged an Indiana judge to dismiss a 3M subsidiary's bankruptcy lawsuit, claiming it was as unjustified as a Johnson & Johnson unit's failed bankruptcy application.

A committee representing over 200,000 veterans and active-duty service members with claims against 3M Co. told an Indiana bankruptcy judge that 3M subsidiary Aearo Technologies LLC's bankruptcy filing is heavily reliant on a series of rulings that allowed J&J's talc unit to continue its bankruptcy case. However, the Third Circuit overruled both findings and ordered the bankruptcy case to be dismissed, and the military members believe the Indiana court should do the same.

It's impossible to imagine a more straightforward move than LTL Management LLC referring to the J&J business that declared bankruptcy. In almost every case, the names 'LTL' and 'J&J' could easily be substituted with 'Aearo' and '3M,' and the analysis would be spot on. To the degree that there are disparities, they either support dismissal more strongly or are unimportant.

The LTL bankruptcy occurred at a time when the business was dealing with billions of dollars in liabilities due to J&J's talc products, which tens of thousands of patients alleged caused mesothelioma, ovarian cancer, and other terrible illnesses. On Jan. 30, the Third Circuit rejected the Chapter 11 complaint, stating that the firm could not be in financial difficulty given a valued funding deal with its parent company and J&J itself.

The service members said that the LTL funding arrangement served as a model for 3M's funding agreement with Aearo, which was signed one day before Aearo declared bankruptcy. The 3M agreement assures that Aearo will stay functioning, independent of the continuing dispute against 3M's Combat Arms Earplugs Version 2, according to military personnel.

They also claimed that Aearo's bankruptcy was not filed in good faith, claiming that 3M was utilizing the bankruptcy process to gain a tactical edge in the hundreds of outstanding litigation cases involving their military earplugs. According to the military members, Aearo filed for bankruptcy after juries awarded over $300 million in damages to service members in 13 bellwether cases.

Aearo's counsel did not immediately reply to a request for comment, but 3M justified the Aearo bankruptcy as helping to decrease the expense and time necessary to resolve the earplug lawsuits on an individual basis.

If the motion to dismiss is granted and maintained on appeal, it will unnecessarily disrupt the well-established Chapter 11 process by returning to prolonged litigation under the mass tort system, which has not offered clarity or certainty after sixteen trials to date, Aearo said in a statement.