Drug Injury Watch

Products Recall: Philips Bi-Level PAP, CPAP, and Mechanical Ventilator Devices Using PE-PUR Sound Abatement Foam

For Patients with Polyester-based Polyurethane (PE-PUR) Exposures, Potential Health Risks Include Cancers and Organ Failures

 

(Posted by Tom Lamb at Drug Injury Watch)

 

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UPDATE: On June 30, 2021 the FDA issued this document to alert and inform patients, "Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication", which listed the Philips Respironics ventilators, BiPAP, and CPAP machines manufactured between 2009 and April 26, 2021 that are covered by the June 2021 Philips products recall.

(6/30/2021)

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In June 2021, the healthcare technology company Royal Philips issued a products recall for certain Philips Bi-Level PAP, CPAP, and Mechanical Ventilator devices due to possible toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in these Philips products.  From our perspective,  a few cancers and some organ failures are the most serious possible medical conditions for patients with toxic exposures of PE-PUR from these Philips products.

We start with this June 14, 2021 document, "Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices", with this stated purpose at the outset:

[P]rovides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

From these excerpts from that June 2021 Philips recall notification, we get some important details:

• Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.
• Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.

In a separate document, "Medical Device recall notification (U.S. only) / field safety notice (International Markets)", from Philips Respironics, there is some product identification information about the various Philips Bi-Level PAP, CPAP, and Mechanical Ventilator devices affected by this June 2021 Philips products recall -- as well as what Philips products are not affected by this recall, and why.

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For another viewpoint on this Philips medical device safety issue, we refer you to this June 23, 2021 document issued by the United Kingdom's Medicines and Healthcare products Regulatory Agency, "National Patient Safety Alert: Philips ventilator, CPAP and BiPAP devices: Potential for patient harm due to inhalation of particles and volatile organic compounds".

Based on current information, here are the most serious possible related medical conditions for a patient with past harmful particulate exposures and/or chemical exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in the recalled Philips Bi-Level PAP, CPAP, and Mechanical Ventilator devices:

Cancers, such as:

-- Lung Cancer
-- Liver Cancer
-- Kidney Cancer

Organ Failures, such as:

-- Liver Failure
-- Kidney Failure

We are investigating product liability lawsuits against Philips for patients with toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in the Philips products recalled in June 2021.  These lawsuits could be personal injury cases or wrongful death cases, depending on the facts.

If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips. You can use our online Philips Breathing Devices Case Evaluation Form or, if you prefer, call us on our toll-free number, 800-426-9535.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Tasigna Drug Injury Lawsuits Consolidated for Pretrial Proceedings: June 2021 Update

New Jersey Tasigna Multi-county Litigation (MCL), Federal Court Tasigna Multidistrict Litigation (MDL)

 

(Posted by Tom Lamb at Drug Injury Watch)

 

In early June 2021, the New Jersey Supreme Court consolidated Tasigna drug injury lawsuits filed against Novartis Pharmaceuticals Corp. before one judge for pretrial proceedings as part of a New Jersey state court multi-county litigation (MCL). And in July 2021 the U.S. Judicial Panel on Multidistrict Litigation (JPML) is expected to hear arguments in support of a request that all Tasigna drug injury lawsuits filed in the U.S. federal court system be consolidated as a Tasigna multidistrict litigation (MDL). All of these Tasigna lawsuits involve alleged Tasigna side effects suffered by patients.  These two Tasigna litigations are often referred to, respectively, as the New Jersey Tasigna MCL and the federal court Tasigna MDL.

Tasigna (nilotinib) was approved by the FDA in 2007 for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). Tasigna has been linked to atherosclerosis, which is a disease that results in thickening, hardening, and blocking of the arteries due to the buildup of plaque. In turn, strokes, heart attacks, and lower limbs amputations can be Tasigna side effects as these are serious medical conditions that can result from, or are secondary to, atherosclerosis-related diseases.

In more detail, the following medical conditions are considered to be atherosclerosis-related diseases:

• peripheral arterial disease (PAD) involving lower limbs;
• peripheral arterial occlusive disease (PAOD);
• ischemic heart disease; and
• ischemic cerebrovascular disease.

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As background, in Canada the drug company Novartis Pharmaceuticals has issued stronger warnings about atherosclerosis-related diseases being Tasigna side effects — compared to what is found on the US version of the Tasigna drug label. This situation has given rise to the contention that warnings about Tasigna side effects in the current US drug label are insufficient, or a failure to adequately warn. In turn, Tasigna drug injury lawsuits have been filed against Novartis here in the U.S.

For more, you can read one or both of these two earlier articles about Tasigna side effects from back in 2018:

1. Tasigna Side Effects Include Ischemic Cerebrovascular Events, Ischemic Heart Disease, And Peripheral Arterial Occlusive Disease -- Less Warning About These Atherosclerosis-Related Diseases By Novartis In The US, It Seems, Compared To What Has Been Done By The Drug Company In Canada
2. Tasigna And Atherosclerosis-Related Diseases: A Snapshot Of The Medical Literature From Back In April 2013 -- Despite Evidence That Tasigna Accelerates Atherosclerosis, Novartis Does Little To Warn Doctors And Patients In The US

We are currently investigating Tasigna side effects cases as possible Tasigna drug injury lawsuits against Novartis for patients who have developed any of the medical conditions mentioned above during their use of Tasigna.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Beovu Vision Loss Side Effects Continue to Plague Novartis, Ending 3 Key Clinical Trials in May 2021

And Novartis "has yet to identify the root cause behind Beovu’s safety problem", According to a News Report

 

(Posted by Tom Lamb at Drug Injury Watch)

 

Starting back in February 2020, when the American Society of Retinal Specialists (ASRS) issued a note to members about 14 cases of retinal vasculitis, Beovu vision loss side effects have handed Novartis setbacks in its efforts to capture market share from Eylea. And in late May 2021, the latest development concerning Beovu safety issues has resulted in Novartis ending three key clinical trials, MERLIN, RAPTOR, and RAVEN.

To begin our coverage of what happened with these three terminated Beovu clinical trials, we turn to this June 1, 2021, FiercePharma news report, "Novartis calls off 3 Beovu trials testing more frequent dosing on concerns of vision-threatening side effect":

The Merlin trial, as well as the Raptor and Raven studies, were testing Beovu given every four weeks. The drug currently carries an FDA label for dosing every eight to 12 weeks after three initial monthly loading doses....

Novartis launched the Merlin trial to see if the more frequent dosing could help age-related macular degeneration patients who still have unresolved retinal fluid despite anti-VEGF therapy. On the efficacy front, 6 mg monthly Beovu matched up to 2 mg monthly Eylea in change in visual acuity after one year of treatment. The drug also bested Eylea on some anatomical secondary endpoints, Novartis said.

But Beovu doubled the rate of intraocular inflammation compared with [Eylea], with 9.3% percent of patients suffering the complication in the Beovu trial arm. That compared with 4.5% for Eylea. None of the Eylea patients developed reginal vasculitis or retinal vascular occlusion, while those side effects happened in 0.8% and 2% of Beovu patients, respectively. The problem could potentially damage a person’s vision.

In Merlin, the rate of vision loss from any cause was 4.8% for Beovu patients and 1.7% for Eylea patients....

The company has yet to identify the root cause behind Beovu’s safety problem.

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You can learn more about these three terminated Beovu clinical trials, MERLIN, RAPTOR, and RAVEN, by looking at their respective pages over at the CliniclTrials.gov website (accessed June 1, 2021):

• Study of safety and efficacy of brolucizumab 6 mg dosed every 4 weeks compared to aflibercept 2 mg dosed every 4 weeks in patients with retinal fluid despite frequent anti-VEGF injections (MERLIN).
• Assessing the efficacy and safety of brolucizumab versus aflibercept in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (RAPTOR). 
• Assessing the efficacy and safety of brolucizumab versus aflibercept in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (RAVEN). 

For a concise characterization of this latest Beovu vision loss side effects development, here is the beginning of a June 1, 2021 article by Endpoints News Senior Editor Amber Tong:

Safety concerns have forced Novartis to slam the brakes on a trio of late-stage clinical studies for its eye drug Beovu, marring grand ambitions to challenge the throne currently occupied by Regeneron’s Eylea.

If one is interested in how Novartis is seeking to present the current status of its lingering Beovu safety issues, this is their May 28, 2021, Media Release item: "Novartis reports one year results of Phase III MERLIN study evaluating Beovu® every four week dosing and provides update on Beovu clinical program". Significantly, it includes this statement:

Novartis has proactively communicated these data to health authorities and will pursue an update to the Beovu prescribing information globally.

We are watching for this forecasted Beovu label change which will, presumably, add new and updated warnings about Beovu vision loss side effects.

In the meanwhile, for background, we point out our June 17, 2020 article, "Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020".

On a different front, we continue to investigate drug injury lawsuits against Novartis for Beovu when causing vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, and intraocular inflammation. As we have reported previously, starting in January 2021, Beovu lawsuits have been filed for patients alleging Novartis failed to warn doctors and patients about these Beovu vision loss side effects.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)