Global Justice Network (GJN) and Italian consumer rights organisation ADUSBEF are promoting a “first-ever Europe-wide class action” against Philips, reaching out to over a million potential claimants who have used the Dutch company’s ventilators suspected of releasing harmful chemicals.
GJN and ADUSBEF invited consumers who have used the company’s Continuous Positive Airway Pressure (CPAP) respiratory devices to join the class action.
Those Philips ventilators, used by patients suffering from respiratory problems including sleep apnea, were withdrawn from the market in 2021, following concerns that their polyester-based polyurethane (PE-PUR) foam used to reduce noise was degrading and releasing harmful chemicals that presented possible health risks.
In April 2024, Philips reached a $1.1 billion agreement in the US to settle all personal injury claims without admitting fault or liability. The US litigation involved more than 50,000 plaintiffs, though not all claimants fell within the terms of the settlement.
Philips told Euractiv that the recall decision was made “in an abundance of caution, after careful consideration of a reasonable worst-case scenario, rather than deferring the recall decision to conduct more definitive testing”.
Class action ebbs across the Atlantic
ADUSBEF and GJN filed a case against the Dutch giant at the end of June in Milan, where Philips’ Head of Quality for Europe is based. GJN wants to use the idea of opting in to an action, supported by the EU’s Representative Actions Directive, which sets minimum standards for protecting consumer interests, to reach more potential claimants.
“This is the first-ever Europe-wide class action we are talking about. It’s an initiative open to more than 1.2 million European citizens using this device,” Stefano Bertone, president of GJN, told at a launch event in Brussels.
Bertone said that technical experts they hired in oncology, epidemiology and toxicology identified 53 harmful chemical compounds that presented dangers to human health. “Our experts said [they are] damaging to the respiratory tract, cardiovascular, musculoskeletal or renal function.”
With the launch of the website and a contact form, the lawyers hope to increase the number of participants in the class action. Carlos Villacorta, treasurer of the GJN, said the class action was “the beginning of an enormous wave” of claims.
The lawyers are requesting €70,000 per patient for emotional stress and more compensation for patients who have actually suffered health damage from the defective respirators and for relatives of deceased patients.
European class actions
The Representative Actions Directive (RAD) came into force on 25 June 2023. A European Commission spokesperson told Euractiv that 19 member states have transposed the directive into national legislation so far and that Czechia was expected to do the same imminently.
Seven member states have not fully transposed the directive, though three have notified the Commission of partial transposition, and the Commission services are verifying compliance with the directive.
The directive insists upon an opt-in procedure, where consumers have to explicitly express their wish to be represented by the ‘qualified entity’, a recognised consumer interest organisation, in the representative action for redress measures.
Systemic problems
Villacorta said that the entire safety oversight system needs to be reviewed.
“The European Union has created a safety oversight system, which holds everything in the hands of the manufacturer, which is more or less the same that happens in the United States, where the oversight and safety oversight system is totally privatised.”
Were national authorities left in the dark?
One of the plaintiffs, a Romanian citizen, attended the press conference and shared his experience of using the CPAP ventilator, stating that “it’s every night, about six to eight hours a night.” He expressed personal doubts over whether the national authorities had been informed of the adverse health effects associated with Philips respirators.
He received two letters from Romanian authorities, the first stating that he had to install more filters on the device and the second one that the device should be replaced. However, at no point was further information regarding the reason for the replacement provided.
Romanian lawyer Mariana Robu, who was present at the press conference, highlighted the low level of awareness in Eastern European countries compared to Western member states. She said the launch of the website will help people to reach out and join the class action.
Philips response
Philips told Euractiv that Philips Respironics has conducted extensive testing since June 2021 and, based on the results to date, the company and third-party experts have concluded that the use of the sleep therapy devices is not expected to result in appreciable harm to health in patients.
They added that “further testing related to the sleep therapy and ventilator devices remains ongoing.”
Despite this, the US Food and Drugs Administration (FDA) issued a press release in 2023 stating that it remains unconvinced by Philips testing to date.
“We do not believe that the testing and analysis Philips has shared are adequate to fully evaluate the risks posed to users from the recalled devices”.
The FDA said further testing was required to verify Philips’s assessment that the device was unlikely to cause “appreciable harm to health”.
In an agreement with the FDA in April, Philips agreed to carry out further tests using an independent expert.
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