Hundreds of thousands of European patients use a Philips apnea device that might be making them ill. Philips promised to replace the devices, but declines to say how many have so far been replaced in each EU country. Follow the Money contacted all European supervisors and discovered that Philips’ replacement effort hasn’t yet properly got under way everywhere. So far, only France has taken a tough stance. They do so with the risk of putting patients in other countries at a disadvantage.
- Last year, Philips announced that the apnea devices from its subsidiary Respironics could potentially cause health problems. The sound-absorbing foam releases particles, which might cause cancer.
- Philips advises patients to continue using their device until they receive a new one, as stopping treatment is likely to be more harmful to their health.
- In one year, the US supervisor FDA received over 21,000 reports of potential health problems resulting from the use of these apnea devices. In 124 cases, patients died. Causal relationships have not been demonstrated.
- Philips is working on a global replacement effort, but it is proceeding slowly. Philips has already adjusted their schedule more than once.
- How many appliances need to be replaced or repaired in the EU per Member State, and how far along is Philips currently? In search of answers to these apparently simple questions, Follow the Money gets the runaround. European supervisors and Philips contradict one another.
- Philips claims it will distribute new devices to patients across the EU proportionally. Information from the supervisors shows however that patients in some EU countries are waiting much longer than in others.
At a shareholder meeting on May 10, Philips CEO Frans van Houten asks for understanding. Not just from the shareholders, but also from users of the defective sleep aid devices from its American subsidiary Respironics. Philips is working hard on replacing these devices, he says.
Because the sound-absorbing foam detaches and can potentially cause cancer, Philips needs to replace or repair 5.5 million machines worldwide. A complex operation, but progress is being made, Van Houten reports at the shareholders’ meeting. Normally, Philips builds a million of them per year. Now, that has been bumped up to three million, in spite of the current shortage of semiconductors.
Philips sells the devices through healthcare suppliers, but, according to Van Houten, the company is becoming ‘increasingly more effective’ in reaching patients. The Philips CEO, who received a bonus of 1.8 million euros this year, says: ‘I want to emphasise how sorry we are for disrupting or influencing the lives of patients.’
Apnea patient Arne Bezemer isn’t impressed. ‘I’ve lost faith, a bit,’ he says, when Follow the Money plays him some clips from the shareholder meeting. ‘It hasn’t gotten better at all, of course.’
‘Really, I don’t want to sleep with it. But if I don’t sleep, I can’t function’
Bezemer, who recently turned 50, works as an insurance expert in the financial sector. He is one of the hundreds of thousands of Europeans who need the Philips device to be able to sleep without disturbance. He was diagnosed with apnea two years ago. Bezemer: ‘Your breath keeps halting, so you don’t reach your second or third REM sleep. You become more and more tired, which makes you very irritable.’
In the summer of 2021, Philips reported that it will have to replace the devices, because the foam is potentially carcinogenic. Shortly afterwards, users were informed that they can and, in most cases, should continue to use the machine until it is replaced.
Bezemer uses the device several nights a week, when he needs to be well rested the next day. But he does so reluctantly. ‘Really, I don’t want to sleep with it. But if I don’t sleep, I can’t function. If I stopped using that thing for two months, I’d have to go on sick leave.’
Like many other patients, Bezemer does not know when his device will be replaced. ‘It is not yet clear when it will be your turn for the replacement. We will contact you when your appliance is going to be replaced,’ he was told in January by his supplier Vivisol. Apnea patients with other suppliers likewise received no concrete commitment.
This is why he reacts with scorn to the compassionate words of the Philips CEO. ‘If 99 percent of the people have been helped, I understand his reaction, and that he expects to not have to return his bonus. But obviously it hasn’t been resolved, not for me.’
Philips recently announced that 90 percent of its appliances will have been replaced by the end of this year. The company declines to divulge details about where things currently stand.
Follow the Money set out to answer two seemingly simple questions. How many appliances need to be replaced or repaired in the EU per Member State? How far along is Philips now?
Confidential, thanks to Europe
In late February, we ask Philips: can the company provide an overview of the number of devices to be replaced per European Member State? No, it replies in mid-March: ‘It is correct that we have not published the number of registered devices per country, because we are still discussing this with the various competent authorities,’ a spokesperson reported. ‘We are looking at how we will publish this, probably not per country, but per region. I expect to be able to provide an update on that shortly.’
We then asked with which authorities Philips was having these discussions, and how they affect whether or not the data is published. For eight weeks, there was no response, even after multiple emails and phone calls.
In the meantime, we tried to get in touch with those ‘competent authorities’: the supervisors in the field of medical devices.
The Inspectie Gezondheidszorg en Jeugd (IGJ) speaks of ‘tens of thousands of apnea devices’ in the Nettherlands, but refuses to give an exact number. How many have been replaced so far, the IGJ isn’t allowed to say, because: ‘It is primarily up to the manufacturer to provide this information.’
The German regulator responds in a similar vein. That is the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), which is also the European ‘coordinating competent authority’, as Philips applied for the required certificate in Germany.
The BfArM cannot provide an overview of the number of devices to be replaced per Member State. ‘Please ask the manufacturer for the figures. We consider this information to be confidential,’ said a spokesperson.
Supervisor: ‘The information that we were given, to be able to monitor the situation, was provided on a confidential basis’
When asked about the legal basis of that position, the BfArM refers to the European regulation for the marketing of medical devices. The IGJ refers to the same rules when explaining why it is not allowed to say how the replacement effort is going in the Netherlands. ‘The information that we were given, to be able to monitor the situation, was provided on a confidential basis,’ according to the Inspectorate.
On April 25th, 2022, Philips published its quarterly report. It states that the company is shipping replacement devices or repair kits for 2.2 million devices. With 5.5 million devices worldwide, that’s 40 per cent. However, that percentage tells us nothing about the geographical distribution of the devices, nor whether they have reached the patients yet. Because as far as Philips is concerned, the healthcare suppliers are their customers.
Does the European Commission know how many devices are involved per Member State? They don’t either: ‘The Commission does not have such an overview, the matter is dealt with at [the] national level.’
While companies that sell medical devices must all comply with the same EU rules, oversight is handled on a national level. Health care is a sensitive policy area in which Member States are unwilling to give up any of their sovereignty.
In April of 2020, Helmut Brand, Professor of European Public Health at Maastricht University, made this point to Follow the Money, in the context of the European response to the Covid19 outbreak. ‘Europe can only be as strong as its Member States allow,’ Brand said. ‘The Member States have clearly said: when it comes to health and social security, we want to keep our powers.’
So we asked all 27 supervisors individually for information. Their answers show that the confidentiality rules are interpreted differently throughout the EU – and that there is even a Member State taking measures that may jeopardise European solidarity.
Some supervisors, such as those in Denmark, Sweden, and Romania, toe the same strict line as the German BfArM: even the number of Philips devices in use in their Member State is confidential. Other national supervisors, such as those in Poland and Ireland, are willing to disclose the number of affected devices, but not which percentage has been repaired.
Yet other supervisors see no problem in providing this data. The authorities in Estonia, Finland, Slovakia, Slovenia, and Belgium let us know exactly how many devices are involved, and what percentage has so far been replaced or repaired. Exactly the same European rules apply in those countries, but apparently they do not hinder the provision of information that other countries have labelled as confidential.
Even within Member States, differences in interpretation are apparently possible. Although the BfArM did not want to provide numbers, citing confidentiality, it later referred us to the government of the Bavarian district Upper Palatinate. On May 18, the district did announce percentages: ‘around 30 percent’ has been replaced or repaired.
‘Oh my god’
Responses from supervisors who do provide insight, show that the recall is not proceeding at the same speed in every Member State. Making comparisons is tricky, because Member States did not all have up-to-date figures at hand, but even with that caveat, the answers show that the rates at which the devices are being replaced vary considerably.
In Estonia, 30 per cent of the machines had been replaced by mid-March, while, a month and a half later, Croatia was only at 14 per cent. In Slovenia, too, only 14 per cent has been replaced.
‘Oh my god,’ apnea patient Bezemer exclaims upon hearing about that 14 per cent. ‘That is shocking. I had a feeling this would take a lot longer, but this is so much worse. If it’s 14 per cent in Slovenia, I don’t expect it to be 80 per cent here.’
According to the Belgium Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG), Philips has ‘assured’ them that the recall is being ‘performed at the same speed in all countries’. However, the supervisors’ replies show that patients in some Member States have to wait longer for a replacement device.
Supervisors also judge Philips’ pace differently. The Estonian supervisor considers the speed with which the devices have been replaced (30 per cent) to be ‘acceptable’, while the Croatian supervisor (14 per cent) finds it ‘unsatisfactory’. The watchdog in Finland, where the exchange rate at 13 per cent is even lower than in Croatia, is satisfied with Philips.
The Swedish Medical Products Agency (Läkemedelsverket) cannot answer the question of whether it is satisfied with Philips with a simple yes or no. ‘In view of the problems with a large recall and the fact that the manufacturer does not have replacement products available to any great extent, it is natural that it takes time to implement the measures.’
At other authorities, the sympathy for Philips’ difficult task is slowly but surely fading. The Irish supervisor HRPA says: ‘While [we] recognise that there are complex supply chain dynamics impacting the repair and replacement of devices, the progress of the remediation by Philips has not met HPRA expectations.’
The Slovenian authority, JAZMP, is dissatisfied as well. In April, they asked Philips for an explanation and requested that the company guarantee that the measure is being implemented proportionately in all Member States. ‘We have not received relevant answers from Philips.’
France makes tough demands
One supervisor has turned its dissatisfaction into firm action. In February, the French Agence nationale de sécurité du médicament et des produits de santé (ANSM) announced that only 7 per cent of the devices had been replaced or repaired at that time.
The ANSM demands that Philips replace or repair 75 per cent of its appliances in France by June at the latest, ‘by any means necessary’. Before the new year, all devices must be replaced or fixed. An ANSM spokesperson stated that these deadlines correspond to the original replacement schedule as drawn up by Philips in August of 2021.
If Philips does not adhere to the schedule demanded by ANSM, the French supervisor can file a complaint against Philips, which could lead to fines.
In the formal resolution, the French agency emphasises the importance of timely replacement of the devices. While stopping the use of the devices poses a greater health risk than continuing to use them until they are replaced, it is important that the transition period to a new device be as short as possible.
German supervisor BfArM concurs: they are not recommending unlimited use of the units, ‘but only until repair/replacement (maximum one year)’.
On May 19, the US supervisor FDA announced that between April 2021 and April 2022, they received over 21,000 medical device reports (MDRs) mentioning reasonable suspicions that a Philips device with peeling foam contributed to health problems. In 124 cases, users of the devices had died.
Symptoms vary from headaches, coughs, and dizziness to cancer, pneumonia, and asthma. Some of these reports came from Philips, some from healthcare workers, consumers, and patients.
The supervisor emphasises that an MDR in and of itself does not constitute proof of a causal relationship between the device and death, illness, or symptoms. The FDA says that the MDR system has limitations, in that inaccuracies can appear in the reports, but it also says that there may also be underreporting happening. The FDA is still investigating.
Meanwhile, scientists are also conducting research into possible negative effects of using the devices. Late last year, a study was published concerning users of Philips Respironics devices in Canada, that concluded that they had no higher risk of developing cancer than users of other apnea devices. This month (May) a new study was published by Swedish scientists. They found a link between the use of Philips apnea devices and increased use of medication for irritated airways.
Bezemer is enthusiastic about the French policy. ‘That's what they should do here, too,’ he says, referring to the IGJ. ‘I suspect Philips would respond to that. It’s a shame that the Netherlands aren’t doing anything like this. They should be tougher on Philips.’
Despite his initial reaction, the French proactivity might actually end up being detrimental to Bezemer and other Dutch apnea patients. After all, Philips has a limited stock of devices and repair kits. The ANSM is now forcing Philips to favour France. If the company does not comply, it risks a French fine.
‘This is a worldwide corrective action, involving over 5 million devices. Demanding national targets is of little use’
That is why various European supervisors stress that they will not impose deadlines on Philips. ‘This is a worldwide corrective action, involving over 5 million devices,’ says the Belgian FAGG. ‘Demanding national targets is of little use in an effort of this magnitude.’
The Slovenian authority says that if one Member State ‘puts pressure on Philips, it could lead to a delay in the implementation of the measure in another Member State’. Bezemer can see the truth in this, as well. ‘That would, of course, be unfair. Of course it would. It’s tricky. In a way, I think it is good that the French authority is doing that for the French. I get it. Only, we should not be the victims of that.’
The ANSM says they have coordinated their measures against Philips with the other supervisors. The French told the other supervisors of their plans nearly two weeks before the decision was taken, according to documents released by the European Commission. But in the email, France is not asking for permission or feedback, they are simply informing them.
When asked, the European Commission confirmed that the French measures are not in conflict with European law, because health policy is simply a matter for the Member States.
Inspectorate wants to keep talking
In a response to the French measures, the IGJ says that it also believes ‘things should be going faster’ and that it understands the frustration of users. ‘Like the French regulator, we also want Philips to hurry with the replacements, and to communicate clearly. We talk to Philips more directly than the French regulator does.’
A similar response comes from Belgium: ‘The FAMHP does not comment on actions carried out by other Member States.’
Incidentally, there’s no sign of any preferential treatment of France on the part of Philips. On May 20, the ANSM announced on its website that suppliers had replaced 21.5 per cent of sleep apnea devices, over half of them with a brand other than Philips. According to ANSM, Philips itself reported that by early April, 18 per cent of the apnea machines to be replaced in France had been produced and shipped.
Philips: ‘We’re not asking for permission. It’s our decision to hold off publishing the numbers’
When Follow the Money finally manages to speak to a Philips spokesperson – ‘We’re just really busy,’ he says – he informs us that Philips has challenged the French decision. ‘We have appealed it. We cannot and will not favour any particular country. We’re trying to be as fair as possible.’
Over two months after our first request for information, Philips has still not decided whether it will publish statements per Member State. Although, now, the spokesperson is willing to tell Follow the Money that, in the Netherlands, Philips needs to replace ‘about a hundred thousand devices’ and that ‘around 27 percent’ is now on its way to healthcare providers.
The spokesperson also finally clarifies that, while Philips is talking to authorities about possible publication of figures, that does not mean that they get a deciding vote. ‘We’re not asking for permission. It’s our decision to hold off,’ says Philips. ‘We want it to come out in a controlled way.’
However, the latter appears to be a pipe dream, in a Europe with 27 supervisors. While some supervisors regard the data as confidential, there are also those who have disclosed the figures. Whether, as a patient, you are able to find out how long you’ll have to wait, depends on the Member State in which you live.
A few days ago, we presented Philips with our findings and asked them to clarify the differences that we encountered. ‘In some countries, the exchange program started earlier, in others, we had logistical limitations,’ the spokesperson says. ‘The capacity of our distribution channels is not the same in all countries, as do those of the healthcare provider.’
In Arne Bezemer’s case, in the end, the answer came via his supplier, Vivisol. The company informs Follow the Money that as of May 17, 25.7 percent of customers have received a replacement device. ‘We respond quickly, so we immediately replace devices, as soon as Philips supplies them,’ says Vivisol.
As a client, Bezemer has never received such updates from Vivisol. ‘The number is a bit higher than in some countries, but I think it is very low. At this rate, it won’t be done in a year. Maybe not even in two years.’
In collaboration with Ilona Dahl
Translation: Chris Kok