Dutch mass case against pharmaceutical company Allergan because of dangerous breast implants

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Dutch mass case against pharmaceutical company Allergan because of dangerous breast implants

litigate American style. The Bureau Clara Wichmann foundation is sending pharmaceutical company Allergan this week a notice of liability on behalf of many tens of thousands of Dutch women with breast implants from this company. It will be the first product liability case to make use of the Mass Damages in Collective Action Settlement Act (Wamca), which came into effect last year. This law makes it easier to claim compensation on behalf of a large group of people.

Allergan is held liable for the defective so-called Biocell implants and the health risks that women run as a result. Bureau Clara Wichmann conducts proceedings in which women’s rights are central. It had already announced last summer that it wanted to tackle this matter.

The most far-reaching risk for women with the implants is a rare lymphoma, BIA-ALCL. At least seventy women in the Netherlands have this form of cancer. Two thirds of them have or had Biocell implants from Allergan.

In addition, many women with implants reported other complaints, such as headaches, fatigue and muscle pain. These are associated with breast implants, but scientists disagree.

It is estimated that 60,000 Dutch women have this type of Allergan implants. In recent years, regulators around the world have banned them from the market. They are no longer used in the Netherlands either.

Allergan, part of the American pharmaceutical company AbbVie, has been held liable for marketing a defective product. “As a woman, you are not going to tackle such a billion-dollar company on your own,” says Anniek de Ruijter of Bureau Clara Wichmann. “Certainly not when it comes to product liability, which is legally complex.”

Similar mass cases are underway in Great Britain and the United States. In Spain, the judge awarded a woman 38,000 euros last month because she had contracted lymphoma with Allergan implants.

Non-profit

The special thing about such a liability claim based on the Wamca is that Bureau Clara Wichmann acts on behalf of tens of thousands of women, without them having to do anything themselves. This is only possible with a non-profit organisation, such as a foundation or association, explains Jantina Hiemstra, lawyer of the Bureau. “And it shows that it is a suitable party to represent the victims.”

The call for this new legislation was fueled by a certain jealousy about the class action in the U.S. In the diesel scandal surrounding Volkswagen, for example, Americans were compensated much faster and easier with those cars. But parties such as the Consumers’ Association also wanted to be able to obtain compensation for a large group more easily in smaller cases.

Incidentally, cases have already been brought under the new legislation; against TikTok about violation of privacy, and against Airbnb about unjustly paid service costs. This is the first case involving product liability.

In the US, more than 80 percent of women diagnosed with BIA-ALCL had the Biocell implants last year. Supervisor FDA says the risk of this cancer with this type of Allergan implants is about six times higher than with other comparable breast implants. This is especially distressing for women who have opted for a radical step such as breast reconstruction with implants because they had breast cancer or an increased risk of it.

Still, women should not panic, says Mintsje de Boer, a plastic and reconstructive surgeon in training. She will be awarded a doctorate in December at Maastricht UMC for this lymph node cancer. “A breast implant greatly improves the quality of their lives for many women. That is why it is important that women with these implants know that the risk of this type of cancer is really very small.”

It is not entirely clear why women with breast prostheses can get this disease. “There are indications that women with a hereditary increased risk of breast cancer also have an increased risk of this cancer, but that relatively small study has not yet been confirmed by others,” says De Boer. “Other studies point to certain bacteria around the breast prosthesis. However, no firm conclusions can be drawn from these studies either.”

The Health Care Inspectorate advises women with these breast implants to check carefully whether their breasts are getting bigger or whether a lump develops. With a prompt diagnosis of cancer, the prospects for survival are good.

Insufficient research

For many years, Allergan was one of the largest producers of breast implants. In 2017, it invested 350 million euros in it. A year later, the sales ban came for Europe, in 2019 for the US. The US regulator wrote to Allergan that it had failed to adequately investigate the risks of the implants. In 2020, the company was bought by pharmaceutical giant AbbVie for 55 billion euros.

Allergan offers women with cancer a meager compensation, according to De Ruijter. “For example, we have contact with a woman who could no longer work because of lymphoma. She was offered 6,000 euros. She would also have to pay for the surgery to remove the implants. And she was never allowed to hold Allergan liable again. That is far too little. Yet some women have signed such contracts.”

Bureau Clara Wichmann is now demanding 10,000 euros for women who have not become ill, because of the health risks they run. With that, they can pay for an implant replacement surgery if they want to. For women who have developed lymphoma, the foundation wants at least 60,000 euros in compensation.

Approval of medical devices, which officially includes implants, is different from that of medicines. “Medications are looked at very closely: there are studies with large numbers of patients,” says De Ruijter. “Medical devices are approved by private companies. Once a CE mark has been obtained for a product, it can be marketed anywhere in Europe.”

A well-known example are the PIP breast implants from the French Poly Implant Prothèse. They were filled with industrial rather than medical grade silicone. Thousands of women worldwide were victims of this. The German company that approved the implants was held liable by the French judge and had to pay compensation.

In 2010, the French regulator recalled the implants and PIP was liquidated. Its boss was jailed for four years in 2013.

Dutch mass case against pharmaceutical company Allergan because of dangerous breast implants
Source link Dutch mass case against pharmaceutical company Allergan because of dangerous breast implants

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