Blind, without a uterus, lame and without seeing a single euro: misfortunes and litigation after a failed operation

On July 29, 2014, Adolfo Aguilera entered the operating room at the La Arruzafa Clinic in Córdoba to have a retinal detachment. A simple operation as told. According to statistics, of every 2,000 people who are operated, 1999 manage to improve their vision. But in the case of Aguilera it was not a problem of the doctors or the operation.

"They they told me that the operation was a small thing, which did not matter … until that came out and they saw what it was, "recalls this Cordovan who is now 74 years old and was one of the first victims in Spain of the faulty departure of Ala Octa, a perfluoroctane eye drops used in surgeries detachment and manufactured by the German company Alamedics. In total, 116 people lost their sight in our country until on June 26, 2015 the Spanish Medicines Agency (Aemps) issued a health alert to all the autonomous communities to stop using the product.

The life of all these people became a nightmare. Some lost the sight of one eye and others like Aguilera – who already had a lazy eye – they were completely blind.

"In my life I got scared of nothing and now i live scared, if I hear any noise I startle, or I think that something happened to my granddaughters, "he explains to El Confidencial." I find myself fatal because I have vertigo when walking, I think I'm going to fall, and besides fear i have depression"The detachment operation also meant the end of its independence. Now it has to be constantly taken care of and taken everywhere.

The Implant Files, published in November 2018 by El Confidencial and other international media, put hundreds of cases on the table in which a defective medical device – from hip implants to vaginal meshes – ruined someone's life in Spain. The investigation managed to produce some changes, such as Health enabling a new incident notification system or that the Aemps made public 20,500 alerts that remained secret.

However, for the affected patients the disclosure of their situation changed very few things. Once the lights went out, they continued trying to associate in Facebook groups and went on a pilgrimage to court just to see how his illusion of being compensated kept moving away, one resource after another.

Like the rest, Aguilera was put in the hands of Gómez Menchaca Abogados, the Bilbao law firm that is taking the majority of those affected by the Octa Wing. Finally, the Court of 1st Instance of Madrid ruled in its favor in June 2019. His case was also a pioneer since, after several sentences against several regional health systems, for the first time he was sentenced to indemnify him with 307,808 euros for an operation carried out in private health.

Those affected by the Implant Files have continued pilgrimage by courts trying, without success, to be compensated for the damages suffered

The difference is important given that the last person in charge is the insurance company Allianz, with whom Alamedics – who presented a contest of creditors after the scandal broke out– had signed liability insurance in Germany. Hence the legal gibberish that keeps all these affected in limbo.

The small print of insurance

In statements to El Confidencial, a spokesman for the insurer explains that "Allianz Versicherungs-AG in Germany is the civil liability insurance company of Alamedics GmbH. For this reason, we respond as a responsible insurer," they detail. "Allianz Seguros de España is not an insurer in this case and has no influence on liability control".

The lawyers of the insurer in Spain have used this same reasoning, which should be judged by German law and not by Spanish law, but in the case of Aguilera the judge considered that Article 5 of Regulation 864/2007 of the European Parliament established that the law applicable to liability for defective products was not the German, but the Spanish one "for being that of the country of the injured party where the product was marketed".

"Both Alamedics and we are aware of many cases following the exercise of legal actions," they explain from the German insurer. "We are aware of the tragic consequences that those affected have to face."

In the case of public hospitals, the affected patients achieved with a pioneer sentence issued by the Cantabria Court of Justice that the administration compensated them as the ultimate supervisor of the use of that product. In this way, health services could then sue against the manufacturer, but the victims would have already been compensated.

Resources and resources

However, not everything was going to be so simple. Many of these autonomous communities, such as Cantabria or the Canary Islands, raised appeals. In some cases the judgments made the CCAA directly responsible, in others such as that of the Valencian Community they declared them mere subsidiaries: they should only compensate the patients if the manufacturer or insurer did not do so.

The last sentence to leave was that of the Provincial Court of Madrid, in December 2019. Allianz already has the ruling. "Currently, we are reviewing this ruling and our way of proceeding in this case, therefore, we cannot provide more information", says the insurer, which adds:" According to our first evaluation, said court would have misapplied the law, so we will present the appropriate recourse to the Supreme Court. "

For cases such as Aguilera, without administration, the situation also leads them to a new waiting room. "Until they pay me they will have to continue pulling forward," says the retiree. "So we have been five and a half years and still having won… look what a ruin".

In short, everything has been left to the Supreme Court.

"The usual tendency is that, in these cases, the administration pays and then life is sought with the manufacturer," explains lawyer Carlos Gomez, whose Octa Ala cases will be keys to set jurisprudence in all cases affected by defective products. "It will be a matter of cassation nature, hence the importance of this sentence."

Beyond the Octa Wing

Recently, the sentences regarding ASR hip metal prostheses, marketed by DePuy, owned by the multinational Johnson & Johnson, have also been issued. On January 21, the Supreme Court confirmed the conviction for which condemns the manufacturer to pay 515,647 euros to a patient from Marbella. In this particular case there is also the aggravating fact that J&J refused to facilitate the identity of the manufacturer of the prosthesis.

This lawsuit, filed in 2013 with two others, was the first in Spain against the US giant for an implant that, according to the judgment, was commercialized knowing its defectiveness. The prostheses loosened and rubbed against each other, which being composed of metal caused an added problem: the toxic particles of chrome and cobalt released by rubbing were incorporated into the body causing cardiac or mental problems to the carriers.

This is the first of approximately one dozen civil proceedings initiated against Johnson & Johnson throughout Spain for hip prostheses. In the United Kingdom, DePuy has been convicted since the end of 2018 for the same reason.

"The sentence is interesting because it confirms the responsibility of the manufacturer," says Gomez Menchaca. "It is an accredited jurisprudential line at European law level; the next step would be to declare the responsibility not only of the manufacturer but of the service provider administration for the damage caused and thus avoid demanding that the manufacturer, in cases like the Octa Wing, it is missing".

"The crazy docks"

It is one of the few good news that patients affected by a defective medical product have been able to celebrate. On the opposite extreme are Rita Fernández and the hundreds of associates of the Essure Free Platform, the contraceptive manufactured by the German company Bayer which ended up becoming a nightmare for thousands of women around the world. "Nothing to do with other implants, this is an economic, political and gender problem," he explains to El Confidencial. "It's not that we haven't received compensation, it's that they haven't even given us what would have been expected, good medical attention."

This palentina denounces that "instead what we have received is much rejection, concealment and obstacles when it comes to informing and attending to us", and adds that in some query they have heard how they called those affected by Essure as "the crazy docks".

This tubular vaginal mesh, designed as a definitive contraceptive for women who did not want to have more children, was placed in the fallopian tubes but was able to pierce the uterus or the tubes themselves. In addition, Essure was implemented everywhere even though there was no specific protocol for device removal. Even when Sanidad and Aemps ordered their withdrawal in 2017, the agency warned: "It is not appropriate to advise the withdrawal of the device or modify the tracking guidelines of carriers ".

In some query they have heard what they called the people affected by Essure as "the crazy docks"

"There have been more than 3,000 affected and none has had a good result in terms of compensation," says Fernandez. "Bayer for Essure has not paid a single euro, what only thing we have got is to be removed of the market and even so, we believe that in countries like India it is still used ".

In the absence of any ruling in Spain proving them right, the contraceptive has left a trail of "hysterectomized 30 year old women", as the spokeswoman indicates. Sharing luck with Aguilera and so many other patients is no consolation, but the Supreme could soon strike on the table where someone will shake. Maybe they, maybe the industry.