Soledad Valle Madrid
Madrid
Updated Thursday, February 8, 2024-02:08
Affected patients Blinded by an ophthalmological product in poor condition?
Gómez-Menchaca
's office
has handled almost a hundred people affected by
Ala Octa
(perfluoroctane)
in different autonomous communities, out of a total number of around 125 people with damage from the toxic eye drops. The majority of patients have already been compensated by the autonomies with sentences from
their regional courts
in which the responsibility of these health services is recognized.
However, that legal interpretation changed with a ruling from the Supreme Court of December 2020, in which it made it clear that the repair of the damage generated by
Ala Octa
had
to be sought in the Spanish Agency for Medicines and Health Products (Aemps),
dependent on Health,
or in the Alamedics laboratory
(disappeared) or, failing that, in the laboratory's insurer, Allianz.
THE SUPREME LAID THE RED CARPET TOWARDS THE AEMPS
Then, Gómez-Menchaca turned to the Aemps and
obtained a historic sentence
. The Central Contentious-Administrative Court number 1 of Madrid, in a resolution of November 2023, sentenced the Agency to compensate with 25,000 euros to a woman from Cantabria who had gone blind in one eye in which the toxic eye
drops had been applied.
.
The historic nature of the ruling lies in the fact that it is the first time that the Aemps has been sentenced to compensate a patient for the
lack of supervision of a medical product
(which already comes with the EU certificate for its marketing in Spain). After this first resolution against the Agency,
Gómez-Menchaca has eight more lists of patients with blindness due to
Octa Wing.
What novelty does this action of the Prosecutor's Office introduce to the judicial processes?
Well, in the midst of this entire judicial process in search of the person or persons ultimately responsible, the Prosecutor's Office has taken a step forward and has filed a complaint against the German company
Alamedics GmbH&Co KG
(manufacturer of the product),
BSI Group Deutschland.
(certifying entity) and the marketing company, based in Barcelona,
WM Bloss SA
.
The National Court has accepted the complaint for processing
.
Carlos Gómez-Menchaca,
lawyer and partner of the firm that bears his name, has assessed for this newspaper the scenario that this complaint opens, answering the previous question and others.
According to the lawyer, the Prosecutor's demand for criminal liability, that is,
prison sentences for both the German manufacturer and the distributors in Spain
, "does not change anything about the compensation already paid or those that are in progress, but
adds pressure to compensate those who are still waiting
", which he estimates are
"between 30 and 35 people"
.
However, he highlights that the judge of
the National Court Francisco de Jorge
, in his admission to processing the complaint, requests "the complete list of those affected who are distributed throughout almost the entire Spanish territory."
CAN THE NUMBER OF THOSE AFFECTED BY EYEWEAR GROW?
"I think there may be some people who still do not know that they are blinded by this eye drops. In fact, in recent days I have received several calls from people who believe they may be in these cases. They are
waiting to be assessed, but for whom it is difficult obtain reports
," says Gómez-Menchaca, who clarifies that the judge's request is to the Aemps, which must deliver that list of those affected.
However, Aemps sources have assured this newspaper that the affected people are "125, in 28 health centers in 13 autonomies" and that "the list is public." They warn that it is a number that has not changed and is the result of the Agency's surveillance work on the medical product.
From August 2013 to June 26, 2015
,
Ala Octa
was in the Spanish market as an intraoperative adjuvant in ophthalmic surgery for retinal detachment, among other interventions.
The withdrawal of the product was carried out
on June 26, 2015,
through an alert that the Agency gave "preventively", after, days before, the distributor of the product,
WM Bloss
, learned that 20 people treated with
Ala Octa
had visual acuity problems.
Regarding the actions against the manufacturer, the lawyer explains that "it went bankrupt." "Civil liability, which may arise from the criminal process, given that the manufacturer has gone bankrupt, is the responsibility of the insurer
Allianz
, whose evasive behavior towards the victims
is deplorable"
(Gómez-Menchaca has up to three final rulings from the Supreme Court that condemns
Allianz
to compensate with a million-dollar sum several clients of his office who were intervened in private healthcare and when up to a year has passed since the oldest of these sentences, the insurer has not recorded the compensation).
On the other hand, the lawyer considers that
"it is not common for a distribution company to be sued for the same crimes as the manufacturer
. "
He deduces that this situation "is due to data derived from the Prosecutor's Office study."
But, in any case, the judicial procedure does not divert the office from continuing to pursue the possible responsibility of the Aemps "due to lack of surveillance" of the medical product.
"I wish to make it very clear that we will pursue the responsibilities that correspond to the Aemps for its lack of vigilance, this being its main obligation. And
we do not want to think that the current complaint by the Public Prosecutor's Office is an attempt to evade
the responsibility of an organization dependent on the government. central court [in reference to the Aemps]. In fact, eight other claims are underway against the Aemps similar
to the one that resulted in a final ruling from a central court."
In addition, he says: "We are going to appear formally, one by one, with all our injured clients
to collaborate with the National Court
and show ourselves as part and request as many criminal and civil actions as are appropriate to clarify the responsibilities of the defendants. That is, manufacturers and distributor of the highly toxic product".