MAMMARY PROSTHESIS MANUFACTURERS OF DEFECTIVE ARE REQUIRED TO INDEMNIFY THE IMPLANT PATIENTS AS THE SUPREME TRIBUBAL :
The Case December 9, 2010 the Plenum of the Civil Division of the Supreme Court condemns the manufacturer of defective breast implants, to compensate patients undergoing implants for the moral damage caused by premature removal of them.
A) The Supreme Court condemns only the manufacturer of breast prostheses, absolving the trading company in Spain, to pay the compensation sought by the actors for the moral damage suffered by reason of having had implants breast implants that later were taken following a recommendation of the Ministry of Health.
TS resource estimates as to the imputation of liability on the manufacturer of breast implants, concluding the implanted product is defective. Thus, the absence of studies of the manufacturer on the audit of the possible toxic effects of the fillers of the prosthesis, shows a product defect determining liability for damage, damage consisting of the damage caused by the premature removal of implanted prostheses with the expectation to be functional for a period of time.
On the other hand, the manufacturer has not established that the lack of checks on the toxicity of the prosthesis to obey the state of scientific and technical knowledge at the time they were put in circulation. Not detract from the defectiveness of the product that does not prove so definitive toxicity, as "defective product" is not only toxic or dangerous, but which is put into circulation without sufficient checks to exclude the existence of such toxicity or danger.
the Board concludes that the manufacturer of the product has to compensate the plaintiffs in amounts ranging from 18,000 to 24,000 euros, acquitting the distributor in Spain for lack of standing passively.
B) The product (breast prosthesis) began his employment in Spain in 1994, after the controls, and its conformity with Directive 93/42/EEC of 14 June, obtained the "CE" and admitted its distribution in all European Union countries. The prostheses were fitted to the provisions of RD 414/96 on medical devices, which are operated by the transposition into English law of that directive.
In Spain, the Department of Pharmacy and Health Products, Ministry of Health issued the decision of July 27, 2000, which were located remembered that carriers of these prostheses and advised to submit to explantation following the protocol annexed, and the replacement of prostheses for other patients to choose, at no cost to them as they ran with the British company trading costs.
The explanation of the recommendations contained in the resolution, was a prudent measure based on Article 26 LGS, although so far to address on appeal was not known that genotoxic effects had been reported in patients carrying or their offspring.
The applicants followed the recommendation of the English health authority and were made to the collection, all of which will rise to a series of injury from physical, mental and moral, for those who sue for compensation. One of them accepted the offer economic marketer during the process and stayed outside.
C) Product Liability:
1 º) Article 3 LRCPD establishing the legal concept of a faulty saying that "the term defective product that did not offer the security that might legitimately be expected, taking into account all the circumstances and particularly its presentation, the reasonably foreseeable use of it and the time of entry into service. "
As shown, the defectiveness of the product, linking the birth of responsibility, responding to circumstances of an objective consistent in that the product does not offer the safety objective that could legitimately expect depending, among other circumstances reasonably foreseeable use of it and the date of its entry into service.
Following the objective nature of this responsibility LRCPD Article 5 states that "an injured person seeking to obtain compensation for damages must prove the effect, damage and causal link between the two." It is not, therefore, it is proved the existence of negligence by the manufacturer or importer responsible.
LRCPD
Article 6 provides, among the causes of exoneration from liability (except for collecting the call progress risks), the manufacturer or importer shall not be liable if they prove "[q] hat the state of scientific and technical knowledge at the time of the circulation did not allow assessing the existence of the defect." This exception is also an objective, as evidenced by the circumstances are taken into account in determining the liability exemption.
The concept of security that may reasonably be expected to protect against the harmful consequences that result from the toxicity or potential hazards. It follows that fail to respond to safety which may reasonably be expected to use those products, among others, they can offer risks of failure verification at the time of entry into service of the lack of toxicity or danger, when it appears as reasonably possible. In these cases only liability may be exempted from the importer or manufacturer as proof that the absence of these findings reflects the fact of not being enforceable in accordance with "the state of scientific and technical knowledge at the time of entry into service" . Security flaw is, in short, not only those who embodied in the existence of risks associated with toxic or dangerous, but that is the absence of the checks needed to exclude such risks, as this absence is, in itself itself a risk.
In the present case, on the facts as proven supporting the decision under appeal can not be modified on appeal, the extraction is advised to carry the prosthesis to which it imputes the existence of a defect was due to British agency responsible for distribution of health services had been reported local complications as the manufacturer raised the issues of long-term safety of the device, and especially toxicological data on the degradation products from soybean oil, which was the fill material was not able to respond to questions raised by lack of the necessary studies, and opted to stop the marketing and production of the prosthesis in Europe. English medical authorities, according to this account of events, chose the same solution, advising the removal of the prosthesis in place.
2 º) From these facts should conclude the defectiveness of the product in place, under the following reasoning:
a) In accordance with the general doctrine that has been exposed, the lack of studies in manufacturer on checking the possible toxic effects of filling of the prostheses, reveals a defect determining product liability for damage caused.
b) This damage is the damage caused by the premature removal of prostheses implanted with the expectation to be functional for a period of time. This damage is attributable to the defective nature of goods, since the need for premature removal did not take place for reasons attributable to the patients or which may be taken as an inevitable risk in normal use, it integrates directly with the absence of safety which may reasonably be required of any breast implants, of which we can expect a degree of stability and security guaranteed by the studies enough requirements made in advance.
c) The defendant failed to prove that the lack of checks on the toxicity of the prosthesis to obey the state of scientific and technical knowledge at the time they were put in circulation.
d) The need for any prosthesis similar to those the subject of this process are removed within a more or less dilated is no obstacle to holding that the premature removal of such prosthesis involves damage in this case attributed the defectiveness of the product. On the one hand, stability is a quality directly related to safety which may require the product when, as is the case, requires a surgical procedure, complex and not safe, deployment and extraction. On the other hand, can not compare the effects of the removal of a prosthesis derived from its expected expiration or recurrent problems in its implementation and maintenance, with an extraction that is necessary or advisable to stop toxic potential unintended consequences on the body of the patient.
e) The fact that the administrative authorities to act for reasons of precaution does not prevent the existence of responsibility for the defectiveness of the product. The levels of security required in today's society behave as noted, not only the outstanding prohibition of toxic or dangerous products, but also the need to ensure through the necessary pre-checks that those circumstances are not present. The defendant has not established that these checks had been made, whose absence, by itself, be determinative of a security flaw in the product, estimated at the risk involved in wearing a prosthesis for which is unknown possible toxic nature or dangerous and lacks reasonable assurance about the absence of these circumstances.
f) The moral damage caused by the precautions taken by public authorities is objectively attributable manufacturers and importers of the product, as were measures proportionate to the need to check the possible toxicity of a product that had been put into service without a thorough check on the absence of this feature.
g) The fact that not definitively prove the product's toxicity without prejudice to their defective nature, then, as stated above, the defective product is not only the toxic or dangerous, but one that is put into circulation without sufficient checks to exclude the existence of such toxicity or danger.
3 º) Accredited the defectiveness of the product in accordance with the decision when considering the appeal, be regarded as sufficiently established the causal link between the need for extraction of prostheses defective character and moral damages suffered by those affected, which, considering the different degrees of involvement are evident expert reports submitted in the first instance, be quantified as follows:
(i) those affected appellant (Ms PFAG) has suffered significant material damage to a moderate extent inherent in medical treatment and suffered anxiety , taking into account the days of hospitalization and impediment to the exercise of its normal activities, it is up compensation of 18,000 euros.
(ii) For those affected appellant (Ms Berlanga Gertrudis Pérez Andújar) who has suffered pecuniary damage more intense degree, inherent in the condition of aesthetic effects, in addition to medical treatment and anxiety suffered, taking into account days in hospital and unable to fulfill their usual activities, account for a compensation of 21,000 euros.
(iii) For those affected applicants (Ms Ms Mary SPF and MMCM) that have suffered damage in the highest degree moral, inherent limitations arising from the medical indication not to get pregnant, as well aesthetic defects of the disease, medical treatment and anxiety suffered, taking into account the days of hospitalization and impediment to the exercise of its ordinary activities account for a compensation of 24,000 euros.
4 º) The amounts include the various concepts outlined in that specific demand, which under various titles, reference to different aspects of the moral damage suffered.
5 º) The awards accrue statutory interest from the date of the filing of the application in accordance with the provisions of art. CC 1108 because, according to the most modern jurisprudence, which exceeds the first in illiquidis non fit mora [illiquid case of sums not produce the delay] (STS 16 November 2007, CR No. 4267/2000) - the accrual of interest on the sums operates granted as compensation the value of money and should be considered justified when there is no substantial difference can be seen between the amount requested and granted, taking into account the difficulties of quantifying the concepts for which claims when they have no proprietary in nature.
The Case December 9, 2010 the Plenum of the Civil Division of the Supreme Court condemns the manufacturer of defective breast implants, to compensate patients undergoing implants for the moral damage caused by premature removal of them.
A) The Supreme Court condemns only the manufacturer of breast prostheses, absolving the trading company in Spain, to pay the compensation sought by the actors for the moral damage suffered by reason of having had implants breast implants that later were taken following a recommendation of the Ministry of Health.
TS resource estimates as to the imputation of liability on the manufacturer of breast implants, concluding the implanted product is defective. Thus, the absence of studies of the manufacturer on the audit of the possible toxic effects of the fillers of the prosthesis, shows a product defect determining liability for damage, damage consisting of the damage caused by the premature removal of implanted prostheses with the expectation to be functional for a period of time.
On the other hand, the manufacturer has not established that the lack of checks on the toxicity of the prosthesis to obey the state of scientific and technical knowledge at the time they were put in circulation. Not detract from the defectiveness of the product that does not prove so definitive toxicity, as "defective product" is not only toxic or dangerous, but which is put into circulation without sufficient checks to exclude the existence of such toxicity or danger.
the Board concludes that the manufacturer of the product has to compensate the plaintiffs in amounts ranging from 18,000 to 24,000 euros, acquitting the distributor in Spain for lack of standing passively.
B) The product (breast prosthesis) began his employment in Spain in 1994, after the controls, and its conformity with Directive 93/42/EEC of 14 June, obtained the "CE" and admitted its distribution in all European Union countries. The prostheses were fitted to the provisions of RD 414/96 on medical devices, which are operated by the transposition into English law of that directive.
In Spain, the Department of Pharmacy and Health Products, Ministry of Health issued the decision of July 27, 2000, which were located remembered that carriers of these prostheses and advised to submit to explantation following the protocol annexed, and the replacement of prostheses for other patients to choose, at no cost to them as they ran with the British company trading costs.
The explanation of the recommendations contained in the resolution, was a prudent measure based on Article 26 LGS, although so far to address on appeal was not known that genotoxic effects had been reported in patients carrying or their offspring.
The applicants followed the recommendation of the English health authority and were made to the collection, all of which will rise to a series of injury from physical, mental and moral, for those who sue for compensation. One of them accepted the offer economic marketer during the process and stayed outside.
C) Product Liability:
1 º) Article 3 LRCPD establishing the legal concept of a faulty saying that "the term defective product that did not offer the security that might legitimately be expected, taking into account all the circumstances and particularly its presentation, the reasonably foreseeable use of it and the time of entry into service. "
As shown, the defectiveness of the product, linking the birth of responsibility, responding to circumstances of an objective consistent in that the product does not offer the safety objective that could legitimately expect depending, among other circumstances reasonably foreseeable use of it and the date of its entry into service.
Following the objective nature of this responsibility LRCPD Article 5 states that "an injured person seeking to obtain compensation for damages must prove the effect, damage and causal link between the two." It is not, therefore, it is proved the existence of negligence by the manufacturer or importer responsible.
LRCPD
Article 6 provides, among the causes of exoneration from liability (except for collecting the call progress risks), the manufacturer or importer shall not be liable if they prove "[q] hat the state of scientific and technical knowledge at the time of the circulation did not allow assessing the existence of the defect." This exception is also an objective, as evidenced by the circumstances are taken into account in determining the liability exemption.
The concept of security that may reasonably be expected to protect against the harmful consequences that result from the toxicity or potential hazards. It follows that fail to respond to safety which may reasonably be expected to use those products, among others, they can offer risks of failure verification at the time of entry into service of the lack of toxicity or danger, when it appears as reasonably possible. In these cases only liability may be exempted from the importer or manufacturer as proof that the absence of these findings reflects the fact of not being enforceable in accordance with "the state of scientific and technical knowledge at the time of entry into service" . Security flaw is, in short, not only those who embodied in the existence of risks associated with toxic or dangerous, but that is the absence of the checks needed to exclude such risks, as this absence is, in itself itself a risk.
In the present case, on the facts as proven supporting the decision under appeal can not be modified on appeal, the extraction is advised to carry the prosthesis to which it imputes the existence of a defect was due to British agency responsible for distribution of health services had been reported local complications as the manufacturer raised the issues of long-term safety of the device, and especially toxicological data on the degradation products from soybean oil, which was the fill material was not able to respond to questions raised by lack of the necessary studies, and opted to stop the marketing and production of the prosthesis in Europe. English medical authorities, according to this account of events, chose the same solution, advising the removal of the prosthesis in place.
2 º) From these facts should conclude the defectiveness of the product in place, under the following reasoning:
a) In accordance with the general doctrine that has been exposed, the lack of studies in manufacturer on checking the possible toxic effects of filling of the prostheses, reveals a defect determining product liability for damage caused.
b) This damage is the damage caused by the premature removal of prostheses implanted with the expectation to be functional for a period of time. This damage is attributable to the defective nature of goods, since the need for premature removal did not take place for reasons attributable to the patients or which may be taken as an inevitable risk in normal use, it integrates directly with the absence of safety which may reasonably be required of any breast implants, of which we can expect a degree of stability and security guaranteed by the studies enough requirements made in advance.
c) The defendant failed to prove that the lack of checks on the toxicity of the prosthesis to obey the state of scientific and technical knowledge at the time they were put in circulation.
d) The need for any prosthesis similar to those the subject of this process are removed within a more or less dilated is no obstacle to holding that the premature removal of such prosthesis involves damage in this case attributed the defectiveness of the product. On the one hand, stability is a quality directly related to safety which may require the product when, as is the case, requires a surgical procedure, complex and not safe, deployment and extraction. On the other hand, can not compare the effects of the removal of a prosthesis derived from its expected expiration or recurrent problems in its implementation and maintenance, with an extraction that is necessary or advisable to stop toxic potential unintended consequences on the body of the patient.
e) The fact that the administrative authorities to act for reasons of precaution does not prevent the existence of responsibility for the defectiveness of the product. The levels of security required in today's society behave as noted, not only the outstanding prohibition of toxic or dangerous products, but also the need to ensure through the necessary pre-checks that those circumstances are not present. The defendant has not established that these checks had been made, whose absence, by itself, be determinative of a security flaw in the product, estimated at the risk involved in wearing a prosthesis for which is unknown possible toxic nature or dangerous and lacks reasonable assurance about the absence of these circumstances.
f) The moral damage caused by the precautions taken by public authorities is objectively attributable manufacturers and importers of the product, as were measures proportionate to the need to check the possible toxicity of a product that had been put into service without a thorough check on the absence of this feature.
g) The fact that not definitively prove the product's toxicity without prejudice to their defective nature, then, as stated above, the defective product is not only the toxic or dangerous, but one that is put into circulation without sufficient checks to exclude the existence of such toxicity or danger.
3 º) Accredited the defectiveness of the product in accordance with the decision when considering the appeal, be regarded as sufficiently established the causal link between the need for extraction of prostheses defective character and moral damages suffered by those affected, which, considering the different degrees of involvement are evident expert reports submitted in the first instance, be quantified as follows:
(i) those affected appellant (Ms PFAG) has suffered significant material damage to a moderate extent inherent in medical treatment and suffered anxiety , taking into account the days of hospitalization and impediment to the exercise of its normal activities, it is up compensation of 18,000 euros.
(ii) For those affected appellant (Ms Berlanga Gertrudis Pérez Andújar) who has suffered pecuniary damage more intense degree, inherent in the condition of aesthetic effects, in addition to medical treatment and anxiety suffered, taking into account days in hospital and unable to fulfill their usual activities, account for a compensation of 21,000 euros.
(iii) For those affected applicants (Ms Ms Mary SPF and MMCM) that have suffered damage in the highest degree moral, inherent limitations arising from the medical indication not to get pregnant, as well aesthetic defects of the disease, medical treatment and anxiety suffered, taking into account the days of hospitalization and impediment to the exercise of its ordinary activities account for a compensation of 24,000 euros.
4 º) The amounts include the various concepts outlined in that specific demand, which under various titles, reference to different aspects of the moral damage suffered.
5 º) The awards accrue statutory interest from the date of the filing of the application in accordance with the provisions of art. CC 1108 because, according to the most modern jurisprudence, which exceeds the first in illiquidis non fit mora [illiquid case of sums not produce the delay] (STS 16 November 2007, CR No. 4267/2000) - the accrual of interest on the sums operates granted as compensation the value of money and should be considered justified when there is no substantial difference can be seen between the amount requested and granted, taking into account the difficulties of quantifying the concepts for which claims when they have no proprietary in nature.
.
0 comments:
Post a Comment