165
Chapter 2: Reaction against malpractice/Patients Compensation
LETHAL MEDICINE: THE SAFETY OF MEDICAL PRODUCTS AND CRIMINAL
166
CHAPTER 2 Lethal medicine: the safety of medical products and criminal liability
Lex Medicinae, N.º Especial (2014) Coimbra Editora ®
market. In the period 1958‑1962 alone, about 845 cases of phococomelia appear in west Germany.
However, very few (if any) cases are registered in countries where the approval of this drug was refused or restricted, such as the USA, where thalidomide was not allowed due to insufficient investigation.
One of the most important questions posed by this case to the criminal court was that relating to the criterion needed to establish a causal connection between the injuries and thalidomide, since this was a new medicine and the studies about its conse‑
quences were few. However, the court did affirm the causality between the drug and the injuries suffered by the children based on the personal belief of the judge regarding this causal relation. This decision was therefore much criticized (4).
2.2. The Baxter Althane disaster
In the Autumn 2001 occured an outbreak of deaths in patients with renal disease who routinely performed haemodialysis (5). Fifty three sudden deaths of patients were reported in Spain, Croatia, Italy, Germany, Taiwan, Colombia and the USA.
All had received hospital treatment with Althane hemodialysis equipment, a product manufactured and commercialized by Baxter International, USA.
(4) With further developments, Sousa, Susana Aires de, A Responsabilidade Criminal e o Topos Causal em Direito Penal, Doctoral Dissertation, Coimbra, 2012, p. 14 and ff.
(5) Cf. Ramos González, Sonia, Responsabilidad Civil por Medicamento.
Defectos de Fabricación, de diseño y en las Advertencias o Instruciones, Madrid:
Thomson/Civitas, 2004, p. 36 and f.; also Sousa, Susana Aires de, «Medicamentos e responsabilidade criminal: problemas jurídico‑criminais suscitados a partir de uma análise casuística», Lex Medicinae, ano 5 (2008), n.º 9, p. 84 and f.
In Barcelona four people died in four days. The investigation of the spanish Public Prosecutor led to the hemodialysis equipment used by those patients.
In other countries the official investigations initially found no link between the cases. However, the inves‑
tigation conducted simultaneously by Baxter and the FDA (Food and Drug Administration) identified in some dialysers the unusual presence of a liquid sub‑
stance used to detectet leaks during the manufactur‑
ing process of the equipment (6). For unclear reasons, this test fluid was not removed adequately. In contact with the blood of the patient during the process of dialysis, this liquid created micro bubbles which caused hypoxemia with fatal consequences.
Baxter also announced the discontinuation and permanent recall of all Althane equipment. The families of most non‑US victims were compensated by Baxter voluntarily, while US plaintiffs settled an agreement with the company. Until this moment no criminal condemn was decided, to the best of our knowledge.
The importance of this case stems from the fact that the danger to life came from a medical equip‑
ment and not from a medical substance. It clearly states that the safety of patients is also dependent on the safety of the medical equipment.
2.3. The NECC and the meningitis outbreak In October 2012 an outbreak of fungal meningi‑
tis was reported in the USA. The fungal contamina‑
(6) Canaud, Bernar, «Performance liquid test as cause for sudden deaths of dialysis patients: perfluorohydrocarbon, a previously unrecognized hazard for dialysis patients», Nephrol Dial Transplant (2002), p. 547.
167
Susana Aires de Sousa CHAPTER 2
Coimbra Editora ® Lex Medicinae, N.º Especial (2014)
tion originated in three lots of medication used for epidural steroid injections for back pain (7). The medi‑
cation was packaged and marketed by the New Eng‑
land Compounding Center (NECC), a compound‑
ing pharmacy (pharmacies which combine, mix or alter ingredients to create specific formulations of drugs in order to meet the specific needs of individ‑
ual patients, and only in response to individual pre‑
scriptions) in Massachusetts. Doses from these three lots were distributed to seventy five medical facilities in twenty three states, and doses were administered to approximately 14,000 patients after May 21 and before September 24, 2012. Patients began reporting symptoms in late August, but due to the unusual nature of the infection clinicians did not realize that the cases had a common cause until late September.
Infections other than meningitis were also associ‑
ated with this outbreak, which spanned 19 states in the USA. The company was accused of “unsafe manufacturing practices” that led to 61 deaths and more than 749 injuries in patients infected with a fungus responsible for a rare but deadly form of meningitis. Presently, the latest news indicated that the top executives of the New England Com‑
pounding Center are likely to be criminally pros‑
ecuted on federal charges that carry possible prison sentences (8).
(7) Cf. http://www.cdc.gov/hai/outbreaks/currentsituation/ (accessed in September 2013).
(8) Cf. http://www.tennessean.com/article/20130518/NEWS07/305170134/
Meningitis‑outbreak‑criminal‑probe‑still‑ongoing (accessed in September 2013).
3. The portuguese law
3.1. The protected interests
The production and commercialization of medicine products are particularly connected to both individual and collective interests: life, indi‑
vidual health, patrimonial interests of the consumer, public safety and public health. These interests are protected by civil, administrative and criminal law.
However, criminal law should be the ultima ratio of this protection. Its sanctions are the most serious and heavy foreseen in the law. Thus they should be convoked to face the most serious attacks to legal goods and interests. If the protection of these inter‑
ests can be fully and sufficiently reassured by other means, then criminal law is not required.
Nevertheless, the presence of an offence of these legal interests through the use, production and commercialization of medicine products can and must raise, in serious cases, the question of criminal liability. A defective product causing major injuries can, under specific requirements of the criminal dog‑
matic, demand and justify a criminal responsibility.
Although the portuguese law has a long history with respect to the protection from the damages caused by defective products (e. g, the penal Code of 1852 punished in its article 249 the apothecary that sold or applied damaged medicine products) (9), the present criminal rules are minimal and are not fully adequate for the protection of these interests.
(9) With further developments about this matter, Sousa, Susana Aires de, Reponsabilidade Criminal pelo Produto…, op. cit., p. 516 and ff.
168
CHAPTER 2 Lethal medicine: the safety of medical products and criminal liability
Lex Medicinae, N.º Especial (2014) Coimbra Editora ®
Portugal thus fails to accomplish its international obligations in this domain, in particular those assumed in 2011 with the signature of the Coun‑
cil of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health.
Which are then the consequences of the pro‑
duction or commercialization of a defective medical product under portuguese legislation? How would the cases presented be treated under portuguese law?
3.2. The administrative sanctions and the Statute of medicine products (Decreto-Lei n. 176/2006)
As previously stated, criminal law is the ultima ratio of the legal order. If the protection of these interests can be fully and sufficiently reassured by other means, then criminal law is not required.
This idea is particularly obvious on the por‑
tuguese law of pharmacy and medicine products (Decreto‑Lei n. 176/2006, 30‑08). The violation of the rules regarding quality and safety on the produc‑
tion and commercialization of medicine products is sanctioned essentially by administrative law. Article 181 of this Act establishes that:
“without prejudice of the criminal, civil and disciplinary liability or administrative measures that may be applicable, the violation of the duties pre‑
viewed in the present act, which are supervised by the INFARMED [National Authority of Medicines and Health Products], constitutes an administrative illicit punishable under the terms of the present section”.
Decreto‑Lei n. 176/2006 sanctions with penalty from € 2000 to € 3740,98, in case of an individual person, or up to € 44 891,81 in case of a collective person, situations such as, among others:
— The production, commercialization, distribu‑
tion, exportation, importation, selling to the public, use of experimental medicine products without requesting the necessary authoriza‑
tion or using an invalid authorization.
— The production and distribution of medicine products or experimental medicine without the necessary technical authorization.
— The violation of the required information about the medicine product.
— The violation of the required conditions to produce the medicine products (previewed in articles 59, 61 and 62, 63, 65 to 72).
— The modifications to the authorization made in disconformity with the law;
— The violation of the control obligation by a supervisory entity.
In the Portuguese legal system, the infractions related to bad practices in the production or com‑
mercialization of medicine products are primarily dealt by administrative sanctions. Criminal law has a very restricted intervention in the protection of these interests.
3.3. The portuguese criminal law
In Portugal the most relevant crimes concerning to medicine products are established in the Criminal Code.
169
Susana Aires de Sousa CHAPTER 2
Coimbra Editora ® Lex Medicinae, N.º Especial (2014)
a) When medical malpractice or defective medicine are connected with the death or with an health injury of a patient, a possible criminal liability emanates from the offence of homicide or physical injuries.
However, the criminal liability can not be founded in a simple co‑relation between the death of the patient and the consumption of the medicine products. A first requisite is the need of a causal link between the medicine and the event. This is one of the most problematic issues concerning product criminal liability which was well illustrated by the thalidomide case. When the medicine is new, it is extremely difficult to establish a causal connection.
The belief of the judge about that causal connec‑
tion is not sufficient to affirm that the drug was the cause of harm. This causal link must be supported in scientific knowledge: the judge can not ignore the science and he can not formulate scientific judgments.
This causal link was proved in the Althane case.
However, there is no notice of a condemnation for imprudent or involuntary homicide.
b) Another important disposition is the article 282 of the Criminal Code: Corruption of food or medical substances.
The conduct of adulteration of a food substance or of a medical substance in the several possible moments of production and commercialization, with danger to life or health of the consumer, is punished with imprisonment from 1 to 8 years.
This norm also requires that the life or health of a person to be put in a concrete and specific danger, which is likely to be difficult to prove in the circumstances of massive consumption.
The case of the NECC meningitis outbreak would be a clear example of criminal liability by corruption of a medical substance, concerning the people whose life was put in danger by the use of the contaminated drug.
These are the principal criminal dispositions concerning dangerous medicine products in the portuguese legal system. As we have pointed out, portuguese criminal dispositions are minimal and reduced to the protection of individual interests such as life or individual health. Portugal has kept the protection of other interests related to medicine sub‑
stances, such as public health, outside the criminal range. In fact, the protection of public health has no autonomy in the portuguese criminal code from the protection of individual interests such as life or physical integrity. For example, the counterfeiting of medical products only has criminal relevance if the life or physical integrity of a specific person is put in danger. The conduct itself has no criminal value.
This is currently an important question because Portugal has signed the Council of Europe Conven‑
tion (MediCrime) on the counterfeiting of medical products and similar crimes involving threats to public health.
4. The Medicrime Convention
The Convention will enter into force when rati‑
fied by five states, including three Council of Europe Member States. Until March 2014, 20 countries had signed the Convention and it had been ratified by three states (Spain, Ukraine and Hungary).
170
CHAPTER 2 Lethal medicine: the safety of medical products and criminal liability
Lex Medicinae, N.º Especial (2014) Coimbra Editora ®
The object and purpose of this convention are the prevention and combat to threats to public health by:
— Providing for the criminalisation of certain acts, namely counterfeiting of medical pro‑
ducts;
— protecting the rights of victims of the offen‑
ces established under this Convention;
— promoting national and international co‑
‑operation.
One of the main obligations of the parties of this convention is to undertake the necessary legisla‑
tive and other measures to establish the intentional manufacturing of counterfeit medical products (both medicinal products and medical devices), active sub‑
stances, excipients, parts, materials and accessories, as an offence under its domestic law. That offence is independent of any individual and concrete danger to the life or health of a particular person.
The convention also establishes, among others, the criminalization of the intentional supplying, offer‑
ing to supply, and trafficking of counterfeit medical products, active substances, excipients, parts, materi‑
als, and accessories — which is also not foreseen in the Portuguese criminal law.
This Convention deals with the rights of the patients as well. In fact, patients and other users of medical products are given strong protection by
the MEDICRIME Convention. A victim of crimes under the Convention is defined very broadly as
‘any natural person suffering adverse physical or psychological effects as a result of having used a counterfeit medical product or a medical product manufactured, supplied or placed on the market without authorization or without being in compli‑
ance with the conformity requirements as described in Article 8’ (Article 4, k).
The rights and interests of victims are protected in particular by ensuring that victims have access to information relevant to their case and which is necessary for the protection of their health; also by assisting victims in their physical, psychological and social recovery; finally, by providing in domestic law the right of victims to compensation from the perpetrators (Article 19). Parties to the Conven‑
tion must also take the necessary legislative and other measures to protect the rights and interests of victims at all stages of criminal investigations and proceedings, including providing full access to infor‑
mation regarding those proceedings, access to proper legal representation (and legal aid if necessary), and protection against intimidation (Article 20).
As a conclusive note we see that there still is a long way in what concerns the criminal protection of the patient in the Portuguese legal system. This path has now been more emphasized by the Med‑
icrime Convention.
171
Chapter 2: Reaction against malpractice/Patients Compensation