Country
France
Court
Cour d'appel de Rennes, 28 November 2012
Topics
Causal link
Defect
Articles
Facts
In February 2003, the claimant started to develop symptoms of Parkinson's disease and was consequently prescribed the drug Requip by a neurologist to treat the disease's symptoms. Because of the persistence of symptoms, the physician gradually increased the drug's doses until summer 2004. At this time, the claimant started to experience behavioural disorders (addiction to gambling, obsessional sexual urges, depression) which led to harmful or criminal acts (dilapidation of the household's money until indebtedness, thefts, adultery...). Such behavioural disorders stopped when the patient ceased the treatment.
The plaintiff brought a claim against the drug manufacturer and the prescribing physician in January 2006, before a Regional commission for conciliation and compensation for medical accidents, iatrogenic disorders and nosocomial infections (CRCI). The CRCI found both the product manufacturer and the physician liable, the former for 80% of the damage and the latter for 20%. The National office for the indemnification of medical accidents, iatrogenic and nosocomial infections (ONIAM) subsequently made an indemnity offer to the plaintiff, but this latter turned it down on the grounds that it did not include the economic losses he had suffered.
In February 2008, the plaintiff brought this claim before the Nantes Court of first instance. The court held the product manufacturer liable and rejected the physician's liability. An appeal was filed.
Legal questions
From which elements of facts can the defectiveness of a drug linked to a lack of information be inferred?
Should the prescribing physician be held liable for not having informed the patient of the risks associated with the prescribed drug, given that these risks were mentioned in the scientific literature at that time?
What kind of damage can be compensated?
Decision
The Rennes court of appeal upheld the reasoning of the court of first instance.
Regarding the drug manufacturer's strict liability:
The product's defectiveness was acknowledged on the grounds that the drug manufacturer had not mentioned these behavioural adverse effects in the product's leaflet.
Regarding the demonstration of the causal link, several elements were taken into account by the court and were deemed conclusive presumptions of fact from which the causal link could be inferred. First, different experts concluded to the existence of a causal link between the behavioural troubles and the treatment. Moreover, the court took into account the chronology of events: the behavioural disorders occurred after the beginning of the treatment and stopped shortly after its end. Finally, the facts that these side effects were mentioned in the drug's leaflet from 2006 onwards and that the French drug regulatory agency (ex-Afssaps) started to warn physicians about such effects in 2009 led to conclude to the existence of a causal link.
As regards damages, the court granted both compensation for material damages (such as health expenses, gambling losses or professional inactivity losses) and compensation for moral injury, in accordance with the plaintiff's claim.
Regarding the prescribing physician's liability:
The court deemed the physician's prescription appropriate with regards to the data he had at hand. Indeed, he had not been informed of possible behavioural side effects by the drug's manufacturer or by the French drug regulatory agency. Therefore, the prescribing physician's liability for failing to provide information about the drug's side effects to the patient was rejected.
Commentary
This case emphasizes the importance of information about possible risks in product liability cases and establishes a difference between drug manufacturers and prescribers regarding their duty to inform.
Drug manufacturers have the duty to disclose their products' side effects. Indeed, the lack of information regarding adverse effects known at the time of the prescription leads to qualify the product as defective. In this case, the fact that the manufacturer changed the product's leaflet in 2006, while such information had been available in the scientific community before 2003, was deemed conclusive. This solution echoes a decision of the Court of cassation regarding Hepatitis B vaccine (Cour de cassation, 1re Civ., 9 July 2009, pourvoi n 08-11.073), in which the product's defectiveness had been inferred from the incomplete labelling of the package leaflet regarding the risks linked to the vaccine. Indeed, at the time of the vaccination, the medical dictionary Vidal mentioned multiple sclerosis as a possible adverse effect, while this risk was absent on the product's leaflet.
The scope of the solution in the case at hand is restricted to patients who received the treatment before 2006. After this date, it would prove necessary to demonstrate the product's intrinsic defectiveness, i.e. the existence of an adverse risk-benefit ratio. Due to the scarcity of alternative treatments for Parkinson's disease and to the fact that this drug continues to provide more benefits than risks for the majority of patients, intrinsic defectiveness would be difficult to establish.
An interesting point concerns the fact that when a lack of information is acknowledged in product liability cases, the reasoning differs from other cases where this issue is also at stake, such as medical liability. Indeed, when a physician fails to inform his/her patient of the risks associated with a given act or treatment, courts look at the probability that the patient would have objected to the medical act or treatment had he/she been given the information. Consequently, the amount of damages granted reflects this probability: this is the "loss of opportunity" approach. Such an analysis is absent in product liability cases, maybe because judges tend to presume that information about the potential risk is likely to prevent harm from happening, or at least to consolidate. In other words, if information provided by the manufacturer is recognized as such a crucial element, it is because it induces patients and prescribing physicians to be vigilant about possible side effects as soon as they appear.
As regards physicians, various obligations regarding information have been acknowledged in the past years. They must for instance prove that their patient has been informed of the risks at stake (Cour de cassation, 1re civ., 25 February 1997, pourvoi n 94-19.685), even uncommon ones (Cour de cassation, 1re civ., 7 October 1998, pourvoi n 97-10.267), and has understood them. In the case at hand, by stating that the physician could not be held liable since he had not been informed of the risks at stake by the manufacturer, the court acknowledged that the physician's duty to get information and to inform patients is limited to the risks mentioned in the product's leaflet and in the physicians' medical dictionary and database (Vidal).
Bibliography
S. Canselier, « Le traitement de la maladie de Parkinson et la responsabilité du fait des médicaments. Note sous CA Rennes, 28 novembre 2012 », Revue de droit sanitaire et social 2013 p. 476
