PRODUCT LIABILITY DEVELOPMENTS IN ITALY. THE TOBACCO CASE STALTERI v. B.A.T. Italia

1. PRODUCT LIABILITY DEVELOPMENTS IN ITALY. THE TOBACCO CASE STALTERI v. B.A.T. Italia Stefano Bertone Studio legale Ambrosio e Commodo (TO)

2. INTRODUCTION Our law firm deals mainly with personal injury cases, either in Italian courts and foreign Courts. We are working together with LCHB and other non-US law firms since 2003 on the second generation of blood factor cases. We also represent foreign victims (mainly British citizens) for claims arising from car accidents, medical malpractice and hotel-related injuries occurred in Italy. I will focus my attention today on what is probably the most important case from the recent Italian case law on product liability, a case capable of drawing new lines in the development of mass tort litigation either in our country and abroad.

3. One of the most important and innovative cases from the Italian case law: Stalteri v. British American Tobacco Italia Stalteri vs. British American Tobacco Italia (formerly ETI-Monopoli di Stato, before BAT acquired the Italian state owned company in 2003) was the first tobacco product liability case to be filed in Italy (in 1994) and the second one in Europe. It was a wrongful death action brought by the spouse and son of the deceased, Mr. Mario Stalteri, a pack-a-day smoker who quit smoking in 1987, four years before the manufacturer (upon a mandatory national law) issued certain warnings, and who died in 1991. The Rome Tribunal dismissed the claim in 1997 for lack of causation and lack of liability on ETI. On Appeal, in March of 2002 a panel ad hoc appointed by the Civil Court of Appeal in Rome released its expert witness opinion on specific causation: the panel concluded that the disease that caused Mr. Stalteri’s death (lung cancer) was for over 80% attributable to smoking.

4. In March 2005 the Rome Court of Appeal confirmed the panel’s findings and issued what at this stage is the first and only appellate court decision ever in favour of plaintiffs in Italy and – as far as I now - in Europe. This decision can easily be defined (and so it has been) as a historical landmark in product liability litigation. There are at least 2 (interconnected) reasons why this decision is extremely convincing, innovative and why it puts a good light on the plaintiff side for future lawsuits against big tobacco: • the value of statistical data as an evidence for causation (liability is a less important issue for the Appellate Court) and • the value of genetic mutations as specific means of demonstrating that Stalteri’s death was related to smoking.

5. Statistical data The Court experts found that it was over 80% probable that smoking caused Mr. Stalteri’s lung cancer and death. This, not only because of the harmful potential of smoking substances such as the Polycyclic Aromatic Hydrocarbons which are present in Benzopirene[1], but also because other factors should be excluded. [1] See for instance Goldman et al. Smoking Increases Carcinogenic Polycyclic Aromatic Hydrocarbons in Human Lung Tissue; Cancer Research 61, 6367-6371, September 1, 2001.

6. They put in relation Mr. Stalteri’s life with statistical data of diseases in the general population and in smokers, and found that the probability that smoking was the causative agent was at least 80% because of: • profession: agricultural teacher not dealing with pesticides (contrary to what had been suggested by the defendants) • his living conditions: always lived in small cities=lower pollution=lesser contributing/causative factors • his family history: no history of carcinomas in parents or brothers • his genetic background (see below)

7. Genetic mutations Genetic mutations were the most combated points during confrontation between the parties and the Court’s experts. The panel worked with an approach similar to those used in cases of toxic torts and tried to find the fingerprints of carcinogens of tobacco smoke. According to the best forensic evidence, these traces can be found in the victim's cells collected and preserved at the time of hospital administration (As a practical point, I suggest that every plaintiff firm dealing with tobacco litigation carefully looks after and stores these data with his clients while they are still alive).

8. Genetic mutations As a first instance, the Court’s experts found the nature of primitive cancer that attacked Mr. Stalteri, thus excluding that it was inducted by other carcinomas already affecting his body (secondary cancer would have presented different characterizations). Specifically, peculiar K-ras gene mutations in lung differ from K-ras mutations typical of colon cancer. Specimens showed only traces of lung K-ras mutations. Then they had to deal with the key point: what caused the victim’s primitive cancer?

9. What caused the victim’s primitive cancer? Scientific literature suggests that different genetic mutations of certain genes (p53 and K-ras, again) occur in smokers and not in non-smokers. The Court of Appeal will call them later “indicative biomarkers”. Similarly to what had been found in previous epidemiological studies, the mutation of K-ras genes was an evidence that Polycyclic Aromatic Hydrocarbons had caused a molecular injury causing on its turn the lung carcinoma.

10. What caused the victim’s primitive cancer? As the Court observed “scientific literature cited by the panel…links such a mutation to the mutagenic action of the Polycyclic Aromatic Hydrocarbons on the DNA…in a way that the mutation becomes a thorough specific biomarker indicating that cancer derives from smoking”. The panel was therefore sufficiently convinced that these data, being present in Stalteri’s specimens, showed a credible proof of causation and concluded that "a serious and reasonable criterion of probabilistic evidence confirms that smoking has been a sufficient and adequate causation of the specific cancer":

11. What caused the victim’s primitive cancer? The Rome Court of Appeal was on its turn convinced that “the existence of a causal link between lung cancer and smoking of cigarettes can be said to be ascertained following a serious scientific criteria, beyond any reasonable doubt”.

12. …and liability… Having resolved the issue of causation, the Court had to deal with its third issue, liability. As Mr. Stalteri had only smoked one brand for nearly 40 yrs., there were no issues regarding other potential defendants who might have contributed with their negligence. The Court relied heavily on the level of knowledge of the defendant: “who manufactures tobacco and puts it into commerce can not ignore the risks for health on consumers…through its technicians it knows the composition of tobacco and toxic substances contained”.

13. …the defendant is not an ordinary party… “As an entity interested in producing and trading, it can not be reasonably considered as ignoring the scientific studies that…since at least 1950, have as subject the effect of smoking on human health…studies which showed in a more and more convincing way that smoking causes injuries…and at high rates…of lung cancer”.

14. (More on liability…) The Court limited itself on saying the above on knowledge, and I am not aware whether plaintiff ever submitted any documents to the Court’s attention to go beyond this point (that is: presumption of knowledge on the defendants). It is evident to me that the tobacco companies’ real awareness is much more intense: it is not only to be presumed, but it is easily provable (suggestion: plaintiffs firms should always be sure to produce these documents in their court proceedings) that they had complete control and consciousness of these implicit risk/harm factors, as these statements from big tobacco officials and scientists which I selected for the limited purpose of this paper, prove:

15. (the companies knew) By a scientist at Liggett: "if we can eliminate or reduce the carcinogenic agent in smoke we will have made real progress“ (Liggett, 1954)P. J. Hilts, Smokescreen - The Truth Behind the Tobacco Industry Cover-Up, 1996, Addison Wesley, p26 quoting CV Mace, Memo to R N DuPuis, Untitled, 1958, 24 July

16. (the companies knew) Senior Philip Morris scientists look into the possibility of a "‘Medically Acceptable Cigarette’, which will take seven to ten years because it will require a major research effort, because carcinogens are found in practically every class of compounds in smoke“ (Philip Morris, 1961) H. Wakeham, Tobacco and Health – R&D Approach, 1961, 15 November {Cipollone 608; Minn. Trial Exhibit 10,300}

17. (the companies knew) And still "Because known carcinogens are produced from such a wide variety of organic materials during the process of pyrolysis, it is most unlikely that a completely safe form of tobacco smoking can be evolved" (F Roe, M Pike, 1965 or 1966) F. J. C. Roe, M.C. Pike, Smoking and Lung Cancer, Undated, {Minn. Trial Exhibit 11,041}

18. Letting apart the above comments, the Courtfound that: “ETI, manufacturing and trading tobaccos exercised a dangerous activity according to art. 2050 c.c. because tobacco, having as its only destination consumption through smoking…contained a potential harmful charge, being it possible that smoking caused a threat to health…the entity was obliged to use every precaution to avoid that the risk became a concrete injury”. And what could have the defendant done to avoid the injuries? “First elementary rule…to inform the consumer… information campaigns…inserting labelling…as it is in use since years in medicinal products”…

19. ..but onus of proof on ETI/BAT was not fulfilled The onus of proof which was on ETI (to prove that they had used any effort to avoid the harm) was not satisfied (by simply asserting, like they did, that no laws had been infringed), according to the Court, and even the free choice of the smoker is irrelevant, since the defendant did not prove on the contrary of any “conduct suitable to avoid the harm”. The finding that genetic alterations / mutations (such as those found on Stalteri’s specimens) occur on smokers differently than in non-smokers might, as Mr. Stalteri’s son recognized in a scientific publication “have interesting implications in the field of mass torts, tobacco as well as non-tobacco related”

20. Of course, it must be remembered that Mr. Stalteri’s case was “facilitated” in some way by the deceased’s style of life, his places of living and his profession – this means that the Court’s findings can not automatically be extended to any other tobacco case, and that it will be on the plaintiff’s firms to carefully choose their best claim to put forward tobacco litigation in our country, but if we can manage to handle this scientific and epidemiologic data, we will be able to rely on “identity cards” for smoking-related lung cancers (or other smoke-related carcinomas).This ruling is able to open the doors to new scenarios in non-tobacco mass tort litigation (product liability litigation but also toxic exposures, for instance) in which medically traceable injuries or – as the Rome Court of Appeals calls them – “indicative biomarkers” help plaintiffs match our Supreme Court’s requirements on causation, which is currently “logical probable cause”.

21. Conclusion Given this precedent one shouldn’t be surprised that, by the own words of another big tobacco company (PM) broadly commenting the results of litigation: “The best way to achieve tobacco control aims is not litigation, but regulation. Good policy is about making sure the future works, rather than arguing about the past”[1] I believe that families of the >80.000 people passing away every year for tobacco-related pathologies in our country[2] stand a fundamental right to argue in Court about the past of their loved ones and to determine if they died as a result of a series of tortious acts. This, wherever they should bring their claims (in the US or Italy), by individual or group actions. Thank you for your attention. [1]http://www.philipmorrisinternational.com/PMINTL/pages/eng/press/Litigation.asp, may 18, 2005. [2] Ministero della Salute – Direzione Generale della Prevenzione Sanitaria,VII Convegno nazionale tabagismo e Servizio Sanitario Nazionale 31 maggio 2005 – Istituto Superiore di Sanità – Roma.