Celine case: Bayer not liable for Yasmin contraceptive pills
by Gabriel Avigdor
WHAT THE CASE IS ABOUT
On Wednesday, 21 January 2015, the Swiss-German press reported the verdict handed down by the Swiss Federal Court in the Celine Case, better known to the media as the Yasmin Pills Case. This is a case that created a scandal in the canton of Zurich, as well as at the national level, concerning the use of the latest generation of contraceptive pills in Switzerland. In this case, the Swiss Supreme Court found that Bayer AG did not breach the Swiss Product Liability Act for lack of information in the medication leaflet.
This article outlines the key legal issues relating to drug liability under the Swiss framework and compares the situation between Switzerland and the US in particular from lawsuits perspective involving 4th generation contraceptive pills.
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In 2008, a 16-year-old girl was hospitalized in an emergency and found herself paralyzed following a pulmonary embolism. The consequence was a lack of oxygen leading to severe head injury. Yet it had only been two months since this young woman started taking the contraceptive “Yasmin”, a prescription-based “4th generation” contraceptive pill that many women around the world use. As a result of this serious disability, the young woman represented by her mother, as well as her health insurer, CSS Assurances, brought the case before the courts claiming CHF 5.3 million for tort and CHF 400,000 for moral damage. In the end, the Swiss Supreme Court upheld the previous decisions and dismissed the appeal of the girl and her health insurance, declaring that the drug manufacturer, Bayer AG, could not be held liable. However, Bayer waived its right to claim reimbursement of the appellant’s costs and expenses to Celine, which amounted to CHF 120,000 as a result of the duration of the proceedings, including attorney and courts fees. CSS Insurance did not get this chance.
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LIMITED INFORMATION DUTY OF THE PHARMACEUTICAL COMPANY
In this case, Bayer was accused of not mentioning in the patient package insert that the risk of undergoing pulmonary embolism was twice as high with the “Yasmin” pill as with other similar contraceptives. In essence, the Federal Court considered, in its judgment of 5 January 2015 (4A_365/2014 and 4A_371/2014 (in German)), that the German pharmaceutical company was not liable for this lack of information for patients, the mere fact that doctors had access to this information being sufficient. The Federal Court pointed out that the placing of a medicinal product on the market and the standards for obtaining the necessary authorisations from Swissmedic for their marketing do not oblige a pharmaceutical company to inform patients of a higher risk than other equivalent products. With regard to prescription drugs, the patient is not in a position to judge the risks involved, so it is up to doctors to evaluate the benefits and risks of the various products on the market to redirect the patient to the appropriate medical treatment.
Thus, the Federal Court acknowledged that the drug was not defective and that the company could not be held liable under the Swiss Federal Product Liability Act (PLA). The “causal liability” mechanism of this law allows the victim of a defective product to claim damages from the manufacturer, without any fault (art. 1 § 1 PLA). However, the product must be considered defective for the manufacturer to be liable for the damage caused.
In particular, the distinctions between manufacturing defects, design defects and presentation defects can be found in the famous “coffee maker case“, where the Supreme court clarifies the causes of a defect for products that have been validly placed on the market.
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INEQUALITIES IN LOCAL LEGISLATION: COMPARISON BETWEEN SWISS AND US LITIGATION
Market access authorisation framework and liability for defective drugs:
The case of Switzerland
The authority shall grant a market access authorisation for a drug for a renewable period of 5 years and must comply with the legal requirements of the Swiss Federal Therapeutic Products Act (TPA), in particular requiring the approval of Swissmedic.
Market access shall only be granted where a pharmaceutical company:
How the pharmaceutical company decides to label its product and the way in which the information is highlighted in the leaflet are also essential conditions for obtaining such authorisation (Art. 11 § 1 let. f TPA). However, to the extent those conditions are met, the manufacturer cannot be held liable for a defective product, unless its market access
authorisation was not granted properly. The responsibility for defective drug usually extends to suppliers, i.e. distributors and importers, but this excludes the medical liability of doctors or pharmacists.
1) provides evidence that the drug or a manufacturing process is of high quality, safe and effective;
2) holds an authorisation as a manufacturer, importer or wholesaler issued by the competent authority; and
3) has its domicile or its registered office in Switzerland, or has established a subsidiary in Switzerland (Art. 10 TPA).
In summary, the manufacturer’s liability for defective product it is a rather difficult to obtain, especially when a consumer has to pay very large amounts of legal fees and expenses in advance. Therefore, as a result of this case Bayer was not convicted in Switzerland by the Federal Court, which sets a precedent for pharmaceutical companies active in selling 4th generation contraceptive pills.
Situation in the USA
Mass compensation
Since 2013, the German pharmaceutical company has already paid out around USD 1.4 billion in the United States to compensate victims of similar cases by way of settlement in legal proceedings involving a total of more than 6,760 plaintiffs (the figures are not uniform, see the following reports here). These US trials are more broadly related to 3 contraceptive pills “Yaz”, “Yasmin” and “Ocella”. In the USA, the U.S. Food and Drug Administration (FDA), the authority responsible for approving and marketing consumer products, including medicines (which is the equivalent to Swissmedic in Switzerland), must ensure that a drug meets two requirements:
- Manufacture of safe drugs with precise statements of any potential risks; and
- Precisely warns under what circumstances the drug may or may not be used.
Le Monde.fr recently mentioned the impressive figure of 15,000 legal actions filed against the pharmaceutical group. The American judicial system allows, thanks to class actions and specific ethical rules on the legal profession (pactum de quota litis), to have a different means of pressure on large companies than in Switzerland where each individual must find their way alone to a long and costly trial.
Position of patient advocates
Pharmaceutical trials in the United States are particularly fascinating for civil law lawyers. For example, the drugwatch website provides information on lawsuits related to pills sold by Bayer and arguments that the attorneys may raise in court against the German manufacturer. The challenges and costs of those trials as well as the risks for manufacturers are so hihg, that some law firms become specialists defending clients in trials for those pills. They do not hesitate to document their willingness to defend the victims with explanatory videos motivating patients to consult and hire them free of charge as long as the pharmaceutical company do not pay anything to compensate any damage caused to them. You can also find links to a free medical assessment form intended for assessing the medical situation of a relative or read sentences such as: “If your loved one has died as a result of using these contraceptives, you may be able to file a wrongful death lawsuit“. There is also an American website specific to the Yaz & Yasmin trials.
On another level related to conspiracy, press articles try to establish a link between FDA members and the German manufacturer. Also from the the FDA we can find reporting risks associated with Beyaz, Safyral, Yasmin and Yaz in highly technical reports.
It’s hard to find your way around in this American romantic universe…!
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CONCLUSIONS AND LESSONS LEARNED FROM THE SWISS DECISION
The Federal Court’s decision highlights several elements:
- A pharmaceutical company is not required to inform patients that its drug presents a higher risk compared to other competing therapeutic products.
- The Swiss Supreme Court implicitly confirms the principle that a physician has an obligation to inform the patient of the nature of the risks and the degree of danger associated with taking such a drug. Indeed, the consumer does not have access to the same information as his doctor and is not in a position to make a decision without consulting him and having a free and informed opinion.
- Prescription drugs are not treated in the same way as those that do not require them to obtain them. Indeed, when a prescription is mandatory, the doctor must intervene to prescribe the drug in question to his patient, who has the knowledge to refer the patient, supported by a medical record. It is therefore up to the doctor to assess the risk and appropriateness of the patient taking a medicinal product on the basis of information intended for health professionals. The assessment of a pharmaceutical company’s liability for a non-prescription drug would probably be different if the risks are not sufficiently indicated.
- Obtaining compensation from the manufacturer of a drug for lack of information is not easy. Where appropriate, and under certain conditions, the civil and/or criminal medical liability of a doctor, or even a pharmacist or other health professionals may be incurred where, as a result of insufficient information, a damage to health occurs which could have been avoided if adequate information had been provided.
The information in the Yasmin pill package insert and contraindications are available on the website of the Swiss Compendium of Medicines.
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By Gabriel Avigdor | NTIC.ch
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