argued that there was an agreement between themselves and the hospital to carry out the trial of a new drug, and hence a contractual relationship between the company and the hospital, but there was no contractual relationship between the company and the patient
plaintiff. In contrast, the plaintiff argued that the hospital had clearly informed the patient (research participant)
that the hospital was only a representative of the trial
sponsor, and further that the research participant had been informed that the company had entrusted/endorsed the hospital to sign the contract with trial participants. On these grounds, the plaintiff declared that a contractual relationship existed between the plaintiff and the company. The Chaoyang Court ultimately accepted the plaintiff’s claim as a dispute of contract.
Having accepted the suit, the court requested the parties to provide the relevant documents. It repeatedly requested the company to provide a copy of the insurance
contract, and explained this requirement to the company, but the company resisted and did not submit the insurance contract. The court also asked the hospital for the insurance contract, but the hospital responded that it had been unaware that it should request that documentation. Similarly, the hospital ethics committee
had not required confirmation of an insurance contract at the time the protocol was approved. The hospital argued that it had signed a clinical trial
contract with the company, which had declared that it had purchased special insurance to cover economic loss by the subjects participating in the study, including any harm
caused by the drugs. The third page of the participant information sheet
for the study stated: “Adverse drug reactions related to angiography include angiography reaction, such as skin reaction; some will imply allergic reaction, such as anaphylactic shock”. Thus an adverse event
from the double lower-limb vein angiography was included.
The plaintiff then requested the hospital ethics committee
to seek help from the SFDA, but the committee were informed that the SFDA did not have this document either. In short, no one but the company had access to a clear description of the amount of compensation
during the earlier stages of the case.
Later in the court process, the pharma company provided Chaoyang Court with certification of insurance
purchased from a German provider, certifying that the company purchased insurance effective from January 1, 2002, which covered the study overseas and participants from all countries. Each person’s maximum insurance was approximately 500,000 Euro. (Chao Min Chu Zi 2009).
The court asked the company to provide a Chinese version of the insurance contract, but the company refused. After several requests, the court, the plaintiff and her family were informed that it would take a long time to prepare such a translation and that it would be too expensive (estimated cost CNY 20,000, approximately USD 3,000 at that time).
This meant that the available documentation – namely, the consent
form and insurance contract – included no clear description of the exact amount of compensation
, nor how to compensate for different situations, types of injury, different countries, etc. When the plaintiff claimed EUR 150,000 compensation, the company argued that there was no reasonable basis for such a claim.
Though no specific
were provided about the amount of compensation, the civil judgement included a clause referring to the insurance
company’s view that where the company was responsible for the compensation
of subjects, the insurer should provide the compensation based on the requirements of the local laws where the injury occurred (Chao Min Chu Zi 2009). The pharmaceutical company
requested a non-public hearing for the appeal, which made information unavailable. The plaintiff explained that she was persisting with her appeal as she suspected that there was an unfair clause in the insurance contract and that there was an unequal description of compensation for HICs and LMICs.
After five years, the lower court’s judgement was issued in February 2013. The Beijing Chaoyao Court determined that according to the Chinese Good Clinical Practice
regulations, the company should compensate the plaintiff with EUR 50,000. However, the plaintiff did not accept this, and appealed to the Beijing Second Middle Level Court. That court rejected the appeal.
In summary, between 2009 and 2011, nine hearings were held. The final conclusion came out in February 2013. The entire process of litigation
and appeal lasted for five years. Compensation
of EUR 50,000 euros was paid directly by the company, not by the insurance
company. This suggested that the process of SAE
compensation was dealt with internally within the company, rather than through a formal procedure that involved the insurance company.
Due to the SAE and consequent extended hospitalization, the patient
was placed on strict bed rest, even though rehabilitation from the original knee replacement surgery would have required her to move. Her dream had been to travel abroad after the surgery, but participating in the trial
delayed her rehabilitation from the surgery.