Toxicology expert witness advises on a case happened in South Dakota involving a diabetes sufferer who claims the drug caused bladder cancer. Plaintiff filed a product liability action against the defendant manufacturer of a Type II diabetes drug alleging she developed bladder cancer from the drug. The plaintiff alleges that the defendants concealed and continue to conceal their knowledge of the drug’s unreasonably dangerous risks from plaintiff, his physicians, other consumers and the medical community. The defendants failed to adequately inform consumers and the prescribing medical community about the risk of bladder cancer associated with the drug’s use.
Question(s) For Expert Witness
- Is the drug at issue capable of causing bladder cancer in humans because it causes bladder tumors in rats?
Expert Witness Response
There is insufficient evidence to conclude that the pharmaceutical causes bladder cancer in humans based upon findings in rats. Cancer will afflict 40% of all people in their lifetime. Bladder cancer is the fifth most common cancer. Cancer is caused by lifestyle, spontaneous alterations in genetic material and other endogenous processes rather than other exogenous factors.
The use of animal tests cannot be used to determine causation in humans without sufficient evidence in studies in humans, because the cancer mechanism in experimental animals may not be relevant for human cancer. Chemicals, including pharmaceuticals, that are known human bladder carcinogens are genotoxic and have been shown to cause cancer through genotoxic mechanisms, whereas studies of this pharmaceutical do not show that it is genotoxic.
Studies of this pharmaceutical in experimental animals have identified some increases in bladder tumors but the likely mechanism involves indirect toxic effects mediated by the formation of crystals in the urine causing tumor promotion. These crystals would not be expected to occur in humans due to differences in the urine biochemistry between rats and humans. Consequently, the findings of bladder tumors in rodents are not predictive of the development bladder cancer in humans.
The expert relied on his experience as a toxicologist, researcher and physician, published scientific and toxicology literature on this pharmaceutical and similar drugs.
The expert is a physician, biochemist and certified toxicologist with more than 40 years of toxicology research. He has authored peer-reviewed articles on carcinogenicity, tumor promotion, cancer mechanism, and DNA changes associated with chemical exposure.