Pharmacology Expert Witnesses Discuss Life-Threatening Side Effects from Cholesterol Medication

This case involves a patient with a preexisting glandular disease. She was prescribed a common cholesterol medication by the defendant due to slightly elevated cholesterol. After she was administered the drug, she suffered a series of side effects, including diabetes and kidney disease, which subsequently resulted in a below the knee amputation of her left leg. She was prescribed the medication for only one week before she followed up with her primary care physician for pain and fatigue. She was eventually seen by a specialist who realized that she was suffering from side effects of the cholesterol medication. While the patient was taking multiple other medications at the time as well, the deterioration of her condition was primarily linked to an adverse reaction to the cholesterol drug specifically.

Question(s) For Expert Witness

1. Are you familiar with this medication and its effects on patients?

2. What are the contraindications of the medication?

Expert Witness Response E-005901

This drug is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, a critical enzyme involved in biosynthesis of cholesterol. Therefore, it is indicated for treatment of hyperlipidemia in patients at risk for development of atherosclerotic vascular disease. Clinically, it (as well as other statin drugs) have been shown to significantly reduce the risk of myocardial infarction (i.e., heart attack) and stroke in these patients. In the medical literature, there is evidence that it can cause type II diabetes and associated renal impairment. Studies in the medical literature indicate a causal link based on pre-existing risk factors, ethnicity, or co-administered medications. In particular, there is evidence that the risk for developing type II diabetes mellitus is elevated in patients taking selective serotonin re-uptake inhibitors (SSRIs) such as Lexipro. Additionally, it is known to be a causative agent in drug-drug interactions, particularly with respect to lipophilic drugs that require hepatic metabolism before elimination in the urine. Contraindications for the drug include patients that show symptoms of hypersensitivity to the drug, patients with clinical evidence of acute liver disease (i.e., elevated serum transaminases), and pregnant or lactating women.