A class action lawsuit has been filed against Genzyme Corporation, the maker of the drug Cerezyme, after a Colorado man claimed the company distributed and sold impure and untested drugs. Cerezyme, which costs $200,000 a year or more, is prescribed to treat Gaucher disease, a rare enzyme deficiency that is inherited from an individual’s parents.
What is Cerezyme?
Cerezyme is a modified form of the human enzyme, glucocerebrosidase. It is produced using genetic engineering technology, also called recombinant DNA technology, and has been shown to be effective in the treatment of Type 1 Gaucher Disease. It is prescribed for adults and children with Type 1 Gaucher disease that results in one or more of the following symptoms:
- Low blood platelet counts
- Enlargement of the spleen or liver
- Bone disease
Once considered a miracle drug for those suffering from Gaucher Disease, Cerezyme was contaminated with vesivirus sometime prior to July 2009 and according to the complaint, the company cut doses to less than a third for many Gaucher patients due to a shortage of the drug. The company allegedly knew the diluted medication was experimental and dangerous and still elected to give it to certain patients, including the plaintiff, who now suffers from an incurable cancer.
According to court documents, after Genzyme contaminated its bioreactors with the dangerous virus, the company was forced to temporarily close its main factory in Boston, greatly reducing the output of Cerezyme. Genzyme did not restore full supplies of Cerezyme until January of 2011, much later than initially expected.
Because Genzyme could not meet customer demand for Cerezyme, the company implemented a plan that was designed to ration the drug that was allegedly illegal to sell or market in the first place, according to the complaint, because it was “experimental, mislabeled, impure, contaminated, ineffective, diluted and illegally substituted but marketed as if it were a beneficial treatment for Gaucher Disease,” although it was never previously tested in animals or human beings.