Inadequate Chinese Facilities Making Inadequate Generic Drugs

Our country has certainly seen a surge of problems and lawsuits associated with dangerous or defective Chinese made products including tainted fish, drywall, baby formula, and toys. It is now becoming clear that generic drugs manufactured in Chinese factories will result in a string of product liability and wrongful death lawsuits.

The most recent lawsuit to make the news comes from Texas and the family of Lloyd James Robinson. Mr. Robinson died after having an adverse reaction to Heparin he received at a DaVita Dialysis Center. The family has filed suit against both the dialysis center and the manufacturer of the drug. As it pertains to the drug manufacturer, the theory of liability is that the Chinese facility in which the drug is manufactured does not meet US regulations. Reports of adverse reactions to the Heparin injections began in early 2008 and led to a partial and then total recall of Heparin products on the market. Following the recall, the Food and Drug Administration discovered the drugs were contaminated with a “heparin-like molecule,” identified as over-sulfated chondroitin sulfate. This contaminant accounted for up to 20 percent of the total mass of the each sample tested.

In order for a product liability case to be successful the plaintiffs must prove either:

  • The product design was defective
  • The product was manufactured in a defective way
  • The unsafe product lacked sufficient warning or direction

While I am unfamiliar with the facts surrounding this case, it appears that the attorneys are targeting option 2 above. Cost cutting measures in Chinese laboratories that do not meet US regulations caused a safe drug, such as Heparin, to become contaminated and, thereby, defective.