When “Clean Rooms” Result in Defective Drugs

By Peter DePaolis

A Washington, D.C., Virginia, and Maryland Injury Attorney Explains the Dangers

Six of the world’s largest pharmaceutical companies are based in the United States, which includes the $61 billion juggernaut Johnson & Johnson, the largest company by revenue. With factories throughout the nation, the United States synthesizes and creates a significant portion of the world’s medicine. These factories utilize “clean rooms” to ensure that the medications they make are free of contamination. However, failures in the safety features of these rooms can result in the sale of defective medication to the public and significant harm to pharmaceutical employees.

The Uses and Dangers of Clean Rooms

“Clean rooms” are sections of manufacturing facilities that use a combination of procedures and equipment to provide an environment that is relatively free of contaminants. They are common in factories that produce highly sensitive products like pharmaceutical drugs and microchips.

Despite their safeguards, clean rooms do not always prevent medications from suffering dangerous contaminations. Drug safety can be compromised due to:

  • Mechanical failures in decontamination equipment
  • Worker error
  • Contaminated raw materials for the medication
  • Deteriorated, stale, or expired raw materials
  • Errors or ignorance of operating procedures
  • Unlawful manufacturing practices
  • Flawed facility design

Although the Food and Drug Administration has the power to recall contaminated batches of medication, the agency typically does not issue a recall until several serious injuries or deaths have occurred.

In the past year, there have been two significant medication recalls due to manufacturing contamination. One involved spinal injections that were infected by viruses that cause meningitis, while another involved a bipolar medication that was contaminated with an antibiotic.

If You Suspect that You Were Hurt

Federal law strictly regulates pharmaceutical manufacturing, and it may be a simple matter of investigating the medicine’s batch to see if it has harmed patients. However, pharmaceutical companies will often do everything in their power to prevent news about contamination from spreading. Individuals hurt by a possibly defective medication should contact a Virginia, Maryland, or Washington, D.C. injury attorney.

Clean rooms can also harm the people who work inside of them. If employers neglect to maintain the ventilation equipment, pharmaceutical workers may inhale the raw ingredients of the drugs. In some cases, older clean rooms may have been built with asbestos-maintaining materials. Companies can be held liable for the workplace injuries caused by their failure to provide a safe workplace.

We Know How to Investigate Drug Injuries

Our Washington, D.C., Maryland, and Virginia injury attorneys are experienced with pursuing compensation for injuries caused by contaminated or defective drugs. If you suspect that you or a family member was hurt by a medical product, contact our firm today. We are available for clients in Virginia, the District of Columbia, Maryland, and all throughout the United States.

About the Author
Peter DePaolis joined the firm in 1980 and has since represented a large number of individuals involved in automobile collisions, truck accidents, bus crashes, defective products, and medical malpractice cases. A significant portion of Mr. DePaolis’ practice is devoted to working on behalf of people suffering from asbestosis, mesothelioma, and other asbestos-related cancers. He has led his firm’s fight against the asbestos industry and has recovered over $30 million in damages for asbestos victims and their families.