They went because they were in pain, suffering back and neck trouble. Current estimates are that over 14,000 people across the United States sought joint pain relief by receiving steroid injections near their spinal column. Never even approved by the Food and Drug Association (FDA) for epidural injection, contaminated steroid lots have now sickened over 400 people, and killed 30.
The far-reaching impact of the prescription of an unapproved procedure involving contaminated materials is historic in the area of products liability law. Although no cases were reported in our state of Oklahoma, product liability injuries of this sort may well arise in the future.
In late November, officials from the FDA will testify before the Congressional Energy and Commerce Committee to discuss its investigation of the New England Compounding Center (NECC), a specialty pharmacy that supplies medicines to doctors and hospitals.
As defective product attorneys, we represent clients suffering injury from products that are improperly designed or defective, or sold with insufficient warnings. In its investigation, the FDA found the following defective manufacturing conditions at NECC:
- A quarter of the steroid vials contained greenish black foreign matter, and 50 vials sent for analysis revealed fungus.
- Non-sterile pharmaceutical and raw materials were used to prepare drugs.
- Sterilization procedures were not documented.
- Self-analysis by NECC revealed the presence of microbial contamination in laboratory clean rooms.
No official explanation has been provided by NECC officials regarding the injectable steroid compound that was recalled on September 26 of this year.
The extent of damage from this unapproved procedure and contaminated product is unknown. It is known that many people were sickened and killed because they relied on a dangerous medical procedure and a defective product to relieve their pain. If injured by a defective product or drug, contact us online at Cummings & Mears. We can help.