Manufacturing pharmaceutical and medical products requires extreme precision. The drugs and other solutions that these companies make are either ingested into the body or otherwise exposed to it. If these manufacturers are careless and have an impurity introduced into their process, the lives and health of the patients who are relying on them are at risk. One example of a breakdown in the manufacturing process that has sickened people is exposure to the bacteria called Burkholderia Cepacia.
According to the FDA, Burkholderia Cepacia is a bacteria that is found in soil and water. Ordinarily, you would think that it has no place in pharmaceuticals. This bacteria is dangerous because it is often resistant to regular antibiotics. The bacteria poses a serious threat to those who already have compromised immune systems and babies who have not yet developed a fully functioning immune system.
The infection that results from exposure to this bacteria can be life-threatening. When patients with a serious condition such as cystic fibrosis have been infected by this bacteria, the fatality rate has reached as high as 35%.
Serious Recent Burkholderia Cepacia Outbreaks
Some serious outbreaks of Burkholderia Cepacia infections include:
- In 2016, prefilled saline flush syringes contaminated with the bacteria resulted in a multistate outbreak of infections, sickening 163 people and killing 7.
- PharmaTech liquid docusate products were tied to two different outbreaks in consecutive years. An infant died after taking the stool softener, and the parents filed a wrongful death lawsuit against the manufacturer. There were 63 known cases of infection over a two-year span.
- In December 2020, the FDA issued a recall for the topical skin product Regenecare HA Hydrogel because of Burkholderia Cepacia contamination that could reach the bloodstream.
There have been numerous instances of tainted drugs and medical products in recent years as companies have outsourced the process of making their drugs to contract manufacturers that often operate where oversight is less stringent. Even when the FDA has jurisdiction, it does not always do what is necessary to stop these outbreaks before they occur. These companies take shortcuts, and consumers end up paying the price. All it takes is for one supervisor or employee to overlook details, and an entire lot of drugs can be tainted.
Reach out to a Florida Products Liability Attorney
Companies can be found responsible for both manufacturing and design defects in a product liability lawsuit in Boca Raton. The company is responsible for the product at all points of the manufacturing process. Regardless of how and why the outbreak occurred, the drugmaker can be made to pay in a lawsuit. Even if a contract manufacturer made the product, the company under whose name it was sold can be liable.
If you or a loved one have been sickened by Burkholderia Cepacia, chances are that a drug that you used is to blame. When that happens, you need legal help to get the compensation that you deserve. Call the attorneys at Ged Lawyers LLP at (561) 995-1966 or contact us online to learn more about your legal options at no risk to you.