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Illinois-Based Pharmaceutical Company Cited by the FDA

It almost sounds like fodder for a children’s song, but there’s nothing funny about the cause underlying the U.S. Food and Drug Administration’s most recent pharmaceutical recall: bugs in drugs.

Our Illinois personal injury attorneys were concerned to read an article published by MSNBC, detailing the fact that the FDA has very recently posted a warning letter to Schaumberg, Illinois-based APP Pharmaceuticals LLC., citing violations at one of the corporation’s plants, including insects found in what were supposed to be clean rooms, as well as in vials of distributed drugs, and failures to report defects such as vials contaminated with foreign matter and glass.

Abraxis Pharmaceutical Products, or APP Pharmaceuticals, is major, international pharmaceutical conglomerate centered in the suburbs of Chicago, Illinois. Prior to this series of defilements, APP Pharmaceuticals has most recently been in the news because federal health officials have allowed the firm to ramp up production of scarce medications to treat childhood leukemia, following a nationwide shortage. Fortunately the children’s cancer medications are not produced at the same plant in which insects were found in vials of sterile drugs, but the company is liable nonetheless.

“You continued to find insects in your manufacturing area, in finished product (two vials), and you received a complaint for an insect in a distributed vial,” said the letter sent by Ronald M. Pace, director of the FDA’s district in which the violations occurred.

According to a report published by the U.S. Food and Drug Administration earlier this year, particulate matter or other foreign objects in medications – such as the bugs in the drugs in this particular case – can be extremely harmful when introduced into the body. Potential adverse effects may include such things as internal irritation and inflammation, tissue death, and in more serious cases, anaphylactic shock, and death. The potential for hazard is enormous.

Illinois product liability law is an area of personal injury law that focuses on dangerous and defective products; manufacturers, distributors, retailers, and others who manufacture and disseminate goods to the public are held responsible for the injuries caused by those products. “Products” in this instance covers a wide range of categories, including medical devices and pharmaceuticals.

When corporations manufacture a product, they have the responsibility to ensure the safety of that product before the merchandise is put on the market and sold to consumers. This is especially true for pharmaceutical companies whose products must undergo extensive testing before they are distributed to consumers. When a company makes a product that is defective or dangerous – or, as in this situation, contains dangerous inclusions – and that product harms the person using that product, the company may be held legally responsible for the customer’s injuries.

As it applies in this case, if it is found that the use of APP Pharmaceuticals’ medications has led to sickness in consumers because of the insects in the sterile drugs, APP Pharmaceuticals may be liable for damages from the product’s hazardous effects, and may be made to pay compensation for medical and hospital bills, lost wages, and pain and suffering caused by the illness.

At this point, APP Pharmaceuticals has 15 days from the date of the FDA letter to respond to the problems, including how insects came to be found in an aseptic, or sterile room, used to produce crucial drugs, reported MSNBC. If you or a loved one have suffered as a result of using an unsafe product, contact an attorney to be apprised of your rights under the law.