Mass Torts Update - Wednesday, July 1, 2009 7:34 - 0 Comments

The FDA failed to shut down a troubled plant

Natalie Fullerton died a tragic death at a tender age. Natalie, a one-year-old child, underwent a double-lung transplant and had a remarkable recovery after the surgery. Her father carefully tended to Natalie, following an intricate regimen to keep her healthy, and never suspected any real difficulties. After doctors implanted a tube in Natalie’s chest to give her intravenous medication, her father dutifully used fluid-filled syringes to clean it. A few days after he started using the syringes, the child was back in a Texas hospital, breathless and feverish, and in real trouble. Bacteria had infected her blood, the first in a cascade of complications over a period of four months. Sadly and inexcusably, Natalie died on March 12, 2008.

Natalie’s father had used syringes from a contaminated lot made in a North Carolina factory. That batch and another have since been linked to four deaths and 162 illnesses nationwide, including 22 in Illinois. Moreover, an examination of inspection reports and other documents reveals that the U.S. Food and Drug Administration had several chances to stop the tainted syringes from being used by patients and failed to act.

Three months before the prefilled syringes were shipped in October 2007, an FDA inspector visited the plant in North Carolina where they were made. She investigated reports of red, brown and black particles in syringes and reported that managers at the plant had a plan to deal with rust. But the inspector failed to note that the plant had switched to an unreliable sterilization method. A week later, the FDA learned that a distributor was recalling 1.3 million of the syringes. The agency’s own operations manual required that a thorough inspection be done, but that didn’t happen. An FDA spokeswoman now says that, because the agency is so understaffed, it no longer follows the policy. That is, unless the recalled product poses a reasonable probability of serious injuries or deaths. The conditions at the syringe manufacturing plant certainly should fit within the criteria. It’s difficult to understand why follow-up investigations by the FDA didn’t take place.

Finally, after receiving reports of harm in late 2007, FDA inspectors did go back to the plant, called AM2PAT, and discovered a “gummy brown” substance on the syringe-filling machine and brown water flowing from taps, among other safety-related problems. The plant was closed in January 2008. Federal prosecutors went after Dushyant Patel, the president of AM2PAT, who lived in Chicago. He had commuted from his home to operate the plant. An indictment on fraud, conspiracy and other charges alleges that Patel’s firm lied about performing sterility tests and produced prefilled syringes laced with bacteria.

In an effort to avoid prosecution, Patel fled the country. Two employees, including the plant manager, were sentenced in February to prison terms for fraud and for allowing tainted drugs into the marketplace. For some reason, the syringe case has not received much media attention. It’s clearly another example of the FDA dropping the ball on a serious safety issue. Consumer advocates and experts who follow the FDA say safety breakdowns at the agency are the predictable result of a long-term shift from aggressive enforcement to “partnership” with the industries the FDA oversees. That sort of thing – historically – has never worked for any regulatory agency.

Margaret Hamburg, the newly-appointed FDA Commissioner, has pledged to make product safety a “top priority.” She had this to say about the Patel plant:

This incident underscores my belief that it is critically important for the FDA to take an aggressive approach to inspections and maintain vigilance in ensuring that manufacturers fully comply with their regulatory, legal and moral obligations to ensure that the products they produce for the American people are safe and effective.

The Obama Administration and Congress must make an overhaul of the FDA a top priority and make sure that it happens. It will take increased funding and authority to deal with the health and safety issues that the FDA is charged with upholding. The death of this small, innocent child should never have occurred. Nothing like this should happen in the future.

Source: Chicago Tribune