Latest Drug Contamination Incident Underscores Need for Stepped-up FDA Oversight of Compounding Pharmacies, Columbia Lawyer Says

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The August 11, 2013, nationwide voluntary recall by a Texas compounding pharmacy of injectable drugs that may cause bacterial infections is evidence that Congress needs to act soon so that more innocent patients are not harmed, according to South Carolina injury attorney Bert Louthian.

Columbia, SC Injury Lawyer

S.C. Attorney Bert Louthian

The FDA needs to be able to regulate these companies to ensure the safety of all Americans.

South Carolina pharmaceutical litigation lawyer Bert Louthian today called for quick Congressional action on the proposed Pharmaceutical Quality, Security and Accountability Act, which would help prevent illnesses and deaths caused by tainted products of compounding pharmacies. “For the second time in less than a year, patients have been harmed by tainted drugs produced by compounding pharmacies,” Louthian said. “The FDA needs to be able to regulate these companies to ensure the safety of all Americans.”

On August 11, 2013, the Food and Drug Administration announced a nationwide voluntary recall of all sterile products from Specialty Compounding, LLC, in Cedar Park, TX, after 15 patients at two Texas hospitals developed bacterial bloodstream infections following injection with calcium gluconate. The mixture was distributed to patients across the country, except in North Carolina. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research stated in the agency’s press release, “The FDA believes that use of these products would create an unacceptable risk for patients. Giving a patient a contaminated injectable drug could result in a life-threatening infection.”

A 2012 fungal meningitis infection that spread in contaminated vials of medicine distributed by the New England Compounding Center in Framingham, Mass., led to 61 deaths in 20 states, as well as 749 people becoming ill, according to a July 30, 2013, editorial in the Washington Post which supported passage of SB 959, the Pharmaceutical Quality, Security and Accountability Act.

At a July 16, 2013, hearing on SB 959, Rep. Henry A. Waxman, Ranking Member on the Committee on Energy and Commerce, stated, “We have learned that there is a gaping hole in our drug safety laws. American families expect us to work together to develop an effective legislative response. And we need to do this as quickly as possible. We know that otherwise it will not be if another dangerous catastrophe occurs with compounded medicines, but when.”

“Now we know when,” said Louthian, “. . . less than one month later.”

About the Louthian Law Firm:
The Louthian Law Firm, P.A., of Columbia, S.C., has been obtaining fair compensation for personal injury victims since 1959. The firm was founded by Herbert Louthian, who has more than 50 years of trial experience and is licensed to practice in all courts in South Carolina. In addition to pharmaceutical injury claims, the Louthian Law Firm also handles cases involving medical malpractice; car, truck and motorcycle accidents; and other serious and catastrophic injuries throughout South Carolina. The firm’s office is located in the Marlboro Building, Suite 300, 1116 Blanding Street, Columbia, SC 29201 (local phone (803) 454-1200). For a free, confidential case evaluation, contact the firm toll free at (866) 410-5656

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