U.S. health officials announced on Monday, October 8, that 13,000 patients in 23 states, including Connecticut, New Hampshire, and Rhode Island, have been exposed to a potentially hazardous steroid treatment manufactured by a Framingham compounding company. The medication has been linked to a national outbreak of meningitis. On the day of the announcement, the U.S. Centers for Disease Control and Prevention (CDC) declared 14 new reported cases of the outbreak, and another death in Tennessee, adding to the additional 105 cases and eight deaths that have been confirmed nationally. Most of these cases and fatalities have been reported in the South and Midwest.
According to the CDC, the steroid was shipped to 75 health care facilities in California; Connecticut; Florida; Georgia; Idaho; Illinois; Indiana; Maryland; Michigan; Minnesota; North Carolina; New Hampshire; New Jersey; Nevada; New York; Ohio; Pennsylvania; Rhode Island; South Carolina; Tennessee; Virginia; Texas; and West Virginia.
The outbreak was first identified in Tennessee’s St. Thomas Outpatient Neurosurgery Center in Nashville, which received 2,000 vials of the steroid, more than any other facility in the state.
The steroid, typically used to treat back pain, is called methylprednisolone acetate. It was produced by New England Compounding Center (NECC) in Framingham, Massachusetts. The company voluntarily stopped operations on October 3 due to investigations of the steroid and its adverse effects. Subsequently, the company voluntarily recalled all 1,200 products made at the Framingham facility on Saturday October 6.
The U.S. Food and Drug Administration (FDA) is investigating an outbreak of meningitis among patients who had received an injection of the steroid in their spine. According to the FDA, fungal contamination was detected in foreign matter taken from a sealed vial of the steroid collected from NECC; therefore, they recommend that health care facilities and consumers not use any product produced by the Framingham pharmacy.
Pharmaceutical companies are in the business of manufacturing and selling drugs to make a profit. Manufacturers are constantly introducing new drugs into the market and, each year, thousands of people are injured or killed due to dangerous and defective characteristics.
The FDA is the primary governmental agency involved in overseeing the introduction and performance of new drugs and medications. In certain circumstances, the FDA may recall a dangerous drug, or may require that certain warnings accompany the product. Pursuing litigation against a large drug company requires experience, persistence, and resources. Defective drug cases often involve evaluations of scientific studies and assessments of the pre-market testing and investigation performed by the drug manufacturer. Compounding companies such as NECC present particular concerns, since they are not subjected to many of the strict regulations covering large pharmaceutical companies.
Swartz & Swartz, P.C. is committed to the persistent and unrelenting pursuit of drug manufacturers who cause serious injury or death to unsuspecting consumers. If you or a loved one has been the victim of a dangerous drug and would like to speak with an attorney, please contact us; you can call us at (617) 742-1900, or if you are outside the Boston area, call toll-free at 1-800-545-3732. We are here to answer your questions and discuss how to protect your legal rights.