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FDA Rule Change Could Hold Generic Drug Manufacturers Liable

In 2004, Nancy Bartlett, a secretary for a New Hampshire insurance company visited her doctor complaining of shoulder pain and was prescribed the non-steroidal anti-inflammatory drug Clinoril. Ms. Bartlett received the generic version, sulindac, from her pharmacist.

Shortly after, Ms. Bartlett suffered Stevens-Johnson syndrome, a severe drug reaction that caused two-thirds of her skin to slough off, burned her lungs and esophagus, and left her disabled and legally blind, among other injuries. Ms. Bartlett sued the manufacturer of sulindac and was initially awarded $21 million in damages, a verdict upheld on appeal until the process reached the U.S. Supreme Court.

In June, the Supreme Court overturned the verdict in a 5-4 ruling, holding the generic manufacturer harmless for the damage done to Ms. Bartlett because of labeling restrictions placed upon generic drug makers.

In July, the Food and Drug Administration (FDA) took the first step to close a loophole that allows generic drug manufacturers to escape liability for the products they sell. With the proposed rule change, the FDA hopes to accomplish the following:

  • Create parity between generic and brand-name drug makers in the revision of drug labels to alert users of newfound risks and side effects
  • Permit patients harmed by generic drugs to obtain compensation for damages they suffer because of negligence or defect

Anticipated changes to labeling laws come too late for Ms. Bartlett, now 53, disfigured and surviving on disability checks. While her struggle and others’ may have moved the FDA to alter its ruling, the price was too high.

If you have questions about a medication error or defect, speak with a knowledgeable attorney.

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