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Washington, DC-For the third time in a matter of minutes, Karen Bartlett puts drops in her eyes to substitute for the tears she no longer produces. Legally blind, Karen's eyes are a noticeable injury from her Stevens-Johnson syndrome (SJS), a lifetime condition resulting from taking sulindac, a generic drug prescribed for shoulder pain.
Tomorrow, the U.S. Supreme Court will hear Karen's case about the legal responsibility generic drug manufacturers have for the safety of their drugs. This case, Mutual Pharmaceutical v. Bartlett, will decide the responsibility generic makers have in the overall design of the drugs they produce. Karen's legal team will argue sulindac was unreasonably dangerous compared to similar drugs. Three lower courts concurred, awarding Karen $21 million in damages for her injuries. Mutual argues it is only making a copy of the brand drug, and therefore it has no legal responsibility for its design or safety.
"Generics account for eighty percent of all prescription drugs. All drug manufacturers should be held responsible for the design and safety warnings of their drugs," said American Association for Justice (AAJ) president Mary Alice McLarty. "Accountability should not be a matter of brand or generic."
Karen's SJS resulted in her spending months in a burn unit in a medically induced coma, covered in gauze because her skin would stick to any fabric it touched, resulting in over 60 percent of her skin peeling off. She had 13 eye surgeries, numerous cornea implants, and now has trouble walking as far as out to her own mailbox. She cannot drive, read, or eat as she once did. She is lucky to be alive.
In 2011, the U.S. Supreme Court ruled in Pliva v. Mensing that a generic drug maker has no responsibility to update its warning label with new or undisclosed risks because the drug must follow the brand label. As a result, courts have dismissed hundreds of cases of patients that have been injured by dangerous generic drugs, including cases involving generic Darvocet, Reglan, Phenergan, and Ambien, citing Mensing.
"The [U.S. Food and Drug Administration] FDA approves drugs and devices based on the manufacturers' testing, this does not mean the product is safe," added McLarty.
New undisclosed risks often emerge years after a drug has been on the market. Often this results in a new warning and sometimes, as with Darvocet and Bextra, being pulled off the market for being unreasonably dangerous.
"The Supreme Court has even asserted the importance of lawsuits in consumer safety, helping discover new or undisclosed risks," asserted McLarty.
The U.S. Supreme Court opinion in Wyeth v. Levine stated:
State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.