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Motrin Prescription Label Never Published by McNeil or J&J

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Report adverse events to FDA's MedWatch reporting system by completing a form on line at FDA's MedWatch
Faxing (1-800-FDA-0178) Mail using the postage-paid address form provided on line (5600 Fishers Lane, Rockville, MD 20853-9787) Telephone (1-800-FDA-1088)

drug side effects
Preventable Adverse Drug Reactions

Over 2 MILLION serious ADRs yearly

100,000 DEATHS yearly

ADRs 4th leading cause of death ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths

Nursing home patients

ADR rate 350,000 yearly

Institute of Medicine, National Academy Press, 2000

Stevens-Johnson Info:

Side Effects

IV Immunoglobulin

Keith Jensen obtained the largest verdict in NH history and that case is before the U.S. Supreme Court

Woman Injured by Pain Medicine Tests Generics Makers' Immunity From Suits


WASHINGTON—The Supreme Court on Tuesday heard a generic-drug maker's argument that it should escape liability for selling a defective medication that left a New Hampshire woman disfigured, legally blind and unable to swallow food.

The court has held that brand-name manufacturers can be sued under state law for failure to provide adequate warning labels, but in 2011 carved out an exception for generic producers, reasoning that they can't be liable because they are required to use the same labels the Food and Drug Administration approves for the branded versions.

The question Tuesday was whether that exception rules out any suit against generics makers, or whether they can still be sued for selling a defective product even if the label itself is immune from challenge. The case involves a drug made by generics manufacturer Mutual Pharmaceuticals, subsequently acquired by India's Sun Pharmaceutical Industries Ltd. 524715.BY +3.13%

On Tuesday, the manufacturer's lawyer, Jay Lefkowitz, told the justices that separating a defective label from a defective product is "a distinction without a difference in real life." That is because "the lack of a clearer warning made the product itself more dangerous," he said.

Justice Ruth Bader Ginsburg said that argument could turn Food and Drug Administration drug approvals from authorization to sell a product into a right to sell it regardless of its hazards, leaving states "no role with respect to the safety and efficacy of the drug."


Court Weighs Drug Liability

The case involves Karen Bartlett, 53 years old, who was prescribed sulindac, annonsteroidal anti-inflammatory drug, to treat shoulder pain. While Ms. Bartlett's doctor had prescribed branded drug Clinoril, the pharmacist substituted a generic version.

The drug triggered a condition known as toxic epidermal necrolysis that caused more than 60% of her skin to burn off. Her burn surgeon said that reduced her life to "hell on earth."

She can no longer drive, read or eat normally and has little prospect of returning to work as an executive secretary, her doctor said.

In 2010, Ms. Bartlett won a $21 million judgment at trial for her injuries. The Supreme Court's 2011 ruling immunizing generic makers from failure-to-warn claims cast doubt on her position, but the First U.S. Circuit Court of Appeals in Boston upheld the judgment, agreeing that distinction could be drawn between an inadequate warning label and a defective product.

Justice Antonin Scalia said that approach effectively would transfer drug-safety decisions from FDA experts to untrained jurors. "That's wonderful," he said, sarcastically. "Twelve men tried and true decide for the whole state what the cost-benefit analysis is for a very novel drug that unquestionably has some deleterious effects, but also can save some lives."

Justice Stephen Breyer told Ms. Bartlett's attorney, David Frederick, that he sympathized with his position, much as he did with that of the injured patient in the 2011 generics case. He was among the four dissenters from the 2011 opinion by Justice Clarence Thomas.

Still, questions from some justices who joined Justice Thomas, including Chief Justice John Roberts, suggested some concern about denying Ms. Bartlett any remedy. A ruling is expected by the end of June.

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Motrin can cause SJS & TEN, which can cause blindness, kidney failure, and death. What McNeil & J&J Have Never Told Parents.

Tylenol Liver Damage

TEN in a Child

Can Cause Death
FDA & Tylenol



Stevens Johnson Syndrome