The injuries that Karen Bartlett suffered after taking a mild pain pill are enough to make anyone squeamish.

By KATIE THOMAS
The New York Times: March 4, 2013

Ms. Bartlett, who lives in Plaistow, N.H., developed a rare but severe reaction to the anti-inflammatory drug sulindac after a doctor prescribed it to treat shoulder pain in 2004. Within weeks of taking the drug, her skin began to slough off until nearly two-thirds of it was gone.

She spent almost two months in a burn unit, and months more in a medically induced coma. The reaction permanently damaged her lungs and esophagus and rendered her legally blind.

Ms. Bartlett sued Mutual Pharmaceutical Company, which made the drug she took, a generic pill, arguing that the drug’s design was dangerous and defective. During her trial in 2010 in Federal District Court in Concord, N.H., her burn surgeon described her experience as “hell on earth,” and a jury awarded her. An appeals court upheld the verdict.

“I wouldn’t want anybody to go through what I went through,” Ms. Bartlett said in a recent interview. “It was horrible. And this medication that I took, sulindac, I don’t think it should be prescribed.”

Now, in a case that is being closely watched by pharmaceutical companies, federal regulators and others, the Supreme Court will hear arguments this month on whether Mutual can be held responsible for Ms. Bartlett’s injuries. The outcome is likely to further clarify the legal recourse for patients who take generic drugs, which now account for 80 percent of all prescriptions in the United States.

Two years ago, the Supreme Court severely limited the conditions under which consumers of generic drugs could sue the manufacturers, ruling in Pliva v. Mensing that such companies did not have control over what warning labels said and therefore could not be sued for not alerting patients to the risks of taking their drugs.

Ms. Bartlett’s case is slightly different because she did not argue that the drug’s warning label was inadequate. She claimed that the drug itself was defective. But Mutual has contended that the rationale is the same since, like the label, it has no control over the drug’s design.

Under federal law, generic companies are not allowed to deviate from the brand-name drug they are copying. Sulindac is the scientific name for Clinoril, a drug similar to ibuprofen that was approved by the Food and Drug Administration in 1978 and is sold by Merck. Like ibuprofen, sulindac is in a class of drugs known as nonsteroidal anti-inflammatory drugs or Nsaids, which are in widespread use.

Mutual is appealing a decision by the United States Court of Appeals for the First Circuit, in Boston, that upheld the jury verdict and argued that even if Mutual could not have changed the drug’s design, it had no obligation to continue selling a defective product and could have taken the drug off the market. Mutual is a subsidiary of Sun Pharmaceutical of India.

Interest groups on both sides say any decision could have serious consequences.

If the court agrees with Mutual and rules that generic companies cannot be sued for defective products, trial lawyers warn that patients will be left with very few options if they are injured by a generic drug.