Can a patient sue a generic drug manufacturer?

(CBS News) WASHINGTON - Generic drugs are big business. They account for nearly 80 percent of the prescriptions written in this country-- more than 3 billion every year. But what happens when something goes wrong? Can the maker of a generic drug be sued when the FDA has declared the name-brand version safe? That was the question before the Supreme Court Tuesday.

Karen Bartlett was an active, vibrant woman who loved the outdoors, and most of all spending time with her son Matt.

But in 2004, Bartlett, suffering shoulder pain, took an anti-inflammatory drug -- known by its generic name as Sulindac -- and suffered a rare allergic reaction so severe, her life, as she knew it, was over.

The generic drug caused her to lose the skin from 65 percent of her body. Today, Bartlett is legally blind and needs near-constant assistance. For her, the hardest thing she's dealing with is her loss of independence. "I can't just jump in the car and go somewhere," she told CBS News. "I just feel sometimes like a burden to people."

Bartlett sued the manufacturer of the generic drug, Mutual Pharmaceutical, and a jury awarded her $21 million. Mutual doesn't dispute the drug caused her reaction.

Before, Karen Bartlett was a vibrant woman who loved the outdoors (left). But when she took a generic anti-inflammatory drug,she suffered a rare allergic reaction that left her to lose her skin from 65 percent of her body (left).

/ CBS News

But at the Supreme Court Tuesday, the company's lawyer, Jay Lefkowitz, argued it can't be held responsible since, by law, it was merely copying a brand-name drug.

"Federal law doesn't permit a generic drug company to change either the design of its drug or the warning," Lefkowitz told reporters.

The Obama administration is siding with the drug maker, arguing that the Food and Drug Administration had approved the medication as safe and the generic drug company shouldn't be responsible.

Several justices seemed to agree. Justice Stephen Breyer said "what's worrying me" is that a jury of "12 people instead of the FDA" could determine drug safety.

But Bartlett said her injuries are proof the drug should be off the market.

"When I dream, in my dreams, I can see perfectly and I can do whatever I want," she said, "And then when I wake up, it's a horrible reality check that I can't."

Bartlett is now 53 years old. She said a ruling in her favor would force drug companies to make medications safer. But the drug companies say that if the court rules for Bartlett, it going to cause the price of drugs to go up for everyone, especially if juries decide which drugs are safe and which aren't. A ruling in the case is expected by July.

[Penny1225]

Why was my remark not printed yesterday? Too honest for the liberals out there? EVERYONE needs to know the name of this deadly drug reaction: Stevens Johnson Syndrome. Look it up and pray it never happens to you or anyone you care about. This woman is lucky to be alive. My Mother wasn't so lucky which is normally the case.

[caljack430]

As horrible a situation as it for this woman... unless there are other cases where this same drug causes horrific side effects, I don't think you can blame the composition of the drug. Was the drug at fault? Yes. But can you really sue them for millions of dollars because you are the only person to have a freak allergic reaction to a drug that has been safe for all other users? Doubtful. The drug may have caused the reaction, but it seems like its this woman's body that has a problem (as tragic as that is), not the drugs composition.

[foreverbaby1956]

I'm not a doctor, but this appears to be a clear cut case of Stevens-Johnson Syndrome. If it is, then the drug, generic or not, is not at fault here. Rather it was a genetic luck of the draw for the unfortunate Ms Bartlett. Yet, your report makes no mention of this possibility. I absolutely can't believe that this case has gone all the way to the Supreme Court and NOBODY in the medical profession or FDA has considered this yet. An entire industry and the healthcare of millions appears to have been placed in jeopardy because of an unbelievable case of medical oversight.

[caljack430]

Chances are they HAVE already thought of that... and ruled it out.

[foreverbaby1956]

I'm not a doctor, but this appears to be a clear cut case of Stevens-Johnson Syndrome. If it is, then the drug, generic or not, is not at fault here. Rather it was a genetic luck of the draw for the unfortunate Ms Bartlett. Yet, your report makes no mention of this possibility. I absolutely can't believe that this case has gone all the way to the Supreme Court and NOBODY in the medical profession or FDA has considered this yet. An entire industry and the healthcare of millions appears to have been placed in jeopardy because of due to an unbelievable case of medical oversight.

[noneyabiznes]

My Dr. told me that "by law a generic drug can have a +/- of 30% of the active ingredient in a brand name drug". Is this true,if so,it should have been mnentioned in this story.