McKinney family finds generic meds not equal under the law

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by JANET ST. JAMES

WFAA

Posted on July 13, 2012 at 10:33 PM

Updated Saturday, Jul 14 at 9:38 AM

MCKINNEY - Christian Welsh's skin is clear now, but last fall it was a mess.

"I developed a really bad rash, red," recalled the 18 year old. "Really sensitive skin kind of rash, and it was all over my body."

Doctors suspected he had Stevens-Johnson Syndrome, a rare inflammatory skin disorder that can be life threatening. The rash was an allergic response to a prescription drug, a generic equivalent of Bactrim.

Lawsuits against Bactrim pepper the Internet, but the Welsh family says the label on the generic form did not contain adequate warnings.

"I contacted the generic manufacturer because I was upset that we had this allergic reaction to it," said Greg Welsh, Christian's father.

Despite FDA assertions that generic drugs are the same as name brand, they are not the same when it comes to the law.

In an e-mail response, the company that made the generic drug Christian took pointed out a recent Supreme Court ruling. In PLIVA versus Mensing, the justices ruled 5-to-4 that generic drug makers have more protection from lawsuits than brand name drug makers when it comes to warning patients about potentially harmful side effects.

The high court ruling is based on a federal "sameness" statute. That statute states that a generic drug's labeling must be the same as the original brand name for which it was approved, even if safety concerns are discovered afterward.

"I was just shocked by that," Christian's father said.

Generic drugs account for seven out of 10 prescriptions, according to industry analysis. In many cases, including the Welsh's, insurance companies require patients to buy generic prescriptions over name brand drugs because they are cheaper. The FDA's own website reassures patients that generics are equal to name brands.

But, the generic drug company told the Welsh's that the Supreme Court ruling "bars the type of lawsuit" they were considering, so the company was "not in a position to offer any compensation."

"I just don't think there's any other product in America that I can think of that is exempt from any kind of product liability," said Mr. Welsh.

The Welsh family racked up thousands of dollars in medical bills and some expensive wisdom. 

They created a website, genericsafety.org, to inform the public of what they call a public injustice.

And, the Welsh's say in the future, they will request and pay for a name brand drug, so that in case the medicine doesn't work, the law will.

E-mail jstjames@wfaa.com

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