Good article by Pat Shellenbarger.

Opponents fight drug company lawsuit shield, but Michigan Senate leader says he will uphold ban

by Pat Shellenbarger | The Grand Rapids Press

Monday April 20, 2009, 4:49 AM

Nancy Luckhurst says she suffered side effects from an antibiotic.

SHERIDAN — When Nancy Luckhurst underwent knee surgery five months ago, she was unaware an antibiotic she was given could cause joint pain and ruptured tendons. She also didn’t know she would become part of an effort to repeal a Michigan law barring most lawsuits against pharmaceutical companies.

The day after surgery, both knees, including the one that had not been operated on, were so painful, “it was like someone had whacked me with a baseball bat,” she said. Then, both her Achilles tendons became swollen and painful.

At her computer she typed in “Levaquin,” the name of the antibiotic she was given. That’s when she found out the U.S. Food and Drug Administration, after being sued by Public Citizen, a consumer watchdog group, required the drug maker to issue a “black box warning” listing the potential side effects, including ruptured tendons and joint pain. The risk was particularly high for patients over 60, she learned.

“I went, ‘Oh, my God,’” recalled Luckhurst, 60, a retired truck driver. “Until then, I didn’t have a clue.”

She talked to a lawyer about suing the drug maker, Ortho-McNeil-Jansen Pharmaceuticals, a subsidiary of Johnson & Johnson, but was told a 1996 Michigan law prohibited it unless she could prove the company had committed fraud, bribery or withheld information from the FDA.

“Frivolous lawsuits have ruined this country,” said Luckhurst, a self-described Republican leaning toward Libertarian. “This isn’t frivolous.”

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said Michigan’s immunity law is the most restrictive in the nation.

“Anyone who sees there is no other state with a law like Michigan’s must conclude either all the other 49 states are wrong or Michigan is wrong,” he said. “I think it’s the latter.”

Lawsuits provide an additional check on drug companies, advocates for repeal say, since some undesirable side effects go unnoticed until after the FDA approves a drug and it reaches the market.

Mike Bishop

The state House last month passed bills to repeal Michigan’s immunity law, but state Senate Majority Leader Mike Bishop, R-Rochester, said he does not intend to allow a vote on it in the Senate.

“There are some things I have to be a stopper for,” he said. “I don’t have any intention of taking this issue up.”

A major goal of the law was to attract more pharmaceutical companies to Michigan, Bishop noted. He pointed to a University of Michigan studyreleased in February that estimated bioscience contributed $9.34 billion to Michigan’s economy in 2006 and accounted for nearly 100,000 jobs.

That same study found the number of Michigan residents employed by private bioscience companies declined by 10.5 percent from 2002-2006, largely because pharmaceutical companies pulled out.

The effort to repeal the immunity law “is pure politics of the worst kind,” Bishop charged, adding that trial lawyers have “commandeered the Democratic Party.”

Sen. John Gleason, D-Flushing, an advocate for repeal, returned the insult, claiming “Republicans sold out to the drug makers at a high cost to our citizens.”

Henry Greenspan, founder of Justice in Michigan, a nonpartisan group, said such sniping creates a false impression of a partisan divide. In 2007, one-third of House Republicans voted to repeal the law, he said, adding that his coalition includes “Republicans and Democrats, conservatives and liberals.”

“The real issue is why should Michigan stand alone saying, ‘You can’t sue?’” asked Greenspan, a psychologist, playwright and University of Michigan lecturer. (He emphasized he is acting as a private citizen, not a U-M faculty member.)

“Mostly what people want is acknowledgment or at least their day in court,” he said.

Last week, the professor and the retired truck driver met in Lansing to tape a cable television interview urging repeal of Michigan’s law.

Back at her Montcalm County home, Luckhurst said her knees and tendons remain painful. She spends much of her time corresponding with others who believe they were harmed by drugs, and she wrote to members of the state Senate, urging them to repeal the immunity law.

And she’s still looking for a way to sue the drug maker.

“I’m not expecting to get rich,” she said. “It’s not about me, per se. It’s about getting this brought out and forcing these drug companies to be held accountable.”

E-mail Pat Shellenbarger:

My parents and I sent Nancy a packet of quinolone articles so that she can use that in her efforts with contacting people in the Michigan state senate. I have been in contact with Pat Shellenbarger about him possibly doing a story on quinolone toxicity. He is an investigative journalist. I mailed him a big packet of quinolone documentation for an investigative story on this poisoning. It would be great if other quinolone victims could email him to let him know that this toxicity is potentially severe, long term and crippling. If you have had your life ruined like I have from these antibiotics please let him know your own horror story and its effects on your family. Thanks very much for everyone’s help in getting our collective horror story to the media. Everyone deserves the right to know that there is a “black box” warning associated with these antibiotics. Presently, nobody is informing people that get a prescription for these antibiotics. The drug companies, doctors, and the pharmacies don’t provide this information. That is criminal. In my opinion, people deserve the right of informed consent.    

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