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Bill would empower Michigan patients to sue drug manufacturers

-TheGrandRapidsPress

04/06/2009 - Kathy Roaleen, 59, of Rockford, suffered life-changing side effects after taking tablets that might have contained higher dosages of morphine than prescribed. The drug maker later recalled the medicine. Lawyers told Roaleen she cannot sue.

ROCKFORD -- Following back surgery, Kathy Roaleen did what the doctor ordered: She filled a prescription for a pain killer and began taking two pills a day, unaware the medication could be causing serious physical problems.

She developed pneumonia. She became forgetful. She dropped things. She lost her ability to concentrate, couldn't write a coherent paragraph or follow a simple recipe.

"A lot of it's still a blur," she said. "I was just not right."

After three weeks, when she returned to her Rockford home, she found a letter from the pharmaceutical company recalling the morphine sulfate. That's when she learned the tablets she had been taking might have contained up to twice the dosage of morphine the doctor ordered.

Roaleen consulted three attorneys about suing the pharmaceutical company, but each gave her the same answer: Under Michigan law, she could not sue.

The state House of Representatives last month passed a bill that would repeal Michigan's 13-year-old law shielding pharmaceutical companies from most lawsuits. The bill, however, faces strong opposition in the state Senate, where similar measures have failed in the past.

"I was horrified," Roaleen said. "I couldn't see why any particular manufacturer shouldn't be held accountable for what they produced, whatever it was."

Is law good for business?

The Legislature approved the law 13 years ago, granting pharmaceutical companies immunity from product liability lawsuits as long as the drug was approved by the U.S. Food and Drug Administration and the drug makers did not misrepresent or withhold information from the FDA. Backers hoped the law would attract pharmaceutical companies to the state.

Democrats argue the law, the strictest in the nation, has not delivered on that promise, noting Michigan has lost thousands of jobs in recent years as pharmaceutical companies left the state.

"The arguments for the law just weren't washing," said Rep. Robert Dean, D-Grand Rapids, who co-sponsored the repeal. "The drug companies that moved from Michigan went to states that didn't have (immunity) laws."

Rep. Roy Schmidt, of Grand Rapids, was one of five Democrats who joined 43 Republicans voting against the repeal.

Repealing the immunity law "sends the wrong message in this business environment," said Schmidt, a former sales representative for pharmaceutical giant Wyeth. "We need every job we can get."

State Sen. Mark Jansen, R-Grand Rapids, did not respond to messages asking his position on the issue.

The repeal is opposed by the Michigan Chamber of Commerce, Michigan Manufacturers Association and other business groups.

Michigan's law is not affected by a U.S. Supreme Court ruling last month, allowing lawsuits against drug companies even if the allegedly defective medication was approved by the FDA. In that case, a Vermont jury awarded $7 million to a guitarist who had to have part of her arm amputated after she was improperly injected with an anti-nausea drug as part of treatment for a migraine.

Justice Department sues

In an effort to repeal Michigan's law, Roaleen rallied her friends to call and write their legislators, and she spoke to a staff member of her representative, Tom Pearce, R-Rockford.

TIME TO OVERTURN IT?

The 1996 Michigan law that limits lawsuits against drug companies:

• Was intended to attract more pharmaceutical companies to Michigan.

• Grants the companies immunity from lawsuits if the FDA approved an allegedly defective drug and the drug maker had not misrepresented or withheld information from federal regulators.

• Is supported by business groups and most Republican legislators who say repealing it will lead to frivolous lawsuits and create an anti-business climate.

• Is opposed by most Democratic legislators who favor repealing it, noting large drug firms are located in states that don't offer the same legal protection.

• Would be repealed by bills passed in the state House last month by a 61-48 margin, but faces strong opposition in the Republican-controlled Senate.

But Pearce said he voted against repealing the law not because he believes it will attract more pharmaceutical companies, but because he hopes it will help control drug costs. Attorneys he consulted told him Roaleen could sue under current law, he said.

"They all were of the opinion this should be a consumer protection issue," he said. "In her situation, the company mislabeled what the drug was."

The company, Ethex Corp., a division of St. Louis-based KV Pharmaceutical Co., issued several recalls for dozens of drugs last year and earlier this year, including some that delivered up to twice the dosage on the label.

In March, the U.S. Justice Department sued the company, accusing it of distributing unapproved drugs. The company agreed to stop making drugs until it convinces the FDA it meets federal standards. Ethex Corp. officials did not respond to requests for comment.

Lucky to survive, doctors say

Roaleen, a psychologist, said it did not occur to her the morphine was causing her neurological and physical problems. After back surgery at Metro Health last October, she went to her sister's home in St. Johns to recuperate.

In November Roaleen developed pneumonia, which she believed the morphine caused by lowering her respiration.

When she came home to Rockford, she found the letter from Ethex recalling the morphine. She stopped taking it.

Her doctors told her she is lucky she survived.

"She's a fortunate lady," said Bill Lear, a neuro-psychologist helping her regain the memory and other cognitive functions. "She needs time to recover. If it's going to happen, it's going to be in the next six to eight months."

The double dose of morphine likely caused the neurological problems by reducing oxygen to her brain, Lear said.

She's doing the mental exercises he prescribed, Roaleen said, but is having difficulties. She got lost driving from her son's house in Grand Rapids to hers in Rockford.

"Last month, I sat down to balance by checkbook, and I thought, 'I don't know how to do this,'" she said. "It took me half a day to figure it out.

"I was very, very afraid until last week that my entire future was going to be derailed."

She recently began rebuilding her counseling practice.

Ethex sent her a $20 check reimbursing her for the mislabeled drugs.

"I didn't cash it," Roaleen said. "I'm not going to let them get away with that.

"There isn't another state in the union that says you cannot sue. That is so wrong. It doesn't make any sense. It doesn't make any sense at all."

If you or a loved one have been injured by Ethex Morphine or Ethex Propafenone you may be entitled to compensation. Contact the attorneys of Ennis & Ennis, P.A. today for a free case evaluation by filling out the form on this page or calling the toll free number listed below. Our staff is standing by to answer any questions you may have about the Ethex Morphine Recall, Ethex Propafenone Recall, and potential Ethex Corporation lawsuits.