Levaquin causes tendon rupture

Was it too lucrative for its makers to warn patients?

In the moment just before it happened, John "Bob" Schedin was sitting calmly in his Edina living room, reading the paper just as he had for 50 years.

But this time, when he went to stand up, an excruciating pain ripped through the back of his ankle.

Bob fell back onto the sofa. It felt like a knife was sawing into his left Achilles tendon.

Source: Court exhibit from the Levaquin case.

"I can't get up," he hollered to his wife.

Vicki walked into the room. Her 77-year-old husband never complained, so she knew something must be seriously amiss.

"What's wrong?" she said.

"I can't stand up."

"You better call the Medica nurse hotline," she urged.

Bob punched in the number and reached a nurse named Sally.

"Can I help you?" Sally asked.

Bob explained his sudden ankle pain.

"Are you taking any medication?" Sally asked.

Bob told her he was taking Levaquin and a steroid, which his doctor had prescribed three days earlier for a pesky upper respiratory tract infection.

"Hold on a moment, please," Sally said.

After several minutes, she returned to the line.

"Stop taking Levaquin," she said. "It can rupture your tendons. And call the doctor in the morning."

Bob stopped taking the drug. But over the next several days, the pain didn't go away. So he called for another appointment.

When the physician saw Bob's tender, painful ankles, he prescribed physical therapy. But after four sessions, Bob didn't feel any better.

This time, the physician said, he would need an MRI.

The images revealed that the damage was far worse than Bob had anticipated. His right Achilles tendon was shredded to half its natural thickness, and the left one was hanging together by just a few fibers.

Bob's tendons never fully healed and he must constantly wear a brace just to get around.

"I used to walk two miles a day in Southdale in the winter," Bob recalls wistfully. "Now I'd love to walk 30 feet."

  

HOLDING ALOFT A medicine bottle, Congressman Edolphus Towns of Brooklyn, New York, leveled his complaint.

"Every time we give our children or grandchildren medicine like this bottle of children's Tylenol that was included in the recall, we expect it to be safe, and we expect it to help the children get better—not create problems for them," he said.

It was May 2010, and Johnson & Johnson was before a House investigatory panel, defending itself against increasing evidence that the company's safety controls were in shambles. The House had convened the special hearing after the medicine maker recalled more than 136 million bottles of liquid children's Tylenol, Motrin, Benadryl, and Zyrtec amid suspicions that they were contaminated.

Worse yet, it looked like the pharmaceutical company had delayed reporting the problems to the FDA. In one case, Johnson & Johnson hired a private contractor to quietly pull Motrin from store shelves—effectively launching a secret recall. Now, the FDA was considering fines.

The May hearings were just the beginning of the company's publicity woes. In August, it announced a recall of millions of one-day contact lenses from store shelves in Asia and Europe after consumers in Japan complained of stinging eye pain. Two days later, the firm disclosed that it was pulling two popular hip implants after discovering the devices had an unacceptably high failure rate, requiring a second surgery.

This year, the pharmaceutical giant is facing allegations that it paid nursing homes to boost sales of its anti-dementia drug, which was later shown to speed death. And it confessed to bribing doctors in Europe and paying kickbacks to the regime of Saddam Hussein, for which the company had to pay $70 million in fines.

In 1886, Johnson & Johnson set out on a mission to make the world a more sanitary, healthy place with the first commercially available sterile bandages in the United States. Over the years, the company built an image of trust with products designed for children, like No More Tears baby shampoo, and Tylenol, the first prescription aspirin-free painkiller. The corporation gave Americans dental floss, Listerine, and haloperidol, an early medication to treat schizophrenia.

Today, the bandage maker from New Brunswick, New Jersey, has ballooned into a Fortune 500 company with revenue of $61.6 billion and 250 subsidiaries in 60 countries.

But a lawsuit in Minnesota threatens to further tarnish the company's once-pure reputation.

The case alleges that Johnson & Johnson understood that Levaquin was more likely to cause tendon rupture than other drugs, and that the company did not adequately warn doctors. Hundreds whose lives have been devastated by ruptured tendons have joined the suit.

"Johnson & Johnson has been a company that has long been the gold standard of ethics for many, many years," says Bill Trombetta, a professor of pharmaceutical marketing at Saint Joseph's University in Philadelphia. "It looks they stubbed their toe on this one."

   

INSIDE A MASSIVE red brick industrial complex along the bank of a tributary of the Rhine that runs through Frankfurt, six healthy men lay inert.

It was January 1987, and the scientists of Hoechst AG were performing an important experiment. The men—all employees of the pharmaceutical company—had signed up to be subjects in a clinical trial that had the potential to generate millions.

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