U.S.

Deadly Defect?

By CBSNews.com staff CBSNews.com staff

August 9, 2001 / 5:22 PM EDT / CBS

Seventeen people may have died because of defective asthma inhalers made by Schering-Plough Corp., including five whose deaths might have been avoided with a quicker recall, a consumer advocacy group charged Thursday.

The group, Public Citizen, cited government death reports in asking Health and Human Services Secretary Tommy Thompson to begin a criminal investigation of how Schering handled the recall of 59 million inhalers.

"There is evidence that the company not only failed to recall millions of defective asthma inhalers for three months after learning ... of a death of a woman using one of these inhalers, but that there were many deaths in people which would have been avoided," Public Citizen's Dr. Sidney Wolfe wrote Thompson.

A Schering spokesman denied any deaths were linked to the inhalers, which were recalled because of concerns they did not contain albuterol, the medicine needed to fight an asthma attack.

"We have no evidence that a patient was ever harmed by an inhaler subject to the recalls," said Schering spokesman William O'Donnell. "While there are some lawsuits claiming otherwise," he said, "we are contesting them vigorously."

Claritin Lawsuit

In a separate development, a coalition of consumer groups Thursday said it had filed a lawsuit against Schering-Plough, alleging deceptive advertising and overpricing of Claritin.

The suit, filed in state Superior Court in New Jersey by the Prescription Access Litigation project, alleges that advertisements for Claritin falsely claim the drug works for everyone, thereby boosting demand and prices.

The lawsuit cites studies performed or requisitioned by Schering-Plough that allegedly prove Claritin works only half the time. Yet, Schering-Plough's ads make "numerous statements of unqualified and absolute effectiveness and no mention of the limited usefulness of Claritin products," the lawsuit states.

Schering-Plough officials said any claims that the company's advertisements break the law are false, but would not comment on the research.

The Food and Drug Administration, the HHS agency responsible for drug safety, already was examining complaints about the recall.

"We're going to look at this letter and the new information that's contained in it very carefully," said FDA spokesman Brad Stone.

It is the latest salvo against New Jersey-based Schering, already in troube with the FDA. Inspectors have found repeated manufacturing violations at Schering plants. The FDA even has held up review of Clarinex, the company's long-anticipated successor to its popular Claritin allergy medicine, until the violations are cleaned up.

"The case that Public Citizen makes is fairly compelling. And if nothing else, it probably raises the public's awareness of Schering-Plough's mishandling of FDA concerns, and to that extent, puts increased pressure on the FDA to treat Schering-Plough less leniently," said analyst Timothy Anderson of Prudential Securities.

Schering recalled a small batch of inhalers in September 1999 and 58 million more in March 2000. Wolfe already had urged FDA to investigate whether Schering knowingly shipped defective inhalers, citing an internal audit that found manufacturing deficiencies.

Wolfe's new allegation: FDA records show 17 deaths for which the Schering drug was listed as "primary suspect" from late 1998 through spring 2000, the period that potentially defective inhalers were on the market. Ten patients had used inhalers from batches later recalled, the records show; identifying lot numbers aren't listed for the other seven.

The first death was reported to Schering on Jan. 4, 2000, yet Schering didn't expand the recall until March, Wolfe said. That woman had had well-controlled asthma until abruptly dying in September 1999 while using an inhaler that ultimately would be recalled, he said.

Between her death and the March 2000 recall, five more inhaler users died, Wolfe said.

Responded Schering's O'Donnell: "To date, every inhaler returned to us by a patient claiming injury and alleging that the canister lacked active ingredient has been tested and found to contain active ingredient."

The inhalers were sold under the brand names Proventil and Warrick. Schering-Plough said on March 29, 2000, that it was recalling those brands of prescription albuterol inhalers made before Sept. 30, 1999, "as a precaution to address the remote possibility that an aerosol inhaler may not contain active drug."

"Schering-Plough believes the product recalls and related communications to the media and the medical community were conducted properly and appropriately," O'Donnell said.

The resulting uncertainty has bashed Schering-Plough's share price. The stock has fallen more than 20 percent since Feb. 15, when the issues were disclosed, and was down $1.14, or 3 percent, at $37.21 in afternoon New York Stock Exchange activity.