Drug Makers Put Children at Risk, Class Says

CHICAGO (CN) - Drug maker McNeil Consumer Healthcare and parent company Johnson & Johnson were cited for 20 major violations at manufacturing plants for children's pain and allergy medicines, "exposing innocent children ... to dangerous products which never should have been sold," a class claims in Federal Court. The drug makers then compounded the injury by offering consumers "worthless coupons" for replacements of the recalled drugs when and if they arrive on store shelves, the lawsuit states.

Lead plaintiff John Smith of Melrose Park, Ill., bought Children's Tylenol, one of four drugs yanked from the market after federal regulators found 20 violations at plants making the drug.

The other drugs recalled by the firms are Children's Motrin, Children's Zyrtec and Children's Benadryl.

Smith claims the bond of trust between consumers and the drug companies was broken on May 4, after federal regulators announced McNeil had been "flagrantly violating the rules and regulations set by the U.S. Food and Drug Administration" to protect children from harmful drug products.

In their report, detailing an inspection of McNeil's facilities in Fort Washington, Pa., regulators noted such "major deficiencies" as an absence of laboratory controls based on sound scientific practice, failure to inspect containers to assure weights and measures of the medicines were accurate, and a routine failure to review any unexplained discrepancies that were found in the drug batches.

Smith says the drug companies then botched the recall by establishing a system that effectively ensures that at least some impacted consumers - those who might have thrown the drugs away or otherwise don't have the detailed information about their product that the firms are demanding - will not be able to get refunds.

As a result, McNeil is offering only "select" consumers "the opportunity to request a refund or a high value coupon for a free replacement when the products become available again," the complaint states.

Smith claims such coupons are worthless to consumers today, as McNeil has stopped manufacturing the drugs and "assumes wrongly that all consumers will want to purchase the company's children's product at some uncertain future date."

On a related note, lawmakers in Washington have scheduled a hearing Thursday to look into the recall, and three others initiated by the companies over the past seven months.

Among those expected to testify before the House Committee on Oversight and Government Reform is Colleen Goggins, the worldwide chairwoman for Johnson & Johnson. A panel of Food and Drug Administration officials will also be at the hearing.

The class is represented by Manuel von Ribbeck and Monica Kelly of Ribbeck Law Chartered in Chicago.

Plaintiffs demand compensatory, treble and punitive damages, disgorgement of the profits from the sale of the drugs, cash refunds for purchases, and injunctive and declaratory relief.

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