Federal judge in Baltimore rules parents of blind girl cannot sue

Daily Record, The (Baltimore), May 24, 2006 by Ann W. Parks

The parents of a 6-year-old girl who went blind after taking a generic amoxicillin product for strep throat cannot sue the drug's manufacturer, a federal judge in Baltimore has held.

Apothecon Inc. and its parent company, Bristol-Myers Squibb Co., won on summary judgment last week. Chief U.S. District Judge Benson Everett Legg recognized Maryland's use of the learned intermediary doctrine, under which a manufacturer has no duty to warn the consumer of the risks posed by a drug if the prescribing doctor has received adequate notice of those risks.

Mark D. Gately, a Baltimore lawyer who represented the New York- based defendants, called it a classic example of the doctrine, which comes up constantly in drug cases, he said.

The duty to warn runs not to the patient, but to the doctor, he said. The important thing is that the doctor is aware of the risks.

Rare but serious risk

The child's pediatrician, Dr. Alvaro Ramos, testified that he was aware of the risk of Toxic Epidermal Necrolysis (TEN) - a hypersensitivity reaction associated with amoxicillin products that can cause death - and a less severe condition known as Stevens- Johnson Syndrome (SJS).

He also testified that he would continue to prescribe the drug - even for his own child - in spite of the SJS/TEN risk; and that a change to the package warnings would not have either added to his own knowledge or affected his decision.

According to a defense expert in the case, only one out of every 3.5 million people taking a 10-day amoxicillin regimen develops SJS/ TEN. Ramos' patient had, in fact, taken the drug on four previous occasions without having an adverse reaction, according to the opinion.

Dr. Ramos was fully warned of the risk of TEN from his medical training and by reading the warning label for another Amoxicillin product, Legg wrote. Thus, the learned intermediary doctrine applies and is dispositive.

Nor was the package insert of the product - known as Trimox - defective, the judge concluded. The insert specifically mentions SJS/ TEN under the heading of Adverse Reaction but not under the heading of Warnings.

The Warnings section states that [s]erious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy.

One might prefer to have SJS/TEN listed in the Warnings section, but the present structure cannot be said to be unreasonable merely because it requires the reader to make a cross-reference, Legg wrote.

No fault

Maryland residents Wendy Ames and John P. Welch Jr. brought suit in January 2004, almost three years after Ramos prescribed amoxicillin for their daughter's strep throat.

The pharmacy filled the prescription with the defendants' generic brand. (All generic brands are identical in composition and have identical warnings, according to the opinion.)

After taking the medicine for 10 days in February 2001, the girl developed a fever and rash and was admitted to Carroll County Hospital.

She was later moved to Sinai Hospital and was promptly diagnosed with SJS/TEN. The rash, however, developed into lesions and the girl's corneas were scarred.

Counsel for the plaintiffs did not return phone calls for comment by press time yesterday.

Gately said amoxicillin is close to, if not the most, widely prescribed drug in the world.

It truly is one of those very sad, very rare occurrences, he said, but it's not anybody's fault.

In March, Maryland's Court of Appeals declined to apply the learned intermediary doctrine to the case of a consumer suing a pharmacy chain over advice contained in a package insert. In that case, the insert added to a package of doxycycline had been written by the pharmacy itself.

WHAT THE COURT HELD

Case:

Wendy Ames et al. v. Apothecon Inc. et al., USDMD No. L-04-267. Published. Opinion by Legg, J. Decided May 15, 2006.

Issue:

Was a grant of summary judgment in favor of a drug manufacturer appropriate in a products liability case alleging a failure to adequately warn of the drug's risks?

Holding:

Yes. Under the learned intermediary doctrine, if the prescribing doctor has received adequate notice of a drug's risks, the manufacturer has no duty to warn the consumer.

Counsel:

Bernice Lynne Latou, James Conner Barber (Texas), John C. Evans (Pa.) and Megan L. Faust (Pa.) for the plaintiffs; Lauren Schultz Colton and Mark D. Gately for defendants.