Contaminated albuterol leads to class action.

Attorneys across the nation are watching closely as a class action trial unfolds in federal district court in Cheyenne, Wyoming. The trial, which started June 14, pits a representative group of seven plaintiffs who allege injuries from contaminated albuterol a generic drug, against Copley Pharmaceutical, Inc., which manufactures more than 90 different drug products.

(In re Copley Pharmaceutical, Inc. "Albuterol" Products Liability Litigation, MDL No. 1013 (D. Wyo. partial certification Oct. 28, 1994).)

"Very few class actions go to trial said Paul Rheingold of New York City, who served as vice chair of the plaintiffs' steering committee for the multidistrict litigation (MDL). Those that do usually involve issues that are local or regional, such as employment discrimination suits brought against police or fire departments.

The albuterol litigation is the first class action involving a nationally distributed consumer product to come to a comprehensive trial, according to attorneys who are trying the case. The litigation reveals both the benefits and the shortcomings of class actions and suggests why this approach to litigation continues to be controversial.

Albuterol is a generic drug that expands the air passages of the lungs. It is used by people who suffer from asthma, chronic obstructive pulmonary disease, and other breathing disorders. The drug is commonly administered by inhaling vapor from a nebulizer.

Until January, 1994, Copley Pharmaceutical was a major supplier of albuterol. Copley's product was distributed under its own name as well as under the brand names Aligen, Astra, Geneva, Goldline, Harber, Major, Moore, H.L. Moore, Qualitest, Rugby, Schein, and Xactdose.

In the closing days of 1993, Copley recalled four batches (44,000 vials each) of its 20 ml. vials of albuterol because of "microbial contamination." On January 6, 1994, the recall was expanded to include all 3.7 million bottles of the drug the firm had ever made.

According to the U.S. Food and Drug Administration (FDA), the contaminating organism - then assumed to be pseudomonas fluorescens - "could cause serious infections, particularly in people with cystic fibrosis, chronic obstructive lung disease, or compromised immune systems." (Albuterol Recall, FDA Talk Paper T94-4, Jan. 6, 1994.)

Plaintiffs claim the medicine contained the more dangerous pseudomonas aurignosa bacteria. People who used the contaminated albuterol to relieve upper respiratory problems found that their medicine made them worse. The predominant injury was bacterial pneumonia. "In some cases," said Rheingold, "the pneumonia was life threatening. In a few, it was deadly."

On May 20, 1944, the Judicial Panel on Multidistrict Litigation assigned all the Copley albuterol cases to Judge Clarence Brimmer of the U.S. District Court of Wyoming. On October 28, he selected 1 of 11 class actions as the lead case and defined the class as "all persons throughout the United States and its territories who suffered damages as a result of the inhalation of albuterol manufactured, supplied, distributed, or placed in commerce by Copley Pharmaceutical, Inc." Attorney Stanley Chesley of Cincinnati was named lead counsel for the class.

In approving class certification, Brimmer noted that "the most persuasive argument" came from an attorney who represented only six plaintiffs, none with very large claims. Without class certification, the attorney argued, neither he nor his clients had the resources to have their day in court against a large defendant like Copley.

Meanwhile, attorneys were finding out more about Copley's albuterol processing facility at Canton, Massachusetts. An ATLA litigation group was formed to pool resources and share discovery information, and depositions from about 50 current and former Copley employees revealed that the firm had tolerated operational problems for years.

Mark Riley, a former quality assurance inspector at the plant, left Copley in 1993 and took his complaints about the sloppy manufacturing procedures first to the FDA and then to the U.S. attorney in Boston. A federal grand jury investigation that began in September 1994 is ongoing.

Riley reported that workers' mistakes went unremedied because workers were unsupervised, products were tested in a haphazard manner, and supervisors regularly falsified records to indicate they, had monitored production. "Presigned paperwork was common," he said. (Susan Diesenhouse, Double Trouble for Copley Pharmaceutical, N.Y. Times, Dec. 25, 1994, at F4.)

Depositions revealed that

* The quality control scientist in charge of testing gave "zero thought" to how to test the product for the presence of bacteria.

* A self-study ordered by Copley in January 1994 concluded that water supply piping had not been cleaned for three months, even though company procedures call for cleaning "between shifts" - three times daily.

* An independent consultant's report to Copley warned specifically that biofilm could form in uncleaned pipes. Biofilm is a slime produced by bacteria that protects them from ordinary chemicals.

Plaintiffs in the case are not limiting their focus to the four admittedly contaminated batches of medicine. They are setting out to prove that Copley's manufacturing facility was contaminated from the first batch of albuterol the company ever manufactured. "It was pretty much random whether you got a good bottle or a contaminated one," said Rheingold.

The defense contends that the class action will turn on three individual issues:

* Did the individual plaintiff use albuterol that was contaminated?

* Did the plaintiff suffer injury?

* Did the defendant's product cause the injury?

However, Brimmer noted that certain common questions of liability must be answered before these individual issues are considered. For example,

* Were the defendant's manufacturing processes defective?

* Was the defendant negligent in its manufacture and distribution of albuterol?

* Did the defendant breach any warranties in selling its product?

* Are pseudomonas fluorescens or other possible contaminants dangerous to the human body?

The distinction between common and individual issues is crucial, and it is the source of many attorneys' dissatisfaction with the course of the class action. Brimmer's "partial certification" allows the common issues (liability, negligence, breach of warranties, requests for declaratory relief) to be tried to a single jury in a unified trial. But issues of causation, compensation, and punitive damages are considered individual issues.

"[I]ndividual questions predominate as to the issues of causation and injury ... because most of the plaintiffs who claim physical injury had a significant health problem that necessitated their use of albuterol in the first place," Brimmer wrote.

He ruled that the MDL trial will consider causation, compensation, and punitive damages issues only for the named plaintiffs in the class action. Unnamed plaintiffs will have to pursue their individual cases in separate trials to determine if they suffered an injury from the contaminated albuterol. Rheingold, for example, faces the prospect of trying 500 individual cases on compensation and damages issues after the class action has concluded.

Many plaintiffs who joined the litigation before this ruling have since opted out of the class action. The ATLA litigation group is hoping that resolution of the common liability and negligence issues will make it easier for others to win a verdict.

Janet Abaray, a Chesley associate who is trying the case in Cheyenne, said, "It would be difficult to justify the level of expense and expertise we have here for a single case. Some of the plaintiffs got pneumonia or aggravated asthma. These are serious injuries, but the damages do not reach a level to justify assembling a group of international experts. And you need this level of expertise in order to win."

Abaray said the unnamed plaintiffs "will benefit from the class action because they will be able to use the liability findings of this trial in their own. For example, if this jury finds that the product was contaminated from beginning to end, an unnamed plaintiff will be that far ahead. He will simply have to prove that he was sick and that his doctor said the product made him sick."

The named plaintiffs include four people who claim personal injury, two people (a mother and a wife) who claim damages because of injury to a loved one, and one husband who claims wrongful death for his wife.

Brimmer admits that his partial certification solution "may not be the most efficient," but he believes that it is "the most equitable approach to the mixture of common and individual facts in the present litigation."

Plaintiffs presented their case in three weeks; the defense has asked for eight. If this timetable holds, the trial should conclude near the end of August.