By Miles Moore
Rubber & Plastics News
July 30, 2001

WASHINGTON—Litigation, legislation, regulation—words that have become of crucial importance to the natural rubber latex glove industry during the past several years.

About 500 lawsuits by latex-allergic plaintiffs are in federal courts and nearly 500 more in state courts, according to Wayne Spivey, the Philadelphia attorney who oversees the federal multidistrict litigation on latex allergies. Spivey will bring the next scheduled lawsuit to trial in October in Philadelphia federal district court before Judge Edmund Ludwig, the judge in charge of the multidistrict litigation.

On the legislative front, latex glove manufacturers and their representatives are dismayed at the recent passage of a Rhode Island bill banning latex gloves in the food service industry—a law, they said, that could lead to broader interdictions against latex. The Rhode Island measure passed in June, two months after the Arizona Department of Health Services approved new food safety requirements that, among other things, ban the use of latex gloves in food service.

These events—as well as the pending final rule from the U.S. Food and Drug Administration placing new powder and protein limits on latex medical gloves—have the latex glove industry busy framing its responses to defend the safety of its products and its own financial position.

Allegiance Healthcare Corp., the McGaw Park, Ill.-based health care firm and subsidiary of Cardinal Health Inc., was spun off from Baxter Healthcare Corp. and represents that company’s former glove manufacturing operations.

It has indemnified Baxter Healthcare for all the latex allergy lawsuits naming Baxter Healthcare as a defendant, including the one which to date has resulted in the biggest judgment.

Nancy Goolsby, a health care worker, won $5 million in punitive damages last April in a Jefferson County, Texas, court case against Baxter Healthcare. Goolsby, who started using Baxter gloves in 1988, developed latex-related dermatitis in 1992.

She claimed in her lawsuit that she was a potential victim of life-threatening anaphylactic shock because of her allergy.

Allegiance is appealing the decision, according to a company spokeswoman. “This was the jury’s verdict, and we don’t know when the judge’s ruling will come down” she said. “We do know there is some sort of rule in Texas about a limit on what multiple of actual damages the punitive damages can be.”

The case pending in Philadelphia in October also names Baxter, and by proxy Allegiance, as its main defendant. That case involves a nursing home nurse who became allergic to latex through exposure mostly to powdered gloves, Spivey said.

Allegiance declined to discuss its strategy regarding litigation.

However, the spokeswoman said company representatives testified before legislative committees in Rhode Island regarding the bill to ban latex, and also met with Rhode Island Gov. Lincoln Chafee.

“We’re certainly paying attention to legislation,” she said. “We’re just trying to stay on top of it, and when it makes sense, we’re going and presenting some testimony.”

Although anti-latex legislation is a real concern to Allegiance, it doesn’t foresee the latex glove industry collapsing because of it, according to the spokeswoman.

“An all-out ban on latex in a state is not very feasible, and there are some real benefits to using latex gloves as opposed to synthetic materials,” she said.

Also watching anti-latex legislation closely is the Malaysian Rubber Export Promotion Council.

The MREPC, which opened its Washington office in June, was founded to promote the low-protein, high-barrier protection Standard Malaysian Glove and defend latex against negative legislation born of panic over latex allergies.

“The MREPC is closely following developments in the states, and is concerned about efforts to legislate restrictions on the use of natural rubber gloves,” the council said in a prepared statement.

“The superior barrier protection provided by SMG gloves cannot be duplicated by synthetics,” it said. “We believe it is important that decision makers know that there are risks associated with not using latex.”

According to the American Nurses Association, 10 latex-oriented bills were introduced in six states in the 2000–2001 legislative year.

Before the passage of the Rhode Island measure, only two bills passed: one in Illinois to proclaim “Latex Allergy Awareness Week” and another in Pennsylvania creating a committee including health care professionals to study the adverse effects of latex products.

Among other bills introduced in state legislatures recently was a New York measure requiring restaurants and other food service establishments to post warning notices if employees use latex gloves during food preparation. The bill passed the New York Assembly May 31, but stalled in the Senate.

The Oregon and Maine legislatures played host to more sweeping legislation that didn’t make it past introduction.

The Oregon bill would have made multiple requirements of health care facilities, including the provision of information about latex allergies to employees and non-latex medical products to latex-sensitive employees and patients.

The Maine legislation simply would have banned the use of powdered latex gloves in health care facilities, punishable by fines of up to $500 per violation.

Anti-latex sentiment among Maine nurses runs so high that members of the Maine State Nurses Association voted April 28 to withdraw from the American Nurses Association, partly because the national agency doesn’t support a total latex ban.

There has even been federal legislation, albeit fairly mild, on latex. A House resolution introduced by Rep. Danny K. Davis, D-Ill., in July 2000 would have created a National Latex Allergy Awareness Week.

The bill quietly died with the 106th Congress.

The 500-pound gorilla among all pending government action involving latex, however, is the FDA proposed rule. That regulation, which was circulated to the industry and other interested parties July 30, 1999, sought to place latex medical gloves under the special controls specified for Class II medical devices.

It also divided medical gloves into four categories: powdered surgeons, powder-free surgeons, powdered patient examination and powder-free patient examination gloves.

Among other things, the rule would set FDA limits of no more than 120 milligrams of powder per powdered glove and no more than 1,200 micrograms of extractable protein for any glove.

Gloves would have to carry a label stating the FDA limits along with the glove’s actual powder and/or protein content.

Powdered synthetic gloves would have to carry powder labels, the same as powdered latex gloves.

The agency received about “60 or so” comments on the proposed rule, and now is formulating the final rule, according to Mel Stratmeyer, chief of the Health Services Branch within the Office of Science and Technology in the FDA Center for Devices and Radiological Health.

Stratmeyer said he couldn’t predict when the final rule would be issued, because the Center for Devices and Radiological Health is still writing it, which must then be considered by the full FDA and the Office of Management and Budget.

The International Glove Association/Glove Shippers Association expects the final rule to come down sometime in 2002, according to James Murphy, managing director of the IGA/GSA.

“We originally planned our 2002 conference for next May in Las Vegas, but moved it back to September because of the new regulation,” he said.

Latex allergy litigation is a major concern for the members of the IGA/GSA, mostly mid- to high-level glove distributors.

Their main problem is that product liability insurance is fast being priced out of their reach, according to Murphy.

“Only three lawsuits have been litigated, but there are thousands out there,” he said. “Insurance companies are basically paying lawyers for discovery, but at $300 to $500 per hour, that gets very costly. So the insurance industry is saying it can’t do that anymore. It’s looking at latex as the next equivalent to asbestos abatement.”

What IGA/GSA members need to do is form their own offshore captive insurance company, and the association is taking steps to do just that, according to Murphy.

“We need to band together in order to compete with those larger companies, such as Baxter, Ansell (Healthcare Products Inc.) and Kimberly-Clark (Corp.), which self-insure,” he said.

If the association can get 10 to 20 members to sign on, a captive insurance program for the industry should be feasible, Murphy said.

Member representatives will meet in Chicago in the next couple of months to discuss the formation of a captive insurance company.

The IGA/GSA also is talking to AIG Global and CNA Global to see which can help manage the program, he said.