Commentary: Why Inoculating Big Pharma from Vaccine Lawsuits Makes Sense

It seemed like Washington at its backroom-dealing worst. With no debate, congressional conferees in November quietly inserted language into the Homeland Security Act that prevents parents from suing Eli Lilly & Co. (LLY ) and other makers of the mercury-containing preservative, thimerosal--an ingredient once used in infant vaccines that some believe is responsible for mushrooming rates of autism in young children. Parents and some consumer advocates have been complaining about the provisions ever since. "The legislation gives Lilly a get-out-of-court-free card," says Janell M. Duncan, legislative counsel at Consumers Union.

Washington is abuzz with allegations that the drug industry's political friends were behind it. The provisions were authored by newly named Senate majority leader Bill Frist (R-Tenn.) and stuck in the bill by Representative Dick Armey (R-Tex.). "It appears this provision was added at the last minute as a payback to a powerful political supporter," charges Senator Debbie Stabenow (D-Mich.), who vows to strip the offending language from the bill after Congress reconvenes in 2003.

The process was indeed dubious. Rather than trying to avoid the politically charged issue, Congress should have openly debated the pros and cons. But sometimes even shady dealmaking can yield decent policy. Far from being a disaster, the provision makes sense, especially as part of a package of vaccine policy proposals that Congress is expected to take up.

To understand why, jump back to a mid-1980s crisis. Although vaccines had revolutionized public health, their side effects were prompting suits against vaccine makers. As a result, many companies left the low-profit business. That raised the specter of shortages and a resurgence of such diseases as polio. So in 1986, Congress limited companies' liability by creating a national injury compensation program--in essence, a vaccine court--to evaluate claims and hand out damages. And if people don't like the awards they get, they're free to sue in regular court.

That law, however, contains a loophole that plaintiff's lawyers representing parents with autistic children have since tried to exploit. Because the vaccine court's compensation program has a three-year statute of limitations, lawyers seeking damages for children who got the disease earlier than 1999 have been going after the ingredient makers. The new bill would give these companies the same legal protections as vaccine makers. That would eliminate the discrepancy in how the cases are treated, ending much fruitless litigation; courts have quashed some attempts to sue the likes of Lilly.

The new law, moreover, would keep claims against ingredient producers in the vaccine compensation program, which was set up to handle these difficult issues. Even many trial lawyers who back changes to vaccine policy--including an extension of the statute of limitations--would rather deal with the vaccine court. For one thing, the awards can reach into the millions of dollars. In theory, many cases also have a better chance, since parents and their lawyers need not prove liability, says plaintiffs' lawyer Clifford J. Shoemaker. That's crucial in the case of alleged injury from thimerosal, because there's no proof it causes autism. To the contrary, autism rates have increased since 2000, when vaccine makers began reducing the amount of mercury used.

Unless Congress closes the loophole that threatens ingredient makers, a repeat of the 1980s liability crisis that drove companies out of the business could occur. "If we vote to strike these provisions," argues Senator Frist, "we're putting at risk our manufacturing base."

Yet Congress shouldn't stop there. It also needs to improve the compensation program. Lengthening the statute of limitations is one fix, particularly as more time is needed for research on whether mercury plays any role in autism. With studies under way, "it makes sense to wait for the results," says plaintiff's attorney Michael L. Williams, chair of the Mercury Vaccine Alliance.

Every child stricken with autism is a cause for sorrow. It's only human to assign blame and seek damages. But with a program in place to handle these questions, allowing endless rounds of extra litigation makes no sense. Even when it goes about things the wrong way, Congress sometimes gets it right.

By John Carey

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