Anthrax Vaccine's Liability Issue

Anthrax Vaccine's Liability Issue

BioPort suits face a difficult road

Matt Fleischer-Black and Bob Van Voris
The National Law Journal
October 23, 2001


When a company makes a product that, its critics claim, has injured hundreds of people and killed a half dozen, you can expect it to be the target of many lawsuits. But that's not the case for BioPort Corp., which is the sole supplier of the anthrax vaccine used by the military and by a small number of U.S. civilians.

As people around the country are gripped by fears of anthrax at home and the potential for biological warfare on distant battlefields, a handful of ambitious lawsuits charge that the only available anthrax vaccine in the U.S. is unsafe and possibly ineffective. To succeed, plaintiffs will have to find a way around the company's near-immunity to being sued, the result of its unusual position as the maker of a product that the military deems essential to national security.

So far, two lawsuits and an administrative petition have been filed by military and National Guard officers who assert they were either court-martialed or forced to resign solely because they refused to accept what in recent weeks has become a much-desired, though generally unavailable, commodity: a shot of vaccine to protect against anthrax attack.

A third suit, filed on Oct. 19, will try to hold Lansing, Mich.-based BioPort responsible for the wrongful death of an Army sergeant.

The obstacles the plaintiffs face in these cases are illustrated by the fact that, while all the cases target BioPort's high-profile vaccine, each takes a different path, from a suit under the federal False Claims Act to another seeking declaratory relief to the wrongful death case to a citizen's petition with the federal Food and Drug Administration.

A GOOD DEFENSE?

Any plaintiff suing over military-related injuries must contend with the so-called Feres doctrine, which stems from a U.S. Supreme Court case that reflects the historical reluctance of American judges to intrude in military decisions. Feres v. U.S., 340 U.S. 135 (1950). The case generally bars people in the military from suing the U.S. government for injuries that result from their duties. The rule has been applied even to shield army commanders who secretly slipped LSD to a master sergeant in 1958.

As a result, in just a handful of known attempts in the past few years, no one has successfully sued the government to compensate them for alleged anthrax-vaccine injuries.

In addition, the government has taken the unusual step of inoculating BioPort against lawsuits by indemnifying the company for adverse effects and claims that the vaccine simply fails to protect against anthrax. If BioPort loses a claim of this type, the government pays. In the 1970s, the government indemnified manufacturers when it launched a mass immunization against swine flu, an ineffective program that left the government with a liability tab in the tens of millions when the vaccine caused death and paralysis in some patients.

BioPort may also claim that, as a government contractor, it was responsible merely for carrying out the Army's specifications, and is therefore not liable.

"A key with the government-contractor defense is how much control the government had over the design," says James M. Beck, of Philadelphia's Pepper Hamilton, who represents defendants in drug and medical device cases.

However, to the extent BioPort departed from government specifications, plaintiffs may be able to sue.

Since 1998, more than half a million soldiers have been inoculated with the vaccine. Some 1,600 have reported to the FDA adverse reactions from the vaccine, including 15 cases of anaphylaxis, a severe allergic reaction that can result in death. Critics claim that military doctors often do not report adverse reactions to the FDA, resulting in statistics that greatly understate their incidence.

But BioPort's general counsel, Catherine Ruster, says the publicity surrounding the vaccine in recent years may actually encourage some patients to overreport side effects.

And while the FDA has received reports that six people died after receiving the anthrax vaccine, the Army says it has studied the cases and concluded there was no link.

The Department of Defense reports that, since the start of the vaccinations, at least 400 soldiers have quit or been subject to court-martial rather than submit to the inoculation.

Two of those who quit, Russell Dingle and Thomas Rempfer, have challenged BioPort by filing a False Claims Act suit in federal court in Michigan. Dingle v. BioPort Corp., No. 00-124.

Beginning in 1998, after officers in their Connecticut Air National Guard unit were ordered to get inoculated against anthrax, Dingle and Rempfer have campaigned against the vaccine, enlisting sympathetic politicians, including Connecticut Attorney General Richard Blumenthal. The two men have testified before Congress, where their cause received additional support.

"Without an ensured supply of modern vaccine in hand, continuing to order soldiers, sailors, airmen and Marines to start a course of shots they may never finish constitutes, in my judgment, military malfeasance and medical malpractice," U.S. Rep. Christopher Shays, R-Conn., told his colleagues last year.

The false-claims case, filed in October 2000 but only recently unsealed by the court, accuses BioPort of making numerous misleading statements to the government so as to maintain its lucrative anthrax vaccine contract. (U.S. Rep. Walter Jones, R-N.C., estimated that the Department of Defense has so far paid BioPort approximately $150 million under the contract, according to the online magazine Salon.) Claiming BioPort's conduct amounted to fraud on the government, Dingle and Rempfer seek treble damages.

On Sept. 21, after considering the case for nearly a year, the U.S. Department of Justice declined to intervene, paving the way for Dingle and Rempfer to sue on their own behalf. They are seeking a lawyer to represent them.

More recently, on Oct. 12, Dingle and Rempfer filed a petition with the FDA, asking the agency to revoke BioPort's license and to prevent the use of existing vaccine stocks.

SKIN AND INHALED ANTHRAX

BioPort's vaccine was approved in 1970 for protecting against anthrax infection through the skin. The FDA hasn't specifically approved its use as a shield against inhaled anthrax. An airborne attack is considered the most likely means of military attack and the most deadly. Of those who show symptoms of inhalation anthrax before being treated with antibiotics, about 80 percent can be expected to die.

Retired Maj. Sonnie Bates and Capt. John Buck, both from the Air Force, are not seeking monetary damages, but are seeking a declaration by the U.S. District Court for the District of Columbia that the anthrax vaccine, as used by the U.S. DOD to ward off inhaled anthrax, is an investigational new drug. Bates v. Rumsfeld, No. 01-941. The suit will test, for the first time, a 2000 law that says the Department of Defense cannot give experimental medicines to troops without their informed consent.

Bates decided to refuse the vaccine after witnessing fellow Air Force pilots inoculated for the Gulf War fall ill. He says he was promptly forced to resign.

Buck, an emergency physician, was court-martialed after he refused to be vaccinated. In May, a jury of officers at his base sentenced him to two months in the brig and docked him $21,000 in pay. His commanding general then withheld his $15,000 doctor's pay.

Should Bates and Buck succeed in their case, the soldiers could then use that finding to petition the military's administrative panels to overturn, or lessen, their punishments.

As part of their suit, the two soldiers have included a Sept. 20, 1996, filing that BioPort made to the FDA that, the soldiers contend, is an application by BioPort to use its anthrax vaccine as an investigational drug.

"We believe the claim is entirely without merit," says Ruster, BioPort's general counsel. "The anthrax vaccine is a product fully licensed by the FDA and has been since 1970," she says, and is not an investigational new drug. Ruster says difficulties in renovating its manufacturing facilities, which the company purchased from the state of Michigan in 1998, are partly responsible for the many FDA citations that have stopped vaccine production.

According to Ruster, BioPort submitted documents to the FDA by Oct. 12 and hopes to restart vaccine production as soon as possible.

Ruster says BioPort has not received notice of the other cases involving the company and is unable to discuss them.

"If the drug is investigational, then it needs to be treated as an investigational drug," says John J. Michels of Richmond, Va.-based McGuireWoods, who represents Bates and Buck.

WRONGFUL DEATH SUIT

Alan C. Milstein filed a wrongful death lawsuit on Oct. 19 in federal court in Washington, D.C., claiming the vaccine killed Army Sergeant Sandra Larson, and made Army pilot Ronda (Breneman) Wilson permanently disabled. Milstein is a partner at Pennsauken, N.J.'s Sherman, Silverstein, Kohl, Rose & Podolsky.

Milstein disputes that BioPort fits the definition of a government contractor, and contests the notion that the government's indemnification of BioPort protects the company against liability. "I see the government as BioPort's insurance company," he says.

Even if BioPort is a government contractor, Milstein says, its shield is vitiated by its woeful record of breaking FDA regulations. "The defense does not hold if they perform the contract in a manner that is contrary to the standard of care in the industry," he insists. "The FDA suspended BioPort's authorization to culture vaccine three years ago."

Milstein contends his clients received shots from a bad lot of vaccine. He also argues that products liability law required BioPort to warn about the vaccine's side effects and risks. BioPort forfeited its immunity, he concludes, when it didn't take full steps to ensure that army doctors and soldiers received the whole story about the vaccine.