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The Difference: Bruesewitz v Berkovitz by F. Edward Yazbak, MD, FAAP

The Difference
Bruesewitz v Berkovitz

22 years
Different Decisions
Different US Supreme Courts
Different Press and Public Opinions

The United States Supreme Court recent decision in Bruesewitz V. Wyeth did not only affect a family. It affected thousands, who after unsuccessfully pursuing a claim through the National Vaccine Injury Compensation Program, will no longer be able to hold a vaccine manufacturer accountable for injuries believed to be due to an FDA-approved vaccine. By its majority decision, the court indicated that such secondary lawsuits would be countering the intent of the National Childhood Vaccine Injury Act of 1986 and risking the proliferation of tort-based cases the Act was created to prevent.

On February 22, 2011, the Associated Press announced:

“Parents Lose High Court Appeal in Vaccine Case”

The article started with a harsh paragraph:

“The Supreme Court closed the courthouse door Tuesday to parents who want to sue drug makers over claims that their children developed autism and other serious health problems from vaccines. The ruling was a stinging defeat for families dissatisfied with how they fared before a special no-fault vaccine court.”

On the same day, the New York Times published a Pfizer Inc press release titled “U.S. Supreme Court Decision In Bruesewitz V. Wyeth A Win For Public Health” under “Business Day Markets”:

WASHINGTON--(BUSINESS WIRE)--Feb. 22, 2011-- Today, in a 6-2 decision, the U.S. Supreme Court affirmed the ruling of the U.S. Court of Appeals for the Third Circuit in favor of Pfizer’s subsidiary Wyeth, in Bruesewitz v. Wyeth. The Third Circuit determined that the National Childhood Vaccine Injury Act prevents civil suits against manufacturers of FDA-approved childhood vaccines based on a claim that a particular vaccine should have been designed differently.

“Vaccines are one of modern medicine's greatest success stories,” said Pfizer Executive Vice President and General Counsel Amy Schulman. “Their nearly universal administration to children is responsible for the elimination of polio and smallpox in the United States, and the near-elimination and containment of other childhood diseases. The Vaccine Act that Congress enacted nearly 25 years ago appropriately places the responsibility for determining the optimal design of life-saving childhood vaccines in the hands of expert federal agencies, not a patchwork of state tort systems. We are pleased that the U.S. Supreme Court affirmed the ruling of the Third Circuit.”

The document ended with a commercial for Pfizer:

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at

Source: Pfizer Inc.

The Pfizer Executive even mentioned the family: “We have great sympathy for the Bruesewitzes” []

The press release was provided by Pfizer Inc to many other newspapers and outlets including the Wall Street Journal.  []

Many have discussed the Bruesewitz case and by now, those interested in the subject are well aware of the decision and of the fact that Justices Ruth Bader Ginsburg and Sonia Sotomayor dissented.

Two quotes from that black day are worth remembering: One by Justice Sotomayor: “Nothing in the 1986 law remotely suggests that Congress intended such a result" and the other by Attorney David Frederick, the Bruesewitz family attorney: "I'm disappointed for the families of victims of defectively designed vaccines, who now have no remedy at law for their injuries."


Things were certainly different in 1988, when the United States Supreme Court decided Berkovitz v. United States.

First the “Media Reaction” then the case and the decision:

On Tuesday June 14, 1988, the Washington Post carried the first report about the decision:

“Court rules Government Liable for Negligence”

The detailed article included the following remarkable quote by Justice Thurgood Marshall: “We intend specifically to reject the government’s argument that a provision of the Federal Torts Claims Act shields the government for liability for any and all acts arising out of the regulatory problems of federal agencies.”

On the same day, the New York Times reported the decision and its details in its Supreme Court Roundup under the title:

“Court Eases Way to Sue U.S. For Safety Policy Violations”

On Friday June 17, the Washington Post published the following opinion:

One perennial nightmare of all parents is the possibility that a defective vaccine might injure a child. The drug companies have always been liable for damages in those cases. But these vaccines are produced under stringent federal regulation, and now the Supreme Court says the government can be sued if it fails to carry out its own safety rules.

No responsible parent would allow a child to remain unprotected against polio or any of several other deadly diseases, and this kind of pharmaceutical disaster is rare. But it happens. The FDA says that there are currently four other polio vaccine cases pending in lower courts.

In the case that went to the Supreme Court, an infant two months old had been given a dose of Orimune, an oral vaccine that resulted in a full-blown case of polio and severe paralysis. The manufacturer, Lederle Laboratories, settled out of Court. Then the child’s parents sued the government charging that the FDA had allowed the vaccine to be distributed in violation of its own standards. The Government lawyers argued that Congress has specifically given regulators discretion, and granted them immunity from lawsuits when they exercise it.

Not so fast, said the Supreme Court. Justice Marshall, writing for a unanimous court, agreed that Congress has given administrators discretion to make rules. But once the rules are set, administrators don’t have the discretion to evade or bend them. Congress, he said, never intended to protect regulatory corner-cutting.

The injured child’s parents charge that some of the FDA’s employees allowed the vaccine to be shipped with the knowledge that it was not quite up to standard. The court’s decision now gives the parents an opportunity to prove that accusation in a trial and, if they succeed, to collect damages from the Government itself.

This decision reaches far beyond vaccines to every kind of health, safety and environmental regulation. For all of the endless talk in the Reagan administration about the revolt against the regulators, those are three areas in which the principles laid down in the 1970s remain undiminished. There has been plenty of deregulation over the years, but it has been elsewhere – in finance, transportation and communications. The federal laws to protect your life and your health have not been rolled back.

Now the Supreme Court has created a powerful sanction to force tighter enforcement of those laws and the administrative regulations that carry them out. No one who has ever watched a child be vaccinated will doubt that, in its impact on the regulators, the effects of this decision can only be healthy.”

I believe I can safely say that we are not likely to ever read again anything remotely similar to this in any newspaper anytime soon.


Berkovitz v. United States, 486 U.S. 531 (1988) was argued in the United States Supreme Court on April 19, 1988 and decided June 13, 1988.

As mentioned, Justice Thurgood Marshall, a giant, delivered the unanimous opinion of the Court. He started: “The question in this case is whether the discretionary function exception of the Federal Tort Claims Act (FTCA or Act), 28 U.S.C. 2680(a), bars a suit based on the Government's licensing of an oral polio vaccine and on its subsequent approval of the release of a specific lot of that vaccine to the public.”

Justice Marshall went on discussing the details of the case and what happened in the lower courts summarizing the opinion of the court relative to the vaccine lots as follows:

“Viewed in light of these principles, petitioners' claim regarding the release of the vaccine lot from which Kevan Berkovitz received his dose survives the Government's motion to dismiss. Petitioners allege that, under the authority granted by the regulations, the Bureau of Biologics has adopted a policy of testing all vaccine lots for compliance with safety standards and preventing the distribution to the public of any lots that fail to comply. Petitioners further allege that notwithstanding this policy, which allegedly leaves no room for implementing officials to exercise independent policy judgment, employees of the Bureau knowingly approved the release of a lot that did not comply with safety standards. See App. 13; Brief for Petitioners 20-21; Reply Brief for Petitioners 15-17. Thus, petitioners' complaint is directed at a governmental action that allegedly involved no policy discretion. Petitioners, of course, have not proved their factual allegations, but they are not required to do so on a motion to dismiss. If those allegations are correct - that is, if the Bureau's policy did not allow the official who took the challenged action to release a noncomplying lot on the basis of policy considerations - the discretionary function exception does not bar the claim. 13 Because petitioners may yet show, [486 U.S. 531, 548]   on the basis of materials obtained in discovery or otherwise, that the conduct challenged here did not involve the permissible exercise of policy discretion, the invocation of the discretionary function exception to dismiss petitioners' lot release claim was improper.


For the foregoing reasons, the Court of Appeals erred in holding that the discretionary function exception required the dismissal of petitioners' claims respecting the licensing of Orimune and the release of a particular vaccine lot. The judgment of the Court of Appeals is accordingly reversed, and the case is remanded for further proceedings consistent with this opinion.

It is so ordered.


There was indeed a difference between Bruesewitz and Berkovitz.

The Berkovitz decision was right and fair.

The Bruesewitz decision was neither.

By now, many have forgotten Berkovits.

As of now, many more will remember Bruesewitz and the unfortunate decision that is certain to affect thousands just as it has affected a devastated deserving and loving family.

F. Edward Yazbak MD
Falmouth, Massachusetts
March 8, 2011

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