How the Fall of Vaccine Manufacturers Could Impact Public Health
Feb 25, 2011

“What if manufacturers stopped making vaccines?”
Someone recently posed this question on our Vaccinate Your Baby Facebook page.  It’s a difficult question really?  If companies were no longer willing or able to manufacture vaccines, how many people would suffer, and perhaps die, from dangerous and contagious diseases, and how many would be children?
Fortunately, as a result of action taken by Congress in 1986, we have yet to discover the answer to this question.  However, history shows that it wasn’t all that long ago when public health administrators were seriously concerned about this very real possibility.       
At that time, considerable media attention was focused on speculations surrounding a specific diphtheria, tetanus and pertussis vaccine (DTP). While suggestions of adverse reactions escalated in the media, so did the public’s concern over the safety of this particular vaccine.  Subsequently, the number of vaccine injury claims being brought to court had escalated, from one DTP-related lawsuit in 1979, to 255 cases by 1986, with a total of over $3 billion sought by claimants.     
As a result, manufactures began abandoning the market in droves.  Despite the fact that they won the overwhelming majority of their cases and that the science would eventually illustrate that these cases were frivolous, their legal fees were in the millions of dollars and their expenses began to exceed their profits.  As the number of manufacturers continued to fall, from 26 in 1967 to just 3 by 1986, it became obvious that the excessive legal action was making it unsustainable for corporations to remain in the vaccine industry.  
These dangerous conditions prompted Congress to take action with the creation of the National Childhood Vaccine Injury Act (NCVIA) in 1986.  In moving to “secure vaccine supply, promote safety and future research, and compensate innocent victims” the NCVIA was considered a “top public health priority.”  In a blog post entitled Supreme Court Saves Nation’s Immunization Program, John Snyder of Science Based Medicine, explains it best: 
With the future of our vaccination program at risk, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986 and established the National Vaccine Injury Compensation Program (NVICP). Funded by an excise tax on each vaccine component administered, the NVICP was designed as a no-fault, expedited process to compensate families who claim their child has suffered a vaccine-related injury. No proof of causation is necessary to be eligible for compensation. A child simply has to have a documented problem that occurred in the specified time frame following a vaccination, and that problem has to be on the table of problems recognized by the NVICP as potential vaccine adverse events. Cases are reviewed by a Special Master, who makes a determination based on minimal evidence, with the primary goal being a prompt resolution. If a claim is successful, compensation is granted for medical, rehabilitation, counseling, special education, and vocational training expenses, and $250,000 when the claimed outcome is death. Patients may accept the ruling or take their case through the usual tort process by suing the manufacturer. However, a major aspect of this process, and the one which saved the vaccine program from total collapse in the 1980s, is the significant liability protection granted to the vaccine manufacturers. Before suing a vaccine manufacturer, a claimant must first go through the NVICP process, or the so called “Vaccine Court”. But if a parent rejects an NVICP ruling and decides to sue in court, the vaccine manufacturer is immune from liability, assuming they have complied with all regulatory requirements and have not committed outright fraud or other crimes in the manufacture of the vaccine. Most importantly, the NCVIA stipulates that,

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

Though some may argue that the National Vaccine Injury Compensation Program has proved favorable for manufacturers by shielding them from costly lawsuits, one must also acknowledge that the program was intended to serve the families as well.  Prior to the program, civil law suits were both time-consuming and costly, not only for the manufacturers, but also for the families.  Additionally, families had to prove, beyond a reasonable doubt, that the injury was in fact a result of the vaccine.  This was complicated by the lack of medical expertise in those reviewing the cases.  In essence, the new no-fault system was created to ensure that families received appropriate compensation in a timely manner, free from lengthy and costly litigation, being reviewed by experts but without the difficult burden of proof.   While the law states that families must go through the Vaccine Court first, parents retain the right to sue in civil court if they lose a vaccine court ruling, or are dissatisfied with the outcome .   The fact that few seek this option may indicate that families are being served well by the program.   Additionally, over $2 billion in claims has been paid since the creation of the law and every claimant’s legal expenses have been paid, regardless of the court judgment. 
Which brings us to this week’s Supreme Court ruling in the case of Bruesewitz vs. Wyeth. 
In this particular case, the Bruesewitz family claimed that the DTP (diphtheria-tetanus-whole cell pertussis) vaccine administered to their daughter Hannah in 1992 caused her to have seizures at that even now, at age 19, she continues to suffer from “residual seizure disorder” requiring lifelong care.  As explained by CNN, the family “alleges another vaccine owned by Wyeth — known as Tri-Solgen — had proven in earlier tests to result in fewer potential side effects. The Bruesewitzes claim the company and the federal Food and Drug Administration were lax in pushing use of the alternative, potentially safer vaccine.”  (It is important to note that the original drug given to Hannah was discontinued by Wyeth in 1998 and that further scientific development has resulted in an improved DTaP vaccine in use today, which utilizes the acellular pertussis component, and is currently administered to children with fewer side effects and injury.) 
When the Special Vaccine Court ruled that Hannah’s injuries couldn’t be linked with the vaccine, based upon a pre-established table of accepted injuries, the family tried to move the case to separate state and federal courts.    Their lawyers argued that Congress did not intend to block all vaccine-related lawsuits, especially those filed when the harmful side effects were avoidable.  However, the Third Circuit Court of Appeals eventually ruled that the claim was pre-empted by federal law, and concluded that all design-defect claims were to be barred under the statute.  Despite that ruling, the manufacturer urged The Supreme Court to hear the case, in hopes that their decision would finally provide a resolution for the broader legal questions at hand.  Is it possible for a vaccine manufacturer to be tried in a civil suit, and if so, under what conditions? 
While many manufacturers and public health administrators were concerned that an overturned ruling would adversely impact the efforts made by Congress back in 1987, parents with pending litigation anxiously awaited the decision.  Then, earlier this week, the announcement was made that The Supreme Court had ultimately upheld the ruling.    
While there continues to be various opinions regarding this case, it is important to understand the complexities that I have not been able to fully address in this summary.  I have listed several articles that may offer greater insight into the specifics of the ruling.  It appears that if the ruling had gone the other way, the potential would have been to subject vaccine manufacturers to a new litany of law suits.  For now, that possibility has been avoided.  However, while the ruling is in, the people’s verdict is still out.   What are your thoughts regarding this case? Check out some of the opinions expressed in the articles below and share your thoughts with us.   

Articles of Interest:

At Science Based Medicine, the ruling is hailed as a legal victory for public health.  The article Supreme Court Saves Nation’s Immunization Program, offers an excellent explanation of the concerns surrounding the whole cell DTP vaccine and the steps that were taken in this case.  
In another piece, Arthur Allen provides significant insight with his article The Real Problem With Vaccines published in Slate this week.  The byline reads “Our system for compensating injured children is hurting – and this week’s Supreme Court ruling doesn’t help”. In discussing the vaccine injury table used to calculate compensation, Mr. Allen raises concerns over changes that have been made to the table that have adversely affected this particular case.   
The New York Times piece, Justices Reject Suit Faulting a Vaccine, specifically addresses the various opinions of the judges hearing this case.  
USA Today:  The Supreme Court rules against parents in vaccine case 
CNN:  Justices rule for drug makers in vaccine dispute
 The Wall Street Journal:  The Supremes Win One For Science

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