Overturning the Lower Court’s Holding Would Lead to Consequences Contrary to

Congressional Intent and Not in the Best Interest of the Secretary

The Secretary argues a claim that is found to be untimely is, in effect, no claim at all. It is as if the claim was never fi led. Adopting that reasoning may result in consequences that the Secretary has not completely considered. To understand these consequences, some explanation is necessary.

On August 1, 1997, two mercury-containing vaccines were added to the Vaccine Injury Table that resulted in children receiving seven additional mercury-containing vaccines during the fi rst year of life. Prior to that time, the only mercury-containing vaccine was DPT. When a new vaccine is added to the Vaccine Injury Table, the act provides that, “If at any time the Vaccine Injury Table is revised and the effect of such revision is to permit an individual who was not, before such revision, eligible to seek compensation under the [VICP] . . . such person

may . . . fi le a petition . . . not later than two years after

the effective date of the revision,” as long as the death or injury did not occur more than eight years before the Table revision. 42 U.S.C.A. § 300aa-16(b). (emphasis added). In other words, children who received Hepatitis B vaccines and Hib vaccines before August 1, 1997, and who were injured by those vaccines, did not have to fi le a claim in the VICP before fi ling civil suits against the administrators or manufacturers of the vaccines. Since the state statutes of limitations have not run on most of those cases, there are thousands of potential civil plaintiffs who are not time barred from fi ling civil lawsuits, and those lawsuits will

not be subject to this Court’s ruling in Bruesewitz. See Bruesewitz v. Wyeth LLC, 131 S. Ct. 1068 (2011).

It is important for the Court to understand the differences between how Congress intended the VICP to function and how it is actually functioning today. A program that was designed to be petitioner friendly, informal, non-adversarial, generous and prompt is in fact none of those things. As noted supra n.7, the program is highly adversarial, and claimants are facing the resources of the Secretary and the Department of Justice without the benefi t of meaningful discovery, knowing that their experts may be the subject of unnecessary published critiques that seem designed to discourage others from participating in the program. See e.g.– Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378 (Fed. Cir. 2009), Porter v. Sec’y of Health and Human Servs., 663 F.3d 1242, 1249-50 (Fed. Cir. 2011). Even in cases where causation is conceded, the proceedings are often still protracted, and the very limited damages provided in the program are subjected to adversarial scrutiny and arguments that seem designed to pressure claimants to settle for less than to what they might otherwise be entitled.

This case, challenging the reimbursement of fees and costs in a case that was fi led in good faith and with a reasonable basis because it was found to be untimely fi led, represents yet another layer of complexity that the Secretary is trying to add to an already complex and diffi cult program that was meant to be simple and generous. Two examples are provided below, which hopefully will aid the Court in understanding the full ramifi cations of a decision in this case. In a claim currently being handled by

the Vaccine Injury Legal Clinic that was fi led in July of 2004 by the Petitioner, pro se, the Secretary fi led a report conceding “that the medical evidence demonstrates that [claimant] suffered encephalomyelitis as a result of her MMR vaccine and that her present condition is a sequela of that injury. Furthermore, there is not a preponderance of evidence that [claimant’s] condition is due to factors unrelated to her MMR immunization. Accordingly, but for the timeliness of the petition, claimants would have been entitled to receive an award of compensation in this case.” The Secretary moved to dismiss the claim saying that the claimant’s parents had fi led her claim one day too late. Id. After the clinic became involved in the case, a hearing was held where experts for both the claimant and the Secretary testifi ed about whether the onset of symptoms was one day or the next day. In an order after the hearing, the special master concluded: “The undersigned having reviewed the entire record fi nds the Petition timely fi led. In making this fi nding, the undersigned emphasizes that it was a diffi cult and very close determination.” The special master agreed with petitioner’s expert, and since causation was already conceded and agreed to by the expert for the Secretary, the case proceeded to the damages phase. Clearly, the case was fi led in good faith and with a reasonable basis, and the claimant was entitled to compensation as well as reimbursement for attorneys’ fees and costs. The clinic’s decision to enter the case and represent the claimant was also made in good faith and with a reasonable basis. If the special master would have ruled against the claimant and concluded, as the Secretary urges this Court to conclude, that a claim was never fi led, then not only would claimant not have received any compensation, but claimant would also not have been reimbursed for any costs incurred in pursuing the claim.

A hypothetical example that illustrates many of the points raised in this brief may be helpful. Jane Doe was born on January 10, 1997, and given a Hepatitis B vaccination the next day. She received the normal vaccinations scheduled for her 2 months, 4 months, and 6 months well baby visits. On January 20, 1998, despite the fact that she had a cold, Jane received the MMR vaccine. Seven days later, on January 27, she experienced a seizure and was rushed to the hospital, where she was admitted and prescribed medication for seizure control. After that, Jane’s parents noticed that she was no longer as responsive and she lost the few words that she had started using. Over the next couple of years, Jane’s parents complained to doctors that she was not meeting milestones and not developing like her older brother had. It was not until December of 2001 that a doctor suggested that Jane might be autistic, and when they asked him if the seizures after the MMR vaccination might have caused this, he said he did not know. Jane’s parents did not fi nd out about the availability of the VICP until January 26, 2002. After making some inquiries, they obtained the name of a lawyer who practiced in the VICP and called him. The lawyer immediately recognized that the statute of limitations was about to expire, and fi led a claim that same day. Over the course of the next several months, the case worked its way through the VICP. All of the medical records were paid for and collected by Jane’s parents, sent to the attorney, and fi led. Jane’s parents provided video of her as a baby to show how she went from being a normal baby prior to the MMR vaccine to a child who was now diagnosed with severe developmental delay. An expert for the respondent reviewed the videos and concluded that Jane was exhibiting signs of autism in the videos taken before the MMR shot. He pointed to some fl apping of

the arms and being unresponsive to the parents a couple times as evidence of this. Claimant’s expert countered that these were normal baby movements, but even if there was something very mild going on, the MMR vaccine caused a signifi cant aggravation of the condition. Respondent’s expert disagreed and gave the opinion that the cold Jane was experiencing when she was vaccinated continued and caused a fever, which then caused the seizure. While admitting that Jane experienced an encephalopathy seven days after the MMR vaccine, respondent’s expert said it did not fi t the defi nition of encephalopathy in the Vaccine Injury Table, so there was no presumption of causation for the claimant. The special master wrote a decision indicating that both experts were highly qualifi ed, but she agreed with the respondent’s expert that the MMR vaccine did not cause a signifi cant aggravation of Jane’s condition and that the onset was a couple months before the MMR vaccine. When an application for fees and costs was fi led, respondent objected, arguing that a timely claim was never fi led. The court agreed. The attorney decided that since a claim was never fi led, and since he did not have to fi le a claim for injury from the Hepatitis B and Hib vaccines, he could now proceed with traditional civil litigation against the manufacturers of the Hepatitis B and Hib vaccines without having to worry about the restrictions on fi ling civil lawsuits imposed on claimants who have rejected the judgment of VICP and without having to worry about the ruling of the Supreme Court in Bruesewitz.

An alternative to this hypothetical scenario is that the claimant never fi led a claim, because Jane’s parents were inundated with her medical bills and could not risk pursuing a claim where they might not be reimbursed

for their attorneys’ fees and costs. This is unfortunate, because had they fi led the claim, a different special master would have heard the case and ruled that the video was not proof of an earlier onset and, even if it was, the MMR vaccine did indeed cause a signifi cant aggravation of Jane’s condition.

CONCLUSION

In conclusion, the Majority opinion in the lower court made the correct ruling when they found that attorneys’ fees are still available on untimely petitions that were filed in good faith and with a reasonable basis. The plain language of the statute allows for the possibility of awarding attorneys’ fees for petitions fi led outside the limitations period, and the Act is a remedial statute, not a waiver of sovereign immunity, which obviates the need for narrow, strict interpretations of the provisions.

It is in the best interests of the Program, as well as Congress’s intent, to remove fi nancial concerns as an obstacle to file reasonable, good faith petitions, and overturning the lower court’s holding will shift the fi nancial burden to the claimants and reduce their access to experienced, competent counsel. Affi rming the Federal Circuit decision will not result in an increase in unnecessary, expensive proceedings as the Secretary’s concerns about “shadow trials” is overstated and the VICP program overall is characterized by extremely low transaction costs and much lower than average attorney compensation. The current statute of limitations has likely excluded many individuals from even fi ling petitions for their vaccine-related injuries, but a reversal by this Court would prohibit individuals whose petitions were fi led

in good faith with a reasonable basis but ultimately an arguable onset from having their day in court and from being properly represented by counsel.

Respectfully submitted, CLIFFORD J. SHOEMAKER Counsel of Record SHOEMAKER, GENTRY & KNICKELBEIN 9711 Meadowlark Road Vienna, VA 22182 (703) 281-6395 [email protected] PETER H. MEYERS THE GEORGE WASHINGTON UNIVERSITY LAW SCHOOL 2000 G Street, N.W. Washington, D.C. 20052 (202) 994-5793