Russell BRUESEWITZ, et al., Petitioners, v. WYETH LLC, fka Wyeth, Inc., fka Wyeth Laboratories, e...

1. Impact

1.1. Kevin RAYMO and Heather Raymo, Legal Representatives of a Minor Child, H.T.R., Petitioners, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

1.1.1. On October 11, 2011, Kevin and Heather Raymo filed a petition on behalf of their minor child, H.T.R. Petitioners alleged that as a result of receiving the human papillomavirus (“HPV”), meningococcal, hepatitis A, and diphtheria, tetanus and acellular pertussis (“DTaP”) vaccinations on October 13, 2010, H.T.R. developed transverse myelitis. Petition at Preamble. Further, petitioners alleged that H.T.R. experienced residual effects of the injury for more than six months. Source:Westlaw

1.1.1.1. On February 24, 2014, then-Chief Special Master Vowell issued a Ruling on Entitlement finding petitioners entitled to compensation. On November 5, 2015, the parties filed a stipulation. The stipulation stated that respondent continued to deny that the vaccines were the cause of H.T.R.'s alleged transverse myelitis and/or any other injury, but the parties nevertheless agreed that a decision should be entered awarding the compensation described in the stipulation. Stipulation at ¶¶ 7–8. The undersigned issued a Decision awarding petitioners compensation pursuant to the stipulation the same day

1.1.1.2. Raymo v. Sec'y of Health & Human Servs., No. 11-654V, 2016 WL 7212323, at *1 (Fed. Cl. Nov. 2, 2016), review denied, decision aff'd, 129 Fed. Cl. 691 (2016)

1.2. Marek MILIK and Jolanta Milik, legal guardians and parents of A.M., Petitioners, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

1.2.1. Parents of child who allegedly suffered neurological disorders after receiving vaccination for measles, mumps, and rubella (MMR) petitioned for review of decision of special master, at 2014 WL 6488735, denying compensation for their claim under National Childhood Vaccine Injury Act

1.2.1.1. The Court of Federal Claims, Campbell-Smith, Chief Judge, held that:

1.2.1.2. 1 special master's determination, that onset of child's global developmental delay preceded his MMR vaccine, was not arbitrary or capricious, and

1.2.1.3. 2 reviewing court was not required to consider objections to special master's alternate findings, once it determined that his findings as to onset of child's disability were not arbitrary or capricious.

1.2.1.4. Petition denied.

1.2.1.5. Milik v. Sec'y of Health & Human Servs., 121 Fed. Cl. 68 (2015), aff'd, 822 F.3d 1367 (Fed. Cir. 2016)

2. Influence

2.1. Influence on businesses

2.1.1. Vaccine makers are aware that there is a law that protects them from strict liabilty plus design defects

2.1.1.1. Manufacturers are protected from costly litigation costs

2.1.1.1.1. The FDA has also protected some food/device and pharma industries from liabilities as a result of this case.

2.2. This case for some have strengthened the anti-vaccine movement.Some parents refuse to vaccinate their children for fear of adverse effects.

2.3. Influence on families

3. Importance:

3.1. Businesses especially the pharmaceutical industries are protected by the NCVIA. This will greatly reduce the financial liability imposed on these vaccine makers as a result of vaccine injury claims.

4. Facts

4.1. Parties

4.1.1. Russell Bruesewitz,et al.,

4.1.2. Wyeth LLC,fka Wyeth,Inc.,fka Wyeth Laboratories,et al

4.2. Hannah Bruesewitz who was born on October 20,1991 received doses of the Diphtheria,pertussis and tetanus vaccine according to the CDC's recommended childhood immunization schedule on April 1992 at the age of six months.

4.2.1. 24hours after the vaccine,Hannah started seizing and over the next month,she suffered over hundred seizures.

4.2.1.1. She was diagnosed with ''residual seizure''disorder and developmental delay.

4.2.1.2. Hannah who is now a teenager is still diagnosed with both disorders.

4.3. Procedural History

4.3.1. Petitioners filed a vaccine-injury petition in the Court of Federal Claims,claiming that Hannah became disabled after receiving the diphtheria,tetanus and pertussis(DTP) vaccine made by Wyeth.

4.3.2. The claim was denied

4.3.2.1. Petitioners sued Wyeth LLC in a Pennsylvania court alleging that Wyeth was subject to strict liability and liability for negligent design under Pennsylvania law.

4.3.3. Wyeth removed the suit to the Federal Court.

4.3.3.1. It granted Wyeth summary judgment, holding that the relevant Pennsylvania law was preempted by 42 U.S.C. § 300aa–22(b)(1), Source: Westlaw

4.3.3.1.1. The provision protects vaccine maufacturers protection from damages arising from a civil lawsuit for a vaccine related injury or death and for a vaccine's unavoidable side effects.

5. Conclusion

5.1. The Supreme Court, Justice Scalia, held that National Childhood Vaccine Injury Act (NCVIA) preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.

5.1.1. The U.S. Supreme Court affirmed the lower court's judgement.

5.2. Bruesewitz v. Wyeth LLC, 562 U.S. 223, 131 S. Ct. 1068, 179 L. Ed. 2d 1 (2011)

6. Issues

6.1. The issue is whether 42 U.S.C. § 300aa–22(b)(1), of the NCVIA protects vaccine manufacturers from tort liability suits in the case where children are injured as a result of design defects?

7. Rule of Law:

7.1. Strict product liability

7.1.1. The plantiff must prove that

7.1.1.1. A vaccine side effect could have been avoidable by use of a different vaccine not containing the harmful element

7.1.1.2. The product was unreasonably dangerous

7.1.1.3. That no feasible alternative design exist

7.1.1.4. That there was no alternative product that would have served the same purpose as the product in question.

7.1.1.5. The injury was due to the defective product

7.2. NCVIA

7.2.1. The NCVIA preempts all design defect claims claims against vaccine manufactureres

7.2.1.1. Section 22(b)(1) provides: *251 “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 **1087 were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” § 300aa–22(b)(1) Bruesewitz v. Wyeth LLC, 562 U.S. 223, 250–51, 131 S. Ct. 1068, 1086–87, 179 L. Ed. 2d 1 (2011) Westlaw

8. Analysis

8.1. The plaintiff argue that under Pennsylvania common law that the defective design of the DTP vaccine was the cause of Hannah's disabilities and therefore company should be exposed to strict product and defective liability

8.1.1. The court holds that the vaccine manufacturer shall not be held liable in the civil law in any vaccine related injury.

8.1.1.1. The structure of the NCVIA and of vaccine regulation in general reinforces what § 300aa–22(b)(1)'s text suggests. Design defects do not merit a single mention in the Act or in Food and Drug Administration regulations that pervasively regulate the drug manufacturing process. Bruesewitz v. Wyeth LLC, 562 U.S. 223, 224, 131 S. Ct. 1068, 1071, 179 L. Ed. 2d 1 (2011)

8.1.1.1.1. The federal court rules that the defendant is therefore protected under NCVIA

8.1.2. Hannah's parents argue that Wyeth should have developed a safer vaccine therefore should be held liable due to the adverse effects of the vaccines defective design.

8.1.2.1. The NCVIA preempts all design defect claims claims against vaccine manufactureres

8.1.2.1.1. Section 22(b)(1) provides: *251 “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 **1087 were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” § 300aa–22(b)(1) Bruesewitz v. Wyeth LLC, 562 U.S. 223, 250–51, 131 S. Ct. 1068, 1086–87, 179 L. Ed. 2d 1 (2011) Westlaw

8.2. Defendants argue that section 22 (b) 1 of the act protects them from all vaccine related injury and so protects them from liability lawsuit.

8.2.1. Defendants also argue that they are also exempted from strict liability rules due to production of unsafe products that are unavoidable.

8.2.1.1. Restatement (Second) of Torts § 402A, Comment k, which exempts from strict liability rules “unavoidably unsafe products.” “Unavoidable” is ha Bruesewitz v. Wyeth LLC, 562 U.S. 223, 224, 131 S. Ct. 1068, 1071, 179 L. Ed. 2d 1 (2011)

8.2.1.1.1. Wyeth argue that these vaccine related complaints and the litigation process is too lengthy and expensive and is becoming a public health concern which may cause parents to decline vaccination for their children.