BRUESEWITZ ET AL. v. WYETH LLC,

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BRUESEWITZ ET AL. v. WYETH LLC, by Mind Map: BRUESEWITZ ET AL. v. WYETH LLC,

1. Facts: Who is invovled and what is going on?

1.1. Parties

1.1.1. Plaintiff: Russel and Robalee Bruesewitz,. Their daugther Hannah was adminstered a DTP (diptheria, tetnus, pertussis) vaccine; they claimed it caused her residual seizure disorder. They claimed Lederele (later Wyeth) was responsible for strict liabilities and liability for neglifent design.

1.1.2. Defendant: Wyeth LLC (formerly known as Wyeth Inc, FKA Wyeth Laboratories), which owned Lederele Laboratories, the manufacturer of the DTP vaccine administered to the Bruesewitz child.

1.2. What happened

1.2.1. The Plaintiff's child, Hannah, was adminstered a DTP (diptheria, tetnus, pertussis) vaccine at age of 6 months, Within a few hours, the child began suffering from seizures and was hospitalized for several weeks. The child, three years old at the time of petition, had continued to suffer from residual seizure disorder. The Plaintiff claimed that a defective design in the vaccine caused the injuries to their daughter.

1.2.2. In 1986, Congress passed the National Childhood Vaccine Injury Act of 1986. This act provided a no-fault compensation program to address the rise in vaccine-related tort litagation. Parents of children who were allegedly injured by vaccines may file a petition with the Court of Federal Claims. They may choose to accept that court's ruling, or reject it and seek relief from teh vaccine manufacturer.

1.3. Procedural History

1.3.1. The Plaintiff filed a petition with the Court of Federal Claims. Their petition was rejected; the seizure disorder had been removed from the list of covered conditions a month before the petition was submitted.

1.3.2. The Plaintiff chose to reject the unfavorable ruling and filed suit against Wyeth, LLC in the state courts of Pennsylvania.

1.3.3. The Defendent had the case removed (ie, changed the venue) from the Pennsylvania State Court to the Federal District Court.

1.3.3.1. The Federal District Court granted Wyeth a summary judgement saying that the NCVIA premented relevant Pennsylvania state law

1.3.3.2. Why a change of venue? Wyeth held that they were protected under the federal NCVIA. A State court does not have jurisdiction over Federal law. See: Issue and Rule.

1.3.4. The Plaintiff appealed that decision as well.

1.3.4.1. The third Circuit Court upheld the Federal District Court's Ruling.

1.3.5. The Plaintiff appealed a final time, to the Supreme Court of the United States (SCOTUS)

1.3.5.1. SCOTUS heard the arguments in the October Term of 2010 under Chief Justice: Roberts. The court rendered its opinion in February of the following year. Justice Scalia would write the majority opinion, with Justices Kennedy, Thomas, Breyer, and Alito joining. Justice Breyer also submitted a concurring opinion of his own.Justice Sotomeyer filed a dissenting opinion with Justice Ginsberg joining. Justice Kagan took no part.

2. Issue: what's the problem here?

2.1. There were two issues at stake: 1) Could litagtion be brought against the Defendant (and others like them) in a state court, when there was a federal law covering the issue? 2) Was the Defendant liable for damages to the Plaintiff under the NCVIA ?

3. Rule of Law: What is being used to figure this out?

3.1. Common law: Products-liability law, generally; NCVIA Specifically

3.1.1. Products-liability law, a form of unintentional torts, holds that manufacturers of products may be held liable for adverse outcomes arising form use of their products. Negligance torts,

3.1.1.1. Among the types of liability under consideration: Negligent design, which would hold a maker responsible for damages arising from foreseeable risks arising from not using a different design for the product.

3.1.1.1.1. The first part of the Design defect test is "Is a reasonable alternative available?" the second part that a plaintiff must show is that by not adopting the alternative design, the defendant had an unsafe product.

3.1.2. The key passage of law from the NCVIA under review was as follows: No vaccine manufacturer shall be liable in a civil secion for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October , 1998, 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.

3.1.2.1. The "properly prepared and was accompanied by proper directions and warnings" may be read as a Good Samaritan Clause additionally protecting physicians and nurses who are following accepted standards of care as well as manufacturer product directions in administering the vaccines.

3.2. Constitutional Law. Interstate Commerce clause. This holds that the Federal Government has the right to legislate (and enforce legislation) involving business that occurs across state lines.

3.2.1. The Interstate Commerce clause was critical to this case in establishing both Wyeth's right to have the case removed from the Pennsylvania State Courts to the Federal District Court, and to the pre-emptive quality of the NCVIA over any state-level tort law.

4. Impact: Other cases citing Bruesewitz v. Wyeth

4.1. American Home Products Corp. v. Ferrari

4.1.1. In this case the Appellee is the manfacturer; the Appellant(s) are the parents of a child who suffered injury following the administration of a vaccine. It is an Appeals case following the original series of procedures initiated by the Ferrari party in the State of Georgia. the initial court held that there were two legitimate readings of the NCVIA (the majority and the dissent opinions of Bruesewitz v. Wyeth), but weighed in favor of the majority opinion reading. The parents appealed, the Georgia State Court of Appeals reversed the lower court's decision. Then the manufacturer appealed, and in raising to SCOTUS, SCOTUS in turn kicked it back down to the Supreme Court of Georgia.

4.1.1.1. This is a case of SCOTUS saying "we've said all we have to say on this matter, now you all go figure out what we meant for yourselves."

4.2. Levesque v. Lynch

4.2.1. The Plaintiff, Levesque, was a lawful permanent resident of the United States, but who engaged in and was found guilty of wire fraud, bilking her victims out a sum totalling more than $29,000. While she was sentenced to five years probation and ordered to pay back the monies she fraudulently obtained. Following her conviction, the department of Homeland Security initiated deportation proceedings against the Plaintiff, under the rule of law that committing an "aggravated felony" was grounds for deportation. The Plaintiff brought a petition against the Attorney General of the United States, Lorretta Lynch, claiming that since the Plaintiff was not incarcerated for her crimes, it was not an aggravated felony. The First Circuit Court denied the Plaintiff's petition, and she was told to pack her bags.

4.2.1.1. The citation of Bruesewitz in this case rests upon the grammatical innuendos of prepositional placement within the drafting of a statute of law. Thus, one hopes that would-be legislators and judges either had Roman Catholic nuns teaching them how to diagram a sentence, or binge-watched the Schoolhouse Rock "Conjunction Junction" episode repeatedly.

5. Conclusion: what did the court decide?

5.1. SCOTUS held that the NCVIA adequately shields manufacturers overall, and particularly the Defendant from unavoidable adverse outcomes, as serving to advance the public good of ensuring access to and application of vaccines. Additionally, it supercedes any state-level products-liability law under the Interstate Commerce Clause of the US Constitution.

6. Analysis: Who said what, and why?

6.1. Plaintiff

6.1.1. The company owned by the Defendant made the vaccine; our daughter suffered injury following the application of that vaccine; the Defendant is now liable for the damage afllicting our daughter. the Piaintiff contends that there was a design flaw in the vaccine itself "negligent design.")

6.2. Defendent

6.2.1. The NCVIA sheilds us from liability for unavoidable adverse affects; the condition the Plaintiff's daughter suffers from is not covered on the scheudule of conditions under the NCVIA; while the NCVIA provides that the Plaintiff may reject the decision and pursue tort relieft litagation, it also preempts any state-level products-liabiltiy law.

6.3. Court

6.3.1. Formulation of the NCVIA: Drafting and intent were considered

6.3.1.1. Letter of the law: Justice Scalia, in the syllabus of the case, provides textual analysis of several key phrases within the the wording of the NCVIA. The dissent, led by Justice Sotomeyer, also reviewed the same passage, although drew different conclusions.

6.3.1.1.1. Key phrases reviewed by the Court: "even though" and "unavoidable" (majority) and "if" (dissent).

6.3.1.1.2. The majority opinion also stated that by implication, the law covers the vaccine as designed, thus, the Plaintiff's suit on the basis of "negligent design" is not valid.

6.3.1.2. Spirit of the Law: the court considered the intent with which the NCVIA was drafted, namely to advance the overall public good through continued adherence to medically recommended vaccination schedules as well as to ensure that businesses would continue to manufacture these vaccines despite growing ligatation. Specifically (see textual analysis above) manufacturers are protected against litagation arising from unadvoidable adverse side-effects. In other words, no product, especially a medicinal one, is ever completely safe under all circumastances, for every single indiviudal who might use it; in the case of vaccines, the overall protection they bring to the public outweighs the unusual and unexpected harm that comes to a relative few.

6.3.1.2.1. Purely personal comment: If Ruth Basder Ginsberg could appreciate Scalia's legal mind, I suppose I can too. And in this case, I happen to admire the application of the Risk-Utility Analysis premise along with his elegant sentence deconstruction, noted above.

6.3.1.2.2. Justice Scalia also notes that vaccines, like other FDA-approved medications, are subject to extensive testing for safety and efficacy before being brought to market.

7. Influence

7.1. Continued product innovation: Pharmaceutical companies have continued to bring new vaccines to market, including such newer ones as Varicella, HiB and rotavirus. This ruling has given pharmaceutical companies the leeway to continue working with researchers to identify and develop vaccines that reduce childhood mortality and protect the well-being of millions of children. Additionally, the decision allows them to withstand claims (sometimes based on false science, such as the now widely dismissed MMR-autism link) that vaccines are inherently harmful.

7.2. Reduced insurance costs: By upholding the NCVIA and its application, the decision benefits pharma's ROI for vaccine innovation. Since unavoidable outcomes are covered by the relief fund provided for under the law (and endowed via surcharges on the vaccines), and a company can not be held liable for not coming up with a "better" design (ie, Scalia's ruling that the law covers the design "as is", excluding claims of negligent design), companies do not have to carry as much products-liability insurance as they might otherwise.

8. Importance: Getting into the head of a pharmaceutical executive.

8.1. Can this company continue to pursue innovative products that help people with conditions we known and understand, or does the continued expansion of biomedical knowledge mean that any drug designed to work within the knowledge parameters of today will face legal challenges based on the discoveries of tomorrow?

8.2. Will the cost of liability claims and/or insurance premiums outstrip the profit on a drug? Will we have to discontinue a vaccine that saves millions of lives because the insurance just makes it too expensive?