1. Module 4 Case
2. References Used:
2.1. Copy of the NVCIA (H.R. 5446) Congress.gov, retrieved online 06 Nov 17. H.R.5546 - 99th Congress (1985-1986): National Childhood Vaccine Injury Act of 1986
2.2. Copy of 42 CFR seciton 100, which references the vaccine table of recognized known sde effects. Retrieved online from GPO.gov 07Nov17. https://www.gpo.gov/fdsys/pkg/CFR-2001-title42-vol1/pdf/CFR-2001-title42-vol1-chapI-subchapJ.pdf
2.3. Class Text.
2.4. Wadman, Meredith. "Vaccines on Trial: U.S. Court separates fact form fiction." April 2017 SCIENCE magazine. Recovered online 07 Nov 17. Used to find cases influenced by Bruesewitz. Vaccines on trial: U.S. court separates fact from fiction
2.5. Brown et al. "Bruesewitz v. Wyeth’s Impact on the Vaccine Safety Debate" American Bar.org. 2011. Used to gain more information on the vaccines/autism lawsuits were impacted by Bruesewitz. Bruesewitz v. Wyeth’s Impact on the Vaccine Safety Debate
2.6. Wexler, Sara. "Breusewitz v. Wyeth: The 'unavoidable' vaccine problem." Duke Journal of Const. Law. 2011. Volume 6:93 pages 93-110. Recovered online 12 Nov-17 https://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=1068&context=djclpp_sidebar
2.7. Hooker v Sec H&HS https://ecf.cofc.uscourts.gov/cgi-bin/show_public_doc?2002vv0472-132-0
2.8. Cedillo v Sec H&HS http://www.uscfc.uscourts.gov/sites/default/files/cedillo.fedcir.pdf
2.9. Omnibus Autism Proceedings, various petitioners vs. Sec H&HS http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism%20Update%201%2012%2011.pdf
2.10. I have worked in drug and life sciences manufacturing since 2011. In many places I am drawing on my own industry and regulatory knowledge.
3. Facts
3.1. Parties
3.1.1. Wyeth (Pharmaceuticals)
3.1.2. Russel Bruesewitz et al.
3.2. What Happened
3.2.1. Hannah Bruesewitz received a routine TDaP vaccination made by Wyeth in 1992 which gave her immediate and permanent nervous system damage.
3.2.1.1. The family petitioned for compensation two and a half years later, it seems when they realized that their daughter's condition was permanent and expensive. Unfortunately they were denied
3.2.1.1.1. The family filed suit against Wyeth claiming that they should have, but failed to design a safer version of the vaccine.
3.3. Procedural History
3.3.1. In 1986 the government created legislation that protects vaccine manufacturers from most tort liability suits, but also provides a mechanism for people adversely affected by known, legitimate side effects of vaccines to seek remediation.
3.3.2. 42 CFR 100 contains the vaccine injury table under which Bruesewitz could have been compensated, however the symptom she suffered was taken off this table shortly before their family filed the claim. (from Oyez.org {{meta.pageTitle}}
3.3.3. DTP is an old vaccine, approved in the 1940s, and has had many lawsuits brought against it. Notably, there have been times when so many suits were brought against this drug that the market was destabilized. This is one of the primary reasons for the NCVIA.
4. Issue
4.1. Whether federal law (National Childhood Vaccine Injury Act, 1986) prevents all lawsuits against the vaccine manufacturer for design defects and liability.
5. Rule of Law
5.1. Types of liability that are protected for the manufacturer of a vaccine under NCVIA
5.1.1. The law states that it shall apply to "unavoidably unsafe products". Vaccines are in a special liability category because of their high benefit, but known risks.
5.1.2. Arguments by both sides in the surpreme court hearing focused on the specific language the NCVIA uses
5.1.2.1. In order to win this case the plaintiff has to establish that what happened to them is not preempted by the NCVIA and thus the company is liable for damages.
5.1.2.1.1. I think that if the plaintiff had brought a different question before the court, they might have won this case.
5.1.2.1.2. The plaintiff should have brought suit against the Secretary of Health for failure in their duties, as detailed in HR 5546 Part D. The secretary should bear the burden of proving that the law is in keeping with their duty to ensure safe childhood vaccines. 42 CFR 100 states that Hannah's case is not considered covered by NVCIA because her first seizure occurred too quickly after injection. Can they prove that be preponderance of the evidence that the 5-15 day window for the first convulsion is appropriate? How do they account for a case like Hannah's, what is the logic?
6. Analysis/Application
6.1. Bruesewitz argues that the manufacturer Wyeth should be liable for design defect.
6.1.1. He claims that Hannah's condition was not 'unavoidable' as described by the NVCIA.
6.1.2. He claims that the manufacturer should have done more to come up with a safer vaccine
6.1.2.1. In support of this claim, the DTP vaccine that caused his daughter these problems was taken off the market some years after she received it.
6.1.2.2. The plaintiff bears the burden of proving that an alternative reasonable design was available to the manufacturer.
6.1.2.2.1. This is a poor legal situation for the plaintiff. Justice Scalia is quite correct that there are always alternative ways to design a drug that will trade some risks for other risks. Rarely if ever is a vaccine or complex drug risk free. Its unlikely they could meet this burden.
6.1.2.2.2. Justice Scalia states in his writing for the court that the 'even though' clause in the federal law is important. It would seem odd to use the words 'even though' if there were circumstances other than those that followed wherein the manufacturer remained liable.
6.2. The intent of the NVCIA is to limit the liability of vaccine manufacturers to lawsuits for known risks associated with vaccines, while also providing compensation to those legitimately affected by the side effects of these medicines.
6.2.1. It is clear from several sections of H.R. 5546 that the primary spirit of the law is aimed at acknowledging the massive benefit of a product like vaccines and maintaining them as a tool for public health.
7. Conclusion
7.1. The court concluded that vaccine manufacturers are protected by the specialized federal system set up for legal issues arising from their use.
7.1.1. The overall social benefit of vaccines outweighs the risks of their use. Complex drugs carry inherent and unavoidable risks; but they make our current standard of living possible. This is especially true of vaccines and antibiotics.
7.1.2. The court ruled in favor of Wyeth, that they were not liable for defect in design.
7.2. IMPACT
7.2.1. Bruesewitz V Wyeth influenced a broad range of pending litigation against pharmaceuticals companies, one article claimed as many as 5,000 cases were immediately impacted.
7.2.1.1. Most notably numerous lawsuits alleging that vaccines cause autism
7.2.1.1.1. Hooker v secretary of H&HS (2017), Cedillo vs secretary of H&HS (2010), Hazelhurst v. secretary of H&HS (2010)
7.2.1.2. US federal claims court Omnibus Autism proceeding. various petitioners v. secretary of H&HS.
7.2.2. It also likely prevented a widespread decline in vaccine manufacturing. Had the court ruled wyeth liable many manufacturers would have been incentivised to exit this risky market.
7.2.3. The broad implication of this suit as well as the myriad suits brought against the Secretary of H&HS has been that legitimate damages directly related to a vaccine are hard to prove.
7.2.3.1. While I agree with that in principle, I think that the angle of such suits should be altogether different. The plaintiffs have failed to question the suitability and appropriateness of the law. Part of the duties of the H&HS is to ensure that the law results in a safe childhood vaccination program, but no one has challenged that as far as I have seen.
7.2.3.1.1. That suggests to me this set of laws is somewhat overdue for a review. There are opportunities for clarity in both 42 CFR sec 100 and NVCIA.
7.3. IMPORTANCE
7.3.1. From a business perspective, Wyeth should be seen as caught in the crossfire of these events.
7.3.1.1. The Bruesewitzes have unquestionably been adversely affected, and it would seem most likely that some combination of events, one of which being the vaccine, and the other genetic or infection related complications, led to their daughter's injury.
7.3.1.2. The company should protect itself by having a well controlled policy for the development of its drugs, so that under scrutiny by an expert they could defend the design decisions they made about this vaccine. This case could easily have resulted in Wyeth having to defend itself and it's decisions.
7.3.1.2.1. It is also simply ethical to concur with Justice Sotomayor. They company is not completely innocent of risks associated with its products. IF they really have made decisions for profit over safety, or been neglectful, someone should and I'm sure eventually would hold them accountable. They should maintain an ethical culture regardless of the court.
7.4. INFLUENCE
7.4.1. cGMP (current Good Manufacturing Practices) are a set of policies widely used by drug companies to ensure that they can defend themselves against claims of manufacturing and labeling defects.
7.4.1.1. cGMP is also a regulated term used by the FDA in its enforcement of 21 CFR. 21CFR is updated yearly and incorporates all current industry legal and scientific knowledge to set out regulations by which companies maintain the quality of drug products.
7.4.1.1.1. In her article in 2011 in the Duke Journal of Constitutional Law and Public Policy Sidebar, Sara Wexler suggested clarity issues such as the seemingly different interpretation of regulations in 21 CFR between Bruesewitz v Wyeth, and Wyeth v. Levine in 2009. (URL https://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=1068&context=djclpp_sidebar)
7.4.2. ISO 9001 is a set of industry regulations that govern quality management. It is widely used in many industries including drug manufacturing. It was last update in 2015. Although not specifically referring to Bruesewitz, it references industry and legal trends in its guidance. It applies in many similar situations to 21 CFR as a sort of 'additional assurance' to both management and the customer that the company uses good practices to ensure it doesn't produce manufacturing or labeling defects.