Legal Perspectivesis aimed at informing healthcare providers, emergency planners, and other decision makers about important legal issues related to public health and healthcare preparedness and response. The articles describe these potentially challenging topics and conclude with the authors' suggestions for further action. The articles do not provide legal advice. Therefore, those affected by the issues discussed in this column should seek further guidance from legal counsel. Readers may submit topics of interest to the column's editor, Brooke Courtney, through the Journal's editorial office atjfox@upmc-biosecurity.org.
See, eg, Blackmon v. Am. Home Prods. Corp.328 F. Supp. 2d 659 (S.D. Tex. 2004); Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007)Am. Home Prods. Corp. v. Ferrari, 668S.E.2d 236 (Ga. 2008).
4.
Bruesewitz v. Wyeth, Inc.508 F. Supp. 2d 430, 433-435 (E.D. Pa. 2007).
5.
Bruesewitz v. Wyeth, Inc.508 F. Supp. 2d 430, 434 (E.D. Pa. 2007).
6.
First approved in 1948, TRI-IMMUNOL® was prepared using whole, inactivated pertussis cells. The whole-cell vaccine was effective at reducing pertussis infections, but it was also linked to adverse events. Sixty-five reports of adverse events were made due to vaccines from the same lot of TRI-IMMUNOL® as Hannah's. Later, Wyeth developed an acellular version of the vaccine (ACEL-IMUNE®) that received U.S. Food and Drug Administration (FDA) approval. However, until December 1996, ACEL-IMUNE® was approved only for the fourth and/or fifth dose of the DTP regimen, not for the first 3 shots of the series. When Hannah received TRI-IMMUNOL®, no acellular pertussis vaccine was commercially available for the third doseSee Bruesewitz v. Wyeth, Inc.508 F. Supp. 2d 430 (E.D. Pa. 2007); Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3d Cir. 2009).
7.
Bruesewitz v. Sec'y of HHSNo. 95-0266V, 2002 WL 31965744 (Fed. Cl. Dec. 20, 2002).
8.
Bruesewitz v. Wyeth, Inc.508 F. Supp. 2d 430, 433 (E.D. Pa. 2007).
9.
42 U.S.C. § 300aa-21, et seq.
10.
Bruesewitz v. Wyeth, Inc.508 F. Supp. 2d 430 (E.D. Pa. 2007).
11.
Bruesewitz v. Wyeth, Inc.561 F.3d 233 (3d Cir. 2009).
12.
Petition for a Writ of Certiorari. Bruesewitz v. Wyeth, Inc.(No. 09-152).
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“Whether Section 22(b)(1) of the Act encompasses both negligent and strict liability design defect claims is not at issue in this petition.” Question Presented. Bruesewitz v. Wyeth, Inc(No. 09-152).
14.
Transcript of Oral Argument. Bruesewitz v. Wyeth, Inc.(No. 09-152).
Health Resources and Services Administration. Comparison of Countermeasures Injury Compensation Program (CICP) to the National Vaccine Injury Compensation Program (VICP)http://www.hrsa.gov/countermeasurescomp/comparison.htm. 2010 March 26.
22.
Brief in Response to Petition for a Writ of Certiorari, at 5, 6, 26. Bruesewitz v. Wyeth, Inc.(No. 09-152).
BinzerP. The PREP Act: liability protection for medical countermeasure development, distribution, and administration. Biosecur Bioterror, 2008; 6,4:293–298.
30.
42 U.S.C. § 247d-6d(d).
31.
42 U.S.C. §§ 247d-6d, 247d-6e.
32.
Health Resources and Services Administration. Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Interim Final Rule. 75 Fed. Reg. 63656-63688, October15, 2010.
Health Resources and Services Administration. Public Readiness and Emergency Preparedness Act Countermeasures Injury Compensation Program, Procedures for Submitting a Letter of Intent to File Requests for Benefits75 Fed. Reg. 26773-26774May12, 2010.
35.
According to the PREP Act, the CICP was intended to follow, with some exceptions, the eligibility and compensation determinations of the Smallpox Vaccine Injury Compensation Program (SVICP). Health Resources and Services Administration. Countermeasures Injury Compensation Program (CICP)Administrative Implementation, Interim Final Rule75 Fed. Reg. 63656-63688October15, 2010.
Unlike the seasonal flu vaccine, the pandemic vaccine would not qualify under the VICP unless CDC recommends it as a routine childhood vaccination. According to HHS, “[i]f the H1N1 pandemic vaccine becomes a component of the trivalent seasonal vaccine (as is currently planned for next year's flu season), then it would be covered by the VICP and not the CICP at that time.”RoosR. HHS preparing to handle claims of harm from H1N1 vaccine. CIDRAP News, March12, 2010.
38.
Department of Health and Human Services, Office of the Secretary. Pandemic Influenza Vaccines—Amendment74 Fed. Reg. 30294-30297June25, 2009.
39.
Health Resources and Services Administration. Personal communication, June10, 2010.
BarnesR. Justices split on childhood-vaccine case. Washington Post, October13, 2010; A2.
42.
According to this case, the Vaccine Act “instead provides that a vaccine manufacturer cannot be held liable for defective design if it is determined, on a case-by-case basis, that the injurious side effects of the particular vaccine were unavoidable.”Am. Home Prods. Corp. v. Ferrari668 S.E.2d 236, 237-238 (Ga. 2008).
43.
SandburgB. Should vaccine makers ever be liable for design defects? Supreme Court amicus briefs argue question. The Pink Sheet, 2010; 72,35:21–22.
44.
Brief in Response to Petition for a Writ of Certiorari at 18. Bruesewitz v. Wyeth, Inc.(No. 09-152).
45.
“There were 26 companies producing vaccines in 1967. By 1977, however, half the commercial vaccine manufacturers had stopped producing and distributing vaccines. By 1985, only four commercial firms were producing and distributing the primary vaccines used in compulsory vaccination programs. Today, Wyeth, GSK, Merck, and Sanofi are among a handful of companies that sell childhood vaccines domestically. Most troubling, there remain only one or two domestic manufacturers of several critical vaccines, including the measles, mumps, and rubella (‘MMR’) vaccine.”Brief of GlaxoSmithKline LLC, Merck Sharp & Dohme Corp. (formerly known as Merck & Co., Inc.), and Sanofi Pasteur Inc. as Amici Curiae in Support of Respondent at 3,7,8. Bruesewitz v. Wyeth, Inc.(No. 09-152).
46.
Brief in Response to Petition for a Writ of Certiorari at 2. Bruesewitz v. Wyeth, Inc.(No. 09-152).
47.
Brief of GlaxoSmithKline LLC, Merck Sharp & Dohme Corp. (formerly known as Merck & Co., Inc.), and Sanofi Pasteur Inc. as Amici Curiae in Support of Respondent at 19. Bruesewitz v. Wyeth, Inc.(No. 09-152).
48.
Petition of Amici Curiae National Vaccine Information Center, Its Co-Founders and 24 Other Organizations in Support of Petitioners at 5. Bruesewitz v. Wyeth, Inc.(No. 09-152).
49.
Petition for a Writ of Certiorari at 4. Bruesewitz v. Wyeth, Inc.(No. 09-152).
50.
“[T]he PREP Act grants nearly complete legal immunity to manufacturers of the H1N1 vaccine. By contrast, the Vaccine Act strikes a careful balance between the compensation of vaccine-injured persons and the limitation of claims that can be brought against vaccine manufacturers in a civil action. Individuals alleging injury from a vaccine covered by the Vaccine Act could seek compensation if the injury was caused by a manufacturing defect or inadequate warnings, but as to vaccines covered by the PREP Act, no such claims may be asserted. The PREP Act therefore demonstrates that Congress felt it necessary to provide vaccine manufacturers with even greater protections from tort liability than is provided in the Vaccine Act.”Brief in Response to Petition for a Writ of Certiorari at 26. Bruesewitz v. Wyeth, Inc.(No. 09-152).
