No recall for glass found in vaccines made in Monroe County
December 31st, 2016
December 10, 2016 - Story reported by Sam Kennedy of the Morning Call - Sanofi Pasteur, one the world's leading vaccine makers, had a potentially serious and costly problem on its hands: Its Monroe County plant discovered tiny pieces of glass in batches of a vaccine intended for babies.
The glass was first detected in April 2013 in samples of a vaccine that had already been distributed to customers and which would not expire until September 2014.
Sanofi sent the samples to an outside laboratory for analysis. The lab found evidence of delamination — which occurs when vaccine vials shed flakes of glass called lamellae.
The health risks posed to any individual by vaccine vial delamination are widely believed to be minuscule. None has been documented.
Nonetheless, the U.S. Food and Drug Administration has warned that lamellae could cause serious health problems such as an adverse immune system reaction. When confronted with glass contamination, medical manufacturers have erred on the side of caution, alerting the public and issuing sweeping product recalls.
In at least one case, a manufacturer in 2013 recalled a vaccine with a glass contamination rate that was much lower than the rate Sanofi found in its Haemophilus b conjugate vaccine, or ActHIB.
Sanofi, on the other hand, allowed doctors and nurses throughout the country to continue injecting babies with the potentially problematic ActHIB for another year and a half.
The FDA did not push back, either. After the regulatory agency found out about the issue, it accepted the company's assurances that the vaccine was safe.
About Hourigan, Kluger & Quinn, PC
Hourigan, Kluger & Quinn is considered one of the top civil litigation and commercial law firms in Northeastern Pennsylvania. The firm’s Personal Injury Team has won some of the largest verdicts and settlements in the region's history and was recently recognized for one of the top 20 Verdicts in Pennsylvania.
The Personal Injury Team, led by Attorney Joseph A. Quinn, Jr. focuses on a wide array of personal injury claims and civil litigation, including medical malpractice, auto and truck accidents, aviation accidents, unsafe vehicles, dangerous or defective products, workplace injuries (worker's compensation), construction site accidents, claim denials by insurance companies, dangerous drugs, defective children's products, nursing home abuse and neglect, and falls due to unsafe conditions (slip and fall).
Attorney Joseph A. Quinn, Jr. is one of only 100 attorneys in the United States (and one of only three in Pennsylvania) honored with membership in the Inner Circle of Trial Advocates, and one of only 500 attorneys worldwide chosen to be a Fellow of the International Academy of Trial Lawyers. He has been a Pennsylvania Super Lawyer every year since the program began and has been listed in The Best Lawyers in America every year since the publication was established in 1987. Best Lawyers also named him top personal injury attorney for Northeastern Pennsylvania and the Lehigh Valley. In addition, Best Lawyers, in conjunction with U.S. News & World Report, has designated HKQ a Tier 1 Best Law Firm for personal injury and medical malpractice litigation in Northeastern Pennsylvania and the Lehigh Valley.
Since the inception of the firm, the Commercial / Corporate Team led by Attorney Allan Kluger has provided comprehensive, integrated legal services to many of Northeastern and Eastern Pennsylvania's largest corporations, businesses, banks, non-profits and institutions, handling matters involving labor and employment, wills, trusts and estate planning, estate administration, elder law, commercial transactions, residential and commercial real estate, zoning, land use and development, telecommunications, mediations and arbitrations, commercial litigation, title insurance, business planning and business succession, corporate/business structuring, employment discrimination law for employers, banking, creditor’s rights, finance, lender liability defense, covenants not to compete, construction law, mergers and acquisitions and other business matters.
Additional information can be found at www.HKQLaw.com or by calling (800) 760-1529.