Gardisil Vaccines Recalled for Broken Glass

The Centers for Disease Control and Prevention (CDC) recently issued a media statement informing hospitals and patients that at least one lot of the Gardasil HPV vaccine has been recalled due to glass contamination. Gardasil’s manufacturer, Merck, voluntarily recalled over 743,000 shipments, which went out between August 20 and October 9, 2013. Gardasil attorneys at Pintas & Mullins Law Firm are currently reviewing cases of serious injury caused by broken glass in vaccine vials.

The recalled Gardasil vials can be identified by lot number J007354. Since the vaccines were shipped out starting in August, it is likely that some patients have already received injections potentially contaminated with broken glass shards. Merck contends the contamination occurred during the manufacturing process.

Fortunately, to date, only mild reactions have been reported by Gardasil patients, such as redness and swelling around the injection site. Clinicians who see any type of negative reaction from the vaccine should report the event to the Vaccine Adverse Event Reporting System (VAERS), found here. The CDC has been pushing clinicians to increase HPV vaccination among boys and girls aged 11 and 12, which has been met with some controversy.

About 79 million Americans have HPV, with some 14 million new infections every year. Gardasil (along with another similar vaccine, Cervarix) is administered in a three-shot series to protect against four types of HPV, which can cause several types of cancer in both men and women. The most serious side effects from the vaccine include fainting, generalized weakness, and unusual neurological symptoms. There have been a few dozen deaths linked to Gardasil on VAERS, however, none can be conclusively linked to the vaccine itself.

Gardasil contains synthetic protein particles and aluminum, which is supposed to protect patients against HPV, however, the exact mechanism is unknown. The vaccine was fast-tracked into American markets in 2006 despite being tested in less than 1,200 girls under the age of 16, so it is currently unknown if the vaccine can protect against HPV long-term.

One hundred years before Gardasil’s introduction, the U.S. Supreme Court ruled in Jacobson v. Massachusetts that it was within the power of each state to enact a required vaccination law. This decision was based on the benefits of the smallpox vaccine, which Massachusetts wished to require all residents to receive. SCOTUS agreed, with the exception of children with a physician-signed certificate noting they were unfit for vaccination.

There is intense debate among state legislatures on whether or not to require school-aged students to receive an HPV vaccine, as the virus is believed to cause virtually all cases of cervical cancer, and there is no cure for the infection. In the U.S., about 3,700 women die each year from cervical cancer, and it is the second leading killer of women throughout the world.

42 states have now introduced legislation to either require the vaccine or fund educational efforts on HPV. About 2 of those states enacted such legislation. New Hampshire provides the vaccination free of charge, and Virginia requires the HPV vaccine for all female students entering the sixth grade.

Vaccination attorneys at Pintas & Mullins Law Firm remind patients injured by recalled or dangerous drugs that you may recover damages for your time away from work, medical bills and other expenses. We have over two decades of experience working with these types of cases, and offer free legal evaluations to potential clients nationwide.

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