Gardasil Lawsuits Warrant Centralization After Vaccine Court Proceedings, Plaintiffs Argue

A group of plaintiffs who have filed Gardasil lawsuits in the federal court system are pushing back against Merck’s claims that the litigation should not be consolidated before one judge for pretrial proceedings, calling the vaccine manufacturer’s arguments against centralization “nonsense.”

Gardasil was first introduced in 2006, as a vaccine for prevention of HPV infections, which can be sexually transmitted and lead to the later development of cervical cancer.

Following years of marketing by the drug maker that suggested the vaccine was safe and effective, the injection has been widely recommended for young girls and boys before adolescence and potential sexual activity, since it was thought to carry few, if any, serious side effects.

In recent years, dozens of Gardasil HPV vaccine lawsuits have been brought against Merck, indicating that side effects caused teens and young adults to develop postural orthostatic tachycardia syndrome (POTS), autoimmune disorders, neurological side effects and other complications. Plaintiffs claim that Merck failed to adequately research the product before aggressively marketing it for use among children nationwide, and withheld important safety information from families and the medical community.

In April, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML), calling for all Gardasil vaccine injury lawsuits to be centralized in either the District of Arizona or the Western District of Wisconsin, as part of a federal multidistrict litigation (MDL). The motion indicated there are at least 34 different lawsuits pending in 25 different federal courts nationwide, and Gardasil lawyers indicate that number is likely to increase significantly in the coming weeks and months.

In response to the motion, Merk filed a brief in opposition to the consolidation last month, urging the JPML should not consolidate the cases because Gardasil injury claims, arguing that the claims first must proceed through the Vaccine Court, which is specifically for complaints involving vaccines injuries. However, the process has largely shielded manufacturers from liability in return for the allegedly low financial returns they get by providing millions of vaccines to the country.

Plaintiffs filed a response brief (PDF) last week, indicating that Merck’s objections were without merit, and that it is appropriate for the federal Gardasil litigation to be centralized for pretrial proceedings, as individuals file lawsuits after going through the administrative Vaccine Court process.

“Merck seems to suggest the sole purpose of the Vaccine Act was to limit lawsuits against vaccine manufacturers. To the contrary, the goal of the Vaccine Act was to ensure that children get vaccinated,” according to the plaintiffs’ brief. “Preventing an MDL here, solely because Gardasil is subject to the Vaccine Act compensation, would not only run afoul of Congress’ purpose for establishing the Vaccine Act, but would also run afoul of Congress’ intent to promote just and efficient resolution of related proceedings through coordinated pretrial proceedings.”

Plaintiffs indicate the Merck is attempting to distract the Court by casting the litigation as a part of an “anti-vaxxer” movement, and specifically targeted attorney Robert F. Kennedy, Jr., nephew of late President John F. Kennedy, and son of his brother, the late Robert F. Kennedy, who has been critical of vaccine policies and is an attorney representing some plaintiffs in the Gardasil litigation.

“These cases are about one vaccine, Gardasil. Indeed, the safety concerns regarding Gardasil were not raised by Mr. Kennedy or ‘anti-vaxxers,’ but by scientists in the peer reviewed literature,” the response brief states. “And, to suggest all the involved plaintiffs’ lawyers are blindly following Mr. Kennedy, with their time, money, and resources, ostensibly making up meritless claims, is nonsense.”

The plaintiffs note that the litigation involves multiple plaintiffs, represented by many different attorneys across the country, involving the same vaccine and the same or similar injuries, which should be grounds enough for consolidation, which is common in complex product liability litigation where large numbers of cases are pending before different judges that involve similar injuries caused by the same product.

The U.S. JPML is expected to consider oral arguments on the motion, including any response filed by the drug maker, during a hearing this summer. The panel will then determine whether centralized management is appropriate at this early stage of the litigation, and the most appropriate forum for the pretrial proceedings.