Merck Opposes Centralization of Gardasil Vaccine Injury Lawsuits

Although a growing number of families and young adults are pursuing Gardasil lawsuits in different U.S. District Courts nationwide, each raising similar allegations that the HPV vaccine caused severe auto-immune problems and other injuries, Merck & Co. indicates that it is opposed to centralizing and consolidating the litigation before one judge in the federal court system.

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 lawsuits have been brought against Merck, indicating that side effects of the HPV vaccine 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.

Last month, 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.

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. Centralizing the claims is intended to reduce duplicative discovery into common issues that will arise in the litigation, avoid conflicting schedules and pretrial rulings, and serve the convenience of common witnesses, lawyers and the judicial system.

In response to the request, Merck filed an opposition to consolidation (PDF) on May 20, saying the JMPL should not entertain the creation of a Gardasil MDL because Gardasil injury claims did not proceed through the Vaccine Court, which is a court specifically for complaints about vaccines designed to shield manufacturers from liability in return for the allegedly low financial returns they get by providing millions of vaccines to the country.

“The Vaccine Court—created by Congress as part of the Vaccine Act—already provided each of the Plaintiffs in the Subject Actions with a no-fault forum to receive compensation for their alleged injuries,” the motion states. “Yet, none of these current Plaintiffs mustered causation evidence sufficient to recover a single dollar of compensation in Vaccine Court for the injuries they attribute to Gardasil.”

Merck also claims the types of injuries listed and circumstances makes the cases too individual to benefit from consolidation for pretrial proceedings.

Plaintiffs disagree, and more have filed motions supporting the Gardasil vaccine injury lawsuit consolidation in the federal court system.

“Although the facts pertaining to individual plaintiffs will vary, the Subject Actions present common, complex factual issues related to the clinical trials, regulatory approval, manufacturing, pharmacovigilance, labeling and marketing of Gardasil and Merck’s knowledge of the vaccine’s adverse effects,” according to a motion in support of consolidation (PDF) filed on May 23 by plaintiff Cooper Humpries. “Coordination of pretrial proceedings is necessary to avoid duplicative discovery, unduly burdensome discovery obligations, and inconsistent rulings on pretrial motions. Centralization will preserve resources of the parties, counsel, and the judiciary.”

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.