Gardasil Injury Lawsuits Consolidated for Pretrial Proceedings in Federal Court System

Federal judges rejected arguments by Merck that consolidating Gardasil injury lawsuits would conflict with the Vaccine Act and promote vaccine hesitancy

Given common questions of fact and laws raised in a growing number of Gardasil injury lawsuits, which have been filed by young adults and teens nationwide left with debilitating injuries after receiving the HPV vaccine, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has decided to centralize and consolidate the cases before one judge for pretrial proceedings.

Merck currently faces dozens of complaints pending in at least 22 different federal courts nationwide, each involving allegations that the drug maker failed to disclose side effects of the HPV vaccine which may cause teens and young adults to develop severe autoimmune disorders, postural orthostatic tachycardia syndrome (POTS), neurological problems and other complications.

Gardasil has been widely recommended for all teens in recent years, as a vaccination to protect against HPV infections that can be sexually transmitted later in life, leading to the development of cervical cancer. However, plaintiffs allege Merck withheld important safety information from families and the medical community while promoting and pushing the wider use of their vaccine among children nationwide.

In April, a group of plaintiffs filed a motion with the U.S. JPML, calling for all Gardasil injury lawsuits to be centralized before one judge to avoid conflicting pretrial rulings, duplicative discovery and other problems associated with nearly identical claims proceeding separately in different courts.

Although it is widely expected that the size and scope of the litigation will increase in the coming months and years, as Gardasil lawyers continue to investigate and file additional claims, Merck filed a brief opposing consolidation of the HPV vaccine lawsuits last month, since the claims must first proceed through a Vaccine Court established specifically for injuries caused by vaccines administered in the U.S.

Following the presentation of oral arguments late last month, the U.S. JPML issued a transfer order (PDF) on August 4, deciding that the Gardasil injury lawsuits do warrant consolidated management at this stage, and determining that the pretrial proceedings should be handled by U.S. District Judge Robert J. Conrad, Jr. in the Western District of North Carolina.

The order addressed several of Merck’s contention that the lawsuits were barred by the Vaccine Act, would result in a flood of meritless claims, and would spread misinformation regarding vaccines and vaccine hesitancy.

“None of these arguments persuades us that centralization is not warranted,” the JPML states in the order, indicating that “concerns about the efficient functioning of the Vaccine Court and vaccine hesitancy are properly raised elsewhere; the questions before us are whether the actions involve common questions of fact and whether centralization of this litigation will serve the convenience of the parties and witnesses and produce efficiencies for the litigants and the judiciary.”

Gardasil Side Effects

Since its introduction, concerns about Gardasil vaccine problems emerged after one of the lead researchers responsible for developing the HPV vaccine, Dr. Diane Harper, indicated the drug’s protection may only last a few years, suggesting that the risks may outweigh the benefits.

Dr. Harper reportedly said at a conference in 2009, that while Gardasil was tested on 15 year old girls, it is commonly being given to girls as young as nine years old. She has called for more detailed warnings to parents about the Gardasil risks and to provide additional information about the unknown long-term benefits for girls who are not likely to be sexually active for several years.

Many health experts strongly support the use of Gardasil, indicating any risks are negligible and claims made by those concerned about vaccinations are often not scientifically supported.

The National Cancer Institute has heralded the HPV vaccine, saying that widespread use could reduce cervical cancer deaths worldwide by as much as two-thirds. Many also suggest men get the vaccine as well in order to promote “herd immunity,” which occurs when a large enough portion of the population is vaccinated against a particular disease that they act as a firewall, preventing that disease’s spread even to those who are not vaccinated.

In complex product liability litigation, where a large number of claims are filed throughout the federal court system by individuals who suffered similar injuries as a result of the same or similar products, it is common for the federal court system to centralize the litigation for pretrial proceedings.

As part of the coordinated management of the Gardasil lawsuits, it is expected that Judge Conrad will establish a bellwether process, where small groups of representative vaccine injury claims will go through case-specific discovery and be prepared for early trial dates, to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation. However, if Gardasil injury settlements are not reached during the MDL proceedings, each case may later be remanded back to the U.S. District Court where it was originally filed for separate trials.