Patients are coming forward and alleging that a Lyme disease vaccine’s , LymeRix, arthritis risks were hidden. LymeRix is manufactured by GlaxoSmithKline LLC.
Two lawsuits were removed to Pennsylvania federal court by the drug maker this week and involve allegations that GlaxoSmithKline’s Lyme disease vaccine, LymeRix, caused treatment-resistant Lyme arthritis, said Law360. The complaint states that the plaintiffs were inoculated with LymeRix in the late 1990s and later diagnosed with post-Lyme disease treatment syndrome, also known as treatment-resistant Lyme arthritis.
The complaint also states that certain patients with a specific genetic blood trait are likelier to develop this condition and that Glaxo, which began selling LymeRix in 1998, knew about these risks, yet continued marketing LymeRix until was pulled from the market in 2002, said Law 360. “Defendants knew of the subject product’s defective and unreasonably dangerous nature … but continued to design, develop, manufacture, market, distribute, and sell it so as to maximize sales and profits at the expense of the health and safety of the public,” the complaint said.
GSK removed the complaints—which were brought by Gregory Pryslak (a New Jersey resident) and Teri Fay (a New York resident Teri Fay)—in the Philadelphia Court of Common Pleas in July, “under the pretense of diverse citizenship,” said Law 360. Although Glaxo does have offices in Philadelphia, it is incorporated in Delaware. Also, as a limited liability corporation, Glaxo’s sole member—GSK Holdings—is incorporated in Delaware. “GSK LLC was not at the time of the commencement of this action or at any time thereafter a citizen of the state of Pennsylvania,” the company said in its removal notice, said Law 360. “GSK Holdings is solely a citizen of Delaware. GSK Holdings is incorporated under Delaware law; GSK Holdings’ officers direct, control and coordinate the work of GSK Holdings primarily in Delaware; GSK Holdings’ ‘never center’ is therefore in Delaware.”
Two district court rulings did affirm Glaxo’s Delaware corporate citizenship; however, a conflicting 2011 decision found that Glaxo’s citizenship was determined by the location of the primary operations of GSK LLC in Philadelphia and not of GSK Holdings. Third Circuit is preparing to hear appeals on the issue, said Law 360. The plaintiffs’ attorney called the move a “blatant attempt to avoid having the case heard in front of traditionally sympathetic juries in Philadelphia.”
Meanwhile, the plaintiffs say that Glaxo continued to claim that LymeRix was safe and effective despite increasing adverse effect claims, said Law 360. For instance, said Law 360, Glaxo, in an attempt to prove the drug’s safety and efficacy, was dosing arthritis-prone mice with the active ingredient in the vaccine, all the while knowing that mice do not possess the trait that causes health issues in humans. “The experiment was meaningless,” the complaint said.
LymeRix was different than other vaccines, said CTV, because instead of urging the immune system to create antibodies to fight a germ, it immunized the disease’s so-called “vector”: The tick. By entering the tick as it fed on a human—which could take an entire day—LymeRix would neutralize the Lyme bacteria (B. burgdorferi) in the tick‘s gut, which would block the germ from entering the human.
After three doses the vaccine was effective in about 78 percent of the cases, according to studies; however, efficacy was unknown as the bacteria were killed in the tick, but humans did not develop immunity, explained CTV.
After the vaccine’s approval, reports began emerging about odd side effects and people developing arthritis; 905 people reported reactions with seven percent deemed serious, said CTV.