The United States Supreme Court heard arguments recently in a case that is expected to have significant implications for hundreds of pending lawsuits against vaccine makers. In these suits, various plaintiffs contend there is a link between childhood vaccines and autism. While the case presently before the Supreme Court does not involve a claim that autism was caused by a childhood vaccination, a recent article
in The New York Times
states that approximately 75 percent of similar claims do involve the disorder. This alleged association has been a hot-button issue for years, as repeated scientific studies have found no connection between vaccines and autism.
SCOTUSblog has previously set forth the particulars of this case, which is styled Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3rd Cir. 2009) (see the Third Circuit Court of Appeals’ order here, from which Plaintiffs appealed). Essentially, the case calls into question whether the National Childhood Vaccine Injury Act (NCVIA) should protect manufacturers from virtually all product liability lawsuits. The NCVIA, established by Congress in 1986, provides that vaccine manufacturers cannot be sued for injuries from vaccines if the injuries resulted from side effects that were “unavoidable.” Elsewhere in the Act, Congress also created an administrative process known as the “Vaccine Court,” which was designed to provide money to children injured by vaccines. Accordingly, the law would preempt such claims in state court. This was critical, Congress believed, because vaccine manufacturers otherwise might have gone bankrupt due to judgments against them and would be unable to make vaccines critical to public health.
Hannah Bruesewitz, the plaintiff in the present case, is an 18-year-old woman who suffered seizures when she was six months old and subsequently suffered developmental problems, according to her parents, after receiving a type of D.T.P. vaccine
that is no longer sold. Bruesewitz’s parents initially brought a claim on her behalf in Vaccine Court, but the severe injuries she reported had been removed from the list of those that qualified for compensation. Her claim was thus rejected, and her parents subsequently filed a product liability lawsuit against Wyeth. Lower courts ruled that her claims were barred by the Vaccine Act.
The parties disagree
about the meaning of the statutory language of the Vaccine Act. The plaintiffs argue that if the vaccine could have been manufactured in a safer way, Hannah Bruesewitz’s injury was not “unavoidable.” They have argued that the manufacturer knew at the time their daughter was immunized that there was a safer version of D.T.P. vaccine but did not produce it. According to The New York Times
, Bruesewitz’s father has said that he and his wife are not opposed to vaccines, but they have pressed their daughter’s claim because they believe vaccine manufacturers needed to face the threat of litigation to produce safer medications.
Wyeth, for its part, argued that the only types of claims that are not preempted are those alleging manufacturing defects or a failure to warn. A number of Amicus Briefs were filed
in support of each party. Those arguing that Congress intended to bar such claims were filed by the solicitor general of the United States, the Chamber of Commerce, and several professional medical groups including the American Academy of Pediatrics. This case certainly will be one to watch. It likely will have huge implications both as to a number of lawsuits filed and to be filed, and within the drug manufacturing industry in general. This case before the Supreme Court has become a true battle of the experts, with constitutional law heavy-hitters weighing in on both sides of the issue.
The debate regarding the alleged vaccine-autism link is sure to rage on. In spite of the numerous scientific studies showing no such causal link, CNN reports
that one in four parents is concerned that vaccines cause autism. The report points out that parents simply are refusing to have their children vaccinated due to unreasonable fears, which can cause a resurgence of preventable diseases.