Manufacturer liability, vaccines

The remaining vaccinia vaccine licensed in the United States (Dryvax, manufactured by Wyeth, Philadelphia, Pa.) is a live, infectious virus prepared from calf lymph. Like all smallpox vaccines that were marketed in the United States, it derived from the NYCBOH strain and contains 108 plaque-forming units per milliliter. Current vaccinia vaccine stocks (> 12 million doses) are held by the CDC. It must be noted that the potency of several lots of this lyophilized vaccine has fallen. Pharmaceutical companies in the United States lack interest in manufacturing new lots of vaccine, owing to the absence of a profitable retail market, antiquation of calf-lymph production techniques and facilities, and the manufacturer s legal liability for vaccination complications. 

A recently filed case in Pennsylvania illustrates a possible new face for liability (Cassidy v. SmithKline Beecham, 1999). The plaintiff claims that the manufacturer of a vaccine for Lyme disease should have warned physicians and patients in its advertisements that 30% of the population ran the risk of developing "treatment-resistant Lyme arthritis" because their particular genotype interacted adversely with the vaccine. This duty to warn is based not in product liability doctrine, but on negligence. 

After a suspected case of the 1918 Spanish flu vims (which, in a global pandemic during World War I, affected half the world s population and killed almost 25 million people in 18 months) was identified in 1976, Congress passed the National Swine Flu Immunization Program, releasing manufacturers from the liability, so that a flu vaccine... 

Vaccine liability issues were also covered in Section 304 of the Homeland Security Act (HSA) of 2002as amended in April 2003, in which Congress enacted liability protection for manufacturers of smallpox vaccines. Vaccine liability can be handled in four different ways the government can substitute itself as the defendant, it can decide nobody need be liable and provide no-fault compensation, it can indemnify manufacturers after they have been sued and lost, or it can alter the normal rules of litigation. In the HSA, the government substitutes itself as the defendant if the HHS Secretary declares an actual or potential bioterrorist incident or other actual or potential public health emergency makes advisable the administration of a covered countermeasure," such as a vaccine. Secretary Tommy Thompson issued the first such declaration on January 24, 2003. 

The HSA states, however, that "covered countermeasures" apply only to smallpox vaccines at this time, and although HSA protects manufacturers and others against liability, it does not directly set forth compensation procedures for vaccine recipients. Under Part C of the HSA, compensation for death benefits is capped at 262,100. If a case does end up in court, the plaintiff must "prove culpability equal to or rising above the level of negligence." It seems assured that the history of vaccine regulations and litigations will continue to change for some hme to come. The swine flu and other vaccine-related ADRs are discussed further in Section 28.4.4.1. 

Adverse events secondary to vaccine products have inspired lawsuits against vaccine manufacturers. Two theories of tort (duties created by law regarding professional conduct) are reviewed when litigation against a vaccine manufacturer ensues. The first regards safe vaccine development, with a vaccine manufacturer strictly liable for defective vaccine products. Liability cases involving defective vaccines rarely occur, and manufac-... 

The VICP largely replaces traditional tort law for deciding vaccine-related injuries and was designed to stabilize the vaccine market by decreasing liability costs of manufacturers and health care providers and to ease reward recovery by eligible claimants... 

The National Child Vaccine Injury Act of 1986 was passed by the U.S. Congress in response to reports of vaccine side effects and liability concerns of vaccine manufacturers and health care providers. With vaccine safety being questioned and manufacturers ceasing the development and marketing of vaccines, the National Vaccine Injury Compensation Program was instituted to offer a no-fault alternative... 

Because most vaccine manufacturers also produce pharmaceuticals, the behavior of firms responding to vaccine liability claims may be similar to their likely behavior in the face of pharmaceutical liability claims. 

The Federal Government has attempted to absorb some of the product liability faced by vaccine manufacturers, potentially offering... 

Although vaccines can bean effective and cost-saving means of preventing diseases, manufacturers of these drugs have been the subject of many liability cases. 

Although claimants may still choose to pursue compensation, this statute essentially constitutes Federal tort reform for eligible childhood vaccine-related injuries. By establishing a no-fault compensation scheme as the first form of redress for injuries and limiting liability for manufacturers who have met FDA requirements, Congress has, in essence, nullified case law that had previously allowed liability findings based on theories of... 

---