Drug & Device News

Supreme Court Declares State Tort Claims Pre-Empted By Vaccine Act

In Bruesewitz v. Wyeth, L.L.C., No. 09-152, the U.S. Supreme Court in February held that the National Childhood Vaccine Injury Act of 1986 (NCVIA) pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine's side effects. The plaintiffs had sought compensation for their daughter, who suffered complications following the administration of a diphtheria, tetanus, and pertussis (DTP) vaccine. After they were denied compensation by the Court of Federal Claims they brought suit for tort damages in Pennsylvania. Wyeth removed the suit to the Federal District Court, which granted Wyeth summary judgment, holding that the Pennsylvania law the plaintiffs brought suit under was pre-empted by 42 U.S.C. ' 300aa-22(b)(1), which provides that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after Oct. 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” The Third Circuit affirmed, as did the Supreme Court.

Pfizer Battles Claims Brought By Unsuspecting Experiment Subjects

It has been almost 15 years since Pfizer Inc., without obtaining permission from their parents, used an experimental drug to treat Nigerian children infected with meningitis. Still, claims brought by 88 of the children's families remain in dispute, and their cases are still in the pre-trial motion phase in the U.S. District Court for the Southern District of New York. Pfizer is seeking dismissal of the actions, which it argues cannot be brought based on the Alien Tort Statute, a 1789 law that gives foreigners the right to bring tort claims in U.S. federal courts for violations of “the law of nations.” The claims were permitted to go forward in 2009 after a split panel of the U.S. Court of Appeals for the Second Circuit voted to revive the suit in its February 2009 decision in Abdullahi v. Pfizer, 562 F.3d 163 (2009). The U.S. Supreme Court declined to review the case. However, another unrelated case brought under the Alien Tort Statute was thrown out in 2010 by a different panel of the Second Circuit, with that court concluding that “corporate liability is not a discernible ' much less universally recognized ' norm of customary international law that we may apply” under the statute. Kiobel v. Royal Dutch Petroleum, 610 F.3d 111. Now, Pfizer wants the court to follow Kiobel's lead and throw the Nigerian plaintiffs' suits out. Any decision the district court makes is likely to end up before the Second Circuit again, for clarification of the issue.

Kidney Mix-Up Prompts Shut-Down of Transplant Program

The hospital at the University of Southern California discontinued its kidney transplant operations in January because of a “process error.” Although the USC University Hospital declined to identify that error, news reporting agencies were more forthcoming: The hospital had transplanted a kidney into the wrong patient. Zarembo and Girion, Los Angeles Times, 2/18/11. The patient who mistakenly received the kidney was lucky, however, because the organ turned out to be a good match. The patient for whom the kidney had been intended received another kidney several days later. California's Department of Public Health is investigating the incident.

Lawyers Before Vaccine Court Not Entitled to
Higher Compensation Scale

The U.S. Court of Appeals delivered a precedential opinion in February when it held in Rodriguez v. Secretary of Health and Human Services that lawyers handling vaccine cases are entitled to recover fees based only on the “reasonable hourly rates” of similar practitioners representing National Vaccine Injury Act claimants. The ruling affirms the decision of a special master in the U.S. Court of Federal Claims, who rejected an attorney's contention that he should be compensated based on the “Laffey Matrix,” a system used by the Department of Justice to determine payment for lawyers who successfully try complex federal cases. The special master and the Court of Appeals agreed that vaccine cases were not as difficult as those in which the Laffey Matrix is applied, because claims brought before the Vaccine Court are not subject to the same complicated procedural, discovery and evidence rules. In addition, attorneys who represent vaccine claimants are assured of compensation regardless of whether they win or lose, and whether they are skilled or unskilled legal practitioners. Gilbert Gaynor, a Santa Barbara, CA, solo practitioner who represented Rodriguez at the Federal Circuit, disagreed with the decision, pointing out that a Vaccine Act claim “may not be as procedurally complex, but it is substantively complex” because such a case “frequently involves highly complex and contested issues with medical and scientific experts on both sides.”

New Test May Help Kidney Transplant Patients

The FDA has approved a new test to monitor the success of kidney transplants in post-operative patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, an immunosuppressant given to transplant patients to help prevent rejection of their new kidneys. Because recipients of transplanted kidneys must take immunosuppressants for as long as they live, and these drugs can have harmful side effects, it is important to keep the right balance of them in each patient's system. The FDA predicts that the QMS Everolimus Immunoassay test, along with careful monitoring of clinical symptoms of organ rejection, tissue biopsies, and other lab tests, could reduce rejection of transplanted kidneys.

Supreme Court Declares State Tort Claims Pre-Empted By Vaccine Act

In Bruesewitz v. Wyeth, L.L.C., No. 09-152, the U.S. Supreme Court in February held that the National Childhood Vaccine Injury Act of 1986 (NCVIA) pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine's side effects. The plaintiffs had sought compensation for their daughter, who suffered complications following the administration of a diphtheria, tetanus, and pertussis (DTP) vaccine. After they were denied compensation by the Court of Federal Claims they brought suit for tort damages in Pennsylvania. Wyeth removed the suit to the Federal District Court, which granted Wyeth summary judgment, holding that the Pennsylvania law the plaintiffs brought suit under was pre-empted by 42 U.S.C. ' 300aa-22(b)(1), which provides that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after Oct. 1, 1988, if the injury or death resulted from side-effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” The Third Circuit affirmed, as did the Supreme Court.

Pfizer Battles Claims Brought By Unsuspecting Experiment Subjects

It has been almost 15 years since Pfizer Inc., without obtaining permission from their parents, used an experimental drug to treat Nigerian children infected with meningitis. Still, claims brought by 88 of the children's families remain in dispute, and their cases are still in the pre-trial motion phase in the U.S. District Court for the Southern District of New York. Pfizer is seeking dismissal of the actions, which it argues cannot be brought based on the Alien Tort Statute, a 1789 law that gives foreigners the right to bring tort claims in U.S. federal courts for violations of “the law of nations.” The claims were permitted to go forward in 2009 after a split panel of the U.S. Court of Appeals for the Second Circuit voted to revive the suit in its February 2009 decision in Abdullahi v. Pfizer , 562 F.3d 163 (2009). The U.S. Supreme Court declined to review the case. However, another unrelated case brought under the Alien Tort Statute was thrown out in 2010 by a different panel of the Second Circuit, with that court concluding that “corporate liability is not a discernible ' much less universally recognized ' norm of customary international law that we may apply” under the statute. Kiobel v. Royal Dutch Petroleum , 610 F.3d 111. Now, Pfizer wants the court to follow Kiobel's lead and throw the Nigerian plaintiffs' suits out. Any decision the district court makes is likely to end up before the Second Circuit again, for clarification of the issue.

Kidney Mix-Up Prompts Shut-Down of Transplant Program

The hospital at the University of Southern California discontinued its kidney transplant operations in January because of a “process error.” Although the USC University Hospital declined to identify that error, news reporting agencies were more forthcoming: The hospital had transplanted a kidney into the wrong patient. Zarembo and Girion, Los Angeles Times, 2/18/11. The patient who mistakenly received the kidney was lucky, however, because the organ turned out to be a good match. The patient for whom the kidney had been intended received another kidney several days later. California's Department of Public Health is investigating the incident.

Lawyers Before Vaccine Court Not Entitled to
Higher Compensation Scale

The U.S. Court of Appeals delivered a precedential opinion in February when it held in Rodriguez v. Secretary of Health and Human Services that lawyers handling vaccine cases are entitled to recover fees based only on the “reasonable hourly rates” of similar practitioners representing National Vaccine Injury Act claimants. The ruling affirms the decision of a special master in the U.S. Court of Federal Claims, who rejected an attorney's contention that he should be compensated based on the “Laffey Matrix,” a system used by the Department of Justice to determine payment for lawyers who successfully try complex federal cases. The special master and the Court of Appeals agreed that vaccine cases were not as difficult as those in which the Laffey Matrix is applied, because claims brought before the Vaccine Court are not subject to the same complicated procedural, discovery and evidence rules. In addition, attorneys who represent vaccine claimants are assured of compensation regardless of whether they win or lose, and whether they are skilled or unskilled legal practitioners. Gilbert Gaynor, a Santa Barbara, CA, solo practitioner who represented Rodriguez at the Federal Circuit, disagreed with the decision, pointing out that a Vaccine Act claim “may not be as procedurally complex, but it is substantively complex” because such a case “frequently involves highly complex and contested issues with medical and scientific experts on both sides.”

New Test May Help Kidney Transplant Patients

The FDA has approved a new test to monitor the success of kidney transplants in post-operative patients. The test, called QMS Everolimus Immunoassay, monitors the blood level of everolimus, an immunosuppressant given to transplant patients to help prevent rejection of their new kidneys. Because recipients of transplanted kidneys must take immunosuppressants for as long as they live, and these drugs can have harmful side effects, it is important to keep the right balance of them in each patient's system. The FDA predicts that the QMS Everolimus Immunoassay test, along with careful monitoring of clinical symptoms of organ rejection, tissue biopsies, and other lab tests, could reduce rejection of transplanted kidneys.