Drug & Device News

In Consumer Product Cases, Little Contact Needed for NJ Jurisdiction

Writing that “[a] state has a strong interest in protecting its citizens from defective products, whether those products are toys that endanger children, tainted pharmaceutical drugs that harm patients, or workplace machinery that causes disabling injuries to employees,” Justice Barry Albin of the New Jersey Supreme Court announced in Nicastro v. McIntyre Machinery America Ltd, A-29-08, that product liability suits can be pursued in New Jersey state courts against foreign manufacturers whose only contact with the state is that one of their products is sold there through an independent distributor. All that is required to invoke this stream-of-commerce-based jurisdiction is for the foreign manufacturer to know of (or be reasonably be expected to have been aware of) the fact that its product would likely be distributed in the United States, to include the forum state of New Jersey.

The Nicastro case involved not a pharmaceutical product but an industrial machine, which severed a worker's fingers while he was on the job. However, the ruling opens the door for similar outcomes in medical device and pharmaceuticals litigations. Justice Albin, writing for the 5-2 majority in Nicastro, said that given the nature of modern international commerce and New Jersey's long-arm rule, there was no reason a foreign manufacturer should expect to be let off the hook just because its contacts with New Jersey are minimal. Wrote Albin, “The increasingly fast-paced globalization of the world economy has removed national borders as barriers to trade. Due process permits this State to provide a jurisdictional forum for its citizens who are injured by dangerous and defective products placed in the stream of commerce by a foreign manufacturer that has targeted a geographical market that includes New Jersey.”

Justice Helen Hoens, in a dissent joined by Justice Roberto Rivera-Soto, said the majority's decision was a “radical departure” from established principles of due process. In a separate dissent, Rivera-Soto suggested the U.S. Supreme Court should consider the case for review.

The Lancet Withdraws Article on MMR/Autism Study

Esteemed British Medical Journal The Lancet in February issued a retraction of a study it published in 1998 linking the MMR (measles, mumps, rubella) vaccination with the onset of autism symptoms. The reason for the withdrawal was that the researchers allegedly did not disclose that they received some of the financing for their study indirectly from the parents of autistic children. Such parents would have had an interest in finding a cause-and-effect relationship between the vaccine and autism. The publication was also concerned that the 12 children who were the subjects of the study were subjected to invasive procedures that may not have been undertaken for the well-being of the children, and those procedures were carried out without the prior approval of ethics watchdogs.

FDA Asks for More Funding

For 2011, the U.S. Food and Drug Administration (FDA) has asked the federal government to give it an additional 23% over what it received in the 2010 budget. The $4.03 billion requested would be used to promote improvements in public health, to include enhancing the oversight of medical product safety. “The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day,” says FDA Commissioner Margaret A. Hamburg, MD.

In Consumer Product Cases, Little Contact Needed for NJ Jurisdiction

Writing that “[a] state has a strong interest in protecting its citizens from defective products, whether those products are toys that endanger children, tainted pharmaceutical drugs that harm patients, or workplace machinery that causes disabling injuries to employees,” Justice Barry Albin of the New Jersey Supreme Court announced in Nicastro v. McIntyre Machinery America Ltd, A-29-08, that product liability suits can be pursued in New Jersey state courts against foreign manufacturers whose only contact with the state is that one of their products is sold there through an independent distributor. All that is required to invoke this stream-of-commerce-based jurisdiction is for the foreign manufacturer to know of (or be reasonably be expected to have been aware of) the fact that its product would likely be distributed in the United States, to include the forum state of New Jersey.

The Nicastro case involved not a pharmaceutical product but an industrial machine, which severed a worker's fingers while he was on the job. However, the ruling opens the door for similar outcomes in medical device and pharmaceuticals litigations. Justice Albin, writing for the 5-2 majority in Nicastro, said that given the nature of modern international commerce and New Jersey's long-arm rule, there was no reason a foreign manufacturer should expect to be let off the hook just because its contacts with New Jersey are minimal. Wrote Albin, “The increasingly fast-paced globalization of the world economy has removed national borders as barriers to trade. Due process permits this State to provide a jurisdictional forum for its citizens who are injured by dangerous and defective products placed in the stream of commerce by a foreign manufacturer that has targeted a geographical market that includes New Jersey.”

Justice Helen Hoens, in a dissent joined by Justice Roberto Rivera-Soto, said the majority's decision was a “radical departure” from established principles of due process. In a separate dissent, Rivera-Soto suggested the U.S. Supreme Court should consider the case for review.

The Lancet Withdraws Article on MMR/Autism Study

Esteemed British Medical Journal The Lancet in February issued a retraction of a study it published in 1998 linking the MMR (measles, mumps, rubella) vaccination with the onset of autism symptoms. The reason for the withdrawal was that the researchers allegedly did not disclose that they received some of the financing for their study indirectly from the parents of autistic children. Such parents would have had an interest in finding a cause-and-effect relationship between the vaccine and autism. The publication was also concerned that the 12 children who were the subjects of the study were subjected to invasive procedures that may not have been undertaken for the well-being of the children, and those procedures were carried out without the prior approval of ethics watchdogs.

FDA Asks for More Funding

For 2011, the U.S. Food and Drug Administration (FDA) has asked the federal government to give it an additional 23% over what it received in the 2010 budget. The $4.03 billion requested would be used to promote improvements in public health, to include enhancing the oversight of medical product safety. “The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day,” says FDA Commissioner Margaret A. Hamburg, MD.