Drug & Device News

Defense Wants Judge to Remove Herself from Accutane Case

Defense attorney Michael Griffinger is asking that Judge Carol Higbee recuse herself from the ongoing New Jersey class action litigation against pharmaceuticals manufacturer Hoffmann-LaRoche. The suit alleges that consumers suffered injuries from their use of the drug Accutane, an acne medication. Griffinger's motion charges Judge Higbee with violating New Jersey's Code of Judicial Conduct Canon 5(a)(1) ' which admonishes judges to avoid conflicts of interest when carrying out their extrajudicial activities ' when she appeared at a defense lawyer organization's seminar event in New Orleans in 2012. There, according to Griffinger's motion, Judge Higbee sat on a panel that included the Accutane plaintiffs' lead counsel, and she “directly addressed [the Accutane] litigation and legal issues relevant to it.” These actions, said Griffinger in his motion papers “inexorably lead to the conclusion that the [c]ourt is no longer impartial and that its appearance of impartiality is irretrievably lost.”

Plaintiff May Test Manufacturing Facility Behind Fungal Meningitis Outbreak

In a December 2012 order, U.S. Magistrate Judge Jennifer Boal granted plaintiff Chad Green the right to conduct minimally “destructive” testing at the New England Compounding Pharmacy, the source of tainted injectable steroid products that allegedly killed or sickened hundreds of patients all over the United States. The court granted the plaintiff's motion to test walls, ductwork and other building infrastructure after he noted that time was of the essence and that delay could lead to deterioration of relevant evidence. The court imposed several limits on the gathering of such evidence, including a requirement that representatives of the U.S. Attorney's office and/or federal law enforcement personnel accompany testers, and that access to the pharmaceutical facility would be limited to four days only. In addition, Green must share the results of the tests conducted with other plaintiffs who request them, as well as with federal and state agencies that ask to see them.

Supreme Court Will Decide Gene Patenting Question

Myriad Genetics owns patents on genes that are associated with a hereditary predisposition toward development of ovarian and breast cancers. Researchers and doctors unsuccessfully challenged those patents on the basis that they concerned products of nature, but an appeals court held that the isolated genes were man-made, laboratory-produced, inventions, and thus were patentable. When the plaintiffs and their amici urged the U.S. Supreme Court to hear the appeal, they noted that continued recognition of the Myriad patents will hamper research that could lead to life-saving cures. The Court granted certiorari on Nov. 30, 2012, and will now consider the question whether human genes are patentable.

Property Forfeiture Hearings Begin for Medical Marijuana Dispensary

On Dec. 20, 2012, in a crowded San Francisco courtroom, a number of players with differing agendas filled the seats while the U.S. Magistrate Judge Maria-Elena James heard the first arguments in a closely watched case involving the sale of medical marijuana. The medical marijuana dispenser, Harborside Health Center, operates out of two leased properties, one in Oakland and the other in San Jose. The business is legally operating under California law, but federal law continues to classify marijuana as an illegal drug, no matter what it is used for. In July of last year federal prosecutors moved to seize the leased properties Harborside occupies, claiming they are being used for the purpose of selling illegal drugs. That action prompted the City of Oakland to file suit against the federal government under the Administrative Procedure Act, alleging federal officials promised not to enforce federal drug laws against California entities that acted in accordance with State law, and then went back on that promise. The City of Oakland claims this “new” federal government tactic will deprive it of approximately $1.4 million in tax revenues each year. At the Dec. 20 hearing, Kathryn Wyer, a Justice Department lawyer, asserted that Oakland lacked standing to interfere in the case, and that allowing the city to do so “would overturn the entire forfeiture scheme.” For their part, Harborside's landlords asked the Judge to order a stop to sales of marijuana at their properties because, as Paul Avilla, lawyer for Concourse Business Center in San Jose, put it, “the very ownership of their property is being threatened.”

Assistant U.S. Attorney Arvon Perteet, who is handling the forfeiture issue for the U.S. Attorney's Office, offered tepid hope to Harborside, saying that by moving to seize the properties the government sought only to stop their illegal operation, not put them out of business: “They can sell popcorn there [at the leased premises]. They can sell candy there.”

Judge James reserved her first rulings until Jan. 8, when she declined to order a stop to the sale of marijuana at the lease premises at the landlords' request. Instead, she said, the federal government must make that appeal, as it is the government, not private citizens, who are charged with enforcing federal drug laws. “Claimants are attempting to use a procedural rule in a civil forfeiture proceeding to bring what amounts to an enforcement action under the [Controlled Substances Act] against Harborside,” James wrote. “This is a measure which the government ' the entity charged with enforcing the statute ' has elected not to pursue.” The court also noted that the leases between the landlords and Harborside had clearly stated the type of business that was going to be operated on each property, the contracts were valid and had not been breached.

Therefore, wrote James, “While the court understands claimants' concern over the potential forfeiture of their properties,” the landlords were not entitled to invoke federal drug laws to “sever business relationships when they suddenly prove risky or to demonstrate cooperation with the government.”

Supreme Court to Clarify Class Action Fairness Act

In a case whose outcome will affect drug companies, which are frequently the targets of class action lawsuits, the U.S. Supreme Court is considering whether plaintiffs may permissibly manipulate the amount in controversy in order to keep their cases in state courts. Congress enacted the Class Action Fairness Act in 2005, which allows defendants in class action lawsuits to removed cases against them to federal court if, among other things, the plaintiff class has more than 100 members and the amount in controversy is over $5 million. The terms of the law seem to indicate that plaintiff attorneys could keep lawsuits in state court by limiting the number of class members ' perhaps by breaking up those members into separate groups ' or by keeping the amount in controversy artificially low. While similar gambits are often used when deciding how to frame all sorts of lawsuits, the Supreme Court is being asked to decide if the letter of the law is paramount, or whether one of Congress' intentions in passing the Class Action Fairness Act ' to prevent plaintiffs from forum shopping by bringing large national lawsuits in plaintiff-friendly jurisdictions ' should rule.

Defense Wants Judge to Remove Herself from Accutane Case

Defense attorney Michael Griffinger is asking that Judge Carol Higbee recuse herself from the ongoing New Jersey class action litigation against pharmaceuticals manufacturer Hoffmann-LaRoche. The suit alleges that consumers suffered injuries from their use of the drug Accutane, an acne medication. Griffinger's motion charges Judge Higbee with violating New Jersey's Code of Judicial Conduct Canon 5(a)(1) ' which admonishes judges to avoid conflicts of interest when carrying out their extrajudicial activities ' when she appeared at a defense lawyer organization's seminar event in New Orleans in 2012. There, according to Griffinger's motion, Judge Higbee sat on a panel that included the Accutane plaintiffs' lead counsel, and she “directly addressed [the Accutane] litigation and legal issues relevant to it.” These actions, said Griffinger in his motion papers “inexorably lead to the conclusion that the [c]ourt is no longer impartial and that its appearance of impartiality is irretrievably lost.”

Plaintiff May Test Manufacturing Facility Behind Fungal Meningitis Outbreak

In a December 2012 order, U.S. Magistrate Judge Jennifer Boal granted plaintiff Chad Green the right to conduct minimally “destructive” testing at the New England Compounding Pharmacy, the source of tainted injectable steroid products that allegedly killed or sickened hundreds of patients all over the United States. The court granted the plaintiff's motion to test walls, ductwork and other building infrastructure after he noted that time was of the essence and that delay could lead to deterioration of relevant evidence. The court imposed several limits on the gathering of such evidence, including a requirement that representatives of the U.S. Attorney's office and/or federal law enforcement personnel accompany testers, and that access to the pharmaceutical facility would be limited to four days only. In addition, Green must share the results of the tests conducted with other plaintiffs who request them, as well as with federal and state agencies that ask to see them.

Supreme Court Will Decide Gene Patenting Question

Myriad Genetics owns patents on genes that are associated with a hereditary predisposition toward development of ovarian and breast cancers. Researchers and doctors unsuccessfully challenged those patents on the basis that they concerned products of nature, but an appeals court held that the isolated genes were man-made, laboratory-produced, inventions, and thus were patentable. When the plaintiffs and their amici urged the U.S. Supreme Court to hear the appeal, they noted that continued recognition of the Myriad patents will hamper research that could lead to life-saving cures. The Court granted certiorari on Nov. 30, 2012, and will now consider the question whether human genes are patentable.

Property Forfeiture Hearings Begin for Medical Marijuana Dispensary

On Dec. 20, 2012, in a crowded San Francisco courtroom, a number of players with differing agendas filled the seats while the U.S. Magistrate Judge Maria-Elena James heard the first arguments in a closely watched case involving the sale of medical marijuana. The medical marijuana dispenser, Harborside Health Center, operates out of two leased properties, one in Oakland and the other in San Jose. The business is legally operating under California law, but federal law continues to classify marijuana as an illegal drug, no matter what it is used for. In July of last year federal prosecutors moved to seize the leased properties Harborside occupies, claiming they are being used for the purpose of selling illegal drugs. That action prompted the City of Oakland to file suit against the federal government under the Administrative Procedure Act, alleging federal officials promised not to enforce federal drug laws against California entities that acted in accordance with State law, and then went back on that promise. The City of Oakland claims this “new” federal government tactic will deprive it of approximately $1.4 million in tax revenues each year. At the Dec. 20 hearing, Kathryn Wyer, a Justice Department lawyer, asserted that Oakland lacked standing to interfere in the case, and that allowing the city to do so “would overturn the entire forfeiture scheme.” For their part, Harborside's landlords asked the Judge to order a stop to sales of marijuana at their properties because, as Paul Avilla, lawyer for Concourse Business Center in San Jose, put it, “the very ownership of their property is being threatened.”

Assistant U.S. Attorney Arvon Perteet, who is handling the forfeiture issue for the U.S. Attorney's Office, offered tepid hope to Harborside, saying that by moving to seize the properties the government sought only to stop their illegal operation, not put them out of business: “They can sell popcorn there [at the leased premises]. They can sell candy there.”

Judge James reserved her first rulings until Jan. 8, when she declined to order a stop to the sale of marijuana at the lease premises at the landlords' request. Instead, she said, the federal government must make that appeal, as it is the government, not private citizens, who are charged with enforcing federal drug laws. “Claimants are attempting to use a procedural rule in a civil forfeiture proceeding to bring what amounts to an enforcement action under the [Controlled Substances Act] against Harborside,” James wrote. “This is a measure which the government ' the entity charged with enforcing the statute ' has elected not to pursue.” The court also noted that the leases between the landlords and Harborside had clearly stated the type of business that was going to be operated on each property, the contracts were valid and had not been breached.

Therefore, wrote James, “While the court understands claimants' concern over the potential forfeiture of their properties,” the landlords were not entitled to invoke federal drug laws to “sever business relationships when they suddenly prove risky or to demonstrate cooperation with the government.”

Supreme Court to Clarify Class Action Fairness Act

In a case whose outcome will affect drug companies, which are frequently the targets of class action lawsuits, the U.S. Supreme Court is considering whether plaintiffs may permissibly manipulate the amount in controversy in order to keep their cases in state courts. Congress enacted the Class Action Fairness Act in 2005, which allows defendants in class action lawsuits to removed cases against them to federal court if, among other things, the plaintiff class has more than 100 members and the amount in controversy is over $5 million. The terms of the law seem to indicate that plaintiff attorneys could keep lawsuits in state court by limiting the number of class members ' perhaps by breaking up those members into separate groups ' or by keeping the amount in controversy artificially low. While similar gambits are often used when deciding how to frame all sorts of lawsuits, the Supreme Court is being asked to decide if the letter of the law is paramount, or whether one of Congress' intentions in passing the Class Action Fairness Act ' to prevent plaintiffs from forum shopping by bringing large national lawsuits in plaintiff-friendly jurisdictions ' should rule.