Drug & Device News

Pre-Emption Case: ChiefJustice Will Sit This One Out

The U.S. Supreme Court has agreed to review the holding in Brueswitz v. Wyeth, but Chief Justice John Roberts Jr. will not take part. Justice Roberts also was not involved in the decision to hear the case, which asks whether children who claim they are injured by vaccines may take their cases to state court with claims of design defects after losing in the Vaccine Court. A panel of the U.S. Court of Appeals for the Third Circuit last year held in Brueswitz that an injured child's right to bring such suits was pre-empted by the1986 National Childhood Vaccine Injury Act. Justice Roberts' reason for recusal is undoubtedly related to his ownership of stock in Pfizer Inc., which took over Wyeth last year.

Advising FDA Committees When Conflicts of Interest Exist

The FDA has issued a new draft guidance concerning the waiver of rules designed to prevent medical experts with conflicts of interest from participating at FDA advisory committee meetings. If such a waiver were sought, its propriety would be evaluated under the guidelines through a three-step inquiry. First, the nature of the conflict would be evaluated. If it were found to be minimal ' such as when a researcher works at an institution that receives grants from the company whose drug is being evaluated, but when he himself does not participate in those studies ' a waiver would more likely be granted. Second, the type of advice the expert would be asked to provide is important. For example, a waiver might be more likely if the expert were needed to testify concerning a policy issue affecting a class of products, rather than a specific product. And, finally, under the draft guidelines, a waiver would be more apt to be granted if a substitute expert without a conflict of interest could not be found.

Lawyer's Claim for Profits from Sale of Thalidomide May Go Forward

A lawyer who says she gave pharmaceuticals company Celgene the idea for using thalidomide as a cancer treatment will be permitted to pursue her claim that the company owes her $300 million. The attorney, Beth Jacobson, says the company reneged on a promise to reward her for her insights, which led to the sale of the notorious birth-defect-causing morning-sickness drug for the treatment of cancer.

In 1995, Jacobson, who had worked at New York's Skadden, Arps, Slate, Meagher & Flom for 15 years, quit her job in order to search for a treatment for her husband, who had been diagnosed with the always fatal cancer multiple myeloma. Jacobson consulted with Dr. Judah Folkman, a well-respected cancer researcher who had studied the use of thalidomide in treating childhood leukemia. Dr. Folkman suggested Jacobson contact Celgene, which held licenses to distribute thalidomide for the treatment of certain illnesses, such as leprosy. The suit says that Jacobson asked Celgene to supply thalidomide for her husband's treatment. Unfortunately, although he received the drug, Jacobson's husband died. However, another patient at the facility where Jacobson's husband was treated heard of the thalidomide therapy and requested it. That patient survived, leading Celgene to conduct successful clinical trails that led to the marketing of thalidomide for the treatment of early-stage multiple myeloma.

While the company acknowledged Jacobson's contributions by suggesting that she take a seat on its board of directors and sponsoring a gala at which she was given the International Myeloma Foundation Courage Award, it did not cut her in for a share of the profits. The suit claims Celgene's chief executive officer inferred to Jacobson that she would receive such compensation. Her suit, which claims Celgene has been unjustly enriched through its misappropriation of her idea, seeks a share of past and future profits.

FDA Issues Warning About 14 External Defibrillator Models

On April 27, the FDA notified hospitals, other medical facilities and individual users that faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, WA, could cause the devices to fail to properly deliver a shock. The devices have also exhibited other problems, including interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and the tendency to be unable to accurately analyze heart rhythms when there is interference or background noise.

The 14 models that prompted the warning include automated and semi-automated devices. They are:

• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E;
• CardioVive models 92531, 92532 and 92533;
• Nihon Kohden models 9200G and 9231; and
• GE Responder models 2019198 and 2023440.

The FDA is recommending that hospitals and nursing homes use alternative external defibrillators until they can repair or replace the affected defibrillators.

The agency also recommends that those who have the affected devices at home obtain alternative defibrillators if possible; if not, such users should continue to use the affected models when necessary, as they may work when needed.

Whistleblower Suits Against AstraZeneca Settle for $520 Million

Drug manufacturer AstraZeneca agreed late in April to pay $520 million to settle federal whistleblower lawsuits that charged the company with, among other things, paying doctors to get them to promote off-label uses for its anti-psychotic drug Seroquel.

Prosecutors claimed the company worked to market the drug directly to doctors for the treatment of conditions like Alzheimer's disease and depression.

Pre-Emption Case: ChiefJustice Will Sit This One Out

The U.S. Supreme Court has agreed to review the holding in Brueswitz v. Wyeth, but Chief Justice John Roberts Jr. will not take part. Justice Roberts also was not involved in the decision to hear the case, which asks whether children who claim they are injured by vaccines may take their cases to state court with claims of design defects after losing in the Vaccine Court. A panel of the U.S. Court of Appeals for the Third Circuit last year held in Brueswitz that an injured child's right to bring such suits was pre-empted by the1986 National Childhood Vaccine Injury Act. Justice Roberts' reason for recusal is undoubtedly related to his ownership of stock in Pfizer Inc., which took over Wyeth last year.

Advising FDA Committees When Conflicts of Interest Exist

The FDA has issued a new draft guidance concerning the waiver of rules designed to prevent medical experts with conflicts of interest from participating at FDA advisory committee meetings. If such a waiver were sought, its propriety would be evaluated under the guidelines through a three-step inquiry. First, the nature of the conflict would be evaluated. If it were found to be minimal ' such as when a researcher works at an institution that receives grants from the company whose drug is being evaluated, but when he himself does not participate in those studies ' a waiver would more likely be granted. Second, the type of advice the expert would be asked to provide is important. For example, a waiver might be more likely if the expert were needed to testify concerning a policy issue affecting a class of products, rather than a specific product. And, finally, under the draft guidelines, a waiver would be more apt to be granted if a substitute expert without a conflict of interest could not be found.

Lawyer's Claim for Profits from Sale of Thalidomide May Go Forward

A lawyer who says she gave pharmaceuticals company Celgene the idea for using thalidomide as a cancer treatment will be permitted to pursue her claim that the company owes her $300 million. The attorney, Beth Jacobson, says the company reneged on a promise to reward her for her insights, which led to the sale of the notorious birth-defect-causing morning-sickness drug for the treatment of cancer.

In 1995, Jacobson, who had worked at New York's Skadden, Arps, Slate, Meagher & Flom for 15 years, quit her job in order to search for a treatment for her husband, who had been diagnosed with the always fatal cancer multiple myeloma. Jacobson consulted with Dr. Judah Folkman, a well-respected cancer researcher who had studied the use of thalidomide in treating childhood leukemia. Dr. Folkman suggested Jacobson contact Celgene, which held licenses to distribute thalidomide for the treatment of certain illnesses, such as leprosy. The suit says that Jacobson asked Celgene to supply thalidomide for her husband's treatment. Unfortunately, although he received the drug, Jacobson's husband died. However, another patient at the facility where Jacobson's husband was treated heard of the thalidomide therapy and requested it. That patient survived, leading Celgene to conduct successful clinical trails that led to the marketing of thalidomide for the treatment of early-stage multiple myeloma.

While the company acknowledged Jacobson's contributions by suggesting that she take a seat on its board of directors and sponsoring a gala at which she was given the International Myeloma Foundation Courage Award, it did not cut her in for a share of the profits. The suit claims Celgene's chief executive officer inferred to Jacobson that she would receive such compensation. Her suit, which claims Celgene has been unjustly enriched through its misappropriation of her idea, seeks a share of past and future profits.

FDA Issues Warning About 14 External Defibrillator Models

On April 27, the FDA notified hospitals, other medical facilities and individual users that faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, WA, could cause the devices to fail to properly deliver a shock. The devices have also exhibited other problems, including interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and the tendency to be unable to accurately analyze heart rhythms when there is interference or background noise.

The 14 models that prompted the warning include automated and semi-automated devices. They are:

• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E;
• CardioVive models 92531, 92532 and 92533;
• Nihon Kohden models 9200G and 9231; and
• GE Responder models 2019198 and 2023440.

The FDA is recommending that hospitals and nursing homes use alternative external defibrillators until they can repair or replace the affected defibrillators.

The agency also recommends that those who have the affected devices at home obtain alternative defibrillators if possible; if not, such users should continue to use the affected models when necessary, as they may work when needed.

Whistleblower Suits Against AstraZeneca Settle for $520 Million

Drug manufacturer AstraZeneca agreed late in April to pay $520 million to settle federal whistleblower lawsuits that charged the company with, among other things, paying doctors to get them to promote off-label uses for its anti-psychotic drug Seroquel.

Prosecutors claimed the company worked to market the drug directly to doctors for the treatment of conditions like Alzheimer's disease and depression.