Drug & Device News

Prominent Researcher Admits Fraud

According to Baystate Medical Center in Springfield, MA, Dr. Scott S. Reuben, one of its doctors, fabricated much of the research data upon which he based claims concerning certain pain medications. Dr. Reuben authored articles in several major medical journals, including Anesthesiology and the Journal of Clinical Anesthesia, and the findings in some of his studies have formed the basis for currently accepted clinical practices. For example, many health care providers have relied on his studies' recommendation that nonsteroidal anti-inflammatory drugs be used for pain control following surgery, rather than opioids. The medical journals in which articles authored by Dr. Reuben have appeared have begun publishing retractions.

Undercover Operation Reveals Irregularities at Drug Trial Monitoring Firm

Coast Independent Review Board (Coast IRB), a company that receives payment for overseeing drug trials, has at the request of the Food and Drug Administration (FDA) stopped approving new studies or adding new subjects to existing studies. The accord came after Coast IRB discovered it had been the subject of a federal government “sting” operation. In a release issued in March on the Coast IRB's Web site, the firm said, “Apparently at the behest of the U.S. House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, agents submitted false credentials and clinical trial data to Coast IRB and possibly other IRBs [independent review boards] to induce them to perform reviews. Evidence of the progress of the trials could then form the basis for arguments critical of FDA and in favor of greater regulatory oversight. Unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, violating wire fraud, mail fraud, and state laws against fraud and false credentialing.” Coast IRB reported at that time that it had been tasked with reviewing a clinical trial being conducted by Device Med Systems of Clifton, VA. In fact, among other irregularities, no such research company exists in Virginia; the address Coast IRB was given for the firm was in a strip mall; and the trial's principal investigator's credentials were forged.

Indeed, federal authorities were checking up on the company, and they were not pleased with what they found: Coast IRB allowed the bogus “tests” to go forward, failing “to perform the robust review needed to approve a study,” according to the FDA. The agency issued a formal warning letter to Coast IRB on April 14, asking that the firm submit a corrective action plan to the agency by the end of that month. The company says it will cooperative fully with the FDA and will “change everything” and “revamp[] every aspect of the company,” according to its CEO, Dan Dueber. The approximately 300 clinical trials that Coast IRB is currently overseeing are not affected by the agreement.

Some State-Law Device Claims Dismissed, But Not All

A Westchester County, NY, court dismissed the portion of a suit against Medtronic Inc. in which a plaintiff sought recovery under a strict liability theory for the alleged defective design of her implantable cardiac defibrillator. She sought damages for injuries sustained when the defibrillator's lead allegedly fractured. Medtronic moved to dismiss, which the court did, noting that the U.S. Supreme Court in Riegel v. Medtronic Inc. had held that state law tort claims against a manufacturer of an allegedly defective medical device that has been given pre-market approval from the FDA are exempted by the preemption clause of Medical Device Amendments ' 360k of 1976. The Supreme Court had found that the law did not allow the imposition of state requirements that would differ from or add to specific federal requirements, as defined by the FDA.

The Westchester County court granted Medtronic's motion to dismiss the plaintiff's claims against it for: strict liability for defective design; strict liability for failure to warn and instruct; negligence; breach of implied warranty; misrepresentation and fraud; unjust enrichment; violations of New York's General Business Law; recovery pursuant to the Medicare as Secondary Payer Statute. The court, did, however deny the motion for dismissal of the claims asserting strict liability because, allegedly: 1) there was a manufacturing defect in the specific lead implanted in the plaintiff; 2) the Sprint Fidelis leads are defectively manufactured; and 3) the facilities and controls used by Medtronic in the manufacture of the leads were not in conformity with the applicable federal requirements. The plaintiff's specific allegation was that the manufacturing process of the Sprint Fidelis leads relied on direct resistance spot welding of two different metals to affix lead cables and that this process could damage the fine, small wires in the cables. In denying the request for dismissal, the court stated, the “Riegel Court specifically noted that the MDA does not prevent a state from providing damages for claims premised on a violation of FDA regulations. Such a claim would not be preempted since it would be a parallel claim that does not impose a requirement that is different from, or in addition to, any federal requirement.”

Younger Women to Get Easier Access to Emergency Contraception

In a short April 22 press release, the FDA announced that it would allow the emergency contraceptive known as “Plan B,” marketed by Duramed Research Inc., to be sold to 17-year-olds without a doctor's prescription. Plan B can prevent pregnancy if taken within 72 hours of sexual intercourse. The FDA's release states, “On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court's order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.” The FDA's announcement followed a New York court's order requiring the FDA to lower the age requirement because the court found the decision to limit access to Plan B to those over 18 years of age had been based not on sound medical science but rather on conservative political concerns. The previous FDA rules were formulated during the Bush presidency.

New York Pharmacies Agree To Better Inform Non-English-Speaking Customers

Several New York pharmacies have agreed to start providing information about prescription drugs in some consumers' native languages: Spanish, Italian, Russian, French and Chinese. New York pharmacists are required by law to personally inform all patients concerning their prescription drugs, both orally and in writing. The law also prohibits pharmacies from conducting business in a way that discriminates against non-English speaking patients. Despite these laws, an undercover investigation conducted by the State's Office of the Attorney General found that patients who spoke primarily foreign languages often received prescription medication information in a language they could not understand. The new agreement between the pharmacies and the State affects Wal-Mart, Target, Duane Reed, A & P supermarkets and Costco Wholesale Corp.

Prominent Researcher Admits Fraud

According to Baystate Medical Center in Springfield, MA, Dr. Scott S. Reuben, one of its doctors, fabricated much of the research data upon which he based claims concerning certain pain medications. Dr. Reuben authored articles in several major medical journals, including Anesthesiology and the Journal of Clinical Anesthesia, and the findings in some of his studies have formed the basis for currently accepted clinical practices. For example, many health care providers have relied on his studies' recommendation that nonsteroidal anti-inflammatory drugs be used for pain control following surgery, rather than opioids. The medical journals in which articles authored by Dr. Reuben have appeared have begun publishing retractions.

Undercover Operation Reveals Irregularities at Drug Trial Monitoring Firm

Coast Independent Review Board (Coast IRB), a company that receives payment for overseeing drug trials, has at the request of the Food and Drug Administration (FDA) stopped approving new studies or adding new subjects to existing studies. The accord came after Coast IRB discovered it had been the subject of a federal government “sting” operation. In a release issued in March on the Coast IRB's Web site, the firm said, “Apparently at the behest of the U.S. House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, agents submitted false credentials and clinical trial data to Coast IRB and possibly other IRBs [independent review boards] to induce them to perform reviews. Evidence of the progress of the trials could then form the basis for arguments critical of FDA and in favor of greater regulatory oversight. Unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, violating wire fraud, mail fraud, and state laws against fraud and false credentialing.” Coast IRB reported at that time that it had been tasked with reviewing a clinical trial being conducted by Device Med Systems of Clifton, VA. In fact, among other irregularities, no such research company exists in Virginia; the address Coast IRB was given for the firm was in a strip mall; and the trial's principal investigator's credentials were forged.

Indeed, federal authorities were checking up on the company, and they were not pleased with what they found: Coast IRB allowed the bogus “tests” to go forward, failing “to perform the robust review needed to approve a study,” according to the FDA. The agency issued a formal warning letter to Coast IRB on April 14, asking that the firm submit a corrective action plan to the agency by the end of that month. The company says it will cooperative fully with the FDA and will “change everything” and “revamp[] every aspect of the company,” according to its CEO, Dan Dueber. The approximately 300 clinical trials that Coast IRB is currently overseeing are not affected by the agreement.

Some State-Law Device Claims Dismissed, But Not All

A Westchester County, NY, court dismissed the portion of a suit against Medtronic Inc. in which a plaintiff sought recovery under a strict liability theory for the alleged defective design of her implantable cardiac defibrillator. She sought damages for injuries sustained when the defibrillator's lead allegedly fractured. Medtronic moved to dismiss, which the court did, noting that the U.S. Supreme Court in Riegel v. Medtronic Inc. had held that state law tort claims against a manufacturer of an allegedly defective medical device that has been given pre-market approval from the FDA are exempted by the preemption clause of Medical Device Amendments ' 360k of 1976. The Supreme Court had found that the law did not allow the imposition of state requirements that would differ from or add to specific federal requirements, as defined by the FDA.

The Westchester County court granted Medtronic's motion to dismiss the plaintiff's claims against it for: strict liability for defective design; strict liability for failure to warn and instruct; negligence; breach of implied warranty; misrepresentation and fraud; unjust enrichment; violations of New York's General Business Law; recovery pursuant to the Medicare as Secondary Payer Statute. The court, did, however deny the motion for dismissal of the claims asserting strict liability because, allegedly: 1) there was a manufacturing defect in the specific lead implanted in the plaintiff; 2) the Sprint Fidelis leads are defectively manufactured; and 3) the facilities and controls used by Medtronic in the manufacture of the leads were not in conformity with the applicable federal requirements. The plaintiff's specific allegation was that the manufacturing process of the Sprint Fidelis leads relied on direct resistance spot welding of two different metals to affix lead cables and that this process could damage the fine, small wires in the cables. In denying the request for dismissal, the court stated, the “Riegel Court specifically noted that the MDA does not prevent a state from providing damages for claims premised on a violation of FDA regulations. Such a claim would not be preempted since it would be a parallel claim that does not impose a requirement that is different from, or in addition to, any federal requirement.”

Younger Women to Get Easier Access to Emergency Contraception

In a short April 22 press release, the FDA announced that it would allow the emergency contraceptive known as “Plan B,” marketed by Duramed Research Inc., to be sold to 17-year-olds without a doctor's prescription. Plan B can prevent pregnancy if taken within 72 hours of sexual intercourse. The FDA's release states, “On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court's order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.” The FDA's announcement followed a New York court's order requiring the FDA to lower the age requirement because the court found the decision to limit access to Plan B to those over 18 years of age had been based not on sound medical science but rather on conservative political concerns. The previous FDA rules were formulated during the Bush presidency.

New York Pharmacies Agree To Better Inform Non-English-Speaking Customers

Several New York pharmacies have agreed to start providing information about prescription drugs in some consumers' native languages: Spanish, Italian, Russian, French and Chinese. New York pharmacists are required by law to personally inform all patients concerning their prescription drugs, both orally and in writing. The law also prohibits pharmacies from conducting business in a way that discriminates against non-English speaking patients. Despite these laws, an undercover investigation conducted by the State's Office of the Attorney General found that patients who spoke primarily foreign languages often received prescription medication information in a language they could not understand. The new agreement between the pharmacies and the State affects Wal-Mart, Target, Duane Reed, A & P supermarkets and Costco Wholesale Corp.