Drug & Device News

If U.S. District Judge Joseph R. Goodwin of the Southern District of West Virginia does not apply a bright-line test to disqualify the doctor, defendants say, he also could disqualify Kohli because: 1) Bard can show it is objectively reasonable for it conclude it has a confidential relationship with the expert; and 2) confidential and privileged information was disclosed by Bard to the doctor. ' Amaris Elliott-Engel , The National Law Journal

Gain-of-Function Research Curtailed

Over the past few years, as the public learned of mix-ups related to anthrax and flu viruses at the National Institutes of Health (NIH) and of scientific breakthroughs in creating more contagious forms of viruses at two laboratories, concern has developed that so-called “gain of function” research on these dangerous biological materials could create super-bugs that might be exploited by terrorists. In response to such concerns, President Obama issued new rules in late September pertaining to research on dangerous biological materials. The new regulations would require researchers to determine whether their studies could produce dangerous biological products (like more lethal versions of viruses), and to disclose any such finding to the National Institutes of Health. The hope was that the new policy ' which carried the unwieldy name United States Government Policy for Institutional Oversight of Life Science Dual Use Research of Concern ' would diminish the risk that scientific research could inadvertently create organisms that might be used in biological warfare. Under the terms of the new rules, scientists intending to conduct research on potentially dangerous substances would have to inform their institutions prior to commencement. Those institutions would then be required to conduct a review of the risks and report their findings to the federal agency that would be funding the study. These institutions would also need to come up with a plan to adequately diminish the risks of the research.

Critics of the new law said it did not go far enough, noting that it affected only studies funded by federal agencies, and that the punishment for failing to follow the new rules was merely withdrawal of funding. Perhaps because of these and other criticisms of the new policies, the White House announced Oct. 17 that the federal government would place a moratorium on funding for any studies seeking to increase the dangerous properties of certain infectious agents, such as the viruses that cause SARS and MERS.

Tired Doctors Prescribe Antibiotics More Frequently

Concern has been growing that many bacteria are growing resistant to antibiotics because of over-prescription. Now, a study published in JAMA Internal Medicine finds that doctors are more likely to write prescriptions for antibiotics as they become more fatigued. Time of Day and the Decision to Prescribe Antibiotics, JAMA Intern Med . Published online Oct. 06, 2014. doi:10.1001/jamainternmed.2014.5225. The results of the review of over 20,000 cases in which acute respiratory infection was diagnosed found that, as the workday wore on, doctors prescribed antibiotics more frequently. In fact, they wrote such prescriptions 26% more often in the fourth hour of work than in the first. Perhaps these doctors are making more mistakes in diagnosis as the day goes on, or maybe they simply lose the will to resist their patients' insistence that they be given the quick fix. In any case, the study's results indicate that care should be taken to avoid over-prescribing antibiotics as the day goes on.

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Did Plaintiff's Expert Change Horses Midstream?

C.R. Bard Inc., a manufacturer of transvaginal mesh facing close to 10,000 cases in federal court, has moved to disqualify one of the plaintiffs' experts. According to the defense, Dr. Neeraj Kohli cannot testify as a general and a case-specific expert for the plaintiffs because he testified for defendant Bard in another case: That case was the first vaginal mesh trial held in California, Scott v. Kannappan. At issue in that case were Bard's Avaullta Plus Anterior and Posterior Biosynthetic Support Systems as well as allegations of medical malpractice by those plaintiffs' physicians, according to Bard. The case resulted in a $5.5 million plaintiffs' verdict with Bard found 60% at fault and a treating physician found 40% at fault. The California case also involved the same defendant, the same type of products and the same scientific issues regarding the use of polypropylene mesh, the defendant said. Kohli also consulted on other transvaginal mesh cases, including two bellwether cases, Bard said. “Dr. Kohli's 'side-switching' creates clear and substantial conflict of interest,” the manufacturer said.

Dr. Kohli specializes in reconstructive pelvic surgery and treating women for pelvic issues. Bard said that Kohli has been privy to “numerous confidential and privileged discussions regarding Bard corporate documents, Bard witnesses, Bard's product design and use, vaginal mesh complications and mesh characteristics.” Bard contends that “[w]here such blatant side-switching has occurred, federal courts, including this court, have applied a bright-line rule and disqualified the expert.”

If U.S. District Judge Joseph R. Goodwin of the Southern District of West Virginia does not apply a bright-line test to disqualify the doctor, defendants say, he also could disqualify Kohli because: 1) Bard can show it is objectively reasonable for it conclude it has a confidential relationship with the expert; and 2) confidential and privileged information was disclosed by Bard to the doctor. ' Amaris Elliott-Engel , The National Law Journal

Gain-of-Function Research Curtailed

Over the past few years, as the public learned of mix-ups related to anthrax and flu viruses at the National Institutes of Health (NIH) and of scientific breakthroughs in creating more contagious forms of viruses at two laboratories, concern has developed that so-called “gain of function” research on these dangerous biological materials could create super-bugs that might be exploited by terrorists. In response to such concerns, President Obama issued new rules in late September pertaining to research on dangerous biological materials. The new regulations would require researchers to determine whether their studies could produce dangerous biological products (like more lethal versions of viruses), and to disclose any such finding to the National Institutes of Health. The hope was that the new policy ' which carried the unwieldy name United States Government Policy for Institutional Oversight of Life Science Dual Use Research of Concern ' would diminish the risk that scientific research could inadvertently create organisms that might be used in biological warfare. Under the terms of the new rules, scientists intending to conduct research on potentially dangerous substances would have to inform their institutions prior to commencement. Those institutions would then be required to conduct a review of the risks and report their findings to the federal agency that would be funding the study. These institutions would also need to come up with a plan to adequately diminish the risks of the research.

Critics of the new law said it did not go far enough, noting that it affected only studies funded by federal agencies, and that the punishment for failing to follow the new rules was merely withdrawal of funding. Perhaps because of these and other criticisms of the new policies, the White House announced Oct. 17 that the federal government would place a moratorium on funding for any studies seeking to increase the dangerous properties of certain infectious agents, such as the viruses that cause SARS and MERS.

Tired Doctors Prescribe Antibiotics More Frequently

Concern has been growing that many bacteria are growing resistant to antibiotics because of over-prescription. Now, a study published in JAMA Internal Medicine finds that doctors are more likely to write prescriptions for antibiotics as they become more fatigued. Time of Day and the Decision to Prescribe Antibiotics, JAMA Intern Med . Published online Oct. 06, 2014. doi:10.1001/jamainternmed.2014.5225. The results of the review of over 20,000 cases in which acute respiratory infection was diagnosed found that, as the workday wore on, doctors prescribed antibiotics more frequently. In fact, they wrote such prescriptions 26% more often in the fourth hour of work than in the first. Perhaps these doctors are making more mistakes in diagnosis as the day goes on, or maybe they simply lose the will to resist their patients' insistence that they be given the quick fix. In any case, the study's results indicate that care should be taken to avoid over-prescribing antibiotics as the day goes on.

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