In a 7-to-0 ruling last week, the Oklahoma State Supreme Court is allowing homeowners who have sustained injuries or property damage from earthquakes blamed on oil and gas company drilling operations to sue for damages in state courts.
This ruling is the first in which the court has specifically addressed whether homeowners could sue for damage believed to be caused by the massive amounts of wastewater injected into the ground by oil and gas drilling in the hydraulic fracturing—fracking—process, the New York Times reports. Continue reading
Cough and cold medicines that contain codeine are being investigated by the U.S. Food and Drug Administration (FDA) for serious side effects in children, including breathing troubles. The agency stated in a safety alert that it was investigating the opioid because it may be released to slowed or difficult breathing in children under the age of 18. Children may be more at risk for these side effects, especially if they are already predisposed to breathing problems.
Codeine is an opioid that is often found in combination with other drugs in over-the-counter (OTC) cough-and-cold medicines. It is used to reduce coughing and mild to moderate pain. The FDA said it “will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete.” according to the July 1st safety alert. Continue reading
On Tuesday, the federal Center for Medicare and Medicaid Services published the federal Open Payments database for 2014 detailing payments between medical device companies and doctors and hospitals. According to Star Tribune, this is the second year that such data has been published. The data was released under the Open Payments program, which was created by the Sunshine Act provisions of the Affordable Care Act in an effort to create transparency and prevent large companies like Medtronic from using financial incentive to influence medicine.
According to Star Tribune, data looking at payments $1 million or greater showed that Medtronic PLC and St. Jude Medical paid a combined $81 million to eight doctors across the country. The database indicates that Minnesota device makers paid over $211 million to doctors and hospitals for reasons not related to research. For the first time, data revealed 99 percent of submitted payment information. Last year’s data redacted more than a third of the information. Continue reading
A Harvard medical professor has urged the Food and Drug Administration (FDA) against easing the restrictions on drug companies marketing their drugs for uses for which they have not been approved—so-called off-label use.
During the summer of 2015 the FDA will hold a public meeting to discuss whether restrictions on what claims drug manufacturers can make about their products improperly infringes the liberty of those companies, HealthNewsReview reports. Dr. Jerry Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Boston’s Brigham and Women’s Hospital, writing in the Annals of Internal Medicine, argues that patients and doctors need the “sovereign” power of the FDA to regulate what claims drug makers can make. Continue reading
The U.S. Food and Drug Administration (FDA) is looking to take regulatory action over liquid nicotine, which is used in electronic cigarettes. On Tuesday, the agency “issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments, data, research, and/or other information related to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s), and potentially for other tobacco products including, but not limited to novel tobacco products such as dissolvables, lotions, gels, and drinks.”
The proposal is open to public commentary for 60 days. The FDA has evaluated data on liquid nicotine and its risks, particularly for accidental exposure among infants and children. The agency notes that as e-cigarettes have become more popular, the number of calls to poison control centers and emergency room visits related to liquid nicotine have increased. Based on this data, the FDA wants more input as to whether it should place warnings about nicotine exposure or require some tobacco products to be sold in child-resistant packaging. Continue reading
A Class I recall has been issued for certain Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks, the U.S. Food and Drug Administration (FDA) announced recently. The agency said the recall was issued because the parts may have “unexpected amounts of manufacturing residues”. The Class I designation is reserved for recalled devices that present a reasonable risk of serious injury or death.
According to the FDA notification, the recalled devices contain higher than expected amounts of residue due to a a process monitoring failure. “These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant.” Continue reading
The U.S. District Court of the District of New Jersey sentenced former OtisMed Corporation chief executive officer, Charlie Chi, to 24 months in prison for his involvement in the distribution of “adulterated” medical devices.
In December 2014, OtisMed agreed to pay more than $80 million to resolve criminal and civil liability related to distributing adulterated medical devices with intent to defraud and mislead. At that time, Chi pleaded guilty to introducing adulterated medical devices into interstate commerce. Chi will also serve one year of supervised release and pay a $75,000 fine, the Imperial Valley News reports. Continue reading
As families prepare to enjoy 4th of July festivities, federal agencies have issued safety alerts about spray-on sunscreens and fireworks.
The Consumer Product Safety Commission (CPSC) issued its annual list of tips for safe use of fireworks and the Food and Drug Administration (FDA) was warned about spray-on sunscreens. Continue reading
Pharmacies have an additional four months to meet track and trace requirements under the Drug Supply Chain Security Act (DSCSA), Regulatory Affairs Professionals Society (RAPS) reports. The DSCSA is under the Drug Quality and Security Act (DQSA) signed into law in 2013 and seeks to keep track of drug products in the supply chain nationwide. The U.S. Food and Drug Administration (FDA) has extended the deadline from July 2, 2015 to November 1, 2015 in response drug dispensers’ requests. The agency said it would use its “enforcement discretion” to allow more time even though the statutory date of compliance remains the same.
The DSCA requires drug packages to carry a unique serial number so that they can easily be tracked by federal regulators. This allows the FDA to more easily pinpoint the source of a problem and reduce the risk of counterfeit products. Every entity in the supply chain must keep track of the packages through this system. Continue reading
Two whistleblowers, a doctor and nurse in Atlanta, could receive more than $110 million for exposing alleged fraud by DaVita Healthcare Partners, the largest dialysis provider in the country. According to their lawsuit, the company intentionally wasted drugs in order to receive reimbursements from the federal government. Before 2011, the Centers for Medicare and Medicaid Services reimbursed dialysis providers for drug wastage from single-use vials. The whistleblowers alleged that DaVita instructed staff to use unnecessarily large vials of the vitamin D supplement Zemplar and the iron drug Vanofer. The scheme allegedly cost taxpayers hundreds of millions.
According to a Department of Justice (DOJ) press release dated June 24th, DaVita paid $450 million to resolve the allegations. The release noted that DaVita reduced its wastage substantially after the Centers for Medicare and Medicaid Services changed its reimbursement policy in 2011 and “wastage derived from single-use vials was no longer profitable “ Continue reading