Week Adjourned: 1.12.18 – CA Wildfires, EAS Systems, Ibuprofen Male Infertility Study

Top Class Action Lawsuits

California wildfires take a predictable turn. Southern California Edison is facing a negligence class action lawsuit filed by nine plaintiffs who allege the company’s negligence let to the largest wildfire in the history of California state.

Specifically, the lawsuit alleges that the wildfire, which began in the evening of December 6, 2017, was caused by Edison’s negligence, in that workers from the utility company were performing construction near a facility in “an unsafe manner.” This caused vegetation to catch fire. Further, the plaintiffs assert the utility company failed to “maintain its overhead electric and communications facilities in a safe manner,” and didn’t remove trees or vegetation around its utility poles.

The lawsuit states that “Had SCE acted responsibly the Thomas Fire could have been prevented.”

Ventura City and the Casitas Municipal Water District are also named as defendants for failing to have working generators on hand that could have helped with water pressure. According to the lawsuit, “For some inexplicable reason, the City of Ventura failed to have on hand properly working backup generators, which prevented desperately needed water pressure to be supplied to the fire hydrants located in the hillside neighborhoods and canyons of Ventura.”

More than 242,000 acres were destroyed including over 1,000 structures. More than 100,000 people were displaced from their homes, according to lawsuit.  So sad. So preventable?

Emerging Issues

Enteral access systems. This week saw two emerging issues of concern, stemming from medical therapies. The first involves reports of life-threatening and fatal pneumothorax events associated with feeding tube placement procedures using two US Food and Drug Administration (FDA)-approved enteral access systems (EAS).

The FDA issued a statement regarding EAS and the reports they’ve received to date. BTW – EAS are designed to aid in the placement of naso-enteric feeding tubes by transmitting real-time positional information to an external visible screen or console. The FDA has cleared three EAS devices for marketing in the United States, each of which uses a different technology to track the position of the feeding tube during the insertion procedure.

The FDA states in its notice to health care professionals that most reports indicate the pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death. Although pneumothorax is a known rare complication of “blind insertion” of feeding tubes, typically less than 0.5 percent, the FDA is alerting clinicians that the use of EAS devices does not eliminate this risk and reminding health care providers of important safety information about these systems.

According to the agency, from January, 2012, to July, 2017, the FDA received 51 Medical Device Reports (MDRs) about pneumothorax events related to the use of the Corpak Medsystems Cortrak 2 device. These included 11 reports of patient death.

The FDA also received 28 MDRs about pneumothorax events related to the use of the Covidien Kangaroo device, including 5 deaths.

The Kangaroo Feeding Tube with IRIS Technology by Covidien employs a camera embedded in the distal end of the tube and provides a video stream of the gastrointestinal tract during placement.

The Cortrak 2 Enteral Access System by Corpak Medsystems uses electromagnetic sensors in a stylet to provide a visual representation of the tip of the tube relative to an external receiving unit placed over the patient’s xiphoid process.

The FDA cautions that for both devices, the relationship between the pulmonary events and the death cannot be concluded definitively in all cases.

Ibuprofen & male infertility. The second involves ibuprofen – and it ain’t good – if you’re a fella. New data from a study published early in January, 2018, show that regularly taking the ubiquitous over-the-counter painkiller may contribute to male infertility. Published in the Proceedings of the National Academy of Sciences (NAC), the researchers found that regular use of ibuprofen may lead to compensated hypogonadism, a condition that can cause infertility, erectile dysfunction, depression and loss of bone and muscle mass, among other medical conditions. Ibuprofen is the generic name for drugs including Advil and Motrin.

In the study by the NAC, the data suggest that the condition can affect young men, who made up the study population, as well as men who smoke and the elderly, in whom infertility is commonly seen.

Thirty one healthy men were enrolled in the study, between the ages of 18 and 35. Fourteen took two 600-milligram doses of ibuprofen a day for six weeks, an amount consistent with what many athletes take to manage aches and pains. The remaining 17 men took placebo pills.

All the participants had blood tests and hormonal analysis throughout the study. After 14 days of ibuprofen use, the researchers observed higher blood levels of luteinizing hormone, which regulates the production of testosterone and other hormones. After 44 days, the levels of luteinizing hormone were even higher. By contrast, testosterone production did not increase, resulting in a lower ratio of testosterone to luteinizing hormone, which is a sign of hypogonadism, the researchers not in their paper.

The researchers also discovered other hormonal disruptions at 14 and 44 days of ibuprofen consumption, suggesting wide-ranging consequences of hypogonadism.

Tests were also done to assess the direct effect of ibuprofen on testicles, using samples from organ donors. The data revealed that the testicle samples produced less testosterone after just 24 hours of exposure to levels of ibuprofen similar to that which would be taken orally: the higher and longer the level of exposure, the more dramatic the impact. Further, gene expression associated with turning cholesterol into steroidal hormones was also impaired.

These findings build on earlier research by the study’s lead author who found that boys born to mothers who took ibuprofen during their first trimester of pregnancy may have impaired testicular development, suggesting that in some scenarios, the drug may have a negative effect on virility.

Well, there’s still acetaminophen…

Ok Folks – That’s a wrap for this week. Here we go 2018!

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