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Does Off-Label Promotion Settlement Signal Change in FDA Policy?

Science & Medicine
Fierce Pharma |

FDA Succeeding in Expedited Approval of Some Drugs, But Failing in Post-marketing Monitoring

The FDA's oversight of drugs doesn't end once they hit the market--or at least, it isn't supposed to. It has an early warning system in place to spot safety issues. Problem is, regulators are struggling to keep up--and falling behind on alerting the public in the process.


The agency's so-called watch list--based on its Adverse Event Reporting System (FAERS)--for the first, second and third quarters of 2015 tardily appeared on the FDA's website on Feb. 5, 2016, Medscape Medical News reports--meaning that the public found out late about potential problems with 39 drugs or drug classes.


Case in point: It took months for news that the FDA had identified stroke and thromboembolic events as a "potential signal of a serious risk" for 7 SGLT-2 diabetes drugs to reach doctors and patients, the publication notes. And while the point isn't for the FDA to allege that the meds caused the adverse events, the agency is required by law to let patients and physicians know within three months that regulators are looking into them.

Science & Medicine
Forbes |

Do Healthcare Data Breaches Expose Providers to HIPAA Violations?

While it’s tempting to think of ransomware as a new cyber threat, the history of digital extortion dates back to the 1980s, and one of the first examples of ransomware was the PC Cyborg Trojan. Like modern ransomware, the Cyborg Trojan (a.k.a. Aids Info Disk) first encrypted files and then demanded payment (to a PO Box in Panama) in the more friendly terminology of a software “license renewal.”


This week yet another healthcare facility was hit by ransomware–and this marks the fourth significant ransomware attack targeting U.S. healthcare just this year. This week’s attack affected MedStar Health–the largest healthcare provider in the Maryland and Washington, D.C., region.

Science & Medicine
James F. McCarty, The Plain Dealer |

Stanford Study Links Fracking to Underground Drinking Water Pollution

A newly released study of fracking in a small Wyoming town has found that common practices in the industry may have widespread impacts on drinking water – a conclusion in direct conflict to U.S. EPA and Yale University reports last year that no such evidence exists.


The latest study was conducted by scientists at Stanford University based on findings from hydraulic fracturing operations in Pavillion, Wyoming, population 231.


The Stanford study found a direct link between fracking operations near the town and underground sources of drinking water. The research cited such unsafe practices as the dumping of drilling and production fluids containing diesel fuel, high chemical concentrations in unlined pits, and a lack of adequate cement barriers to protect groundwater.

Science & Medicine
Legal Newsline |

Is the Evidence Gap in Fracking Earthquake Cases Closing?

The negative publicity surrounding lawsuits alleging the oil and gas industry are responsible for earthquakes in Oklahoma is likely to cause more damage than the outcome of any of the suits - despite the plaintiffs' challenge of finding evidence tying fracking to the surge in activity.


Industry lawyers say the merits of the allegations of a connection between the underground disposal of brine - a byproduct of oil and gas drilling - and a spike in earthquakes may not matter. Meanwhile, the Oklahoma Geological Commission says half of a flurry of recent earthquakes have occurred away from larger injector wells and that it can't be sure that there is any link between fracking and earthquakes.


Science & Medicine
Los Angeles Times |

Device Maker Raised Prices for Replacements After Superbug Outbreak Linked to Scopes

Soon after doctors at UCLA's Ronald Reagan Medical Center traced deadly infections to tainted medical scopes last year, they pressed the device maker to lend them replacements.


But Olympus Corp. refused. Instead, the Tokyo company offered to sell UCLA 35 new scopes for $1.2 million — a 28% increase in price from what it charged the university just months earlier, according to university emails obtained from a public-records request.


Olympus sales manager Vincent Hernandez told UCLA that the company's previous discounts no longer applied. "Supplies are already low, where demand is high with all academic institutions expanding their inventories," Hernandez wrote to the medical center.


The emails show how Olympus continued to push sales even as the devices it previously sold to UCLA and other medical institutions were linked to illnesses and deaths.

Science & Medicine
The Influence |

Pharma’s “Impressive Commitment to Price Gouging”

When did you become aware of the obscene prices the pharmaceutical industry is charging for drugs? For many it was when a smirking Martin Shkreli, founder of Turing Pharmaceuticals, testified on the Hill in February about his price hike of the antiparasitic drug Daraprim from $13.50 to $750, after which he called lawmakers “imbeciles” in a tweeted goodbye.


For others it was the roll-out of Gilead Sciences hepatitis C drug Sovaldi in 2014 at $84,000 for a 12-week course of treatment.


“Let’s hold our position whatever competitors do or whatever the headlines,” a Gilead executive said in an internal email, an impressive commitment to price-gouging in the face of public opprobrium. The Senate Finance Committee, in an understatement, said the price did not reflect research and development but a “revenue” push. Forbes writer Avik Roy noted the same hepatitis C treatment costs $900 a year in Egypt and that US taxpayers are picking up the tab since most US hepatitis C patients are uninsured, underinsured or imprisoned.

Science & Medicine
The Lund Report |

Health Insurance and Patient Quality of Care

OPINION -- The healthcare system is failing patients and physicians. In a recent article, a 46 year old woman initially presented with shoulder pain, and according to her lawyer, eventually had a heart attack, possibly requiring a future heart transplant. This article isn’t about the merit of this particular lawsuit or tort reform in general. I am an internal medicine physician and see the larger issue of a system failure, and such examples are inevitable. Physicians are set up to fail with resulting patient harm. The reason for this article is to delineate the basic flaws. Understanding how they interrelate answers the questions of how and why the system is failing.


Quality care demands continuity of care, but continuity is too frequently broken. The patient mentioned above presented with typical symptoms for a common, benign condition, yet that incident was the needle in the haystack. She then saw multiple providers.


Current documentation is more about data entry for the purposes of research, avoidance of malpractice and billing than for the purported goal of documenting care, compounding the negative effects of the lack of continuity of care. Each provider no doubt tediously entered a note into an electronic health record. Should physicians concentrate on the patient or clicking boxes? One can’t be done without compromising the other. Electronic records sound great, but they are a distraction, producing generic, template driven notes for subsequent providers to use. The patient is reduced to a pattern of checkboxes and nonsensical pull down statements. The patient’s meaningful narrative is lost. This improves billing, but is terrible for documenting clinical analysis.