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Welcome To Our New York Health Care Law Blog

Review of health care litigation underscores broad playing field

Vast. Comprising multiple and diverse participants. Under a layer of state and federal regulatory oversight. Complex.

Those are core descriptors of the American medical industry, which is unquestionably one of the country’s most sprawling and complicated business realms.

J&J gets some upside in DePuy hip-replacement litigation

When a judge allows highly prejudicial and case-irrelevant evidence to be “wafted before the jury to trigger its punitive instincts,” it is likely that an appellate tribunal will take action.

Which is exactly what a federal appeals panel did last week in New Orleans. Appellate judges cited a lower court’s error in allowing plaintiffs’ counsel to inject unnecessarily inflammatory information into a consolidated trial regarding hip replacements. That allowance worked a high-dollar verdict against medical device maker Johnson & Johnson that the appellate panel stated should not have issued. The court threw out the award, leaving the option of a new trial open for the plaintiffs.

The arbitration-or-litigation question is always a key query

The health care sphere is no different from other business realms in New York and nationally in that its participants – hospital administrators, doctors, insurers and myriad other actors – sometimes become embroiled in legal disputes that cannot be settled informally and amicably.

Affected parties in such cases often face hard questions concerning the best strategy to employ to resolve a contractual or other problem with a third party. There is more than one route that can potentially be taken. Every option needs to be timely and carefully considered.

Is your company being targeted in health care fraud probes?

A recent in-depth media profile calls it "a target-rich environment for investigation and prosecution." That same report also stresses that federal criminal enforcement over it "stands poised to become increasingly muscular and robust."

The subject matter comprising "it" in the above piece is health care fraud. That realm is unquestionably a top-tier focus of national regulators and prosecutors presently.

Health business legal landscape gets more complicated

The days of doctors in individual practice are largely gone. As recently as the 1970s, it was not unusual to find health care providers in their own offices. Since then, the country has seen seismic shifts in the business model for how medical treatment is delivered. And the changes show little sign of letting up.

Late last year, CVS Health announced plans to merge with Aetna. Supporters of the pharmacy-insurer deal claim it will deliver lower costs and improve overall patient outcomes to consumers. They say that will be possible by better leveraging the growing pool of information from electronic health records. And just today comes word that Walmart has eyes on acquiring insurer, Humana. Whether either of these deals can clear regulatory hurdles remains to be seen.

5 steps to diagnose medical practice cyberattack risks

Patient safety is, or should be, a top priority in every health care facility in New York and the rest of the country. Safety can be at risk many different ways, as we pointed out in this blog earlier this year. One major threat that deserves particular attention is that posed by cyber attackers going after network-linked equipment and medical data.

To show just how significant this issue is, consider results of a recent survey by the American Medical Association. The AMA reports 83 percent of 1,300 doctor respondents said their practices have been targets of cyber attacks that threatened electronic data. The danger, of course, is that electronic health records could be altered. If that happens and the record is then shared, information that should aid treatment could be a potential hazard.

DOJ upping scrutiny of pharma companies that make, market opioids

Although there seems to be no material disagreement regarding whether states across the country are battling a mass opioid-addiction problem, there are myriad questions concerning the source of the so-called "crisis" and related matters.

Are overprescribing doctors primarily to blame? What about select pharmacy outlets and chains that are pointed to as being especially prominent players when it comes to doling out potent narcotic medicines? How much of a role does street crime play?

FDA's regulation of doctor-assisting software criticized

Much criticism of the U.S. Food and Drug Administration from health care analysts and commentators spotlights alleged overregulation of the medical realm and its adverse effects on both business growth and innovation.

That has once again proven to be true in the response of one industry group to recent FDA-authored draft guidance concerning software that assists physicians treating patients.

What is the health industry's biggest concern in 2018?

Health industry actors in New York and nationally face a number of stressing concerns as they go about their important work each day.

And their thoughts are understandably focused squarely on patients while they perform their duties. "Patient safety is on everyone's mind," duly notes a principal with the ECRI Institute, a national nonprofit group that seeks to closely wed scientific research with improved medical outcomes.

Is FDA hiding behind guidance docs to circumvent formal rulemaking?

The process applicable to formal rulemaking engaged in by federal agencies is lengthy and laborious. A recent Bloomberg article discussing how ideas turn into final administrative rules describes it as "cumbersome."

No one likely knows that better than principal employees of the U.S. Food and Drug Administration. The FDA is an agency that is routinely involved with reams of rule-linked documentation that, in instances of final rule implementation, intimately affects scores of thousands of actors within the health care realm.

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