Drugs/Medical Archive

AMA settlement with United Healthcare

December 10th, 2009. By AbiK

If you remember my rant on out of network fees and the post on how those fees—ie, the reasonable and customary ones—are determined, compliments of a company called Ingenix, which is a unit of United Healthcare, well, here’s a little update.

Back when we were all either contemplating the end of the world as we knew it or laughing at those who were as we rang in the new millennium, another group of individuals was a little miffed with Ingenix and UnitedHealth: the AMA, the Medical Society of the State of New York, and the Missouri State Medical Association. And so, in 2000, they filed a lawsuit charging that United Healthcare Group colluded with others to underpay physicians for out-of-network medical services.

Well, here we are some nine years later and the US District Court for the Southern District of New York has granted preliminary approval of the $350 million settlement that if completely green-lighted will resolve the suit.

The final hearing date is still tbd—but it’ll be with the Hon. D. J. McKenna, US District Judge.

And you thought only patients were getting screwed by those health insurance company out-of-network fees…

Tags: Ingenix, out of network, United Health, United Health Care
Posted in Drugs/Medical | 1 Comment »

James Woods and Hospital Settle Wrongful Death Lawsuit

December 3rd, 2009. By AbiK

After blogging about HAI’s (Healthcare Associated Infections) recently, and recalling some of the recent reports on MRSA, I was thinking about the James Woods trial–the one where his brother, Michael Woods, had gone to the emergency room at Kent Hospital in Rhode Island back in 2006 with a sore throat and vomiting; he wound up dying after a heart attack. The wrongful death lawsuit centered around James Woods’ charge that the hospital didn’t do enough to save his brother’s life.

Well, they’ve settled the lawsuit. Yes, the Woods family did get an “undisclosed” amount of money, but according to the Associated Press, they also got a belated apology from the hospital and an agreement from the hospital that a new institute, the Michael J. Woods Institute at Kent Hospital, will be created to to find ways to reduce human errors at hospitals.

According to AP, “The hospital agreed to invest $1.25 million over the next five years in the institute, which will look at how to reduce the risk of errors based on how humans actually do things, also known as human factors research. Its leadership will include a representative of Michael Woods’ family, as well as experts from inside and outside of the hospital.”

Tags: Hospital Error, James Woods, Wrongful Death
Posted in Drugs/Medical | 3 Comments »

Put the FDA in Charge of Homeopathic Products

December 3rd, 2009. By Hunter West

The Zicam issue brings to the fore yet another issue involving the mandate of the US Food and Drug Administration (FDA), the federal health regulator that has jurisdiction over medical devices and medical drugs—and food. A wieldy mandate indeed and one that, due to funding and staffing issues, the agency has been hard-pressed to undertake effectively. 

That said, naturopathic products, natural-health potions and homeopathic elixirs do not fall under the FDA’s regulatory mandate for approval. 

Given the growing popularity of homeopathic products, the FDA’s mandate should be expanded. 

“Many of our clients believed the FDA had evaluated Zicam before it reached the market,” said lawyer Robert Gordon, a partner with the New York law firm Weitz & Luxenberg. “In fact, Zicam products were not regulated or approved by the FDA because they were listed as homeopathic treatments that use natural ingredients. Mounting evidence from the scientific community is proving Zicam with zinc should never have been sold. Some trusting users are now paying a price with their health.”

The status quo only confuses the public. To be fair, nowhere on the labels for products such as Zicam does it say that the product carries FDA approval. And yet, when there is a problem with a product—homeopathic or otherwise—which agency undertakes the issue of the health alert?

The FDA. The latter is also involved in the negotiation and co-ordination of voluntary product recalls—as it was for Zicam—for products the FDA was not required to approve. That, together with the blurring of the lines between what is medicinal and what isn’t, leaves Joe Q. Public at a loss to explain just who is running the show.

The same holds true for dietary supplements and other weight-loss remedies that use natural ingredients. If it’s homeopathic, then a product does not have to satisfy the FDA before it goes to market.

But here’s the rub: various medicinal ingredients, either on their own or in concert with other ingredients, can elicit side effects and other dangerous risks. Hence the requisite testing required of the manufacturers, with the subsequent vetting through the FDA before the product is approved for sale.

However, just because an ingredient is listed as ‘natural’—a mineral, herb or otherwise—doesn’t automatically suggest it is safe. Natural products can hurt you too, if used in the wrong way and in misguided combination with either another product or in association with an incorrect indication.

People who have used Zicam nasal spray for colds have reported a loss of their sense of smell. Sometimes it is immediate. For others the loss occurred after prolonged use. Some had their sense of smell return after they stopped using Zicam. Others are fearing that their smell loss (and concurrent loss of the ability to taste food) may be permanent, and lawsuits have been launched.

All, because of zinc. Zinc on its own has a benefit to the human body. It’s actually integral, in proper balance with copper, to maintaining a healthy system. However, zinc up the nose is apparently a problem, as various studies and a flood of reports to the FDA now show.

Would this have happened, had this product been required to go through the rigorous FDA approval process?

The FDA is under the gun due to the perception of lax oversight. The agency’s critics cite too many close ties, funding and otherwise, with pharmaceutical companies that only serves to cloud its objectivity. Defenders of the FDA cite the fact that the agency has suffered through years of chronic under-funding and staff shortages and thus cannot hope to cope with a regulatory environment that now sees drugs and medical devices increasingly manufactured offshore.

And now this.

The FDA needs to promote to the American consumer that it does not have jurisdiction over homeopathic products—at least at the approval stage—and therefore the consumer cannot assume that a homeopathic product he is buying comes with the FDA stamp of approval.

Either that, or Congress needs to provide a massive funding and staffing boost to the FDA in order to undertake its current mandate, together with the adoption of a new mandate to regulate the homeopathic industry.

The FDHA—the US Food, Drug and Homeopathic Agency.

Has a nice ring to it.  

Tags: FDA, Homeopathic, Zicam
Posted in Drugs/Medical, Emerging Issues | 9 Comments »

Super Freakonomics, HAI and a new site from Kimberly-Clark

December 1st, 2009. By AbiK

If you’ve read “Super Freakonomics” by Stephen Dubner and Steve Levitt, you’ve read how Dr. Ignaz Semmelweis discovered in the mid-1800’s that doctors washing hands could lower the incidence rate of puerperal fever (often fatal) in the maternity ward at Vienna General Hospital. It’s a timely read—and one that makes you wonder whether we’ve really come a long way baby (couldn’t resist)—given the recent focus in the news on Healthcare Associated Infections (like MRSA).

Things may well be better healthcare infection-wise since the mid-19th century, but none the less, the CDC lists 28 infectious diseases that you can “acquire” in a healthcare setting: Read the rest of this entry »

Tags: CDC, HAI, Healthcare Associated Infections, Hospital Acquired Infections, Hospitals, Kimberly-Clark
Posted in Drugs/Medical | No Comments »

H1N1 Vaccination and Assault and Battery

November 23rd, 2009. By LucyC

When you think of the H1N1 vaccine—do the terms assault and battery also come to mind? Likely not. Well, apparently there are some instances where parents who decided their children should not receive the swine flu vaccine found that their kids had been inoculated by accident. And that constitutes battery, at least according to a New York medical malpractice lawyer. He has issued a press release on the subject, so I would assume this is not an uncommon problem.

 

The incident of a Brooklyn school girl is cited in the press release. Apparently, her parents didn’t sign her up for the vaccine, but she wound getting it anyways and ended up in a hospital. She has epilepsy and one assumes the vaccine somehow caused a serious adverse reaction.

 

“Any unlawful touching or unauthorized administration of medical care not in an emergency situation is a battery, a legal term for an assault. A school district cannot unilaterally administer vaccinations without parental consent, in writing,” the lawyer explained. “If there is a battery,” he is quoted as saying, (medicine given to a child without an emergency situation, or parental consent), “by law the child is entitled to compensatory damages.”

 

Now I would emphasize that the lawyer is only commenting on situations in New York City elementary schools, to the best of my knowledge. And, as always, there are exceptions to the rules, in that in the event of an emergency—schools would be able to provide medical care to the student since they are acting “in loco parentis”—which means instead of the parent—while a child is in their care.

 

The lawyer also warns that school districts and their municipalities are heavily protected against lawsuits…no surprise there…so filing a lawsuit should be a carefully considered decision, as it should be in any event.

 

And, there is a statute of limitations for filing a lawsuit:

 

          “Vaccinating a child without parental consent is a tort that has a one-year statute of limitations. But because the school is part of the City, a parent only has 90 days from the time of the battery to file a Notice of Claim.” And, 90 days means 90 days, not three months.  

 

 

Tags: H1N1 flu, H1N1 Vaccine
Posted in Drugs/Medical, Emerging Issues | 1 Comment »