How a Healthcare Lawyer Helps you Prevent These Costly Mistakes

How a Healthcare Lawyer Helps you Prevent These Costly Mistakes

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Why do you need, or want to hire a healthcare lawyer?

Why get someone who understands health and wellness law, FDA law?

Not just let your business lawyer handle your healthcare practice issues or your health and wellness venture, whether it’s telehealth, mobile medical app, digital platform, or some kind of idea that mediates healthcare and the consumer through technology?

Well, the answer is very simple. Your business lawyer doesn’t speak the language of healthcare law.

Healthcare law is not just about corporate law, not just about drafting documents, but there are also real regulatory risk that you have to face. There are a whole bunch of alphabet soup letter government agencies that are out there. There was a joke when I was a kid, they’d say, “Just because you’re paranoid, doesn’t mean they’re not out to get you.” And I’m not saying that we should not come from a place of fear.

John F. Kennedy said, “Let us never negotiate out of fear, but let us never fear to negotiate.”

And so we need to understand what we’re dealing with. We need to have a realistic sense of the risk. Your business lawyer has no clue how these agencies operate, what their hot buttons on. And just to give you one example, you’re marketing, anything you say, I go back when I was a kid, a lot of kids, I’m dating myself, but a generation before me, a lot of people went to law school because of Perry Mason, really old show, probably more my parents’ generation.

But, when I was six, seven, eight, nine, there was a show called Dragnet. You might remember, “Just the facts ma’am.” I remember in fact, speaking of the cannabis industry, there was a show where they held up this plastic bag and it’s like, “Well, what is that?”

“That’s pot. Kids, you can’t have pot.”

And now, the Dragnet comes in and they say, “Just the facts ma’am, just the facts.”

Well, some parts of the show are dated. Of course, we don’t want pot in elementary schools, but the cannabis industry has matured a lot, but some parts of the show are still the same. And the point of it is that, the regulators are really there, they are in there watching. And so we have, for example, a client who has several clients who were redistributors of products. And so, for example, they had a practice like a medical practice, a chiropractic practice, some type of other clinical practice they were doing just great. And then they bought some kind of gizmo from somebody. And the manufacturer said, well, the gizmo does A, B and C and the client willy nilly repeated that claim on their website.

Now the manufacturer never got in trouble, but the FDA, the FTC, the attorney general, some other regulatory body and, or a private plaintiff all jumped on and basically slammed the healthcare business against the map. Why? Because of a few little words, there are some words that you just cannot say. And if you make claims for your product that are not substantiated by the very high standard for healthcare products, competent and reliable scientific evidence, then it’s false advertising.

So, these are some things that your business lawyer doesn’t know. They don’t know to review your website. They don’t know that you’re marketing claims can get you in trouble. They don’t understand the whole panoply of regulatory risk. In addition to risk that business lawyers deal with, like the risk of getting sued, getting sued will be the least of it, if somebody comes after your medical license. Getting sued, your insurance might handle, but having the FTC come after you for $38 million penalty is not going to be fun.

It’s probably not something you’re insured for. It’s probably not something you’re prepared for. It’s better not to make those three little claims on your website that you got from the manufacturer. And those are the kind of risk that we spot, that we try to prevent, that where we impose our risk mitigation tools. And disclaimers are not the whole answer you’ve got to really anticipate and mitigate risks.

So that’s why you should have a healthcare, FDA and FTC lawyer at your side.

Now why us?

I think part of our unique selling proposition, our USP, if you will, is that we really care. We care and we walk our talk. I can’t tell you for a fact that every person on my staff sits in with their legs folded in lotus and reads Patanjali’s yoga sutras and meditates for 30 minutes, twice daily. I took a course in transcendental meditation.

I did not take the course on levitation, so I don’t know how to lift off the ground. My feet are made of clay and I’m real human and I make mistakes. Not in the law, but plenty of mistakes in my life. And so, it’s interesting as I’m recording this video, people are now talking a lot about politics and the empathy gap and how the empathy gap is something that makes a difference. Well, we don’t have an empathy gap. We’re right there with you, shoulder to shoulder. We’re not gray suited lawyers. I started my career at Davis Polk & Wardwell, and it’s a very large firm, to quote, “White shoe law firm”, we used to call it. Great firm, very prestigious, worked with Morgan Guaranty, Morgan Stanley, of course, I was a cog in a wheel. I wasn’t a partner. I was a lowly associate back then, but I understand the big law firm life and I’ve been there and I have the excellence and I carry in my mind the excellence of the big law firm.

We also close the empathy gap.

We’re right there with you. We love our clients. We love our work.

I taught healthcare law. I’ve written six books, I don’t know, more. Four books published by academic presses. I had a faculty appointment, joint faculty appointment at Harvard School of Public Health and Harvard Medical School. And I had a fellowship at the Harvard Divinity School. So we’re very broadminded and we love the diversity of our clientele. Perhaps we don’t cover every single sub, sub, sub, subspecialty in healthcare law. Maybe just not yet, like being a doctor, you can’t give every single specialty, some things you refer to, but I’m sure that over time we’re going to cover … thank you, bee more and more specialties. And that’s why I record these videos in nature, some of them, I want you to see some of them I have a tie. Some of them I just have a shirt on and we’re right there with you.

We believe in what you do and our mission and our vision is that we provide legal strategies and solutions to businesses and practices that accelerate health and wellness. That’s what it’s about. We think of health and wellness as a continuum, it includes mind, body, environment, spirit, diet, nutrition, fitness, wellness, it’s everything. That’s what I love about healthcare law. That’s why we talked about FDA, which deals with products. That’s why we deal with FTC and false advertising, which has to do with how you market your products. We love all of it. We walk our talk. We live healthy. We strive to have high EQ as well as LQ, legal quotient. And that’s what we bring to you. And that’s part of our unique selling proposition.

So it’s a pleasure to connect with you today. And we look forward to connecting with each one of you and to helping you succeed. That’s our mission. That’s why we’re here. If you have any questions, just get in touch with us. We look forward to speaking with you soon.

Testimonials

  • I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.

    Richard Freedland
    Richard Freedland GRAMedical, CEO
  • Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.

    James Riviezzo
    James Riviezzo Practice On Your Terms

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