[00:00:00] Speaker 02:
237, Ferris versus United States.

[00:01:05] Speaker 01:
Good afternoon, Your Honors.

[00:01:07] Speaker 01:
In this case, the Court of International Trade held that SIGVARIS's graduated compression hosiery was specially designed to relieve symptoms suffered by people suffering from the incurable handicaps of chronic venous insufficiency and lymphedema.

[00:01:28] Speaker 01:
And frankly, the Court's analysis should have stopped there.

[00:01:32] Speaker 01:
Once the Court made those determinations,

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These products had satisfied the requirements for secondary classification under heading 98170096, which implements the Nairobi Protocol to the Florence Convention.

[00:01:49] Speaker 03:
And all that is required.

[00:01:51] Speaker 03:
But doesn't the statute focus on whether it was specifically designed for a person who suffers a substantial impairment

[00:02:02] Speaker 03:
of a life activity.

[00:02:03] Speaker 03:
It doesn't focus on what the nature of the handicap is.

[00:02:07] Speaker 03:
It focuses on the person and whether the person that it's designed for is one who suffers a substantial impairment of a major life activity.

[00:02:18] Speaker 01:
It does not focus on the person, Your Honor.

[00:02:21] Speaker 01:
It focuses on the impairment.

[00:02:23] Speaker 01:
The term in the subheading defines physically or mentally handicapped person.

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not as consisting of people suffering from a physical impairment which substantially limits one or more life activities, but including such persons.

[00:02:42] Speaker 01:
That's language of inclusion, Your Honors.

[00:02:44] Speaker 02:
I don't understand your answer.

[00:02:46] Speaker 02:
I read this as saying precisely that the term person, I mean, Judge O'Malley's point was that this is geared towards what the individual is doing.

[00:02:57] Speaker 02:
And that's exactly what it says.

[00:02:59] Speaker 02:
If the definition says includes any person, that means it's directed to that person who's suffering from a permanent, a chronic physical and mental impairment that substantially limits, yadda da.

[00:03:11] Speaker 01:
And even if your honor read the language that way, our products would qualify because the people who use our products suffer from CVD and lymphedema.

[00:03:22] Speaker 01:
And those are physical impairments that substantially limit one or more life activities.

[00:03:27] Speaker 01:
They are chronic.

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They are incurable.

[00:03:30] Speaker 01:
They are progressive.

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They are ultimately debilitating.

[00:03:34] Speaker 01:
And they have symptoms.

[00:03:36] Speaker 01:
Now, the Nairobi Protocol does not require that the article in question treat symptoms.

[00:03:43] Speaker 01:
There are plenty of examples of articles that have been classified here that have nothing to do with symptoms at all.

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Treat people who are completely asymptomatic.

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And in some cases, the article treats symptoms.

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These articles happen to treat symptoms

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of these debilitating diseases.

[00:04:00] Speaker 02:
Well, the CIT concludes that the symptoms experienced in the early stages do not render someone physically handicapped.

[00:04:08] Speaker 01:
Well, the language in the note says impairment, which substantially limits one or more major life activities.

[00:04:18] Speaker 01:
If the court wants to disassociate the term impairment from the underlying condition, I think that presents a problem.

[00:04:26] Speaker 01:
I mean, a good example would be diabetes.

[00:04:29] Speaker 01:
Customs recognizes that diabetes is a condition that substantially impairs major life activities.

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And customs routinely grants Nairobi protocol treatment to things for the benefit of people with diabetes, even things that do nothing to treat the symptoms.

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For example, a carrying case for diabetes test kit or blood glucose monitor.

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So these things do nothing for the symptoms, but they are designed for the use or for the benefit of people who are suffering from diabetes.

[00:05:04] Speaker 01:
Now, somebody suffering from diabetes may have any sort of a range of symptoms on a given day.

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On one day, their blood sugar may be normal, close to normal.

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But it's only normal because they're treating it.

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It just doesn't randomly become normal.

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It's only normal because they're

[00:05:23] Speaker 03:
testing their blood sugar, they're using insulin, they're taking the medication.

[00:05:29] Speaker 01:
Maybe they're getting treated.

[00:05:30] Speaker 01:
And in fact, it may be because they're taking insulin.

[00:05:33] Speaker 01:
Now, insulin itself, not covered by the Nairobi Protocol, because the Nairobi Protocol doesn't cover drugs and medicines.

[00:05:41] Speaker 01:
But a device that tests somebody and tells them, yes, take insulin, no, don't take insulin.

[00:05:48] Speaker 03:
Because it's specifically designed for a person with the handicap, which is diabetes.

[00:05:54] Speaker 01:
It's designed, yes, it has been held to be specifically designed.

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It could actually, a blood glucose monitor could take the blood sugar level of somebody who doesn't have diabetes.

[00:06:04] Speaker 01:
Now in our case, our products really are specially designed and the court recognized that because our products are engineered products.

[00:06:13] Speaker 01:
What they do is they apply pressure at the ankle, the greatest pressure, graduating up toward the calf.

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And the reason they do that

[00:06:23] Speaker 01:
is because the people they're designed for, remember the lower court said this is specially designed for people suffering from CVD and lymphedema.

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Those people have vein conditions or lymphed conditions where the lymphatic system or the circulatory system does not move blood up back toward the heart.

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And when that happens to you, you are at the mercy of gravity.

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And for people who suffer that affliction, blood, lymph, fluid,

[00:06:54] Speaker 01:
falls to the ground.

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It causes a very painful swelling of legs and ankles.

[00:06:57] Speaker 03:
But isn't there a better analogy here, rather than to people with diabetes, that if there's a product that's specifically designed for someone who might be at risk for diabetes at some point in the future, and the product helps them prevent that risk.

[00:07:11] Speaker 03:
Now, in that case, it wouldn't be covered by the law.

[00:07:13] Speaker 01:
I wouldn't think something that was purely prophylactic would be covered, Your Honor.

[00:07:17] Speaker 03:
And isn't that essentially the findings, though, that were made here?

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That this is a situation where they're not

[00:07:23] Speaker 03:
suffering from a substantial life or substantial impact on a major life function, but instead they are at risk of getting to that point.

[00:07:33] Speaker 01:
Oh, no, not at all.

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I mean, the lower court found that these products were designed for people who are suffering from CVD and lymphedema.

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So that's satisfied.

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Yes, there is that impairment.

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What the court said though, and this is the court's fundamental mistake,

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The court decided, well, we're going to divide the disease.

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We're going to divide the handicap according to a spectrum of symptoms.

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I thought that he said that the court said they were not designed for somebody suffering from CVI, though, right?

[00:08:05] Speaker 01:
No.

[00:08:06] Speaker 01:
The court said they were designed for somebody suffering from CVI.

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But she found that if your symptoms were low, or if you were in the early stages of disease, then in that case, she did not think that CVI

[00:08:19] Speaker 01:
constituted a physical handicap.

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And that's simply incorrect.

[00:08:27] Speaker 01:
She says, I think it's page 18 of the opinion.

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She agrees, all of these things.

[00:08:32] Speaker 01:
She says that these are designed to, specially designed to treat this condition.

[00:08:37] Speaker 01:
They're specially designed, they squeeze your leg so that blood and lymph will move back away from your leg and away from gravity.

[00:08:47] Speaker 01:
And she talks about the symptoms that are suffered by people in the early stages, varicose veins, tired, heavy, achy legs.

[00:08:56] Speaker 01:
These impair your ability to move, to walk, to stand for long periods of time.

[00:09:03] Speaker 01:
People who have these conditions buy these socks and use these socks specifically because without them, they will suffer.

[00:09:12] Speaker 01:
And that's the problem.

[00:09:13] Speaker 01:
And what the court did here.

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First of all, the court latched on to the symptomatic nature.

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And again, Nairobi Protocol goods don't necessarily have to treat symptoms.

[00:09:24] Speaker 00:
If I understand what the Court of International Trade said, it said one, these items are designed to treat mild to moderate conditions, right?

[00:09:34] Speaker 01:
Mild to moderate symptoms of an ultimately debilitating condition.

[00:09:37] Speaker 00:
And you said that mild to moderate isn't a handicap because it doesn't substantially interfere with life activity.

[00:09:44] Speaker 00:
I think that's a problem, Your Honor, because... Am I stating correctly what the Court of International Trade held?

[00:09:51] Speaker 01:
Yeah.

[00:09:51] Speaker 01:
The Court of International Trade made a medical rather than a legal judgment.

[00:09:55] Speaker 01:
The Court of International Trade said, CBI is not a handicap if the symptoms are mild.

[00:10:02] Speaker 01:
And that's not what the law requires the court to do.

[00:10:06] Speaker 01:
And that's a real big problem here.

[00:10:08] Speaker 01:
The Nairobi Protocol provision does not invite the court to play docker.

[00:10:15] Speaker 01:
And that's, I think, what happened here.

[00:10:17] Speaker 01:
And I think it's very important.

[00:10:18] Speaker 02:
So how do you discern whether or not you come within the statutory text that Judge Romali and I were referring to earlier?

[00:10:25] Speaker 02:
If there's a huge span of the symptoms and the effect they have on people, how do you draw the conclusion that it substantially limits one of the major life activities?

[00:10:38] Speaker 01:
Because if you have the condition to the point that you need to apply,

[00:10:44] Speaker 01:
compression to your legs, that's limiting your life activity.

[00:10:49] Speaker 01:
And I think that's what the court needs to understand.

[00:10:53] Speaker 01:
That's a medical judgment?

[00:10:54] Speaker 01:
The only medical testimony was put on by plaintiffs.

[00:10:57] Speaker 01:
Yes.

[00:10:58] Speaker 01:
And the two doctors the plaintiffs had testify indicated that, yeah, this is prescribed for people whose swelling is generally mild.

[00:11:06] Speaker 03:
You know, however- It's so mild that your expert actually testified that essentially they're not much

[00:11:14] Speaker 03:
different from ordinary socks.

[00:11:17] Speaker 01:
They're significantly different from ordinary socks.

[00:11:19] Speaker 03:
The compression is only slightly greater than ordinary socks.

[00:11:24] Speaker 01:
Well, greater.

[00:11:24] Speaker 01:
But the point is it can be slightly greater.

[00:11:27] Speaker 01:
And this is the funny thing.

[00:11:29] Speaker 01:
The customs doesn't even disagree if the compression is higher that these products are orthopedic socks with a handicap.

[00:11:35] Speaker 01:
But where are we going to draw the line between mildly handicapped and grossly handicapped?

[00:11:42] Speaker 01:
And that's the problem.

[00:11:43] Speaker 03:
Well, I mean, the court said that the focus has to be on whether the product at issue is specially designed for handicapped persons according to the statutory meaning, not whether incidental use of the product could help someone who might happen to be handicapped.

[00:11:56] Speaker 01:
Well, she held that they were specially designed for people suffering these lower limb problems.

[00:12:02] Speaker 01:
And what's really interesting is she seizes on the CEAP.

[00:12:05] Speaker 02:
The question is whether those problems satisfy the requirement of substantially limiting one or more major life activities.

[00:12:15] Speaker 01:
And, Your Honor, I believe it does.

[00:12:18] Speaker 01:
I mean, remember, you're not required to be bedridden.

[00:12:21] Speaker 01:
You're not required to be in deep pain.

[00:12:25] Speaker 01:
You know, you're not required to be immobilized in order for this to happen.

[00:12:28] Speaker 01:
I mean, examples we gave included, for example, a suit.

[00:12:33] Speaker 01:
with magnetic closures for people who have arthritis or Parkinson's disease and find it hard to do a button.

[00:12:41] Speaker 01:
The Nairobi protocol does not invite the court to make a judgment about whether that person's arthritis or Parkinson's is severe or not.

[00:12:51] Speaker 01:
The medical judgment tells you that you have this symptom, you have this permanent disease

[00:12:57] Speaker 01:
which if untreated will debilitate you.

[00:13:00] Speaker 01:
These socks treat your condition so that you don't become debilitated or they put it off.

[00:13:06] Speaker 01:
There is an extreme rule of liberality of interpretation of this provision.

[00:13:11] Speaker 01:
This provision is not in competition with any other provision of the tariff.

[00:13:17] Speaker 01:
And what I think is interesting in the lower court took a look at the CEAP scale, which is a medical scale.

[00:13:24] Speaker 01:
that measures the severity of the symptoms of the handicap.

[00:13:29] Speaker 01:
And she said, I'm dividing that in half.

[00:13:32] Speaker 01:
Oh, anything in the scale 0 to 2, not a handicap.

[00:13:36] Speaker 01:
Well, that's not what the medical world is.

[00:13:38] Speaker 01:
Anything 3 and above is a handicap.

[00:13:41] Speaker 01:
And that's a problem because what you're inviting the courts to do here, and they've never done it before.

[00:13:47] Speaker 01:
This is the first court case that ever denied Nairobi protocol treatment to a specially designed article.

[00:13:55] Speaker 01:
You will be inviting the court to make medical judgments, and that's not what this law calls for.

[00:14:03] Speaker 01:
You're into your rebuttal.

[00:14:04] Speaker 01:
I will reserve for rebuttal.

[00:14:05] Speaker 01:
Thank you, Your Honor.

[00:14:09] Speaker 04:
Your Honors, may it please the court.

[00:14:12] Speaker 04:
Plaintiffs' Council of Mr. Peterson has misstated what the trial court's decision actually found.

[00:14:17] Speaker 04:
It found that these goods were designed

[00:14:20] Speaker 04:
for at most varicose veins.

[00:14:22] Speaker 04:
They were not designed for chronic venous insufficiency or lower limb lymphedema.

[00:14:26] Speaker 04:
Those are other products.

[00:14:28] Speaker 03:
Well, I mean, the court specifically said it was specially designed for people with CBD, but at low levels.

[00:14:36] Speaker 04:
Yes, that's right.

[00:14:37] Speaker 03:
It said that.

[00:14:38] Speaker 04:
Yeah, it's designed for lower level CBD, and those are up to varicose veins.

[00:14:44] Speaker 04:
So it's either no clinical symptoms of chronic venous disease or varicose veins, but nothing higher.

[00:14:49] Speaker 04:
That's a different product that is designed for chronic venous insufficiency.

[00:14:52] Speaker 04:
Chronic venous insufficiency describes from edema up to ulcers.

[00:14:57] Speaker 04:
That's not what these products are designed for.

[00:14:59] Speaker 04:
These products are, as we've discussed, are designed for at most varicose veins, but they're also marketed and intended for use as a prophylaxis for pregnant women, if you're traveling long distances.

[00:15:10] Speaker 02:
I don't know anything about the technology, but what about if this hosiery was designed

[00:15:16] Speaker 02:
There's nothing in the record to suggest that this disease is necessarily progressive.

[00:15:25] Speaker 04:
You may just have varicose veins your entire life and that's it.

[00:15:28] Speaker 02:
There's no...

[00:15:37] Speaker 02:
help the progression, deter the progression?

[00:15:41] Speaker 04:
But the statute requires that it be a permanent and chronic impairment that substantially limits the major life activity.

[00:15:47] Speaker 04:
In and of itself, varicose veins or no symptoms or use it as a temporary prophylaxis, that's not a chronic or permanent impairment that's substantially a major life activity.

[00:15:57] Speaker 04:
If you have varicose veins, no clinical symptoms, or you're using this as a temporary prophylaxis, you can walk, you can work, you could

[00:16:05] Speaker 04:
carry out all of life's major activities.

[00:16:08] Speaker 04:
At worst, with those conditions, you may have tired legs at the end of the day.

[00:16:12] Speaker 03:
But in other words, you do those major life activities better if you're wearing a product.

[00:16:18] Speaker 04:
But then, again, there's a performance.

[00:16:22] Speaker 04:
Analogize it to just a different product line that SIGVARS has, which is a sports line.

[00:16:27] Speaker 04:
You see athletes wearing these sleeves and these compression garments on their legs so they can perform better during events.

[00:16:34] Speaker 04:
Absent those products, they're not handicapped and they're the same type of products.

[00:16:39] Speaker 04:
These products here, absent these products, you are just, you are working, you're walking, you're standing.

[00:16:45] Speaker 04:
And again, the record shows that at worst, at very worst, you may have tired legs at the end of the day.

[00:16:51] Speaker 03:
So then doesn't that pose a problem with respect to the specially designed?

[00:16:56] Speaker 03:
finding that the court made that's troubling is that's specially designed for people that suffer from CVD.

[00:17:02] Speaker 03:
I mean, I think the better argument you would have is that they're not specially designed for anyone particularly suffering from anything, just people who want their legs to be less tired at the end of the day.

[00:17:13] Speaker 04:
I completely agree with you, Your Honor.

[00:17:14] Speaker 03:
So what do we do with that factual finding?

[00:17:16] Speaker 04:
I don't think it's factual finding.

[00:17:18] Speaker 04:
I think it's a legal finding because specially designed, it's how that term is used in 9817 in the statute.

[00:17:24] Speaker 04:
I think a more accurate conclusion that the trial court could have made is to say it's just designed for these lower level CVD, but it's not specially designed because specially designed is a term used in the statute to show that it's specially designed for physically handicapped persons.

[00:17:40] Speaker 04:
And that's a finding that the court

[00:17:42] Speaker 04:
that is a decision that the court didn't make, because it said that lower level CVD, which these goods are designed for, does not rise to the level of a good design for physically handicapped persons.

[00:17:59] Speaker 04:
It shouldn't have used the word specially, the lower court.

[00:18:01] Speaker 03:
How do you draw the line, though, between making a medical decision and making a specially designed decision?

[00:18:08] Speaker 04:
I think you have to look at the specific condition, if any,

[00:18:12] Speaker 04:
that the goods are designed for.

[00:18:14] Speaker 04:
So let's look at the specific condition.

[00:18:16] Speaker 04:
And we don't look at the most severe symptoms of that condition.

[00:18:22] Speaker 04:
We don't look at anything beyond the ambit of what those goods are designed for.

[00:18:26] Speaker 04:
There's uncontroversial proof in the record that Sigvarus, they make these goods to appeal to a general population.

[00:18:33] Speaker 04:
They're over-the-counter goods.

[00:18:34] Speaker 04:
You don't need a prescription.

[00:18:36] Speaker 04:
You don't have to be under a doctor's care.

[00:18:38] Speaker 04:
There's no contraindication if you were to just

[00:18:40] Speaker 04:
go to CVS or whatever and buy one of these things and put these on because they're at such a low level of compression.

[00:18:47] Speaker 04:
If you have CVI or an open ulcer, well then you would most likely be under a doctor's care.

[00:18:55] Speaker 04:
It would be a prescription-based.

[00:18:56] Speaker 04:
It would be a custom product, not an over-the-counter product.

[00:19:00] Speaker 04:
And that product would have contraindications because at higher levels of compression, there could be problems with arterial insufficiency.

[00:19:08] Speaker 04:
You don't want to have

[00:19:09] Speaker 04:
You know, problems with blood clots or the like.

[00:19:13] Speaker 04:
But these products are the minimal amount of compression of compression hosiery that are on the market.

[00:19:18] Speaker 04:
They're called class one stocking.

[00:19:20] Speaker 04:
They're in Sigvars' well-being line.

[00:19:22] Speaker 04:
It's their over-the-counter line.

[00:19:23] Speaker 04:
It's not in their sports line.

[00:19:24] Speaker 04:
It's not in their medical line.

[00:19:25] Speaker 04:
They have medical line products.

[00:19:28] Speaker 04:
These are not what we're talking about.

[00:19:29] Speaker 04:
These goods are only designed for, at most, varicose veins.

[00:19:34] Speaker 04:
And they're also as a temporary prophylaxis.

[00:19:36] Speaker 04:
They are not for CVI.

[00:19:38] Speaker 04:
They're not for lower lymphedema.

[00:19:40] Speaker 04:
Those are other products.

[00:19:41] Speaker 04:
Mr. Peterson said that the court found that these are designed for those higher symptoms and for lower lymphedema and CVI.

[00:19:50] Speaker 04:
That's not true.

[00:19:51] Speaker 04:
That's not in the record.

[00:19:55] Speaker 04:
Does this court have any other questions on the government's position or any other matters they would like to address?

[00:20:05] Speaker 04:
Okay.

[00:20:05] Speaker 04:
Thank you, Your Honor.

[00:20:06] Speaker 04:
as the court affirms the trial court's decision below.

[00:20:22] Speaker 01:
Thank you.

[00:20:23] Speaker 01:
On the question of special design, the record reflects that these socks are made in a particular way to apply graduated compression at specific levels, specific millimeters of mercury.

[00:20:36] Speaker 01:
The record indicates that they're made especially on circular knitting machines, which maybe make one sock every 20 minutes.

[00:20:46] Speaker 01:
You can go to the store and expect to pay anywhere from $50 to $70 for a pair of these.

[00:20:51] Speaker 01:
So the special design is very clear.

[00:20:54] Speaker 01:
And the court noted in its opinion, said the symptoms and talked about this being used and prescribed by people who have CVD.

[00:21:03] Speaker 01:
And it says, symptoms experienced by people suffering from the early stages of CBD include varicose veins as well as heavy, tired, and achy legs.

[00:21:15] Speaker 01:
So those are things that substantially impair normal life activities.

[00:21:20] Speaker 01:
Those who are unafflicted by these things may be used to standing, walking for long periods of time.

[00:21:26] Speaker 01:
But if you suffer from CBD,

[00:21:29] Speaker 01:
You're going to have a hard time doing that.

[00:21:31] Speaker 01:
If you have a job in a retail store or as a policeman, you're not going to be able to do it.

[00:21:37] Speaker 01:
These things will never cure your disease.

[00:21:40] Speaker 01:
They will help you get by with them.

[00:21:42] Speaker 01:
And that's all that's required to do it.

[00:21:44] Speaker 03:
What about the point that the government made near the end, which is that the court, especially when it was distinguishing between this hosiery and the compression sleeves, the court said you have to look to

[00:21:58] Speaker 03:
marketing and whether or not there needs to have a prescription, whether or not they're specially designed, whether or not they have to be measured, and found completely different circumstances between the hosiery and the compression sleep.

[00:22:13] Speaker 01:
Nothing in the law suggests that you look to marketing.

[00:22:16] Speaker 01:
The law is definitional.

[00:22:18] Speaker 01:
This product's specially designed for the use of people with physical handicap.

[00:22:23] Speaker 01:
It has a broad expansion of a physical handicap.

[00:22:27] Speaker 01:
You know, the fact that somebody not handicapped might use it is irrelevant.

[00:22:31] Speaker 01:
It's designed for use by the handicap.

[00:22:33] Speaker 01:
If I have no diabetes or no blood problems, I could buy a blood glucose monitor and monitor my blood every day.

[00:22:40] Speaker 01:
What I think is very important is that when you take a look at how the court treated the arm compression sleeves, it did nothing to look into the severity of the handicap.

[00:22:50] Speaker 01:
You know, how bad is the swelling on a particular day?

[00:22:53] Speaker 01:
A woman who's had a mastectomy and lost

[00:22:56] Speaker 01:
Some of her glands may have serious swelling on a given day, no swelling on another day.

[00:23:03] Speaker 01:
And what the court said is, yeah, these things are sometimes used by people suffering that.

[00:23:09] Speaker 01:
And I think in closing, Your Honors, I think the important thing is this is a legal definition and it is a broad definition.

[00:23:17] Speaker 01:
There is a rule of liberality associated with it.

[00:23:20] Speaker 01:
Congress made clear that this was to be given a more liberal interpretation than even the Nairobi Protocol itself.

[00:23:27] Speaker 01:
We do not want to have a situation where the court comes in and makes a medical judgment.

[00:23:34] Speaker 01:
And when the medical doctors say, here's a scale of symptoms of people suffering a recognized permanent debilitating disease, the court comes in and says, well, to this point in the scale, it's not a disease.

[00:23:47] Speaker 01:
It's only a point of a scale.

[00:23:48] Speaker 01:
It's only a disease or handicap after this point in the scale.

[00:23:52] Speaker 01:
That's what the court did here.

[00:23:54] Speaker 01:
And I don't believe this law gives any guide stones that would let future courts make that determination.

[00:24:00] Speaker 01:
So I would urge you to reverse the decision of the Court of International Trade.

[00:24:04] Speaker 01:
Thank you.

[00:24:05] Speaker 01:
Thank you.

[00:24:05] Speaker 01:
We thank both sides.

[00:24:06] Speaker 02:
The case is submitted.

[00:24:07] Speaker 02:
That concludes our proceedings for this morning.

[00:24:10] Speaker 04:
All rise.

[00:24:15] Speaker 04:
The Honorable Court is adjourned until tomorrow morning at 10 AM.