-: It's the matter of Patricia M. Dunn,
The Genzyme Corporation, SJC-12904.
-: Mr. Dougherty.
-: Thank you, Justice Gaziano and the associate justices
who made pleas the court.
My name is John Dougherty,
I represent the appellant, Genzyme corporation.
The issue before the court today is a narrow one.
Does Mrs. Dunn's amended complaint pass muster
under the pleading standard established by this court
in Iannacchino,
in her attempt to assert one more conclusory action
against Genzyme,
that would otherwise be preempted by federal law.
It does not pass an U.S code.
Congress has created, what's been called a narrow gap,
encouraging, plaintiff's state law claim must fit
in order to escape preemption.
That doctrine required Mrs.Dunn's amended complaint,
which by the way
was filed after she was on notice of the preemption issue.
Two alleged facts,
plausibly suggesting A,
that Genzyme violated a federal law or regulation,
B that that alleged violation would be actionable
under Massachusetts law,
in other words it would be identical
or equivalent to a cause of action, Massachusetts.
And of course, thirdly, that there'd be some nexus
between the alleged violation and the alleged injury.
Those facts are not present in the complaint.
-: Attorney Dougherty.
I just want to ask, before you get into that.
Assuming we say that there's a complaint not sufficient,
what would prevent Ms.Dunn from amending her complaint,
or requesting to amend her complaint?
-: What we've argued Justice Budd, it would be futile.
When the original complaint was filed,
it was lots of publicly available information
for her to draw on,
in order to try to support the allegations with facts.
When the amended complaint was filed
she was on notice of the preemption issue.
And as we argued to Justice Clark lee
at the superior court level,
any attempt to amend the complaint at this stage
would simply be futile,
because the facts would not plausibly suggest
that there is a cause of action,
under the laws of the Commonwealth, against Genzyme.
-: So you're saying that there's no way to prove it.
There's information out there,
but that's not gonna help her.
-: I think the information that has been cited,
the information that we're aware of,
would not help her Justice,
but that is our position.
-: Okay, thank you.
-: Justice Lowy, then Justice Kafker,
then Justice Lenk in order.
(chuckles)
-: My question Mr.Dougherty
is probably pretty straightforward.
I don't know what will be the answer, but,
what if the FDA has all the information
and there's no way for the plaintiff to get her hands on?
-: Thank you,
so, first of all, that's counterfactual.
So that's not the case.
The information of, part of the exchange that goes on
between the company and the regulators
under the pre-marketing approval,
is post-approval reporting.
And we would encourage the court
to look at all of the federal appellate cases
that we've cited in the briefs.
Whether or not, they ultimately go for us or against us.
In every one of those cases,
you have specific factual allegations that allow the court
to assess, whether or not there is a federal violation.
In this case,
in fact, in the appellee's brief on pages 13 through 16,
and in the battle of the serve reply, if you will.
All the information in the appellee's sites,
has been publicly available to her,
prior to the filing of the original complaint
in this case.
So there's plenty of information out there and available,
if in fact, there is a violation to allege here.
And I think,
as we take a step back from this case
and take a step back from the question of preemption,
are we in a situation where every case
may have an imbalance of information?
The Supreme Court taught us in Iqbal,
that the lack of information
doesn't allow you to open the door to discovery.
There has to be facts adequately pled,
plausibly suggesting an entirety to relief.
Those facts are not present in this case.
So we don't take the information imbalance,
which you may see across many, many cases.
Remember, over the years
we've developed techniques to deal with that.
There's ways to do investigations or statute limitations,
there's discovery role,
there's lots of ways for us to address that imbalance.
The point is that imbalance doesn't exist in this case.
There's plenty of information out there,
this product has been on the market since 2009.
There's a publicly accessible database
and all safety reporting that's done on this case.
The PMA itself, the safety review body, FDA,
has been sitting up on that website
well before this amended complaint was filed.
So the information is out there
and I don't think we can draw in-
-: I want to take all my colleagues-
-: Thank you, Justice.
-: Thank you, Justice Kafker.
-: Well, I'm confused on the amended complaint issue
for a second.
And I read there's no reply in your reply brief.
And apparently there are examples,
at least two years after this,
of adulterated products, right?
According to the brief, and again,
I have no knowledge if this is true or not,
but again, we're at a motion to dismiss stage,
that when the adulterated product was used
with some of the other people,
they had this immediate, extremely painful reaction.
If they are allowed to file or amend a complaint
that says that,
does that get them over the motion to dismiss?
Because now we tend to allow liberal amendments
in Massachusetts, right?
Why if they allege those facts
and amend a complaint and it survives,
why doesn't it survive the motion to dimiss?
-: Justice Kafker,
because all of the facts that are not part of the complaint
So we've gotta jump over that right?
So they're not properly related, we passed that.
-: Dougherty, I agree.
I read the earlier,
the first complaint is just a list of conclusions.
The abandoned complaint,
adds this idea of adulterated substance
but it doesn't provide any factual detail
of why it's an adulterated substance.
-: Correct.
-: It's also backing my conclusion.
The third, the serve reply is starting to suggest
there's something out there two years later.
That's where I am, go ahead.
-: Yeah, understood.
So, the recall itself, so let's focus on that.
And to answer the question.
The alleged injury in this case,
took place in June of 2015.
The recall happened in December, 2017.
The amended complaint is filed in September of 2018,
recall's publicly known at the end of 2017.
But here's the thing about the recall,
It is one lot, when that happens, the FDA is all over you.
And I think the reason,
that the plaintiff's complaint wouldn't survive
if they were allowed to re-plead that.
Is that there's no nexus
between what happened in that recall,
and her alleged injury.
There is no factual nexus.
Not just that they're temporally distinct
but there's no factual nexus.
-: She's got, again,
I missed the word.
You said there's one line, or one lie.
-: One lot.
-: One lot, okay.
-: One lot, yeah.
-: But, how does she do
a proper adulterated substance complaint?
Does she need to introduce blood data
about what was put into her body
versus what's in this proceeding
what's in this sink back or whatever it's called.
-: Yeah, Synvisc, go on.
-: Does she have to do that at that level of specificity?
How specific does it have, 'cause she doesn't,
does she have access to the chemicals in this stuff?
Is there publicly available data?
-: There's plenty of publicly available data
in terms of the chemicals,
in terms of what is in the product itself,
I'm sure.
I mean, that information, in fact is on the label.
There's lots of published information
about what Synvisc-One is, again,
this is in, on the market.
The FDA studied it quite rigorously.
But to answer your question, Justice Kafker,
I think what we're talking about here,
is what is a plaintiff to do in order to allege those facts.
And if we look across again,
all developed federal appellate cases,
whether it's from the ninth, the fifth,
the 11th, the sixth circuit.
In every one of those, the complaint has detailed facts.
It says for example, there's a warning label.
There is a 43,
what's called a 43 in our business?
It's an inspection report.
Where they come in and look at the manufacturing.
There is a public safety database,
that you and I could go on, and log onto right now,
look up Synvisc-One, and look at all the complaints
safety complaints about Synvisc-One.
And if you look across those other cases
including the three superior court cases in Massachusetts,
that we said in our brief,
in every one of those cases,
that information is publicly available.
The plaintiff is able to muster that information in a way.
And again, if it ties to her injury,
which is an essential requirement here
that if they've been able to allege those facts
in the complaint, with sufficient detail
that the reviewing court can say
it's either plausible or implausible.
We don't have that benefit in this case,
because there are no factual allegations,
other than adulterated,
which is an incredibly broad term in this industry.
It could mean many, many different things.
It's equivalent to saying,
there's a defect, therefore you're liable.
-: In the lot case that you described,
someone identified an improper chemical product.
How was that done?
-: How is the lot, what's the events that lead to the recall?
-: Well, somebody identified that the lot,
the example we're talking about was adulterated, right?
-: If we're talking about Mrs.Dunn's injection.
-: No, I'm talking about just what you said.
There's one adulterated lot or one defected lot,
How did they determine?
-: So, I'm outside the record,
if you permit me, I can give you an answer to that question.
-: Okay well, I guess I shouldn't go there.
-: No, I mean, the general explanation,
and this is publicly available information,
in the quality, as it relates to these companies,
highly regulated, incredibly detailed
very intensive procedures.
There's quality control measures that go all along the way.
The company self-reports,
if there's something that's out of specification.
Because there's testing that's happening at each stage
to make sure that before product is released to the market,
that it meets the standards that the FDA has set down,
and the company itself has set down.
If they find something out of spec,
they issue a recall.
The company will initiate it,
sometimes the FDA casting an assist on it,
but I don't think that's the situation here.
And they go out and grab all that product off the shelf.
So, there's an attempt to look at this
and to bring it all back.
In fact, on recalls what you will find,
is it is quite typical for every company in the FDA
to look beyond the specific event.
So if something happens day one
we notice that there's a contamination here.
They go forward in time and grab everything there.
And they go backwards in time to grab everything there.
They create this buffer around it.
So I don't think the fact that the recall,
that Dunn is attempting to put into the record of this case,
would help her if this case was sent back
and she was allowed to re-plead.
Because not only is there a temporal difference
between her injury and those events,
but what happened in that event is not the injury
that she's complaining about.
-: I think Justice Lenk had a question.
-: Gosh, darn it, I can't keep seeming apart.
-: I can hear you.
(chuckles)
-: Oh, well okay now, all right.
My question has to Iqbal.
On whether or not we're bound by Iqbal?
Because I think it's been widely criticized.
We have, in fact, Massachusetts adopting Iqbal,
and I don't know that we're bound by our own,
we need a very, very, authentic way in this case,
that's in our jurisdiction.
(inaudible)
It's another story entirely.
I guess that my question to you is,
are we really bound by Iqbal?
Are we really round by the federal cases that you cite?
I would think not, but there you have it.
-: Yeah. I'm sorry, just explain.
I think the answer is probably a separate question
as to whether or not you're bound by iqbal.
Let's put that aside because I don't think it matters.
The reason I don't think it matters is because,
in Iannacchino itself,
this court rejected a pleading standard.
That essentially was the old Conway V Gibson standard.
That was the Supreme Court case.
And of course the Nader V Citron standard
that this court had used for many years,
prior to Iannacchino.
But what does Iannacchino teach us?
It teaches us some of the same lessons
that you pull out of Iannacchino.
One, context matters.
Two, the more facts the better.
Three, even if you allege a violation
it doesn't mean that that violation ties to the injury.
So we're calling it Iannacchino,
the point is, in that case not a personal injury case
and not a preemption.
But the plaintiff in that case cited
to a very specific federal door handle statute,
you may recall.
And they said that the Ford motor company
had not followed that.
Now, ultimately what this court did was said, okay
we've got an alleged federal violation here, but
as they looked at the council,
the complaint that they ultimately dismissed,
on the way to get rid of,
going to more of a Twombly standard.
They said there was no linkage
between the violation of that standard
and the injuries that the plaintiffs were complaining about
in that case.
So even if this court were to say,
we're not Iqbal bound,
I think the court would follow Iannacchino.
And I think the teachings of Iannacchino
apply squarely here.
So in the second part of your question, Justice Lenk,
is that you are required to follow any of the federal cases,
federal imbalance cases out there.
And of course there's lots of them.
They're talking about different things.
Is there a high complaining standard?
Isn't there a high complaining standard?
Can it be general?
Does it need to be device specific?
I don't think at the end of the day
that's what your concern is for.
I think they're informative.
I think the reasoning in those cases is instructive.
But I think equally instructive,
is the reasoning of some of the lower court decisions
in the Commonwealth itself.
And we've cited those cases in our brief.
-: Yeah okay, can I just interrupt you and say,
this is my concern with this, which is that,
sometimes it seems to me like
we're putting the cart before the horse here.
Because when I'm listening to you talk about
well, if they were to amend their complaint
to allege this and that,
that would be wrong, because it wouldn't be right.
Because their facts would be wrong.
I mean, that seems to me like
to be something for summary judgment,
not nearly for a motion to dismiss.
It seems to me that, you can't really be arguing
about whether or not their facts are right.
I think it would be dismissal.
-: No, I understand.
And I don't think in fairness, Justice Lenk,
that is what we're arguing about.
We're not arguing about whether their facts are right
we're arguing about whether there are facts.
And I think that's-
(laughs loudly)
-: Okay.
-: And yeah, that's what Iannacchino is teaching us.
That's what we need to look at.
We need to look at facts
and the degree of specificity is gonna vary by case.
Obviously, it's gonna vary by case,
and it's gonna vary by claim.
The amount of facts that you need to put into a complaint
to allege an antitrust violation may be different,
in the amount of facts that you need to put into plea.
Let's put it at the lowest end of the scale,
Ray Simpson.
Mrs.Dunn's complaint is almost Ray Simpson.
Detailed facts about her injury, nothing about how Genzyme
violated a federal law, that would put you in a position
on a de novo review, for example,
to determine what that federal violation is,
let alone get to the next step, which is,
is that actionable under Massachusetts law?
Because there could be federal violations
for which there is no state law equivalent claim,
and those are kind of cited in the briefs.
So we come back to the proposition
that all of that background informs this court,
and what we're asking this court to do,
is simply take Iannacchino and announce
that it's the standard that should apply,
for the parties and the courts,
confronted with a PMA class three preempted claim.
For plaintiff to assert a parallel state law claim,
there must be adequate facts in that complaint
plausibly suggesting a violation.
And that will vary,
but that is where you start.
It's gotta plausibly suggest
that there's a federal violation.
It's gotta plausibly suggest
that there's a nexus between that violation and the injury.
And then we have to plausibly suggest
that Massachusets provides a cause of action
that would not otherwise be preempted.
So we think all the tools, Justice Lenk,
for the decision are already in front of the court.
And we think Iannachhino is the standard,
but that standard should be articulated by this court
to help litigants and the lower courts in the Commonwealth
to understand what to do when confronted
with a preempted medical device case.
And again, the court obviously is not bound
but we've cited the Dwyer case,
a superior court case, the Morris v Rotolo case,
and the Phillips v Medtronic case.
Look at that Phillips case,
that was just as Troy did a very nice job
of kind of walking through the steps and doing the analysis.
So we think all of that is available.
We don't have to create any new law
but we should articulate how that standard applies.
So that there's guidance.
-: Thanks.
-: Any further questions?
Thank you, Mr. Dougherty.
Oh, yeah sorry, Justice Cypher, any question?
-: Just one and that is, attorney Dougherty,
If you were drafting this pleading
what would you include to make it or bring it
to your level of satisfaction?
-: I think you would have to include factual recitations
that show that there is again,
she's alleged her injury adequately.
The facts that aren't alleged, is what the violation is
that Genzyme supposedly committed.
That really is the first step.
And, putting myself in the shoes of the plaintiff,
she has already put in front of you
all the information that's already available to her.
My argument is even if she repackaged that on another try,
it wouldn't be enough.
But if you were-
-: So, if you were the lawyer doing this
you would have to add a fact about
what exactly is defective with the product?
-: That's exactly right, Justice Cypher.
And if you look through those-
-: Is that gonna be as simple as one or two sentences?
-: Well, it could be,
and it depends on what the allegation is.
So for example, in some of the cases that we've cited,
there's like, an implanted device that fails.
The doctor sees that he has to take it out,
he says, "hey, this failed."
They wrote a letter to the company.
The company wrote a letter back,
or there's a warning letter and or inspection report.
Something that says,
"yeah, there's a federal violation here.
"We don't know whether the plaintiff's
"gonna get relief at the end of the day,
"but these are the specific parts of the CFR
"that are violated."
Maybe not specific to the device.
But GMP regulations,
If I put all those regulations
and all the guidances on those regulations,
and all the internal memos of the companies,
it would be a phone book.
It doesn't tell us anything.
-: Justice Kafker.
-: Let me ask a question.
The defective warning claim,
do the warnings for this product indicate
that it's a possibility
that you're gonna have this kind of
terrible pain and outcome from it's injection?
-: Yes, the label does warn of what we call,
injection site reactions.
So that could be swelling in the joints,
which can lead to pain in the knee.
All of that is on the label.
And as we pointed out in our briefs,
she has a fair to warrant claim,
but warrant of what?
And we can't even compare whether
what she's complaining, what wasn't warned of,
is actually already on the label.
There's a lot of information out there.
-: Well, when we watch these on TV,
the ads on medical products,
they go through all these catastrophic possibilities
that can happen,
was one of the part of the warning here, explaining
what would happen to her as she described it,
could possibly happen?
-: Well, as we understand from the allegations
in the complaint,
she got two injections on the same day,
we don't know the position is,
we don't know the conditions under which
any of that was done.
And apparently what happened is,
there was some reaction in her knees
that made it difficult for her to walk,
and then she fell down and suffered her injury.
If you read the label,
it talks about the types of local injection reactions
that you could get.
And it tells people, you may experience this.
So without understanding more about what she says
she didn't know,
and quite frankly, we don't know what her doctor told her.
There's no allegations in the complaint.
And remember, those labels are really for the doctor
to have that informed conversation with the patient.
So we're not really sure what she was told,
but what happened to her, can very easily happen
without there being any problem on Genzyme's part at all.
And that's the difficult, it's not Ray Simpson.
I was injected,
I got sore,
I fell down, I got hurt,
therefore you must be negligent.
That's not the world we're living in here nor should it.
-: Thank you, Mr. Dougherty.
All right if I could go to Mr. Dunn.
Matt: Thank you, may I please the court?
Matthew Dunn, on behalf of the plaintiff, Patricia Dunn.
I apologize for the cut glare that prevents me
from joining in the Zoom,
but I appreciate the opportunity to be before the court.
We see the case, I guess, diametrically opposite
than Genzyme does here.
In this case, the court is asked to weigh
whether an individual who sustained catastrophic
and life altering personal injuries,
immediately after receiving two injections
that's in this one, to forever be precluded
from utilizing Massachusetts courts,
to seek address for those injuries
by asserting viable parallel state law claims
that do not impose any different or additional requirements
and those that are reimposed under federal law.
That a class three, medical device manufacturer
for violating manufacturing and distribution of the product.
Genzyme argues that it should,
simply because it doesn't wanna participate in discovery.
When viewed its like, several balancing of the equities,
in this case, picks the side of Mrs.Dunn's favor.
particularly with such a result
that has already been accepted
by numerous appellate courts, across this country
-: Attorney Dunn, can I ask you a question
before you keep going?
Matt: Yes ma'am.
-: Do you think that your amended complaint does the track,
or do you think that you could amend it even further
to add some detail
that that would make it better, improve it?
Matt: I think it says that the complaint
that is currently pled, is concise and adequate.
However, if the court were to disagree,
would I ask for an opportunity to amend the complaint
based on the guidance of this court,
because this is a case
of first impression before this Commonwealth
as to what needs to be adequately pled,
in order to assert these common law state claims
and that's in a massachusetts court
-: Let me give you an example.
So, you said in the complaint that the defendant violated
a certain current good manufacturing practices
but you don't say which ones.
Matt: Well, the reason for that is because,
I know that my brother had indicated that
all this information is public information.
We disagree with that.
Under federal law, under the PMA approval process.
And I think that's a 21 CFR 814.9, Mrs. Dunn has the access
to Genzyme's specific manufacturing
and distribution practices.
So that was the reason behind the the Bausch v Striker case
with regards to opening the door discovery.
Because the court in that case correctly recognized
that the information that Genzyme is saying
that needs to be fed here,
is only in the possession of Genzyme and the FDA.
And so anybody in Mrs. Dunn's position,
who wants to figure out
how the product that was injected into her knees
and immediately caused more than simply
swelling of her knees or difficulty walking,
but hip myositis
and systematic pseudo-septic, acute arthritis
became adulterated.
And so, that's a locked door for plaintiffs
in Massachusetts, say for,
the ability to proceed through discovery
and obtain information as to Genzyme's manufacturing
and distribution practices.
-: Justice Kafker.
-: So, I listened to you,
just saying something's adulterated ,is a conclusion.
So do we have any evidence that it is adulterated?
Like this chemical methyl bacterium theisonanicum
or whatever it is.
Which was found in the victim-wide.
Do you have any idea whether the product,
I mean, do you have any factual basis
for concluding that it is adulterated?
Or are you just citing the language?
Matt: Well, I think you're onto
that, with regards to that.
I think an inference can be made
that there was something wrong with the product
based on the temporal proximity of the injection
and the injury sustained.
It's almost, and I know my brother disagrees with this
but this is almost arrest,
it's a lock and door type of situation,
where you have-
-: But medical injections,
I take it there's a warning on this product,
that says, a lot of bad things can happen
when you inject it into your knee.
That's your second argument,
the defective warning point, is that not the case,
that one of them is,
you can have really, really bad reactions to your knees
and other things, or is that wrong?
Matt: No, that's correct.
But what we're saying is that,
Genzyme knew or should have known
that there was something wrong with their product,
and that it would cause the type of severe,
immediate reaction, that Mrs. Dunn sustained.
Which is not indicated,
and we don't know what it's called.
-: Mr. Dougherty just told us
that severe reactions are described in the warning label.
I don't have them in front of me.
And I haven't read this in detail.
Is that not the case?
So that do we do a Res ipsa loquitur?
'Cause again, I watch TV every night
and I get the end of those medical ads,
all these disasters can happen.
Is that not the case with this drug?
That there's nothing on the warning label
that indicates it can have a terrible outcome?
Matt: Not of this substance
or this significance, your honor.
My brother's right, -: Are you saying that-
that there is a swelling in the knees and difficulty walking
but systematic pseudo-septic acute arthritis,
It's not on there.
And I think that if anybody had known
that this was an outcome,
then they may have thought twice
about not getting one or two injections of this product.
-: So you're saying that when we look
at the defective warning claim,
when we compare the outcomes to the warning,
there's no way it could be covered
and therefore something was wrong
or the warning was wrong, I'm guessing, is that right?
Matt: Correct.
-: Okay, and then your adulterated product argument,
it's not like you have any scientific basis for it,
but there's just no possibility
unless something else was in it.
Is that your argument?
Matt: Yes, and that the reason why
we can't prove it totally,
and we can't provide that specific information
is because we don't have access
to Genzyme's manufacturing and distribution practices,
because they're confidential under the PMA process.
-: Mr. Dougherty says that the chemicals in this product
are publicly disclosed.
Is that not correct?
Matt: The chemicals used are correct.
But what our argument is that an event occurred,
either during the manufacturing or the distribution process,
that we don't know what happened,
because we can't know what happened,
because it's all subject to how they manufacture
and distribute that product,
is a matter of confidentiality.
-: But again, the chemicals themselves are publicly,
you're saying that there's some stray chemical in there
but you don't have any basis for concluding that.
Like in that lot case,
you're just saying you don't know what the chemical is,
'cause you're assuming something was put in there, right?
Matt: In some way, it became contaminated or adulterated,
based on the-
-: You don't have any medical information from your client,
that indicates some stray chemical,
like methyl, whatever the name is,
was in her system.
Do you?
Matt: I don't have that information at the moment.
No, your honor.
-: Okay, all right, I have no say-
-: Just to get the product examined, I just don't have it.
-: Justice Cipher.
-: Yeah, my question relates to the septic-pseudo arthritis.
You said that was not listed as a side effect?
-: Not that I'm aware of your honor, no.
-: All right, my other question is,
with regard to that adverse reaction
given that it is a septic arthritis,
does that suggest or imply that there is bacteria involved?
Matt: It may be,
the purpose of putting in the information
that the contamination is possible.
That it has happened
and it could have happened in the past,
it's just, we don't have the access to the information
to be able to draw a direct link,
between what happened in 2015, at the Genzyme,
either manufacturing plant
or through its distribution of the product.
-: Okay, thank you.
-: Any further questions for Mr. Dunn?
You have a little bit of time Mr. Dunn, if you wanna sum up.
-: Thank you,
so with regards to the adequacy of the pleading.
The courts where the Iannacchino standard,
we feel that we've met that
based on the information that is available.
That the Genzyme,
The plausibility pleading stair doesn't require a claim
to set out in detail,
the facts on which he or she bases a claim,
rather the claim has facial plausibility
where the plaintiff pleads factual content
and allows the court to draw reasonable evidence,
that the defendant is liable for the misconduct alleged.
And we feel that we've done that,
in the amended complaint.
The factual allegations of the claim
and the favorable emphasis that are drawn from it.
Simple be it,
simple needs to be enough to raise a right of relief,
above the spec at his level.
And we feel we've done that as well.
-: Mr. Dunn, the factual.
Can you point me in some work,
'cause your amended complaint,
I just can't find anything in it,
except for, that the product is adulterated.
Is there anything fact,
and you described your client's injuries,
but there's nothing factually descriptive about the product.
Is there?
-: I'm sorry, your honor,
when you say factually descriptive,
in what context?
-: Meaning, I'm just looking for a fact.
Like, did you mention the septic-pseudo arthritis?
Did you mentioned that in your complaint?
-: Yes.
-: Okay, so that's there.
So that's a fact, we've got.
And didn't you mention that?
That the warning does not mention that?
-: Not in those specific terms,
but that is alleged in different terms.
-: And on the adulterated claim, what facts do we look at
besides the use of the word adult or rated,
is there anything there?
So as referenced in the brief, your honor,
the term adulterated is a term of art
under the United States code.
With regards to supporting facts to show
that it's adulterated, again
it's almost a res ipsa type of argument here,
where you have,
based on the temporal proximity of the injection
and the immediate adverse effects.
And the fact that there's an allegation
in paragraph three of the complaint
that Genzyme was the one that was in control
of designing, producing, manufacturing, marketing,
distributing, packaging, and selling the Synvisc-One,
that was injected into Mrs. Dunn.
So we feel that based on those factors,
the exclusive control and the immediate impact
of the event at the state,
this is a type of injury and severity of an injury,
that doesn't happen in the absence of negligence.
So with regards to the claim,
that the state law claims are somehow preempted,
just like., to point out
that preemption is an affirmative defense,
at Genzyme, lacks ways and proof,
and to do so,
it must show that the claim seeks to impose
a different or additional requirement on it,
that was already required by the FDA and the PMA,
for Synvisc-One.
And that Genzyme itself should do that.
The allegations in this complaint made clear
what this has done, is simply,
seeking a damage remedy from Genzyme,
for violating Massachusetts law.
That parallel the PMA quality Good Manufacturing Practices.
The claims brought, did not impose
any more stringency
to requirements that currently exist in the federal law,
rather than the claims parallel
to the requirements of federal law,
in seeking damage remedy.
This is precisely the scenario that the Supreme court
found in moral and legal,
or state law claims passed through the narrow window
that avoid preemption.
For some guidance on that view,
my brother pointed out to the Phillips case,
but judge Dawson's decision in Brown v Dubois spine
that's cited in my papers,
and I believe it's attached and general
providing an excellent rationale,
why these types of Massachusetts common law claims
are not preempted,
with regards to the specificity of the pleadings.
We're coming to court again to the Bausch V Striker case
at the federal circuit case from the seventh circuit
and would adopt those arguments as well.
But in summary,
the amended complaint is pled with sufficient specificity
that will illustrate the causal connection,
between the Synvisc-One
that was injected into Mrs. Dunn's knees
and the personal injuries that she sustained to satisfy
the plausibility requirement, of Iannacchino
when taken as a whole.
it's also illustrated that Genzyme has failed
to establish it in front of the defense
that are parallel state law claims,
by seeking damage-remedy are preempted by the NBNA.
Mrs. Dunn specifically requested this honorable court,
a hold at the Norfolk superior courts, April 22nd decision
denying Genzyme's motion to dismiss,
the alternative allow her to amend her complaint
to conform to this court's decision.
Thank you, your honor.
-: Thank you Mr. Dunn.
Matters that are rising.