[Congressional Record Volume 144, Number 104 (Wednesday, July 29, 1998)]
[House]
[Pages H6740-H6748]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
[[Page H6740]]
BIOMATERIALS ACCESS ASSURANCE ACT OF 1997
Mr. GEKAS. Mr. Speaker, I ask unanimous consent to take from the
Speaker's table the bill (H.R. 872) to establish rules governing
product liability actions against raw materials and bulk component
suppliers to medical device manufacturers, and for other purposes, and
ask for its immediate consideration.
The Clerk read the title of the bill.
The SPEAKER pro tempore (Mr. LaHood). Is there objection to the
request of the gentleman from Pennsylvania?
Ms. LOFGREN. Reserving the right to object, Mr. Speaker, and I will
not object, but I do want to say how pleased I am and so many of us on
this side of the aisle are to have this wonderful success this evening.
We worked hard, we gained consensus on a bipartisan basis, opponents
have come together for the good of the country, and I think it is
really the way the legislative process should work. I want to thank the
gentleman for his efforts. It has been really a privilege to work on
this, and I know that this will help many in our country who need the
medicine and need the implantables, and they will now be able to get
them.
So, as I say, I reserve the right to object, but I do not object.
Mr. GEKAS. Mr. Speaker, will the gentlewoman yield?
Ms. LOFGREN. I yield to the gentleman from Pennsylvania.
Mr. GEKAS. Mr. Speaker, I thank the gentlewoman not just for yielding
this time to me, but for the continuous effort that she has expended in
promoting the final moments which we are enjoying of the passage of
this bill.
As the gentlewoman knows, some 7 million fellow Americans are at this
very moment living better lives because of the medical devices which
have been developed over the years and which were in danger of being
stopped dead in their tracks by the lack of the flow of materials,
basic materials needed in their manufacture. So this bill will go a
long way in guaranteeing to the people who look forward to these
medical devices in the near and far future.
We also want to put on the record the fact that the administration
has nodded its head and given advanced approval of the bill so the
prospects for its being signed into law are excellent.
Mr. BILBRAY. Mr. Speaker, will the gentlewoman yield?
Ms. LOFGREN. I yield to the gentleman from California.
Mr. BILBRAY. Mr. Speaker, I would just like to thank the gentleman
from Pennsylvania (Mr. Gekas) for this important piece of legislation.
As my colleagues know, we asked the gentleman to take on this cause,
and let me just say I would like to thank the gentleman from
Pennsylvania and the gentlewoman from California for the cooperative
effort for those who need the implants and the biomaterials here, that
we are talking about here today. And let me just say I would like to
sort of congratulate my colleagues in the name of Titus, the young man
who depends on shunts to be able to stay alive every day and was
basically concerned that because of liability and the problems of
liability, the biomaterials that make those shunts to keep him alive
could be restricted from his position so that he could continue the
happy life and the very active life.
If my colleagues met Titus, they would know what I mean. He is one of
my constituents, is a young man that I look forward to watching him
grow up and become prosperous, and with this kind of legislation, Mr.
Speaker, I want to thank my colleagues in the name of Titus and for all
the children and all the citizens in America that will be served by
those biomaterials that might have been denied to people who
desperately need them for life and limb.
Ms. LOFGREN. Reclaiming my time, Mr. Speaker, I would like to say
that this bill is a very fair accommodation that will provide the
relief necessary to keep materials in the marketplace, yet provides an
opportunity should judicial relief be required to be made available.
So it strikes the exact right balance, I am proud to be associated
with it, and as we have all noted at the Committee on the Judiciary, we
believe that this measure should not be expanded in any way. We have
got it where it needs to be, we all agree, and I am glad that we stand
firm in that across the aisle.
Mr. GEKAS. Mr. Speaker, will the gentlewoman yield further?
Ms. LOFGREN. I yield to the gentleman from Pennsylvania.
Mr. GEKAS. Mr. Speaker, I am glad that the gentleman from California
(Mr. Bilbray) brought up the name of little Titus. He actually came
with me at one point and sat on my knee as we both testified jointly
before the relevant committee in the subcommittee of the Committee on
Commerce, and I must say that he carried the day with the poignancy of
the need of the special device which carries his life forward, and so
he with young Tara Ransom it was, Tara Ransom also a child who needs
this continuation of the medical device syndrome to survive, also
testified, and thus we have a nationwide effort, shall we say, that has
brought us to this moment.
Mr. BURR of North Carolina. Mr. Speaker, would the gentlewoman yield?
Ms. LOFGREN. I yield to the gentleman from North Carolina.
Mr. BURR of North Carolina. Mr. Speaker, I wanted to rise in support
of H.R. 872, the Biomaterials Access Assurance Act.
Biomaterials are the raw materials or component parts used by
manufacturing companies to make implantable medical devices. Almost 8
million Americans have had their lives saved or improved by
biomedicals, including anyone using a pacemaker, a heart valve, a hip
joint, a knee joint or who have received sutures during surgery.
Last year the Committee on Commerce found that only 25 percent of the
biomaterials companies are currently willing to supply implant
manufacturers with necessary raw materials for production of medical
devices. The other 75 percent have banned sales of their raw materials
to medical implant markets in the United States. This means that in the
United States my colleagues and their families may no longer be able to
get the pacemaker or heart valve or knee joint, once stockpiles run
out.
Why are these companies no longer willing to provide these lifesaving
products? One hundred percent of the companies surveyed stated that a
key factor driving them out of the American market was our out-of-
control legal system that is bankrupting their operations.
{time} 0050
Tens of millions of dollars are being wasted on litigation cost for
biomaterials suppliers to protect themselves from liability. Tens of
millions of dollars that could be spent on research or making health
care more affordable for the American people.
Any American who has been sued knows how the system works. Even if
they are innocent, they risk going broke just to pay their legal fees
to prove themselves in the case against them.
This bill does not protect the manufacturer of medical devices. They
will still be liable to the injured victim for defective products. Nor
does this bill protect the seller of medical devices. Consumers will
still have every opportunity to get their full recoveries from the
responsible parties.
This bill merely says that the entities who provide the raw materials
used in medical devices, but do not manufacture or sell the device,
and, therefore, are never found liable by the courts should not have to
prove themselves out of the same types of litigation year after year
after year.
H.R. 872 was reported unanimously out of the Committee on Commerce
and has been negotiated on a bipartisan, bicameral basis with the
participation and assistance of the administration.
Eight million Americans are relying on us to protect the continued
supply of raw materials used for medical devices.
I urge everyone in this House to support this unanimous consent
request.
Mr. MORAN of Virginia. Mr. Speaker, I rise today in support of the
Biomaterial Access Assurance Act.
When companies decide to stop producing certain life-saving products
because of the threat of costly litigation, we have reached the point
in our society where our urge to protect smothers our ability to heal.
Medical implants such as heart valves, joint implants, and brain
shunts save or improve the lives of more than 7.5 million people every
[[Page H6741]]
year. The worldwide market for medical devices exceeds $100 billion,
with about half of that supplied by American firms.
Biomaterials are the raw materials, such as silicone, polyester,
urethane, and polyropylene, used to make medical devices. The already
small number of U.S. firms that produce these materials is shrinking,
as businesses face the threat of scatter-shot lawsuits. Under U.S.
product liability laws, any party involved in the creation of a
product--even remote contributors--may be included in product liability
litigation.
It is a troubling paradox that now, when the opportunity for
technical innovation in the use of medical implants has never been
greater, Americans are being robbed of the benefits of these products.
Dupont decided in 1994 to halt the supply of three materials used in
medical implants because the sale of small amounts of these marginally
profitable materials exposed Dupont to very expensive product liability
lawsuits, even if Dupont won.
The growing fear of litigation has led 14 suppliers to cut the supply
of biomaterials to the medical implant market, with many certain to
follow. The uncertainty surrounding the supply of biomaterials has
already caused a technological slowdown. Companies are reluctant to
push forward with new product ideas they're not sure they can ever
afford to insure, manufacture and market.
Suppliers of raw biomaterials (mostly small companies) who do not
make or design medical devices should not be held responsible when a
manufactured product allegedly malfunctions. This protection from
litigation is included in the Biomaterial Access Assurance Act.
This biomaterials reform legislation will not hold the manufacturers
of faulty biomaterial products harmless. The ability to sue a supplier
is maintained in the legislation if the biomaterial is defective, fails
to meet contractual agreements, or where the supplier is also the
manufacturer.
Putting small high-tech firms that make implantable medical devices
out of business is an unfortunate economic consequence of our society's
litigious nature. These firms should be nurtured and supported, not run
out of business because they can't afford the cost of lawsuits, the
vast majority of which they win, but which nevertheless soak up
valuable financial and human resources.
Opponents of product liability reform often speak of their concern
for the victims of defective products. But unless we enact this
legislation, we could soon have more than 7.5 million more victims--
those individuals who depend on medical devices made with biomateials.
I must admit to a certain personal interest in this subject. There is
a medical implant, a small brain shunt, in my daughter Dorothy's head
that serves as a relief valve so that the pressure from any fluid
buildup from cancer growth can be relieved. I don't even know the name
of the company that supplied the materials for the brain shunt. Yet I'm
told by her doctors that our current short-sighted product liability
laws may force the company that helped save my daughter's life to
forego supplying any more such low-cost shunts.
In 1994, when Dorothy was diagnosed with brain cancer, her doctors
gave her 50/50 odds of reaching her fifth birthday. Dorothy turned six
last month, and will attend first grade in September. Her ongoing
recovery is attributable to many factors, the shunt in her hand being
only one. And yet the supplier of the material that forms that shunt
might pull its product off the domestic medical device market, if it
hasn't already, because of the looming danger of financial ruin posed
by potential product liability lawsuits.
We can protect biomaterials suppliers, and provide a better quality
life for the recipients of medical devices, by passing this bill.
Mr. MARKEY. Mr. Speaker, I rise in support of H.R. 872, the
``Biomaterials Access Assurance Act.''
Modern medical science has produced true miracles, and we want to
encourage continued innovation in this area. We all want to assure that
those who suffer from injury or illness can get access to the
treatments and technologies needed to treat or cure them. At the same
time, however, we must recognize that consumers deserve protection from
defective or unsafe medical devices or drugs. Since that the FDA cannot
always be safely relied upon to prevent dangerous or unsafe drugs or
medical devices from reaching the market, consumers currently depend on
our system of tort law to compensate them for the harm caused by such
products and to create incentives for product and materials
manufacturers and suppliers to undertake rigorous product testing,
issue appropriate warnings, and obtain sufficient insurance or
indemnification to guard against litigation risks.
While I am generally skeptical about the notion of carving an entire
class of persons out of tort liability, I agree that we should assure
that patients can obtain access to critically needed medical devices.
The House today is presented with a more narrow and limited
biomaterials bill, which represents a significant improvement over
previous incarnations and minimizes the prospect that injured consumers
would be unable to obtain appropriate redress and compensation.
Specifically, the bill before us today addresses the three concerns I
had raised about legislating in this area in the Subcommittee's
oversight hearing last year. First, it is a free-standing biomaterials
bill, and not part of a broader product liability reform effort.
Second, the so-called ``English Rule'' of the original bill has been
dropped, which would have forced losing litigants to pay litigation
costs. Third, and most importantly, an effort has been made in the
impleading provisions of the bill to address the concerns I raised in
the hearing regarding the need to assure that fraudulent suppliers
could be held liable for their actions.
These are all positive changes, and in light of their adoption I
intend to support this legislation today. I do wish to note, for the
record, however, that I continue to have some concerns about the
extension of the bill to cover manufacturers of component parts in
addition to raw material suppliers. While I understand the arguments
made in support of this legislation as it relates to the supply of raw
materials, this bill also protects the manufacturers of ``component
parts'' of implantable devices. Raw materials, such as silicone or
polyethylene, are vastly different subject matter from components,
which can be as technically diverse as batteries, tubes, wiring and
pacemaker leads. Yet there is little, if any, substantiation in the
legislative record for broadening H.R. 872's protections to the
manufacturers of such components. While I, the gentleman from
California (Mr. Waxman) and others on this side of the aisle support
the bill moving forward, we believe liability protection for
manufacturers of component parts should be very carefully reviewed
before this bill achieves final passage. If the provision remains in
the bill, it should be construed as narrowly as possible to avoid
unintended consequences of limiting liability of the makers of the
manufactured pieces of such devices. I hope that we can work in
conference to address these concerns.
In addition, I am concerned about reports that an effort may be
underway to use this biomaterials bill as a vehicle to get into
conference on a broader product liability legislation, or to broaden
the scope of the bill to cover other medical devices. I want to caution
strongly against either course of action. My support is contingent on
one very specific understanding: that this legislation not be expanded
beyond the form reported by the Commerce Committee.
I would, for example, be strongly opposed to changes in which FDA-
regulated products are included within the class of biomaterials that
receive special protections in this bill. On June 23, 1998, we received
a letter from Jim Benson, executive vice president of the Health
Industry Manufacturers Association (HIMA), assuring us that it is the
intention of that organization to oppose any efforts to change the bill
as reported or encumber it with other legislative items. I commend HIMA
for taking this stance.
This possibility is not mere speculation. On July 9, 1998, the New
York Times reported that Senate Majority Leader Lott had handwritten an
amendment into the Senate version of H.R. 872 on behalf of a major
medical device manufacturer, Baxter International. Baxter recently lost
a $18 million lawsuit to the family of Andrina Hansen, who suffered
severe brain damage because of a faulty Baxter Intravenous, or IV,
connector.
In 1991, Mrs. Hansen underwent surgery for a bleeding ulcer. After
successful surgery, the disconnection of a postoperative IV forced air
into her brain, causing a stroke. Mrs. Hansen spent four years in a
nursing home as a quadriplegic before she died. When her family took
legal action, all defendants settled except Baxter Healthcare, a
subsidiary of Baxter International and the manufacturer of the faculty
IV connector.
According to the court record, Baxter's internal memoranda documented
the company's awareness that its IV connector design allowed IV tubing
to slip. This defect was also the subject of almost 70 lawsuits over 20
years. Baxter also manufactured a newer, improved connector which
prevented fatal incidents like Mrs. Hansen's. But Baxter never warned
patients or health providers of these problems.
The proposed Senate amendment would insulate Baxter and similar
underserving manufacturers of component parts of ``containers and their
related products to be used to collect fluids or tissue from the body
or to infuse or to otherwise introduce fluids or tissue into the body''
from liability for defective and dangerous products. This would be true
even if it was the component, such as Baxter's defective IV connector,
and not the entire device which was the cause of injuries or deaths.
In a July 10 letter to Senate Majority Leader Lott, Alan Magazine,
president, and Ronald
[[Page H6742]]
Dollens, chairman-elect of HIMA wrote of their organization's ``very
serious concerns about expanding [H.R. 872] to medical devices not
considered during the four-year long debate on this legislation.''
I take HIMA at their word in this commitment, and commend them for
making it. I also accept the assurances of our colleagues on the
Commerce Committee that passage of this bill without amendment is their
intention. But if that is not the case--if this bill is amended
adversely or becomes a vehicle for unwarranted Senate changes--then I
will not support it and in fact will do all I can to see that it does
not become law.
In its present form, however, this is a limited bill that I think the
Members can and should support. Thank you, Mr. Speaker, and I yield
back the balance of my time.
Mr. CUNNINGHAM. Mr. Speaker, I rise today in support of the
Biomaterials Access Assurance Act. I want to thank my colleague, Mr.
Gekas, and the Committee Chairmen, Mr. Hyde and Mr. Bliley, for
bringing this important legislation forward.
This legislation seeks to alleviate a critical shortage of
biomaterials available to our nation's medical device manufacturers.
Biomaterials are the raw materials and component parts that go into
life-saving and life-enhancing medical implants and devices. These
devices include heart valves, prosthetics, brain shunts, and many other
devices that provide an unmeasurable benefit to the lives of millions
of Americans. Our citizens can only continue to enjoy these benefits if
the biomaterials that go into such devices remain available.
This legislation will ensure that patients have access to the
biomaterials and medical devices that they need. Over the last several
years, I have met with researchers and doctors who manufacture medical
devices. Each time we meet they stress the importance of this
legislation and show another area of critical shortage in biomaterials
which could prevent them from making the medical devices which save
lives.
I have also met with parents and children who suffer from diseases
which require these important medical devices. One of these young men
is Titus Simonini, 5, who suffers from Hydrocephalus, a condition in
which spinal fluid is blocked and builds up in the brain, often causing
brain damage, paralysis and death. Titus' condition is treated through
the implantation of silastic shunts, a silicon-coated device that
regulates the fluid and prevents the buildup in the brain. These shunts
are manufactured by only two small suppliers in the entire country.
Without this legislation we are approaching the day when children like
Titus won't have these products that make their lives possible.
The Biomaterials Access Assurance Act protects biomaterials suppliers
from the litigation that swarms to them whenever they sell to the
medical device market, even though they take no part in the design,
testing, or sales of medical devices. The Biomaterials Access Assurance
Act gives biomaterials suppliers a quick exit from lawsuits in which
they would not be found liable anyway.
With regards to this important issue, it is equally important to
stress what this bill does not do. The bill does not protect anyone who
is involved in the design, testing, manufacture, or sale of medical
implants. The bill also does not allow biomaterials suppliers to be
negligent or fraudulent in their sale of materials to the medical
market. As everyone knows, medical implants are intricately designed
and rigorously tested in the FDA approval process. The specifications
and tolerances of the materials that go into these devices are very
precise and very narrow. If a biomaterials supplier fails to meet
contractual specifications or specifications given to the Food and Drug
Administration in the premarket approval process, the protections of
this bill evaporate.
Now, these are narrow, technical points that should not detract from
the main focus of this legislation. The threat to biomaterials access
is a problem on which Congress must take action. With the protections
of this legislation material suppliers will continue to provide
important components for medical devices that help Americans live
healthier and more productive lives. I encourage all of my colleagues
to support this important legislation.
Mr. BERMAN. Mr. Speaker, I rise in strong support of H.R. 872, the
Biomaterial Acccess Assurance Act.
I believe a persuasive case has been made that many medical device
manufacturers face a shortage of raw materials and component parts as a
result of their suppliers' exposure to tort claims. It troubles me that
consumers could be denied access to life-saving and life-enhancing
products, and it is for this reason that I have long engaged in efforts
to seek a legislative solution to the problem.
The manufacturers who have made the most compelling case to me are
people I have known for years in my own state of California. Many of
them are small companies who depend for critical supplies on corporate
giants. Because of their deep pockets, these suppliers are almost
invariably brought in as co-defendants in lawsuits brought against
device manufacturers. Because the device manufacturers are often an
inconsequential segment of the market for their raw materials and
components, the suppliers have increasingly refused to sell to them.
This is the problem we need to solve. But as strongly as I feel about
our responsibility to act, I did not embrace this bill as originally
introduced. I felt that it was wrong to completely shield the supplier
who may have a degree of culpability for a faulty device.
That is why I was heartened that further efforts were made to improve
the bill in committee, by spelling out means by which the supplier,
though initially dismissed, can be brought back into the lawsuit.
I believe the appropriate balance has now been struck between
consumer protection from faulty devices and consumer access to life-
saving and life-enhancing devices. For that reason, I enthusiastically
support the bill we have before us today.
I am compelled to make one further statement. I emphatically believe
the case has been made for H.R. 872 in the form in which it is
presented to us today. I do not believe the case has been made for an
expansion of the bill beyond its present countours.
To be more precise, I am well aware that efforts have been made to
expand the scope of the bill to include devices that do not fit the
term ``implant'' as defined in the bill, thereby sweeping in devices
and materials used outside of the body.
I want to be very clear that I will withdraw my support for this bill
if along the way it is expanded beyond its present terms either by
broadening its scope or enrolling it into a broader product liability
bill. Today's floor consideration has long been sought by myself and
other supporters of this bill. But it would be snatching defeat from
the jaws of victory than for anyone to alter the careful balance
achieved by this bill.
I profoundly hope that we can pass this bill today and have it
quickly taken up by the other body, so that the millions of Americans
who depend on life-saving and life-enhancing medical devices can be
assured that they can continue to rely on the products of America's
peerless medical technology industry.
Ms. LOFGREN. Mr. Speaker, I withdraw my reservation of objection.
The SPEAKER pro tempore (Mr. LaHood). Is there objection to the
request of the gentleman from Pennsylvania?
There was no objection.
The Clerk read the bill, as follows:
H.R. 872
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Biomaterials Access
Assurance Act of 1997''.
SEC. 2. FINDINGS.
The Congress finds that--
(1) each year millions of citizens of the United States
depend on the availability of lifesaving or life enhancing
medical devices, many of which are permanently implantable
within the human body;
(2) a continued supply of raw materials and component parts
is necessary for the invention, development, improvement, and
maintenance of the supply of the devices;
(3) most of the medical devices are made with raw materials
and component parts that--
(A) are not designed or manufactured specifically for use
in medical devices; and
(B) come in contact with internal human tissue;
(4) the raw materials and component parts also are used in
a variety of nonmedical products;
(5) because small quantities of the raw materials and
component parts are used for medical devices, sales of raw
materials and component parts for medical devices constitute
an extremely small portion of the overall market for the raw
materials and medical devices;
(6) under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), manufacturers of medical devices are
required to demonstrate that the medical devices are safe and
effective, including demonstrating that the products are
properly designed and have adequate warnings or instructions;
(7) notwithstanding the fact that raw materials and
component parts suppliers do not design, produce, or test a
final medical device, the suppliers have been the subject of
actions alleging inadequate--
(A) design and testing of medical devices manufactured with
materials or parts supplied by the suppliers; or
(B) warnings related to the use of such medical devices;
(8) even though suppliers of raw materials and component
parts have very rarely been held liable in such actions, such
suppliers have ceased supplying certain raw materials and
component parts for use in medical devices because the costs
associated with litigation in order to ensure a favorable
judgment for the suppliers far exceeds the total potential
sales revenues from sales by such suppliers to the medical
device industry;
[[Page H6743]]
(9) unless alternate sources of supply can be found, the
unavailability of raw materials and component parts for
medical devices will lead to unavailability of lifesaving and
life-enhancing medical devices;
(10) because other suppliers of the raw materials and
component parts in foreign nations are refusing to sell raw
materials or component parts for use in manufacturing certain
medical devices in the United States, the prospects for
development of new sources of supply for the full range of
threatened raw materials and component parts for medical
devices are remote;
(11) it is unlikely that the small market for such raw
materials and component parts in the United States could
support the large investment needed to develop new suppliers
of such raw materials and component parts;
(12) attempts to develop such new suppliers would raise the
cost of medical devices;
(13) courts that have considered the duties of the
suppliers of the raw materials and component parts have
generally found that the suppliers do not have a duty--
(A) to evaluate the safety and efficacy of the use of a raw
material or component part in a medical device; and
(B) to warn consumers concerning the safety and
effectiveness of a medical device;
(14) attempts to impose the duties referred to in
subparagraphs (A) and (B) of paragraph (13) on suppliers of
the raw materials and component parts would cause more harm
than good by driving the suppliers to cease supplying
manufacturers of medical devices; and
(15) in order to safeguard the availability of a wide
variety of lifesaving and life-enhancing medical devices,
immediate action is needed--
(A) to clarify the permissible bases of liability for
suppliers of raw materials and component parts for medical
devices; and
(B) to provide expeditious procedures to dispose of
unwarranted suits against the suppliers in such manner as to
minimize litigation costs.
SEC. 3. DEFINITIONS.
As used in this Act:
(1) Biomaterials supplier.--
(A) In general.--The term ``biomaterials supplier'' means
an entity that directly or indirectly supplies a component
part or raw material for use in the manufacture of an
implant.
(B) Persons included.--Such term includes any person who--
(i) has submitted master files to the Secretary for
purposes of premarket approval of a medical device; or
(ii) licenses a biomaterials supplier to produce component
parts or raw materials.
(2) Claimant.--
(A) In general.--The term ``claimant'' means any person who
brings a civil action, or on whose behalf a civil action is
brought, arising from harm allegedly caused directly or
indirectly by an implant, including a person other than the
individual into whose body, or in contact with whose blood or
tissue, the implant is placed, who claims to have suffered
harm as a result of the implant.
(B) Action brought on behalf of an estate.--With respect to
an action brought on behalf of or through the estate of an
individual into whose body, or in contact with whose blood or
tissue the implant is placed, such term includes the decedent
that is the subject of the action.
(C) Action brought on behalf of a minor or incompetent.--
With respect to an action brought on behalf of or through a
minor or incompetent, such term includes the parent or
guardian of the minor or incompetent.
(D) Exclusions.--Such term does not include--
(i) a provider of professional health care services, in any
case in which--
(I) the sale or use of an implant is incidental to the
transaction; and
(II) the essence of the transaction is the furnishing of
judgment, skill, or services;
(ii) a person acting in the capacity of a manufacturer,
seller, or biomaterials supplier; or
(iii) a person alleging harm caused by either the silicone
gel or the silicone envelope utilized in a breast implant
containing silicone gel, except that--
(I) neither the exclusion provided by this clause nor any
other provision of this Act may be construed as a finding
that silicone gel (or any other form of silicone) may or may
not cause harm; and
(II) the existence of the exclusion under this clause may
not be disclosed to a jury in any civil action or other
proceeding and, except as necessary to establish the
applicability of this Act, otherwise be presented in any
civil action or other proceeding.
(3) Component part.--
(A) In general.--The term ``component part'' means a
manufactured piece of an implant.
(B) Certain components.--Such term includes a manufactured
piece of an implant that--
(i) has significant non-implant applications; and
(ii) alone, has no implant value or purpose, but when
combined with other component parts and materials,
constitutes an implant.
(4) Harm.--
(A) In general.--The term ``harm'' means--
(i) any injury to or damage suffered by an individual;
(ii) any illness, disease, or death of that individual
resulting from that injury or damage; and
(iii) any loss to that individual or any other individual
resulting from that injury or damage.
(B) Exclusion.--The term does not include any commercial
loss or loss of or damage to an implant.
(5) Implant.--The term ``implant'' means--
(A) a medical device that is intended by the manufacturer
of the device--
(i) to be placed into a surgically or naturally formed or
existing cavity of the body for a period of at least 30 days;
or
(ii) to remain in contact with bodily fluids or internal
human tissue through a surgically produced opening for a
period of less than 30 days; and
(B) suture materials used in implant procedures.
(6) Manufacturer.--The term ``manufacturer'' means any
person who, with respect to an implant--
(A) is engaged in the manufacture, preparation,
propagation, compounding, or processing (as defined in
section 510(a)(1)) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(a)(1)) of the implant; and
(B) is required--
(i) to register with the Secretary pursuant to section 510
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360)
and the regulations issued under such section; and
(ii) to include the implant on a list of devices filed with
the Secretary pursuant to section 510(j) of such Act (21
U.S.C. 360(j)) and the regulations issued under such section.
(7) Medical device.--The term ``medical device'' means a
device, as defined in section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h)) and includes any
device component of any combination product as that term is
used in section 503(g) of such Act (21 U.S.C. 353(g)).
(8) Raw material.--The term ``raw material'' means a
substance or product that--
(A) has a generic use; and
(B) may be used in an application other than an implant.
(9) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(10) Seller.--
(A) In general.--The term ``seller'' means a person who, in
the course of a business conducted for that purpose, sells,
distributes, leases, packages, labels, or otherwise places an
implant in the stream of commerce.
(B) Exclusions.--The term does not include--
(i) a seller or lessor of real property;
(ii) a provider of professional services, in any case in
which the sale or use of an implant is incidental to the
transaction and the essence of the transaction is the
furnishing of judgment, skill, or services; or
(iii) any person who acts in only a financial capacity with
respect to the sale of an implant.
SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.
(a) General Requirements.--
(1) In general.--In any civil action covered by this Act, a
biomaterials supplier may raise any defense set forth in
section 5.
(2) Procedures.--Notwithstanding any other provision of
law, the Federal or State court in which a civil action
covered by this Act is pending shall, in connection with a
motion for dismissal or judgment based on a defense described
in paragraph (1), use the procedures set forth in section 6.
(b) Applicability.--
(1) In general.--Except as provided in paragraph (2),
notwithstanding any other provision of law, this Act applies
to any civil action brought by a claimant, whether in a
Federal or State court, against a manufacturer, seller, or
biomaterials supplier, on the basis of any legal theory, for
harm allegedly caused by an implant.
(2) Exclusion.--A civil action brought by a purchaser of a
medical device for use in providing professional services
against a manufacturer, seller, or biomaterials supplier for
loss or damage to an implant or for commercial loss to the
purchaser--
(A) shall not be considered an action that is subject to
this Act; and
(B) shall be governed by applicable commercial or contract
law.
(c) Scope of Preemption.--
(1) In general.--This Act supersedes any State law
regarding recovery for harm caused by an implant and any rule
of procedure applicable to a civil action to recover damages
for such harm only to the extent that this Act establishes a
rule of law applicable to the recovery of such damages.
(2) Applicability of other laws.--Any issue that arises
under this Act and that is not governed by a rule of law
applicable to the recovery of damages described in paragraph
(1) shall be governed by applicable Federal or State law.
(d) Statutory Construction.--Nothing in this Act may be
construed--
(1) to affect any defense available to a defendant under
any other provisions of Federal or State law in an action
alleging harm caused by an implant; or
(2) to create a cause of action or Federal court
jurisdiction pursuant to section 1331 or 1337 of title 28,
United States Code, that otherwise would not exist under
applicable Federal or State law.
SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.
(a) In General.--
(1) Exclusion from liability.--Except as provided in
paragraph (2), a biomaterials supplier shall not be liable
for harm to a claimant caused by an implant.
[[Page H6744]]
(2) Liability.--A biomaterials supplier that--
(A) is a manufacturer may be liable for harm to a claimant
described in subsection (b);
(B) is a seller may be liable for harm to a claimant
described in subsection (c); and
(C) furnishes raw materials or component parts that fail to
meet applicable contractual requirements or specifications
may be liable for a harm to a claimant described in
subsection (d).
(b) Liability as Manufacturer.--
(1) In general.--A biomaterials supplier may, to the extent
required and permitted by any other applicable law, be liable
for harm to a claimant caused by an implant if the
biomaterials supplier is the manufacturer of the implant.
(2) Grounds for liability.--The biomaterials supplier may
be considered the manufacturer of the implant that allegedly
caused harm to a claimant only if the biomaterials supplier--
(A)(i) has registered with the Secretary pursuant to
section 510 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360) and the regulations issued under such section;
and
(ii) included the implant on a list of devices filed with
the Secretary pursuant to section 510(j) of such Act (21
U.S.C. 360(j)) and the regulations issued under such section;
(B) is the subject of a declaration issued by the Secretary
pursuant to paragraph (3) that states that the supplier, with
respect to the implant that allegedly caused harm to the
claimant, was required to--
(i) register with the Secretary under section 510 of such
Act (21 U.S.C. 360), and the regulations issued under such
section, but failed to do so; or
(ii) include the implant on a list of devices filed with
the Secretary pursuant to section 510(j) of such Act (21
U.S.C. 360(j)) and the regulations issued under such section,
but failed to do so; or
(C) is related by common ownership or control to a person
meeting all the requirements described in subparagraph (A) or
(B), if the court deciding a motion to dismiss in accordance
with section 6(c)(3)(B)(i) finds, on the basis of affidavits
submitted in accordance with section 6, that it is necessary
to impose liability on the biomaterials supplier as a
manufacturer because the related manufacturer meeting the
requirements of subparagraph (A) or (B) lacks sufficient
financial resources to satisfy any judgment that the court
feels it is likely to enter should the claimant prevail.
(3) Administrative procedures.--
(A) In general.--The Secretary may issue a declaration
described in paragraph (2)(B) on the motion of the Secretary
or on petition by any person, after providing--
(i) notice to the affected persons; and
(ii) an opportunity for an informal hearing.
(B) Docketing and final decision.--Immediately upon receipt
of a petition filed pursuant to this paragraph, the Secretary
shall docket the petition. Not later than 180 days after the
petition is filed, the Secretary shall issue a final decision
on the petition.
(C) Applicability of statute of limitations.--Any
applicable statute of limitations shall toll during the
period during which a claimant has filed a petition with the
Secretary under this paragraph.
(c) Liability as Seller.--A biomaterials supplier may, to
the extent required and permitted by any other applicable
law, be liable as a seller for harm to a claimant caused by
an implant if--
(1) the biomaterials supplier--
(A) held title to the implant that allegedly caused harm to
the claimant as a result of purchasing the implant after--
(i) the manufacture of the implant; and
(ii) the entrance of the implant in the stream of commerce;
and
(B) subsequently resold the implant; or
(2) the biomaterials supplier is related by common
ownership or control to a person meeting all the requirements
described in paragraph (1), if a court deciding a motion to
dismiss in accordance with section 6(c)(3)(B)(ii) finds, on
the basis of affidavits submitted in accordance with section
6, that it is necessary to impose liability on the
biomaterials supplier as a seller because the related seller
meeting the requirements of paragraph (1) lacks sufficient
financial resources to satisfy any judgment that the court
feels it is likely to enter should the claimant prevail.
(d) Liability for Violating Contractual Requirements or
Specifications.--A biomaterials supplier may, to the extent
required and permitted by any other applicable law, be liable
for harm to a claimant caused by an implant, if the claimant
in an action shows, by a preponderance of the evidence,
that--
(1) the raw materials or component parts delivered by the
biomaterials supplier either--
(A) did not constitute the product described in the
contract between the biomaterials supplier and the person who
contracted for delivery of the product; or
(B) failed to meet any specifications that were--
(i) provided to the biomaterials supplier and not expressly
repudiated by the biomaterials supplier prior to acceptance
of delivery of the raw materials or component parts;
(ii)(I) published by the biomaterials supplier;
(II) provided to the manufacturer by the biomaterials
supplier; or
(III) contained in a master file that was submitted by the
biomaterials supplier to the Secretary and that is currently
maintained by the biomaterials supplier for purposes of
premarket approval of medical devices; or
(iii) included in the submissions for purposes of premarket
approval or review by the Secretary under section 510, 513,
515, or 520 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360, 360c, 360e, or 360j), and received clearance from
the Secretary if such specifications were provided by the
manufacturer to the biomaterials supplier and were not
expressly repudiated by the biomaterials supplier prior to
the acceptance by the manufacturer of delivery of the raw
materials or component parts; and
(2) such conduct was an actual and proximate cause of the
harm to the claimant.
SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST
BIOMATERIALS SUPPLIERS.
(a) Motion To Dismiss.--In any action that is subject to
this Act, a biomaterials supplier who is a defendant in such
action may, at any time during which a motion to dismiss may
be filed under an applicable law, move to dismiss the action
against it on the grounds that--
(1) the defendant is a biomaterials supplier; and
(2)(A) the defendant should not, for the purposes of--
(i) section 5(b), be considered to be a manufacturer of the
implant that is subject to such section; or
(ii) section 5(c), be considered to be a seller of the
implant that allegedly caused harm to the claimant; or
(B)(i) the claimant has failed to establish, pursuant to
section 5(d), that the supplier furnished raw materials or
component parts in violation of contractual requirements or
specifications; or
(ii) the claimant has failed to comply with the procedural
requirements of subsection (b).
(b) Manufacturer of Implant Shall Be Named a Party.--The
claimant shall be required to name the manufacturer of the
implant as a party to the action, unless--
(1) the manufacturer is subject to service of process
solely in a jurisdiction in which the biomaterials supplier
is not domiciled or subject to a service of process; or
(2) an action against the manufacturer is barred by
applicable law.
(c) Proceeding on Motion To Dismiss.--The following rules
shall apply to any proceeding on a motion to dismiss filed
under this section:
(1) Affidavits relating to listing and declarations.--
(A) In general.--The defendant in the action may submit an
affidavit demonstrating that defendant has not included the
implant on a list, if any, filed with the Secretary pursuant
to section 510(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(j)).
(B) Response to motion to dismiss.--In response to the
motion to dismiss, the claimant may submit an affidavit
demonstrating that--
(i) the Secretary has, with respect to the defendant and
the implant that allegedly caused harm to the claimant,
issued a declaration pursuant to section 5(b)(2)(B); or
(ii) the defendant who filed the motion to dismiss is a
seller of the implant who is liable under section 5(c).
(2) Effect of motion to dismiss on discovery.--
(A) In general.--If a defendant files a motion to dismiss
under paragraph (1) or (2) of subsection (a), no discovery
shall be permitted in connection to the action that is the
subject of the motion, other than discovery necessary to
determine a motion to dismiss for lack of jurisdiction, until
such time as the court rules on the motion to dismiss in
accordance with the affidavits submitted by the parties in
accordance with this section.
(B) Discovery.--If a defendant files a motion to dismiss
under subsection (a)(2)(B)(i) on the grounds that the
biomaterials supplier did not furnish raw materials or
component parts in violation of contractual requirements or
specifications, the court may permit discovery, as ordered by
the court. The discovery conducted pursuant to this
subparagraph shall be limited to issues that are directly
relevant to--
(i) the pending motion to dismiss; or
(ii) the jurisdiction of the court.
(3) Affidavits relating status of defendant.--
(A) In general.--Except as provided in clauses (i) and (ii)
of subparagraph (B), the court shall consider a defendant to
be a biomaterials supplier who is not subject to an action
for harm to a claimant caused by an implant, other than an
action relating to liability for a violation of contractual
requirements or specifications described in subsection (d).
(B) Responses to motion to dismiss.--The court shall grant
a motion to dismiss any action that asserts liability of the
defendant under subsection (b) or (c) of section 5 on the
grounds that the defendant is not a manufacturer subject to
such section 5(b) or seller subject to section 5(c), unless
the claimant submits a valid affidavit that demonstrates
that--
(i) with respect to a motion to dismiss contending the
defendant is not a manufacturer,
[[Page H6745]]
the defendant meets the applicable requirements for liability
as a manufacturer under section 5(b); or
(ii) with respect to a motion to dismiss contending that
the defendant is not a seller, the defendant meets the
applicable requirements for liability as a seller under
section 5(c).
(4) Basis of ruling on motion to dismiss.--
(A) In general.--The court shall rule on a motion to
dismiss filed under subsection (a) solely on the basis of the
pleadings of the parties made pursuant to this section and
any affidavits submitted by the parties pursuant to this
section.
(B) Motion for summary judgment.--Notwithstanding any other
provision of law, if the court determines that the pleadings
and affidavits made by parties pursuant to this section raise
genuine issues as concerning material facts with respect to a
motion concerning contractual requirements and
specifications, the court may deem the motion to dismiss to
be a motion for summary judgment made pursuant to subsection
(d).
(d) Summary Judgment.--
(1) In general.--
(A) Basis for entry of judgment.--A biomaterials supplier
shall be entitled to entry of judgment without trial if the
court finds there is no genuine issue as concerning any
material fact for each applicable element set forth in
paragraphs (1) and (2) of section 5(d).
(B) Issues of material fact.--With respect to a finding
made under subparagraph (A), the court shall consider a
genuine issue of material fact to exist only if the evidence
submitted by claimant would be sufficient to allow a
reasonable jury to reach a verdict for the claimant if the
jury found the evidence to be credible.
(2) Discovery made prior to a ruling on a motion for
summary judgment.--If, under applicable rules, the court
permits discovery prior to a ruling on a motion for summary
judgment made pursuant to this subsection, such discovery
shall be limited solely to establishing whether a genuine
issue of material fact exists as to the applicable elements
set forth in paragraphs (1) and (2) of section 5(d).
(3) Discovery with respect to a biomaterials supplier.--A
biomaterials supplier shall be subject to discovery in
connection with a motion seeking dismissal or summary
judgment on the basis of the inapplicability of section 5(d)
or the failure to establish the applicable elements of
section 5(d) solely to the extent permitted by the applicable
Federal or State rules for discovery against nonparties.
(e) Stay Pending Petition for Declaration.--If a claimant
has filed a petition for a declaration pursuant to section
5(b)(3)(A) with respect to a defendant, and the Secretary has
not issued a final decision on the petition, the court shall
stay all proceedings with respect to that defendant until
such time as the Secretary has issued a final decision on the
petition.
(f) Manufacturer Conduct of Proceeding.--The manufacturer
of an implant that is the subject of an action covered under
this Act shall be permitted to file and conduct a proceeding
on any motion for summary judgment or dismissal filed by a
biomaterials supplier who is a defendant under this section
if the manufacturer and any other defendant in such action
enter into a valid and applicable contractual agreement under
which the manufacturer agrees to bear the cost of such
proceeding or to conduct such proceeding.
(g) Attorney Fees.--The court shall require the claimant to
compensate the biomaterials supplier (or a manufacturer
appearing in lieu of a supplier pursuant to subsection (f))
for attorney fees and costs, if--
(1) the claimant named or joined the biomaterials supplier;
and
(2) the court found the claim against the biomaterials
supplier to be without merit and frivolous.
Amendment In The Nature Of A Substitute Offered By Mr. Gekas
Mr. GEKAS. Mr. Speaker, I offer an amendment in the nature of a
substitute.
The Clerk read as follows:
Amendment in the nature of a substitute offered by Mr.
Gekas:
Strike out all after the enacting clause, and insert the
following:
SECTION 1. SHORT TITLE
This Act may be cited as the ``Biomaterials Access
Assurance Act of 1998''.
SEC. 2. FINDINGS.
The Congress finds that--
(1) each year millions of citizens of the United States
depend on the availability of lifesaving or life-enhancing
medical devices, many of which are permanently implantable
within the human body;
(2) a continued supply of raw materials and component parts
is necessary for the invention, development, improvement, and
maintenance of the supply of the devices;
(3) most of the medical devices are made with raw materials
and component parts that--
(A) move in interstate commerce;
(B) are not designed or manufactured specifically for use
in medical devices; and
(C) come in contact with internal human tissue;
(4) the raw materials and component parts also are used in
a variety of nonmedical products;
(5) because small quantities of the raw materials and
component parts are used for medical devices, sales of raw
materials and component parts for medical devices constitute
an extremely small portion of the overall market for the raw
materials and component parts;
(6) under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) manufacturers of medical devices are
required to demonstrate that the medical devices are safe and
effective, including demonstrating that the products are
properly designed and have adequate warnings or instructions;
(7) notwithstanding the fact that raw materials and
component parts suppliers do not design, produce, or test a
final medical device, the suppliers have been the subject of
actions alleging inadequate--
(A) design and testing of medical devices manufactured with
materials or parts supplied by the suppliers; or
(B) warnings related to the use of such medical devices;
(8) even though suppliers of raw materials and component
parts have very rarely been held liable in such actions, such
suppliers have ceased supplying certain raw materials and
component parts for use in medical devices for a number of
reasons, including concerns about the costs of such
litigation;
(9) unless alternate sources of supply can be found, the
unavailability of raw materials and component parts for
medical devices will lead to unavailability of lifesaving and
life-enhancing medical devices;
(10) because other suppliers of the raw materials and
component parts in foreign nations are refusing to sell raw
materials or component parts for use in manufacturing certain
medical devices in the United States, the prospects for
development of new sources of supply for the full range of
threatened raw materials and component parts for medical
devices are remote;
(11) it is unlikely that the small market for such raw
materials and component parts in the United States could
support the large investment needed to develop new suppliers
of such raw materials and component parts;
(12) attempts to develop such new suppliers would raise the
cost of medical devices;
(13) courts that have considered the duties of the
suppliers of the raw materials and component parts have
generally found that the suppliers do not have a duty--
(A) to evaluate the safety and efficacy of the use of a raw
material or component part in a medical device; or
(B) to warn consumers concerning the safety and
effectiveness of a medical device;
(14) because medical devices and the raw materials and
component parts used in their manufacture move in interstate
commerce, a shortage of such raw materials and component
parts affects interstate commerce;
(15) in order to safeguard the availability of a wide
variety of lifesaving and life-enhancing medical devices,
immediate action is needed--
(A) to clarify the permissible bases of liability for
suppliers of raw materials and component parts for medical
devices; and
(B) to provide expeditious procedures to dispose of
unwarranted suits against the suppliers in such manner as to
minimize litigation costs;
(16) the several States and their courts are the primary
architects and regulators of our tort system; Congress,
however, must, in certain circumstances involving the
national interest, address tort issues, and a threatened
shortage of raw materials and component parts for life-saving
medical devices is one such circumstance; and
(17) the protections set forth in this Act are needed to
assure the continued supply of materials for life-saving
medical devices, although such protections do not protect
negligent suppliers.
SEC. 3. DEFINITIONS.
As used in this Act:
(1) Biomaterials supplier.--
(A) In general.--The term ``biomaterials supplier'' means
an entity that directly or indirectly supplies a component
part or raw material for use in the manufacture of an implant
(B) Persons included.--Such term includes any person who--
(i) has submitted master files to the Secretary for
purposes of premarket approval of a medical device; or
(ii) licenses a biomaterials supplier to produce component
parts or raw materials.
(2) Claimant.--
(A) In general.--The term ``claimant'' means any person who
brings a civil action, or on whose behalf a civil action is
brought, arising from harm allegedly caused directly or
indirectly by an implant, including a person other than the
individual into whose body, or in contact with whose blood or
tissue, the implant is placed, who claims to have suffered
harm as a result of the implant.
(B) Action brought on behalf of an estate.--With respect to
an action brought on behalf of or through the estate of a
deceased individual into whose body, or in contact with whose
blood or tissue the implant was placed, such term includes
the decedent that is the subject of the action.
(C) Action brought on behalf of a minor or incompetent.--
With respect to an action brought on behalf of or through a
minor or incompetent, such term includes the parent or
guardian of the minor or incompetent.
(D) Exclusions.--Such term does not include--
(i) a provider of professional health care services in any
case in which--
(I) the sale or use of an implant is incidental to such
services; and
[[Page H6746]]
(II) the essence of the professional health care services
provided is the furnishing of judgment, skill, or services;
(ii) a person acting in the capacity of a manufacturer,
seller, or biomaterials supplier; or
(iii) a person alleging harm caused by either the silicone
gel or the silicone envelope utilized in a breast implant
containing silicone gel, except that--
(I) neither the exclusion provided by this clause nor any
other provision of this Act may be construed as a finding
that silicone gel (or any other form of silicone) may or may
not cause harm; and
(II) the existence of the exclusion under this clause may
not--
(aa) be disclosed to a jury in any civil action or other
proceeding, and
(bb) except as necessary to establish the applicability of
this Act, otherwise be presented in any civil action or other
proceeding.
(3) Component part.--
(A) In general.--The term ``component part'' means a
manufactured piece of an implant.
(B) Certain components.--Such term includes a manufactured
piece of an implant that--
(i) has significant non-implant applications; and
(ii) alone, has no implant value or purpose, but when
combined with other component parts and materials,
constitutes an implant.
(4) Harm.--
(A) In general.--The term ``harm'' means--
(i) any injury to or damage suffered by an individual;
(ii) any illness, disease, or death of that individual
resulting from that injury or damage; and
(iii) any loss to that individual or any other individual
resulting from that injury or damage.
(B) Exclusion.--The term does not include any commercial
loss or loss of or damage to an implant.
(5) Implant.--The term ``implant'' means--
(A) a medical device that is intended by the manufacturer
of the device--
(i) to be placed into a surgically or naturally formed or
existing cavity of the body for a period of at least 30 days;
or
(ii) to remain in contact with bodily fluids or internal
human tissue through a surgically produced opening for a
period of less than 30 days; and
(B) suture materials used in implant procedures.
(6) Manufacturer.--The term ``manufacturer'' means any
person who, with respect to an implant--
(A) is engaged in the manufacture, preparation,
propagation, compounding, or processing (as defined in
section 510(a)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(a)(1)) of the implant; and
(B) is required--
(i) to register with the Secretary pursuant to section 510
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360)
and the regulations issued under such section; and
(ii) to include the implant on a list of devices filed with
the Secretary pursuant to section 510(j) of such Act (21
U.S.C. 360(j)) and the regulations issued under such section.
(7) Medical device.--The term ``medical device'' means a
device, as defined in section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h)), and includes any
device component of any combination product as that term is
used in section 503(g) of such Act (21 U.S.C. 353(g)).
(8) Raw material.--The term ``raw material'' means a
substance or product that--
(A) has a generic use; and
(B) may be used in an application other than an implant.
(9) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(10) Seller.--
(A) In general.--The term ``seller'' means a person who, in
the course of a business conducted for that purpose, sells,
distributes, leases, packages, labels, or otherwise places an
implant in the stream of commerce.
(B) Exclusions.--The term does not include--
(i) a seller or lessor of real property;
(ii) a provider of professional health care services in any
case in which--
(I) the sale or use of the implant is incidental to such
services; and
(II) the essence of the professional health care services
provided is the furnishing of judgment, skill, or services;
or
(iii) any person who acts in only a financial capacity with
respect to the sale of an implant.
SEC. 4. GENERAL REQUIREMENTS; APPLICABILITY; PREEMPTION.
(a) General Requirements.--
(1) In general.--In any civil action covered by this Act, a
biomaterials supplier may--
(A) raise any exclusion from liability set forth in section
5; and
(B) make a motion for dismissal or for summary judgment as
set forth in section 6.
(2) Procedures.--Notwithstanding any other provision of
law, a Federal or State court in which an action covered by
this Act is pending shall, in connection with a motion under
section 6 or 7, use the procedures set forth in this Act.
(b) Applicability.--
(1) In general.--Except as provided in paragraph (2), this
Act applies to any civil action brought by a claimant,
whether in a Federal or State court, on the basis of any
legal theory, for harm allegedly caused, directly or
indirectly, by an implant.
(2) Exclusion.--A civil action brought by a purchaser of a
medical device, purchased for use in providing professional
health care services, for loss or damage to an implant or for
commercial loss to the purchaser--
(A) shall not be considered an action that is subject to
this Act; and
(B) shall be governed by applicable commercial or contract
law.
(c) Scope of Preemption.--
(1) In general.--This Act supersedes any State law
regarding recovery for harm caused by an implant and any rule
of procedure applicable to a civil action to recover damages
for such harm only to the extent that this Act establishes a
rule of law applicable to the recovery of such damages.
(2) Applicability of other laws.--Any issue that arises
under this Act and that is not governed by a rule of law
applicable to the recovery of damages described in paragraph
(1) shall be governed by applicable Federal or State law.
(d) Statutory Construction.--Nothing in this Act may be
construed--
(1) to affect any defense available to a defendant under
any other provisions of Federal or State law in an action
alleging harm caused by an implant; or
(2) to create a cause of action or Federal court
jurisdiction pursuant to section 1331 or 1337 of title 28,
United States Code, that otherwise would not exist under
applicable Federal or State law.
SEC. 5. LIABILITY OF BIOMATERIALS SUPPLIERS.
(a) In General.--Except as provided in section 7, a
biomaterials supplier shall not be liable for harm to a
claimant caused by an implant unless such supplier is
liable--
(1) as a manufacturer of the implant, as provided in
subsection (b);
(2) as a seller of the implant, as provided in subsection
(c); or
(3) for furnishing raw materials or component parts for the
implant that failed to meet applicable contractual
requirements or specifications, as provided in subsection
(d).
(b) Liability as Manufacturer.--
(1) In general.--A biomaterials supplier may, to the extent
required and permitted by any other applicable law, be liable
for harm to a claimant caused by an implant if the
biomaterials supplier is the manufacturer of the implant.
(2) Grounds for liability.--The biomaterials supplier may
be considered the manufacturer of the implant that allegedly
caused harm to a claimant only if the biomaterials supplier--
(A)(i) registered or was required to register with the
Secretary pursuant to section 510 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360) and the regulations issued
under such section; and
(ii) included or was required to include the implant on a
list of devices filed with the Secretary pursuant to section
510(j) of such Act (21 U.S.C. 360(j)) and the regulations
issued under such section;
(B) is the subject of a declaration issued by the Secretary
pursuant to paragraph (3) that states that the supplier, with
respect to the implant that allegedly caused harm to the
claimant, was required to--
(i) register with the Secretary under section 510 of such
Act (21 U.S.C. 360), and the regulations issued under such
section, but failed to do so; or
(ii) include the implant on a list of devices filed with
the Secretary pursuant to section 510(j) of such Act (21
U.S.C. 360(j)) and the regulations issued under such section,
but failed to do so; or
(C) is related by common ownership or control to a person
meeting all the requirements described in subparagraph (A) or
(B), if the court deciding a motion to dismiss in accordance
with section 6(c)(3)(B)(i) finds, on the basis of affidavits
submitted in accordance with section 6, that it is necessary
to impose liability on the biomaterials supplier as a
manufacturer because the related manufacturer meeting the
requirements of subparagraph (A) or (B) lacks sufficient
financial resources to satisfy any judgment that the court
feels it is likely to enter should the claimant prevail.
(3) Administrative procedures.--
(A) In general.--The Secretary may issue a declaration
described in paragraph (2)(B) on the motion of the Secretary
or on petition by any person, after providing--
(i) notice to the affected persons; and
(ii) an opportunity for an informal hearing.
(B) Docketing and final decision.--Immediately upon receipt
of a petition filed pursuant to this paragraph, the Secretary
shall docket the petition. Not later than 120 days after the
petition is filed, the Secretary shall issue a final decision
on the petition.
(C) Applicability of statute of limitations.--Any
applicable statute of limitations shall toll during the
period from the time a claimant files a petition with the
Secretary under this paragraph until such time as either (i)
the Secretary issues a final decision on the petition, or
(ii) the petition is withdrawn.
(D) Stay Pending Petition for Declaration.--If a claimant
has filed a petition for a declaration with respect to a
defendant, and the Secretary has not issued a final decision
on the petition, the court shall stay all proceedings with
respect to that defendant until such time as the Secretary
has issued a final decision on the petition.
[[Page H6747]]
(c) Liability as Seller.--A biomaterials supplier may, to
the extent required and permitted by any other applicable
law, be liable as a seller for harm to a claimant caused by
an implant only if--
(1) the biomaterials supplier--
(A) held title to the implant and then acted as a seller of
the implant after its initial sale by the manufacturer; or
(B) acted under contract as a seller to arrange for the
transfer of the implant directly to the claimant after the
initial sale by the manufacturer of the implant; or
(2) the biomaterials supplier is related by common
ownership or control to a person meeting all the requirements
described in paragraph (1), if a court deciding a motion to
dismiss in accordance with section 6(c)(3)(B)(ii) finds, on
the basis of affidavits submitted in accordance with section
6, that it is necessary to impose liability on the
biomaterials supplier as a seller because the related seller
meeting the requirements of paragraph (1) lacks sufficient
financial resources to satisfy any judgment that the court
feels it is likely to enter should the claimant prevail.
(d) Liability for Failure to Meet Applicable Contractual
Requirements or Specifications.--A biomaterials supplier may,
to the extent required and permitted by any other applicable
law, be liable for harm to a claimant caused by an implant if
the claimant in an action shows, by a preponderance of the
evidence, that--
(1) the biomaterials supplier supplied raw materials or
component parts for use in the implant that either--
(A) did not constitute the product described in the
contract between the biomaterials supplier and the person who
contracted for the supplying of the product; or
(B) failed to meet any specifications that were--
(i) accepted, pursuant to applicable law, by the
biomaterials supplier;
(ii) published by the biomaterials supplier;
(iii) provided by the biomaterials supplier to the person
who contracted for such product;
(iv) contained in a master file that was submitted by the
biomaterials supplier to the Secretary and that is currently
maintained by the biomaterials supplier for purposes of
premarket approval of medical devices; or
(v) included in the submissions for purposes of premarket
approval or review by the Secretary under section 510, 513,
515, or 520 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360, 360c, 360e, or 360j), and received clearance from
the Secretary if such specifications were accepted, pursuant
to applicable law, by the biomaterials supplier; and
(2) such failure to meet applicable contractual
requirements or specifications was an actual and proximate
cause of the harm to the claimant.
SEC. 6. PROCEDURES FOR DISMISSAL OF CIVIL ACTIONS AGAINST
BIOMATERIALS SUPPLIERS.
(a) Motion to Dismiss.--A defendant may, at any time during
which a motion to dismiss may be filed under applicable law,
move to dismiss an action against it on the grounds that the
defendant is a biomaterials supplier and one or more of the
following:
(1) The defendant is not liable as a manufacturer, as
provided in section 5(b).
(2) The defendant is not liable as a seller, as provided in
section 5(c).
(3) The defendant is not liable for furnishing raw
materials or component parts for the implant that failed to
meet applicable contractual requirements or specifications,
as provided in section 5(d).
(4) The claimant did not name the manufacturer as a party
to the action, as provided in subsection (b).
(b) Manufacturer of Implant Shall be Named a Party.--In any
civil action covered by this Act, the claimant shall be
required to name the manufacturer of the implant as a party
to the action, unless--
(1) the manufacturer is subject to service of process
solely in a jurisdiction in which the biomaterials supplier
is not domiciled or subject to a service of process; or
(2) a claim against the manufacturer is barred by
applicable law or rule of practice.
(c) Proceeding on Motion to Dismiss.--The following rules
shall apply to any proceeding on a motion to dismiss filed by
a defendant under this section:
(1) Effect of motion to dismiss on discovery.--
(A) In general.--Except as provided in subparagraph (B), if
a defendant files a motion to dismiss under subsection (a),
no discovery shall be permitted in connection with the action
that is the subject of the motion, other than discovery
necessary to determine a motion to dismiss for lack of
jurisdiction, until such time as the court rules on the
motion to dismiss.
(B) Discovery.--If a defendant files a motion to dismiss
under subsection (a)(3) on the grounds that it did not
furnish raw materials or component parts for the implant that
failed to meet applicable contractual requirements or
specifications, the court may permit discovery limited to
issues that are directly relevant to--
(i) the pending motion to dismiss; or
(ii) the jurisdiction of the court.
(2) Affidavits.--
(A) Defendant.--A defendant may submit affidavits
supporting the grounds for dismissal contained in its motion
to dismiss under subsection (a). If the motion is made under
subsection (a)(1), the defendant may submit an affidavit
demonstrating that the defendant has not included the implant
on a list, if any, filed with the Secretary pursuant to
section 510(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(j)).
(B) Claimant.--In response to a motion to dismiss, the
claimant may submit affidavits demonstrating that--
(i) the Secretary has, with respect to the defendant and
the implant that allegedly caused harm to the claimant,
issued a declaration pursuant to section 5(b)(2)(B); or
(ii) the defendant is a seller of the implant who is liable
under section 5(c).
(3) Basis of ruling on motion to dismiss.--The court shall
rule on a motion to dismiss filed under subsection (a) solely
on the basis of the pleadings and affidavits of the parties
made pursuant to this subsection. The court shall grant a
motion to dismiss filed under subsection (a)--
(A) unless the claimant submits a valid affidavit that
demonstrates that the defendant is not a biomaterials
supplier;
(B) unless the court determines, to the extent raised in
the pleadings and affidavits, that one or more of the
following apply:
(i) the defendant may be liable as a manufacturer, as
provided in section 5(b);
(ii) the defendant may be liable as a seller, as provided
in section 5(c); or
(iii) the defendant may be liable for furnishing raw
materials or component parts for the implant that failed to
meet applicable contractual requirements or specifications,
as provided in section 5(d); or
(C) if the claimant did not name the manufacturer as a
party to the action, as provided in subsection (b).
(4) Treatment of motion as motion for summary judgment.--
The court may treat a motion to dismiss as a motion for
summary judgment subject to subsection (d) in order to
determine whether the pleadings and affidavits, in connection
with such action, raise genuine issues of material fact
concerning whether the defendant furnished raw materials or
component parts of the implant that failed to meet applicable
contractual requirements or specifications as provided in
section 5(d).
(d) Summary Judgment.--
(1) In general.--
(A) Basis for entry of judgment.--If a motion to dismiss of
a biomaterials supplier is to be treated as a motion for
summary judgment under subsection (c)(4) or if a biomaterials
supplier moves for summary judgment, the biomaterials
supplier shall be entitled to entry of judgment without trial
if the court finds there is no genuine issue of material fact
for each applicable element set forth in paragraphs (1) and
(2) of section 5(d).
(B) Issues of material fact.--With respect to a finding
made under subparagraph (A), the court shall consider a
genuine issue of material fact to exist only if the evidence
submitted by the claimant would be sufficient to allow a
reasonable jury to reach a verdict for the claimant if the
jury found the evidence to be credible.
(2) Discovery made prior to a ruling on a motion for
summary judgment.--If, under applicable rules, the court
permits discovery prior to a ruling on a motion for summary
judgment governed by section 5(d), such discovery shall be
limited solely to establishing whether a genuine issue of
material fact exists as to the applicable elements set forth
in paragraphs (1) and (2) of section 5(d).
(3) Discovery with respect to a biomaterials supplier.--A
biomaterials supplier shall be subject to discovery in
connection with a motion seeking dismissal or summary
judgment on the basis of the inapplicability of section 5(d)
or the failure to establish the applicable elements of
section 5(d) solely to the extent permitted by the applicable
Federal or State rules for discovery against nonparties.
(e) Dismissal With Prejudice.--An order granting a motion
to dismiss or for summary judgment pursuant to this section
shall be entered with prejudice, except insofar as the moving
defendant may be rejoined to the action as provided in
section 7.
(f) Manufacturer Conduct of Litigation.--The manufacturer
of an implant that is the subject of an action covered under
this Act shall be permitted to conduct litigation on any
motion for summary judgment or dismissal filed by a
biomaterials supplier who is a defendant under this section
on behalf of such supplier if the manufacturer and any other
defendant in such action enter into a valid and applicable
contractual agreement under which the manufacturer agrees to
bear the cost of such litigation or to conduct such
litigation.
SEC. 7. SUBSEQUENT IMPLEADER OF DISMISSED BIOMATERIALS
SUPPLIER.
(a) Impleading of Dismissed Defendant.--A court, upon
motion by a manufacturer or a claimant within 90 days after
entry of a final judgment in an action by the claimant
against a manufacturer, and notwithstanding any otherwise
applicable statute of limitations, may implead a biomaterials
supplier who has been dismissed from the action pursuant to
this Act if--
(1) the manufacturer has made an assertion, either in a
motion or other pleading filed with the court or in an
opening or closing statement at trial, or as part of a claim
for contribution or indemnification, and the court finds
based on the court's independent review of the evidence
contained in the record of the action, that under applicable
law--
(A) the negligence or intentionally tortious conduct of the
dismissed supplier
[[Page H6748]]
was an actual and proximate cause of the harm to the
claimant; and
(B) the manufacturer's liability for damages should be
reduced in whole or in part because of such negligence or
intentionally tortious conduct; or
(2) the claimant has moved to implead the supplier and the
court finds, based on the court's independent review of the
evidence contained in the record of the action, that under
applicable law--
(A) the negligence or intentionally tortious conduct of the
dismissed supplier was an actual and proximate cause of the
harm to the claimant; and
(B) the claimant is unlikely to be able to recover the full
amount of its damages from the remaining defendants.
(b) Standard of Liability.--Notwithstanding any preliminary
finding under subsection (a), a biomaterials supplier who has
been impleaded into an action covered by this Act, as
provided for in this section--
(1) may, prior to entry of judgment on the claim against
it, supplement the record of the proceeding that was
developed prior to the grant of the motion for impleader
under subsection (a), and
(2) may be found liable to a manufacturer or a claimant
only to the extent required and permitted by any applicable
State or Federal law other than this Act.
(c) Discovery.--Nothing in this section shall give a
claimant or any other party the right to obtain discovery
from a biomaterials supplier at any time prior to grant of a
motion for impleader beyond that allowed under section 6.
SEC. 8. EFFECTIVE DATE.
This Act shall apply to all civil actions covered under
this Act that are commenced on or after the date of enactment
of this Act, including any such action with respect to which
the harm asserted in the action or the conduct that caused
the harm occurred before the date of enactment of this Act.
Mr. GEKAS (during the reading). Mr. Speaker, I ask unanimous consent
that the amendment be considered as read and printed in the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Pennsylvania?
There was no objection.
The SPEAKER pro tempore. The question is on the amendment in the
nature of a substitute offered by the gentleman from Pennsylvania (Mr.
Gekas).
The amendment in the nature of a substitute was agreed to.
The bill was ordered to be engrossed and read a third time, was read
the third time, and passed, and a motion to reconsider was laid on the
table
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