[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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