(c) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that specifies periodic payments for future dam-
ages at any amount other than $50,000 or that mandates 
such payments absent the request of either party. 
SEC. 8. PRODUCT LIABILITY FOR HEALTH CARE PRO-
VIDERS. 
A health care provider who prescribes, or who dis-
penses pursuant to a prescription, a medical product ap-
proved, licensed, or cleared by the Food and Drug Admin-
istration shall not be named as a party to a product liabil-
ity lawsuit involving such product and shall not be liable 
to a claimant in a class action lawsuit against the manu-
facturer, distributor, or seller of such product. 
SEC. 9. COMMUNICATIONS FOLLOWING UNANTICIPATED 
OUTCOME. 
(a) PROVIDER COMMUNICATIONS.—In any health 
care liability action, any and all statements, affirmations, 
gestures, or conduct expressing apology, fault, sympathy, 
commiseration, condolence, compassion, or a general sense 
of benevolence which are made by a health care provider 
or an employee of a health care provider to the patient, 
a relative of the patient, or a representative of the patient 
and which relate to the discomfort, pain, suffering, injury, 
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or death of the patient as the result of the unanticipated 
outcome of medical care shall be inadmissible for any pur-
pose as evidence of an admission of liability or as evidence 
of an admission against interest. 
(b) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that makes additional communications inadmis-
sible as evidence of an admission of liability or as evidence 
of an admission against interest. 
SEC. 10. NOTICE OF INTENT TO COMMENCE LAWSUIT. 
(a) ADVANCE NOTICE.—A person shall not com-
mence an action against a health care provider unless the 
person has given the health care provider 90 days written 
notice before the action is commenced. 
(b) EXCEPTIONS.—A lawsuit against a health care 
provider filed within 6 months of the statute of limitations 
expiring as to any claimant, or within 1 year of the statute 
of repose expiring as to any claimant, shall be exempt 
from compliance with this section. 
(c) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that establishes a different time period for the 
filing of written notice. 
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SEC. 11. AFFIDAVIT OF MERIT. 
(a) REQUIRED FILING.—Subject to subsection (b), 
the plaintiff in an action alleging medical negligence or, 
if the plaintiff is represented by an attorney, the plaintiff’s 
attorney shall file simultaneously with the health care law-
suit an affidavit of merit signed by a health professional 
who meets the requirements for an expert witness under 
Sec. 12 of this Act. The affidavit of merit shall certify 
that the health professional has reviewed the notice and 
all medical records supplied to him or her by the plaintiff’s 
attorney concerning the allegations contained in the notice 
and shall contain a statement of each of the following: 
(1) The applicable standard of practice or care. 
(2) The health professional’s opinion that the 
applicable standard of practice or care was breached 
by the health professional or health facility receiving 
the notice. 
(3) The actions that should have been taken or 
omitted by the health professional or health facility 
in order to have complied with the applicable stand-
ard of practice or care. 
(4) The manner in which the breach of the 
standard of practice or care was the proximate cause 
of the injury alleged in the notice. 
(5) A listing of the medical records reviewed. 
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(b) FILING EXTENSION.—Upon motion of a party for 
good cause shown, the court in which the complaint is filed 
may grant the plaintiff or, if the plaintiff is represented 
by an attorney, the plaintiff’s attorney an additional 28 
days in which to file the affidavit required under sub-
section (1). 
(c) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
this Act) that establishes additional requirements for the 
filing of an affidavit of merit or similar pre-litigation docu-
mentation. 
SEC. 12. EXPERT WITNESS QUALIFICATIONS. 
(a) IN GENERAL.—In any health care lawsuit, an in-
dividual shall not give expert testimony on the appropriate 
standard of practice or care involved unless the individual 
is licensed as a health professional in 1 or more States 
and the individual meets the following criteria: 
(1) If the party against whom or on whose be-
half the testimony is to be offered is or claims to be 
a specialist, the expert witness shall specialize at the 
time of the occurrence that is the basis for the law-
suit in the same specialty or claimed specialty as the 
party against whom or on whose behalf the testi-
mony is to be offered. If the party against whom or 
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on whose behalf the testimony is to be offered is or 
claims to be a specialist who is board certified, the 
expert witness shall be a specialist who is board cer-
tified in that specialty or claimed specialty. 
(2) During the 1-year period immediately pre-
ceding the occurrence of the action that gave rise to 
the lawsuit, the expert witness shall have devoted a 
majority of the individual’s professional time to one 
or more of the following: 
(A) The active clinical practice of the same 
health profession as the defendant and, if the 
defendant is or claims to be a specialist, in the 
same specialty or claimed specialty. 
(B) The instruction of students in an ac-
credited health professional school or accredited 
residency or clinical research program in the 
same health profession as the defendant and, if 
the defendant is or claims to be a specialist, in 
an accredited health professional school or ac-
credited residency or clinical research program 
in the same specialty or claimed specialty. 
(3) If the defendant is a general practitioner, 
the expert witness shall have devoted a majority of 
the witness’s professional time in the 1-year period 
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preceding the occurrence of the action giving rise to 
the lawsuit to one or more of the following: 
(A) Active clinical practice as a general 
practitioner. 
(B) Instruction of students in an accred-
ited health professional school or accredited 
residency or clinical research program in the 
same health profession as the defendant. 
(b) LAWSUITS AGAINST ENTITIES.—If the defendant 
in a health care lawsuit is an entity that employs a person 
against whom or on whose behalf the testimony is offered, 
the provisions of paragraph (1) apply as if the person were 
the party or defendant against whom or on whose behalf 
the testimony is offered. 
(c) POWER OF COURT.—Nothing in this subsection 
shall limit the power of the trial court in a health care 
lawsuit to disqualify an expert witness on grounds other 
than the qualifications set forth under this subsection. 
(d) LIMITATION.—An expert witness in a health care 
lawsuit shall not be permitted to testify if the fee of the 
witness is in any way contingent on the outcome of the 
lawsuit. 
(e) STATE FLEXIBILITY.—No provision of this sec-
tion shall be construed to preempt any State law (whether 
effective before, on, or after the date of the enactment of 
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this Act) that places additional qualification requirements 
upon any individual testifying as an expert witness. 
SEC. 13. DEFINITIONS. 
In this Act: 
(1) ALTERNATIVE DISPUTE RESOLUTION SYS-
TEM; ADR.—The term ‘‘alternative dispute resolution 
system’’ or ‘‘ADR’’ means a system that provides 
for the resolution of health care lawsuits in a man-
ner other than through a civil action brought in a 
State or Federal court. 
(2) CLAIMANT.—The term ‘‘claimant’’ means 
any person who brings a health care lawsuit, includ-
ing a person who asserts or claims a right to legal 
or equitable contribution, indemnity, or subrogation, 
arising out of a health care liability claim or action, 
and any person on whose behalf such a claim is as-
serted or such an action is brought, whether de-
ceased, incompetent, or a minor. 
(3) COLLATERAL
SOURCE
BENEFITS.—The 
term ‘‘collateral source benefits’’ means any amount 
paid or reasonably likely to be paid in the future to 
or on behalf of the claimant, or any service, product, 
or other benefit provided or reasonably likely to be 
provided in the future to or on behalf of the claim-
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ant, as a result of the injury or wrongful death, pur-
suant to— 
(A) any State or Federal health, sickness, 
income-disability, accident, or workers’ com-
pensation law; 
(B) any health, sickness, income-disability, 
or accident insurance that provides health bene-
fits or income-disability coverage; 
(C) any contract or agreement of any 
group, organization, partnership, or corporation 
to provide, pay for, or reimburse the cost of 
medical, hospital, dental, or income-disability 
benefits; and 
(D) any other publicly or privately funded 
program. 
(4) CONTINGENT FEE.—The term ‘‘contingent 
fee’’ includes all compensation to any person or per-
sons which is payable only if a recovery is effected 
on behalf of one or more claimants. 
(5) ECONOMIC DAMAGES.—The term ‘‘economic 
damages’’ means objectively verifiable monetary 
losses incurred as a result of the provision or use of 
(or failure to provide or use) health care services or 
medical products, such as past and future medical 
expenses, loss of past and future earnings, cost of 
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obtaining domestic services, loss of employment, and 
loss of business or employment opportunities, unless 
otherwise defined under applicable State law. In no 
circumstances shall damages for health care services 
or medical products exceed the amount actually paid 
or incurred by or on behalf of the claimant. 
(6) FUTURE
DAMAGES.—The term ‘‘future 
damages’’ means any damages that are incurred 
after the date of judgment, settlement, or other reso-
lution (including mediation, or any other form of al-
ternative dispute resolution). 
(7) 
HEALTH
CARE
LAWSUIT.—The 
term 
‘‘health care lawsuit’’ means any health care liability 
claim concerning the provision of goods or services 
for which coverage was provided in whole or in part 
via a Federal program, subsidy or tax benefit, or 
any health care liability action concerning the provi-
sion of goods or services for which coverage was pro-
vided in whole or in part via a Federal program, 
subsidy or tax benefit, brought in a State or Federal 
court or pursuant to an alternative dispute resolu-
tion system, against a health care provider regard-
less of the theory of liability on which the claim is 
based, or the number of claimants, plaintiffs, de-
fendants, or other parties, or the number of claims 
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or causes of action, in which the claimant alleges a 
health care liability claim. Such term does not in-
clude a claim or action which is based on criminal 
liability; which seeks civil fines or penalties paid to 
Federal, State, or local government; or which is 
grounded in antitrust. 
(8) HEALTH
CARE
LIABILITY
ACTION.—The 
term ‘‘health care liability action’’ means a civil ac-
tion brought in a State or Federal court or pursuant 
to an alternative dispute resolution system, against 
a health care provider regardless of the theory of li-
ability on which the claim is based, or the number 
of plaintiffs, defendants, or other parties, or the 
number of causes of action, in which the claimant al-
leges a health care liability claim. 
(9) HEALTH
CARE
LIABILITY
CLAIM.—The 
term ‘‘health care liability claim’’ means a demand 
by any person, whether or not pursuant to ADR, 
against a health care provider, including, but not 
limited to, third-party claims, cross-claims, counter- 
claims, or contribution claims, which are based upon 
the provision or use of (or the failure to provide or 
use) health care services or medical products, re-
gardless of the theory of liability on which the claim 
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is based, or the number of plaintiffs, defendants, or 
other parties, or the number of causes of action. 
(10) HEALTH
CARE
PROVIDER.—The term 
‘‘health care provider’’ means any person or entity 
required by State or Federal laws or regulations to 
be licensed, registered, or certified to provide health 
care services, and being either so licensed, reg-
istered, or certified, or exempted from such require-
ment by other statute or regulation, as well as any 
other individual or entity defined as a health care 
provider, health care professional, or health care in-
stitution under State law. 
(11) HEALTH
CARE
SERVICES.—The term 
‘‘health care services’’ means the provision of any 
goods or services by a health care provider, or by 
any individual working under the supervision of a 
health care provider, that relates to the diagnosis, 
prevention, or treatment of any human disease or 
impairment, or the assessment or care of the health 
of human beings. 
(12) MEDICAL PRODUCT.—The term ‘‘medical 
product’’ means a drug, device, or biological product 
intended for humans, and the terms ‘‘drug’’, ‘‘de-
vice’’, and ‘‘biological product’’ have the meanings 
given such terms in sections 201(g)(1) and 201(h) 
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