99–006 

112TH CONGRESS REPT. 112–39 " ! HOUSE OF REPRESENTATIVES 1st Session Part 2 

HELP EFFICIENT, ACCESSIBLE, LOW-COST, TIMELY 

HEALTHCARE (HEALTH) ACT OF 2011 

MAY 23, 2011.—Committed to the Committee of the Whole House on the State of 

the Union and ordered to be printed 

Mr. UPTON, from the Committee on Energy and Commerce, 

submitted the following 

R E P O R T 

together with 

DISSENTING VIEWS 

[To accompany H.R. 5] 

[Including cost estimate of the Congressional Budget Office] 

The Committee on Energy and Commerce, to whom was referred 

the bill (H.R. 5) to improve patient access to health care services 

and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system, 

having considered the same, report favorably thereon with amendments and recommend that the bill as amended do pass. 

CONTENTS 

Page 

Amendment .............................................................................................................. 2 

Purpose and Summary ............................................................................................ 2 

Background and Need for Legislation .................................................................... 2 

Hearings ................................................................................................................... 6 

Committee Consideration ........................................................................................ 7 

Committee Votes ...................................................................................................... 7 

Statement of General Performance Goals and Objectives .................................... 18 

New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 18 

Earmark ................................................................................................................... 18 

Committee Cost Estimate ....................................................................................... 18 

Congressional Budget Office Estimate ................................................................... 18 

Federal Mandates Statement ................................................................................. 25 

Advisory Committee Statement .............................................................................. 25 

Applicability to Legislative Branch ........................................................................ 25 

Section-by-Section Analysis of the Legislation ...................................................... 25 

Changes in Existing Law Made by the Bill, as Reported ..................................... 29 

Dissenting Views ..................................................................................................... 30 


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2The Congressional Budget Office document is available at the following link: http:// 

www.cbo.gov/ ftpdocs/1200xx/ doc12085/ 03-10-ReducingTheDeficit.pdf. 3 AMA’s ‘‘Medical Liability: By late career, 61% of doctors have been sued’’: http://www.amaassn.org/amednews/2010/08/16/pr120816.htm. 4David M. Studdert, Michelle M. Mello, William N. Sage, Catherine M. DesRoches, Jordan 

Peugh, Kinga Zapert, Troyen A. Brennan, Defensive Medicine: Among High-Risk Specialist Physicians in a Volatile Malpractice Environment, 293 J. AM. MED. ASS’N 2609 (2005). 

The amendments (stated in terms of the page and line numbers 

of the introduced bill) are as follows: 

Page 14, line 21, strike ‘‘or’’. 

Page 15, line 2, strike the period at the end and insert ‘‘; or’’. 

Page 15, insert after line 2 the following: 

(C) the defendant caused the medical product 

which caused the claimant’s harm to be misbranded or adulterated (as such terms are used in 

chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.)). 

PURPOSE AND SUMMARY

H.R. 5 seeks to improve patient access to quality health care 

while reducing the overall cost of health in America. 

BACKGROUND AND NEED FOR LEGISLATION

Introduction 

The nation’s medical liability system imperils patient access and 

imposes tremendous costs on our nation. It has forced doctors out 

of practicing in certain specialties; it has caused trauma centers to 

close; it has forced pregnant women to drive hours to find an obstetrician. This badly broken system also imposes tremendous financial burdens: Americans spend over $200 billion every year in unnecessary ‘‘health care’’ costs; 1 the Congressional Budget Office has 

reported to the Committee that comprehensive medical liability reform will save American taxpayers $62 billion over 10 years.2

President Obama has repeatedly cited the importance of medical 

tort reform, but nothing meaningful in this area was included in 

his signature Patient Protection and Affordable Care Act (PPACA), 

enacted on March 23, 2010. 

In sharp contrast, states like California and Texas, as well as 

others, have already enacted comprehensive medical liability reforms. As discussed below, enacting these reforms nationally will 

decrease the costs of defensive medicine, reduce medical liability 

fears that inhibit quality of care improvement, end years of Washington inaction on this recurring crisis, and, as shown by the 

states, increase patient access to quality care while reducing costs, 

including liability premiums. 

The Costs of Defensive Medicine 

Doctors are sued at an alarming rate (by the age of 55, 61% of 

doctors have been sued) 3 and forced to practice defensive medicine. 

In fact, a 2005 survey published in the Journal of the American 

Medical Association revealed that 93% of doctors said they have 

practiced defensive medicine and 92% said they made referrals to 

specialists and/or ordered tests or procedures in part to insulate 

themselves from medical liability.4


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5See note 5. 

6 NAIC, ‘‘Countrywide Summary of Medical Malpractice Insurance, Calendar Years 1991– 

2009,’’ provided to CRS on December 16, 2010. 7Lawrence I. McQuillan, Hovannes Ahramyan and Anthony P. Archie, Jackpot Justice: The 

True Cost of America’s Tort System, Pacific Research Institute (Mar. 2007). 

Part of defensive medicine is called assurance behavior where a 

monetary value assigned. This occurs when a doctor orders a test 

or procedure where at least some of the motivation is to avoid 

being second-guessed in retrospect and possibly named in a medical 

liability suit. This is not fraud. Medicine is not an exact science. 

No doctor can tell whether the patient in front of them is the one 

who may have the rare clinical condition that may have been detected with an additional test. Faced with the possibility of a professionally devastating malpractice suit, many physicians will order 

the extra test. Sixty percent of malpractice cases are dropped or 

dismissed and never go to court, but it costs a doctor an average 

of $18,000 to defend against a lawsuit. Doctors are found not negligent in 90% of the cases that do go to trial, but each of these 

cases costs an average of $100,000 to defend.5

Defensive medicine is not done to increase income. If an internist 

orders a CAT scan, the radiologist gets paid, not the internist. 

Medical malpractice premiums written in 2009 totaled approximately $10.8 billion.6 Indirect costs, particularly increased use of 

tests and procedures by providers to protect against future lawsuits 

(‘‘defensive medicine’’), have been estimated to be much higher 

than direct premiums. 

The Pacific Institute puts the cost of defensive medicine at some 

$200 billion and estimates that these additional liability-based 

medical care costs add at least 3.4 million Americans to the rolls 

of the uninsured.7 Nearly half of all medical malpractice claims do 

not involve injury or medical error. Less than 15 cents of every litigation-related dollar goes to those injured from medical negligence. 

Likewise, the Manhattan Institute concluded that about ten cents 

of every dollar paid for health care services goes to cover malpractice premiums, defensive medicine, and other costs associated 

with excessive litigation. 

Medical Liability Fears Inhibit Quality of Care Improvements 

Fear of medical liability makes it more difficult to improve systems by making doctors reluctant to discuss and study errors and 

‘‘near misses’’ or participate in morbidity and mortality conferences 

if the findings are ‘‘discoverable’’ in a malpractice claim. 

Another common myth claims that it is a small group of bad doctors who are responsible for most malpractice cases and the current 

medical tort system is needed or they will be free to repeatedly 

harm patients through their negligence. According to a 2007 analysis of National Practitioner Data Bank (NPDB) files by Public Citizen, ‘‘The vast majority of doctors—82 percent—have never had a 

medical malpractice payment since the NPDB was created in 1990. 

Just 5.9 percent of doctors were responsible for 57.8 percent of all 

malpractice payments since 1991, according to data from September 1990 through 2005. Just 2.3 percent of doctors, having 

three or more malpractice payments, were responsible for 32.8 percent of all payments. Only 1.1 percent of doctors, having four or 


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8Public Citizen, Congress Watch, The Great Medical Malpractice Hoax: NPDB Data Continue 

to Show Medical Liability System Produces Rational Outcomes, (January 2007). http:// 

www.citizen.org/publications/publicationredirect.cfm?ID=. 9 AMA 2007–2008 Physician Practice Information survey. 

10Mello MM, Brennan TA. Deterrence of medical errors: theory and evidence for malpractice 

reform. Texas Law Review. 2002; 80:1595–638. 11 A. Russell Localio, JD, MPH, MS; Ann G. Lawthers, ScD; Joan M. Bengtson, MD; Liesi E. 

Hebert, ScD; Susan L. Weaver; Troyen A. Brennan, MD, JD; J. Richard Landis, PhD, Relationship Between Malpractice Claims and Cesarean Delivery, JAMA. 1993;269(3):366–373. 12 Hospital Emergency Department Administration Survey, ‘‘Federal Medical Liability Reform,’’ 2004, the Schumacher Group, Alliance of Specialty Medicine, July 2005. 13 Under Medicare, the federal government pays a percentage of doctors’ liability premiums 

through the practice expense component of the physician fee schedule. The federal government 

also incurs costs because of defensive medicine. 14The text of the June 2009 speech can be found here: http://www.whitehouse.gov/the-pressoffice/remarks-president-annual-conference-american-medical-association. 

more malpractice payments, were responsible for 20.2 percent of all 

payments.’’ 8

However, Public Citizen’s own report highlights the problem. According to the AMA Physician Practice Information Survey, 75.4% 

of cardiothoracic surgeons, 68.3% of general surgeons, 79.1% of 

neurosurgeons, 70.3% of orthopedic surgeons and 69.6% of OB/ 

GYNs have been sued.9 The numbers don’t add up. Either there 

are a lot of frivolous lawsuits or almost all doctors are really bad 

doctors. The truth is that most claims are meritless and do not result in a payment, yet most doctors have to defend themselves from 

these unnecessary claims at a substantial cost to themselves and 

the nation’s health care system. 

The medical liability tort system does not improve quality. A 

number of studies have failed to show that the current system of 

medical liability deters medical errors or promotes patient safety.10

This has been most extensively studied in the specialty of obstetrics where the fear of medical liability has not been shown to result 

in fewer complications or cesarean sections.11 There is evidence, 

however, that fears of medical liability deter doctors from treating 

high risk patients, performing high risk procedures, entering high 

risk specialties and practicing in states without liability reform. 

H.R. 5 will make it easier to promote efforts at improving patient 

safety and quality of care by allowing doctors and hospitals to examine the causes of medical errors and make systemic improvements without the fear of litigation that exists in states without liability reform. 

A Recurring Crisis, Yet Washington Has Failed To Act 

Medical malpractice reform has surfaced as a national issue repeatedly over recent decades during periods of ‘‘crisis’’. A 2004 survey found that three out of four emergency rooms had to divert ambulances because of a shortage of specialists due to medical liability 

issues.12 The evidence from states like California that medical liability reform works has been available for over three decades. Unnecessary costs and defensive medicine exact a negative effect on 

the federal health care programs of Medicare and Medicaid.13

President Obama has repeatedly expressed his support for meaningful medical liability reform. In a 2009 speech before the American Medical Association, the President acknowledged that defensive medicine leads to more tests and needless costs because doctors must protect themselves from frivolous lawsuits.14 Again, during a speech to a Joint Session of Congress in September 2009, 

President Obama said ‘‘I don’t believe malpractice reform is a silver 


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15The text of this address can be found here: http://www.whitehouse.gov/the-press-office/remarks-president-a-joint-session-congress-health-care. 16 In his January 25, 2011, State of the Union address, President Obama specifically called 

for ‘‘medical malpractice reform to rein in frivolous lawsuits.’’ On January 27, Republicans on 

the Committee wrote directly to the President seeking his leadership in crafting such legislation. 

There has been no response from the Administration. 17 112th Congress Committee on the Judiciary Report on the ‘‘Help Efficient, Accessible, LowCost, Timely Healthcare Act of 2011.’’ 18http://washingtonexaminer.com/blogs/beltway-confidential/2009/08/dean-says-obamacareauthors-dont-want-challenge-trial-lawyers. 19The American Medical Association’s written testimony for January 20, 2011, House Judiciary Committee hearing: http://www.ama-assn.org/ama1/pub/upload/mm/399/ama-statementmedical-liability-reform-2011.pdf. 20Texas Medical Association’s ‘‘Proposition 12 Produces Healthy Benefits’’: http:// 

www.texmed.org/Template.aspx?id=5238. 

bullet, but I’ve talked to enough doctors to know that defensive 

medicine may be contributing to unnecessary costs.’’ 15 In his most 

recent State of the Union address, President Obama again included 

medical liability reform as part of his agenda.16

A common question from the American people is why there were 

no meaningful medical liability reform provisions in the health reform law. An October 2009 survey conducted by the Health Coalition on Liability and Access found that 69% of Americans wanted 

medical liability reform included in health care reform legislation.17 One of the most truthful answers came from Governor Howard Dean when he commented as follows on the House bill (H.R. 

3200): 

This is the answer from a doctor and a politician: ‘‘Here’s 

why tort reform is not in the bill. When you go to pass a 

really enormous bill like that, the more stuff you put in it, 

the more enemies you make, right? And the reason that 

tort reform is not in the bill is because the people who 

wrote it did not want to take on the trial lawyers in addition to everyone else they were taking on. And that is the 

plain and simple truth.’’ 18

As Shown by the States, Comprehensive Reform Will Increase Patient Access to Quality Care While Reducing Costs 

States that adopted caps saw tremendous benefits. Patients who 

are harmed are still compensated 100% for economic losses (anything to which a receipt can be attached), suffered as the result of 

a health care injury. California’s landmark legislation, the Medical 

Injury Compensation Reform Act of 1975 (MICRA) signed into law 

by Governor Jerry Brown (D), helped to stabilize the California 

medical liability insurance market. From 1976 through 2009, California’s medical liability insurance premiums increased by 261% 

compared to a total increase of 945% for the other 49 states.19

Additionally, Texas adopted comprehensive medical malpractice 

reform, including caps on non-economic damages, in 2003, and 

these reforms have yielded remarkable outcomes, including an increase in new physicians, additional obstetricians, and reduced 

medical liability premiums. From 2003 through 2009, the Texas 

Medical Board saw an increase of roughly 60% in their new physician licensure applications.20 While other states were losing obstetricians, Texas actually gained obstetricians. The number of obstetricians in Texas increased by 218 between 2002 and 2009 to a 


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21The chart detailing obstetricians in Texas can be found here: http://www.tapa.info/ 

Downloads/ImprovinglAccess/2010lCharts/06lTAPAlObstetricians.pdf. 22Texas Medical Association ‘‘Professional Liability Insurance Reform’’: http:// 

www.texmed.org/Template.aspx?id=780. 23 In July 2007, a Los Angeles County Court awarded a plaintiff over $96 million in damages while abiding by MICRA’s $250,000 cap on non-economic damages. www.micra.org. 24 AANS/CNS PowerPoint Presentation ‘‘The State of Medical Liability Reform: Successes and 

Challenges for the Future’’, February 19, 2010. 25 ‘‘The Medical Malpractice Crisis’: Trends and the Impact of State Tort Reforms,’’ Kenneth 

E. Thorpe, (January 21, 2004) at 20–30. 26Daniel P. Kessler and Mark B. McClellan, ‘‘Medical Liability, Managed Care, and Defensive 

Medicine,’’ National Bureau of Economic Research (NBER) Working Paper 7537 (February 2000) 

at 16. 27 NEJM ‘‘Claims, Errors, and Compensation Payments in Medical Malpractice Litigation.’’: 

http://www.nejm.org/doi/full/10.1056/NEJMsa054479. 

total of 2,444.21 Finally, all major physician liability carriers in 

Texas have reduced their rates resulting in nearly all Texas physicians having their premiums lowered by at least 30% and some by 

well over 40% since 2004.22

Caps on non-economic damages do not deny injured patients the 

ability to have their cases heard. States that have enacted caps 

have not seen a significant reduction in the number of claims, only 

in the number of unpredictable and unreasonably large awards for 

pain and suffering.23 States that have not enacted reform continue 

to allow a few patients and their attorneys unlimited awards while 

everyone else is burdened with limited health care and rising costs. 

Twenty-eight states have enacted meaningful medical liability reform that includes, among other provisions, a cap on non-economic 

damages, while twenty-two states continue to operate within the 

national health care system without meaningful liability reform.24

In states with caps on non-economic damages, liability premiums 

are 17% lower than they are in states without such caps.25

In those states that have enacted meaningful reform, malpractice 

premiums are affordable, defensive medicine costs are lower and 

patients have greater access to care when and where they need it. 

For example, two thorough studies that used national data on 

Medicare populations concluded that states with medical litigation 

reforms saw an average reduction of 4.3% in hospital costs for patients in managed care programs.26 This is not the case in states 

that have refused to enact meaningful reform. 

In states without liability reform, the system does not serve anyone except trial lawyers. Injured patients are not compensated in 

a timely or equitable way. They are forced to wade through several 

years of litigation and receive, on average, only 46 cents of every 

dollar awarded while the remaining 54 cents goes to their lawyers 

and other administrative fees.27

State reforms show that comprehensive medical liability reform, 

like H.R. 5, will improve patients’ access to quality care while reducing the overall cost of health care in America. 

HEARINGS

On April 6, 2011, the Subcommittee on Health held a hearing entitled, ‘‘The Cost of the Medical Liability System and Proposals for 

Reform, including H.R. 5, the Help Efficient, Accessible, Low-cost, 

Timely Healthcare (HEALTH) Act of 2011.’’ At the hearing, the 

Subcommittee examined the nation’s medical liability system and 

approaches for reform. The Subcommittee received testimony from: 

Lisa M. Hollier, MD, MPH, Fellow, American College of ObstetriVerDate Mar 15 2010 20:34 May 26, 2011 Jkt 099006 PO 00000 Frm 00006 Fmt 6659 Sfmt 6602 E:\HR\OC\HR039P2.XXX HR039P2

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cians and Gynecologists; Allen B. Kachalia, MD, JD, Harvard Medical School; Troy M. Tippett, MD, Past President, American Association of Neurological Surgeons; Joanne Doroshow, Executive Director, The Center for Justice and Democracy; and, Brian Wolfman, 

JD, Visiting Professor, Georgetown University Law Center. 

COMMITTEE CONSIDERATION

On May 10–11, 2011, the Full Committee met in open markup 

session and favorably ordered H.R. 5 reported to the House, as 

amended, by a roll call vote, a quorum being present. The Committee received only a time-limited, additional referral on this legislation. 

COMMITTEE VOTES

Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion 

to report legislation and amendments thereto. The following are 

the recorded votes taken on amendments offered to the measure, 

including the names of those Members voting for and against. A 

motion by Mr. Upton to order H.R. 5 reported to the House, as 

amended, was agreed to by a roll call vote. 


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STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES

The goal of H.R. 5 is to improve patient access to quality health 

care by reducing the excessive burdens the medical liability system 

places on the health care delivery system. 

NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX

EXPENDITURES

In compliance with clause 3(c)(2) of rule XIII of the Rules of the 

House of Representatives, the Committee finds that H.R. 5, the 

Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) 

Act of 2011, would result in no new or increased budget authority, 

entitlement authority, or tax expenditures or revenues. 

EARMARK

In compliance with clause 9(e), 9(f), and 9(g) of rule XXI, the 

Committee finds that H.R. 5 contains no earmarks, limited tax benefits, or limited tariff benefits. 

COMMITTEE COST ESTIMATE

The Committee adopts as its own the cost estimate prepared by 

the Director of the Congressional Budget Office pursuant to section 

402 of the Congressional Budget Act of 1974. 

CONGRESSIONAL BUDGET OFFICE ESTIMATE

Pursuant to clause 3(c)(3) of rule XIII of the Rules of the House 

of Representatives, the following is the cost estimate provided by 

the Congressional Budget Office pursuant to section 402 of the 

Congressional Budget Act of 1974. 

U.S. CONGRESS, 

CONGRESSIONAL BUDGET OFFICE, 

Washington, DC, May 23, 2011. 

Hon. FRED UPTON, 

Chairman, Committee on Energy and Commerce, 

House of Representatives, Washington, DC. 

DEAR MR. CHAIRMAN: The Congressional Budget Office has prepared the enclosed cost estimate for H.R. 5, the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011. 

If you wish further details on this estimate, we will be pleased 

to provide them. The CBO staff contact is Tom Bradley. 

Sincerely, 

DOUGLAS W. ELMENDORF. 

Enclosure. 

H.R. 5—Help Efficient, Accessible, Low-cost, Timely Healthcare 

(HEALTH) Act of 2011 

Summary: H.R. 5 would impose limits on medical malpractice 

litigation in state and federal courts by capping awards and attorney fees, modifying the statute of limitations and the ‘‘collateral 

source’’ rule, and eliminating joint and several liability. 

CBO expects that those changes would, on balance, lower costs 

for health care both directly and indirectly: directly, by lowering 

premiums for medical liability insurance; and indirectly, by reducing the use of health care services prescribed by providers when 


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faced with less pressure from potential malpractice suits. Those reductions in costs would, in turn, lead to lower spending in federal 

health programs and to lower private health insurance premiums. 

Because employers would pay less for health insurance for employees, more of their employees’ compensation would be in the 

form of taxable wages and other fringe benefits. As discussed 

below, the bill also would increase revenues because it would result 

in lower subsidies for health insurance. In total, CBO and the staff 

of the Joint Committee on Taxation (JCT) estimate that enacting 

H.R. 5 would increase federal revenues by almost $10 billion over 

the 2012–2021 period. 

Enacting H.R. 5 would reduce federal direct spending for Medicare, Medicaid, the government’s share of premiums for annuitants 

under the Federal Employees Health Benefits (FEHB) program, 

and other federal health benefits programs. CBO estimates that direct spending would decline by about $48 billion over the 2012– 

2021 period. 

Because enacting the legislation would affect direct spending and 

revenue, pay-as-you-go procedures apply. In total, CBO estimates 

that enacting H.R. 5 would reduce deficits by almost $14 billion 

over the 2011–2016 period and by about $57 billion over the 2012– 

2021 period. 

Federal spending for active workers participating in the FEHB 

program is included in the appropriations for federal agencies, and 

is therefore discretionary. H.R. 5 would also affect discretionary 

spending for health care services paid by the Departments of Defense (DoD) and Veterans Affairs (VA). CBO estimates that implementing H.R. 5 would reduce discretionary spending by about $2 

billion over the 2012–2021 period, assuming appropriations actions 

consistent with the legislation. 

H.R. 5 contains an intergovernmental mandate as defined in the 

Unfunded Mandates Reform Act (UMRA) because it would preempt 

state laws that provide less protection for health care providers and 

organizations from liability, loss, or damages (other than caps on 

awards for damages). CBO estimates the cost of complying with the 

mandate would be small and would fall well below the threshold 

established in UMRA for intergovernmental mandates ($71 million 

in 2011, adjusted annually for inflation). 

H.R. 5 contains several mandates on the private sector, including 

caps on damages and on attorney fees, a more restrictive statute 

of limitations, and the fair share rule. The cost of those mandates 

would exceed the threshold established in UMRA for private-sector 

mandates ($142 million in 2011, adjusted annually for inflation) in 

four of the first five years in which the mandates were effective, 

rising to $1.4 billion per year in 2016, and totaling $3.3 billion over 

the 2012–2016 period. 

Estimated cost to the Federal Government: The estimated budgetary impact of H.R. 5 is shown in the following table. The costs 

of this legislation fall with multiple budget functions, primarily 550 

(health) and 570 (Medicare). 


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By fiscal year, in billions of dollars— 

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2012– 

2016 

2012– 

2021 

CHANGES IN REVENUES 

Estimated Revenues: 

On-budget ......... * 0.1 0.3 0.6 0.8 0.9 1.0 1.0 1.1 1.2 1.8 7.0 

Off-budget ........ * * 0.1 0.2 0.3 0.3 0.3 0.4 0.4 0.4 0.7 2.5 

Total ......... * 0.1 0.4 0.8 1.1 1.2 1.3 1.4 1.5 1.6 2.5 9.6 

CHANGES IN DIRECT SPENDING 

Estimated Budget Authority .................... ¥0.1 ¥0.5 ¥1.8 ¥3.6 ¥5.3 ¥6.2 ¥6.7 ¥7.3 ¥7.9 ¥8.4 ¥11.3 ¥47.8 

Estimated Outlays ..... ¥0.1 ¥0.5 ¥1.8 ¥3.6 ¥5.3 ¥6.2 ¥6.7 ¥7.3 ¥7.9 ¥8.4 ¥11.3 ¥47.8 

NET INCREASE OR DECREASE (¥) IN THE DEFICIT FROM CHANGES IN REVENUES AND DIRECT SPENDING 

Impact on the Deficit: 

On-budget ......... ¥0.1 ¥0.6 ¥2.1 ¥4.2 ¥6.1 ¥7.1 ¥7.7 ¥8.3 ¥9.0 ¥9.6 ¥13.1 ¥54.8 

Off-budget ........ * * ¥0.1 ¥0.2 ¥0.3 ¥0.3 ¥0.3 ¥0.4 ¥0.4 ¥0.4 ¥0.7 ¥2.5 

Total ......... ¥0.1 ¥0.6 ¥2.2 ¥4.4 ¥6.4 ¥7.4 ¥8.0 ¥8.7 ¥9.4 ¥10.0 ¥13.8 ¥57.4 

CHANGES IN SPENDING SUBJECT TO APPROPRIATION 

Estimated Authorization Level ............... 0 * ¥0.1 ¥0.1 ¥0.2 ¥0.2 ¥0.2 ¥0.3 ¥0.3 ¥0.3 ¥0.4 ¥1.6 

Estimated Outlays ..... 0 * ¥0.1 ¥0.1 ¥0.2 ¥0.2 ¥0.2 ¥0.3 ¥0.3 ¥0.3 ¥0.4 ¥1.6 

Notes: Components may not add to totals because of rounding. 

* = increase in revenues, reduction in spending, or reduction in deficits of less than $50 million. 

Basis of estimate: H.R. 5 would establish: 

• A three-year statute of limitations for medical malpractice 

claims, with certain exceptions, from the date of discovery of an injury; 

• A cap of $250,000 on awards for noneconomic damages; 

• A cap on awards for punitive damages that would be the larger 

of $250,000 or twice the economic damages, and restrictions on 

when punitive damages may be awarded; 

• Replacement of joint-and-several liability with a fair-share 

rule, under which a defendant in a lawsuit would be liable only for 

the percentage of the final award that was equal to his or her 

share of responsibility for the injury; 

• Sliding-scale limits on the contingency fees that lawyers can 

charge; 

• A safe harbor from punitive damages for products that meet 

applicable FDA safety requirements; and 

• Permission to introduce evidence of income from collateral 

sources (such as life insurance payouts and health insurance) at 

trial. 

Over the 2012–2021 period, CBO and the staff of the Joint Committee on Taxation estimate that enacting H.R. 5 would reduce direct spending by about $48 billion and increase federal revenues by 

almost $10 billion. The combined effect of those changes in direct 

spending and revenues would reduce federal deficits by $57 billion 

over that period, with changes in off-budget revenues accounting 

for about $3 billion of that reduction in deficits. (Because those estimates assume enactment of H.R. 5 near the end of fiscal year 

2011, no budgetary effects are expected in that year.) 

In addition, CBO estimates that implementing H.R. 5 would reduce discretionary spending for the FEHB program, DoD, and VA 

by about $2 billion over the 2012–2021 period. 


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1See Congressional Budget Office, letter to the Honorable Orrin G. Hatch regarding CBO’s 

Analysis of the Effects of Proposals to Limit Costs Related to Medical Malpractice, (October 9, 

2009). http://www.cbo.gov/ftpdocs/106xx/doc10641/10-09-TortlReform.pdf. 

Effects on National Spending for Health Care 

CBO reviewed recent research on the effects of proposals to limit 

costs related to medical malpractice (‘‘tort reform’’), and estimates 

that enacting H.R. 5 would reduce national health spending by 

about 0.5 percent.1 That figure comprises a direct reduction in 

spending for medical liability premiums and an additional indirect 

reduction from slightly less utilization of health care services. 

CBO’s estimate takes into account the fact that, because many 

States have already implemented some elements of H.R. 5, a significant fraction of the potential cost savings has already been realized. Moreover, the estimate assumes that the reduction of about 

0.5 percent would be realized over a period of four years, as providers gradually change their practice patterns. 

Revenues 

CBO estimates that private health spending would be reduced by 

about 0.5 percent. Much of private-sector health care is paid for 

through employment-based insurance that represents nontaxable 

compensation. In addition, beginning in 2014, refundable tax credits will be available to certain individuals and families to subsidize 

health insurance purchased through new health insurance exchanges. (The portion of those tax credits that exceed taxpayers’ liabilities are classified as outlays, while the portions that reduce 

taxpayers’ liabilities are recorded as reductions in revenues.) 

Lower costs for health care arising from enactment of H.R. 5 

would lead to an increase in taxable compensation and a reduction 

in subsidies for health insurance purchased through an exchange. 

Those changes would increase federal tax revenues by an estimated 

$9.6 billion over the 2012–2021 period, according to estimates by 

JCT. Social Security payroll taxes, which are off-budget, account 

for $2.5 billion of that increase in federal revenues. 

Direct Spending 

CBO estimates that enacting H.R. 5 would reduce direct spending for Medicare, Medicaid, the Children’s Health Insurance Program, the Federal Employees Health Benefits program, the Defense Department’s TRICARE for Life program, and subsidies for 

enrollees in health insurance exchanges by roughly $48 billion over 

the 2012–2021 period. 

For programs other than Parts A and B of Medicare, the estimate assumes that federal spending for acute care services would 

be reduced by about 0.5 percent, in line with the estimated reductions in the private sector. 

CBO estimates that the reduction in federal spending for services 

covered under Parts A and B of Medicare would be larger—about 

0.7 percent—than in the other programs or in national health 

spending in general. That estimate is based on empirical evidence 

showing that the impact of tort reform on the utilization of health 


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2One possible explanation for that disparity is that the bulk of Medicare’s spending is on a 

fee-for-service basis, whereas most private health care spending occurs through plans that manage care to some degree. Such plans limit the use of services that have marginal or no benefit 

to patients (some of which might otherwise be provided as ‘‘defensive’’ medicine), thus leaving 

less potential for savings from the reduction of utilization in those plans than in fee-for-service 

systems. 

care services is greater for Medicare than for the rest of the health 

care system.2

Spending Subject to Appropriation 

CBO estimates that implementing H.R. 5 would reduce federal 

spending for health insurance for federal employees covered 

through the FEHB program by about 0.5 percent—in line with the 

estimated reductions in the private sector—and would reduce 

spending for health insurance and health care services paid for by 

the Departments of Defense and Veterans Affairs by lesser 

amounts. CBO expects that the impact on those agencies would be 

proportionally smaller than the impact on overall health spending 

because medical malpractice costs are already lower than average 

for entities covered by the Federal Tort Claims Act. In CBO’s estimation, the cost of health insurance and health care services funded through appropriation acts would be reduced by $1.6 billion over 

the 2012–2021 period. 

Pay-As-You-Go considerations: The Statutory Pay-As-You-Go Act 

of 2010 establishes budget reporting and enforcement procedures 

for legislation affecting direct spending or revenues. The net 

changes in outlays and revenues that are subject to those pay-asyou-go procedures are shown in the following table. Only on-budget 

changes to outlays or revenues are subject to pay-as-you-go procedures. 


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CBO ESTIMATE OF PAY-AS-YOU-GO EFFECTS FOR H.R. 5, AS ORDERED REPORTED BY THE HOUSE COMMITTEE ON ENERGY AND COMMERCE ON MAY 11, 2011 

By fiscal year, in millions of dollars— 

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2011–2016 2011–2021 

NET INCREASE OR DECREASE (¥) IN THE ON-BUDGET DEFICIT 

Statutory Pay-As-You-Go Impact ........................................................................... 0 ¥108 ¥593 ¥2,112 ¥4,186 ¥6,131 ¥7,105 ¥7,672 ¥8,331 ¥9,002 ¥9,574 ¥13,129 ¥54,814 

Memorandum: 

Direct spending ............................................................................................ 0 ¥100 ¥500 ¥1,800 ¥3,600 ¥5,300 ¥6,200 ¥6,700 ¥7,300 ¥7,900 ¥8,400 ¥11,300 ¥47,800 

Revenues ....................................................................................................... 0 8 93 312 586 831 905 972 1,031 1,102 1,174 1,829 7,014 


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Estimated impact on State, local, and tribal governments: 

Intergovernmental Mandates 

The bill contains an intergovernmental mandate because it 

would preempt state laws that would prevent the application of 

any provision of the bill; however, it would not preempt any State 

law that provides greater protections for health care providers and 

organizations from liability, loss, or damages. While the preemption would limit the application of State and local laws, CBO estimates that it would not impose significant costs and would fall well 

below the threshold established in the Unfunded Mandates Reform 

Act for intergovernmental mandates ($71 million in 2011, adjusted 

annually for inflation). 

Other Impacts 

A decline in health care spending is expected to result in a decrease in rates for health insurance premiums. State, local, and 

tribal governments, as employers, would save money as a result of 

lower health insurance premiums precipitated by the bill. State, 

local, and tribal governments that collect income taxes also would 

realize increased tax revenues as a result of increases in workers’ 

taxable income. State spending in Medicaid would decrease by over 

$4 billion over the 2012–2016 period, with additional savings in the 

subsequent years. 

Estimated impact on the private sector: H.R. 5 contains several 

mandates on the private sector, because it would limit the amount 

of compensatory damages that a plaintiff can receive. 

Compensatory damages are paid to compensate a claimant for 

loss, injury, or harm suffered by a defendant’s breach of duty. Laws 

that directly limit the right of plaintiffs to be compensated for 

losses that they incurred as a result of a defendant’s wrongful acts 

impose a mandate. 

Applying this standard, the cap on non-economic damages, the 

statute of limitations, and the fair-share rule included in H.R. 5 

would be considered mandates on the private sector, as defined by 

UMRA, because they would limit the ability of some claimants to 

recover the entire amount of compensatory damages that could be 

collected under current law. In addition, the cap on attorney fees 

is a mandate because it limits the fees that attorneys might otherwise be able to collect from their clients. The cost of those mandates would exceed the threshold established in UMRA for privatesector mandates ($142 million in 2011, adjusted annually for inflation) in four of the first five years in which the mandates were effective, rising to $1.4 billion per year in 2016, and totaling $3.3 billion over the 2012–2016 period. 

Previous CBO estimate: On March 10, 2011, CBO transmitted a 

cost estimate for the HEALTH Act as ordered reported by the 

House Committee on the Judiciary on February 16, 2011. The 

version of H.R. 5 approved by the Committee on Energy and Commerce would permit the introduction of evidence of income from 

collateral sources at trial. The version approved by the Committee 

on the Judiciary did not contain that provision. Differences in the 

CBO cost estimates primarily reflect that difference in the bills. 

Estimate prepared by: Federal Costs: Tom Bradley, Stuart 

Hagen, and Kirstin Nelson; Impact on State, Local, and Tribal GovVerDate Mar 15 2010 20:34 May 26, 2011 Jkt 099006 PO 00000 Frm 00024 Fmt 6659 Sfmt 6602 E:\HR\OC\HR039P2.XXX HR039P2

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ernments: Lisa Ramirez-Branum; Impact on the Private Sector: 

Stuart Hagen. 

Estimate approved by: Holly Harvey, Deputy Assistant Director 

for Budget Analysis. 

FEDERAL MANDATES STATEMENT

The Committee adopts as its own the estimate of Federal mandates prepared by the Director of the Congressional Budget Office 

pursuant to section 423 of the Unfunded Mandates Reform Act. 

ADVISORY COMMITTEE STATEMENT

No advisory committees within the meaning of section 5(b) of the 

Federal Advisory Committee Act were created by this legislation. 

APPLICABILITY TO LEGISLATIVE BRANCH

The Committee finds that the legislation does not relate to the 

terms and conditions of employment or access to public services or 

accommodations within the meaning of section 102(b)(3) of the Congressional Authority Act. 

SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION

Section 1. Short title 

Section 1 establishes the short title of the bill as the ‘‘Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act of 

2011.’’ 

Section 2. Findings and purpose 

Section 2 states the findings and purpose of the bill. 

Section 3. Encouraging speedy resolution of claims 

Section 3 states that a health care lawsuit shall be commenced 

3 years after the date of manifestation of injury or 1 year after the 

claimant discovers, or through the use of reasonable diligence 

should have discovered, the injury, whichever occurs first. In no 

event shall the time for commencement of a health care lawsuit exceed 3 years after the manifestation of injury unless tolled for any 

of the following: (1) upon proof of fraud; (2) intentional concealment; or (3) the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured 

person. There is an exception for alleged injuries sustained by a 

minor before the age of 6, in which case a health care lawsuit may 

be commenced by or on behalf of the minor until the later of 3 

years from the date of manifestation of injury, or the date on which 

the minor attains the age of 8. This time period is tolled for minors 

for any period during which a parent or guardian and a health care 

provider or health care organization have committed fraud or collusion in the failure to bring an action on behalf of the injured minor. 

The Committee does not intend the term injury to include business 

injuries. The manifestation of injury occurs when the damaging effect becomes known. The discovery of injury occurs when the damaging effect becomes known and the claimant suspects it was 

caused by wrongdoing. 


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Section 4. Compensating patient injury 

Section 4 sets forth new guidelines regarding patients’ ability to 

recover for certain types of damages. Subsection 4(a) provides that 

in any health care lawsuit, nothing in this Act shall limit a claimant’s recovery for the full amount of available economic damages, 

notwithstanding the limitation in subsection (b). Under subsection 

4(b), there can be no more than $250,000 in non-economic damages 

with respect to the same injury. 

The cap in this section can apply separately to each party with 

a direct personal injury. For example, if there is a single class-action lawsuit where a drug manufacturer sold drugs that were taken 

by several individuals and those individuals suffered adverse 

events, each of those individuals could receive up to $250,000 in 

non-economic damages. Similarly, if a pregnant mother and her 

baby sustain physical injuries during an operation and a health 

care provider is found liable, then the mother and the baby could 

each recover damages up to the cap permitted in subsection 4(b). 

Subsection 4(c) makes clear that courts should apply the 

$250,000 cap for non-economic damages without calculations that 

include discounting to present value. Whether a given award below 

the cap involves discounting, however, remains a function of separate state and Federal law. Juries will not be informed about the 

maximum award for non-economic damages. 

Subsection 4(d) provides that each party shall be liable for the 

amount of damages allocated to such party. This allocation shall be 

determined in direct proportion to such party’s percentage of responsibility for the damages. The Committee notes that this subsection does not override principles of vicarious liability. Furthermore, the ‘‘fair share’’ rule only applies when a judgment of liability is rendered. 

Section 5. Maximizing patient recovery 

Section 5 requires that courts supervise the arrangements for 

payment of damages to protect against conflicts of interests. This 

section also establishes a sliding fee schedule for the payment of 

attorneys’ contingency fees. Payments are allocated as follows: 40 

percent of the first $50,000 recovered by the claimant; 331⁄3 percent 

of the next $50,000 recovered by the claimant; 25 percent of the 

next $500,000 recovered by the claimant; and 15 percent of any 

amount by which the recovery by the claimant(s) is in excess of 

$600,000. 

The requirements for court supervision in the first paragraph do 

not apply outside of judicial proceedings. Thus, disputes settled 

prior to filing a lawsuit would not necessitate court supervision. 

The sliding fee schedule, by contrast, applies in all cases. 

Section 6. Additional health benefits 

Section 6 ensures that, in any health care lawsuit involving injury or wrongful death, a party may introduce evidence of collateral 

source benefits received, or reasonably likely to be received, from 

other parties. This section also restricts a provider of collateral 

source benefits from subrogating a claimant’s recovery or obtaining 

any lien or credit against the claimant’s damage award. 


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Section 7. Punitive damages 

Section 7 specifies guidelines for awarding punitive damages. 

Under this section, punitive damages may be awarded, if otherwise 

permitted by applicable state or Federal law, against any person in 

a health care lawsuit. The amount of punitive damages awarded 

may be as high as two times the amount of economic damages 

awarded or $250,000, whichever amount is greater. 

This section does not permit juries to be informed of the formula 

for calculating punitive damages. Moreover, punitive damages may 

only be awarded if it is first proven by clear and convincing evidence that a defendant acted with malicious intent to injure the 

claimant, or that such person deliberately failed to avoid unnecessary injury that such person knew the claimant was substantially 

certain to suffer. This section states that no demand for punitive 

damages shall be included in a health care lawsuit as initially filed. 

Further, punitive damages in healthcare lawsuits may not be 

awarded if compensatory damages are not awarded. 

Paragraph 7(c)(1) shields manufacturers and distributors of medical products from punitive damages in certain instances. The provision is intended to shield those companies that are fully compliant with all Federal Food, Drug, and Cosmetic Act (FFDCA) laws 

and regulations (in the case of biological medical products, full compliance with the FFDCA and section 351 of the Public Health Service Act (PHSA) is required)). The FFDCA ensures the safety and 

effectiveness of drugs, devices, and biological products, all of which 

are covered by this section. Unless a claimant can demonstrate by 

clear and convincing evidence a lack of compliance with any 

FFDCA or PHSA section 351 law or regulation, then a manufacturer, distributor or supplier is shielded from punitive damages. All 

other damages, if proven, are still available to the claimant. 

Under paragraph 7(c)(1), if a claimant can prove by clear and 

convincing evidence that a manufacturer, distributor or supplier 

has not complied with the FFDCA or section 351 of the PHSA, the 

claimant must then further prove that the harm attributed to the 

medical product resulted from the proven compliance failure. A 

technical violation of the Act that is wholly unrelated to the harm 

will not remove the shield provided for in this section. Rather, punitive damages will only be available to claimants who prove both 

a violation of the Act or regulations, and then draw the nexus between failed compliance and harm. 

Paragraph 7(c)(1) applies to medical products, as defined in section 9. Included in this definition are nonprescription, over-thecounter (OTC) drugs. Some OTC drugs are marketed after approval 

of a new drug application (NDA) or abbreviated new drug application (ANDA). Some OTC drugs are also marketed pursuant to 

monographs or tentative final monographs promulgated by the 

Agency. While a final monograph is a regulation, a tentative final 

monograph represents the Agency’s current position on the requirements for safe and effective labeling, formulation and marketing of 

the OTC drug product. In some instances, tentative final monographs have been in existence for decades, yet have never been finalized. Companies follow these so-called ‘‘tentative’’ monographs 

and deliver safe and effective drug products. The Committee believes that the mere fact that the FDA has not taken the last step 

to finalize monographs in existence for decades should not preclude 


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a manufacturer, distributor or supplier of such products from 

claiming the protections afforded by section 7(c). 

Subsection 7(c) does not create an affirmative obligation on the 

part of the FDA to demonstrate compliance or noncompliance for 

the purposes of private litigation. The section also revokes the 

shield for persons: (1) who knowingly misrepresent information to 

the FDA or withhold information from the FDA; or (2) who bribe 

government officials for the purpose of obtaining approval of medical products. At the markup, the Committee adopted an amendment by Mr. Dingell that provides another exception to this shield. 

Under the amendment, a defendant could be liable for punitive 

damages if the defendant caused the medical product, which caused 

the claimant’s harm, to be misbranded or adulterated. The Committee notes that term ‘‘misbranding’’ includes mislabeling and the 

term ‘‘adulterated’’ includes storing medical products at the incorrect temperature. The Committee also notes that a court or trier 

of fact may make the determination as to whether a product is misbranded or adulterated. There need not be an FDA determination. 

Paragraph 7(c)(2) prohibits a health care provider who prescribes, or who dispenses pursuant to a prescription, a medical 

product that is approved by the FDA from being named as a party 

in a product liability lawsuit. Nothing in the paragraph prevents 

a court from consolidating cases involving health care providers 

and cases involving products liability claims. 

Section 8. Authorization of payment of future damages to claimants 

in health care lawsuits 

Section 8 requires the court, at the request of any party, to order that the award of future damages equaling or exceeding $50,000 be 

paid by periodic payments. 

Section 9. Definitions 

Section 9 defines many of the terms included in the legislation. 

The term ‘‘health care lawsuit’’ does not include a claim or action 

which is based on criminal liability; which seeks civil fines or penalties paid to Federal, State or local government; which is grounded 

in antitrust; or in which the dispute is over the price of health care 

goods or services. The latter exclusion addresses cases concerning 

price-fixing or over charging, not cases involving personal injury. 

Finally, the Committee intends the term ‘‘health care goods and 

services’’ to include those involving ‘‘the assessment or care of the 

health of human beings.’’ Such terms include the monitoring, supervision, and provision of direct assistance to claimants. 

Section 10. Effect on other laws 

Section 10 states that this legislation does not apply to civil actions brought for a vaccine-related injury or death which is covered 

under provisions of the Public Health Service Act. It also states 

that nothing in the Act should affect any defense available to a defendant in a health care lawsuit or action under any other provision of federal law. 

Section 11. State flexibility and protection of state’s rights 

Section 11 specifies many of the rules governing the relationship 

between the HEALTH Act and state and Federal laws. Specifically, 


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subsection 11(a) provides that provisions governing health care 

lawsuits outlined in the legislation preempt state law to the extent 

that state law prevents the application of these provisions. The legislation also supersedes the Federal Tort Claims Act (FTCA) to the 

extent that the FTCA provides for a greater amount of damages or 

contingent fees, a longer period in which a health care lawsuit may 

be commenced, or a reduced application of periodic payments of future damages. The FTCA is also superseded if it prohibits the introduction of evidence regarding collateral source benefits, or mandates or permits subrogation or a lien on collateral source benefits. 

Under subsection 11(b), if an issue is not addressed by a provision of law established by this legislation, it shall be governed by 

otherwise applicable state or Federal law. The subsection further 

states that the Act does not preempt or supersede any law that imposes greater procedural or substantive protections for health care 

providers and health care organizations from liability, loss, or damages. 

Subsection 11(c) states that this legislation does not preempt any 

state law (enacted before, on, or after the date of enactment of H.R. 

5) that specifies a particular amount of compensatory or punitive 

damages (or the total amount of damages) that may be awarded in 

a health care lawsuit. The subsection also provides that the Act 

does not preempt any defense available to a party in a health care 

lawsuit under any other provision of state or Federal law. 

Finally, the Committee notes the interrelationship of a number 

of provisions of H.R. 5. H.R. 5 does not create a cause of action or 

provide for a remedy or recovery that is not available or permitted 

under other provisions of applicable law. Moreover, any protections, 

defenses, or restrictions that are legally enforceable or available 

under contracts would still apply. Before applying the provisions of 

H.R. 5, courts should first review the law applicable to the appropriate claim or cause of action without reference to H.R. 5. Courts 

should then apply the limitations of H.R. 5 where appropriate. 

Section 12. Applicability; effective date 

Section 12 states that the provisions of the legislation apply to 

any health care lawsuit brought in Federal or state court, or subject to alternative dispute resolutions system, that is initiated on 

or after the date of the enactment of the Act, except that any 

health care lawsuit arising from an injury occurring prior to the 

date of the enactment of the Act is governed by the applicable statute of limitations provision in effect at the time the injury occurred. 

CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED

This legislation does not amend any existing Federal statute. 


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1 Hereinafter cited as the HEALTH Act. 

2 Rep. Phil Gingrey, The HEALTH Act: A Real Reform Option (online at: http:// 

gingrey.house.gov/News/DocumentSingle.aspx?DocumentID-240791 (accessed on May 19, 2011). 3See, e.g., remarks of Rep. Frank Pallone (p. 12); Rep. Joe Pitts (p. 18); and Rep. Michael 

Burgess (p. 29) during the full Committee markup of H.R. 5 (House Committee on Energy and 

Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong. (May 10, 2011) (transcript 

of the proceeding) and Ranking Member Henry Waxman (House Committee on Energy and 

Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., p. 21 (May 11, 2011) (transcript of the proceeding). 4 House Committee on the Judiciary, HEALTH Act of 2011, Dissenting Views, 112th Cong., 

p. 88 (Mar. 17, 2011) (H. Rept. No. 112–39, Part 1). 5 Common Sense Health Care Reform and Affordability Act, H. Amdt. 510, 111th Cong. (2009) 

(offered by Minority Leader John Boehner as a substitute amendment to H.R. 3963, the Affordable Health Care for America Act). 6The ACA is comprised of two public laws, P.L. 111–148 and P.L. 111–152. 

DISSENTING VIEWS 

We, the undersigned members of the Committee on Energy and 

Commerce, oppose the passage of H.R. 5, the Help Efficient, Accessible Low-cost Timely Healthcare (HEALTH) Act of 2011, a bill to 

reform the nation’s medical malpractice liability system. Accordingly, we submit the following comments to express our concerns 

about this profoundly flawed and deeply divisive legislation. 

INTRODUCTION

H.R. 5, the Help Efficient, Accessible, Low-cost, Timely 

Healthcare (HEALTH) Act of 2011,1 should not and will not become 

law. And for good reason. It is one-sided. It will not ‘‘fix’’ the problems it purports to address. And in one-fell swoop, it completely upends literally centuries of state law. Pure and simple—and contrary to the argument put forth by the bill’s leading sponsor, H.R. 

5 is not ‘‘meaningful [medical malpractice] reform.2

This is not to suggest that medical malpractic not a problem in 

this country. It is. On this point members on all sides of the issue 

agree.3 But it is also complex and complicated and therefore, deserving of a very thoughtful and measured response. H.R. 5 is anything but that. 

Congresses of the past share this belief. Indeed, since the 107th 

Congress, legislation identical or similar to H.R. 5 has repeatedly 

failed to reach the president’s desk.4 Most recently, the text of H.R. 

5 was rejected in the form of the motion to recomit 5 offered by the 

Republicans at the conclusion of the House debate on the Affordable Care Act (ACA).6 Its failure to become law under Democratic 

or Republican congresses and presidents alike is itself a verdict on 

its merits and efficacy. 

We do not believe the case has been made for this House, for this 

Congress or for this President to follow a different course of action. 

While the current state-based system for dealing with medical malpractice is far from perfect, in our view, it is the framework 

through which appropriate modifications and improvements should 

be developed and implemented. A ‘‘one-size-fits-all’’ approach—the 

very vision of H.R. 5—not only tears this system down; it also imVerDate Mar 15 2010 20:34 May 26, 2011 Jkt 099006 PO 00000 Frm 00030 Fmt 6604 Sfmt 6604 E:\HR\OC\HR039P2.XXX HR039P2

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7 House Committee on the Judiciary, HEALTH Act of 2011, Dissenting Views, 112th Cong., 

pp. 88–120 (Mar. 17, 2011) (H. Rept. No. 112–39, Part 1). 8See Garner, BA (editor-in-chief), Black’s Law Dictionary (9th ed. 2009), (‘‘malpractice: medical malpractice’’) (available online at: http://www.westlaw.com); and Keeton, WP, Dobbs, DB, 

Keeton, RE, and Owen, DG, Prosser and Keeton on Torts (5th ed. 2004), pp. 185–187 (West 

Group, Hornbook Series). 9 Congressional Research Service, Medical Malpractice Liability Reform: Legal Issues and 50- 

State Surveys on Tort Reform Proposals, Rept. No. R411661, P. 2 (Mar. 28, 2011). 10 Id. at Summary. 

poses upon the states, a new, unified, and untested legal structure 

with little regard for the potential consequences. 

There are many particulars in the bill and the arguments of its 

advocates to which we object. The views expressed here focus only 

on those specifics that received extensive attention during the Committee’s consideration of the legislation: • the mis-representation of the California law upon which H.R. 

5 is supposedly based; • the bill’s wholesale preemption of state medical malpractice 

law; • its broad and expansive scope that goes beyond traditional 

medical malpractice; and • its unparalleled protections for manufacturers of drugs and 

medical devices approved by the Food and Drug Administration 

(FDA). 

As such, and in recognition of both the thorough and thoughtful 

analysis of all aspects of the legislation by the Committee on the 

Judiciary minority members and our shared jurisdiction over H.R. 

5, we incorporate by reference herein the dissenting views included 

in the report filed by the Corrittee on the Judiciary on H.R. 5 by 

members of that Committee who oppose the bill.7 We concur in 

those views and stand with these colleagues in wholly rejecting this 

legislation. 

BACKGROUND AND OVERVIEW

A medical malpractice claim is an allegation of harm or injury 

caused by a health care provider. A medical malpractice lawsuit is 

a civil (i.e., non-criminal) action in which an individual making 

such an allegation seeks damages against those health care providers the individual believes is legally responsible or liable for the 

harm or injury that has occurred. Medical malpractice liability 

arises when a health care provider engages in negligence or an intentional wrongdoing.8 ‘‘The general difference between an action 

based in negligence and one based in intentional tort [wrongdoing] 

is that a ‘medical procedure poorly performed might constitute negligence, while a medical proced correctly performed that was not 

consented to might constitute an intentional tort.’ ’’ 9

Traditionally, the principals of medical malpractice liability and 

the procedures for the conduct of medical malpractice lawsuits 

have been governed by state law.10 In fact, it has always been that 

way. 

Periodically, however, Congress has engaged in a debate about 

various aspects of medical malpractice, generally in response to 

sharply rising medical malpractice insurance premiums for physicians as well as reports of activities strongly associated with such 

increases—the difficulty of doctors in some specialties obtaining 

any malpractice coverage at all and the decision of many physiVerDate Mar 15 2010 20:34 May 26, 2011 Jkt 099006 PO 00000 Frm 00031 Fmt 6604 Sfmt 6602 E:\HR\OC\HR039P2.XXX HR039P2

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11 Congressional Research Service, Medical Malpractice: Background and Legislation in the 

112th Congress, Rept. No. R41693, p. 1 (Apr. 26, 2011). 12 Remarks of Rep. Phil Gingrey, House Committee on Energy and Commerce, Markup on 

H.R. 5, HEALTH Act of 2011, 112th Cong., p. 151 (May 11, 2011) (transcript of the proceeding). 13 HEALTH Act, Section (2)(b)(2). 14 Congressional Research Service, Medical Malpractice: Background and Legislation in the 

112th Congress, Rept. No. R41693, p. 1 (Apr. 26, 2011); Testimony of Joanne Doroshow, Executive Director, Center for Justice & Democracy, House Committee on Energy and Commerce, 

Hearing on the Cost of the Medical Liability System Proposals for Reform, Including H.R. 5, 

HEALTH Act of 2011, 112th Cong., p. 25 (Apr. 6, 2011) (transcript of the proceeding). 15This is precisely what happened in the state of California. After the state’s cap on non-economic damages for medical malpractice cases was enacted in 1975 as part of MICRA, malpractice premium rates rose by some 450%. They only dropped in 1988 when state Proposition 

103 was passed, setting up a state regulatory process for insurance rates. (Testimony of Joanne 

Doroshow, Executive Director, Center for Justice & Democracy, House Committee on Energy 

and Commerce, Hearing on the Cost of the Medical Liability System Proposals for Reform, Including H.R. 5, HEALTH Act of 2011, 112th Cong., p. 51 (Apr. 6, 2011) (transcript of the proceeding)). 16 HEALTH Act, Section (2)(b). 17 Congressional Research Service, Medical Malpractice: Background and Legislation in the 

112th Congress, Rept. No. R41693, pp. 4–5; 7 (Apr. 26, 2011); Testimony of Allen B. Kachalia, 

MD, JD, Medical Director, Brigham and Women’s Hospital (p. 34) and Joanne Doroshow, Executive Director, Center for Justice & Democracy (p. 70), House Committee on Energy and Commerce, Hearing on the Cost of the Medical Liability System Proposals for Reform, Including H.R. 

5, HEALTH Act of 2011, 112th Cong., (Apr. 6, 2011) (transcript of the proceeding). 18 Rep. Phil Gingrey, The HEALTH Act: A Real Reform Option (online at: http:// 

gingrey.house.gov/News/DocumentSingle.aspx?DocumentID=240791 (assessed on May 19, 2011). 

See Testimony of Allen B. Kachalia, MD, JD, Medical Director, Brigham and Women’s Hospital, 

House Committee on Energy and Commerce, Hearing on the Cost of the Medical Liability System Proposals for Reform, Including H.R. 5, HEALTH Act of 2011, 112th Cong., p. 34 (Apr. 6, 

2011) (transcript of the proceeding). See also the 2009 letter to Senator Orrin Hatch from the 

Congressional Budget Office (CBO) on the effects of medical malpractice reform in which CBO 

stated that ‘‘. . . imposing limits on [the right to sue for damages that result from negligent 

health care] might be expected to have a negative impact on health outcomes.’’ (Letter from 

Douglas W. Elmendorf, Director, Congressional Budget Office to Senator Orrin G. Hatch, p. 5 

(Oct. 9, 2009) (online at: http:cbo.gov/ftpdocs/106xx/doc10641/10-09-TortlReform.pdf) 19 Congressional Research Service, Medical Malpractice: Background and Legislation in the 

112th Congress, Rept. No. R41693, pp. 4–5 (Apr. 26, 2011). 

cians to leave the practice of medicine altogether because the insurance they could secure was too expensive.11 Reform the system and 

premium charges will subsequently fall, resulting in good things for 

doctors, for their patients, and for the nation’s health care bill—so 

the argument has gone. This flawed logic apparently failed to sway 

past Congresses, which chose not to act upon it. 

Sponsors of the HEALTH Act have put forth the same defective 

reasoning, stating that H.R. 5 ‘‘will . . . bring down the cost of 

medical malpractice insurance which will reduce the overall cost of 

health care in this country,’’ 12 and making lower malpractice insurance premiums one of the driving forces behind the legislation.13 Yet, data indicate that today, the overall medical liability 

insurance market is not in crisis.14 They also show it is the direct 

regulation of insurance companies—and not a cap on non-economic 

damages (one of the core elements of H.R. 5)—that is responsible 

for the reductions in insurance premiums that have been seen.15

Nor is there compelling evidence that the HEALTH Act will 

achieve the other major goals articulated by its advocates 16—to 

eliminate the practice of so-called defensive medicine; 17 to ‘‘put the 

focus back on patients’’; 18 and to significantly reduce health care 

costs.19

Despite the poor prognosis for success of the approach taken by 

H.R. 5, and as previously acknowledged, we believe medical malpractice is a very real and significant concern that requires appropriate attention. Malpractice insurance premiums remain high in 


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20See e.g., Testimony of Troy M. Tippetts, MD, Past President, American Association of Neurological Surgeons, House Committee on Energy and Commerce, Hearing on the Cost of the Medical Liability System Proposals for Reform, Including H.R. 5, HEALTH Act of 2011, 112th Cong., 

p. 115–116 (Apr. 6, 2011) (transcript of the proceeeding); and comments of Rep. Tim Murphy 

during the full Committee markup of H.R. 5 (Remarks of Rep. Tim Murphy, House Committee 

on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., p. 43 (May 

11, 2011) (transcript of the proceeding)). 21Testimony of Allen B. Kachalia, MD, JD, Medical Director of Quality and Safety, Brigham 

and Women’s Hospital, House Committee on Energy and Commerce, Hearing on the Cost of the 

Medical Liability System Proposals for Reform, Including H.R. 5, HEALTH Act of 2011, 112th 

Cong., p. 32 (Apr. 6, 2011) (transcript of the proceeding). 22 Congressional Research Service, Medical Malpractice: Background and Legislation in the 

112th Congress, Rept. No. R41693, p. 6 (Apr. 26, 2011). 23 Classen DC, Resar R, Griffin F, Federico F, Frankel T, Kimmel N, Whittington JC, Frankel 

A, Seger A and James BC, ‘Global Trigger Tool’ Shows That Adverse Events in Hospitals May 

Be Ten Times Greater Than Previously Measured, Health Affairs, 30, No. 4 (2011):581–589. 24 HEALTH Act, Section 2(b). 25 House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 

112th Cong., pp. 201–207; 229–237 (amendment offered by Rep. Ed Towns) (May 11, 2011) 

(transcript of the proceeding). 26 ‘‘Reform should address how well the malpractice system improves the quality of care that 

we provide. After all, this is one of the system’s main goals.’’ (Testimony of Allen B. Kachalia, 

MD, JD, Medical Director of Quality and Safety, Brigham and Women’s Hospital, House Committee on Energy and Commerce, Hearing on the Cost of the Medical Liability System Proposals 

for Reform, Including H.R. 5, HEALTH Act of 2011, 112th Cong., p. 33 (Apr. 6, 2011) (transcript 

of the proceeding)). 27See, e.g., ACA Section 2702 (Medicaid payment adjustment for Health care-acquired conditions); Section 3001 (hospital value-based purchasing program); Section 3008 (Medicare payment 

adjustment for conditions acquierd in hospitals; Section 3011 (national strategy to improve 

health care quality); Section 3012 (interagency working group on health care quality); Section 

3013 (quality measure development); Section 3014 (quality measurement); Section 3015 (quality 

data collection, public reporting); Section 3021 (Center for Medicare and Medicaid Innovation); 

Section 3025 (hospital readmissions reduction program); Section 3026 (community-based care 

Continued 

some parts of the country.20 And the justice system does not always work as it should. Many legitimate malpractice cases are 

never filed and when they are, in some instances, severely injured 

individuals do not receive just compensation; in others, damages 

appear to be excessive.21 These issues can and should be addressed 

in the proper forum. 

But beyond all this lies the root problem of medical malpractice—medical errors. As summarized succinctly by Congressional Research Service experts, ‘‘medical errors can lead to injury, 

and injury is the medical basis on which a malpractice claim is 

made.’’ 22 Such mistakes appear to be at an all-time high. For example, a recent study from the leading journal Health Affairs indicates that the number of confirmed serious, adverse events occurring in hospitalized patients is at least ten times higher than previously reported, with such events taking place in one-third of hospital admissions.23

H.R. 5 makes no attempt to address this fundamental issue. 

Shockingly, other than improving the exchange of information, reducing medical errors and improving patient care is not even listed 

among the purposes of the legislation.24 Moreover, proponents of 

the HEALTH Act specifically rejected an amendment to the bill offered at the full Committee markup that would have included the 

achievement of these goals in that section of the bill.25 This makes 

no sense given that experts on all sides of the malpractice issue 

agree: We must address medical mismanagement as part of any 

fundamental reform of our health care system.26

The Affordable Care Act takes on this challenge. It includes several provisions designed to improve patient safety and reduce unnecessary medical errors.27 The Administration has already begun 


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transitions program); Section 3501 (health care delivery system research; quality improvement 

technical assistance); Section 3503 (medication management services in treatment of chronic disease); and Section 3508 (demonstration program to integrate quality improvement and patient 

safety training into clinical eduction of health professionals). 28For a description of these initiatives, see HHS, Partnership for Patients: Better Care, Lower 

Costs (Apr. 12, 2011) (online at: http://www.healthcare.gov/news/factsheets/ 

partnership04122011a.html). 29 ACA, Section 10607. 30Office of Management and Budget, Exc. Office of the President, Budget of the United States 

Government, Fiscal Year 2012, p. 191 (online at: http://www.whitehouse.gov/omb/budget/Overview/). 31Mello MM, Kachalia A, Evaluation of Options for Medical Malpractice System Reform, 

MedPAC, No. 10–2 (Apr. 2010). 32MICRA is codified at different sections within the California Code. See Cal. Business and 

Professions Code, Section 6146; Cal. Civil Code, Sections 3333.1 and 3333.2; and Cal. Code of 

Civil Procedure, Section 667.7. 33See e.g., Internal Memorandum from Committee Staff to Members of the House Committee 

on Energy and Commerce, Full Committee Markup on May 10–11, 2011, p. 5., in which Committee staff state: ‘‘H.R. 5 mirrors the provisions of MICRA . . .’’ and comments of Rep. Joe 

Pitts during the full Committee markup of H.R. 5. (Remarks of Rep. Joe Pitts, House Committee 

on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., pp. 18–19 

(May 10, 2011) (transcript of the proceeding). 

to use these authorities to address patient safety in a significant 

fashion.28 When fully implemented and evaluated, theses types of 

measures are expected to have a positive impact on the medical 

malpractice situation as it exists today. 

In the meantime and in recognition of the immediate desire to 

address a number of medical malpractice concerns, the ACA also 

provides $50 million for demonstration projects to allow states to 

develop, implement and evaluate alternatives to current malpractice litigation practices and procedures.29 The Department of 

Health and Human Services (HHS) is now in process of awarding 

those grants. In addition, the President’s budget proposal for FY 

2012 calls for $100 million in state medical malpractice demonstration projects (followed by $50 million for each of FY 2013 through 

FY 2015) to be administered by the Department of Justice in consultation with HHS.30 This demonstration project approach to malpractice reform has also been endorsed by a recent study on behalf 

of the Medicare Payment Advisory Commission (MedPAC).31

We believe these efforts, combined with those designed to improve patient outcomes, form the basis for real and truly meaningful medical malpractice reform that can have a substantial impact 

on health care costs. They should be given every opportunity to 

proceed and succeed. As currently structured, H.R. 5 cannot 

produce same results. In our view, then, once again, the legislation 

should be turned back and aside. 

H.R. 5 IS NOT MICRA 

Since its introduction, proponents of the HEALTH Act have suggested that it is modeled on the Medical Injury Compensation Reform Act (MICRA),32 medical malpractice legislation that was enacted in California in 1975.33 At best, this is an unintentional 

misreading of the California law; at worse, it is an attempt to mislead members into believing that a vote for H.R. 5 is a vote for 

MICRA. As the plain language of H.R. 5 makes clear, this is simply 

not true. 

The differences between MICRA and H.R. 5 on a number of key 

issues are stark and important: • MICRA applies only to cases involving a doctor, a nurse, or a 

hospital (and similar health care providers). 


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34 HEALTH Act, Section 9(9). 35 HEALTH Act, Section 9(8). 36 HEALTH Act, Section 7(c). 37Generally speaking, punitive damages cannot be assessed against vaccine manufacturers 

under the National Vaccine Injury Compensation Program (established in Title 21 of the Public 

Health Service Act) in those vaccine injury cases in which an injured person rejects compensation and elects to file a lawsuit in court. However, as discussed in these views on the issue of 

states’ rights, we believe the Compensation Program is a unique and special initiative, completely distinguishable from the HEALTH Act. 38 HEALTH Act, Section 7(b)(2). 39 HEALTH Act, Section 7(a). 40 HEALTH Act, Section 5. 

The Health Act is breathtaking in its scope. Its provisions—including caps on non-economic and punitive damages—cover all 

‘‘healthcare lawsuits,’’ providing protections not only for physicians 

and hospitals, but also for nursing homes, insurance companies, 

health maintenance organizations, medical device manufacturers, 

and pharmaceutical companies.34 This approach goes far beyond 

what is typically contemplated as a medical malpractice case. • MICRA applies only to cases of professional negligence and not 

other causes of action. 

H.R. 5 takes in all ‘‘health care liability actions . . . regardless 

of the theory of liability’’ on which a lawsuit is based.35 This includes cases of intentional wrongdoing—cases in which a patient 

does not consent to a medical or health care service—as well as 

negligence. • MICRA does not include any limitations on claims brought 

against pharmaceutical and medical device companies. 

Except in rare instances, the HEALTH Act provides complete immunity from punitive damages to manufacturers of drugs and devices that have been approved by the FDA or that are generally 

recognized as being safe and effective in accordance with FDA 

standards.36 Such blanket immunity is virtually unprecedented.37

• MICRA does not cap punitive damages or require special action 

before punitive damages can be awarded. H.R. 5 includes a cap on punitive damages—$250,000 or twice 

the amount of non-economic damages, whichever is greater.38

Moreover, H.R. 5 establishes special procedures and conditions that 

must be met before punitive damages can be sought in a lawsuit,39

making it far more difficult for such damages to be awarded. • MICRA restricts its limitations on attorney contingency fees 

only to cases brought against health care providers. 

The HEALTH Act imposes limits on contingency fees for attorneys involved in a much broader spectrum cases, including those 

in which a claim is brought against a pharmaceutical or medical 

device manufacturer.40 Such limits, in effect, create hurdles for an 

injured party to obtain the best possible legal representation. 

These dramatic differences between the two pieces of legislation—along with others—illustrate just how misguided and deceptive it is to assert that H.R. 5 is a MICRA look-alike. Moreover, 

these distinctions highlight the extreme nature of H.R. 5. Indeed, 

the HEALTH Act not only goes far beyond what is covered and considered by MICRA; it is, in fact, a constellation of reforms that 

when taken together in a single package, constitutes a radical 

transformation of the nation’s tort system and not simply medical 

malpractice reform. Such transformation is neither necessary nor 

warranted and certainly is not what MICRA stands for. 


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41States have traditionally set their own rules and procedures for dealing with other healthrelated matters, e.g., licensure of medical professionals and the regulation of health insurance. 42 ‘‘I have heard or been briefed that Section 11 [state flexibility] of H.R. 5 does protect the 

states’ rights, but if you read it, it is extremely restrictive, and most states that have medical 

liability or medical malpractice reform laws will have this federal law supersede it. Read Section 

11. It is a one size fits all.’’ (Remarks of Rep. Lee Terry, House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., p. 26 (May 10, 2011) (transcript 

of the proceeding)). 43 Congressional Research Service, Medical Malpractice Liability Reform: Legal Issues and 50- 

State Surveys on Tort Reform Proposals. Rept. No. R41661 (Mar. 29, 2011). 44 HEALTH Act, Section 9(7). 45The HEALTH Act allows for only two exceptions under which state law would not be preempted: (a) state law that provides greater procedural or substantive protections for health care 

providers and organizations than those found in H.R. 5 (HEALTH Act, Section 11(b)(2)); and 

(b) state law that specifies an exact dollar figure for a cap on either non-economic or punitive 

damages; such figures would remain untouched, regardless of their amount (HEALTH Act, Section 11(c)). The former demonstrates the one-sided approach of the HEALTH Act—state laws 

that protect health care providers and organizations are preserved while state laws that protect 

patients and consumers are tossed out. 46Letter from Assemblyman William Home (NV) and Rep. Jerry Madden (TX), National Conference of State Legislatures, to Rep. Joe Pitts and Rep. Frank Pallone (Apr. 4, 2011) (online 

at: http://www.ncsl.orgdefault.aspx?tabid=22497). 

H.R. 5 IS AN ASSAULT ON STATES’ RIGHTS

At its core, H.R. 5 is a wholesale refutation of the federalist approach to medical malpractice liability under which states have traditionally developed their own law and established their own rules 

to govern these kinds of cases.41 Every state is affected by the legislation and, despite suggestions to the contrary, no state will be 

able to keep its current malpractice law intact.42

Such action is troubling on many fronts. Of greatest concern perhaps—beyond the bill’s direct and unjustified attack on states’ 

rights—is the magnitude of what is contemplated under the legislation. 

In one form or another, all 50 states have addressed the issue 

of medical malpractice liability and no two states have come out in 

exactly the same place. Instead, each has developed a process and 

set of procedures for medical malpractice cases that best meet the 

needs of its citizens and own legal system. Thus, for example, some 

states have enacted caps on damages in malpractice cases; other 

states have laws or even constitutional provisions that specifically 

prohibit them. The same can be said for many of the other reforms 

included in the HEALTH Act such as those related to joint and several liability, statutes of limitations, attorney contingency fees, and 

periodic payments for awards.43

No state, however, has attempted to capture every action against 

‘‘a health care provider, a health care organization, or the manufacturer, distributor, supplier, marketer, promoter, or seller of a medical product, regardless of the theory of liability on which the claim 

is based’’ 44 under the umbrella of a single medical malpractice reform initiative. No state, then—not a single one—has in place the 

‘‘new world’’ malpractice order set out in H.R. 5. 

The sweep of H.R. 5 is simply stunning. In short, advocates of 

the HEALTH Act would have the federal government strike down 

the medical malpractice law of all 50 states 45 and replace it with 

their own, uniform, first-of-a-kind version of what that law should 

be. It comes as no surprise, then, that the bi-partisan National 

Conference of State Legislatures strongly opposes the legislation 

and concludes that ‘‘federal malpractice legislation is unnecessary.’’ 46


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47See, e.g., the debate over the amendment offered by Rep. Tammy Baldwin during the full 

Committee mark up of H.R. 5. The text of that amendment reads: ‘‘Nothing in this Act shall 

be construed to modify or preempt any substantive or procedural state law governing medical 

malpractice or medical liability cases or to impair state authority regarding legal standards or 

procedures used in medical malpractice or medical product liability cases.’’ This language is 

identical to that found in Section 2(c) of H.R. 816, Provider Shield Act of 2011, introduced by 

Rep. Phil Gingrey, the primary sponsor of H.R. 5, in February 2011. Yet Rep. Gingrey, along 

with two other co-sponsors of H.R. 816, Reps. Tim Murphy and Michael Burgess—as well as 

all other proponents of the HEALTH Act—voted against the Baldwin amendment. (House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., pp. 

6–65 (amendment offered by Rep. Tammy Baldwin) (May 11, 2011) (transcript of the proceeding)). All of these members went on to reject a narrower amendment to carve out and preserve only state constitutional provisions that address medical malpractice liability. (House 

Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., 

pp. 66–88 (amendment offered by Rep. John Barrow) (May 11, 2011) (transcript of the proceeding)). During the markup, Rep. Lee Terry emphasized how support for H.R. 5 is inconsistent 

with support for states rights: ‘‘It seems ironic to me that as someone who passionately opposed 

the nationalization of our health care based on the fact that this was extreme federalism and 

usurps states’ rights that now, because it is politically expedient for us on this side of the aisle, 

that we are now engaging in that same philosophical conduct.’’ (Remarks of Rep. Lee Terry, 

House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th 

Cong., p. 26 (May 10, 2011) (transcript of the proceeding)). Rep. Terry’s point is underscored 

in an op-ed piece against H.R. 5, penned by Professor Randy Barnett of Georgetown University 

Law Center at the very time this Committee report is being filed. Professor Barnett is a wellknown and ardent opponent of the ACA who has twice this year testified against the law before 

Congress, co-authored the National Federation of Independent Business’s amicus brief on the 

constitutionality of the Act for the 11th Circuit Court of Appeals, and has appeared with Republicans to promote its repeal. In his op-ed piece, Professor Barnett states: 

But tort law—the body of rules by which persons seek damages for injuries to their person and property—has always been regulated by the states, not the federal government. 

Tort law is at the heart of what is called the ‘police power’ of states . . . Indeed, if Congress can now regulate tort law, which has always been at the core of state powers, 

then Congress, and not the states, has a general police power. . . . While I strongly 

support reforming our malpractice laws to protect honest doctors from false claims and 

out-of-control state juries, this reform must come at the state level, as it has in recent 

years. Constitutional law professors have long cynically ridiculed a ‘fair-weather federalism’ that is abandoned whenever it is inconvenient to someone’s policy preferences. 

If House Republicans ignore their pledge to America to assess the Constitution themselves, and invade the powers ‘reserved for the states’ affirmed by the Tenth Amendment, they will prove my colleagues right. 

Barnett, R. Tort Reform and the GOP’s Fair-Weather Federalism, Washington Examiner (May 

21, 2011). It is also noteworthy that during Committee consideration of H.R. 5, one proponent 

of the bill pointed to the efforts of Mississippi Governor Haley Barbour in enacting a ‘‘comprehensive tort reform law that has significantly reshaped our [Mississippi] medical liability system’’ as a model Congress should ‘‘emulate.’’ (Remarks of Rep. Gregg Harper, House Committee 

on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., p. 47 (May 

10, 2011) (transcript of the proceeding)). Yet Governor Barbour is on record before the Committee in opposing federal legislation that would preempt state medical malpractice law. (Committee on Energy and Commerce, Hearing on the Consequences of Obamacare: Impact on Medicaid and State Health Care Reform, 112th Cong., p. 111 (Mar. 1, 2011) (transcript of the proceeding)). 48We are compelled to comment as well on the inconsistency concerning the assertions of H.R. 

5 advocates regarding the bill’s constitutional authority. They cite Article I, Section 8, Clause 

3 of the Constitution as the basis for the bill, stating that ‘‘health-care related lawsuits are activities that affect interstate commerce’’ and argue that such lawsuits contribute to the high 

costs of health care. (Statement of Rep. Phil Gingrey, Congressional Record, H434 (Jan. 24, 

2011)). Yet, for the past two years, supporters of the HEALTH Act have argued precisely the 

opposite with respect to the ACA—that its provisions violate the Constitution’s Commerce 

Clause even though, they too, are designed to address the high costs of health care. 49See, e.g., the comments of Rep. Brian Bilbray (pp. 23–24); Rep. Phil Gingrey (p. 25); and 

Rep. Bill Cassidy (pp. 31–32) on this point during the full Committee markup. (House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., (May 

11, 2011) (transcript of the proceeding)). 

The inconsistency of this vision cannot go unmentioned. By and 

large, proponents of H.R. 5 are the very same members who have 

staunchly spoken out in favor of states rights—at times even with 

respect to medical malpractice law.47 Yet, in this instance, they 

have squarely turned their backs on this principle. This reincarnation is stunning as well.48

HEALTH Act proponents cite two statutes in support of their 

federalist approach to medical malpractice reform 49—the Federal 


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50 United States Code, Title 28, Chapter 171. 51Public Health Service Act, Title 21, Subtitle 2. 52The following example illustrates how the FTCA interacts with state law. A doctor employed by a federally-qualified health center in Delaware commits medical malpractice on one 

of the center’s patients. Since the doctor is a federal employee, the patient cannot sue either 

the health center or the doctor directly, but can file a claim against the federal government 

under the procedures set forth in the FTCA. Under those procedures, the patient must first file 

an administrative claim with HHS. If the patient is not satisfied with the determination made 

by HHS, she may then file a medical malpractice cause of action against the government in the 

U.S. District Court of Delaware. That action will be based on Delaware state law which does 

not cap non-economic damages. 53See HEALTH Act, Section 9(8), which defines ‘‘health care liability action’’ to include malpractice cases brought in federal as well as state court. Moreover, the HEALTH Act specifically 

supersedes provisions of the FTCA related to damages, attorney contingency fees, statutes of 

limitations, and periodic payments of awards. (HEALTH Act, Section 11(a).) 

Torts Claim Act (FTCA) 50 and the National Childhood Vaccine Injury Act 51—as examples of congressional intervention in medical 

malpractice liability. We submit at neither law is on point. 

Enacted in 1946, the FTCA was established to provide a mechanism through which the federal government could be sued and held 

liable for damages in civil or tort actions. (Until then, under our 

traditional common law borrowed from the British, the government 

enjoyed sovereign immunity, meaning that it could never be held 

liable for claims, regardless of its degree of culpability.) The FTCA 

partially waives the government’s sovereign immunity by authorizing civil suits (with some exceptions) to be brought against the 

United States and making federal employees acting within the 

scope of their employment immune from liability—that is, it makes 

the United States liable for torts of its employees to the extent private employers are liable under state law for the torts of their employees. 

In contrast to the HEALTH Act, the FTCA does not create federal tort law; it simply makes the federal government subject to 

state tort law. The law of the state in which the misconduct occurs 

governs both the substantive and procedural aspects of FTCA 

cases. 

Congress can, however, place limitations on its waiver of sovereign immunity. It has, for example, not waived sovereign immunity for punitive damages so no individual can collect such damages from the federal government. Under the FTCA specifically, 

Congress has capped attorney fees and requires that individuals 

seeking redress against the federal government first file an administrative claim with the appropriate federal agency before bringing 

a lawsuit in federal court. But once that lawsuit is initiated, state 

law will fully apply, including state law regarding the award of 

non-economic damages.52 Under H.R. 5, a completely different set 

of rules—those established under the legislation—would be used 

instead.53

The National Childhood Vaccine Injury Act does not work either 

as a justification for H.R. 5. Created in 1986, this statute established a new ‘‘no-fault’’ system to compensate individuals who have 

been injured by vaccines routinely administered to children. Unlike 

H.R. 5, the scope of this law is quite narrow and targeted. It was 

enacted to address two very specific and overriding concerns with 

which the federal government has a direct interest: ‘‘(a) the inadequacy—from both the perspective of vaccine-injured persons as 

well as vaccine manufacturers—of the [then current] approach to 


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54 House Committee on Energy and Commerce, National Childhood Vaccine Injury Act of 

1986, 99th Cong., p. 7 (Sept. 26, 1986) (H. Rept. 99–908, Part 1). 55 HEALTH Act, Section 9(7). 

compensating those who have been damaged by a vaccine; and (b) 

the instability and unpredictability of the childhood vaccine market.54 As discussed in our Introduction to these dissenting views, 

we do not believe supporters of H.R. 5 have made the same kind 

of compelling argument to rationalize direct federal intervention 

into the issue of medical malpractice liability. Nor do we believe 

that the legislation is designed to adequately address that problem. 

But beyond their differences in purpose and scope is the primary 

substantive distinction between H.R. 5 and the vaccine compensation law. Under the National Childhood Vaccine Injury Act, injured 

patients who meet the relevant and relatively generous eligibility 

criteria are awarded compensation from a fund supported by a federal tax on specified vaccines. Those who are dissatisfied with their 

awards may take their claim to court. 

It is true that such claims are litigated under special rules and 

limitations that, like the HEALTH Act, affect state tort law. But 

those rules and limitations must be understood in the context of 

the larger National Childhood Vaccine Injury Program which, as 

previously noted, makes federally supported compensation—including economic and non-economic damages—available to injured persons. H.R. 5 does not, of course, include a compensation component; 

it merely changes the rules under which compensation can be 

awarded, making it far more difficult for justice to be best served. 

The difference between the two pieces of legislation in this regard 

could not be more profound. 

In sum, H.R. 5 is unprecedented in its approach to, and in its 

reach and impact on, state medical malpractice liability law—for no 

justified end. And there is no relevant federal statute which legitimately serves as its prototype. In our view, then, this legislation— 

on these grounds alone—should be rejected. 

H.R. 5 REACHES TOO FAR AND PROTECTS TOO MANY

As described in our Background and Overview to these dissenting views, medical malpractice typically refers to negligent 

wrongdoing by health professionals, resulting in harm to a patient. 

As we also discussed, H.R. 5 goes well beyond this understanding 

to include all health care liability actions involving ‘‘a health care 

provider, a health care organization, or the manufacturer, distributor, supplier, marketer, promoter, or selIers of a medical product, regardless of the theory of liability on which the claim is 

based.’’ 55 Such a broad, expansive and sweeping perspective of 

medical malpractice is not to be found in the law books of any of 

the 50 states. H.R. 5 simply goes too far. 

Three areas that H.R. 5 touches directly received considerable attention during the Committee’s deliberations over the HEALTH 

Act: 

• the HEALTH Act’s inclusion of intentional torts; 

• its protections for nursing homes; and 

• the inclusion of lawsuits involving FDA-approved drugs and 

medical devices. 


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56 Congressional Research Service, Medical Malpractice Liability Reform: Legal Issues and 50- 

State Surveys on Tort Reform Proposals, Rept. No. R41661, p. 2 (Mar. 28, 2011). 57See Gamer, BA (editor-in-chief), Black’s Law Dictionary) (9th ed. 2009) (‘‘battery: tort’’); 

(‘‘tort: intentional tort’’) (available online at: http://www.westlaw.com); and Keeton, WP, Dobbs, 

DB, Keeton, RE, and Owen, DG, Prosser and Keeton on Torts (5th ed. 2004), pp. 33–54 (West 

Group, Hornbook Series). 58 HEALTH Act, Section 9(7). 59Greenwich Times, Doctor Uses Wrong Man’s Sperm to Produce Twins (Nov. 12, 2009) (online 

at: http://www.ctpost.com/default/article/Doctor-uses-wrong-man-s-sperm-to-produce-twins215345.php). 

Here we address the first two issues; the last is discussed separately in the section, H.R. 5 Is An Unwarranted Windfall for Pharmaceutical and Medical Companies. 

INTENTIONAL HARMS

In the context of medical malpractice, an intentional tort or 

wrongdoing occurs when a patient does not consent to a procedure 

or service—even if it is performed or provided correctly. In such 

cases, the health care provider is ‘‘generally alleged to have intentionally acted in a fashion that ultimately caused harm to the patient.’’ 56 Intentional torts include claims such as assault, sexual assault and rape, battery, false imprisonment (unlawfully holding 

someone against their will), invasion of privacy, conversion (theft), 

misrepresentation, and fraud.57

Except in those instances in which a claim is based upon criminal liability, 58 the HEALTH Act affords its liability protections to 

those who have committed these and similar kinds of acts, including conduct that results in egregious injury or even death to patients. Nothing in the Committee’s deliberations over H.R. 5—not 

a shred of testimony presented at the Health Subcommittee hearing or any point of debate made during the full Committee markup—documents or justifies this position. This is yet another example of how extreme H.R. 5 is in its approach to medical malpractice 

reform. 

Consider these real world examples: 

• Dr. Ben D. Ramaley, a Connecticut obstetrician/gynecologist, 

substituted his own sperm for that of a patient’s husband during 

an artificial insemination procedure. The couple went on to have a 

set of twins, only to learn after their birth and a subsequent paternity test that the treating physician (and not the husband) was the 

biological father. The state’s Department of Public Health fined the 

doctor $10,000 for ‘‘using the wrong man’s sperm’’ in the procedure, 

but allowed him to keep an unrestricted license to practice medicine. The couple’s medical malpractice lawsuit against the physician was settled, but there is no record of Dr. Ramaley’s ever facing 

criminal charges.59

• Dr. Kermit Gosnell, a Pennsylvania physician, performed late 

term abortions on minority and low-income women—many of whom 

were pregnant for the first time—without informing the mothers he 

was doing so. He falsified ultrasounds used to determine the duration of the pregnancy and taught his staff to hold the probe in such 

a way that the fetuses looked smaller. Few, if any, of the women 

who were sedated during the procedure knew that their babies had 

been delivered alive. And because they were misled about the 

length of their pregnancies, none of them was given the opportunity to make an informed choice about what to do about their 


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60MSNBC, ‘House of Horrors’ Alleged at Abortion Clinic (Jan. 19, 2011) (online at: 

http:www.msnbc.msn.com/id41154527/ns/uslnews-crimelandlcourts/t/house-horrors-allegedabortion-clinic/); ABC News, Alleged Victim Calls Philadelphia Abortion Doc Kermit Gosnell a 

‘Monster’ (Jan. 25, 2011) (online at: http://abcnews.go.com/US/alleged-victim-calls-philadelphia-abortion-doctor-kermit-gosnell/storsyid=12731387). 61 Appeal Democrat, Suit Filed in Death of Patient (June 9, 2005) (online at: http:// 

www.appeal-democrat.com/news/prestige-15049-taylor-lawsuit.html). 62 HEALTH Act, Section 9(12). 63 House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 

112th Cong., pp. 103–106 (May 11, 2011) (transcript of the proceeding). 64This is especially true with regard to sexual assaults. See U.S. Department of Justice, Bureau of Justice Statistics, Rape and Sexual Assault: Reporting to the Police and Medical Attention, 1992–2000 (Aug. 2002) (online at: http://bjs.ojp.usdoj.gov/content/pub/pdf/rsarp00.pdf). 65This argument made by H.R. 5 advocates is undercut further by the very language of the 

bill which lists among the factors to be considered in determining punitive damages ‘‘any criminal penalties imposed on [a party] as a result of the conduct complained of. . . .’’ (HEALTH 

Continued 

pregnancy. Dr. Gosnell is now facing criminal charges, but has not 

yet been found guilty of any crime. At least 46 lawsuits have been 

filed against him in the past.60

• Mildred Taylor, who suffered from Alzheimer’s disease, but 

was otherwise healthy, was a resident at the Prestige Assisted Living facility in Marysville, California. On June 24, 2004, the wheelchair-bound, 98-year old was falsely imprisoned when she was left 

outside overnight by facility staff. No one made any attempt to find 

her, even though staff knew she was not in her room. No one called 

Ms. Taylor’s family and no one contacted the police to report her 

missing. She was not found until the next morning when her body 

temperature had dropped to 93 degrees and her right leg had become severely swollen. Ms. Taylor remained bed-ridden and debilitated until her death less than one month later. The California Department of Social Services cited Prestige for violating Ms. Taylor’s 

rights, but did not even fine the company.61

In each of these cases, a ‘‘health good or service’’—as that term 

is defined in H.R. 5 62—was provided, arguably bringing them within the purview of H.R. 5. In the instance of Mildred Taylor, we 

think our position is made even stronger by the comments found 

in the majority views of this Committee report that the term 

‘‘health care goods and services’’ is intended to include those ‘‘involving the assessment or care of the health of human beings’’ as 

well as the ‘‘monitoring, supervision, and provision of direct assistance to claimants.’’ 

Supporters of the HEALTH Act point to the bill’s exclusion of actions constituting criminal liability as the basis for arguing that examples such as these and those discussed during the full Committee markup 63 would fall outside the reach of H.R. 5. But intentional tort is not the same as criminal liability. In criminal cases, 

individuals must be selected for prosecution, tried in a court of law, 

and successfully convicted using a standard of proof that is appropriately high—proof beyond a reasonable doubt. In contrast, many 

incidents of intentional tort—even if they meet the elements of a 

crime—are never reported, let alone prosecuted.64 Indeed, Dr. 

Ramaley does not appear to ever have faced criminal charges; Dr. 

Gosnell has not yet been convicted of anything. And it is unclear 

how an entity such as a nursing home could be charged with a 

crime in a case like Mildred Taylor’s. We submit that under H.R. 

5, these health care providers could escape significant civil liability 

as well.65


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Act, Section 7(b)(E)). If criminal acts are outside the scope of H.R. 5, how can such acts be taken 

into account in determining punitive damages under the legislation? 66 House Committee on Energy and commerce, Markup of HR. 5, HEALTH Act of 2011, 112th 

Cong., pp. 196–199 (May 11, 2011) (transcript of the proceeding). 67 HEALTH Act, Section 7(a). 68 House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 112th Cong., pp. 193–194 (May 11, 2011) (transcript of the proceeding). 69 HEALTH Act Section 7(a). 70 HEALTH Act Section 7(b)(2). 71Such an example is the elimination of the legal standard of joint and several liability which 

allows injured persons to sue all responsible parties and recover from each one in proportion 

to the degree of fault, or to sue any one party and recover the entire amount of damages. 

(HEALTH Act Section 4(d)). 72 House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 

112th Cong., pp. 190–200; 222–229 (amendment offered by Ranking Member Henry Waxman) 

(May 11, 2011) (transcript of the proceeding). 

Advocates of H.R. 5 also maintain that even in the absence of 

criminal activity, cases like these are not protected under the bill 

because they are extreme and non-therapeutic in nature and thus 

do not meet the definition of a health care good or service.66 We 

struggle to find text in the legislation that supports this argument. 

At the very least, the language is ambiguous on the point. Regardless, there is no bright line here. Consider, for example, the situation in which a psychiatrist has consensual sex with a patient because he believes—and convinces the patient—that this is the best 

way to ‘‘treat’’ her emotional problems. Do the protections of H.W. 

5 apply in any subsequent malpractice lawsuit brought by the patient? Again, based upon the text of the legislation, we believe the 

answer is unclear at best. 

Supporters of the HEALTH Act argue further that the availability of punitive damages in cases in which ‘‘malicious intent to 

injure’’ 67 occur should address any concerns we have about the inclusion of intentional torts in this legislation because, in their view, 

such actions are de facto, ones of this character.68 We are not comforted at all by this assertion; indeed, we believe it is Orwellian. 

The purpose of H.R. 5’s provisions on punitive damages is to 

limit them or cut them out altogether. Although ‘‘malicious intent 

to injure’’ is one ground upon which an injured person may seek 

punitive damages, the punitive damages procedural hurdles 69 and 

monetary limits in the bill—$250,000 or two times the amount of 

economic damages awarded 70—still apply. Moreover, this argument ignores other features of the legislation that may adversely 

affect an individual who has experienced an intentional tort and 

seeks compensation for the wrong that has occurred.71 In sum, we 

believe it is unconscionable for the federal government to place 

these kinds of restrictions on anyone—such as those individuals described in the cases above—who has been injured as a result of an 

intentional tort. 

We find these provisions of the bill particularly troublesome because during the debate over the issue of intentional torts, there 

appeared to be consensus among the members who participated 

that these activities are not the stuff of traditional medical malpractice cases. And so it was especially disappointing that an 

amendment to clarify and resolve the matter was not adopted. 

Under that amendment, intentional torts would be removed from 

the scope of the bill.72 Much to our amazement and consternation, 

the amendment was resoundly defeated, keeping intact liability 

protections for actions that—regardless of one’s position on medical 


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73 HEALTH Act, Sections 9(7) and 9(10). 74GAO, Nursing Home Quality: Prevalence of Serious Problems, While Declining, Reinforces 

Importance of Enhanced Oversight, pp. 3–4, GAO–03–561 (July 2003). 75GAO, High-Risk Series: An Update, p. 159, GAO–11–278 (Feb. 2011). 76 House Committee on Energy and Commerce, Markup on H.R. 5, HEALTH Act of 2011, 

112th Cong., pp. 103–105 (May 11, 2011) (transcript of the proceeding). 77See, e.g., the comments of Rep. Pete Olson on this point. (Remarks of Rep. Pete Olson, 

House Committee on Energy and Commerce, Markup of H.R. 5, HEALTH Act on 2011, 112th 

Cong., pp. 106–108; 110–113 (May 11, 2011) (transcript of the proceeding)). 78 Aon Risk Solutions, 2010 Long Term Care General Liability and Professional Liability Actuarial Analysis (Aug. 2010) (online at: http://img.en25.com/Web/AON/ 

LTC%20Benchmark%20Studyl2010lFINAL.pdf). 

malpractice reform—never should have been a part of the 

HEALTH Act in the first place. 

NURSING HOMES AND OTHER HEALTH CARE ENTITIES

H.R. 5 covers lawsuits brought against not only providers such 

as physicians or hospitals—the typical medical malpractice situation—but also cases involving ‘‘health care organizations,’’ including nursing homes, health maintenance organizations (HMOs), and 

health insurance companies.73 As such, these entities are entitled 

to the liability protections afforded under the bill, including the 

caps on non-economic and punitive damages. 

We have found no credible evidence to support the inclusion of 

these entities within the range of the HEALTH Act. Nursing 

homes, HMOs, and insurance companies were not even discussed 

during the Health Subcommittee hearing on the legislation. And 

the debate in the full Committee markup did nothing to persuade 

us to see the need to include these organizations within the realm 

of ‘‘medical malpractice reform.’’ 

In fact, our concern over H.R. 5’s inclusion of these businesses 

has only grown. This is especially true with respect to nursing 

homes which continue to be the subject of countless cases of negligence and even intentional wrongdoing. According to a Government Accountability Office (GAO) report on this topic, the proportion of nursing homes with serious quality problems remains unacceptably high, despite a decline in the incidence of such reported 

problems. Actual harm or more serious deficiencies were cited for 

20% or some 3500 nursing homes during an 18-month period.74 A 

more recent GAO report concludes that serious care problems in 

nursing homes continue to be of concern.75 These findings were reinforced by the several examples provided during the debate over 

this issue in the full Committee markup.76

Supporters of the legislation contend that liability protections are 

necessary for nursing homes to decrease their liability costs and increase access to liability insurance coverage.77 But a recent study 

conducted by the same firm whose work was cited in support of 

this argument suggests that these issues have been largely resolved. In fact, according to this study, the average annual loss 

(i.e., expenses related to liability insurance claims) per nursing 

home bed decreased from $1,710 in 2001 to $1,270 in 2009.78 And 

an article in Insurance Journal on the study concluded that ‘‘liability insurance pricing and availability for long term care providers 


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79 Insurance Journal, Growth, Stability and Changes in Store for Long Term Care Market 

(Nov. 14, 2010) (online at: http://www.insurancejournal.com/magazines/mag-features/2010/11/14/ 

160493.htm). 80 Aon Risk Solutions, Highest Long Term Care Liability Costs in Arkansas, Tennessee and 

West Virginia: Aon Study Costs Across the Rest of the Nation Remain Stable (Aug. 5, 2010) (online at: http://ir.aon.com/phoenix.zhtml?c=105697&p=irol-newsArticle&ID=1457169&highlight=). 81 Insurance Journal, Growth, Stability and Changes in Store or Long Term Care Market (Nov. 

14, 2010) (online at: http://www.insurancejournal.com/magazines/mag-features/2010/11/14/ 

160493.htm)). 82Physician groups now supporting H.R. 5 have in the past argued fervently in favor of ensuring that HMOs are held fully accountable for injuries that occur to their patients. (See, e.g., the 

position of the American Medical Association on this issue. (American Medical News, Both Sides 

Ready for HMO Liability Fight (Feb. 2004) (on line at: http://www.ama-assn.org/amednews/2004/ 

02/16/gvsb0216.htm)). 83Testimony of Brian Wolfman, JD, Visiting Professor of Law, Georgetown University Law 

Center, House Committee on Energy and Commerce, Subcommittee on Health, Hearing on The 

Cost of Medical Liability System Proposals for Reform. Including H.R. 5, HEALTH Act 2011, 

112th Cong., p. 5 (Apr. 6, 2011). 84 As discussed in the Background and Overview section of these dissenting views, we do not 

believe H.R. 5 will achieve any of the primary goals set forth by its supporters. 85See e.g., the comments of Rep. Joe Pitts during the full Committee markup of H.R. 5. (Remarks of Rep. Joe Pitts, House Committee on Energy and Commerce, Markup on H.R. 5, 

HEALTH Act of 2011, 112th Cong., p. 18 (May 9, 2011) (transcript of the proceeding)). 

are good and getting better’’ and attributed this trend to a newfound emphasis on quality of care.79

With regard to the impact of tort reform on these promising results, study documents observe that ‘‘while long term care liability 

costs are stable across much of the nation, Arkansas, Tennessee 

and West Virginia are experiencing high expenses—known as loss 

costs—related to insurance claims.’’ 80 In the context of the 

HEALTH Act, it is worth noting that two of these states—Arkansas and West Virginia—have both enacted some form of tort reform; 81 yet, according to this study, the insurance market in these 

states remains turbulent. This suggests that such reform is not the 

cure-all advocates of H.R. 5 would have us believe. 

Thus we remain unconvinced that nursing homes (or any other 

health care organization) 82 should receive the unprecedented protections provided to them under the HEALTH Act. In this respect, 

too, the legislation is unnecessarily and inappropriately broad in its 

scope and therefore, should be rejected. 

H.R. 5 IS AN UNWARRANTED WINDFALL FOR PHARMACEUTICAL AND

MEDICAL DEVICE COMPANIES

H.R. 5 sweeps so-called ‘‘medical products,’’ or FDA-approved 

drugs, biologics, and devices into its overly broad span. Lawsuits 

involving drugs and medical devices are not the kind of cases that 

are traditionally considered medical malpractice cases, which are 

ostensibly the subject of the legislation. A typical ‘‘medical malpractice’’ lawsuit is one filed by an injured patient against his or 

her treating physician. In contrast, cases involving medical products are filed by patients who are injured—and often killed—by defective drugs and medical devices against large, extremely wellresourced pharmaceutical or medical device companies.83

The primary rationales advanced by supporters of H.R. 5 for the 

legislation 84 simply do not apply to lawsuits relating to FDA-approved drugs and medical devices. For instance, proponents of the 

HEALTH Act argue that it is necessary to curtail the practice of 

defensive medicine.85 They claim the legislation will bring down 


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86See e.g., the comments of Rep. Phil Gingrey during the full Committee markup of H.R. 5. 

(Remarks of Rep. Phil Gingrey, House Committee on Energy and Commerce, Markup on H.R. 

5, HEALTH Act of 2011, 112th Cong., p. 151 (May 10, 2011) (transcript of the proceeding)). 87See e.g., comments of Rep. Tim Murphy during the Health Subcommittee hearing on H.R. 

5. (House Committee on Energy and Commerce, Subcommittee on Health, Hearing on The Cost 

of Medical Liability System Proposals for Reform, Including H.R. 5, HEALTH Act 2011, 112th 

Cong., pp. 101; 104 (Apr. 6, 2011) (transcript of the proceeding)). 88 House Committee on Energy and Commerce, Subcommittee on Health, Hearing on The Cost 

of Medical Liability System Proposals for Reform, Including H.R. 5, HEALTH Act 2011, 112th 

Cong., pp. 51–52; 104–107; 117–121 (Apr. 6, 2011) (transcript of the proceeding). 89Testimony of Brian Wolfman, JD, Visiting Professor of Law, Georgetown University Law 

Center, House Committee on Energy and Commerce, Subcommittee on Health, Hearing on The 

Cost of Medical Liability System Proposals for Reform, Including H.R. 5, HEALTH Act 2011, 

112th Cong., p. 5 (Apr. 6, 2011). 90 Id. 91 Id. 92 Id. 93 Id. at 12. 94Wyeth v. Levine, 129 S.Ct. 1178 (2009). 95 Id. 96 Id. 

the cost of medical malpractice insurance 86 and also fix doctor 

shortages caused by liability exposure.87

Absolutely no justification has been asserted during the Committee’s deliberations on the legislation for H.R. 5’s inclusion of medical products. To the contrary, there was much debate about the 

danger and inappropriateness of covering drugs and devices, particularly during the testimony of Professor Brian Wolfman at the 

Health Subcommittee’s hearing on the bill.88

In our view, the HEALTH Act will have an especially devastating impact on patients injured by defective or inadequately labeled drugs and devices. For instance, in addition to failing to fully 

compensate victims of dangerous drugs and devices for their noneconomic damages, H.R. 5’s $250,000 cap on non-economic damages 

would make it very difficult for these individuals to retain competent counsel who would be willing to take on the typical large, 

and well endowed pharmaceutical or medical device company.89

Most individuals who are injured by these products cannot begin 

to pay for the out-of-pocket expenses necessary to finance a potentially massive lawsuit against a drug or device manufacturer.90 Instead, they rely upon a contingency system in which an attorney 

is willing to represent them in exchange for a certain percentage 

of any final recovery in the case.91 Particularly in cases that are 

complex and difficult or include very well-financed defendants, a 

limit of $250,000 in non-economic damages would be insufficient to 

enable most attorneys to afford the protracted litigation process 

such cases involve.92

In his testimony at the Health Subcommittee hearing on H.R. 5, 

Professor Wolfman provided a disturbing illustration of this concern.93 He described a conversation he had with the attorney who 

represented Diana Levine, the injured party (plaintiff) in the recent 

U.S. Supreme Court case, Wyeth v. Levine.94 Ms. Levine brought a 

lawsuit against Wyeth, one of the country’s largest pharmaceutical 

companies, having lost her arm by amputation after receiving an 

inadequately labeled Wyeth drug.95 After years of litigation, Ms. 

Levine’s case was eventually heard by the Supreme Court, which 

affirmed that persons injured by an inadequately labeled FDA-approved drug can sue the manufacturer of that product.96


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97Testimony of Brian Wolfman, JD, Visiting Professor of Law, Georgetown University Law 

Center, House Committee on Energy and Commerce, Subcommittee on Health, Hearing on the 

Cost of Medical Liability System Proposals for Reform, Including H.R. 5 HEALTH Act 2011, 

112th Cong., p. 12 (Apr. 6, 2011). 98 Id. at 19. 99 Under Section 7(c)(4) of the HEALTH Act, punitive damages may be awarded in such cases 

only when a person: (a) before or after premarket approval, clearance, or licensure of the medical product at issue, knowingly misrepresented to or withheld from the FDA information that 

is required to be submitted under the Federal Food, Drug, and Cosmetic Act or section 351 of 

the Public Health Service Act (regulation of biological products) that is material and is causally 

related to the harm which the injured party allegedly suffered; or (b) made an illegal payment 

to an official of the FDA for the purpose of either securing or maintaining approval, clearance, 

or licensure of such medical product. 100 H.R. 5, Section 7(c). 101Testimony of Brian Wolfman, JD, Visiting Professor of Law, Georgetown University Law 

Center, House Committee on Energy and Commerce, Subcommittee on Health, Hearing on The 

Cost of Medical Liability System Proposals for Reform, Including H.R. 5, HEALTH Act 2011, 

112th Cong., p. 20 (Apr. 6, 2011). 102 House Committee on Energy and Commerce, Markup of H.R. 5. HEALTH Act of 2011, 

112th Cong., pp. 162–164 (amendment offered by Rep. John Dingell) (May 11, 2011) (transcript 

of the proceeding). 

Subsequent to the Court’s decision, Professor Wolfman spoke 

with Ms. Levine’s lawyer. Professor Wolfman asked the attorney if 

he would have taken the Levin case if there had been a $250,000 

limit on non-economic damages; after a long pause, the attorney 

hesitantly responded ‘‘no.’’ 97 Unquestionably, then, had the provisions of H.R. 5 been in place during the litigation, Ms. Levine 

might well have lost out in securing the stellar and long-term representation she was able to obtain under current law. Thus, as the 

Levine case clearly demonstrates, the adverse effects of the kinds 

of caps found in the HEALTH Act go beyond simply imposing an 

artificial dollar amount on damages. 

The limits H.R. 5 puts on attorney contingency fees would only 

exacerbate this problem. With draconian caps on the amount that 

an attorney could collect through his or her contingency contracts 

in place, most plaintiffs’ attorneys would financially unable to take 

on complex product liability cases involving drugs and devices.98

Mr. Wolfman’s testimony about his conversation with the attorney 

in the Levine case underscores this point as well. 

H.R. 5 would also abolish punitive damages in cases pertaining 

to FDA-approved drugs and devices, except in the most limited circumstances.99 Specifically, H.R. 5 would prohibit punitive damages 

in cases in which a drug or device either received FDA approval 

or is ‘‘generally recognized among qualified experts as safe and effective.’’ 100

Because much information is gained about the safety and effectiveness of drugs and devices after they are on the market and in 

use by a broad population of people, it is misguided to tie the availability of punitive damages to these products’ initial FDA approval. 

Indeed, most product liability lawsuits regarding drug safety relate 

information that was not presented to the FDA at the time of the 

drug’s approval.101 But under the HEALTH Act, even a manufacturer that fails to exercise due diligence and investigate reports of 

a safety problem could be immunized from punitive damages. 

Although an amendment was adopted during the full Committee 

markup of the bill that would permit an award of punitive damages 

in cases in which the defendant caused the drug or device to be 

misbranded or adulterated,102 H.R. 5 would still have the effect of 


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103Testimony of Joanne Doroshow, Executive Director, Center for Justice & Democracy, House 

Committee on Energy and Commerce, Subcommittee on Health, Hearing on The Cost of Medical 

Liability System Proposals for Reform, Including H.R. 5, HEALTH Act 2011, 112th Cong., p. 32 

(Apr. 6, 2011). 104Kessler, D and Vladeck D, A Critical Examination of the FDA’s Efforts to Preempt Failureto-Warn Claims, Georgetown Law Journal, 96:461, 463 (Jan. 2008) (online at http:// 

www.georgetownlawjounalorg/issues/pdf/96-2/Kessler&Vladeck.PDF). 105Porter, MJ, The Lohr Decision: FDA Perspective and Position, Food & Drug Law Journal, 

52:7, 11 (Jan. 1997). 106Wyeth v. Levine, 129 S. Ct. 1187 (2009). 107 H. Con. Res. 34 (adopted by the House of Representatives on Apr. 15, 2011). 

severely restricting the availability of punitive damages in lawsuits 

involving medical products. 

Punitive damages have a unique and specific function: They 

serve to punish exceptionally outrageous, deliberate or harmful 

misconduct, and to deter both the wrongdoer and others from engaging in similar misconduct in the future.103 By severely limiting 

punitive damages in drug and device cases, H.R. 5 places all of us 

in danger because in effect, it removes the most potent and effective means of deterring bad actors. There is simply no justification 

for this drastic action. 

This is especially true in light of FDA’s recognition of the valuable role state-based litigation plays in complementing the agency’s 

regulation of drugs and medical devices.104 FDA is on record in 

finding that drug and device lawsuits help to uncover post-market 

safety risks that are unknown to the agency at the time of approval. Indeed, as a former FDA chief counsel has stated: ‘‘FDA 

regulation of a device cannot anticipate and protect against all 

safety risks to individual consumers. Even the most thorough regulation of a product such as an important medical device may fail 

to identify potential problems presented by the product. Regulation 

cannot protect against all possible injuries that might result over 

time.’’ 105

Drug and medical device manufacturers will always be better positioned and better equipped than the FDA to know the safety profile of their products, since they develop and manufacture the products, typically receive safety reports about the products first, and 

are required to alert the FDA to any product-related risks they uncover. FDA, on the other hand, is responsible for overseeing the 

safety of hundreds of thousands of drugs and medical devices. The 

U.S. Supreme Court recently recognized this reality in Wyeth v. Levine, in which it found: ‘‘The FDA has limited resources to monitor 

the 11,000 drugs on the market, and manufacturers have superior 

access information about their drugs, especially in the post-marketing phase as new risks emerge.’’ 106

Simply put: H.R. 5 would weaken the tort system’s critically important layer of consumer protection at the very time when FDA’s 

ability to assure the safety of our drugs and medical devices is in 

great peril. The Republican FY 2012 budget resolution calls for a 

return to FY 2008 funding levels for discretionary funding across 

all government agencies.107 For FDA, this translates into a funding 

cut of over $600 million—almost 20% of the agency’s entire budget. 

Reductions of this magnitude will only exacerbate FDA’s inherent 

difficulty both in monitoring the post-market safety of the tens of 

thousands of FDA-approved products on the market and in sending 

timely safety information to physicians and patients. 


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108 House Committee on the Judiciary, HEALTH Act of 2011, Dissenting Views, 112th Cong., 

p. 118 (Mar. 17, 2011) (H. Rept. No. 112–39, Part 1.) 

For these reasons and more, it is irresponsible—even dangerous—to sweep drug and medical device cases within the scope 

of the HEALTH Act. In our view, such lawsuits should continue to 

stand on their own—subject to the substantive and procedural law 

that now governs them—so as to help ensure that these products 

remain as safe as possible while at the same time, providing the 

opportunity for adequate compensation for those individuals who 

have been harmed. 

CONCLUSION

Our colleagues on the Committee on the Judiciary who have also 

filed dissenting views on the HEALTH Act have summed up our 

own views quite well: 

Collectively, the ‘reforms’ proposed by H.R. 5 would limit 

a patient’s ability to recover compensation for damages 

caused by medical negligence, defective products, and irresponsible insurance practices. In addition to raising core 

issues of fairness, H.R. 5 preempts the law in all 50 states, 

with little regard for the consequences. The legislation was 

designed more than 20 years ago to resolve an insurance 

‘crisis’, but all available evidence shows that the insurance 

market is not in crisis today. H.R. 5 does not make insurance more available, does not cut spending to any appreciable degree, and does not address issues of access to justice or patient safety. Because H.R. 5 solves few problems 

facing Americans and exacerbates many real ones, we believe the Congress should reject this bill.108

We concur in this assessment of the HEALTH Act and join with 

these colleagues in opposing H.R. 5. 

HENRY A. WAXMAN. 

MIKE DOYLE. 

DONNA M. CHRISTENSEN. 

CHARLES A. GONZALEZ. 

ANTHONY WEINER. 

LOIS CAPPS. 

JAN SCHAKOWSKY. 

JAY INSLEE. 

TAMMY BALDWIN. 

ANNA G. ESHOO. 

FRANK PALLONE, JR. 

G. K. BUTTERFIELD. 

DORIS O. MATSUI. 

EDWARD J. MARKEY. 

EDOLPHUS TOWNS. 

BOBBY L. RUSH. 

JOHN D. DINGELL. 

DIANA DEGETTE. 

GENE GREEN. 

Æ 


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