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Category: Drug and Medical Device Litigation
Pharmaceuticals are subject to what are, in effect, two overlapping and often conflicting regimes for overseeing drug safety:
mandatory regulation by the U.S. Food and Drug Administration and lawsuits seeking billions of dollars in damages in the common-law state tort system.
This dual system is both irrational and destructive, particularly insofar as it discourages innovation, raises drug prices, and denies patients access
to many medicines that are reasonably safe and effective.
The FDA’s regulatory regime, while imperfect in many respects, is nonetheless better suited to weighing the benefits and risks of
new medicines than state courts, which may consider liability for harm only to the particular plaintiffs before them. State tort litigation thereby
exacerbates the effects of the FDA’s biases and raises consumer prices. In many instances, state tort law directly contradicts the FDA’s considered
decisions. Product-liability directives can vary from state to state—indeed, from courtroom to courtroom—and jurors’ decisions are impaired by a
lack of expertise, hindsight bias, and rules that prohibit the very kind of social cost-benefit analysis that the FDA is obliged to employ. Public
policy reforms should focus on providing just compensation for victims while minimizing waste, containing costs, and ensuring that the public
has access to a wide array of safe medical products. This goal can be accomplished most effectively by allowing for federal preemption of state
courts in drug and medical device litigation along with administrative compensation modeled after the Vaccine Injury Compensation Program.
[Spotlight] [Commentary] [Research] [Events] [News]
Commentary
- Name Of Game In Health Care: Cheaper, Better, Faster, Jennifer Rossa, Wall Street Journal, 6-23-10
- Can Technology Cure Health Care?, Jacob Goldstein, Wall Street Journal, 4-13-10
- Health-Care Reform Could Create a Litigation Explosion, Curt Levey, Wall Street Journal, 2-11-10
- Healthcare And Tort Reform, Jim Copland, Metropolitan Corporate Counsel, 12-1-09
- Counting the blessings of American medicine, John Olsen, Seattle Times, 11-25-09
- . . . And a Buried Tort Bomb, Wall Street Journal editorial, 11-12-09
- Tort-Bar treat, Jim Copland, New York Post, 11-3-09
- Lawyers are expensive, Corrine Hess, Milwaukee Business Journal, 10-14-09
- Trial bar v. tort reform, Sen. Lamar Smith, Politico, 10-1-09
- Why Medical Malpractice Is Off Limits, Philip Howard, Wall Street Journal, 9-29-09
- An Empty Nod to Tort Reform, Dr. Gilbert Ross, The American, 9-24-09
- Conservative Leaders on Costly Lawsuits and Health Care Reform, American Spectator Blog, 8-27-09
- Toward a healthier economy, Newt Gingrich and Wayne Oliver, Philadelphi Inquirer, 4-7-09
- Don't reverse state drug liability law, Detroit News editorial, 3-18-09
- Dark Days Ahead for "Big Pharma" -- and You, Dr. Gilbert Ross, TCS Daily, 3-12-09
- When Suing Companies Means Harming Patients, Jeff Stier, Forbes.com, 2-27-09
- Court verdict could give generic drug makers an unfair advantage, Peter Pitts, Washington Examiner, 2-23-09
- Anatomy of a Scare, Newsweek, 2-21-09
- The Pfizer Drug Warning, Wall Street Journal, 1-28-09
- Is That Device Safe?, New York Times editorial, 1-27-09
- Pfizer Weds Wyeth, Henry Miller, Forbes.com, 1-27-09
- Lawyers' bills pile high, driving up health care costs, USA Today, 12-29-08
Research
- Truth or Consequences: The Benefits of Off-Label Drug and Device Promotion, Gregory Conko and Jerome Arnett, Jr., Competitive Enterprise Institute, 4-13-10
- Health Care and Medical Malpractice Reform: The Necessity of Reform in the Current Debate, Honorable John Cornyn and Edwin Meese III, The Heritage Foundation, 1-28-10
- MEDICAL ERROR REDUCTION AND TORT REFORM THROUGH PRIVATE, CONTRACTUALLY BASED QUALITY MEDICINE SOCIETIES, Duncan MacCourt, J.D., M.D. and Joseph Bernstein, M.D., M.S., American Journal of Law & Medicine,
- Trial Lawyer's Inc Update: Healthcare, Manhattan Institute, 10-14-09
News
- Glaxo Plans $2.3 Billion Liability Charge, New York Times, 7-16-10
- California Court Reinstates Pharmacy Suit Over Pricing by Drug Makers, Wall Street Journal, 7-14-10
- Scientists grow a rat lung in the laboratory, Washington Post, 6-24-10
- Medical-Devices Sector Could Face Tougher Regulatory Pathway, Wall Street Journal, 2-10-10
- Lawyers v health care, Economist, 10-20-09
- Medical Malpractice System Breeds More Waste, New York Times, 9-24-09
- Malpractice changes are a part of health debate, Yahoo, 3-17-09
- Drug-Industry Shakeout Hits Small Firms Hard, Wall Street Journal, 3-10-09
- Six Top Vaccine Myths, Newsweek, 2-23-09
- Lawmakers Seek to Return Right to Sue Device Makers, New York Times, 2-19-09
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