Science in the Courts
cmonforton | November 12, 2013My jaw continues to drop when I think about the scathing reports this month from the Center for Public Integrity about the law firm Jackson Kelly and their scheming with clients to screw coal miners out of black lung benefits. In “Coal industry's go-to law firm withheld evidence of black lung, at expense of sick miners,” Chris Hamby explains the deceitful and devious manner in which Jackson Kelly attorneys intentionally withheld medical reports that validate diagnoses of serious respiratory disease in coal miners.
The irony---the disgusting irony---is how coal operators insist that their…
sgorman | July 17, 2013 Since 1994, when a Nigerian woman and her two daughters were granted asylum in the U.S. based on fear of female genital mutilation (FGM) in their native country, the legal community has been avidly debating the question of whether FGM should be considered grounds for asylum. A 1996 case, in re Kasinga, established a precedent for granting asylum to women based on a well-found fear of persecution in the form of FGM.
Today, the question is still, however, controversial. There is no standard definition of “persecution,” a fear of which is required for asylum seekers to gain asylum, and even…
lborkowski | June 28, 2012by Kim Krisberg
For me, there were few better places to hear about today's 5-4 Supreme Court ruling upholding the Affordable Care Act and its individual insurance mandate than at a meeting of the American Public Health Association (APHA). Here in Charlotte, N.C., for APHA's Midyear Meeting, I was surrounded by hundreds of public health practitioners, researchers and advocates as we all watched the magnified scroll of Scotusblog.com, anxiously waiting for the decision.
At 10:08 a.m., the blog declared: "The individual mandate survives as a tax."
That was when the cheers (and tears) began. You…
cmonforton | August 15, 2011The Republican chairmen of the House Education and the Workforce Committee and its Subcommittee on Workforce Protections are invoking "sound science" and "transparency" in a request to the National Institute for Occupational Safety and Health (NIOSH) for data and draft publications of a cancer mortality study of underground miners exposed to diesel exhaust. Congressman John Kline (R-MN) and Tim Walberg (R-MI) wrote to NIOSH director John Howard onJuly 8, suggesting that the agency is violating a 2001 federal court order. That order stemmed from a lawsuit filed more than 15 years ago by the…
cmonforton | May 27, 2011[June 3, 2011: Update below]
[May 31, 2011: Update below]
The West Virginia Supreme Court has taken up the case by Massey Energy shareholders to block the $8.5 Billon sale of the firm to Alpha Natural Resources. The Charleston Gazette's Ken Ward Jr., and National Public Radio's (NPR) Howard Berkes have followed the day-to-day event on the suits (here, here, here, here.) Now, their organizations are part of the action.
The two news outlets filed a motion today before the WV Supreme Court, urging the judges to reject the request by the California State Teachers Retirement System (a…
sb admin | May 14, 2008by David Egilman, MD, MPH
I just finished watching the Waxman hearings on FDA preemption and must comment on Christopher Shays' (R-CT) comments. Christopher Shays is the last remaining Republican congressman from New England. Hopefully the November elections will result in the extinction of this last remaining
remnant of the age of the dinosaurs.
He repeatedly stated that he "had no dog in this hunt" concerning the impact of preemption and torts suits on drug safety. This is a peculiar position for a Congressperson who must decide whether or not the FDA's actions are appropriate. It's…
sb admin | April 4, 2008No, not V-8 the vegetable drink, but C8, the common name for ammonium perfluorooctanoate, an ingredient in Teflon and other non-stick products. Ken Ward of the Charleston Gazette reports today on the levels of perfluorooctanoic acid in the blood of about 69,000 residents living near the DuPont Co.'s Parkersburg, WV plant where C8 was manufactured. The results are posted on the West Virginia University's Health Science's center website.  The median C8 blood-level was
"more than five times the U.S. general population."
The highest median blood-concentration levels (i.e., 132 ppb…
sb admin | April 3, 2008by Susan F. Wood, PhDÂ
The FDA Amendments Act (FDAAA) of 2007 includes a small section addressing direct to consumer (DTC) advertising. The bill doesn't limit advertising to consumers, nor does it give FDA authority to put a moratorium on advertising while more data on safety or effectiveness is collected during the first months or years that a product is on the market.  A moratorium was recommended by the IOM in it's drug safety report in 2006, but was not adopted by Congress - perhaps due to arguments about first amendment rights, but perhaps due to objections by both the…
sb admin | February 21, 2008In an 8-1 decision in Riegel v. Medtronic, the Supreme Court has ruled that medical-device manufacturers whose products secured pre-market FDA approval are immune from liability for personal injuries. So, if youâre injured by a medical device (like a drug-coated stent or prosthetic hip) thatâs received this approval, you wonât be able to sue the manufacturer.
This might not be such a problem if we could have faith in FDAâs approval process. But, as reports from the Institute of Medicine and the FDAâs own Science Board have made clear, the agency lacks the resources and scientific…
sb admin | November 9, 2007The news is out that Merck has agreed to settle 27,000 Vioxx lawsuits for $4.85 billion. Plaintiffs who claim they or their family members suffered injury or died after taking the anti-inflammatory drug will, on average, receive just over $100,000 before legal fees and expenses, reports the New York Timesâ Alex Berenson.
The Vioxx debacle is an example of how not to interpret clinical trials data. Even before the FDA approved the drug, there was extensive evidence that taking Vioxx increased the risk of a cardiovascular event. Yet the FDA approved it and an estimated 20 million Americans…
sb admin | September 16, 2007By David Michaels
Updated Below
The lead story in todayâs New York Times reports something weâve been writing about here at the Pump Handle for quite some time (here and here and here, for example): responsible corporations recognize the need for public health and environmental regulation.
In industry and after industry, corporations and trade associations are asking the Bush Administration for regulation. In some of these cases industry has realized that voluntary regulation has failed, and without mandatory regulation, consumers will reject their product. But some of the push for federal…
sb admin | September 10, 2007By David Michaels
It is time for Congress to enlist the nationâs science and policy experts to help develop a federal workers' compensation program for 9/11 rescue, recovery, and cleanup workers. The inadequacy of state worker programs led Congress to legislate special compensation programs for uranium miners, and civilian workers in nuclear weapons facilities. We did not require the families of those killed in the terrorist attacks to rely on state workers' compensation programs. The September 11th Victim Compensation Fund (pdf) provided more than $7 billion to families of the victims. Â…
sb admin | August 27, 2007By David Michaels
Tort "reformers" have long contended (with little evidence) that fear of litigation has scared off vaccine manufacturers from developing new vaccines.
It has been more than twenty years since Congress established the National Vaccine Injury Compensation Program. The program was designed to ensure that anyone injured by a vaccine would be fairly compensated, while protecting vaccine manufacturers from liability. Even with this program, the pace of new vaccine development slowed to a crawl in the 1990s. Opponents of law suits, including President George W. Bush, regularly use…
sb admin | July 16, 2007By David Michaels
Gretchen Morgenson, the terrific New York Times reporter, has a disturbing piece that describes how the toothless Consumer Products Safety Commission (CPSC) has little ability to force hazardous consumer products of the shelves of toy stores.
The focus of her report is on super powerful miniature toy magnets. They are candy colored and easily eaten by small children. Morgensonâs article is a powerful case for new legislation that gives the CPSC some real power. It is also another piece of evidence documenting how law suits serve as the de facto regulatory system, since our…
sb admin | May 29, 2007By David Michaels
We've been writing for the past few months about U.S. regulatory agencies' failure to take meaningful action on diacetyl, a toxic component of artificial butter flavor, despite having been aware of its risks since at least the start of this decade. Now, mounting evidence suggests that some flavor manufacturers have known about diacetyl's association with severe lung disease and failed to take appropriate action for even longer - since the early 1990s, when diacetyl started killing workers in flavor plants. Disabled workers are currently suing flavor manufacturers over their…
sb admin | April 19, 2007By David Michaels
An editorial in the latest issue of Nature takes up a problem that public health advocates have been battling for years: confidentiality orders that keep important scientific data hidden from the public, scientists, and even regulatory agencies.
One recent case of such data being kept secret, which Nature reporter Jim Giles covers in an accompanying article, is Eli Lillyâs schizophrenia drug Zyprexa. David Egilman, a physician who had access to confidential documents about Zyprexaâs dangers, is being threatened with jail time for his role in the release of the papers to,…
sb admin | April 2, 2007A few hours ago, the Supreme Court ruled in Massachusetts vs. EPA that EPA has the authority to regulate carbon dioxide from auto emissions. (For background on the case, see this post.)
David Stout of the New York Times summarizes:
In a 5-to-4 decision, the court found that the Clean Air Act expressly authorizes the E.P.A. to regulate carbon dioxide emissions, contrary to the E.P.A.âs contention, and that if the agency still insists that it does not want to regulate those emissions, it must give better reasons than the âlaundry listâ of invalid considerations it has offered so far.
Todayâs…
sb admin | March 13, 2007By David Michaels
Dr. David Healy is the probably the single person most responsible for identifying the link between anti-depression drugs like Zoloft and suicide risk. His work led to the FDA to require the addition of a âblack boxâ to the label of selective serotonin reuptake inhibitors (SSRIs), warning of the increased risk for âsuicidality.â A few years before the FDA instituted this policy, Dr. Healy was asked to testify about the effects of Zoloft in a lawsuit filed by the parents of Matthew Miller, a teenager who hanged himself soon after starting taking the drug for depression.…
sb admin | March 3, 2007By David Michaels
The state of Pennsylvania has filed lawsuits against three drug manufacturers, claiming the firms fraudulently marketed antipsychotic drugs. According to Bloomberg News, the state alleges that Eli Lilly & Co. âhid the risks and exaggerated the benefits of its antipsychotic medication Zyprexa while persuading doctors to prescribe it for unapproved uses.â AstraZeneca and Johnson & Johnson's Janssen Pharmaceutical are accused of doing the same for other drugs:
The defendants cost Pennsylvania's Medicaid and drug assistance for the elderly program millions of dollars for…