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Last fall, we warned that a Supreme Court decision on medical device companies’ liability would remove a powerful incentive for device manufacturers to ensure their products’ safety. In that case, Riegel v. Medtronic, the Court ruled that as long as devices are FDA-approved, consumers injured by the devices can’t sue the manufacturers for liability in state courts – in short, FDA approval preempted those lawsuits. This wouldn’t be such a problem if FDA weren’t such a woefully under-resourced agency.
We feared that the Court might again rule in manufacturers’ favor in a similar case, this one involving pharmaceuticals. But in Wyeth v. Levine, the Court upheld a jury verdict awarded to musician Diana Levine, whose arm had to be amputated after an incorrectly administered injection of Wyeth’s anti-nausea drug Phenergan. (Levine claimed Wyeth’s warning against the administration method she received should have been stronger.) The New York Times’ Adam Liptak explains why the Court’s decision on pharmaceuticals differed from its decision on medical devices, and what the larger implications are:
Or is it: what wouldn’t we know without investigative journalist Andrew Schneider??? Would the town Libby, Montana mean anything? How about the words Zonolite, Diacetyl, or GRAS? These terms and places are familiar because of Andy Schneider, the Pulitzer Prize (and other) award winning reporter, who’s an integral part of our public health community. Schneider’s worked recently for papers in Seattle, St. Louis, Baltimore and back to Seattle, but no matter where his feet land, stellar investigations follow.
Right now, it appears that Schneider is staked out at the Russell Smith Courthouse in Missoula, Montana providing us a day-to-day accounts of the federal criminal trial against W.R. Grace and five Grace officials. They are charged with conspiring to cover-up the health hazard the company created by mining asbestos-containing vermiculite in the town of Libby, MT.
Cross-posted from Sustained Outrage: a Gazette Watchdog Blog
by Ken Ward, Jr.
Bayer CropScience hasn’t said yet if it will challenge $143,000 in fines issued by the U.S. Occupational Safety and Health Administration for 13 serious and 2 repeat violations related to the August 2008 explosion and fire that killed two Institute plant workers. But a vigorous court fight seems likely, given who Bayer has hired as its lawyer in the matter.
Robert C. Gombar is well known for his efforts to help companies that butt heads with OSHA over allegations that they weren’t complying with workplace health and safety rules. Gombar is head of the OSHA, MSHA & Catastrophe Response Group at the Washington, D.C., offices of the law firm of McDermott, Will & Emery. The firm’s Web site says Gombar has been “primary outside counsel to companies in over 30 industrial disaster situations.”
In late November, a three-judge panel of the U.S. Court of Appeals for the Third Circuit heard oral arguments on the two petitions for review of OSHA’s health standard on hexavalent chromium (CrVI). The transcript of the proceeding (52-page PDF) reveal that these judges did their homework. They knew the history and content of the final rule. I was heartened to read one judge interrupt the Labor Department attorney with:
“Well, one thing that concerns me [about this final rule] is the requirement for notifying employees at the action level of the risk. And I’m not certain why OSHA chose not to impose the notification point here. I just don’t understand that.”
by Bob Snashall, retired Labor Dept employee (Op-Ed Charleston Gazette, Nov 7, 2008)
George W. Bush & Company did one thing well – it bagged a lot of public information and taxidermied it into secrets. The shroud of secrecy even spread over mine safety. Mine safety? The law envisions everybody chipping in to protect miners from the perils of fire, water, gas and roof falls. So it helps the public to know what is going on. My federal legal career spanning 30 years embraced both mine safety and freedom of information.
In a democracy – you know, in a government of, by and for the people – people should know what the government is up to and what they’re getting for their money. The public generally has a right to federal agency records under the Freedom of Information Act. Presidents, Republican and Democrat, pretty much went along with it. Until W.
On the eve of the election, The Nation reminds us that the next president will play a crucial role in determining the makeup of the Supreme Court. Herman Schwartz describes the Court’s current makeup and rattles off current rulings that would be threatened by the appointment of another conserviative justice. Then, other contributors explain how the Court has shaped the legal landscape on workers’ rights, healthcare, and consumer safety.
The State of Rhode Island’s efforts, which began in 1999, to force lead-paint manufacturers to clean-up contaminated homes received a mortal blow when the State’s Supreme Court reversed a lower court’s 2006 decision. (Full decision from 7/1/2008) This early ruling was a result of the longest civil jury trial in Rhode Island history, with the decision going against the defendants Sherwin-Williams, NL Industries, and Millennium Holdings, holding them liable for creating a public nuisance by selling lead-based paint.
The R.I. Supreme Court said:
“We do not mean to minimize the severity of the harm that thousands of children in Rhode Island have suffered as a result of lead poisoning. Our hearts go out to those children whose lives forever have been changed by the poisonous presence of lead. But, however grave the problem…public nuisance law simply does not provide a remedy for this harm.”
This tells me that we need some better laws so that we can hold peddlers of dangerous products accountable for their actions. As David Rosner and Jerry Markowitz masterfully document in their paper “Cater to the Children” and their book Deceit and Denial, the lead industry knew by the 1930’s the adverse health consequences that would be caused by their actions, but they didn’t care and greed won out. The R.I. Supreme Court’s decision gives a free pass to the lead industry’s despicable behavior.
Today’s Washington Post includes a great article by Lyndsey Layton that contrasts European Union and U.S. chemical laws and explores how EU actions might affect products on U.S. shelves. Here’s Layton’s explanation of EU law and the philosophy that guides it:
No, 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) were found among residents who get their tap water from the Little Hocking Water Association in Ohio. Ward’s story indicates the median level in the general U.S. population is 5 ppb.
by Susan F. Wood, PhD
It’s not often, if ever, that an FDA sponsored report calls out for more resources, more direct action and organizational change for FDA. The recently released report (PDF) by the Subcommittee on Science and Technology for the FDA Science Board does just that. Although I wouldn’t necessary agree with all of the recommendations, and would call out for a few more, the report identifies some of the real needs at FDA for strengthened science. The FDA Science Board, an Advisory Committee to the FDA, has issued earlier reports, but none with the timeliness and potential impact of this one. Most of the press coverage has been on the call for expanded resources – which are truly needed – but the report also identifies some of the scientific infrastructure needs that trail behind our expectations of this critical public health agency. I don’t know if FDA expected this type of report, but hopefully it can be useful as a way to move the agency forward.
From the report:
