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Aug. 5, 2009 by Matt Shudtz

Thoughts on Tuesday's Senate Hearing on Preemption

Following up on Ben’s post about Tuesday’s Senate HELP Committee hearing on medical device preemption, I’d like to respond to three issues that came up during the question-and-answer session.

Innovation: Senators Harkin and Hatch had a bit of a disagreement about whether the possibility of tort liability stifles innovation by medical device firms. Peter Barton Hutt, who Senator Hatch lauded as the “dean of all FDA lawyers,” noted that he sits on the board of ten small biotech firms and that “decisions made by venture capitalists based upon such issues as potential liability directly affect every one of those companies.”

Two points here. First, it is a good thing that investors take into account potential tort liability. In the context of FDA-approved medical devices, tort law simply ensures that companies are operating according to a duty of care defined by a standard of reasonableness. It is not a high bar for them to meet and as consumers we should expect companies to only develop and market products that meet that standard. Second, as CPR Member Scholar Tom McGarity told the committee, there is no strong empirical evidence to back up the anecdotal claims like those made by …

Aug. 4, 2009 by Ben Somberg
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CPR Member Scholar Thomas McGarity testified this afternoon at a hearing of the Senate Committee on Health, Education, Labor, and Pensions on the issue of medical device safety (written testimony, press release).

Currently, individuals injured by a faulty medical device generally cannot sue the device manufacturer in state courts if that device was fully approved by the FDA, even if the manufacturer was aware of new research showing faults in the product. The Senate is considering a bill that would exempt state common law claims from the express preemption clause in the Medical Device Amendments to the Food, Drug and Cosmetics Act. The House is considering a similar bill.

"The implicit assumption in preempting medical device injury claims in state courts is that the FDA can and is performing its job perfectly, but that's just not the case," McGarity says. "Common law still has an important …

July 31, 2009 by Ben Somberg
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More New Yorkers are fishing off area piers in this economy, and, in many cases, eating unsafe amounts of fish contaminated with PCBs and mercury. That was the thrust of a NY Daily News report earlier this month. They also reported that there were extremely few signs alerting the public to any kind of danger. New York City official soon responded that they'd put up more warning signs.

CPR Member Scholar Catherine O'Neill discussed the fish contamination issues on WNYC's Leonard Lopate Show on Wednesday.

O'Neill says that warning signs have regularly proven ineffective across the country. The information often fails to reach and inform its intended audience. Among other things, signs often don't cover all the languages they'd need to, and advisories frequently fail to convey complex information in a way that is understandable. In addition, the alternatives suggested (or …

July 13, 2009 by Yee Huang
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Perhaps – as a byproduct of a recent, revealing report by the Government Accountability Office and the economic downturn – the bubble of market growth for the bottled water industry may finally deflate, if not outright burst.  Pop!  The report, released last Wednesday, further debunks the myth that the quality of bottled water is better than tap water (see also CPR Member Scholar Christine Klein's exploration of this myth).

According to the GAO, regulation of bottled water is generally weaker than regulation of municipal drinking water (tap water).  The two types of water are regulated under different agencies: the Environmental Protection Agency regulates tap water under the Safe Drinking Water Act (SDWA) while the Food and Drug Administration regulates bottled water as a food product under the Federal Food, Drug, and Cosmetic Act (FFDCA).  The EPA sets national maximum contaminant levels for tap water according to the use …

July 2, 2009 by Thomas McGarity
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On Wednesday, Representative Henry Waxman introduced a comprehensive “Food Safety Enhancement Act” (116-page discussion draft) to repair part of a federal food safety protection regime that has been badly broken for several decades. Waxman was joined by Representatives Diana DeGette, John Dingell, Frank Pallone, Bart Stupak, and Betty Sutton; the House Energy and Commerce Committee will hold a hearing on the issue on Wednesday, June 3.

A key problem with the current system is that it employs regulatory tools developed during the early twentieth century to address the risks posed by a radically different twenty-first century food production and delivery system.

The existing regime is built upon the assumption that state and local governments can adequately address the risks of a largely local food supply with occasional assistance from a federal Food and Drug Administration that focuses primarily on animal feeds, food additives and a modest quantity …

July 2, 2009 by Catherine O'Neill
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California has expanded its fish consumption advisory, warning people to curtail or eliminate entirely their consumption of nineteen species of fish caught off the Palos Verdes Peninsula in Los Angeles County.  Among the new advisory’s recommendations is that humans should avoid eating white croaker, topsmelt, or barred sand bass caught in an area extending more than 30 miles from the Santa Monica pier south to the Seal Beach pier, and that, additionally, women and children should avoid barracuda or black croaker from this area.  The advisory also includes less strict recommendations for a broader area of coastline, stretching more than 100 miles in total, including the entire coastlines of Los Angeles and Orange counties, and part of Ventura County. The primary contaminants of concern behind these advisories are DDT and PCBs (both human carcinogens) but mercury and a host of other substances also threaten the health …

June 22, 2009 by Matt Shudtz
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While his colleagues (and former colleagues) jockey for the healthcare reform limelight, Rep. Frank Pallone is quietly busy making sure that, regardless of who pays for healthcare, the sick and injured will have safe and effective solutions to their problems. Last Thursday, Rep. Pallone held a hearing to assess FDA’s ability to properly oversee the medical device industry. The testimony outlined a troubling picture.

GAO has been closely monitoring FDA’s medical device program for years. On Thursday, Marcia Crosse, the head of the government watchdog’s health care division, testified about three serious shortcomings in FDA’s work. To begin, FDA isn’t necessarily reviewing high-risk devices according to the most stringent premarket review processes, meaning the devices might reach the market without adequate review of their inherent dangers, putting patients at increased risk. That problem leads to the second flaw GAO identified – FDA is …

March 9, 2009 by Matthew Freeman
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CPR Member Scholar Thomas McGarity had op-eds over the weekend in three Texas newspapers -- the Dallas Morning News, Houston Chronicle and Austin American-Statesman.  His topic is Wyeth vs. Levine, last week's blockbuster case from the Supreme Court, in which the Court rejected the Bush Administration's multi-year effort to use the federal regulatory process as a backdoor method of shielding manufacturers from lawsuits brought by customers their products injure.

 

The case was brought by professional musician Diana Levine, who went to a clinic with a migraine headache, and received nausea medication that eventually resulted in her arm being amputated.  Such outcomes were a possibility known to Wyeth, the manufacturer, but the label on the drug, according to the jury that decided the case in Levine's home state of Vermont, failed to adequately warn about how to prevent it from happening.  Wyeth argued in court that …

Jan. 14, 2009 by Matthew Freeman
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If you’re a consumer of health and environmental news, you’ve almost certainly heard it said that “children are not just little adults.” The warning comes up a lot in the context of medical research, because children’s bodies metabolize some things differently than do adults. That’s particularly important because somewhere in the vicinity of 80 percent of drugs prescribed for children have never been adequately tested for pediatric use. Lacking viable alternatives, doctors have gotten in the habit of prescribing them off-label. But the lack of testing means that there’s a lot docs can’t know for sure – like, how effective and safe the drugs actually are, what the best dosage is, and more.

 

The warning comes up a lot in discussions of toxics, as well, because children are often more vulnerable to certain chemicals than adults – for most of the same reasons …

Nov. 28, 2008 by Matthew Freeman
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CPR's Tom McGarity has an op-ed this morning in the Austin American Statesman on Wyeth vs. Levine, the Supreme Court case testing an assertion by pharmaceutical manufacturer Wyeth that FDA approval of its proposed drug label shields the company from tort litigation over harm that drug subsequently causes.  The Court heard oral arguments on the case on November 3, and a ruling is expected later this term.

 

The case arose out of one of those medical disaster stories we all fear.  Diana Levine went to visit a doctor, complaining of a migraine.  Her treatment included an injection of Wyeth's anti-nausea drug, phenergan.  The label on the drug carries a caution about the so-called IV-push method of injection -- a shot.  The better method is an IV-drip -- where a bottle is hung and the drug introduced more slowly into the vein.  The danger is that the drug …

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