Legal: August 2010 Archives

At the heart of Cedillo v. US DHHS was the claim that thimerosal-containing vaccines damaged Michelle Cedillo's immune system, which then allowed attenuated measles virus in the MMR vaccine to injure her brain, thereby causing autism. It's a convoluted (and medically illogical) argument, but one that was ostensibly supported, at least in part, by data from a questionable Dublin-based laboratory, Unigenetics.

In the original 2009 decision against the petitioner in the Omnibus Autism Proceeding,* Special Master George Hastings found the detection of vaccine-derived measles virus by Unigenetics in an intestinal sample from Cedillo "not reliable." The decision was based partly on expert testimony from Stephen Bustin, PhD, a UK-based molecular biologist who, as part of UK vaccine litigation, had obtained access to the Unigenetics laboratory and some of its relevant data. On the basis of a number of procedural flaws at Unigenetics, Bustin testified both in the UK and US courts that the company's work was plagued with potentially contaminating errors. Bustin also suggested that results from Unigenetics might even be fraudulent, after reviewing some of the laboratory's altered notebooks.

Access to documents from Unigenetics, on which Bustin based his expert opinion, was the crux of a recent appeal by Cedillo's parents to the US Court of Appeals for the Federal Circuit. This appeal was denied Friday, August 27th. And while the appeal court ruled that Special Master Hastings "erred in permitting the government to introduce the expert reports and testimony of Dr. Bustin because the government did not make available the underlying Unigenetics documents upon which Dr. Bustin relied," the court also noted that Hastings had given the petitioners virtually every opportunity to obtain this information from the UK court themselves, which they apparently did not try to do. (It should be noted that the government argued against the reliability of Unigenetics with other expert testimony. It is presumed on this basis that the Special Master's error was not a reversible one.)

In 2007, the government, in its case preparation, successfully petitioned the UK court to release the Bustin reports, but it did not request the laboratory notebooks or other data on which Bustin relied. The appellate decision further describes the background facts, 

The government explained at oral argument that UK counsel informed them that an application to the UK court requesting "everything" from the UK litigation would be denied as overbroad, and as a result, they needed to narrow their request to the most essential items. The government therefore subsequently "honed down" their request to cover solely the three reports, two of which were filed by Dr. Bustin, that they eventually obtained.

The upshot: Cedillo v. US DHHS has been put to bed.

In a coda to this case, it can be said that life, outside the courtroom, moves relatively quickly and in curious directions. Unigenetics dissolved as a company 5 years ago, although its former director, pathologist John O'Leary, is evidently still working in Dublin at Trinity College. In 2008, O'Leary, in an apparent effort to regain academic credibility, was coauthor of a multi-institutional study ("Lack of association between measles virus vaccine and autism with enteropathy: a case-control study" in PLoS One) that essentially negated the results produced by his own company for Cedillo.

DHHS = Department of Health and Human Services; MMR = measles-mumps-rubella.

* Which was affirmed by Judge Thomas Wheeler in the US Court of Federal Claims.

Gird yer loins, Austin "Jack" DeCoster. You're about to receive uncompromising media and Congressional attention. And the metaphoric (and partially ironic) tarring and feathering may long be overdue, if archived news stories are any indication.

The growing recall of Salmonella-tainted eggs is focusing widespread attention on DeCoster (photos here and here), who is the owner of Wright County Egg in Galt, Iowa, and Quality Egg, a supplier of chicks and feed to Hillendale Farms in New Hampton, Iowa. On August 13, Wright County recalled 380 million eggs that it had shipped since May 19. Hillandale recalled 170 million eggs on Friday, according to USA Today.

The FDA says that the Wright County eggs had been distributed to "food wholesalers, distribution centers and food service companies in California, Illinois, Missouri, Colorado, Nebraska, Minnesota, Wisconsin and Iowa." These companies distribute eggs nationwide. The recalled eggs were packaged under the brand names of Lucerne, Albertson, Mountain Dairy, Ralph’s, Boomsma’s, Sunshine, Hillandale, Trafficanda, Farm Fresh, Shoreland, Lund, Dutch Farms  and Kemps. [Writer's note: Because Lucerne consistently provides the least expensive dairy products in Chicago-area Dominick's stores, I've always been skeptical of their origin. BTW, Lucerne's cheese is absolutely tasteless.]

DeCoster, who also has a history in hog farming, is reportedly no stranger to alleged health, safety, or labor violations, which date back to at least the mid-1990s.

Reports USA Today,

• In 1997, DeCoster Egg Farms of Turner, Maine, agreed to pay $2 million to settle health and safety citations. Employment conditions at DeCoster's farm were publicly denounced by Labor secretaries Robert Reich (he called them "dangerous and oppressive") and Alexis Herman (who said they were "simply atrocious"). See the NYT's "In Maine, Egg Empire Is Under Fire."
• In 2000, Iowa (as in the state of) called DeCoster a "habitual violator" of environmental regulations. One infraction: allowing hog manure to run off into waterways. DeCoster was prohibited from building new farms. See a 2000 statement from the Iowa Attorney General.
• In 2002, DeCoster paid more than $1.5 million in a settlement with the EEOC regarding sexual harassment claims (including rape) from Mexican women who worked at Wright County.

Other violations, including those of animal mistreatment, are reported by the Washington Post and detailed by Mercy for Animals here and here. DeCoster's heavy use of battery cages to house chickens has been linked to the spread of Salmonella on egg farms.

More than 1000 Americans have been sickened by Salmonella-tainted eggs in the current recall, according to the latest news reports, and the obligatory litigation is in the works. This may be one case in which it is reasonable to root for personal-injury attorneys. 

The improved outlook for Medicare's solvency, which increased from 2017 to 2029, is due to PPACA, say Medicare's trustees* in their newly released summary report (the full report can be found here). The trustees essentially borrowed on the projected savings (or really anticipated cost-cutting measures) from legislated healthcare reform to extend the life of Medicare's Hospital Insurance Trust Fund specifically.

The life of Medicare's Part B service, which covers outpatient and prescriptions costs for seniors, was also extended. But the trustees' current projection on Part B assumes that the SGR-defined cut in Medicare reimbursement to physicians will kick in December 1, reports MedPage Today. The cut now stands at 23%. Congress has repeatedly voted to stall the cut but is yet to repeal the formula; to do so would add substantially to the deficit. (One healthcare expert recently predicted in the NEJM that Congress will never repeal the formula.)

The trustees' report, in some ways, is a veiled warning to those Republicans (and Republican states—lookin' at you, Missouri) who would attempt to mess legislatively with PPACA. You repeal PPACA, they might say to detractors, you doom Medicare (and Social Security) to an earlier death.

PPACA = Patient Protection and Affordable Care Act; SGR = sustainable growth rate.

* Timothy F. Geithner, Secretary of the Treasury; Kathleen Sebelius, Secretary of HHS; Hilda Solis, Secretary of Labor; and Michael J. Astrue, Commissioner of Social Security.