Union Says FDA Is Hiding Document | Courthouse News Service
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Union Says FDA Is Hiding Document

LOS ANGELES (CN) - The FDA wrongfully redacted "almost every portion" of a crucial report on problems with an implanted heart defibrillator, to avoid embarrassing the manufacturer - and itself, a union claims in court.

Unite Here sued the U.S. Food & Drug Administration in Federal Court.

The FDA is the only defendant.

The union seeks information on FDA reports on implantable cardioverter defibrillator devices (ICDs) manufactured and sold by St. Jude Medical (SJM).

It claims the devices have been implanted in "thousands of patients," including Unite Here members.

"This is an action under FOIA challenging defendant FDA's unexplained insistence on redacting almost every portion of an inspector's report which identified actual or potential problems with a medical device implanted inside thousands of patients," the complaint states. "FDA failed to explain its redactions beyond simply citing FOIA Exemption 4 (trade secrets or confidential information, 5 USC §552(b)(4)), but such exemption cannot reasonably be construed to preclude release of information likely available from other sources such as the company's own published product descriptions, and no of aid to competitors in copying a company's product but instead likely showing the company put public health at risk. Construing the exemption to insulate from release all mention of patient ailments related to a medical devices [sic] would be contrary to the purpose of FOIA. Embarrassment due to exposure of public health risks is not an interest protected by Exemption 4. Plaintiff appealed administratively but this appeal has gone unaddressed for substantially longer than the customary deadline for rendering a decision."

Unite Here says its health benefits plans provide care for "hundreds of thousands" of member and their families, and cover the implantable defibrillators and other medical products regulated by the FDA.

St. Jude Medical is not a defendant, though the 44-page complaint focuses upon its medical products.

The complaint states: "SJM's ICDs are devices installed inside patients' chests to treat irregular heartbeats known as arrhythmias. They contain a cable (known as a 'lead') which runs through the patients' veins into their hearts through which an electric shock is supposed to be provided by a battery-powered device installed inside the patient's chest.

"FDA issued a recall of SJM's Riata-brand ICDs in a Class 1 recall, one of FDA's most serious classes, due to serious problems with its leads. The Wall Street Journal has reported claims by physicians that years before SJM and FDA took action as to these devices, several physicians had warned SJM of problems with the devices.

"SJM's later brand of ICD known as the Durata has also been questioned publicly in the press by some prominent physicians. The Durata has been implanted in thousands of patients. SJM has posted publicly hundreds of pages of information about the materials used inside the Durata and their configuration, and about the problems SJM sought to avoid."

In late 2012, FDA inspectors reviewed St. Jude Medical's procedures and records for testing its Durata defibrillators and issued a report, which was publicly posted in redacted form by St. Jude, as part of an SEC filing, according to the complaint.

"On October 31, 2012, plaintiff requested from FDA an unredacted version of such report, explaining why plaintiff believed the redactions in SJM's posting were excessive under the law," Unite Here says.

In response, the FDA posted a "somewhat-less-redacted version" of the report on its website, the only additional information being that the product was Durata, which was already known thanks to postings by St. Jude, the complaint states.

The FDA reports are known in the industry as 483 Reports: i.e., FDA Form 483.

The complaint states: "FDA has still redacted every description of the problems considered by the inspector and SJM so that it is impossible to know whether they were purely cosmetic or instead serious risks of device failure and heart attack. For example, here is how several inspectional findings look after the redactions:

"'You failed to follow your written test procedures during design verification testing of your [ ] test which ensures the [ ] is not greater than [ ] to prevent a potential [ ].'

"'Your Durata risk analyses (2007) identified canine testing as a mitigation addressing [ ]. *** you failed to evaluate one of the study results which stated, [ ].'

"'Your [ ] out for all [ ] leads states a severity of [ ] and probability of [ ] when your design team stated the Durata design decreased the risk of this [ ] root cause.'" (Empty brackets and asterisks as in complaint. Citations to paragraphs omitted.)

The only explanation the FDA offered for the censoring of the reports was Exemption 4.

But Unite Here says: "FDA cannot carry its burden of showing the requested information is covered by Exemption 4, including:

"(a) FDA deleted all discussion of problems with the devices and patients so as to make it impossible to know whether FDA and SJM were merely concerned with cosmetic issues or instead with serious health issues, but the issues arising with ICD devices and patients and the specific components and configuration of Durata are already a matter of public record and not even close to a trade secret, for indeed SJM discusses them at length on its website;

"(b) information which may embarrass FDA and SJM showing there has been lax safety review up until now is not within the protection of Exemption 4, which instead protects only information useful in ordinary competition such as revealing a formula which a competitor could borrow from SJM. Unite Here is not a competitor and there is no evidence that competitors would use the information in competition which is being sought by Unite Here. Nor is there evidence that FDA's future access to information would be retarded by release of the information sought by plaintiff, as FDA has ample power both under the law and in practice to obtain information from medical device manufacturers."

Unite Here wants to see the unredacted FDA reports on SJM's Durata testing and review, or a copy for the court's review for release to plaintiff.

They are represented by Andrew Kahn with Davis, Cowell & Bowe in San Francisco.

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