“Grandfathering” Drugs into the U.S. Marketplace
Most people don’t realize that the U.S. Food and Drug Administration, or FDA, does not test the much-vaunted drugs that finally make their way into the consumer marketplace in the United States. This, even though the FDA is the lead agency for such screenings. In the absence of testing, one wonders where all the federal-budget dollars go. Others speculate that the FDA may be a case of too many chiefs and too few Indians.
In fact, not only does the FDA do no drug testing, or even mandate company testing, but in many instances simply assumes drugs are safe via the “grandfather rule”. That is, if a new drug comes into the marketplace with a chemical profile and a purpose which largely matches another previous product, it is automatically assumed to be as safe and efficacious as its grandfather drug. Otherwise, drug companies are expected to test their own drugs, from R&D to human trials, and provide accurate and truthful reports. Given the billions of dollars involved in getting a successful drug into the consumers’ hands, these latter two requirements invite all sorts of chicanery.
Granuflo Gets “Grandfather” Approval
Few in the drug or legal profession realize that Granuflo came into the U.S. drug marketplace via this very same grandfathering. The original substance, Granulyte, established the equivalence (of Granuflo) and was approved by the FDA in 1992 and approved for sale in March of 1994. Subsequent to that, and without filing a new 510(k), German manufacturer Fresenius Medical Care (FMC), which has offices in the U.S., in 2003 also got a license for a non-granulated form of Granuflo.
Evidence would suggest that all generations of the drug contained sodium diacetate.
Fresenius Fails to Inform
Fresenius, the largest dialysis services and products in the world, used these formulations in its clinics to provide dialysis care to victims of kidney failure. When it was discovered that sodium diacetate was the root cause of a series of medical emergencies, some resulting in death, FMC product executives finally elected to inform managers and physician’s at Fresenius’s dialysis clinics of the problem.
This internal memo, which divulged remedial action for patients with high bicarbonate and potassium levels, was never revealed to non-FMC clinics, clinic managers, or physicians. Remember, FMC not only had its own clinics but sold dialysis supplies and systems to other medical entities.
It took another 16 months for Fresenius executives in product manufacturing to churn out a two-page memo in response to an FDA inquiry. This, dated March 27, 2012, did not even mention the very high risk to dialysis patients in an acute – as opposed to chronic – phase of kidney failure.
The Revolving Door Dance
It should come as no surprise that an FMC Renal Therapies Group manager chairs the Association for the Advancement of Medical Instrumentation (AAMI)’s committee for Renal Disease and Detoxification. But this is only the tip of the iceberg. The FDA and drug companies also regularly play the “revolving door dance” (that is, back and forth between government and the corporate world). Drugs slide in under that same door via grandfathering – the drug companies don’t need an exact match. In fact, they only have to come close. Moreover, the FDA treats Granulyte/Granuflo as a medical device rather than a drug, thus forestalling lawsuits based on the 2008 Supreme Court determination that said devices are exempt from liability under state laws if they have been pre-approved by the FDA.
In addition to women’s products like insertable birth control devices, Granuflo and its adjuncts – as well as a basketful of medical devices protected under the grandfather clause as Class III items (equivalent to a product in existence before 1976 and thus escaping testing) – are increasingly the focus of personal injury lawsuits.
Jurists Create MDL
In March of 2013 a panel of jurists created a multi-district litigation panel, also known as an MDL. Lawsuits against FMC will be tried before this legal unit, the U.S. Judicial Panel on Multi-District Litigation, in a single federal district court in Massachusetts. This is an effort to simplify and streamline pre-trial depositions and other legal necessities, but each case remains separate, producing better representation and – as one jurist notes – considerably larger settlements per capita than a class action suit.
This pending litigation now contains 161 actionable cases, of plaintiffs who became ill or died from metabolic alkalosis, a dialysis complication which results in cardiac arrhythmia, cardiopulmonary arrest, hypokalemia (low potassium), hyposemia (low oxygen levels in arterial blood), hypercapnia (a high proportion of carbon dioxide in the blood), or low blood pressure.
On March 29, 2012, the FDA issued a Class 1 recall of Granuflo (and NaturaLyte, an adjunct dialysis chemical) based on evidence of 941 deaths resulting from its use in FMC’s dialysis clinics alone!
Class I is the most severe level of recall, based on the likelihood that the product(s) in question will have dangerous health consequences. Even FDA-bashers will consider that a good call, and evidence that the agency is not beyond redemption.