Federal Preemption: Is the FDA testing process fail-safe and protecting you, the patient?
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Cardiopulmonary bypass disposables are subject to a voluntary recall.
You might still be asking whether issues involving federal preemption are worth the fifteen minutes it takes to write to your Congressman about. Well consider the following. Are you smart enough to know how this recalled product might affect you?
The FDA issues alert notices about recalls. They are available to everyone to read. I’ve copied one concerning patients who might undergo certain procedures having to do with the heart. Read the one below. It’s copied word for word.
Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass
Contact:
Daniel Beach
Public Relations
763-505-2603
FOR IMMEDIATE RELEASE -- MINNEAPOLIS – May 7, 2008 – Medtronic, Inc. today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. Food and Drug Administration's April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.
Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. However, the U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS.
Medtronic has not received reports of any OSCS-related adverse events arising from the use of Carmeda CPB products. It is unclear, however, if exposure to Carmeda-coated medical devices, made with comparatively small amounts of heparin, could cause adverse events similar to those observed with injectable heparin formulations. As a result, Medtronic has initiated a precautionary recall of affected Carmeda products.
In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Medtronic's ultimate goal is to remove contaminated products from the market. However, based on the current data, the benefit of using the affected products outweighs any potential risk to patients. Since the maximum possible patient exposure to heparin from Trillium is extremely low, customers can continue to use the affected Trillium products until a replacement is available.
The above actions are being made with the knowledge of the U.S. Food and Drug Administration. Patients with questions should talk to their physician. Physicians or Pefusionists with medical questions related to Medtronic therapies should contact Medtronic at 1-800-638 0218, Monday – Friday, 8:00 a.m. to 5:00 p.m. CDT
Now that you’ve read it you should feel comfortable with knowing how to protect yourself and which medical procedures involve the recall. You should be able to describe the problems and surgical procedures might involve the recalled item. Do you? Can you?
I’ve copied the recall notice above so you can see what I’m talking about. As patients we are in the dark when it comes to what medical devices work and which do not. In the case of the “selected products” featuring the “Cameda BioActive surface” patients have suffered serious injury and death when administered injectable heparin products containing high levels of OSCS.
What are the “adverse events” to which the notice refers?
Some people are comfortable letting their physician and hospital staff make all the decisions and to look out for their safety. And that’s alright but some of us are not. As my mother was fond of saying, ignorance is bliss. But an education goes a long way and after attending law school ignorance is no longer an option. What if the doctor and hospital staff doesn’t protect you? What if the make a mistake and use one of the contaminated coated medical devices? What then? I’m not blaming them; I’m just saying it’s entirely possible. Why do we buy insurance if not for these types of mistakes?
And what about federal preemption issues that we’ve been talking about? Remember the manufacturer argued the FDA had approved this product for use and therefore it’s safe, or reasonably safe, and that approval is the seal of approval for which they can’t be sued. If that’s true why then are we getting this recall notice? If medical devices are thoroughly tested during the FDA approval process and declared safe, how did this one slip through? I thought the FDA approval testing process was nearly fail-safe? No? If medical device lawsuits are preempted then when you’re injured, you’re out of luck.
So is federal preemption always good and fair? Not in this case it would appear.