Quaid last month urged Congress to preserve patients' rights to sue drug and device makers in state courts, after his twin newborns nearly died after accidentally overdosing on a blood-thinning drug sold by Baxter International. He has sued the company.

While Quaid's example is clearly ridiculous on account of the fact that it was a facility error, not Baxter's, Reuters goes on to highlight that...

...Democrats in Congress are considering legislation to protect a patient's ability to sue drugmakers if the Supreme Court further restricts the lawsuits, backing so-called "pre-emption" of state laws by federal.

This all, of course, comes in the wake of the recent decision that the manufacturer of a device that's gone through the PMA process cannot be held liable.

That said, the effect upon medical innovation of leaving the door open to liability at a state level would be disastrous. At best, it increases the legal overhead associated with doing business as a device or drug manufacturer, thus further increasing the cost of medical care.

However, worse than that, it takes the focus off of the root cause: the purpose of the FDA is to ensure the safety and efficacy of the medical products on the market. If a faulty product slips through (as is inevitably the case), the liability lies with the arbiter of "good enough": the FDA.

If being good enough for the FDA isn't, then the federal government might as well dissolve the agency and spend our tax dollars elsewhere, letting case law (and lay-person juries) decide what the public requires in terms of safety. Obviously a less desirable solution, but it remains the only logically intact one should we leave the door open for every ambulance chaser to try and extract a ransom from big-name medical manufacturers.

From the FDA:

This draft guidance, announced in today's Federal Register discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing submission. It also provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. Because these stents combine device and drug technology, this guidance contains expertise and input from two agency centers—the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.

Also included are draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device's overall safety.

The full document is below, so you can print it right from here.

FDA Document: Guidance for Industry: Coronary Drug-Eluting Stents- Nonclinical and Clinical Studies

Press release: FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries

From the FDA:

This is an important step forward in the FDA's plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters," said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. "Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market."

Building the FDA's capacity outside of the United States supports the agency's "Beyond our Borders" initiative. The initiative facilitates the building of stronger cooperative relationships with the FDA's counterpart agencies around the world and enhanced technical cooperation with foreign regulators. The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality.

It's obvious that greater regulatory scrutiny needs to be applied to food and drugs (and medgadgets!) made in China, but we're doubtful that eight new employees, operating only with the permission of the notoriously restrictive, secretive and corrupt Chinese government, are really going to effect much change.

More from the US Food and Drug Administration...

Article abstract in the Journal of Medical Devices...

Press release: Stanford researchers publish review of US medical device regulation

Finding the best matches is a complex task. Doctors tend to consider some patients higher priority than others. For example, although dialysis allows most patients to survive after their kidneys have failed, patients who cannot be treated with dialysis will die without a transplant. If a patient had donated a kidney when healthy, a sense of justice calls for that patient to receive one when sick. Doctors also favor giving higher priority to children.

Furthermore, some matches are better than others. Donor and recipient must have compatible blood types and sufficient immunological compatibility for a transplant to be possible. But in addition, there are degrees of immunological compatibility: the better the match, the longer a transplanted kidney is likely to keep working. Another consideration is that transplants are least expensive and easiest on doctors and families when the donors and patients live near one another, so that all the surgeries can take place in the same locality.

Read more about the math from MathTrek @ Science News...

Flashback: How to Barter a Kidney ...

(via BoingBoing)

This capricious state of affairs is the reason I think that the states or Congress should establish a qualified regulatory compliance defense to tort liability under which FDA approval would ordinarily, but not always, pre-empt such liability. In practice, this means that a drug manufacturer that receives FDA approval could obtain summary judgment against injured claimants, unless they could show that the manufacturer failed to fully inform the agency of risks about which it should have known.

This issue has gained fresh saliency for two reasons. First, the FDA is now issuing regulations whose preambles assert that state tort law is pre-empted. The courts will decide whether only Congress, not the agency, can do this -- an issue I do not address. Second, criticisms of FDA safety regulation have sharpened, most recently with reports that a popular diabetes drug, Avandia, increases heart problems. As I explain below, the remedy for the FDA's shortcomings is not to use tort law as a separate regulatory system but rather to strengthen its regulatory capacity, as Congress is about to do, and to limit tort to situations where manufacturers misled the agency.

New, improved drugs can save countless lives and improve the quality of life for millions. This social cornucopia, however, depends on the willingness of the pharmaceutical industry, operating in a fiercely competitive international market, to invest vast sums of money and many years of research and development in hopes of coming up with a blockbuster drug like Lipitor to make up for the far more numerous duds. But since a few adverse jury verdicts can destroy a product -- or even a company -- drug manufacturing is a high-stakes roll of the dice. To elicit the necessary large, long-term investments, some legal predictability is needed.

He goes on from there, intelligently outlining arguments as to what's to be done, making a great case for severely restricting the plaintiff's ability to gain compensation on a properly regulated product. It's really a breath of fresh air to see a well reasoned commentary online (as opposed to a preaching-to-the-choir rant).

More from Law.com...

Shelhigh is one such company. Makers of a heart valve fixative process for cardiothoracic surgery, they've been manufacturing with substandard practices for years, causing accelerated aging in their contaminated surgical implants, FDA alleges. After countless warnings, the FDA got tough:

A seizure is an enforcement action taken as a last resort to remove a dangerous product from commerce. The FDA initiates the action by filing a complaint with the District Court where the product is located, and a US marshal is then directed by the court to take possession of the goods until the matter is resolved. The complaint against Shelhigh was filed on April 16, 2007.

The US Marshal did not physically remove the devices from the plant but rather "seized them in place," meaning Shelhigh cannot remove, attempt to remove or in any way interfere with the products without the prior written permission from the US Marshal. The firm's products have also been embargoed by the state of New Jersey.

In fact, the story here is not that the FDA can recruit US Marshals and can function like the DEA when it needs to -- the real story is that they waited five years between their first warning and their second, and sent a half-dozen increasingly shrill warnings over 18 months before finally acting in May:
It's difficult to understand how Shelhigh believes it has a legal leg to stand on in light of the FDA's last 7 years of warnings, threats and promises. Investigators documented deficiencies in the firm's Union City facility in 2000 and 2005, and those inspections resulted in warning letters to Shelhigh in April 2000 and December 2005.

A December 14, 2005 warning letter spelled out what Shelhigh was facing. "Your failure to comply with any post-approval-requirement, the FDA explained, constitutes a ground for withdrawal of the Human Device Exemption and commercial distribution of a device that is not in compliance with these conditions is a violation of the Federal Food, Drug, and Cosmetic Act."

...As for its part, according to Mr Gaudio, the FDA would not comment on why it waited 5 years between warning letters and then nearly a year-and-a-half between the December 2005 letter and the seizure, or why it then waited 2 more weeks after the seizure to send Shelhigh a formal request for a product recall.

More from the FDA...

Shelhigh's perspective...

The U.S. Food and Drug Administration (FDA) is alerting health care professionals and consumers to the availability of audio broadcasts that provide emerging drug safety information. The broadcasts, commonly known as podcasts, can be transmitted to personal computers and personal audio players.

The service is part of the agency's ongoing effort to broaden and speed its communications concerning the safety of marketed medications when unexpected adverse events are reported to FDA. The broadcasts are an addition to FDA's traditional print- and Web-based public health advisories (PHAs) and anyone can subscribe to them for free at http://www.fda.gov/cder/drug/podcast/default.htm.

Press release: FDA Announces Audio Broadcasts on Emerging Drug Safety Information ...

Like a growing number of aging baby boomers, I recently had knee surgery. During a follow-up visit, my doctor showed me an x-ray of my knee, and I saw that a metal screw had been implanted during the surgery. I didn't know the screw was being placed there, and I knew nothing about who had made it, how well these devices had performed in long-term studies or whom I would tell if I had a problem with the device.

When I buy an appliance these days, the manufacturer asks me to register the product so it can match me with the product details. In health care, we don't do this. If there is a product recall, I won't know whether to be concerned about the screw in my knee because I don't know its make, model or lot number...

Active monitoring would match product with patient. If a patient has a problem but does not see the original physician or visit the same hospital, the new clinical team would have access to all of the information on the patient's device and other medical history. Moreover, the medical staff could report concerns back through the system to the FDA and the manufacturer.

Such a system also could notify patients about product recalls and other developments, or it could be used to survey patients to study questions about medical devices.

More writing from Prof. Kevin Schulman...

2nd Sight Medical has just received USFDA investigational device exemption (IDE) to begin clinical trials for their Argus II Retinal Prosthesis System.

In case you haven't been following Second Sight, their retinal prosthesis uses an array of electrodes to stimulate the retina, restoring a low level of vision in patients with degenerative diseases. Their first implant had 16 electrodes, the new Argus II has 60...

The Argus II implant consists of an array of electrodes that are attached to the retina and used in conjunction with an external camera and video processing system to provide a rudimentary form of sight to implanted subjects. An IDE trial of the first generation implant (Argus™ 16), which has 16 electrodes, is ongoing at the Doheny Eye Institute at the University of Southern California. The Argus 16 was implanted in six RP subjects between 2002 and 2004 and has enabled them to detect when lights are on or off, describe an object's motion, count discrete items, as well as locate and differentiate basic objects in an environment. Five of these subjects are now using their Argus 16 retinal prostheses at home.

The next generation Argus II retinal stimulator is designed with 60 independently controllable electrodes, which should provide implanted subjects with higher resolution images. Second Sight remains the only manufacturer with an actively powered permanently implantable retinal prosthesis under clinical study in the United States, and the technology represents the highest electrode count for such a device anywhere in the world.

More from Second Sight's main page, their clinical trials page, and their full press release...

Flashbacks: Second Sight Implant: Positive Results Reported in the Study; Diamond Coating for Second Sight Implant