Articles Posted in Medical Devices

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Stryker’s CEO Stephen MacMillan was on Squawk Box this morning talking about the President’s speech and Stryker’s recent boost in profitability. He looked like a nice guy, he really did. I was on the treadmill so I did not get what prompted the joke but in response to something Joe Kernen said, MacMillan said that next time he would bring with him a really good hip replacement (or words to that effect).

The comment underscored to me how in the world of big business, litigation is just one piece of a very large puzzle. I would think MacMillan would be a little more sensitive about the fact that just a few years ago they had to recall Stryker hip implants to the point where he wouldn’t have thought it a joke. But Stryker has settled most of those cases and clearly moved past it.

I don’t know what my point is, really. I’m not even saying the joke was inappropriate. The whole thing just struck me as odd.

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History tells us that it is not the crime but the cover-up that often causes the most damage. In drug and medical device cases, there is usually a Nixonian leitmotif: what did you know and when did you know it with respect to the potential harm caused by the drug.

Last month, another DePuy class action lawsuit was filed. The claim is an interesting cover-up allegation. The class action claims that after the DePuy ASR recall, the company deceived patients by agreeing to make things right and in exchange, getting access to hip recall victims’ medical records. Making things right is relative. DePuy has essentially promised victims nothing in exchange for something, which is the essence of this class action lawsuit.

This byproduct DePuy hip recall lawsuit is probably a sideshow to the core of these hip implant lawsuits. Rummaging through plaintiffs’ medical records while pretending to promise them something in exchange is awful. It is a clear end-run artifice designed to fool plaintiffs into believing they don’t need a lawyer. But the compensation for this inappropriate conduct pales in comparison to the real injuries that stem from the DePuy ASR hip recall. But this class action lawsuit underscores that people are mad and DePuy is not making things any better by not playing it straight with victims.

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St%20Jude%20Logo-06-22-10%29.gifThe California Watch wrote about questionable ties between a cardiologist, Dr. Michael Burnam, and a medical device company, St. Jude Medical, Inc.

The allegations are that Dr. Burnam convinced St. Jude to give his son a $200,000 a year job in exchange for a lot of new business. St. Jude manufactures defibrillators, and one patient is accusing Burnam of arranging for a completely unnecessary defibrillator implant surgery. That surgery almost cost a patient his life, when the implanting surgeon accidentally stabbed the patient’s heart with the implant.

This kind of quid pro quo is intolerable, particularly to the extent that patients have no idea of the relationship between their physicians and medical device manufacturers. Part of the problem, in this case, is that, as alleged by the patient, the cardiologist deliberately misinformed the implanting surgeon about the patient’s medical history. Had he been properly informed, the surgeon would have realized that the surgery was unnecessary.

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This week in Maryland, the manufacturers of radiology equipment met to discuss the planned fail-safe devices for machines set to be sold in the next two years. The goal is to create machines with software that prevents or minimizes errors in radiation dosage.

Radiation overdose is not just an abstract concern, but can cause real injuries and death—see an article by the New York Times about radiation accidents and a 43-year-old man who was rendered deaf, visually impaired, burned, and with ulcers in his mouth and neck before he finally succumbed to radiation-caused injuries.

Some “fixes” that need to be instituted are ways to ensure the radiation is properly directed and that the radiation dose is age-appropriate. Many machines used now rely on the technologist’s discretion for when and how to perform these safety checks. New machines will make the process mandatory at set intervals.

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The FDA is warning patients and doctors about possible risks posed by 280,000 defibrillators, manufactured by Cardiac Science of Bothell. These are external defibrillators, the kind you find in airports, at hospitals, nursing homes, and at swimming pools.

The devices may not provide the correct shocks, may not properly evaluate heart rhythms. There are 14 devices subject to the warning, including Cardiac Science Powerheart, CardioVive, Nihon Kohden (NK), and GE Responder External Defibrillators manufactured between 2003 and 2009.

Users should continue to use the defibrillators (which are potentially better than nothing) until they can get replacements or repairs. Obviously, the FDA recommends that high-risk locations (hospitals, nursing homes, etc…) immediately arrange for repair/replacement and use alternative devices in the meantime.

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Guidant%20in%20Jail-04-21-10%29.JPGThe New York Times published an article yesterday, “When Heart Devices Fail, Who Should Be Blamed?” The article puts a nice gloss on how and whether a company and people in charge of a company can properly make amends and taking personal/corporate responsibility.

The backstory is, of course, that a federal judge is considering whether to accept a $296 million fine, and a guilty plea to two criminal misdemeanors by Guidant (now Boston Scientific). Two cardiologists are urging the judge to reject the deal, and instead, want prosecution of the company “and the individuals responsible.” The cardiologists, who cared for a 21-year-old patient who died because his Guidant device did not properly function, further stated that:

Manufacturers control the quality of their products. Manufacturers are the first to know when a medical device is dangerous or underperforming. Thus, it is in the best interest of patients, and society in general, for manufacturers to be liable for the safety and effectiveness of their products. To allow a repeat offender, like Guidant, to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety.

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Colonoscope-03-31-10.jpgNews reports in the past couple of days have hit on part two of the CT radiation overexposure inquiry. Before, the issue was whether certain CT devices because of manufacturing, design, or technician error, provided too much radiation to patients. A secondary question was whether patients were receiving too much radiation through scans over the course of their lives (the FDA reports that the average person’s radiation exposure has doubled in the last thirty years).

Now, the question is focused on whether CT scans are a good idea for screening purposes where a patient has no indication that they have any disease—the three that have been most mentioned are whole-body CTs (to see if there is anything wrong); CT colonoscopy (to detect colon cancer), and CT scans of the heart (to detect heart disease). Most of the debate has been centered around the colonoscopy procedure.

On one side are those who believe that traditional methods—a colonoscopy, are best to detect colon cancer. Proponents (including the American College of Gastroenterology, who come out on the side of their financial interests in the question) state that CT colonoscopies are not as certain as the traditional visual colonoscopy; that removal of polyps would require a second procedure with a CT colonoscopy (versus being done at the same time in the traditional procedure), and those incidental findings on a CT scan may lead to unnecessary procedures. Additionally, repeating these scans increases patient exposure to radiation.

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Hernia-repair-03-30-10.jpgThe first federal Kugel Mesh hernia repair lawsuit began in the U.S. District Court for the District of Rhode Island, yesterday. Plaintiff John Whitfield claims that the mesh, manufactured by Davol, Inc., was defective and broke after it was implanted, causing bowel obstruction, abdominal pain, nausea, permanent bowel injuries, and necessitating additional surgery.

This is the first of four bellwether trials, designed to give lawyers on both sides a sampling of how jurors will deal with the information and trial strategies. This may assist the parties to reach settlements in remaining cases after they learn the strengths and weaknesses of each side.

There are 1,300 other hernia mesh cases that are consolidated in the Rhode Island federal court MDL. An additional 1,774 cases are in Rhode Island state court, with the first trial expected later in the summer. Many of the hernia patches were recalled since 2004.

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Contrary to the good corporate responsibility of Boston Scientific for their quickly recalled defibrillators, DePuy seems to have taken their sweet time with their ASR hip implants, besides trying (and failing) to direct public misinformation on the issue.

DePuy-ASR-03-17-10.jpgFirst the background: the DePuy ASR hip implant is used for hip resurfacing (which is apparently not an issue), and more traditional hip replacement, which is at issue. The device is a metal-on-metal ball and socket, which can cause metal debris early in the implant’s life. That metal debris causes inflammation and can lead to damaged muscles and soft tissue. The end result is that a very expensive and painful replacement surgery intended to last about 15 years ends up needing revision within two or three years.

The use of the device in the United States started in 2005. Since 2008, the FDA has received approximately 300 complaints (most people don’t complain to the FDA, so this shows that the problem is much larger) from patients or their doctors about the early failure of the device.

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Radiopharmaceuticals%20BETA-02-10-10%29.JPGThe FDA issued a press release Tuesday focusing on unnecessary radiation exposure from CT scans, nuclear medicine studies (use of radiopharmaceuticals taken internally creates the radiation, unlike an x-ray, which bombards the body with radiation externally) and fluoroscopy (process to see real-time moving images of internal structures).

The FDA reports that these three types of diagnostic imaging use ionizing radiation, which can increase lifetime cancer risks. A single exposure to high levels of ionizing radiation causes hair loss, skin burns, and cataracts.

The FDA recommends two areas to minimize radiation risk: