Articles Posted in Medical Device Manufacturers

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Ethics-Definition-05-25-10.jpgSean Wajert of the MassTortDefense Blog has a post on a court’s denial of a plaintiff’s ethics expert in an OBTape MDL pending in Georgia. We routinely disagree with Sean’s blog (we’re on different sides of the aisle, of course), but there isn’t much disagreement with this post.

Disclaimer: I haven’t been following the OBTape litigation too closely, so all my information is secondhand.

The plaintiffs hired a business ethicist, Professor Ann Buchholtz, to testify that the product manufacturer should have provided certain information about the product to physicians and consumers. This is essentially a failure to warn claim. The problem with hiring a business ethicist (who, apparently has no particular expertise in medical devices or medical ethics, which arguably could alter the analysis) is that she is unnecessary. A jury is tasked with determining whether a company failed to warn about specific dangers. Having an expert say what is “ethically” required is merely an attempt to substitute an expert’s opinion for that of the jury. And the danger is that the opinion comes cloaked in the guise of expert testimony, so a jury might be more willing to accept the expert’s viewpoint.

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Baxter-Pump.jpgThe FDA has analyzed safety information and ordered Baxter to recall approximately 200,000 Colleague Volumetric brand infusion pumps. There are serious potential defects that have gone unaddressed, and under a 2006 agreement with the FDA, if Baxter did not adequately address the concerns, the FDA could require a recall at any time. The recall was prompted because Baxter informed the FDA that they would make the next round of corrections in May 2012 (not fast enough for the FDA, and not fast enough for customer comfort, I’m sure). Now, these devices must be recalled and destroyed.

The pump is a device that delivers various fluids in a hospital, nursing home, or even home setting. According to the FDA, the Colleague-brand pump has had problems going back as far as 1999, including “battery swelling, inadvertent power off, service data errors, and other issues.” Baxter’s attempted solutions have not been successful. Baxter has been ordered to provide replacement or refund to all customers.

All told, the FDA has received 56,000 adverse event reports in the past five years and has found that the pump may be linked to over 500 deaths.

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In a bold move, Judge Donovan Frank rejected a $296 million plea deal, offered by Boston Scientific and prosecutors. The proposed agreement was offered for Guidant’s failure to timely report problems with some of its defibrillators, which have caused at least seven deaths and numerous injuries. Boston Scientific purchased Guidant back in 2006. The federal Minnesota judge considered the arrangement, but ultimately rejected deal (which included a guilty plea by Guidant for two misdemeanors: submitting a false and misleading report to the FDA, and failing to notify the FDA about a device safety correction).

Judge Frank stated that “[a]t a minimum, the public’s interest in accountability would be served by Guidant and Boston Scientific being placed on probation, regardless of the fact that Boston Scientific acquired Guidant after the events in question. And, the court believes that a period of probation would likely benefit, rather than harm, Guidant’s and Boston Scientific’s public image.” The judge indicated that some measure of community service would be appropriate.

More Guidant/Boston Scientific Information

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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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Guidant-Timeline-04-07-10.jpgSometimes, personal responsibility is hard to come by. The same can be true of corporate responsibility, which is another version of personal responsibility (under the law, corporations are entities capable of suing and being sued, and doing many of the same things that people do).

Exhibit A is Guidant’s plea in federal court on Monday. Guidant (recently acquired by Boston Scientific) pleaded guilty to criminal violations of the Federal Food, Drug, and Cosmetic Act. Specifically, it pleaded guilty to two violations:

  1. making a materially false statement in a required submission to the FDA (Ventak Prizm 2DR)
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Two prominent Chicago orthopedic surgeons are calling for the recall of Zimmer’s NexGen CR-Flex Knee replacement devices. There has already been a recall of related devices to a part of the knee.

The porous femoral component (that is, the part of the replacement that covers the head of the femur, the bone that goes from the pelvis to the knee) is associated with a high rate of failure. The two Chicago surgeons calling for the Zimmer recall, Richard Berger and Craig Della Valle from Rush University Medical Center, have observed after two years’ of use that 36% of the implants were loose, and 9.3% were revised or set to be revised because of looseness and associated pain.

The doctors stated that “This component is still commercially available but should not be used for any patient.” They also questioned the fact that the product was released for sale to the public without clinical testing. Dr. Berger described the failure rate as “horrific.”

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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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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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Boston%20Scientific%20ICD%202-03-16-10%29.JPGHeart devices and the companies that manufacture them have had a rocky road the past few years (excluding Medtronic’s failed Sprint Fidelis leads: despite needlessly shocking patients, claims for injuries have been found by a federal trial court to be preempted). These include Guidant, which was subjected to recalls and numerous lawsuits over its defibrillators because of a short-circuiting problem.

Now, Boston Scientific (which acquired Guidant in 2006) has voluntarily recalled all (non-implanted) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). An ICD is a device that monitors heart rhythms and delivers life-saving shocks if dangerous rhythms are detected. A CRT-D treats certain types of heart failure by coordinating the pumping of the heart’s ventricles. The units recalled fall under the COGNIS, CONFIENT, LIVIAN, PRZM, RENEWAL, TELIGEN and VITALITY lines.

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