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Articles Posted in Medical Devices

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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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Here are this week’s stories:

  • Blood Products: The FDA hit the Red Cross with $16.2 million in fines for blood safety violations. Maybe I should take my donations to the local hospital, instead…
  • Hormone Therapy: Pfizer needs to get ready to try its hormone therapy cases all over the country, now that cases have been sent from Arkansas to their home states (with more awaiting transfer). Some think the upcoming cost will be an incentive for settlement. (HT: Bloomberg).
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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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The president of the American Association for Justice, Anthony Tarricone, comments about the extreme costs associated with medical device immunity. As one example, he cites to the Sprint Fidelis lead wires which have a high rate of breakage and unnecessary shocks. The manufacturer, Medtronic, is so far immune from claims of injury by people who had the device implanted.

In this day of concern over rising medical costs, the fact that consumers, taxpayers, and insurance companies have to foot the bill for problems created by medical device companies should be an outrage. And that doesn’t even take into account the unquantifiable pain and human distress caused by defective devices.

Here is a short video featuring people who have experienced first-hand the pain of repeated electric shocks by the Sprint Fidelis lead, and a description of the legal issues.

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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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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.