Articles Posted in Medical Device Manufacturers

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We’re just hearing about a May 7, 2010 FDA warning letter to Medtronic over Medtronic’s failure to establish protocols to review customer complaints and to validate device designs. The letter relates to image-guided surgical systems for spinal, cranial, and ENT applications.
This probably isn’t a huge deal, and doesn’t imply any particular defects. On the other hand, it’s hard to know about defects if Medtronic isn’t actively looking for them…

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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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Here are this week’s stories:

  • Medtronic: Medtronic reported that it paid $15.7 million to U.S. doctors in the first 3 months of 2010. Payments were for consulting fees and royalties. This report comes well in advance of the new law requiring disclosure beginning in 2013. See Medtronic’s searchable database of payments.
  • Digitek: A request for a class certification was recently denied in the Digitek MDL. The MassTortDefense Blog has an update.
  • PediaCare Recall: over 100,000 bottles of PediaCare, formerly manufactured by Johnson & Johnson (and, still being manufactured in their facility), have been recalled. This is a precautionary recall, based on the known problems with the J&J manufacturing facility.
  • AstraZeneca and Social Media: Here is AstraZeneca’s take on the transparency/social media issue.
  • Generic Drugs: The Supreme Court asks Obama’s administration for an opinion as to whether generic drug manufacturers can be sued for inadequate labeling that matches labeling of brand-name drugs. Here is the Eighth Circuit’s opinion, deciding that generic drug manufacturers can be held liable.
  • Celebrities in the News: Dennis Quaid is bringing public awareness to injuries caused by pharmaceutical companies. He settled with the hospital on the heparin overdose of his children, but now he’s going after the pharmaceutical company, Baxter Healthcare Corp.
  • More on Whistleblowing: Wyeth (through Pfizer) is accused of illegally promoting its kidney transplant drug for other organs and specifically among African-Americans, who have greater risks associated wit the drug.

Happy Wednesday!

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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.

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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The FDA Law Blog has a great post on the recent Baxter Colleague Infusion Pump Recall. They outline the authority the FDA is using to demand the recall (it is based on a consent agreement entered some years back between Baxter and the FDA after continued pump problems). The FDA Law Blog questions whether Baxter is required to refund purchase prices or reimburse for current pump values. There’s an interesting calculation of Baxter’s expected loss (though, Baxter is hoping to be able to replace the Colleague pumps with other Baxter pumps).
See our prior post on the Baxter pump recall here.

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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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We’ve been getting a lot of questions over the past few days about Seroquel. That usually means I need to put up a new post, especially in light of recent events.

Earlier this week, AstraZeneca (the manufacturer of Seroquel) agreed to pay $520 million to settle a federal inquiry into Seroquel marketing practices. As we have stated before, Seroquel is approved to treat schizophrenia and bipolar disorder. However, investigators and plaintiffs believe that AstraZeneca marketed the drug for myriad other unapproved uses, including depression, obsessive-compulsive disorder, dementia, and post-traumatic stress disorder.

whistle.jpgThere are no criminal charges associated with the deal. Giving credence to plaintiffs’ claims (aside from the credibility arising from the mere fact of a whopping large settlement), is that federal investigators got much of their information from AstraZeneca whistleblowers, drug sales rep, James Wetta (who had some involvement in the whistleblowing at Eli Lilly around 2003).

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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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Here are the stories we’re following this week: