I have always found the weather and the people to be a little cold in Minnesota.
Reporters like a little action and the Midwestern penchant for not creating any ripples is frankly a little disappointing.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
This morning, however, was unlike any other I have experienced in covering medical devices.
St. Jude Medical, which has been battling negative publicity about its faulty Riata ICD leads, most recently from Minneapolis cardiologist Robert Hauser, displayed some raw nerves pulling its crosstown rival Medtronic into the fray.
A quick backgrounder: Hauser compared the recalled Riata and Riata ST ICD leads of St. Jude with Medtronic’s Quattro Secure lead and found that the St. Jude leads killed 22 people while Medtronic’s lead killed five. A higher number of deaths were recorded for both companies’ products but those deaths were not caused by the leads, Hauser concluded. The information was based on the MAUDE database at the Food and Drug Administration. which involves voluntary report of adverse events in people wearing medical devices. Hauser’s analysis and resulting manuscript was accepted for publication by the Heart Rhythm Journal and that is where things began to get a little heated.
St. Jude Medical launched a blistering attack against the cardiologist on Good Friday asking for the retraction of the article. St. Jude Medical called the study biased and inaccurate.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
On Monday, the editor-in-chief of the Heart Rhythm Journal declined to retract the article and. St. Jude Medical responded Tuesday by posting the contents of the MAUDE database that shows that 377 deaths occurred in people wearing Medtronic’s Quattro Secure Lead and not 62 as reported by Hauser.
“The company has called upon Dr. Hauser to state specifically whether or not he stands behind the factual accuracy of the number 62 used in comparing the St. Jude Medical Riata and Riata ST leads to the Medtronic Quattro Secure device,” a St. Jude statement read.”The company also invites Medtronic to review the MAUDE database report findings.”
A Medtronic spokesman declined to engage in any kind of dueling contest in public, which leads me to speculate whether Medtronic will make its displeasure known to St. Jude behind the scenes.
In an call yesterday, Hauser declined all comment in response to St. Jude’s Good Friday demand for retraction, other than to say that he stood behind his data. Stay tuned to see whether he will change his mind today and respond more forcefully. Hauser discovered and reported problems with Boston Scientific’s Guidant ICDs using the MAUDE database search. Ultimately Guidant’s products were recalled.
The term “unprecedented” has come up twice in conversations about St. Jude’s public response to Hauser’s critique of the Riata leads. For me, the dumping of the Midwestern calm for a bit of stormy skies is a welcome development.
[Photo Credit: Ambro]
