Guidant’s recall of defribillators poorly handled

Posted by jd
July 6, 2005

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In terms of an effective product recall strategy, I have argued that there need to be two fundamental elements:

  1. Development of a strategy at the same time the product is launched so that in case of a problem, everyone knows what to do.
  2. Be proactive in recalling rather than dragging your feet.

Guidant Corporation did neither of the two. When first report came out that that the company continued to sell defective cardiac defbillators, the process of delays and denials started. Only now the company has finally decided to recall a series of devices (Ventak Prizm, Contak Renewal, Vitality AVT, etc.). Since then, the FDA has also classified the recalls. For instance, PRIZM 2 DR, CONTAK RENEWAL, and CONTAK RENEWAL 2 devices have been classified as a class I recall, which means that there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death. VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT devices have been classified as Class II recalls or the malfunctioning product may cause temporary or medically reversible adverse health consequences; however the probability of serious adverse health consequences is remote.

There is a very important reason why we at iProceed insist that our clients have a product recall strategy in place and always demonstrate the highest ethical values – the impact of lawsuits. A few recent examples of drugs like Vioxx, Bextra, Tysabri, Adderall, etc. show that when companies delayed their recall process, they were hit with more class action lawsuits and attorneys find it easier to show bad intent and negligence when companies deliberately hide information and/or do not act fast enough.

So when the president and CEO Ronald Dollens says, “Patient safety is paramount and our highest priority,” it sounds as hollow as Merck’s motto “Where patients come first.”

Picture of a Ventak Prizm defribillator that has since been recalled. Photo courtesy: Guidant

What does it mean for you?

  1. Product recall strategy should be a part of a company’s risk management program. It is not a good idea to avoid dealing with this issue.
  2. Never show a careless attitude about the well-being of your customers (particularly where health is concerned). People understand that things may go wrong or some products may be manufactured with defects; the problem gets worse when a company engages in a “fight” with the customers hoping that they can either make the problem go away or that they can simply ignore those who have been injured.
  3. Research cases of companies that have recalled products in your industry (if no examples are available, analyze cases of similar studies) and learn from them in developing your strategy.

Related article: Strategic lessons from recall of Vioxx and Bextra

Pfizer mishandles Viagra controversy, particularly if a recall happens in the future

Business strategy

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