More on J&J, Synthes Warning Letter

More on J&J, Synthes Warning Letter

March 7th, 2012 // 1:15 pm @

Source: Pharmalot

No acquisition comes without its warts. Consider Synthes. Last year, Johnson & Johnson agreed to pay $21.3 billion for a line of hip screws, surgical tools and other devices for treating spinal and soft-tissue injuries. The deal was lauded on Wall Street for allowing J&J to shore up one of three strategic legs at a time when the others – pharmaceuticals and over-the-counter meds – are under pressure.

Synthes may well ring the register, but the device maker certainly poses some challenges. Why? The FDA recently sent a warning letter to say that a two-part inspection conducted last summer and fall revealed a host of ongoing, systemic problems, particularly when it came to investigating and following up complaints about its devices, and filing timely reports with the agency.

For instance, a dedicated unit for handling complaints failed to review a complaint database each month to assure all investigations were completed in a timely manner; there was a lack of a good faith effort to obtain all info necessary to evaluate and investigate complaints; and employees who received complaints or adverse event info failed to “immediately communicate” with the complaint unit.

One example involved a failure to maintain a record of an investigation into a complaint. A document contained info from an analyst of a review, but did not have the name of the investigator or the date, and the review was not overseen by the complaint unit. When the unit sought the documentation, it had gone missing. During the FDA inspection, the documents turned up in a Synthes office in San Diego, but even then, the complaint investigation documents were only partially completed.

Another problem: a review of N-Fix II/N-Hance Rod MDR-reportable complaints found that reports were either closed before investigations were completed or open issues were not followed-up by the so-called Complaint Handling Unit investigator in a timely manner. In fact, some complaints were never followed-up at all, while the time from the date of event to the follow-up date varied. The FDA found that device history reviews were not documented on a timely basis for 48 complaints.

synthes-click-headMeanwhile, FDA regs require reports to be filed no later than 30 days after receiving or becoming aware of info that suggests a device has malfunctioned and would likely cause or contribute to a death or serious injury if the malfunction were to recur. But Synthes blew past the deadline more than once and did so egregiously. In one instance, the device maker was aware of a problem on July 1, 2009, but the agency did not receive a the report until July 14, 2011.

This sort of delay happened more than once (here is the FDA warning letter). And so the FDA not only wants Synthes to hire a consultant to straighten things out, but a copy of the consultant’s report must be submitted and certified by Synthes ceo Mike Orsinger.

Synthes, you may recall, has a checkered past. Last fall, four former execs were sentenced to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths (see here). But the larger issue for J&J is convincing the medical community and patients that Synthes products are safe and any safety issues, if they arise, are followed up appropriately. The FDA warning letter notes that, in some cases, Synthes failed to rectify problems with documentation over an extended period.

And device safety is a problem for J&J right now, given the controversy over artificial hip devices. Last summer, its DePuy Orthopaedics unit recalled the ASR hip system, after researchers found a second operation, or revision surgery, was needed after five years at rates higher than expected. The so-called ‘metal-on-metal’ devices contained design defects that generated cobalt and chromium particles causing tissue death, fractures, and other injuries, according to lawsuits. The failure rate was estimated to be about 12 percent. The problems led to a shake up at DePuy, by the way (read here).

More recently, reports surfaced that DePuy continued to market an artificial hip in Europe and elsewhere overseas even after the FDA rejected the devices for the US market, based on a review of safety studies run by the health care giant. Such disclosures are likely to place added pressure on Alex Gorsky, who heads the J&J device business, as he replaces Bill Weldon next month as ceo (see this).

Given the myriad setbacks already confronting J&J – notably, quality control gaffes that hurt its OTC business – Gorsky will have to work extra hard to convince doctors and patients that he is part of the solution, not part of the problem – and is somehow capable of restoring suitable quality control systems companywide. You can add Synthes to the check list of items he must tackle.

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