It's about time the FDA tightened its lax rules on devices. All a device company has to prove is that a new device is functionally similar to a previous one. The original device to which it was compared to might have absolutely no data to support it, since it may have been grandfathered into practice.

This case is worse than the Vioxx debacle. Other companies that make hip implants and pacemaker leads have similar philosophies--let the failed devices surface before recalling them. An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.

Johnson & Johnson never released those projections for the device, the Articular Surface Replacement, or A.S.R., which the company recalled in mid-2010. But at the same time that the medical products giant was performing that analysis, it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.