I’ve officially been at this legal reporting thing too long when I start recognizing patterns from a case that started 14 years ago.

I reported last week in Mealey’s Emerging Drugs & Devices that a Texas federal judge denied an order protecting some doctors from subpoenas. The plaintiff had an artificial spinal disc implanted in him and it failed. When he sued the manufacturer, he subpoenaed doctors who, he alleges, conducted clinical studies of the device while they had a financial stake in its approval and success.

The plaintiff wasn’t the first to raise eyebrows or questions: in February, the New York Times reported on the doctors’ financial interests and the New Jersey Attorney General later subpoenaed information.

So where have I — and maybe you — heard this before? Pedicle screws. The medical device with the funny sounding name was another spinal device: they were screwed into the vertebra of patient’s to hold plates and rods in place. One of the many issues in that fascinating litigation was whether doctors and organizations involved in clinical trials had financial interests in the devices getting approved and becoming successful. The outcome of the pedicle screw litigation was a mixed bag: very few cases made it to trial; medical device preemption was taking off at the same time; medical malpractice figured in many cases; and the litigation eventually settled.

But one thing that was clear about the pedicle screws litigation is that it wasn’t the spinal device industry’s finest hour. Initial clinical studies were rejected. There was evidence that some were considered fraud. A federal grand jury was convened, but there were no indictments. There was discovery into stock and stock options held by doctors whose pedicle screw inventions were being commercialized. Much was discovered about a meeting between industry reps and the FDA, at which the FDA reportedly suggested that if the devices couldn’t get approved as “pedicle screws,” they could be submitted as “bone screws.” Indeed, while everyone referred to it as the “pedicle screw MDL,” its official name is “Orthopedic Bone Screw Products Liability Litigation.” A lot of the devices got approved not as new “premarket approval (PMA)” devices that underwent clinical trials and heavy FDA scrutiny, but as 510k devices, ones that were similar to previously approve devices. In other words, the allegation went, the FDA told the spine industry to market “pedicle screws” as “bone screws” for off-label use. Like I said, the whole thing left a bad taste.

Fast-forward 14 years later, and here we are again with discovery into whether doctors conducting clinical trials for an artificial spinal disc had a financial interest. The judge in the artificial disc case said subpoenas will be useful in judging the accuracy of reports disseminated by the doctors and the defendants prior to FDA approval.

I’ve been fortunate enough never to have had a back problem. From what I’ve heard, I wouldn’t wish it on anyone: the pain, the inability to work, to sit, to stand, to live a normal life. Doctors are the healers, and often, they’re in the best position to make innovations. If they come up with one, why shouldn’t they profit it from it while their patients benefit? But if the pedicle screw litigation showed one thing, it’s the need for transparency. All the cards should be on the table so no one thinks data was tweaked to help get a payoff.