Wake of Reigel - medical device complaint amended to add claims that FDA was misled

The NY Times reports of the amendment of a complaint to add claims that the inventor of a spinal device misled the FDA about safety and effectiveness in obtaining approval for the device (read here).  This is one of the cases alluded to in the NY Times in a recent article about accusations that the financial interests of physicians inappropriately influences safety and effectiveness clinical studies.   Read here about my prior post on this article. 

The amendment comes in the wake of the momentous decision of the Supreme Court earlier in the week preempting state court lawsuits against the manufacturers of Class III approved medical devices.  There have been numerous postings about the decision, and I commend readers to the series of posts at the Beck Hermann blog (read here).

I bring this action to your attention because already it seems that the plaintiff's bar is taking up the exception to preemption articulated by Justice Scalia in Reigel to the effect that state law is not preempted if the state law allows for remedies in the event that the device company misled the FDA.  I wrote about the likelihood that this will become a new battleground in medical device cases in my post about the decision yesterday (read here).

The attorney for the plaintiff in the case discussed in the Times article names two factors that distinguish his case from Reigel.  One, he says that the product was not manufactured the way that it was supposed to.  This seems to be a manufacturing defect claim, which would probably not be affected by the Reigel decision.

The other theory is more troubling.   He states that the financial interests of the investigators raises questions about the validity of the data provided to the FDA.  This thesis is at the center of my criticism of the earlier Times article.  Where is the beef - where is the evidence of an improper influence on the data?  The Times article, which relied heavily on this case, did not point out any instance in which the results were affected by such an interest.  If this theory is afforded validity, then the preemption protections afforded by Reigel will be gutted as all Class III cases involving any kind of financial interest by any clinical investigator will be subject to suit.  Surely, that is not what the Supremes intended by their decision earlier this week.

Comments

[Financial Interests of Investigators]

I find you're last paragraph interesting and we see how quickly the tables are turned in this ruling.
1. "raises questions about the validity of the data provided to the FDA". How often have we heard or at least had questions about the fact that the data has been hidden, ignored or obscured and/or that investigators are in the pocket of the drug/device companies?
2. "Surely, that is not what the Supremes intended by their decision earlier this week." This is the exact same verbiage used by those who questioned the intent of peemption in the first place.