Friday, January 20, 2006
The New York Times won access yesterday to documents in the products litigation regarding Guidant's defibrillators. According to reports describing the ruling, the documents may reveal a decision to sell off inventory even after a problem was identified. [Update: The Times story has more, including a mention that still more documents may be coming; Guidant obtained a stay of part of the order pending appeal.]
It's just based on a hunch from watching a bunch of mass tort litigation, but it seems that reporters are getting more involved in document discovery issues -- specifically the proper scope of confidentiality designations -- than they ever were before. At least occasionally, none of the actual direct participants in litigation are seeking to unseal or dedesignate documents, but media outlets intervene as here. Along with the flip side, in which litigants seek to explore whether medical journals are intentionally affecting litigation, the lines seems to be getting fuzzier.
Good or bad? Dunno. My next article is related to litigation-driven scholarship and discovery into peer review (as part of a broader exploration of law and science), so at the least, it gives me interesting things to think about.
As an aside, Guidant has been getting a ton of attention for the bidding war between Boston Scientific and Johnson & Johnson. Based on that, one might think that the pending litigation regarding Guidant's defibrillators was a non-issue, or at least an insignificant issue, and it's struck me that most of the reports about the ever-escalating bidding war don't even mention the potential exposure. Here's how Guidant described the litigation status relevant to its defibrillator and pacemaker products (including both civil and criminal contexts) in its latest 10-Q (from November):
Approximately forty-five product liability class action lawsuits and approximately fifty individual lawsuits have been filed in various state and federal jurisdictions against the Company following the Company’s recent implantable defibrillator and pacemaker systems field actions. The majority of these cases are pending in federal court. In late September 2005, the Judicial Panel on Multi-District Litigation conducted a hearing to determine the sole issue of the location for consolidating the federal cases in front of one judge. To date, no decision has been made. An additional six lawsuits have been filed in Canada. The complaints in these product liability lawsuits generally allege strict liability, negligence, warranty and other common law and/or statutory claims. The majority of claimants alleges no physical injury, but is suing for medical monitoring and anxiety. The complaints generally seek class certification, monetary damages and injunctive relief.
The Company has received three requests for information in the form of Civil Investigative Demands (CID) from the attorneys general of Arizona, Oregon and Illinois. These attorneys general advise that approximately thirty-one other states and the District of Columbia are cooperating in these CID demands. The CIDs pertain to whether the Company violated any applicable state laws in connection with certain of its implantable defibrillators. The Company is cooperating with these investigations.
On November 2, 2005, the Attorney General of the State of New York filed a civil complaint against Guidant pursuant the New York’s Consumer Protection Law (N.Y. Executive Law § 63(12)). In the complaint, the Attorney General alleges that Guidant concealed from physicians and patients a design flaw in its PRIZM 1861 defibrillator from approximately February of 2002 until May 23, 2005. The complaint further alleges that due to Guidant’s concealment of this information, the Company has engaged in repeated and persistent fraudulent conduct in violation of New York Executive Law § 63(12). With respect to damages, the Attorney General is seeking permanent injunctive relief, restitution for patients in whom a PRIZM 1861 defibrillator manufactured before April 2002 was implanted, disgorgement of profits, and all other proper relief. Guidant plans to vigorously defend itself in this lawsuit.
The absolute numbers of suits are relatively small and maybe they'll stay that way. And clearly J&J and Boston Scientific are sophisticated players with plenty of familiarity with the unpredictability of tort litigation. So maybe it all makes sense after all...but it's still a bit surprising not to have that potential exposure mentioned more often.