Sometimes it’s that simple. Melton v. Ortho-McNeil Pharm., Inc., 2014 U.S. Dist. LEXIS 78917, at *1-2 (N.D. Oh. June 10, 2014), is another Ortho Evra birth control patch case in which the plaintiff suffered a pulmonary embolism. The manufacturer’s label and one of its dear health care provider letters explicitly warned of this risk;
In July, 2011 we posted about the post-Sorrell citizen petition that seven major drug companies filed with the FDA concerning the Agency’s restrictions on truthful off-label promotion.
On June 6, 2014, the FDA “granted” the petition. It’s nothing like D-Day, however. Nothing earth-shattering here. The FDA’s “grant” is more like a “dodge.”
That being said, the FDA’s response is still interesting, sometimes as much for what the Agency didn’t say as for what it did. The petition dealt with the FDA’s convoluted regulatory positions on four situations involving the dissemination of medical and scientific information about off-label uses:
FDA Response at 2. The petitioners also asked in a 2013 supplement (that is, after the Caronia decision) “that [FDA] provide clear interpretations of key definitions to assure that our regulatory scheme better aligns with . . . the limitations under the First and Fifth Amendments.” Id. at 3.Continue Reading Less To This “Grant” Than Meets The Eye
Today the United States Supreme Court ruled in POM Wonderful v. Coca-Cola Co., No. 12-761, slip op. (U.S. June 12, 2014), that at least in food cases – where “the FDA does not preapprove [product] labels,” id. at 5 – the FDA’s food regulations do not preclude competitor lawsuits under another federal statute, the Lanham Act. The opinion (by Justice Kennedy) was unanimous.
We’re mostly interested in prescription medical products, and in preemption of state product liability litigation, so what does POM mean for our clients? Not a whole lot, at least directly. The Court made sure, right off the bat, to explain what POM was not. Here’s the second paragraph of the legal analysis portion (Part II) of POM:
First, this is not a pre-emption case. In pre-emption cases, the question is whether state law is pre-empted by a federal statute, or in some instances, a federal agency action. This case, however, concerns the alleged preclusion of a cause of action under one federal statute by the provisions of another federal statute. So the state-federal balance does not frame the inquiry. Because this is a preclusion case, any “presumption against pre-emption,” has no force.
POM, slip op. at 7 (citations omitted). So anybody worried that the Court would damage the preemption arguments of either side can rest easy. Nor is the status of the presumption against preemption changed.
Half our readership now clicks away.Continue Reading Breaking News: No FDCA Preclusion of Lanham Act Food Cases
One of us was recently on a conference call discussing possible federal rules amendments (no, not e-discovery), and concern was raised about federal judges making up new grounds for liability in cases based on state law, a problem that several speakers complained was particularly widespread in class actions.
We’ve seen that in drug/device cases as well, particularly but hardly exclusively in cases involving preemption, where judges run roughshod over state law in support of novel theories of liability. Most of the posts under our Erie Doctrine topic header concern this problem.
The consensus on the call was that, while a serious problem, judicial expansion of state tort law in diversity jurisdiction cases is a substantive issue ill-suited to solving by a federal rules change. But it occurs to us that it could be addressed by a federal statute, since Congress may legislate concerning the powers of the federal judiciary, to the extent that those powers are not set by the Constitution. The venerable Anti-Injunction Act, 28 U.S.C. §2283, is one example of such legislation that springs readily to mind.Continue Reading There Ought To Be A Law
This post was actually written by Steve McConnell who is currently on vacation in a little country that gave Jay Gatsby an award for military heroism. So where in the world is Stevie Mac?
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Any day now you might be getting your piece of the settlement proceeds in the Ticketmaster class action litigation, which has been banging around since 2003. The complaint alleged that the fee labels were misleading. Maybe everybody already suspected that the “convenience” fee (a misnomer if ever there was one) was a profit center, but the plaintiffs alleged that order processing and delivery fees were, too – that they had little to do with, er, order processing or delivery. The proposed settlement would offer roughly $400 million in credits to 50 million ticket buyers. But the defendant estimates that the settlement would cost it only $35 million, because of the low participation rate in class action settlements. Meanwhile, the plaintiff lawyers are seeking $15 million in fees, along with up to $1.5 million in expenses. The math speaks for itself.
The same day that we read about the Ticketmaster settlement, we read Judge Posner’s opinion that rejects – actually hammers – a proposed settlement of the Pella windows litigation. Posner called the settlement “scandalous,” pointing out plaintiff counsel’s conflicts of interest and challenging the valuation of the settlement. Judge Posner did some math on his own, and concluded that the purported $90 million settlement was more likely to be something on the order of $1 million. It is a judicial beat-down.Continue Reading Settling Down, part 2
Off-label use was a concept that it took some time to wrap our minds around as young drug and device lawyers. Manufacturers undertake extensive product development and clinical trials, and they spend months, sometime years developing FDA-approved drug labeling that sets forth the products’ uses and indications. Then physicians in their medical judgment decide to
The test for determining whether a state law claim is impliedly preempted is whether or not the claim would exist in the absence of the FDCA.
Rarely do we drug and device law bloggers read such a pleasing sentence. It’s lyrical. It reads like romance language. Well, at least to us it does. The opening
Breast implant litigation seems like ancient history. We are by no means young. Just trust us on this one. We remember when the Watergate hearings riveted America, when the space shuttle first flew, and when Milli Vanilli said they were better than the Beatles, but were later exposed as lip-syncing phonies. But for some reason
Here’s a guest post we received from Reed Smith’s Andrew Stillufsen about a discovery topic that afflicts drug/device defendants, as well as those representing any large corporate entity – the applicability of the attorney/client privilege to communications authored by in-house counsel. Andy describes a recent successful outcome in a case involving a large oil company, but for the underlying subject matter, the dispute could just as easily have arisen in drug/device litigation. As always, all the credit and/or blame for this post goes to the guest poster.
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In-house counsel everywhere, and those who rely on their advice, breathed a sigh of relief last month when the Fifth Circuit overturned a district court decision and found that a memo drafted by in-house counsel at the request of a business colleague in connection with a contract negotiation was in fact protected by the attorney-client privilege. This case serves not only as a validation of the role of in-house counsel in corporate transactions, but also is an important reminder of the importance of establishing the elements of the privilege on the face of a document, and thus be able to withstand even the most demanding court review.
In Exxon-Mobil Corp. v. Hill, ___ F.3d ___, 2014 WL 1796646 (5th Cir. May 6, 2014), the court was presented with a question that many courts grapple with every day: is a document drafted by an in-house lawyer a confidential communication for the purpose of providing legal advice, or merely a business communication that happened to be drafted by a lawyer? Since the answer was not apparent on the face of the document, the court was forced to take a deep dive into the context of the drafting of the memo, and fortunately found that, given this context, it was in fact privileged.
The document at issue, called the Stein Memo after its author, was created in a fairly typical manner. In the late 1980s Exxon was negotiating with another company over a contract to clean its oilfields and store the cleaned materials, which included substances contaminated by naturally occurring radioactive materials (“NORM”). A business person involved in the negotiations asked in-house counsel Stein for advice regarding how to respond to a request from the other company for some relevant test results. Stein’s advice, including which test results to disclose and proposed language to accompany the test results, was memorialized by her in the Stein Memo.Continue Reading Guest Post – Big News From The Big Easy: The Fifth Circuit Protects The Privilege For Communications Between In-House Counsel And Their Business Colleagues
As one of our other bloggers have recently revealed, Bexis recently went on vacation for two weeks. He was diligent, however, and pre-wrote two posts (not time sensitive) that appeared in his absence. As for the co-blogger’s quip about Bexis’ “active, muscular vacations” well, in this instance that’s probably right. For most of Bexis’ two-week absence, he was rafting through the Grand Canyon.
With Bexis otherwise occupied, the blog’s other denizens did an admirable job of keeping up with current developments in case law, but nonetheless items piled up in Bexis’ inbox awaiting his return. Most of them weren’t even judicial opinions. It’s time to empty that inbox.
Perhaps the most important development was the approval, on May 29, by the full Federal Judicial Conference’s Standing Committee on Rules of Practice and Procedure, of the discovery-related rules changes that we’ve been covering on the blog. Bexis has been heavily involved in this effort through the Lawyers for Civil Justice (“LCJ”), and LCJ sent him notice of the approval. We’d pass it along, except it includes internal LCJ business as well. So we’ll just hit the highlights.
First, there were no changes to the language of the proposed amendments themselves, which we have previously discussed. The only changes from the version published in the subcommittee’s agenda book were: (1) a new sentence in Note for Rule 26(b)(1) encouraging computer search technology (that is to say, predictive coding), and (2) modifying the Note for Rule 37(e) concerning the role of prejudice in subsection (e)(2). Thus, the main benefits of the amendments from our perspective remain: