We commented on the Obama Administration’s anti-preemption search and destroy mission at the time, back in 2009. To recap, a presidential memorandum directed all federal administrative agencies to seek out, identify, and correct any “unjustified” statements about preemption that took place during the prior ten years (read: during the Bush administration). The FDA was, of
JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee. He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee. He can be reached at jmbeck@reedsmith.com. His LinkedIn page is here.
Alien Tort Claim Certiorari Grant
Back in 2009, we named an Alien Tort Claim case, Abdullahi v. Pfizer, 562 F.3d 163 (2d Cir. 2009), to our “bottom ten” list of the worst cases of the year. We were offended that any court would allow a pharmaceutical company to be prosecuted for irregularities in overseas clinical trials under a law…
TwIqbal, And Moore
We found the decision in Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), interesting for at least three reasons. First of all, it’s another TwIqbal dismissal, so it goes on our TwIqbal cheat sheet.
But what’s even more interesting is precisely what the plaintiff wasn’t able to plead. …
Interesting E-Discovery Developments
The program at a Product Liability Advisory Council, Inc. (“PLAC”) meeting are always interesting, and the one just before Columbus Day was no exception. It focused on social media and e-discovery. Here are some highlights:
“Patent” Model Order on E-Discovery
Everybody knows the expense of e-discovery in modern litigation is out of control. Well, it’s just as much a problem in patent cases as in mass torts, but at least the patent bench and bar are taking concrete steps to do something about it. The Advisory Council for the Federal Circuit created a special subcommittee with the sole aim of creating a model court order to govern e-discovery. Here’s a copy of the model order, which the special committee unanimously endorsed.
The model order was introduced a couple of weeks ago by Chief Judge Rader of Federal Circuit, at a Texas judicial conference. For those interested in a more complete discussion, here’s a copy of Judge Rader’s talk (it’s nominally about patent litigation, but mostly about e-discovery). This order has features that we’re certain could be usefully applied to e-discovery in all types of litigation, especially mass torts. Specifically, the model order provides:
- “Disproportionate” e-discovery requests are grounds for cost shifting.
- Absent “good cause,” metadata (all that stuff lurking in the background of most electronic documents) is not discoverable – period.
- Discoverable background information about a document is limited to when it was sent/received and the distribution list.
- No more “general” demands for production of email.
- Production of email is limited to “specific issues” that must be separately stated in any request.
- Email production is to be “phased,” and may only take place after exchange of “initial disclosures” and “basic documentation.” A mass tort case would similarly tie email production to specific claimed defects or acts of negligence.
- No blanket email production. Specific custodians, search terms, and time frames must be stated to limit the scope of production.
- Unless the parties agree, email requests are presumptively limited to five custodians per producing party and five search terms per custodian.
- With leave of court, email production of an additional five custodians per producing party and five more search terms per custodian may be had. Anything more than that, and the requesting party must pay for the extra e-discovery itself.
- Limits on overbroad search terms are imposed, and enforced by cost-shifting.
- Privileged e-discovery cannot be used by the requesting party.
- There is no waiver of privilege by the inadvertent production of e-discovery
- “Mere production” of e-discovery as part of a “mass production” is not a waiver for “any purpose.”
We think this model order, and particularly its hard caps, an excellent start to taming the e-discovery monster, which Chief Judge Rader said in his talk “endanger[s] the entire system” and had become “such a burden” that “outweigh[s] any benefit.” The basic foundations of the model order: (1) hard numerical limits; (2) specificity of requests, and (3) cost-shifting for “disproportionate” e-discovery demands, are universal. Since the problems with e-discovery extend far beyond patent cases, we recommend the model order, with minor subject-matter-specific modifications, for use in any litigation, and especially mass torts.Continue Reading Interesting E-Discovery Developments
Aspartame Assessment Of E-Discovery Costs Largely Affirmed
Last August we posted about a notable clerk’s order in the Eastern District of Pennsylvania that taxed, as costs, several hundred thousand dollar’s worth of e-discovery expenses against the losing party in an antitrust case.
We thought that was notable because, in prescription medical product liability litigation, our clients’ e-discovery costs are typically orders of magnitude greater than anything the other side has to spend. Thus, when it comes to taxing e-discovery as costs that the prevailing party can recover, we’re probably going to have lots more costs to tax than does the other side when they win.
Anyway, we’re now able to report that the clerk’s opinion has been largely affirmed by the District Court, which strengthens the precedential value of the taxation order immeasurably. See In re Aspartame Antitrust Litigation, No. 2:06-cv-01732-LDD, slip op. (E.D. Pa. Oct. 5, 2011).
The clerk awarded the three prevailing defendants some $565,000 in e-discovery costs, on the basis of a “heavy presumption” in favor of taxation of costs generally against the loser. The District Court (Davis, J.) affirmed about 90% of the clerk’s award. The affirmance contains a useful discussion of the current split of authority about the taxability of e-discovery costs, and what particular e-discovery expenses are properly taxable. Aspartame, slip op. at 3-6 (collecting cases). Siding with the opinions that support taxation of e-discovery costs, the court emphasized that all parties benefited from various efficiencies and savings arising from the availability of e-discovery, and significantly the court applied the same burden of proof in e-discovery as in other types of cost taxation. Id. at 2-3.Continue Reading Aspartame Assessment Of E-Discovery Costs Largely Affirmed
Recent HT Wins Worth Knowing About
As much as we like blogging, first and foremost we’re lawyers who represent clients in court. Our clients tell us how much we can say about litigation we’re involved in, and when they say “not much,” that’s what we do. If that has the odd effect that we’re sometimes more effusive about other lawyer’s wins…
Twice Nice?
Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues. Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses. We also felt that way while we were involved in the Fagan v. AmerisourceBergen litigation involving the then novel concept of liability of non-counterfeiters for injuries caused by counterfeit drugs.
We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way. We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.
Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field. The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling. 2011 WL 4470701, at *3. Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use: the reprocessing and reuse of products whose labeling is limited to single use. Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices). After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart. Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own). Plaintiff sued both the aftermarket and original equipment manufacturers.
The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.Continue Reading Twice Nice?
Successful Class II Medical Device Preemption Decision
We don’t see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it’s a big deal. Here’s one. Today, in Degelmann v. Advanced Medical Optics, Inc., No. 10-15222, slip op. (9th Cir. Sept. 28, 2011), the…
Cross-Fertilization
With our focus on prescription drug and medical device product liability litigation, we sometimes overlook developments that occur outside the boundaries of our own little sandbox. While that’s necessary to restrict the blog’s scope to something manageable, nonetheless it’s somewhat artificial. Drug and device law doesn’t exist in some kind of vacuum, cut off from the rest of tort law. What we do here sometimes affects other types of cases, and what goes on in other types of cases certainly can have significant impact on our clients.
One of the other things that Bexis does around here to make himself useful is to prepare monthly memoranda that summarize newly decided cases involving Pennsylvania tort and product liability law generally (he’s a glutton for punishment). In that capacity, he came across Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 3740472 (E.D. Pa. Aug. 25, 2011), which on its face has nothing to do with prescription drugs or devices. Instead, it has to do with injury allegedly suffered from a child car seat.
The accident apparently happened when, for unknown reasons, the child’s mother plowed her minivan headlong into a tree. The father originally brought the suit, but also for unknown reasons – possibly due to the parents’ questionable actions – a bank ended up as guardian ad litem. See Pennsylvania Trust Co. v. Dorel Juvenile Group, Inc., 2011 WL 2789336 (E.D. Pa. July 18, 2011) (parents sanctioned for recklessly spoliating the product); Waltman v. Dorel Juvenile Group, Inc., 2009 WL 2877153 (E.D. Pa. Aug. 28, 2009) (parents entered into secret release, and then hid it during discovery).
The Dorel opinion at No. 3740472 addressed with a plethora of “in limine” (that means evidentiary matters presented before trial) motions. We’re old enough to remember when in limine motions were thought of as unusual; but they’ve propagated faster than rabbits since we’ve been practicing – but back to the point.Continue Reading Cross-Fertilization
The New One-Two
As you can tell from our old drug preemption cheat sheet (before we split off generic preemption after Mensing), the Smith/Morris/Wilson trilogy out of Kentucky has been hanging fire for quite awhile, since before Levine, actually. No longer. Today the Sixth Circuit ruled and delivered a one-two punch that’s…