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Get 40% Off – Bexis’ Book On Drug/Device Product Liability

admin — Fri, 18 Sep 2009 00:20:21 +0000

Last week we came through for our readers with a $200 discount to ACI’s Drug/Medical Device Conference.

This week, we’ve gotten Law Journal Press, the publisher of Bexis’ book – officially Beck & Vale, “Drug & Medical Device Product Liability Deskbook,” (LJP 2004) – to offer it to blog readers at a 40% discount. That’s a more than a $100 savings from its ordinary price of $259.

If you like heavily-cited posts like the Limits to Duty essay we put up yesterday, then you’ll love Bexis’s book. That post discussed the contents of about three footnotes from the book – and the book is more than 700 pages of the same kind of stuff. It covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated products, and it’s been updated twice a year ever since 2004 so that everything’s current (more work for Bexis).

Interested? If you’re involved in product liability litigation involving drugs and medical devices, you should be. To order Bexis’ book and save 40%, go to LawCatalog.com, and be sure to use promo code 2121663 at checkout to get your discount. It’s for blog readers only, and won’t be mentioned anywhere else.

druganddevicelaw.blogspot.com

Twombly/Iqbal And Product Liability, How Much Progress Is There?

admin — Thu, 06 Aug 2009 15:39:04 +0000

Earlier in the week we got tagged by Amlaw for one of our posts about how boilerplate design and manufacturing defect claims recently got dismissed under Twombly/Iqbal.

That’s cool. Amlaw drives a lot of traffic to little blogs like ours when it says “you’re it.”

But we were a little surprised by the attention given that post. We’ve been writing about applying Twombly/Iqbal pleading rules in our sandbox for some two years. We spotted the significance of Twombly itself – the case that started all that – a week after that decision came down back in 2007. We predicted then that Twombly would apply to pleading in all actions, almost two years before the Supreme Court removed all doubt on that score in Iqbal. We brought to you the first case that we found applying the Twombly pleading standard in a drug/device product liability case. That case was Heck v. American Medical Systems, Inc., 2008 WL 1990710 (D. Md. April 30, 2008), decided well over a year ago. And we’ve discussed a number of times, most recently here, about how Twombly/Iqbal doesn’t let plaintiffs get away with bare “defendant violated the FDCA” allegations any more. Even our critics seem to agreewith us about that kind of allegation being bad.

So the timing of the AmLaw tag leads to wonder – is this really big news? Haven’t there been a bunch of Twombly/Iqbal dismissals of vague (the new legal buzz word is “formulaic”) pleadings in other product liability cases before now? So we decided to find out. We’re taking the blinders off for the time being and looking for recent examples of product liability cases generally getting thrown out under the Supreme Court’s tightened pleading standards.

It’s not rocket science. The research is no more sophisticated than throwing “Twombly” and “Iqbal” (we’re glad both cases have relatively unusual names) in a Westlaw (allfeds) search along with “product liability” (with an after 2006 date restriction for good measure) and seeing what the computer spits out.

Here goes.

Ouch.

There’s 354 cases on Westlaw. Not all of them will be valid hits, of course. A lot of them won’t even be product liability cases. But that looks like a lot of work just to prove a point.

Still, that’s more than we thought. Simply on the basis of that number, we have to say that it’s the legal press that belatedly getting interested in the issue – not the courts and certainly not the lawyers.

Anyway, that size of a number means we’ll have to figure out how we want to do this. We’re going to try categorizing what we find by the type of claim that’s been dismissed. We’ll give cites and parentheticals if there’s anything particularly interesting.

As far as what we’re not doing. . . . Since we’re dealing only with Twombly/Iqbal dismissals here, we’re not getting into fraud or consumer fraud, since those claims are not governed by Rule 8 – what Twombly/Iqbal construes – by rather under the tougher Rule 9(b) standard requiring fraud to be pleaded with “particularity.” Nor are we getting into medical device cases where the dismissal is primarily based upon federal preemption, and only incidentally on pleading grounds. Those cases were covered last week in our preemption post.

Well, here goes:

Dismisssal of Everything

O’Neil v. Simplicity, Inc., ___ F.3d ___, 2009 WL 2168891 (8th Cir. July 22, 2009) (failure to allege physical injury); Watkins v. Safety-Kleen Systems, Inc., 2009 WL 2240556 (E.D. Ky. July 27, 2009) (product identification); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2009 WL 1921902 (D. Minn. July 1, 2009) (causation, injury); Whitson v. Bumbo, 2009 WL 1515597 (N.D. Cal. April 16, 2009) (failure to allege physical injury); In re Bausch & Lomb Inc., 2007 WL 3046682, at *7 (D.S.C. Oct. 11, 2007) (damages).

Product Liability Generally

Stearns v. Select Comfort Retail Corp., ___ F. Supp.2d ___, 2009 WL 1635931, at *3 (N.D. Cal. June 5, 2009) (damages); Sherman v. Stryker Corp., 2009 WL 2241664, at *5 (C.D. Cal. March 30, 2009) (product identification); Chappey v. Ineos USA LLC, 2009 WL 790194, at *5 (N.D. Ind. March 23, 2009) (product identification; manufacturer status); Markel American Insurance Co. v. Pacific Asian Enterprises, Inc., 2008 WL 2951277, at *6 (N.D. Cal. July 28, 2008) (numerous deficiencies); Heck v. American Medical Systems, Inc., 2008 WL 1990710, at *3 (D. Md. April 30, 2008) (numerous deficiencies); Taylor v. Shetler Lincoln Mercury Ltd., 2007 WL 4551935, at *4 (W.D. La. Dec. 18, 2007) (manufacturer status); Provencio v. Armor Holdings, Inc., 2007 WL 2814650, at *2 (E.D. Cal. Sept. 25, 2007) (numerous deficiencies).

Design Defect Claims

Lewis v. Abbott Laboratories, 2009 WL 2231701, at *4 (S.D.N.Y. July 24, 2009); Burks v. Abbott Laboratories, ___ F. Supp.2d ___, 2009 WL 2246740, at *7 (D. Minn. July 24, 2009); Frey v. Novartis Pharmaceuticals Corp., 2009 WL 2230471, at *7 (S.D. Ohio July 23, 2009).

Manufacturing Defect Claims

Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 283-84 (E.D.N.Y. 2009); Lewis v. Abbott Laboratories, 2009 WL 2231701, at *5 (S.D.N.Y. July 24, 2009); Burks v. Abbott Laboratories, ___ F. Supp.2d ___, 2009 WL 2246740, at *8 (D. Minn. July 24, 2009); Frey v. Novartis Pharmaceuticals Corp., 2009 WL 2230471, at *7 (S.D. Ohio July 23, 2009); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6-7 (D.N.J. March 5, 2009); Rice v. Kawasaki Heavy Industries, Ltd., 2008 WL 4646184, at *10 (E.D.N.Y. Oct. 17, 2008).

Warning Defect Claims

Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597, 608-09 (11th Cir. 2008) (failure to plead the label available to the doctor under the learned intermediary rule); Lewis v. Abbott Laboratories, 2009 WL 2231701, at *5 (S.D.N.Y. July 24, 2009) (inadequacy of warnings to doctors); Burks v. Abbott Laboratories, ___ F. Supp.2d ___, 2009 WL 2246740, at *9 (D. Minn. July 24, 2009) (against one of two defendants); McCracken v. Ford Motor Co., 588 F. Supp.2d 635, 642-43 (E.D. Pa. 2008).

Implied Warranty

Lewis v. Abbott Laboratories, 2009 WL 2231701, at *6 (S.D.N.Y. July 24, 2009); Stearns v. Select Comfort Retail Corp., ___ F. Supp.2d ___, 2009 WL 1635931, at *7 (N.D. Cal. June 5, 2009) (fitness for particular purpose); American International Insurance Co. v. Gastite, 2009 WL 1383277, at *3-4 (S.D. Ind. May 14, 2009); Great West Casualty Co. v. Volvo Trucks North America, Inc., 2009 WL 588432, at *5 (N.D. Ill. Feb. 13, 2009) (unconscionability); In re Saturn L-Series Timing Chain Products Liability Litigation, 2008 WL 4866604, at *13-14 (D. Neb. Nov. 7, 2008); Markel American Insurance Co. v. Pacific Asian Enterprises, Inc., 2008 WL 2951277, at *5-6 (N.D. Cal. July 28, 2008); Heck v. American Medical Systems, Inc., 2008 WL 1990710, at *3 (D. Md. April 30, 2008) (numerous deficiencies).

Express Warranty

Burks v. Abbott Laboratories, ___ F. Supp.2d ___, 2009 WL 2246740, at *10 (D. Minn. July 24, 2009); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009); In re FEMA Trailer Formaldehyde Products Liability Litigation, 2008 WL 5217594, at *10 (E.D. La. Dec. 12, 2008) (reliance); Simmons v. Stryker Corp., 2008 WL 4936982, at *1-2 (D.N.J. Nov. 17, 2008); Stearns v. Select Comfort Retail Corp., 2008 WL 4542967, at *4-5 (N.D. Cal. Oct. 1, 2008) (reliance, breach); Markel American Insurance Co. v. Pacific Asian Enterprises, Inc., 2008 WL 2951277, at *5-6 (N.D. Cal. July 28, 2008); Stratford v. SmithKline Beecham Corp., 2008 WL 2491965, at *7 (S.D. Ohio June 17, 2008); Parker v. Howmedica Osteonics Corp., 2008 WL 141628, at *6 (D.N.J. Jan. 14, 2008).

Negligence Generally

Bailey v. Janssen Pharmaceutica, Inc., 288 Fed. Appx. 597, 609 (11th Cir. 2008); Hagen v. U-Haul Co., 613 F. Supp.2d 986, 993-94, 999 (W.D. Tenn. 2009) (special relationship allowing a duty, product identification); McCracken v. Ford Motor Co., 588 F. Supp.2d 635, 643 (E.D. Pa. 2008) (duty, foreseeability); Adkins v. Cytyc Corp., 2008 WL 2680474, at *3 (W.D. Va. July 3, 2008) (sales rep duty; causation); Wolicki-Gables v. Arrow International, Inc., 2008 WL 2773721, at *2 (M.D. Fla. June 17, 2008) (product identification); Heck v. American Medical Systems, Inc., 2008 WL 1990710, at *3 (D. Md. April 30, 2008) (duty, breach).

Negligent Manufacturing

Gibbs Patrick Farms, Inc. v. Syngenta Seeds, Inc., 2008 WL 822522, at *6 (M.D. Ga. 2008).

Negligence Per Se

Chappey v. Ineos USA LLC, 2009 WL 790194, at *3 (N.D. Ind. March 23, 2009) (failure to specify violation).

Gross Negligence

Sykes v. Bayer Pharmaceuticals Corp., 548 F. Supp.2d 208, 217 (E.D. Va. 2008).

RICO

Southeast Laborers Health and Welfare Fund v. Bayer Corp., 2009 WL 2355747, at *3-12 (S.D. Fla. July 30, 2009) (predicate acts, pattern, causation, damages).

Miscellaneous

Lewis v. Abbott Laboratories, 2009 WL 2231701, at *7 (S.D.N.Y. July 24, 2009) (piercing corporate veil); Norfolk Southern Railway Co. v. Trinity Industries, Inc., 2009 WL 362437, at *8 (N.D. Tex. Feb. 13, 2009) (piercing corporate veil); Sprouse v. American Tire Distributors, Inc., 2009 WL 111601, at *2 (E.D. Va. Jan. 14, 2009) (negligent installation); McCracken v. Ford Motor Co., 588 F. Supp.2d 635, 644 (E.D. Pa. 2008) (intentional infliction of emotional distress); Tyco Safety Products Canada, Ltd. v. Abracon Corp., 2008 WL 4753728, at *2 (S.D. Fla. Oct. 28, 2008) (negligent misrepresentation).

So what do we conclude from all this?

First, the courts started applying the Twombly standard to dismiss “formulaicly” pleaded product liability litigation within weeks of the Supreme Court’s decision. Like us they immediately recognized that Twombly’s logic wasn’t limited to any particular type of case.

Second, the legal press didn’t pick up on pleading issues until recently – probably because of the publicity given to Sen. Specter’s legislative proposal. But lawyers and judges sure did.

Third, there’s precedent out there for dismissing virtually any product liability-related claim under Iqbal/Twombly – provided the complaint is vague enough.

Fourth, the pace and scope of Iqbal/Twombly dismissals in product liability cases is increasing.

Fifth, there seem to be a disproportionately large number of drug/device cases applying Iqbal/Twombly when compared to the universe of product liability. If we flatter ourselves, maybe our early and frequent advocacy helped bring that about. If we don’t, maybe we’ve just been harping on something that’s obvious to anybody.

Sixth, we weren’t as good as we thought. There were several Twombly dismissals in drug/device product liability cases before the Heck case that we proudly paraded around as the first of its kind.

Seventh, we really don’t want to look through 350 cases again – just to make a point.

druganddevicelaw.blogspot.com

Product Liability Comes To Thailand – Drug/Device Implications

admin — Mon, 16 Mar 2009 15:48:36 +0000

Our first ever overseas guest post comes all the way from Thailand, where
law firm reports on new Thai laws on product liability and their possible impact on/creation of product liability claims involving drugs and medical devices.
Needless to say neither Bexis nor Herrmann had anything to do with the substance of this post, as neither of them knows much about
beyond liking the food.
Take it away Doug.
Damage awards in Thailand for defective goods claims have traditionally been very low compared to the U.S., but two new laws aim to change or, at the very least, tighten this gap. On 21 February 2009, the Unsafe Product Liability Act, B.E. 2551 (the Product Liability Act) came into force. Six months earlier, in August of 2008, a procedural law which supports many of the new concepts introduced by the Product Liability Act, the Consumer Case Procedures Act, B.E. 2551 (the CCPA), came into force. These two laws, together, stand poised to materially change the tort law terrain of Thailand.
One issue of great significance to drug and device maker is that plaintiffs in Thailand will not carry the burden of proving a product is defective. Product liability laws in the U.S. and the EU dispense with the negligence requirement and impose strict liability once a product is established to be “defective”, but the plaintiff still carries the burden of proving that a product is, in fact, defective. Not so in Thailand.
Section 6 of the Thai Product Liability Act provides that the plaintiff only carries the burden of proving that damage was caused by a product in “ordinary use or storage”. Once a plaintiff makes this bare minimum showing, the burden shifts to “business operators” (a defined term, but for purposes of this discussion, suffice to say that it clearly covers drug and device manufacturer) to prove the product was “not unsafe”. Stated more directly without the diplomatic double negative, business operators carry the burden of proving a product was safe if an injury occurs from that product.
This is an intentional feature of the new legal terrain created by the Product Liability Act and the CCPA. The CCPA and the Product Liability were passed at the same time by the same appointed legislative body (although the Product Liability Act did not come into force until six months later), and the CCPA contains an evidentiary burden provision which dovetails with and reinforces Section 6 of the Product Liability Act. Section 29 of the CCPA provides that if the Court believes that facts relating to “production, assembly, design or mixtures of the goods, the provision of services or other undertakings” are exclusively known by a business operator, that business operator carries the burden of proof relating to such matters. The Product Liability Act expressly recognizes design defects, meaning that a drug or device manufacturer carries the burden of proving that the design of a medical device or the formulae of a drug is safe when a product liability case is filed in a Thai Court.
The Product Liability Act is a thin law – consisting of 16 clauses and about four pages of text – and in some ways the issues it does not address may be more significant than those that are addressed. There is, for example, no test or stated principle for determining what constitutes a defective product (e.g., the reasonable consumer test, the risk utility test) and in a civil law system where the burden is on the manufacturer to prove a product is a safe, this could be problematic, particularly for drug and medical device makers. Nor does the Act mention the learned intermediary rule.
Although drugs and medical devices have indisputably improved the quality of our lives immensely, they can also cause very real injuries. In Thailand, this means that every time a consumer suffers an injury – perhaps, say, from a drug that otherwise saves millions of lives – she or he will have a potential product liability claim against the manufacturer of that drug or device. And more important, drug and device makers will carry the burden proving that a formula or design was safe. Complicating matters further, the law sets no standards or even provides any guidance on what constitutes a safe design. And because the principle of ratio decidendi does not exist under Thai law, even Thai Supreme Court decisions may not be able to fill this gap.
If a business operator fails to convince a Thai court that the formula of a drug or the design of a device was safe, that determination can be used against the manufacturer in future cases by other plaintiffs pursuant to CCPA Section 30. Section 30 permits factual findings against a defendant in one case to be used against that same defendant in another case. Once the design of a drug or device is found to be defective in one case, it could be used against that same manufacturer by other plaintiffs in other cases. For Thai law, which also doesn’t have a concept of stare decisis (or class actions), this is a major change. And these findings only cut one way – new plaintiffs are not bound by prior findings that the product was safe. This means that every time a design defect claim is filed, manufacturers must aggressively defend that design lest one court decides the design was defective. A finding by one court that the formulae of a drug or the design of a medical device is defective opens up the maker of that drug or device to claims by every person who claims to have been injured by the drug or device.
The CCPA also permits Thai Courts to issue orders requiring business operators to make announcements about and recall unsafe products. These are essentially mandatory injunctions, and because it is generally difficult to procure injunctions of any kind in Thailand (including prohibitory ones enforcing intellectual property rights), it is unclear how the courts will exercise this specific grant of power in practice.
These problems have not gone unnoticed. A proposal to exempt drugs, medical devices and medical professionals from these laws has been put forward. You may be wondering why it includes the medical profession. While the Product Liability Act only applies to products (drugs and devices), the CCPA extends to “services”, including the services rendered by physicians, and it contains many provisions very similar to the Product Liability Act.
Moreover, although the CCPA is not yet six months old, it has been employed very effectively in a number of cases and garnered popular support in a country not well known for US or EU safety standards. For example, an airline passenger used the CCPA to recover emotional distress damages when an airline failed to use a metal detector to screen airline passengers. The metal detector was apparently “on loan” to a local university. (Don’t ask – it doesn’t make sense to us either.) A lawyer plaintiff is now using the CCPA in a high profile case where a fire on New Year’s Eve at a popular Bangkok nightclub fire claimed 66 lives. The lawsuit essentially claims the pub was a fire trap and seeks recovery directly against 33 directors and owners of the pub. This latter aspect of this case is significant because of the alleged identity of some of those owners (say, a high official in an organization responsible for policing the pub) and because the CCPA contains a provision allowing claimants to pierce the corporate veil, something that is otherwise virtually impossible to do in Thailand. All of this, of course, has little to do with medical drugs or devices, but it does help explain the popularity of these new laws, and why proposals, at least at this time, to reduce their scope or exempt certain products might not receive a warm reception in the Land of Smiles.

druganddevicelaw.blogspot.com

Your Humble Scribes On Levine In BNA Product Safety Reporter

admin — Mon, 16 Mar 2009 12:32:26 +0000

is a Counsel resident in the Philadelphia office of Dechert LLP. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He can be reached at james.beck@dechert.com.
is a partner resident in the Chicago office of Jones Day. He is the author of, among other things,
(2006), and Statewide Coordinated Proceedings: State Court Analogues to the Federal MDL Process (2d rev. ed. 2004) (with Geoff Ritts and Katherine Larson). He can be reached at mherrmann@jonesday.com.

druganddevicelaw.blogspot.com