In a first for the DDLaw Blog, we’re an official “Media Partner” for the American Conference Institute’s 19th Annual Drug & Medical Device Litigation Conference, to be held December 8-10, in New York City.
That means we’re going to be there – and you can be too. More cheaply than usual, it turns out. Anybody
Those of us whose childhood had low tech play options and at least a touch of OCD recall playing with dominoes. Not whatever the game is where the number of dots on a tile matters, which we understand exists from witnessing it in screen classics like “Boyz n the Hood.” No, we mean the activity where you line up a series of dominoes in a sequence where tipping over the first one will cause a chain reaction where many or all fall over. If you were really motivated or bored, then the arrangement of dominoes might have included the construction of elaborate stairs, towers, or catapults or tiles falling off of tables to start new chains. There is probably some app for this now.
The decision in Grabowski v. Smith & Nephew, Inc., No. 14-433, 2014 La. App. LEXIS 2367 (La. Ct. App. Oct. 1, 2014), reminds us of dominoes. (We do try to have our non-legal introductions have something to do with our purported point.) The case was really a detour from what looked like a medical malpractice action against a surgeon who performed a knee replacement with an insert that was too small for the tray he used. The details of the two part implant system are not terribly important here, but the sizing of the insert and tray should match up. The surgeon blamed the sizing error on the sales rep present at the implant after learning about it from another rep at a revision surgery three months later. Skipping over some procedural parts and a whole section of the decision about a motion to recuse the judge—arrangements of dominoes sometimes have dead ends on purpose—plaintiff sued the original rep, the distributor with whom he had a contract at the time of the implant surgery, and the manufacturer of the implant with whom he used to have a contract. The defendants eventually moved for and were granted summary judgment.
The basic idea was the rep was not liable for negligence because the duty of providing medical care to the patient—including using the right size of any medical device—rested solely with the surgeon. In addition, the distributor was not liable for acts or omissions of someone who was its independent contractor and the manufacturer was not liable for someone with whom it had no direct contractual relationship. On appeal, all the tiles fell to bring the deep pockets back into the case. (We cannot tell what happened in terms of litigation between the plaintiff and the surgeon.)Continue Reading Louisiana Liability For A Sales Representative’s Sizing Error
A federal court recently placed Colorado amongst the states that apply Restatement (Third) of Torts §6(c) in design defect cases. That’s a good place to be when you’re defending a medical device company. Section 6(c) creates a tougher burden for design defect plaintiffs than does Restatement (Second) of Torts. Showing a safer alternative design isn’t enough. And that’s important, because there are often alternative designs for medical devices. Section §6(c) instead focuses on prescribing doctors and their risk-benefit analysis:
A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.
Restatement (Third) of Torts § 6(c). In short, if a reasonable doctor would choose to use the device for any class of patients, knowing the risks, it is not defectively designed – regardless of whether there might be an alternative design.
The facts of the Colorado case, Haffner v. Stryker Corp., No 2014 U.S. Dist. LEXIS 137214 (D. Col. Sep. 29, 2014), show how this can work. The plaintiff had knee replacement surgery, but later needed revision surgery. He was allergic to the cobalt and nickel contained in the knee replacement system. So he sued, claiming, amongst other things, that the system was defectively designed. Id. at *1, 2, 7.Continue Reading A Colorado Federal Court Adopts Restatement (Third) of Torts Section 6(c)
This is actually a post from Reed Smith’s Rachel Weil. While this is not her first post, she is still a mere “guest poster” at this point and takes sole responsibility for the content of her posts. We have allowed her to use first person plural pronouns, though.
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On this unseasonably warm day where we are, as we lament the passage of another summer and the demise of its bounty of strawberries, blackberries and peaches, we rejoice that a recent trip to our local grocery uber-chain revealed a silver lining in the return of perfect clementines. Clementines, those
Lilliputian cousins of the tangerine, represent nature’s engineering at its best. Easily accessible, their perfect sections are joined in a seamless whole, uniformly sweet and unmarred by “bad spots” or detritus.
Such are the attributes of a tidy little decision out of the Ortho Evra® MDL. (We have blogged about other Ortho Evra® decisions, like here and here, for example, but this is the first that was postured in a fashion that facilitated total victory for the defendants in one shot. Today’s breaking news post, also comes from the Ortho Evra® MDL.) In Giffen v. Ortho McNeil Pharmaceutical, Inc., No. 3:12 oe 40001, 2014 U.S. Dist. LEXIS 136587 (N.D. Ohio. Sept. 26, 2014), Plaintiff was given samples of the Ortho Evra® birth control patch and used them for one month. Alleging that the patch caused her to suffer a stroke, Plaintiff asserted the standard failure to warn, negligence, design defect, and warranty claims, along with a litany of fraud-based claims. Defendants
moved in the alternative (wisely, as you will see) for judgment on the pleadings or for summary judgment on all of the Plaintiff’s claims. Id. at *1-2.Continue Reading A Juicy Little Decision
For over seven years, we’ve been following the odd little romance that the other side of the “v.” has been having with purported federal preemption of state litigation practices that allow our side to conduct voluntary, informal interviews with treating physicians – since our “HIPAA Does Not Preempt State Litigation Practice” post back in DDLaw’s formative Beck/Herrmann days. To put our position in one sentence, since HIPAA has an explicit exception for litigation (45 C.F.R. §164.512(e)), HIPAA has no preemptive effect on state law that accords both sides the same right to talk to treating physicians informally.
We cheered when the New York Court of Appeals got it right and hissed when a Missouri intermediate appellate court got it wrong. Well, we’re cheering again, and we like that better.
Last Friday the Eleventh Circuit decided Murphy v. Dulay, ___ F.3d ___, 2014 WL 5072710 (11th Cir. Oct 10, 2014), and rejected a HIPAA challenge to a Florida statute allowing – indeed effectively routinizing (if the doctor is willing) – informal treater interviews. Murphy isn’t going to help our clients directly, since the statute in question applies only to medical malpractice cases, and general Florida law, according to our 50-state survey of informal interview law is adverse. Still, precedent is precedent, and a federal appellate court rejecting bogus HIPAA preemption arguments should be rather persuasive, as well as fun to blog about.Continue Reading No, HIPAA Does Not Preempt Informal Treater Interviews
This post is from the non-Reed Smith side of the blog only.
It’s been a while since we’ve seen a legal reference to Scylla and Charybdis, the sea monsters of Greek myth who posed an intractable dilemma to all sailors who attempted to navigate between the two. It is a tried and true metaphor, like its modern English counterpart — between a rock and a hard place. But it is particularly fitting in products cases dealing with pre-market approved medical devices. So, even though it is another favorable InFuse decision and we probably would have blogged about it anyway, the court’s clever turn of phrase was enough to reel us in:Continue Reading The Scylla and Charybdis of PMA Preemption
The Ninth Circuit’s opinion in PhRMA v. County of Alameda, No. 13 16833, 2014 WL 4814407 (9th Cir. Sept. 30, 2014), is a triumph of petty local politics over sound public policy. At issue is an ordinance enacted in Alameda County, California, that requires drug manufacturers worldwide to fund a local “stewardship program” under which Alameda County’s residents can dispose of their unused drugs. See Alameda Health and Safety Code §§ 6.53.010 et seq. We support the safe and proper disposal of pharmaceutical products, but this targeted tax on drug companies is remarkably ill conceived.
Under the ordinance, any drug manufacturer in the world whose products find their way into Alameda County—in whatever quantity and by whatever means—has to set up “disposal kiosks” throughout the county for the collection of unused drugs. Not just its own drugs; any company’s drugs. The kiosks must be “convenient and adequate to serve the needs of Alameda County residents,” and manufacturers have to promote the “stewardship program” to the public via “educational and outreach materials.” After drugs are collected in the kiosks, manufacturers are responsible for disposing of the products at medical waste facilities. Id. at *1.
There are additional strings attached, and here is where it gets interesting. The ordinance prohibits manufacturers from implementing any fee to recoup the cost of the “stewardship program,” either at the time the drugs are sold in Alameda County or when the drugs are collected for disposal. The ordinance also exempts local pharmacies from any responsibility for collecting and disposing of unused drugs. This is true even though local pharmacies are most directly connected to the purchase of drugs within the county and are in the best position to spread the cost of collection and disposal among the consumers who actually purchase, use, and dispose of the products. (It may be that county lawmakers were motivated to exempt pharmacies because more than one large pharmacy chain has a world headquarters in Alameda County, but we are speculating.)Continue Reading Local Drug Disposal Tax Should Go Down The Drain
Back in February, we hosted a guest post about United States ex rel. Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014), an extremely important False Claims Act (“FCA”) decision for the defense-side’s effort to prevent the FCA from being converted into an improper private enforcement mechanism for the FDCA.
Here’s a much briefer guest post (see our original one for details of the original decision) from Reed Smith partner Colin Wrabley (a member of the victorious team), putting this latest development in context. As always our guest posters get all the credit (and any blame) for their work.Continue Reading Another Guest Post on Rostholder FCA Developments
We’ve always been of the opinion that the rationale for preemption in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), concerning: (1) the FDA’s exclusive enforcement power, and (2) the adverse effects that common-law second-guessing of the sufficiency of submissions to the FDA would have on the Agency’s ability to do its job, should have impact well beyond cases labeled “fraud on the FDA.” In particular, we’ve pointed out “embedded” fraud on the FDA claims of various sorts, including where plaintiffs seek to introduce fraud on the FDA evidence to support some other sort of claim and were stopped cold by preemption.
Here’s another one, In re Incretin Mimetics Products Liability Litigation, 2014 WL 4987877 (S.D. Cal. Oct. 6, 2014). Incretin involved an MDL discovery dispute – plaintiffs sought “to compel production of adverse event source documents and databases” relating to the product in question. Id. at *1. Their excuse for being entitled to rummage through all of the defendant’s adverse event reporting was “all of the source documents underlying the adverse event reports are necessary to determine whether Defendants misreported or under-reported information to the FDA.” Id.Continue Reading Buckman Preempts Adverse Event Fishing Expedition