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A lot of companies rely on retired and otherwise former employees for information in litigation – including product liability litigation. Particularly where a product (such as a drug that’s now gone generic) has a long history, they are often the best source of knowledge about what happened years ago.  In dealing with ex-employees, however, defendants must keep in mind that, for purposes of the attorney/client privilege, discussions with ex-employees are subject to being treated much differently (and less protectively) than corporate communications with current employees.

The recent case, Newman v. Highland School District No. 203, 381 P.3d 1188 (Wash. 2016), although not involving prescription medical products, or even product liability, is a cautionary tale.  The defendant in Newman was a governmental entity, a school district.  The plaintiff alleged that he suffered a brain injury playing high school football, and that the injury occurred because the plaintiff was allegedly allowed to play in a game the day after suffering a concussion in practice.

The plaintiff in Newman didn’t sue until some three years after the injury. Id. at 1189-90.  By then, most of the coaching staff had turned over, and the individuals with the best knowledge of what had happened were employed elsewhere.  The school district’s litigation counsel contacted the ex-coaches and when they were deposed, claimed to represent them.  Id. at 1190.  Plaintiff challenged that representation as a conflict of interest and “sought discovery concerning communications between [the defendant] and the former coaches.”  Id.  The defendant resisted discovery with a claim of attorney/client privilege, and plaintiff opposed.  The defendant lost, and appealed denial of its motion for a protective order.  Id.Continue Reading A Reminder To Be Careful With Ex-Employees And Confidential Information

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As drug and device lawyers we live in a comment k dominated world.  When we say comment k on this blog, everyone knows what we mean.  We aren’t talking about a scientific discovery regarding potassium.  We aren’t reviewing a new flavor of k-cup for the Keurig.  We aren’t posting about breakfast cereals.  And we definitely are not passing comment on the Kardashians, Kobe, Keanu, or K-Fed.

But just in case you need a refresher, here is the comment k that concerns us:

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts §402A, comment k (1965)  (emphasis added).  As you can see from the highlighted language, comment k recognizes that some products – drugs and medical devices in particular – are “unavoidably unsafe” and therefore not defective if properly prepared and accompanied by an adequate warning.  Most courts to have considered the issue have interpreted comment k to mean that manufacturers do not face strict liability for properly manufactured prescription drugs that are accompanied by adequate warnings.  That is true in Washington.  Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”).Continue Reading No Error With Comment k Jury Instruction

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We admit it.  We (and “we,” in this instance, should be read in the singular) are fans of certain social media, particularly the one that involves “posting” on a “wall” then sitting back and basking in the “likes.”  We tend to eschew any intellectually-challenging material that may be available on this medium.  Instead, when we are not ourselves posting pictures of the Drug and Device Law Rescue Pets, we most enjoy reading accounts of others’ rescues of doggies and kitties.  (Don’t start – we know.)   These stories always begin with horrific, heart-wrenching facts but generally wend their way to satisfying endings.

Today’s case, Taylor v. Intuitive Surgical, Inc., 2015 Wash. App. LEXIS 1442 (Ct. App. Wash. July 7, 2015), follows a similar formula, although the ending is happy only for “learned intermediary” jurisprudence, not for plaintiff’s unfortunate decedent.  Taylor involved the da Vinci System, manufactured by defendant Intuitive Surgical, Inc. (“ISI”).   The highly complex da Vinci system allows surgeons to perform minimally-invasive prostatectomies, remotely operating small instruments inserted through very small incisions in the patient’s body.  Taylor, 2015 Wash. App. LEXIS at *3.

Apparently, ISI tightly controls physician access to its system.  We are not sure how, but the opinion describes a specific credentialing process under which every surgeon is required to be credentialed, before using the da Vinci system, by the hospital where the procedure will be performed.  Each hospital sets its own credentialing protocol.  Surgeons must initially perform proctored cases – two, or a number set by hospital protocol.  Id. at *4-5.  Next, ISI requires surgeons to “choose simple cases for their first four to six unproctored procedures and to slowly progress in case complexity.”  Id. at *5 (internal punctuation and citation omitted).   During their early surgeries, “surgeons are advised to choose patients with . . . BMI of less than 30 and no prior history of lower abdominal surgery.”  Id. Continue Reading No Duty for Device Manufacturer to Provide Separate Warnings to Hospital, According to Washington Court of Appeals

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This just in, courtesy of Bruce Hamlin of Martin Bischoff, an intermediate appellate court in Washington State has rejected an attempt by plaintiffs to expand the duty to warn under the learned intermediary rule from the current “adequately warn a prescribing physician” standard to “warn every health care provider.”  Falsberg v. Glaxosmithkline, PLC,…

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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