We call it the Iron Triangle—that confluence of plaintiffs’ counsel and activists, government and media producing a steady, sensationalist stream of messaging that often culminates in the mass litigation that keeps industry GCs awake at night.

Shook, Hardy & Bacon attorneys are well-positioned to assist companies face their governmental compliance obligations, take a hard look at risk mitigation and develop cost-effective solutions to the challenges of complex litigation in this environment. We make ‎it our mission to protect our clients’ reputation and bottom line, and we have been trusted to represent companies in this sector for 40 years.

Global Counsel, in its “Life Sciences Industry Report,” said that Shook is “universally acknowledged as having the premier U.S. industry practice in this area” with “almost unrivaled experience in drug and device issues.”

Representative Matters

Shook serves as national counsel in litigation involving Boston Scientific Corp.’s pelvic mesh products that are designed to treat stress urinary incontinence and pelvic organ prolapse.  This litigation currently involves an MDL in West Virginia and consolidated proceedings in Massachusetts.  In Cardenas v. Boston Scientific Corp., a Shook team obtained a defense verdict in August 2014, in the second bellwether pelvic mesh device trial.  A Massachusetts jury cleared the company of all liability involving the Obtryx-brand sling following two days of deliberation and a two-week trial.  Finding that the device was not defectively designed and that the company provided adequate warnings, this latest verdict was Shook’s second favorable result for Boston Scientific.  In July 2014, a Middlesex County jury found in Boston Scientific’s favor at a trial involving its Pinnacle Pelvic Floor Repair Kit device. Albright v. Boston Scientific Corp.  This was the first defense verdict achieved for any defendant in pelvic mesh suits. 

Shook serves as national counsel in litigation involving Covidien PLC’s pelvic mesh products.  This litigation currently involves more than 8,000 plaintiffs with an MDL in West Virginia and consolidated proceedings in Massachusetts. 

Shook attorneys serve as national counsel in litigation relating to the 2006 recall of ReNu® with MoistureLoc® contact lens solution which was purportedly linked to an alleged increased incidence of Fusarium keratitis.  This litigation has involved approximately 1,300 cases with an MDL in South Carolina and consolidated proceedings in New York.  Following extensive briefing and a three-day joint Frye/Daubert hearing, Justice Kornreich (New York Coordinated Proceedings) and U.S. District Court Judge Norton each issued rulings in favor of Bausch & Lomb.  In August 2012, Bausch & Lomb, Inc. moved for summary judgment as to all remaining non-Fusarium cases in the New York litigation (pending).  This case is currently on appeal in the New York Coordinated Proceedings.

Affirming two lower court rulings on behalf of a firm client, the Washington Supreme Court rejected a plaintiff’s attempts to expand a pharmaceutical manufacturer’s duty to warn under state law to all treating health-care providers instead of the prescribing physician alone and to require, as part of the duty to warn of a potential adverse event, that product labeling not only identify the medication’s potential side effects, but inform physicians on how to diagnose and treat the condition.  The Washington courts soundly rejected these unwarranted expansions of state law.  The plaintiff had sought to recover for injuries he allegedly sustained from using a medication made by Shook’s client.  On its behalf, the firm’s attorneys argued that the label was adequate as a matter of law, because it specifically warned prescribing physicians of the precise injury alleged.  The trial court granted its summary-judgment motion six weeks before trial was set to begin.