April 25, 2017, Inside Medical Devices

Last week, in its opinion in Rembrandt Wireless Technologies, LP v. Samsung Electronics Co., Ltd., the Federal Circuit resolved one question about patent marking under 35 U.S.C. § 287 but left another open—whether the marking statute applies on a claim-by-claim or patent-by-patent basis. The case stemmed from a jury verdict in the Eastern District of...… ...

August 29, 2016, Inside Medical Devices

Earlier this month in ScriptPro LLC v. Innovation Associates, Inc., the Federal Circuit overturned a district court’s grant of summary judgment based on a lack of written description under 35 U.S.C. § 112. The device patent at issue, ScriptPro’s U.S. Patent No. 6,910,601 (“the’601 patent”), “is directed to a ‘collating unit’ used with a control...… Continue ...

May 27, 2016, Inside Medical Devices

Earlier this month, the United States Patent and Trademark Office (“PTO”) issued an update to its Interim Guidance on patent subject matter eligibility under 35 U.S.C. § 101. The May 2016 update is the latest in a series of guidance documents regarding subject matter eligibility issued by the PTO over the past two years.  It...… Continue Reading

January 15, 2015, Inside Medical Devices

Discussion of the applicability of preemption doctrine in medical device product liability cases usually centers on two types of devices: (1) Class III medical devices approved pursuant to FDA’s premarket approval process, and (2) devices cleared through the less rigorous 510(k) process. A recent case reminds us of a different pathway to approval, which ...

October 28, 2014, Inside Medical Devices

Johnson & Johnson secured a sweeping victory last week in the first bellwether trial in the multidistrict litigation relating to DePuy’s Pinnacle system metal-on-metal hip implant device.  The plaintiff argued that the components of the device could grind together causing pain, swelling, and the introduction of toxic metal fragments into the bloodstream, and ...

September 22, 2014, Inside Medical Devices

Last week, a state court jury in Dallas awarded the plaintiffs in a pelvic mesh device litigation against Boston Scientific approximately $23.5 million in compensatory damages and $50 million in punitive damages. In the bellwether case, Salazar v. Lopez, plaintiffs Martha Salazar and her husband Felix Salazar sued Boston Scientific alleging she was injured ...

April 14, 2014, Inside Medical Devices

A decision by a federal district court in Allen v. Bayer Healthcare Pharms., Inc., 2014 WL 655585 (E.D. Missouri Feb. 20, 2014), demonstrates key complexities in a common strategy used by device companies in product liability lawsuits — removing the case from state to federal court.  In the case, twenty-five plaintiffs from eleven states (including Delaware)...… ...

February 7, 2014, Inside Medical Devices

As we have previously discussed, removal of a medical device case to federal court can be an important strategic advantage for a defendant manufacturer.  Even when proper diversity jurisdiction exists, there are several restrictions that limit a defendant’s ability to remove a case to federal court.  One such limitation, set forth in 28 U.S.C. §...… Continue ...

January 30, 2014, Inside Medical Devices

When medical device companies are faced with product liability lawsuits, often one of the most critical issues is whether the court will permit expert testimony on key issues, such as whether the device caused the alleged injury.  While the Daubert standard, which governs the admission of expert testimony in federal courts, has been adopted by...… Continue ...

November 21, 2013, Inside Medical Devices

We frequently post about developments in medical device preemption.  Preemption doctrine is a key issue in medical device product liability cases, and often a powerful tool for medical device manufacturers defending product liability claims.  As a general matter, under preemption doctrine, devices approved by a premarket approval application (PMA) are exempt ...

July/August 2011, Food & Drink Magazine