The FDA and Medical Devices Effective Use of FDA Evidence And 510(k) Clearance Data In Medical Device Product Liability Litigation ABA Section of Litigation Regional CLE Workshop Philadelphia, PA November 4, 2016

Our Panel: Carrie Watt Teleflex Incorporated Marta L. Villarraga Wayne, PA Marta L. Villarraga Exponent, Inc. Philadelphia, PA Michael Anderton Tucker Ellis LLP Cleveland, OH Moderator: Robert R. Simpson Shipman & Goodwin LLP Hartford, CT

Yes or No? Will FBI Director Comey share any further information about the emails recovered during the Anthony Weiner/Huma Abedin investigation? Yes No

Choose One: Who will have the most significant impact on medical device litigation in the next four years? Donald Trump Hillary Clinton Notorious RBG (Justice Ruth Bader Ginsberg) ABA Section of Litigation

True or False? 510(k) is considered a loophole/rubber stamp by some to get a medical device to market without adequate testing. True False

True or False? 510(k) is the most often used regulatory pathway to get medical devices to the market. True False

True or False? Regulatory evidence is always admissible in medical device cases because it forms the framework for devices being cleared or approved. True False

True or False? A sound trial strategy is a game plan that assumes regulatory evidence being admitted. True False

True or False? There is no in vivo testing through the 510(k) process.

The 510(k) Framework

510(k) v. Pre Market Approval (PMA)

510(k) v. Pre Market Approval (PMA) Premarket Notification 510(k) Premarket Approval PMA New device is substantially equivalent to a legally marketed device that does not require a PMA Evidence (usually clinical data) providing reasonable assurance that new device is safe and effective Less stringent – clinical data is not required Most stringent type of premarket review Faster FDA decision Slower FDA decision Standard Fee: $4,690 (FY2017) Standard Fee: $234,495 (FY 2017) FDA Clearance FDA Approval

Choose One: How often do you believe that there is internal tension on whether a product should proceed through 510(k) v. PMA? < 25% of the time 25-50% of the time 51-75% of the time >75% of the time

510(k) Testing

Yes or No? Do you ever have in vivo human or animal testing as part of the 510(k) Application?

Testing as part of the 510(k) What is required? Can in vivo human or animal testing be part of the 510(k) submission?

Hypothetical Trump Women's Healthcare wants to introduce a new medical device to the market, the HRC. The company debates whether to do a line extension, seek 510(k) clearance, or secure approval through a PMA. Trump WHC performs 100 tests on HRC. Seventy of the tests show significant superior performance over the predicate device. Fifteen tests show that the device performs at the same level as the predicated device. Fifteen tests also show that the device performs inferior to the predicate device. Trump WHC decides to seek 510 (k) clearance from the FDA. The FDA gives Trump the clearance to market and sell HRC. Four years after the sale of HRC, the product is the subject of an MDL.

510(k) Safety Risk or Safe and Effective?

Safety Risk The 510(k) “pathway does not consider safety and effectiveness…” Brent M. Ardaugh et al., The 510(k) Ancestry of a Metal-on-Metal Hip Implant, 368(2) N. Engl. J. Med. 97 (2013).

“Because of this loophole, companies that market these devices are often legally able to obtain clearance without demonstrating safety and effectiveness through clinical studies….” Brent M. Ardaugh et al., The 510(k) Ancestry of a Metal-on-Metal Hip Implant, 368(2) N. Engl. J. Med. 97 (2013).

In re Zimmer Nexgen Knee Implant Prods. Liab. Litig. Safety Risk “FDA’s finding of substantial equivalence, as a matter of law, is not a safety determination.“ In re Zimmer Nexgen Knee Implant Prods. Liab. Litig. 2015 WL 5145546, at *14-15

Safe and Effective Substantial Equivalence is the standard “Safe and Effective” is part of the 510(k) Review

Admissibility of 510(k) Clearance

Agree or Disagree? Trump WHCI wants testimony at trial that HRC was cleared through the 510(k). It depends

Admissibility KEEP IT OUT KEEP IT IN

Impact of 510(k) Evidence or Lack Thereof at Trial

Impact Be Ready! Stay Ready! You don’t know how the Court will rule. Cases excluding admission of 510(k) evidence In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Sys. Prod. Liab. Litig. 810 F.3d 913 (4th Cir. 2016). In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., No. 11-md-02272, 2015 WL 5145546, at *14-15 (N.D. Ill. Aug. 21, 2015) Cases admitting 510(k) evidence Block v. Woo Young Med. Co., Ltd., 937 F. Supp. 2d 1028, 1047 (D. Minn. 2013). McClellan v. I-Flow Corp., No. 07-cv-01309, 2010 WL 3954092 (D. Or. Oct. 7, 2010).

Compliance

Compliance Compliance Issues Post Clearance 522 Submissions Withdrawals Recalls Changing in Classification

Final Thoughts And Questions

Thank You ! Our Panel: Carrie Watt Michael Anderton Teleflex Incorporated Wayne, PA Michael Anderton Tucker Ellis LLP Cleveland, OH Marta L. Villarraga Exponent, Inc. Philadelphia, PA Robert Simpson Shipman & Goodwin LLP Hartford, CT Thank You !