Reasonable jury verdict: J&J pays $3M for surgical mesh patient harm

No retrial for Ethicon in $3m pelvic mesh loss

AUGUST 19, 2015 BY BRAD PERRIELLO 

A federal judge today shot down a bid by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon to overturn a $3.3 million judgment in a pelvic mesh product liability lawsuit and denied the company’s move for a new trial.

A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.2 million, finding in September 2014 that Ethicon’s TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks.

Ethicon asked Judge Joseph Goodwin, who’s overseeing 10s of thousands of product liability lawsuits brought over pelvic mesh products, to overturn the verdict or, alternatively, to grant a new trial.

But Goodwin today declined to disturb the jury’s verdict, finding that “[t]he evidence on the defective design claim is particularly strong and is capable of upholding the verdict on its own.”

A reasonable jury, Goodwin ruled, could conclude that the risks of the TVT-O product “are not justified by the benefits, and as a result, the TVT-O cannot, as a matter of law, qualify as an unavoidably unsafe product.”

“In short, while Ethicon produced evidence of the TVT-O’s usefulness and benefits, the plaintiffs countered with evidence of the TVT-O’s high risks of injury and how Ethicon could have mitigated those risks through alternative designs,” Goodwin wrote, according to court documents. “Taking the evidence as a whole and viewing it in the light most favorable to the plaintiffs, it is clear that reasonable persons could balance the risks and benefits against Ethicon. As a result, I cannot displace the jury’s verdict on these grounds.”

Goodwin also cited evidence produced at trial that Huskey’s physician would not have used the TVT-O device had she been warned that it was contra-indicated for active patients like Huskey. The doctor was also unaware of other risk factors from the product, the judge ruled, including that the mesh itself could cause infection and that the amount of mesh material in the product could cause more complications.

“The plaintiffs presented sufficient evidence on Ethicon’s knowledge of dangerous propensities of the TVT-O and failure to warn about those propensities such that a reasonable jury could conclude that Ethicon was negligent,” Goodwin wrote.

http://www.massdevice.com/no-new-trial-for-ethicon-in-3m-pelvic-mesh-loss/

Is your legislator on "the list"? Patient safety at risk by political lobby $$$.

Who are medtech's favorites in Congress?

March 17, 2015 by Brad Perriello  FiDA Highlight

Republicans, mostly, as the GOP got the lion's share of the more than $4.5 million in donations the medical device industry gave legislators last year, according to OpenSecrets.org.

The medical device industry doled out more than $4.5 million to legislators on Capitol Hill last year, with most of the donations going to Republicans and incumbents, according to the Center for Responsive Politics' OpenSecrets.org website.

Senators and representatives from the Grand Old Party received more than $2.7 million from medtech last year, compared with just more than $1.8 million for Democrats (and just $2,000 for "others"), according to the nonpartisan website.

Incumbents also took in more than 1st-time candidates, pulling in $4.0 million of the total donated. 

In the U.S. House of Representatives, 158 Republicans received an average contribution of $10,625, compared with an average of $6,842 sent to some 140 Democratic representatives (and no independents). 

Democrats did better in the Upper Chamber, with 41 receiving an average of $17,460, compared with 37 Republicans who got an average of $16,896 from medtech's coffers, according to the website.

Not surprisingly, Rep. Erik Paulsen (R-Minn.) received the most from the medical device industry in 2014, at $93,049. Paulsen has long been a friend to the sizeable medtech cluster in the North Star State and has spearheaded efforts in the House to repeal the medical device tax. He's the lead sponsor of H.R. 160, the "Protect Medical Innovation Act of 2015."

Interestingly, another medical device stalwart, Sen. Orrin Hatch (R-Utah), does not appear on the list of the top 20 recipients of medtech's largesse. Hatch is the sponsor of the Senate's companion bill for repealing the medical device tax, S. 149 or the "Medical Device Access & Innovation Protection Act."

Here's a look at that top 20 list, from both the House and Senate and whether they've signed on to the medtech tax repeal bills in their respective chambers:

Rep. Erik Paulsen (R-Minn.)	$93,049	sponsor of HR 160
Sen. Mitch McConnell (R-Ky.)	$86,323	has not signed S 149
Sen. Ed Markey (D-Mass.)	$76,100	has not signed HR 160
Sen. Kay Hagan (D-N.C.)	$73,761	did not win reelection
Sen. John Cornyn (R-Texas)	$64,950	has not signed S 149
Sen. Ron Wyden (D-Ore.)	$63,150	has not signed S 149
Rep. Ron Kind (D-Wis.)	$59,900	has signed HR 160
Sen. Lamar Alexander (R-Tenn.)	$58,500	has signed S 149
Rep. John Boehner (R-Ohio)	$56,100	has not signed HR 160
Sen. Rob Portman (R-Ohio)	$53,949	has not signed S 149
Sen. Al Franken (D-Minn.)	$49,199	has not signed S 149
Rep. Anna Eshoo (D-Calif.)	$48,909	has not signed HR 160
Rep. Fred Upton (R-Mich.)	$48,750	has signed HR 160
Ryan, Paul (R-WI)	$43,197	has not signed HR 160
Sen. Amy Klobuchar (D-Minn.)	$41,900	has signed S 149
Rep. Marsha Blackburn (R-Tenn.)	$40,100	has signed HR 160
Rep. David Joyce (R-Ohio)	$37,700	has signed HR 160
Rep. Tim Scott (R-S.C.)	$37,300	has not signed HR 160
Rep. Kevin McCarthy (R-Calif.)	$37,000	has not signed HR 160
Sen. Joe Donnelly (D-Ind.)	$35,900	has signed S 149

 http://www.massdevice.com/news/who-are-medtechs-favorites-congress