Monday, October 5, 2015

J&J Wins 1st Trial Over Prosima Pelvic Mesh - Law360

J&J Wins 1st Trial Over Prosima Pelvic Mesh - Law360


Law360, Dallas (October 5, 2015, 4:10 PM ET) -- A Texas state court jury on Monday cleared Johnson & Johnson of liability in the first trial over the company's Prosima pelvic mesh device, rejecting claims the device was defectively designed and that the company didn't adequately warn consumers about the risks involved.

J&J has defended the efficacy of its product and said it more than adequately warned doctors about the inherent risks of using the Prosima pelvic mesh device. (Credit: AP)
In a 10-2 verdict, Dallas County District Court jurors rejected plaintiff Carol Cavness' claim that the Prosima device was defectively designed and that J&J's Ethicon Inc. unit had failed to give adequate warnings about the risks associated with the mesh device. Cavness, who had the device implanted in 2012 and says she has suffered debilitating pain and other medical problems since then, had asked jurors to award $9.56 million in actual damages and a substantial punitive damages award that would send a message to J&J about its decision to market the Prosima device.

Jurors deliberated for about seven hours following seven days of testimony.

"We're pretty shocked," David Matthews of Matthews & Associates, Cavness' attorney, said after the verdict.

Matthews said it's "sad" Johnson & Johnson took the strategy of attacking Cavness' past medical history instead of addressing her concerns about the Prosima device.

"I think they never defended the product at all," Matthews said. "I think there's a lot of information still to come to light about the Prosima."

Ethicon spokesman Matthew Johnson said in a statement Monday the jury's decision "reflects the facts in this case."

"Ethicon acted appropriately and responsibly in the research, development and marketing of the product and Prosima was not the cause of the plaintiff’s continuing medical problems," Johnson said. "We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events. We have always made patient safety a top priority and will continue to do so."

Cavness alleged after she was implanted with the mesh in 2012, she suffered debilitating pain and has spent three and a half years in and out of hospitals and undergoing multiple surgeries, along with depression and anxiety and other medical problems related to the mesh.

She argued J&J knew before it ever launched Prosima that the device was risky and carried with it the threat of permanent damage to women who were treated with it, but that the money-hungry company pushed the device to market to avoid losing ground to competitors.

"This is an epidemic," Matthews said in his closing argument. "These meshes are health care disasters. Does anyone really think this product was pulled from the market because of sales? This product was pulled because it's dangerous."

J&J has defended the efficacy of its product and said it more than adequately warned doctors about the inherent risks of using the device. It said Cavness' injuries are not the result of an adverse reaction to the Prosima but instead were caused by a pelvic floor disorder that was triggered by the same on-the-job injury that initially led her to seek surgery for pelvic organ prolapse.

"Mesh is not, was not and will not be the cause of her pain," said William Gage of Butler Snow LLP, an attorney for J&J. "There is no proximate cause."

After the verdict was read, several jurors said they were frustrated by the questions they had to answer. Two jurors said the jury thought they would get questions about whether Cavness had mesh remaining in her, not whether the product was defectively designed. Deliberations were heated, and around noon today, the jury thought they might not be able to come to a consensus, the jurors said.

Juror Godwin Egbobawaye said many of the jurors shed tears during deliberation out of sympathy with Cavness, but ultimately did not think she proved the Prosima device was the proximate cause of her injuries. 

The Dallas trial is the country's first involving Prosima. Other J&J pelvic mesh products have racked up a mixed verdict in state court and bellwether federal trials. The company faces tens of thousands of lawsuits in federal multidistrict litigation, and is set for several state court trials in Texas in the next six months involving its mesh products.

Saturday, October 3, 2015

A public health approach to reducing gun deaths // Kristof // New York times

A New Way to Tackle Gun Deaths - The New York Times
by Nicholas Kristof
What we need is an evidence-based public health approach — the same model we use to reduce deaths from other potentially dangerous things around us, from swimming pools to cigarettes. We’re not going to eliminate guns in America, so we need to figure out how to coexist with them.

First, we need to comprehend the scale of the problem: It’s not just occasional mass shootings like the one at an Oregon college on Thursday, but a continuous deluge of gun deaths, an average of 92 every day in America. Since 1970, more Americans have died from guns than died in all U.S. wars going back to the American Revolution.

When I reported a similar figure in the past, gun lobbyists insisted that it couldn’t possibly be true. But the numbers are unarguable: fewer than 1.4 million war deaths since 1775, more than half in the Civil War, versus about 1.45 million gun deaths since 1970 (including suicides, murders and accidents).
If that doesn’t make you flinch, consider this: In America, more preschoolers are shot dead each year (82 in 2013) than police officers are in the line of duty (27 in 2013), according to figures from the Centers for Disease Control and Prevention and the FBI.

More than 60 percent of gun deaths are suicides, and most of the rest are homicides. Gun enthusiasts scoff at including suicides, saying that without guns people would kill themselves by other means. In many cases, though, that’s not true.
,,,Actually, cars exemplify the public health approach we need to apply to guns. We don’t ban cars, but we do require driver’s licenses, seatbelts, airbags, padded dashboards, safety glass and collapsible steering columns. And we’ve reduced the auto fatality rate by 95 percent.
One problem is that the gun lobby has largely blocked research on making guns safer. Between 1973 and 2012, the National Institutes of Health awarded 89 grants for the study of rabies and 212 for cholera — and only three for firearms injuries.

Wednesday, September 30, 2015

So the Pope Met Kim Davis // Rick Garnett // Mirror of Justice

 The Pope Met Kim Davis // Mirror of Justice

by Rick Garnett // Notre Dame Law School

***Like Rob Vischer (read his piece here), I think the Kim Davis case presents some tricky questions.  It is not as clear to me as it is to some that she can, in this moment, expect to be exempted from performing duties that attach to her elected, official position.  (This is not to say that it does not make sense to find ways -- as Robin Fretwell Wilson and others have described -- to accommodate, if possible, public employees' religious objections to participating in the legal recognition of same-sex marriages, if it can be done in a way that does not deny anyone legal rights.)  At the same time, I think Matt Bowman is clearly right to warn that those who control the power to define what "doing your job" means (or to control access to various positions and professions through licensing, accreditation, etc.) will be trying to use that power in the coming years against, say, pro-life doctors and nurses, or judges who belong to "discriminatory" organizations, or student groups and religious colleges with "discriminatory" views, practices,  or mission statements, etc.  Stay tuned.

9th Circuit Affirms, Modifies NCAA Anti-trust Ruling in O'Bannon Case

In O'Bannon v. NCAA the U.S. Court of Appeals for the 9th Circuit has affirmed the District Court finding that  the NCAA has violated anti-trust laws.  The court writes:
Section 1 of the Sherman Antitrust Act of 1890, 15 U.S.C. § 1, prohibits “[e]very contract, combination . . . , or conspiracy, in restraint of trade or commerce.” For more than a century, the National Collegiate Athletic Association (NCAA) has prescribed rules governing the eligibility of athletes at its more than 1,000 member colleges and universities. Those rules prohibit student-athletes from being paid for the use of their names, images, and likenesses (NILs). 
But the panel limited the remedy, saying that
"the district court identified one proper less restrictive alternative to the current NCAA rules¯i.e., allowing NCAA member to give scholarships up to the full cost of attendance¯but the district court’s other remedy, allowing students to be paid cash compensation of up to $5,000 per year, was erroneous. The panel vacated the district court’s judgment and permanent injunction insofar as they required the NCAA to allow its member schools to pay student-athletes up to $5,000 per year in deferred compensation."
- gwc

Saturday, September 26, 2015

Experts say ethicon did not disclose dangers

Friday, September 25, 2015

PrawfsBlawg: Justice and fairness v. procedure

Prof. Howard Wasserman points out that Judge Bunning has overreached in his order to Kim Davisto process all qualifying marriage license applicants.He has got individual plaintiffs before him.  If he wants to broaden the order he should certify a class under FRCvP 23. - gwc

PrawfsBlawg: Justice and fairness v. procedure


Thursday, September 24, 2015

F.D.A. Panel Weighs Complaints on Essure Contraceptive Implant - The New York Times

F.D.A. Panel Weighs Complaints on Essure Contraceptive Implant - The New York Times

SILVER SPRING, Md. — A panel of experts convened by the Food and Drug Administration weighed the evidence Thursday on a contraceptive device that has received thousands of complaints from women who say they were harmed by it.
The device, called Essure, is a small metal and polyester coil implanted into a woman’s fallopian tubes to make her permanently sterile. The F.D.A. approved Essure 13 years ago after a fast-track review process that prioritized the device because it offered the first alternative to surgical sterilization and promised a quick recovery.
But since then, allegations that the device has caused severe pain, perforations of fallopian tubes and possibly even death, and that it has failed to prevent pregnancy in some cases, have accumulated, and the agency decided to hold a daylong public meeting at its headquarters on Thursday to talk about them.

The large auditorium was unusually full, and the ordinarily dry scientific discussion was punctuated with emotional testimony by women who gave accounts of their experiences with Essure. Many spoke of health problems that surfaced after the device was implanted, and of odysseys through the health care system in search of diagnoses.
The panel of experts, which included gynecologists, obstetricians and other specialists, is not expected to vote on questions that would lead to action on the part of the agency, but the exercise will inform the agency’s view on the device as its tale continues to unfold.
Keep reading
The device’s producer, Bayer HealthCare Pharmaceuticals, stands by it, saying its safety “is supported by more than a decade of science, with more than 10,000 women studied.” The company estimates that a million Essure devices have been distributed around the world, most of them in the United States.

Wednesday, September 23, 2015

Race and Class Collide in a Plan for Two Brooklyn Schools - The New York Times

Race and Class Collide in a Plan for Two Brooklyn Schools - The New York Times

by Kate Taylor

At Public School 8 in Brooklyn Heights, the auditorium’s stage is crowded with music stands that were stored there when the music room had to be turned into a first-grade classroom.
The prekindergarten program was cut because of lack of space. And with the school operating far above capacity, 50 families who live within its zone — which also includes Dumbo and much of another Brooklyn neighborhood, Vinegar Hill — were placed on a waiting list for kindergarten last spring.
To the city, the solution for the overcrowding at P.S. 8 seemed obvious: move those two neighborhoods from P.S. 8’s zone and into that of P.S. 307, which is nearby and has room to spare. The proposal, however, has drawn intense opposition, and not only from the families who would be rezoned from the predominantly white P.S. 8 to the mostly black P.S. 307. Some residents of the housing project served by P.S. 307 also oppose the rezoning, worried about how an influx of wealthy, mostly white families could change their school.
For all its diversity, New York City, by some measures, hasone of the most segregated school systems in the country, in part because many elementary schools are effectively closed off to children who live outside their zones. And although the Brooklyn rezoning is mainly a response to crowding, it is becoming a real-life study in the challenges of integrating just one of the city’s schools.
It is also, perhaps, an unavoidable result of the gentrification in its part of Brooklyn. For many years, the area that came to be named Dumbo, for Down Under the Manhattan Bridge Overpass, was a decaying industrial district with relatively few families.
Keep reading

Monday, September 21, 2015

J&J Faces Pelvic Mesh Liability Trial in Dallas // Law 360

J&J Pelvic Device Gets 1st Court Test In Dallas Trial - Law360

Law360, Dallas (September 18, 2015, 7:51 PM ET) -- A pelvic mesh device made byJohnson & Johnson’s Ethicon Inc. unit to treat pelvic organ prolapse will get its first courtroom test on Monday, as Dallas jurors are set to hear a trial alleging the Gynecare Prosima Pelvic Floor Repair System was defectively designed.

The case is a rematch of sorts for the plaintiffs’ lawyers and J&J after an April 2014 trial before the same Dallas district court judge ended in a $1.2 million verdict and a finding Ethicon’s TVT-O pelvic mesh device had been defectively designed.

Most of the litigation involving Ethicon's pelvic mesh products, including the handful of cases that have previously reached trial, focused on the TVT family of devices, used to treat stress urinary incontinence. The Prosima is a treatment for pelvic organ prolapse, which occurs when the supportive muscles and tissues of the pelvis become weak and causes the organs inside the pelvis to drop from their natural positions.

The suit claims the Prosima device was unreasonably dangerous, not reasonably safe for its intended use and that alternative and safer devices were available. The suit also claims J&J and Ethicon failed to warn patients of the dangers and risk associated with the pelvic mesh products.

Here, Law360 takes a look at what’s at issue in the suit and reviews J&J’s history of wins and losses in pelvic mesh cases around the country.