Maker Hid Data About Design Flaw in Hip Implant, Records Show
By BARRY MEIER
Johnson & Johnson executives knew years before they recalled a troubled artificial hip in 2010 that it had a critical design flaw, but the company concealed that information from physicians and patients, according to internal documents disclosed on Friday during a trial related to the device’s failure.
The company had received complaints from doctors about the device, the Articular Surface Replacement, or A.S.R., even as it started marketing a version of it in the United States in 2005. The A.S.R.’s flaw caused it to shed large quantities of metallic debris after implantation, and the model failed an internal test in 2007 in which engineers compared its performance to that of another of the company’s hip implants, the documents show.
Still, executives in Johnson & Johnson’s DePuy Orthopaedics unit kept selling the A.S.R. even as it was being abandoned by surgeons who worked as consultants to the company. DePuy executives discussed ways of fixing the defect, the records suggest, but they apparently never did so.
Plaintiffs’ lawyers introduced the documents on Friday in Los Angeles Superior Court during opening arguments in the first A.S.R.-related lawsuit to go to trial. The company faces more than 10,000 lawsuits in the United States in connection with the device. An estimated 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.
DePuy executives insisted before the A.S.R.’s recall in mid-2010 that the implant was working well, despite years of complaints from doctors that it was failing early. In late 2009, the company announced plans to phase out the model but said it was doing so because of slowing sales, not safety concerns.
In opening arguments — followed remotely over the Courtroom View Network — a lawyer for DePuy, Alexander G. Calfo, reiterated those positions, telling jurors that DePuy had behaved ethically throughout the A.S.R. episode.
“The evidence will show that DePuy acted as an extremely responsible manufacturer,” Mr. Calfo said.
But a lawyer for Loren Kransky, the plaintiff in the case, painted a far different picture of DePuy’s behavior for jurors in his opening arguments.
Health insurance law debate heats up with GOP praise, Democratic bills to change it
Posted Jan. 25, 2013, at 5:57 p.m.
AUGUSTA, Maine — Lawmakers traded barbs Friday on a 2011 health insurance reform law that Republicans praise for leading to lower premiums in the individual and small-group markets, but Democrats deride for allowing insurers to raise rates without scrutiny.
Democrats made the health insurance reform law a central theme during the 2012 campaign season that ended with them recapturing legislative majorities in both the House and Senate. Now that lawmakers are back at the State House, Democrats already have introduced two bills that target key elements of the law.
Meanwhile, Republicans this week celebrated a new analysis from the state Bureau of Insurance that shows a growing percentage of customers renewing their small-group policies have seen premiums drop since the health insurance reform law passed.
“Some of my Democratic colleagues have said they want to change the law, but in light of the numbers we’re beginning to see as the reform takes effect, we need to be careful about altering this new reform before its potential benefits have been realized,” Rep. Joyce Fitzpatrick of Houlton, the ranking Republican on the Legislature’s Insurance and Financial Services Committee, said in a statement.
The insurance overhaul bill — called Public Law, or PL, 90 — was an attempt to spur more competition in Maine’s health insurance market by making it easier for insurers to offer new plans for small groups and individuals, and by allowing small businesses to band together and negotiate more favorable rates.
The bill also created a high-risk pool — or reinsurance program — to protect insurance companies from the high costs of covering patients who require the most medical care. The law funds the program in part through a $4 assessment on the monthly premium of anyone with private insurance.
In addition, the law allows insurers to charge different rates based on patients’ age, geography and health status. Proponents say that part of the bill is an attempt to woo more young, healthy patients into the marketplace by allowing insurers to charge them less.
Eventually, the law will allow insurers to market plans certified in other states to Maine consumers.
Democrats have said the law does away with important consumer protections and has disproportionately caused premium increases among small businesses in rural areas.
A Flood of Suits Fights Coverage of Birth Control
By ETHAN BRONNER
In a flood of lawsuits, Roman Catholics, evangelicals and Mennonites are challenging a provision in the new health care law that requires employers to cover birth controlin employee health plans — a high-stakes clash between religious freedom and health care access that appears headed to the Supreme Court.
In recent months, federal courts have seen dozens of lawsuits brought not only by religious institutions like Catholic dioceses but also by private employers ranging from a pizza mogul to produce transporters who say the government is forcing them to violate core tenets of their faith. Some have been turned away by judges convinced that access to contraception is a vital health need and a compelling state interest. Others have been told that their beliefs appear to outweigh any state interest and that they may hold off complying with the law until their cases have been judged. New suits are filed nearly weekly.
“This is highly likely to end up at the Supreme Court,” said Douglas Laycock, a law professor at the University of Virginia and one of the country’s top scholars on church-state conflicts. “There are so many cases, and we are already getting strong disagreements among the circuit courts.”
President Obama’s health care law, known as the Affordable Care Act, was the most fought-over piece of legislation in his first term and was the focus of a highly contentious Supreme Court decision last year that found it to be constitutional.
But a provision requiring the full coverage of contraception remains a matter of fierce controversy. The law says that companies must fully cover all “contraceptive methods and sterilization procedures” approved by the Food and Drug Administration, including “morning-after pills” and intrauterine devices whose effects some contend are akin to abortion.
As applied by the Health and Human Services Department, the law offers an exemption for “religious employers,” meaning those who meet a four-part test: that their purpose is to inculcate religious values, that they primarily employ and serve people who share their religious tenets, and that they are nonprofit groups under federal tax law.
But many institutions, including religious schools and colleges, do not meet those criteria because they employ and teach members of other religions and have a broader purpose than inculcating religious values.
“We represent a Catholic college founded by Benedictine monks,” said Kyle Duncan, general counsel of the Becket Fund for Religious Liberty, which has brought a number of the cases to court. “They don’t qualify as a house of worship and don’t turn away people in hiring or as students because they are not Catholic.”
What We Don’t Know Is Killing Us
In one of the 23 executive orders on gun control signed this month, President Obama instructed the Centers for Disease Control and Prevention and other federal science agencies to conduct research into the causes and prevention of gun violence. He called on Congress to aid that effort by providing $10 million for the C.D.C. in the next budget round and $20 million to expand the federal reporting system on violent deaths to all 50 states, from the current 18.
That Mr. Obama had to make such a decree at all is a measure of the power of the gun lobby, which has effectively shut down government-financed research on gun violence for 17 years. Research on guns is crucial to any long-term effort to reduce death from guns. In other words, treat gun violence as a public health issue.
But that is precisely what the National Rifle Association and other opponents of firearms regulation do not want. In the absence of reliable data and data-driven policy recommendations, talk about guns inevitably lurches into the unknown, allowing abstractions, propaganda and ideology to fill the void and thwart change.
The research freeze began at a time when the C.D.C. was making strides in studying gun violence as a public health problem. Before that, the issue had been regarded mainly as a law enforcement challenge or as a problem of disparate acts by deranged offenders, an approach that remains in sync with the N.R.A. worldview.
Public health research emphasizes prevention of death, disability and injury. It focuses not only on the gun user, but on the gun, in much the same way that public health efforts to reduce motor vehicle deaths have long focused on both drivers and cars.
The goal is to understand a health threat and identify lifesaving interventions. At their most basic, gun policy recommendations would extend beyond buying and owning a gun (say, background checks and safe storage devices) to manufacturing (childproofing and other federal safety standards) and distribution (stronger antitrafficking laws), as well as educating and enlisting parents, physicians, teachers and other community leaders to talk about the risks and responsibilities of gun ownership.
But by the early 1990s, C.D.C. gun research had advanced to the point that it contradicted N.R.A. ideology. Some studies found, for example, that people living in a home with a gun were not safer; they faced a significantly elevated risk of homicide and suicide.
The N.R.A. denounced the research as “political opinion masquerading as medical science,” and in 1996, Congress took $2.6 million intended for gun research and redirected it to traumatic brain injury. It prohibited the use of C.D.C. money “to advocate or promote gun control.” Since then, similar prohibitions have been imposed on other agencies, including the National Institutes of Health.
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