FDA seeks expert advice on safety of metal-on-metal hip replacements.

The AP (3/30) reports, "The Food and Drug Administration will hold a two-day meeting in June to discuss growing safety concerns about metal-on-metal hip replacements, which recent studies suggest are more likely to fail than traditional plastic hips." The agency "already asked device companies to conduct additional follow-up studies to monitor problems with the" metal "implants."

        Reuters (3/30) reports that, in a statement, Dr. William Maisel, deputy director of science at FDA's Center for Devices and Radiological Health, said, "We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations."

        Medscape (3/30, Crane) reports, "The expert panel will discuss failure rates and modes, metal ion testing, imaging methods, local and systemic complications, patient risk factors, and considerations for follow-up after surgery." 

Jury faults GE for helicopter crash that killed nine.

The website of KDRV-TV Medford, OR (3/28) reported, "A jury says General Electric is responsible" for a 2008 helicopter crash that killed nine firefighters battling a northern California wildfire. The jury said "G.E. must pay nearly $70 million to a pilot of that helicopter who survived and to the family of the other pilot who was killed." The jury "found the helicopter manufacturer, Sikorsky and the Carson Helicopters were partially at fault, but put most of the blame on G.E., finding it 57% responsible."

        The AP (3/28) added that plaintiffs claimed "the company knew the engines it made for the Sikorsky S-61N helicopter had a design flaw making the equipment unsafe." GE "countered that the helicopter crashed because it was carrying too much weight" and noted that after a two-year investigation, the National Transportation Safety Board "concluded in 2010 that too much weight and a lack of oversight caused the crash." 

BMW recalls 1.3 million cars for electrical problem.

USA Today (3/27) reported, "BMW announced in Frankfurt today that it is recalling it is recalling 1.3 million cars worldwide for an electrical problem." The recall order "covers all 2003 to 2010 model 5- and 6-series cars." In the US, the recall will affect 368,000 vehicles. "BMW says that in a few of the cars, a battery cable covering in the trunk was not installed properly, and it could eventually keep the car from starting and even lead to a fire." According to the company, it's only received a few complaints related to the issue, and there have been no reports of crashes or injuries linked to the defect. 

Rottenstein Law Group Heeds Court Order Setting First Dates in Wright Conserve Multidistrict Litigation

New York, March 26, 2012. The Rottenstein Law Group, which represents clients with claims stemming from the failures of defective hip replacement devices manufactured and sold by Wright Medical, is taking note of the initial deadlines set by the Conserve multidistrict litigation court in its first pretrial order.

In its Pretrial Order no. 1, filed on March 19, the United States District Court for the Northern District of Georgia, in the case styled In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation (no. 1:12-MD-2329), District Judge William S. Duffey, Jr. set forth some rules to govern the initial procedure in those actions transferred to the court by the Judicial Panel on Multidistrict Litigation concerning the Wright Conserve devices, all of which are being consolidated for pretrial purposes.
Judge Duffey ordered, among other things, that all discovery in the MDL action be stayed until further order of the court; accordingly, the parties are not to trade pretrial information just now. The court set the “Initial Organization Conference” in the matter for the morning of April 23, 2012. Counsel for the parties must meet and confer by April 2, and by April 9 must file a Proposed Case Management Order and Proposed Conference Agenda. At the Initial Organization Conference, the parties will provide to the court input regarding the process for selecting Lead and Liaison Counsel—unless the parties agree among themselves which counsel will perform those functions.
The Wright Conserve devices compose a hip replacement system that involves the capping of a patient’s thigh bone with a synthetic ball and the replacement of that patient’s hip socket with a corresponding cup. Both the ball and the cup of the Wright Conserve devices are at least in part made of metal. There has been much recent media coverage of the dangers of metal-on-metal joint replacement devices, including an ongoing series of reports in the New York Times.
The Rottenstein Law Group is imploring anyone with a friend or relative who has received a potentially dangerous hip replacement device to reach out to that person and recommend that he or she consult a physician immediately and then speak to a qualified personal injury lawyer.
The Rottenstein Law Group maintains a Wright Profemur Z Lawsuit Information Page on their website. The site has features that allow for easy sharing, including links for automatic posting on Facebook and Twitter, specifically to enable visitors to spread the word about the dangers of defective medical devices.
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients in consumer product injury, mass tort, and class action lawsuits in a compassionate manner.

Supreme Court arguments on healthcare law begin today.

on the eve of the first day of arguments before the Supreme Court on the constitutionality of the healthcare reform law, print and television coverage continued to be heavy, with nearly three minutes of coverage on network newscasts.

        USA Today (3/26, Wolf) reports, "Not since the court confirmed George W. Bush's election in December 2000 -- before 9/11, Afghanistan and Iraq, Wall Street's dive and Obama's rise -- has one case carried such sweeping implications for nearly every American." USA notes, "A poll this month by the non-partisan Kaiser Family Foundation found 42% were either unsure of the law's status or believed the Supreme Court had already overturned it." USA adds, "This year's presidential election and the agenda of the next Congress will be affected by the justices' ruling, expected in late June."

        The AP (3/26, Sherman) reports, "Polls have consistently shown the public is at best ambivalent about the benefits of the health care law, and that a majority of Americans believe the mandatory insurance requirement is unconstitutional. The administration's public education campaign has come under strong criticism from its allies who say the White House has been timid in the face of relentless Republican attacks."

        First arguments will be about timing of challenge. The Washington Post (3/26, Barnes) reports, "The Supreme Court begins its constitutional review of the health-care overhaul law Monday with a fundamental question: Is the court barred from making such a decision at this time?" The court "will hear 90 minutes of argument about whether an obscure 19th-century law -- the Anti-Injunction Act -- means that the court cannot pass judgment on the law until its key provisions go into effect in 2014." The Post notes that "the Obama administration lawyers and those representing the states and private organization challenging the new law argue that the Supreme Court should decide the constitutional question now," but that a panel of the 4th Circuit Court of Appeals disagreed.

        Votes of Republican-appointed Justices hard to predict. The Washington Times (3/26, Cunningham) reports that "while nobody doubts how the four Democrat-appointed justices will decide, there is no such certainty on how the Republican appointees will rule in the case, which will go a long way toward defining the scope and limits of government power in the 21st century." Among the five other justices, "conservative stalwart Clarence Thomas is the only one viewed as a sure vote against the mandate and possibly other parts of the law."

Dome: Trial lawyers target conservative Democrat for drug vote - Politics - NewsObserver.com

Dome: Trial lawyers target conservative Democrat for drug vote - Politics - NewsObserver.com

Healthcare reform challenge hinges on mandate argument.

USA Today (3/16, Wolf) reports that a key issue for the Supreme Court later this month when it hears arguments on the healthcare reform law challenge will be "whether requiring Americans to buy health insurance is a law with a 'limiting principle.' If President Obama's health care law -- his landmark legislative achievement -- is to withstand legal challenge, government lawyers must convince a majority of justices that the health care marketplace is unique," and by failing to purchase insurance, "millions of Americans transfer $43 billion in health care costs to others in the form of higher premiums." Opponents of the law "contend that the 'minimum coverage requirement' -- more commonly known as the individual mandate -- would set a precedent that could apply to vitamin supplements, daily newspapers or kidney donations."

        The Hill (3/16, Baker) reports in its "Healthwatch" blog, "The Obama administration has shifted its legal arguments as it prepares to defend the president's healthcare law before the Supreme Court." In brief submitted prior to oral arguments, government attorneys, who have previously "defended the mandate as its own regulation of economic activity," are "now stepping http://www.latimes.com/business/la-fi-honda-settlement-20120316,0,978510.storyexperts say the shift could steer the case in a direction that would make Justice Antonin Scalia more likely to uphold the healthcare law's mandate requiring individuals to purchase health insurance."

        McClatchy (3/16, Rau) adds that the individual mandate is seen by legal experts as "the most legally vulnerable part of the 2010 law," and notes speculates by health experts that if the Supreme Court strikes it down but leaves the rest of the law intact, and Obama is re-elected, he try fixing it through legislation that "would create financial incentives for people to not delay enrolling in insurance."

State lawmakers oppose medical malpractice reform bill.

The Hill (3/15, Pecquet) "Healthwatch" blog reports the conference's Law and Criminal Justice committee co-chairmen, South Dakota Sen. Joni Cutler, and Mississippi Rep. Tommy Reynolds wrote House Speaker John Boehner (R-OH) and House Minority Leader Nancy Pelosi (D-CA) "on Wednesday to share their 'strong, bipartisan opposition' to federal medical malpractice reform because it would infringe upon states' rights." The letter says "medical malpractice, product liability and other areas of tort reform are areas of law that are regulated by the states." They wrote, "'The adoption of a one-size-fits-all approach to medical malpractice envisioned in H.R. 5' the letter adds, 'would undermine that diversity and disregard factors unique to each particular state.'" 

House Republicans set up vote for IPAB repeal linked with malpractice provisions.

The Hill (3/14, Kasperowicz) reports in its "Healthwatch" blog, "House Republicans have set up a vote next week to repeal a board created by the 2010 healthcare law that the GOP has criticized as a rationing board that could force Medicare cuts without congressional approval. ... The legislation was originally a medical tort-reform bill, but a version of the bill that appeared Tuesday on the House Rules Committee website included new language to repeal the Independent Payment Advisory Board (IPAB)."
        The Kaiser Health News (3/13) adds that "trial lawyers are already lining up against" the House bill.
        Politico (3/14, Dobias) reports, "As expected, the linkage proved toxic among Democrats, many of whom want to see the IPAB rolled back but don't support the GOP effort to overhaul medical malpractice laws."

U.K. Registry Data Confirm Metal-on-Metal Hip-Implant Problems

Metal-on-metal hip replacements — especially those with larger head sizes — fail at higher rates than other types of bearing surfaces, and the evidence is "unequivocal" according to a Lancet report.

Investigators evaluated registry data on over 400,000 total hip replacements of various types. They excluded ASR implants (a type of metal-on-metal implant that has been withdrawn from the market because of high failure rates).

Metal-on-metal implants had 5-year failure rates necessitating revision that were triple those of the other bearing types — roughly 6% versus 2%. Larger metal-on-metal head sizes were most prone to failure; ceramic-on-ceramic prostheses, however, showed better performance with larger head sizes.

A commentator says the registry data add to the evidence that the problem is not caused by a specific brand of metal-on-metal implant, but rather it is a class effect.

Lancet article (Free abstract)

Lancet comment (Subscription required)

Physician's First Watch coverage of recent BMJ report on metal-on-metal implants (Free)

House GOP plans to offset cost of ending IPAB by limiting medical malpractice suits.

CQ (3/10, Attias, Ethridge, Subscription Publication) reported, "House Republicans are planning to use an amended measure to restrict medical malpractice lawsuits as a way to offset the cost of abolishing" the Independent Payment Advisory Board (IPAB). "Laena Fallon, a spokeswoman for the office of Majority Leader Eric Cantor, R-Va., said the House will offset the cost using an amended version of a measure sponsored by Phil Gingrey, R-Ga. As approved by the Energy and Commerce Committee last May, the bill (HR 5) would impose caps on some damages in malpractice lawsuits, limit attorney fees and establish a statute of limitations for filing health care lawsuits." 

Institute of Medicine suggests improvements to laws governing drug studies.

ModernMedicine (3/8) reports that the Institute of Medicine is proposing improvements to two laws promoting pediatric drug studies. According to the article, the new IOM report "calls for more study of drug use in neonates, for earlier completion of pediatric studies, and for eliminating delays in the completion of studies mandated by the US Food and Drug Administration."

Ohio AAJ official disputes doctors' claims on "defensive medicine" testing.

In a letter to the editors of the Columbus (OH) Dispatch (3/3, DeRose), the president-elect of the Ohio Association for Justice takes issue with an earlier article highlighting studies in which nearly all doctors said responding to surveys said medical tests, referrals or admissions were ordered to protect against malpractice lawsuits. He argued that the real crisis in medicine is "medical errors, and errors ought to be the primary concern of the medical community, not the declining number of lawsuits against hospitals and doctors when those preventable errors occur." He also disputes doctors' self-reports of unneeded testing, arguing that the law does not require any testing beyond what is reasonable for patient care, and noting that under Ohio law malpractice lawsuits require a sworn affidavit from another physician in the same specialty that treatment was unreasonable

Hospice firm settles Medicare fraud allegations with US for $25 million.

The AP (3/2) reports from Milwaukee, WI, "Federal attorneys say Odyssey HealthCare, one of the nation's largest providers of hospice care, has agreed to pay $25 million to settle a Medicare fraud case." The AP continues, "Odyssey, which operates in about 27 states, was purchased by Atlanta-based Gentiva Health Services in 2010. Thursday's settlement resolves allegations that Odyssey submitted false claims to the Medicare program."

The Milwaukee Journal Sentinel (3/2, Vielmetti) reports, "It was the second such settlement in six years for Odyssey Healthcare, Inc., which paid the federal government $12.5 million in 2006, after another Wisconsin-based employee sued. Jane Tuchalski, a registered nurse, was fired by Odyssey after raising concerns about company operations, and she filed the federal suit in 2008. Other Odyssey employees, from Virginia and Texas, later filed their own False Claims Act suits. One was folded into the Milwaukee case and was dismissed." The Wall Street Journal (3/2, Subscription Publication) also reports on the settlement.

Arizona Senate approves bill limiting punitive damages in product cases

The Yuma Sun /Capitol Media Services (2/28, Fischer) reported, "Manufacturers would get protection from punitive damages in product liability lawsuits under the terms of legislation approved Tuesday by the Senate. SB 1336 says these special penalties, imposed to punish a company for unusual wrongdoing or to make an example so others behave, could not be awarded if the product complied with state or federal regulations. The legislation also provides similar protections when the item was designed, manufactured, packaged, labeled or sold in accordance with approval or license of a government agency."

High Court urged to limit reach of Alien Tort Statute

In an op-ed for the Wall Street Journal (2/28, Subscription Publication), David B. Rivkin and Lee A. Casey, who served in the Justice Department under Presidents Reagan and George H.W. Bush, argue that the Supreme Court should rule against corporate liability in two cases involving the Alien Tort Statute. Noting that the court is scheduled to hear arguments today in two cases involving the statute, Rivkin and Casey write that the law is being used in ways that far exceed its original intent