Reglan #2

Reglan

Updated as of 7/2/2012

THIS PAGE IS RESERVED FOR OUR CLIENTS. IF YOU ARE NOT A CLIENT, YOU ARE NOT PERMITTED TO REVIEW THIS INFORMATION. THIS INFORMATION IS CONFIDENTIAL CLIENT INFORMATION. THIS INFORMATION MAY NOT BE DISSEMINATED IN ANY WAY.

Clients can contact Kerri O'Connor: koconnor@rheingoldlaw.com

Dear Reglan Client:

Welcome to the confidential page for our Reglan clients. This page is intended to update you on current information, as well as be a repository for past updates and important documents. This page contains the most updated information. We greatly appreciate that you rely on this information. Inquiries to our office are always welcome about unique questions regarding your claim but asking us to repeat the general information below only slows down our work on the files.

The Superior Court of New Jersey consolidated the Reglan/Metoclopramide litigation in Atlantic County under Judge Higbee. We are deeply involved in this litigation and hold a leadership position amongst the Plaintiffs. Read more about the consolidation here.

Latest News

In a recent decision, the Court has granted the name brand defendants' (Wyeth, Schwarz & Alavan) motion to dismiss the New Jersey Plaintiffs' complaints against them. In these cases the Plaintiffs' ingested the generic form of Reglan and not a product that was produced or sold by the brand defendants. This decision is applicable to all New Jersey Plaintiffs' cases and is based on New Jersey law and precedent. This decision is posted at the bottom of the page.

The recent Supreme Court decision PLIVA v. Mensing has been a significant hurdle for the Reglan litigation. The plaintiff's are currently working to overcome this hurdle, but it's definetly an uphill battle. At the bottom of the page is the most recent brief the Plaintiff's have submitted to Judge Higbee to consider, this could greatly affect the outcome of these cases. If you have any questions feel free to contact our office.

The court is currently reviewing the Plaintiff's and Defendants briefs on the Mensing issue. We hope to have a more substantive update once the issue is decided by the court, but right now we still exploring alternate avenues that may be available to our client's in the event of an unfavorable decision by the court.

For general information about Reglan and related injuries, you can view our general page:

http://www.rheingoldlaw.com/Drugs-Overview/Reglan-Maxolon-Degan-Maxeran-Primperan-Pylomid-Metoclopramide.shtml

Links to latest news in our blog:

http://www.rheingoldlaw.com/blog/2010/07/nj-superior-consolidates-reglan-litigation.shtml

Other Items:

-NJ Superior Court Reglan Master Complaint. http://www.judiciary.state.nj.us/mass-tort/forms/reg-longform-complaint.pdf

-NJ Superior Court Website for Reglan Centralized Management http://www.judiciary.state.nj.us/atlantic/reglan/index.htm

-Feburary 2009 FDA Announcement http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149533.htm

Below are News Articles reposted in their entireity concerning the reglan litigation.

Leahy, Franken, Bingaman, Whitehouse, Brown, Coons, Blumenthal Introduce Bill To Protect Consumers Using Generic Drugs

Bill Addresses Supreme Court Decision In Pliva v. Mensing

April 18, 2012

WASHINGTON (Wednesday, April 18, 2012) - Senator Patrick Leahy (D-Vt.) introduced legislation Wednesday to address a recent Supreme Court decision that threatens to undermine the safety of consumers taking generic drugs. The legislation is cosponsored by Senators Al Franken (D-Minn.), Jeff Bingaman (D-N.M.), Sheldon Whitehouse (D-R.I.), Sherrod Brown (D-Ohio), Christopher Coons (D-Del.) and Richard Blumenthal (D-Conn.).

In a 2011 case, Pliva v. Mensing, a 5-4 majority of the U.S. Supreme Court held that manufacturers of generic drugs cannot be held liable under state tort law for "failure to warn," even if the manufacturer knows that its label is inadequate. The Court based its decision on a federal law that requires generic manufacturers to use the same label as their brand-name counterparts. However, the Supreme Court held in 2008 that brand-name manufacturers can be held liable under state tort law for failure to warn, because federal law permits brand-name drugs to improve their warning labels. The Patient Safety and Generic Labeling Improvement Act introduced Wednesday will address this discrepancy and reverse the effects of the Mensing case.

"The Mensing decision creates a troubling inconsistency in the law governing prescription drugs," said Leahy. "If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries. The Patient Safety and Generic Labeling Improvement Act will promote consumer safety by ensuring that generic drug companies can improve the warning information for their products in the same way that brand manufacturers can under existing law."

Leahy chairs the Senate Judiciary Committee. Under his leadership, the Committee has held a series of hearings in recent years spotlighting the importance of the Supreme Court's decisions on the lives of hardworking Americans, including a number of recent Supreme Court decisions decided by a narrow 5-4 majority that affect the pocketbook issues facing all Americans, from equal pay for equal work, to consumer protections, to the 2010 campaign-finance decision in Citizens United.

"Right now generic drug manufacturers are prohibited from updating their labels to accurately reflect all of the side effects or risks associated with their drugs," said Franken. "This means that a senior in Minnesota may have no idea that a prescription drug she's taking could cause a neurological disorder. That's just not right. This bill will help right this wrong to make sure that Minnesotans know exactly what risks are associated with the medications they're taking."

"While essential to the treatment of many illnesses, prescription drugs can pose risks and have health-threatening side effects. For this reason, prescription drug warning labeling is an important part of ensuring consumer safety," Bingaman said. "By giving generic drug manufactures the ability to update their labeling, this bill will help individuals make an informed decision about the medications they take."

"Consumers of generic prescription drugs should have the same rights as those who are prescribed brand-name drugs," said Whitehouse. "I thank Chairman Leahy for drafting legislation to address this truly wrong-headed decision by the Supreme Court, and I hope we can take action soon to protect Rhode Island consumers."

"Regardless of whether they use generic or brand-name drugs, Ohioans should have full access to information regarding the safety of their prescriptions," Brown said. "This legislation would ensure that generics and brand-names are held to the same labeling standards, which is critical given that approximately 75 percent of prescriptions filled in the U.S. are generics."

"It's common sense that any drug manufacturer - whether generic or brand name - ought to have the responsibility of warning its users of the risks of side effects for the drugs that they sell," Coons said. "According to the Supreme Court's decision last year in Mensing, however, federal law actually prevents generics from warning customers when they discover a new risk. I applaud Chairman Leahy for his work in drafting legislation that will fix this, keeping generic medicines safe, effective, and a key component of affordable health care."

"Generic drug manufacturers must clearly warn patients of known possible life threatening drug side effects - and be held accountable when they fail. Victims in Connecticut have been harmed and left without recourse. I will continue to fight to ensure this loophole no longer jeopardizes patient safety," said Blumenthal.

The plaintiff in Mensing, Minnesota resident Gladys Mensing, developed a severe neurological disorder as a result of the long-term use of a generic drug manufactured by Pliva. She filed suit against Pliva under state tort law, arguing that the drug's label failed to adequately warn of the risks associated with long-term use. In the 10 months since the Supreme Court issued its decision, more than 40 judges have dismissed cases alleging inadequate labeling by generic manufacturers. Over 75 percent of all prescriptions are filled by generic drugs.

In 2008, the Supreme Court held that a patient can sue a brand-name drug manufacturer for failure to warn, in a case involving Vermont musician Diana Levine. Leahy filed an amicus brief in the Supreme Court on behalf of Ms. Levine with 17 Congressmen, including Vermont Senator Bernie Sanders and Vermont Congressman Peter Welch.

Many public interest groups have called on Congress and the Food and Drug Administration to address the Court's decision in Mensing. Companion legislation is expected to be introduced in the House of Representatives by Congressmen Chris Van Hollen (D-Md.) and Bruce Braley (D-Iowa).

Bills Seek to Change Rule on Generic Drug Labels

By KATIE THOMAS
Published: April 18, 2012 in the New York Times

Democrats in the Senate and House introduced companion bills Wednesday that would permit generic drug companies to update warning information about the drugs they manufacture, a change that could allow patients to sue the companies for failing to warn about the risks of taking their drugs.

A Supreme Court decision last year, Pliva v. Mensing, barred patients from suing generic drug companies because the court ruled that the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the drugs' risks.

An earlier Supreme Court decision, by contrast, gave permission to patients who took brand-name drugs to sue the drug manufacturers. Since the decision last year, dozens of judges have thrown out cases filed by patients who claim they were harmed by generic drugs even though in many cases they suffered the same injuries as those who took the brand-name versions.

"The Mensing decision creates a troubling inconsistency in the law governing prescription drugs," Senator Patrick J. Leahy of Vermont, who sponsored the bill along with six other Democrats, said in a statement Wednesday.

"If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries," he said.

Two Democrats in the House, Chris Van Hollen of Maryland and Bruce Braley of Iowa, introduced an identical bill Wednesday. Chances are slim that it will pass the House, which is controlled by Republicans.

The consumer advocacy group Public Citizen has asked the Food and Drug Administration to take a similar action, but the agency said last month that it needed more time to decide on the issue.

Generic drug companies have opposed such a move because they say it could create a chaotic situation in which several different drug companies could publish conflicting warning information about the same drugs. Under current law, only brand-name drug companies can update the labels - the lengthy list of a drug's uses, dosages and risks - and generic manufacturers are then required to follow suit.

"Federal law requiring that generic medicines have the identical label as the corresponding brand products has provided American consumers the confidence to trust in generics for 80 percent of their prescription needs," Ralph G. Neas, president and chief executive of the Generic Pharmaceutical Association, the industry trade group, said in a statement. "This misguided legislation, introduced by Senator Leahy, would disrupt this confidence and unduly burden physicians who would have to be aware of multiple labels for the same product."

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