“Our commitment is to provide aggressive, effective, and informed representation to clients who have suffered harm as a result of Elidel or Protopic.” - Larry Roth

Protopic/Elidel News

The Law Offices of Larry M. Roth, P.A. is accepting referrals from across the United States for potential Protopic and Elidel claims.

Sept 28, 2007 - Company To Pay $515M To Settle Drug Marketing Probes

Bristol-Myers Squibb Co. and a subsidiary have agreed to pay more than $515 million to settle federal and state investigations into their drug marketing and pricing practices, U.S. Attorney Michael Sullivan announced Friday.

Government investigators alleged that Bristol-Myers Squibb paid illegal remuneration from 2000 to 2003 in the form of consulting fees to induce doctors and other health care providers to buy the company's drugs.

Investigators also claimed that from 2002 to 2005, the New York-based drugmaker promoted the sale of Abilify, an anti-psychotic drug, for pediatric use and to treat dementia-related psychoses. Neither use is approved by the Food and Drug Administration

Abilify is used to treat bipolar disorder and schizophrenia.

In the second quarter, the company reported $412 million in sales of Abilify, a 27 percent increase from a year earlier.

Bristol-Myers announced in December that it had tentatively agreed with the U.S. Attorney's Office in Boston to settle an investigation into its marketing activities. At that time, the company did not disclose which drugs were involved.

Besides Abilify, Bristol-Myers Squibb makes Plavix, a blood thinner that is the company's top-selling drug, and Pravachol, a cholesterol-lowering drug.

The settlement with Bristol-Myers Squibb is the latest in a series of settlements the Justice Department has reached with pharmaceutical companies over illegal marketing of their drugs. Sullivan's office has been particularly aggressive in prosecuting health care fraud cases.

Earlier this year, Schering Sales Corp. and its parent company, Schering-Plough Corp., agreed to pay $435 million to settle allegations it lied to the government about drug prices and illegal promoted the drugs Temodar and Intron A for the treatment of cancers they were not approved for by the FDA.

In 2004, Pfizer Inc. paid $430 million in fines to settle allegations it marketed the epilepsy drug Neurontin for pain and psychiatric illnesses.

In 2001, TAP Pharmaceutical Products paid $875 million to settle allegations it inflated prices and bribed doctors to prescribe its prostate cancer drug Lupron.
View Settlement Agreement

Apr 26, 2007 - Skin Drugs Used By Millions Could Pose Cancer Risk

In a word, faith is what pulls the Rev. Johnny Henderson through this time of his life.

Henderson fans picture after picture of himself across the table. And they are of Henderson, but you might not realize it. “This is when it was at its worst,” he said, looking down.

In each picture, his face and body is covered with discolorations and what appear to be growths. He said his doctor called it cancer. Henderson just calls it a living hell.

“That’s that monster,” Henderson said. He has since had months of cancer treatment.
View Full Article

Feb 21, 2007 - Skin Drugs Used By Millions Could Pose Cancer Risk

Some cancer victims and their families say they would not have used the topical medications were the risk made known to them. CBS 2 Investigator Dave Savini reports.

(CBS) CHICAGO Drugs used to treat skin conditions were prescribed to millions of users for years before federal authorities warned that the medicines might cause cancer. CBS 2 Investigator Dave Savini reports on the risks that some say should have been made known from the start.

“I would never have put this in my body had I known how toxic and potent this drug was,” says Traci Reilly of Naperville, who believes two widely prescribed medications may be responsible for her breast cancer. “I noticed a lump in my right breast which is the exact area where I was using the drug.”

Reilly, 41, developed breast cancer after using a topical ointment called Protopic and a similar drug named Elidel. Both are commonly prescribed for skin disorders like eczema or, in Reilly’s case, a condition called vitiligo that caused small patches of discolored skin on her body.
View Full Article

Elidel Lawyer Wins Pre-Emption Ruling With the FDA Tuesday January 23, 6:00 am ET ORLANDO, Fla., Jan. 23 /PRNewswire

In a landmark case ruling, (Perry v. Novartis No. 05-530), Larry Roth, of law offices of Larry M Roth, PA, in cooperation with the law firm of Seeger Weiss, are the first lawyers to win an FDA pre-emption ruling sought by a drug manufacturer in an Elidel lawsuit. Elidel is a topical immunosuppressant drug linked to lymphomas.

The manufacturer, Novartis, is now warning about the risk of developing lymphomas and cancers -- a warning that was not in the original FDA approval in 2001. The Elidel lawsuit is based on this issue; Novartis should have warned doctors about these risks when the drug was approved in 2001 and it should have been warned on the label itself.

"We believe Novartis knew of these risks," says Larry Roth, "because studies they did in order to approve their drug showed incidents of people developing lymphomas and infections."

Novartis argued that, when Elidel was approved, the FDA didn't require warnings of lymphomas, and therefore Novartis could be sued.

Did the FDA expressly pre-empt a particular area or claim or by implication? In January 2006 the FDA reissued a policy statement regarding warnings on prescription drugs. It said that, if the FDA has approved a warning, the drug maker cannot be sued beyond what the FDA has approved.

"In the Perry case, one of the arguments raised was that this is an advisory statement and cannot pre-empt our lawsuit," says Roth. "The lymphoma and cancer warning should have been given in 2001, not 2006. The FDA cannot retroactively go back to 2001 and preclude lawsuits because the original warnings were inadequate."

The court said that, unless the FDA specifically addressed this proposed warning, evidence that the FDA rejected, then there could be no pre-emption of making the claim. "This pre-emption issue came about because the defendant filed a motion to dismiss the claim. Now the lawsuit can proceed because of this warning..."

The Perry case is being handled by lead co-counsel David Buchannan of Seeger Weiss along with Larry Roth.

Deadline For Legal Action Against The Manufacturers Of Protopic Or Elidel Is Approaching, According To Larry M. Roth

"If you have been diagnosed with some form of lymphoma (including Non-Hodgkin's and Hodgkin's Disease), leukemia or skin cancer, you may have a case against the manufacturers of Protopic or Elidel," says Laurilyn Cook-Arrington, para-legal at the law offices of Larry M. Roth.

"However, the public must know that these cases are governed by the statute of limitations and every state has different issues," she explains. For example, some states can have a statute of two years - certain statutes might be running out quicker than others. "Be aware that you may be under a very limited time frame that you can file against these drug companies, depending upon where you live."
Link To Full Article

Protopic and Elidel: Eczema Drugs Have a Cancer Risk

Early this year, the Food and Drug Administration issued a warning about two prescription topical creams for the common skin disease, eczema. Both Elidel and Protopic must now include written material for professionals and patients that warns of a cancer risk based on “information from animal studies, case reports in a small number of patients, and knowledge of how drugs in this class work.”

Though the warning says, “a small number” of people who have used the products “have had cancer (for example, skin or lymphoma),” evidence from the FDA’s own reporting system indicates that this may be an understatement. Pretty alarming for drugs that are applied to the skin, primarily for young children. Doubly so, considering the fact that less than 10% of all serious adverse drug reactions are reported to the FDA.

People with eczema, also known as atopic dermatitis, and parents of children with this chronic skin disorder are often desperate for a treatment that alleviates the severe itchiness and inflammation. Eczema primarily afflicts babies and children, but can continue into adulthood in about 50% or show up (rarely) for the first time in adulthood. There is no cure. A drug might beat it back for a short time, but flare-ups are common.
Link To Full Article

Federal Judge Rules In Favor Of States' Rights To Administer Justice,
Despite Industry Efforts To Escape Accountability

Two-year-old Andreas Perry was prescribed the topical immunosuppressant Elidel to treat his eczema. Six months after treatment, Andreas was diagnosed with lymphoblastic lymphoma, a rare form of cancer. Though Novartis' research indicated that Elidel increases the risk of cancer, his parents were never warned. The FDA ultimately required Novartis to add a "black-box" warning label with Elidel's cancer risks, but that was too late for Andreas' family to make an informed choice. The Perrys sued Novartis, alleging that it had failed to adequately warn of Elidel's known risks.

Novartis tried to have the case dismissed, arguing that the claims were preempted by the FDA's approval of Elidel's label. In a decision last week, U.S. District Court Judge Stewart Dalzell ruled that the FDA's approval of a drug's label does not preempt claims against a drug maker for failing to warn consumers of known risks. The court ruled that, because FDA regulations already permit manufacturers to supplement labels with warnings of newly discovered risks without prior FDA approval, state suits do not conflict with FDA regulations.

This decision is especially important because the FDA recently attempted – in a preamble snuck into new prescription drug regulations without any congressional approval or discussion – to dramatically expand federal preemption. This threatens to prevent Americans from holding the pharmaceutical industry accountable in state courts for failing to warn of a drug's dangers.

In the Agency

The preemption language inserted in the preamble to the FDA's new drug rule highlights the technique various federal agencies are using to eliminate state safety laws designed to protect individuals, like Andreas Perry, in favor of more lax, industry-friendly federal standards. In the past two years, several federal agencies (the National Highway Transportation Safety Agency, the Consumer Product Safety Commission and the Environmental Protection Agency) have all issued documents containing preemption language in at least one phase of a rulemaking proceeding. The preemption efforts utilized by these federal agencies expose the dangerous amount of influence that corporate interests have gained over federal agencies charged with protecting the public.

By the Numbers

$673,701,988: Pharmaceutical industry lobbying expenditures between 1998 and 2004.
$799,182: Drug company contributions to President Bush during the 2000 and 2004 elections.

In the News

FDA Tries to Limit Drug Suits in State Courts
Washington Post, 1/19/06
"People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts, the agency said yesterday in a formal policy statement.... Without state product liability laws, the critics said, drug companies could escape responsibility for injuries and deaths caused by drugs such as Merck & Co.'s Vioxx, which an FDA medical officer estimated had killed as many as 55,000 Americans."

FDA rule may aid drug firms in liability suits
Boston Globe, 1/19/06
"The new rule... drew fire from US Senator Edward M. Kennedy, Democrat of Massachusetts. 'It's a typical abuse by the Bush administration take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry,' Kennedy said in a statement. US Representative Maurice Hinchey also criticized the regulators' actions. 'It runs contrary to everything the FDA was set up for,' said the New York Democrat. 'And it creates a situation where the drug companies are not going to be held responsible, in the way they should be, for the items that they put on the market.'"

May 2006

Protopic and Elidel for Eczema: FDA Takes Inadequate Action on Cancer Risk

Center for Medical Consumers - HealthFacts Newsletter

Early this year, the Food and Drug Administration issued a warning about two prescription topical creams for the common skin disease, eczema. Both Elidel and Protopic must now include written material for professionals and patients that warns of a cancer risk based on “information from animal studies, case reports in a small number of patients, and knowledge of how drugs in this class work.”

Though the warning says, “a small number” of people who have used the products “have had cancer (for example, skin or lymphoma),” evidence from the FDA’s own reporting system indicates that this may be an understatement. Pretty alarming for drugs that are applied to the skin, primarily for young children. Doubly so, considering the fact that less than 10% of all serious adverse drug reactions are reported to the FDA.

People with eczema, also known as atopic dermatitis, and parents of children with this chronic skin disorder are often desperate for a treatment that alleviates the severe itchiness and inflammation. Eczema primarily afflicts babies and children, but can continue into adulthood in about 50% or show up (rarely) for the first time in adulthood. There is no cure. A drug might beat it back for a short time, but flare-ups are common.

April 21, 2006

Texas jury finds against Merck in Vioxx case (Reuters)

RIO GRANDE CITY, Texas , April 21 (Reuters) - A Texas jury on Friday found that painkiller Vioxx caused the death of 71-year-old Leonel Garza and awarded $7 million in compensatory damages and $25 million in punitive damages to his family.

The verdict against Vioxx maker Merck & Co. Inc. <MRK.N> came in the latest lawsuit charging that the company did not disclose for several years that the now-withdrawn medicine caused an increased risk of heart attacks.

April 5, 2006

Jury rules against Merck's Vioxx, awards $4.5 million
By Jon Hurdle (Reuters)

A jury on Wednesday found Merck & Co. failed to warn Vioxx users of the drug's heart risks and ordered it to pay a 77-year-old plaintiff at least $4.5 million in a decision that raises questions about the company's future defense of thousands of lawsuits filed over the medicine.

February 2006

Larry M. Roth's article on the Cancer Risk of Prescription Skin Disease Drugs was published in the ATLA (Association of Trial Lawyers of America) Products Liability Winter 2006 newsletter.

January 20, 2006

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

• Elidel Cream (pimecrolimus)
• Protopic Ointment (tacrolimus)

Read the complete MedWatch 2006 Safety Summary, including links to the FDA Public Health Advisory and the FDA Drug Information Page that includes links to the Healthcare Professional and Patient Information Sheets, at:

• http://www.fda.gov/cder/drug/infopage/elidel/default.htm
• http://www.fda.gov/cder/drug/infopage/protopic/default.htm

January 20, 2006

FDA to Require Warnings on 2 Eczema Drugs
By Andrew Bridges (AP)

The labels on two prescription creams to treat eczema will have to show "black box" warnings of possible cancer risks. According to the FDA, the new labeling requirements also will clarify that the two drugs are recommended for use only after other prescription topical medicines have been tried by patients. The FDA is also issuing a guide updating patients of its cancer concerns.

Link to Full Article

January 19, 2006

Want to treat eczema? Beware of cancer
By Associated Press (Published on CNN.com)

The labels on two prescription skin creams to treat eczema will have to include "black box" warnings of possible cancer risks. The Food and Drug Administration (FDA) action Thursday follows an agency advisory committee recommendation last February that Elidel cream and Protopic ointment carry the label warnings.

November 2005

On behalf of an injured client who developed a lymphoma, the Law Offices of Larry M. Roth, P.A. sued Astellas (formerly known as Fujisawa) and Novartis in Kentucky. The case is pending.

October 18, 2005

Larry M. Roth was recently sworn-in as a member of the New York State Bar.

August 22, 2005

Jury: Merck negligent; Merck blamed for death in Vioxx suit; jury awards $253 million
By Aaron Smith (CNN/Money)

Link to Full Article

Merck has been held liable by a Texas jury in the first lawsuit involving its former blockbuster drug Vioxx, in a case that could have a profound effect on thousands of other cases filed against the company.

Plaintiff Carol Ernst has won her lawsuit in Texas Superior Court in Angleton, which blames Vioxx for the 2001 death of her husband, Robert Ernst, a 59-year-old marathon runner and Wal-Mart worker who was taking the arthritis painkiller at the time of his death. Ernst died of a heart attack.

The verdict held Merck liable for the death. Jurors voted 10-2 in favor of Ernst.

The jury awarded more than $250 million in total damages -- $24 million to Carol Ernst for mental anguish and loss of companionship, and $229 million in punitive damages. Ernst's Houston-based lawyer, Mark Lanier, said the punitive-damages figure was based on "the money Merck made and saved by putting off their product label changes."

Lanier had been seeking $40.4 million in damages, and after the verdict, Lanier said that he expected the punitive-damages award to be reduced according to Texas law.

"Justice is a beautiful thing, isn't it?" Lanier told reporters following the verdict.

August 16, 2005

Prescription Drugs Treating Skin Disease Puts You and Particularly Your Children at Risk for Cancer
By Larry Roth

Link to Full Article

August 12, 2005

Pfizer to Change Drug Advertising Policies
Food & Drug Law Institute SmartBrief, Inc.

Pfizer announced changes in its drug advertising policies, including a pledge not to advertise new drugs directly to the public for at least six months after they enter the market. The decision by Pfizer, the world's largest drugmaker, came in response to new industry guidelines for communicating important information about drugs to doctors and patients. The company said it also would use more disease-awareness ads that do not promote a particular product.

August 3, 2005

Drug Firms Take a Dose of Responsibility for Ads
By Steven Pearlstein (Washington Post)

Those who fear the unchecked power of big, rich corporations might have taken some comfort yesterday as top executives in one of the most profitable and politically potent global industries -- the pharmaceutical sector -- acknowledged that they had gone overboard in advertising some products and laid out a set of voluntary guidelines for doing better in the future.

As one drug executive put it recently, offending large numbers of customers, or the public, isn't a particularly good business strategy -- which is apparently what the industry did with all those ads for little blue pills and lasting erections.

One reason for regulating drug-company advertising is that the market for prescription drugs is highly imperfect. Each product, in effect, is a little monopoly protected from competition by a government patent. And in most cases, the party paying for the product (an insurer or the government) is not the party deciding whether or how much to buy (the patient). From an economic perspective, these market "imperfections" are serious enough to justify some regulation.

That said, the courts have been pretty clear that even big corporations have free-speech rights and that any curbs on them need to be carefully tailored to achieve a compelling public purpose.

Industry critics claim that consumer advertising drives up the cost of drugs. But the Federal Trade Commission concluded that there is very little connection between what drug companies charge for a drug and the costs directly associated with it. What is true, however, is that advertising has been effective in driving up the sales of certain drugs, almost irrespective of price. A study by the Kaiser Family Foundation found that each $1 invested in advertising yields an extra $4.20 in sales. Those extra sales are now reflected in soaring budgets for Medicaid and Medicare, runaway health insurance premiums and the continued rise in the number of Americans without health insurance.

No doubt some of that extra spending has improved the health and quality of life of some Americans. But most independent studies find advertising also induces many patients to ask for prescriptions that they really don't need or that offer low health benefits relative to cost. In theory, doctors should be knowledgeable and hard-nosed enough to turn aside these advertising-induced requests. In practice, they aren't, which is why even physician groups complain that drug advertising is now "interfering with the doctor-patient relationship."

The voluntary guidelines announced by the industry yesterday represent a credible first step in solving some of these problems. They require companies to provide doctors with more timely information about a drug before touting it on the evening news. They should result in ads that give consumers more useful information and present a better balance between medical risks and benefits. And they may even reduce the risk that you'd have to interrupt the Super Bowl to explain erectile dysfunction to your inquiring 8-year-old.

What they probably won't do, however, is curb the growth in unnecessary spending. Giving more factual information to irrational consumers and conflicted physicians operating in a imperfectly competitive marketplace only gets you so far.

What's needed, in addition, is some sort of test that would limit or eliminate advertising for drugs such as Nexium, the acid-reflux medicine that offers little or no advantage over cheaper generics. Or Procrit, a fabulously expensive drug suitable only for a limited number of patients who suffer from anemia as a result of cancer treatments. Or Lovenox, a blood thinner originally designed for people recovering from surgery, which is now peddled as a preventative cure for "Economy Class Syndrome" -- blood clots that develop (rarely, it turns out) after sitting for long periods in cramped spaces.

The reason that these drugs are so aggressively advertised is not because they represent a solution to some widespread, unmet medical need. The purpose, in fact, is to artificially create the impression in the minds of consumers that such a need exists. And that ruse would quickly be exposed if drug companies had to put their products through a reasonable and independently administered cost-benefit analysis before marketing them directly to the public.

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