No, that is referring to other pharmaceutical companies attempting to promote off label truthful uses. Amarin has an injunction against the FDA that very specifically defines what it can say and not be penalized by the FDA no matter where it occurs. The only thing the FDA can do is appeal to the Supreme Court.

I believe that because it's an injunction against the FDA, not just a ruling on a case, it covers the FDA in its entirety, nationwide. One reason believed the FDA did not appeal Caronia to the Supreme Court is it didn't want to risk nationwide and possible more inclusive and clarified law.

The main reason Amarin selected the court in New York is that it is governed by the Second Circuit that made the ruling in Caronia. The judge in New York had no other choice but to rule in Amarin's favor. Federal courts are the same as state. Local courts' rulings only govern that case. Appellate courts govern areas. And if appellate courts differ the supreme courts decide for state or nation wide.

The FDA did not appeal Caronia. That's why the judge had to rule in Amarin's favor, it's established law. The FDA will not appeal Amarin case,futile and doesn't want law even more established and widespread.

Court deadlines are always extended to the next day the court is open

my CVS pharmacy pushes my blood pressure medicine as generic but not Vascepa. I also received email from Amarin reminding to refill and $9 through 2015

Th US adopted the English law where the King can do no wrong, and the government cannot be sued unless it allows it, sovereign immunity. There is the Turner and Tort Claims acts but the FDA has a specific exception.

and most importantly he isn't a crook at Adcoms working for big pharmaceuticals

Dr. William R. Hiatt was a major player in both the Avandia and Vascepa scandals with financial ties to GSK

Pfizer Confronts Surge of Lawsuits Over Lipitor
By Jessica DyeAugust 08, 2014
(Reuters) - Pharmaceutical giant Pfizer is facing a mounting wave of lawsuits by women who allege that the company knew about possible serious side effects of its blockbuster anti-cholesterol drug Lipitor but never properly warned the public.

In the past five months, a Reuters review of federal court filings shows, lawsuits by U.S. women who say that taking Lipitor gave them type-2 diabetes have shot up from 56 to almost 1,000.

Lawsuits began to be filed not long after the Food and Drug Administration in 2012 warned that Lipitor and other statins had been linked to incidents of memory loss and a "small increased risk" of diabetes. According to plaintiffs' lawyers, women face a higher risk than men of developing diabetes from using Lipitor, and gain fewer benefits.

The recent spike in lawsuits followed a decision by a federal judicial panel to consolidate all Lipitor diabetes lawsuits from around the country into a single Federal courtroom in Charleston, South Carolina. Pfizer opposed the consolidation, arguing it would prompt copycat filings. The first case is scheduled to be tried next July.

Pfizer said in a statement that it denied liability and would fight the lawsuits.

It is not uncommon for a drugmaker to get hit with thousands of lawsuits over its products after the FDA orders a label change alerting users to newly found risks. Takeda Pharmaceutical, for instance, is facing more than 3,500 federal lawsuits since 2011 when the FDA ordered it to update the label on its diabetes drug Actos to warn about bladder cancer. Takeda has denied liability.

But several factors set the Lipitor diabetes cases apart from those against other drug companies. For one, Lipitor is the best-selling prescription drug of all time, racking up global sales of more than $130 billion since it went on the market in 1996. More than 29 million patients in the United States have been prescribed the drug, suggesting there is a vast pool of potential plaintiffs.

On the other hand, potentially complicating matters for plaintiffs, the FDA emphasized the benefits of statins even as it warned of the risks.

When the labeling change was released in 2012, a top FDA official underscored that the agency still stood behind the drugs: "Clearly, we think that the heart benefit of statins outweighs this small increased risk (for diabetes)," Amy Egan, a deputy director for safety at the agency's Division of Metabolism and Endocrinology, said in a statement at the time.

RISKS AND BENEFITS

The seemingly mixed message from the FDA suggests that litigation will focus on two questions: how big a diabetes risk do women using Lipitor face, and whether that risk is mitigated by the drug's cardiovascular benefits.

H. Blair Hahn of Mount Pleasant, South Carolina, the lead lawyer appointed to represent Lipitor plaintiffs in federal court, said the plaintiffs contracted diabetes as a consequence of taking Lipitor, and that women with diabetes see the length and quality of their lives reduced.

"We will ask a jury to decide what it's worth to take five years of someone's life," Hahn said. He said the nearly 1,000 cases filed so far represent 4,000 women, and that the number of cases could ultimately reach 10,000 or more.

Pfizer said it believes Lipitor did not cause the plaintiffs' diabetes. Women who are prescribed Lipitor to control cholesterol may share other risk factors that make them vulnerable to the disease, such as high blood pressure or obesity, the company said.

The Pfizer statement said there is an "overwhelming consensus" in the medical community about statins' benefits.

BELLWETHER TRIALS

The first Lipitor trial, scheduled for next July before U.S. District Judge Richard Gergel, will be one of several so-called "bellwethers" used to gauge the strength of other cases. If Pfizer prevails, it could persuade plaintiffs to accept smaller settlements or drop cases.

Pfizer could also opt to settle before a single case is tried to avoid possible negative exposure or to prevent potentially damaging information from coming to light.

If past settlements are any guide, Pfizer's potential exposure could be substantial. Bayer, the maker of one-time rival statin Baycol, paid $1 billion in 2005 to settle about 3,000 cases alleging the drug caused rhabdomyolysis, a disease that breaks down muscle tissue. Baycol was pulled from the market in 2001 after being linked to 31 deaths.

In 2011 AstraZeneca said it would pay $647 million to resolve most of the 28,000 lawsuits it faced alleging its antipsychotic Seroquel caused diabetes and other injuries.

Pfizer has not indicated that it has set aside any money specifically to cover potential future Lipitor judgments, according to its most recent quarterly filing with the U.S. Securities and Exchange Commission.

Michael Green, an expert in mass torts at the Wake Forest University School of Law, said he did not expect Pfizer to settle at this stage, especially given the major obstacle plaintiffs still face.

"(They) have to show they were actually harmed by this agent," he said. "That might be hard."


Reuters Health Information © 2014


Cite this article: Pfizer Confronts Surge of Lawsuits Over Lipitor. Medscape. Aug 08, 2014.

ok
wmjenkins3938@aol.com

can you post or email copy of the opening brief and three exhibits

very nice article for Vascepa but written by spokesperson/consultant for Amarin, so significance?

no, I don't have access, but that's why I believe FDA will want to settle a SPA lawsuit rather than go through the discovery process

the appellate court judges are required to accept and rule on an appeal, but that doesn't mean the lower court ruling will be put on hold

Administration making drugs cheap:

Boon for device and drug startups
THOMAS LEE
Over the past few years, medical device and drug startups have privately and not so privately painted the Food and Drug Administration as a graveyard for innovation. The agency, critics say, makes it nearly impossible for new products and therapies to reach patients because bureaucratic regulators often take years to justify their existence.

But unbeknownst to many, the FDA has recently done something that could transform the relationship between startups and the government. Without much fanfare, the agency rolled out a system that allows anyone to quickly find and access millions of redacted patient records through a Google-like search called openFDA.

The FDA is starting with 3 million records that cover medication errors and side effects from 2004 to 2013 but will eventually expand to product recalls and labeling problems. In the past, people wishing to see the data had to file time-consuming Freedom of Information Act requests.

In short, openFDA is a gold mine for medical startups. Before wasting precious time and money on therapies that might never see the light of day, the startups can learn from the work of others, either by improving an existing technology or avoiding mistakes that doomed past efforts. Perhaps most importantly, openFDA could act like Regulation 101, a place where startups can learn to navigate the long and complicated path to FDA approval.

“OpenFDA is an amazing idea,” said Michael Niaki, founder of InfiniGene, a diagnostics startup at StartX incubator in Palo Alto. “People will be able to pull out data that would have been almost impossible to find. And this is high-quality, evidence-based clinical data that has been put to the test. We can always learn from the past.”

In addition, the data can help inexperienced startups anticipate how the FDA will react to submissions, allowing them to avoid delays that could sink a project, Niaki said.

How the FDA chooses to classify a device ultimately determines how long it will take to review it. For example, an MIT study in 2009 found that new devices classified as orthopedic often take the most time for review. So a startup could theoretically use openFDA data to determine if other companies had developed similar technology that the FDA classified as orthopedic. The startup could either try to convince the FDA to not classify its product as orthopedic, or at least plan accordingly if the agency ultimately does.

“Elucidating factors that predict review times will be of benefit to medical device executives and entrepreneurs,” the study said. “If, for example, one has a high level of confidence that a review will be long, one can defer spending large sums of money. (This) will help entrepreneurs plan for and time fundraising efforts.”

For drug startups, openFDA could provide valuable information about potential side effects. If a startup knew that a competitor had created a similar therapy that caused patients to feel nausea and joint pain, that company could modify its drug to avoid or limit those side effects.

“I think (openFDA) would be very helpful,” said Mark Kroll, a longtime medical technology entrepreneur. “It would be an incredible source of information for a startup, especially in learning from your competitor’s problems.”

For that reason, not all startups are pleased with openFDA. Although one can’t patent experience, lessons learned can be rightly called intellectual property, said Milt McColl, CEO of Gauss Surgical in Los Altos.

“We have a lot of information learned in development that we wouldn’t want our competitors to know about,” McColl said. “OpenFDA makes it easy. So what it took us two years to learn could take our competitor one day to figure out.”

Still, if openFDA can help medical device and drug companies move faster, that could benefit the entire industry.

Investors have often been reluctant to fund these startups because it takes too long for the companies to win FDA approval.

Last year, biotech and medical device firms attracted only 22.4 percent of the $29.4 billion dished out to startups by venture capitalists, according to the MoneyTree report by PricewaterhouseCoopers and the National Venture Capital Association. Medical device dollars alone fell 17 percent, compared with2012.

Meanwhile, software and Internet-related companies captured 62 percent of the pie, partly because investors know these startups can introduce products quickly without needing government approval.

In a broader sense, openFDA represents an entire new way of looking at government. We often complain that the feds hamper entrepreneurs and stifle innovation with regulations.

But perhaps government can give us something other than red tape, specifically piles of valuable data just ready for an investor and entrepreneur to exploit and save a few lives in the process.

Thomas Lee is a San Francisco Chronicle columnist. E-mail: tlee@? sfchronicle.com ? Twitter: @ByTomLee

how much does Amarin get from someone like me that pays, with Amarin discount card, $9 per month?

it would be easy to show if it was a hedge or just someone with inside info

thanks, do you know when this was filed? and if you can get copy of first response from AZN

when I go there it says to "sign on" to get any document other than the Complaint

Pharmacydude can you post the entire paper, link keeps saying expired,thanks

instead of answering the Complaint, AZN filed a motion to dismiss. because there was no answer this allowed Amarin to dismiss without Court permission, without prejudice, i.e., they can refile the case at any time.

are you really that naïve sts, Doctor's Best didn't know, didn't put it there? a little while ago protein supplements were found to contain anabolic steroids. Doctor's Best claims to buy all raw materials and active ingredients and manufactures and observes all raw materials production.

that's why you buy Vascepa, never buy a dietary supplement.

the Guidelines are the FDAs interpretations of the law, they become the law unless challenged, and that is part of the Congressional investigation:

The Committee also expects that, as a matter of public policy and fundamental fairness to the sponsor, FDA should be accountable for continued diligence in identifying issues that bear on the continued enforceability of a SPA agreement and in notifying the sponsor of such issues within a reasonable period of time after FDA becomes aware.

i like in the NEJM Discussion it says, "In this study and in previous studies, plasma levels of nonfasting triglycerides and remnant cholesterol were strongly associated with the risk of ischemic cardiovascular disease." 2-6

if you look at FDA Guidelines SPA section VI.B you will see the "unless public health concerns" part also. We need to write to Congress about this, some members might not be aware, but Amarin has mentioned it.

the FDA guidelines are direct quotes from Congressional Record, PDUFA Letter, and Act section 505(b)(5)(C)(ii). the Guidelines can only help iterpret the law, cannot invent or change

CONGRESSIONAL RECORD 112TH CONGRESS

VII. SPECIAL PROTOCOL QUESTION ASSESSMENT AND AGREEMENT

A. Procedure: Upon specific request by a sponsor (including specific questions that the sponsor desires to be answered), the Agency will evaluate certain protocols and issues to assess whether the design is adequate to meet scientific and regulatory requirements identified by the sponsor.

1. The sponsor should submit a limited number of specific questions about the protocol design and scientific and regulatory requirements for which the sponsor seeks agreement (e.g., is the dose range in the carcinogenicity study adequate, considering the intended clinical dosage; are the clinical endpoints adequate to support a specific efficacy claim).

2. Within 45 days of Agency receipt of the protocol and specific questions, the Agency will provide a written response to the sponsor that includes a succinct assessment of the protocol and answers to the questions posed by the sponsor. If the Agency does not agree that the protocol design, execution plans, and data analyses are adequate to achieve the goals of the sponsor, the reasons for the disagreement will be explained in the response.

3. Protocols that qualify for this program include: carcinogenicity protocols, stability protocols, and Phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim. For such Phase 3 protocols to qualify for this comprehensive protocol assessment, the sponsor must have had an end of Phase 2/pre-Phase 3 meeting with the review division so that the division is aware of the developmental context in which the protocol is being reviewed and the questions being answered.

4. N.B. For products that will be using Subpart E or Subpart H development schemes, the Phase 3 protocols mentioned in this paragraph should be construed to mean those protocols for trials that will form the primary basis of an efficacy claim no matter what phase of drug development in which they happen to be conducted.

5. If a protocol is reviewed under the process outlined above and agreement with the Agency is reached on design, execution, and analyses and if the results of the trial conducted under the protocol substantiate the hypothesis of the protocol, the Agency agrees that the data from the protocol can be used as part of the primary basis for approval of the product. The fundamental agreement here is that having agreed to the design, execution, and analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.

11/12/97 Letter: Goals Pertaining to the Reauthorization of the Prescription Drug User Fee Act
NOV 1 2 1997

VI. SPECIAL PROTOCOL QUESTION ASSESSMENT AND AGREEMENT
A. Procedure: Upon specific request by a sponsor (including specific questions that the sponsor desires to be answered), the agency will evaluate certain protocols and issues to assess whether the design is adequate to meet scientific and regulatory requirements identified by the sponsor.

The sponsor should submit a limited number of specific questions about the protocol design and scientific and regulatory requirements for which the sponsor seeks agreement (e.g., is the dose range in the carcinogenicity study adequate, considering the intended clinical dosage; are the clinical endpoints adequate to support a specific efficacy claim).


Within 45 days of Agency receipt of the protocol and specific questions, the Agency will provide a written response to the sponsor that includes a succinct assessment of the protocol and answers to the questions posed by the sponsor. If the agency does not agree that the protocol design, execution plans, and data analyses are adequate to achieve the goals of the sponsor, the reasons for the disagreement will be explained in the response.


Protocols that qualify for this program include: carcinogenicity protocols, stability protocols, and Phase 3 protocols for clinical trials that will form the primary basis of an efficacy claim. (For such Phase 3 protocols to qualify for this comprehensive protocol assessment, the sponsor must have had an end of Phase 2/pre-Phase 3 meeting with the review division so that the division is aware of the developmental context in which the protocol is being reviewed and the questions being answered.)


N.B. For products that will be using Subpart E or Subpart H development schemes, the Phase 3 protocols mentioned in this paragraph should be construed to mean those protocols for trials that will form the primary basis of an efficacy claim no matter what phase of drug development in which they happen to be conducted.


If a protocol is reviewed under the process outlined above and agreement with the Agency is reached on design, execution, and analyses and if the results of the trial conducted under the protocol substantiate the hypothesis of the protocol, the Agency agrees that the data from the protocol can be used as part of the primary basis for approval of the product. The fundamental agreement here is that having agreed to the design, execution, and analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.

not on that phone call, but there will be settlement efforts before trial

yeah that's all it is

they were intimidated and blindsided. Hiatt took an issue that no one prepared for. Amarin thought decades of studying fish oil and the lack of any problems in Marine, Anchor, and post market kept it off the table. Hiatt was able to say lack of any efficacy by discounting JELIS and Niaspan then adding a theoretical glucose platelet problem and saying Amarin needed to prove complete safety with more studies.

oh I don't think they were all experts except for Hiatt and Smith. I think one ran an obesity clinic with no credentials.

Amarin lost Adcomm because it was blindsided. Dr Hiatt immediately began his rant of Vascepa may cause clinical hemorrhage and convert prediabetics to diabetics. He monopolized the meeting. He said he calculated a 50% increase in bleeding and had to be explained his calculations were misleading and made no sense.
Amarin answered that fish oils have been studied for decades, it was addressed in Marine, there was post-market experience and it was a nonissue. Hiatt responded Amarin's lack of evidence of a problem wasn't evidence it did not exist and needed to be studied more.
Everyone now knows that was a phony issue and Hiatt receives millions from GSK. The Adcomm Chair, Dr. Smith, said Hiatt was wrong and voted for Amarin but the others went along with Hiatt.

FDA pushing fish oil:

http://www.latimes.com/business/la-fi-fda-fish-pregnant-women-20140610-story.html

we all received the same response letter to our CPs, my CP excluded the request for a delay but letter from FDA inducated i asked for delay

no one is suing for damages, declaratory judgment allows a company to function without risking getting into trouble. yes the government provides less protection to commercial speech, it must be truthful

no, Amarin has said a few times if the FDA issues a CRL or if the appeal is finally unsuccessful it will go to court and get a judgment to allow truthful labeling concerning Anchor. Courts don't force companies into risky behavior, they provide declaratory judgments ahead of time.

sort of, this is commercial free speech which is looked at differently than regular free speech