TAKE ACTION FOR LOWER DRUG COSTS! STOP PHARMA’S BACKROOM DEALS!

Working with consumer advocates across the country, Consumer Catalyst has launched a campaign to stop  ‘Pay-for-Delay’ deals that hurt consumer health!

What you can do:

1. Sign the consumer petition on Change.org
2. Join the discussion on twitter and share your story, using the hashtag: Stop the #RxRacket! And ask others to share their stories too. Also follow us at @postscriptrx.
3. Join our community on Facebook to keep up with the campaign and join our email list of impacted consumers by sharing your story.

You can also tell us your story, if you are interested in joining us as a consumer advocate and speaking out on these issues to local media.

Pharmaceutical companies are colluding to keep drug prices high – and taking that money right out of your pocket.

Did you know drug companies have made more than 160 secret, back-room deals that

• Have kept 100 generic drugs or more off the market for years
• Drive up the cost of each drug by an average of $3,000 a year
• Keep all of our prescription costs high, while divvying up the spoils!

Right now, the Supreme Court is currently deliberating over whether these back-room deals are legal – but we know they’re wrong. Since 2005, as many as 142 different generic drugs have been unfairly kept from consumers, according to government reports. Delaying the launch of a generic drug lets the drug companies make bigger and bigger profits, while patients are stuck footing the bill, or going without the medicines they need.

The Supreme Court heard arguments by the drug companies, and fortunately Justices Kagan and Sotomayor raised consumer concerns – but the Court did not hear the perspective of the thousands of Americans unable to afford their medications. That’s because most people don’t even know that these deals are costing consumers thousands, and our health system billions of extra dollars, each year!

Help us raise awareness of this #RxRacket. The public deserves to know how this decision will affect us all – how thousands of Americans are being forced to choose between skipping their medications or going into credit card debt, just so that drug companies can make even more profit. Not to mention, how health care costs for everyone have gone up, because insurers pay most of these higher costs!

Whatever the Supreme Court decides, help spread the word, so we can help make sure that these deals come to an end, once and for all.

Target drugs: 
If you have taken Cipro, Provigil, or Androgel, you have definitely paid more because of a pay-for-delay settlement. And according to legal experts, it is very probable that many drugs including blockbuster drugs like Lipitor, Plavix and Nexium — have been delayed by pay-for-delay deals.*

We need you to tell everyone you know that this is happening, and help gather and share the stories of people you know that have been negatively impacted. Read the stories shared by two women, Tanna and Karen, who were unable to afford their medications due to pay-for-delay deals that kept generic Provigil off the market for six years. Also, read how the companies’ legal arguments make no sense.

You can find all the information you would ever need about this issue on our Pay-for-Delay info page. Please also feel free to add your thoughts on this #RxRacket in the comments, below.

Thank you for helping us protect your right to affordable medicine!

*The Full List – Drugs Likely to Have High Prices from ‘Pay-for-Delay’ Deals:
Adderall XR, Aggrenox, Altace, Arthrotec, Caduet, Carbatrol, Clarinex, Comtan, Duac, Effexor XR, Eloxatin, Ethyol, Femcon Fe, Fentora, Flomax, Lipitor, Lamictal, Levaquin, Lexapro, Loestrin-24 Fe, Loprox, Lotrel, Lybrel, Namenda, Naprelan, Nexium, Niaspan, Niravam, Olux, Opana ER, Ortho Tri Cyclen Lo, Oxytrol, Plavix, Propecia, Razadyne, Razadyne ER, Rythmol SR, Sinemet CR, Skelaxin, Solodyn, Stalevo, Tricor 145mg, Vanos, Vfend, Wellbutrin XL (150 mg), Xopenex, and Zantac!

[Also posted on Postscript]

When drugmakers lie to doctors about a drug’s safety or effectiveness, health plans pay more for substandard care, and patients suffer.

Case in point — the recent guilty plea and $1.5 billion settlement for illegal promotion of the drug Depakote revealed how Abbott Labs misled doctors for nearly a decade. They went to great lengths, profiling doctors, training their salespeople, and inappropriately funding and influencing Continuing Medical Education to get doctors to prescribe Depakote for unapproved treatment of seniors with dementia. Why? Because such off-label promotion instantly expands a drug’s market, and thus the drugmaker’s potential profits.

Unfortunately, class action lawsuits on behalf of consumers and health plans challenging such illegal marketing have met significant legal hurdles, and have been dismissed. This leaves consumers and private market health plans paying billions because of this fraud, while millions of patients receive inappropriate treatment, and are unnecessarily put at risk of side effects, which are often serious.

But progress is being made by State Attorneys-General and the Department of Justice bringing legal challenges under false claim laws. As a result, six of the biggest drugmakers have admitted or pled guilty to illegal promotion of unapproved uses of drugs since 2004. These investigations, most often initiated by whistleblowers, have led to the largest fines in U.S. history, and billions will be recovered this year alone.

But while all these enforcement actions are a welcome development, a recent jury verdict in a trial by the State of Arkansas may become a game-changer in the fight to stop the illegal marketing or promotion of drug products.

This past April, Arkansas Attorney-General Dustin McDaniel won a staggering verdict against Johnson & Johnson for their illegal promotion of the off-label uses of the antipsychotic drug Risperdal. In a trial before a jury, the state won $1.19 billion (yes, that’s ‘b’ ) in fines for violations of the state Medicaid anti-fraud law.

A hefty billion-dollar fine like this from one state sends a very big message — drug companies can no longer pursue profits by scoffing at the laws designed to protect safety-net health plans and the patients they serve.

Even more encouraging is the fact that most of the $1.19 billion in fines will go to the State Medicaid fund, which is looking at a $400 million budget shortfall next year.

What could be better than a deterrent that also helps stabilize funding for a state’s Medicaid plan during these tough economic times? Well, the only thing that could make this victory even better would be for Arkansas’ Medicaid program to earmark some of these recovered funds to correct the misinformation spread by Johnson & Johnson. Setting aside even a small amount of funds to allow trained independent medical professionals to go out into the field and teach doctors about the appropriate and effective alternatives to the unapproved uses of Risperdal will help prevent any ongoing inappropriate use of Risperdal, improving the quality of patient care and protect patients from being harmed by the significant side effects of the drug, like weight gain and diabetes. (See more about such education programs here.)

As we have seen in drug pricing (here and here) and universal coverage, the States often take the lead in on innovative ways to protect consumers. Based on this successful prosecution by the Arkansas Attorney-General, it wouldn’t be a bad idea for the remaining States to beef up their anti-fraud laws and enforcement staff, and go after the drug industry.

– Wells Wilkinson
Director, Prescription Access Litigation
Staff Attorney, Community Catalyst

On October 15th, the Senate Judiciary Committee voted out S. 369 (here is the bill), the ban on pay-for-delay settlements between brand-name pharmaceutical manufacturers and generic-drug companies.  The purpose and result of these settlements is that the generic drugs come to market later.  This means that patients and insurers must wait to have access to the drugs they need at the much lower generic price. This bill would pave the way for cost savings, since generic drugs would come to market faster.  The FTC has estimated the savings at $35 billion to consumers and $12 million to the federal government over ten years.

The House and the Senate each have a bill on this issue, but they differ slightly in terms of enforcement of the ban. The Senate version of the bill says that the agreements would be presumed illegal.  However, the FTC would need to pursue legal action to challenge this agreement.  The drug companies would then have the opportunity to go to court and argue that the agreement is ‘pro-competitive’.  If the FTC wins the court case, they would have the authority to assess significant civil penalties on the drug companies.

The House version  of this bill (here is the House version) is attached to the tri-committee health reform bill and came out of Energy and Commerce.  The ban in the House modifies Section 505 of the Federal Food, Drug, and Cosmetic Act and puts enforcement directly in the hands of the FTC.  This amendment does not provide for rebuttal by the parties in court, but instead would allow the FTC to exempt agreements where the value of the payments to the generic drug company do not exceed certain thresholds.

Both the Senate and the House versions include some parameters for the FTC to utilize when making their decisions about to enforce the ban on drug companies.  The House language leaves the exception determinations to the FTC to resolve, while the Senate version specifically calls for judicial review in the D.C. Circuit Court.

This Senate version of the bill now moves to the full Senate.

On July 6, the Department of Justice (DOJ) filed a brief in the U.S. Court of Appeals for the 2nd Circuit expressing a new DOJ view on pay-for-delay settlements. The brief urges the 2nd Circuit to regard pay-for-delay settlements as “presumptively unlawful under Section 1 of the Sherman Act.” While the DOJ has not always supported a presumption against legality for these settlements, the Federal Trade Commission (FTC) has long been adamant that such settlements are unlawful. Now, more than ever before, the DOJ and the FTC seem to have a similar perspective on pay-for-delay settlements.

The July 6, 2009 brief filed by the DOJ signifies a stark departure from the Bush administration’s position. In 2006 and 2007, the DOJ urged the Supreme Court to refuse to hear two cases involving pay-for-delay settlements, involving the drugs K-Dur and Tamoxifen, because the DOJ felt these settlements were legal. In its latest brief, the DOJ states that “[r]everse payments are scarcely essential to the voluntary settlement of patent disputes.” The DOJ brief then goes on to discuss how such settlements have reduced the affordability of prescription drugs for consumers. The DOJ emphasized that it was not taking a stance on the specific settlement in the case at bar, involving the antibiotic drug Cipro, but made a more general statement about settlements including payments to the alleged patent infringer to keep the generic drug off of the market. The brief echoed earlier statements of Christine Varney, the new Assistant Attorney General, who announced during her confirmation hearings an intent to “align” the position of the DOJ with that of the FTC.

During a speech last month at the Center for American Progress, FTC Chairman Jon Leibowitz estimated that prohibiting pay-for-delay settlements would save consumers $3.5 billion per year. The anti-pay-for-delay sentiment in the FTC and DOJ has also reached Congress. Two bills in Congress, S.369 (introduced by Sens. Herb Kohl (D-WI.) and Chuck Grassley (R-IA)) and H.R. 1706 (introduced by Rep. Bobby Rush (D-IL-1.)) would help bring generic drugs to market sooner. These bills would prohibit brand name and generic drug companies from entering into agreements in which the brand name company pays off the generic company in return for the delay of the generic onto market. You can find out more about this legislation here.

The European Union also recently investigated the legality of pay-for-delay settlements. The EU study found that it took an average of seven months after expiration of the brand name company’s patent for a generic drug to come to market. This delay cost consumers about 3 billion euros (roughly U.S. $4.2 billion) from 2000 to 2007. You can read more about the EU investigation in the NY Times. http://www.nytimes.com/2009/07/09/business/global/09drug.html

PAL’s most important lawsuit and settlement to date wins final approval!

Yesterday, the Massachusetts federal District Court approved class action settlements with publishers First Databank and MediSpan that will require the roll back the illegally inflated prices of over 400 drugs!

PAL coalition members AFSCME District Council 37 Health and Security Plan in New York, and New England Carpenters Health Benefit Fund here in Boston brought the lawsuit against these two publishers, and the pharmaceutical wholesaler McKesson, for their role in unilaterally raising the prices of over 400 drugs through their alleged manipulation of the published “average wholesale price” or AWP. Though the system of pharmaceutical pricing and reimbursement is complex, the AWP is a benchmark that is used by insurers and government programs to reimburse pharmacies. It also effects the cost to cash-paying customers. It is alleged that defendants First Databank, Medispan, and McKesson raised the AWP, while keeping the actual cost (called a ‘wholesale acquisition cost’) the same. This done to give  the large chain and other pharmacies, many of which are McKesson’s customers, an increased return on each of these drugs.

It has been estimated that this 5% increase in the cost of hundreds of drugs by the defendants may have cost consumers, insurers, and government programs over $2 billion in additional drug expenses.

It is estimated that the “rollback” of the price of these 400 drugs could yield between $1.5 Billion or more in future savings on drug costs. Perhaps of even greater importance, this lawsuit, along with other litigation (AWP, Remicade, Lupron) by PAL members, has exposed the weaknesses of the pharmaceutical pricing system that have allowed drug makers and wholesalers to manipulate or “game” the benchmark prices that government programs and insurers use for reimbursement.

The Judge in the case did allow a six month delay before the rollback of the drug prices, ” to alleviate the impact on independent and rural pharmacies.” This addressed the concern raised that small ‘mom and pop’ pharmacies may be forced to bear the full cost of the price rollback if they were unable to renegotiate their supply contracts for drugs with manufacturers and wholesalers.

The settlement also provides $2.7 million to be distributed along with the $350 Million in the preliminary McKesson settlement.

Thanks to PAL members New England Carpenters Health Benefit Fund, and AFSCME District Council 37 Health and Security Plan in New York for their work in bringing this important lawsuit.

Follow these links to see a copy of the Judge’s decision, the First Databank settlement, the Medispan settlement, or the pending McKesson settlement.

Several PAL members are plaintiffs in class action lawsuits concerning alleged schemes by publishers of drug price data and a prescription drug wholesaler to inflate the Average Wholesales Prices of prescription drugs. Notices have been issued concerning settlements in these cases, New England Carpenters Health Benefits Fund, et al. v. First DataBank, Inc., et al. (U.S. District Court, Massachusetts, Case No. 1:05-CV-11148-PBS) and District Council 37 Health & Security Plan v. Medi-Span (U.S. District Court, Massachusetts, Case No. 07-cv-10988-PBS).

The settlements do not provide cash payments by First Databank or Medi-Span. The settlements call for First Databank and McKesson to roll back increases in the published Average Wholesale Prices of hundreds of drugs, and to cease publication of Average Wholesale Price data within 2 years of the settlement becoming final. These changes are expected to have a significant impact on drug prices which will benefit the members of the class.

The classes in the settlements includes consumers who paid for all or part of the cost of certain prescription drugs based on data published by FDB or Medi-Span. You must have made these purchases based on First Databank published prices between January 1, 2000 and the date of Final Court Approval of the FDB Settlement and/or purchases based on Medi-Span published prices between December 19, 2001 and the date of Final Court Approval of the Medi-Span Settlement. The classes also include third party payors. Pharmacy Benefit Managers and consumers who paid “flat” (i.e. fixed) copayments are excluded.

Deadlines related to these settlements are:

• To exclude yourself from the class, you must mail a signed letter, postmarked no later than December 21, 2007, asking to be excluded to: FDB/Medi-Span Settlement Administrator, c/o Complete Claim Solutions, LLC, P.O. Box 24730, West Palm Beach, FL 33416. Include your name, the name of the person or entity seeking exclusion, an address and telephone number.
• To object to the settlements, you must file a written statement with the Clerk of the Court, John Joseph Moakley U.S. Courthouse, 1 Courthouse Way, Suite 2300, Boston, Massachusetts 02210, postmarked no later than December 21, 2007.
• The Court will hold a fairness hearing on January 22, 2008 at 2 PM at the John Joseph Moakley U.S. Courthouse, 1 Courthouse Way, Boston, Massachusetts 02210, to:
  1. determine whether the Settlements are fair, reasonable and adequate and in the best interests of the Class, whether it should be approved by the Court, and whether judgment should be entered;
  2. consider the application of Class Counsel for an award of attorneys’ fees and expenses; and
  3. consider any other issues the Court thinks necessary.

This is just a paraphrasing of the notice. The official note, with forms, instructions and copies of Court documents, can be found at fdbmedispansettlement.com.

McKesson Corporation, the other defendant in the New England Carpenters case, has not agreed to settle, and the case against them is proceeding.

More information about these lawsuits can also be found here.

Back in February, Prescription Access Litigation (PAL) and PAL member AFSCME District Council 37 Health and Security Plan (DC 37) announced that a settlement in a nationwide class-action lawsuit brought by DC 37 and others against EMD Serono, Inc. and Merck Serono International S.A. (jointly, Serono) (NYSE: SRA) had received preliminary approval by the U.S. District Court for the District of Massachusetts.

The $24-million settlement resolves claims that Serono wrongfully encouraged doctors to prescribe the AIDS wasting drug Serostim to patients for whom it was unnecessary. Serostim is a recombinant human growth hormone manufactured by Serono to treat AIDS wasting, a condition involving profound involuntary weight loss in AIDS patients.

On August 16, the Court extended the deadline for Consumers who paid all or part of the cost of Serostim prescriptions to submit claims for payment from this settlement. The deadline has been extended to September 27, 2007. Claim forms, instructions, and answers to Frequently Answered Questions can be found on the settlement website, serostimsettlement.com The deadline for Third Party Payors (insurers/health plans, union benefit funds and self-insured employers) was not extended, and has already passed.

The Court will hold its “Fairness Hearing” on October 9, 2007. At this hearing, the Court will hear testimony from the parties about why the settlement should be approved, and from any class members who have objected to the settlement on why it should not.

The Court’s August 16 order can be found here.

Bristol Myers Squibb (NYSE:BMY) is the latest defendant to reach a settlement with plaintiffs in the massive Average Wholesale Price litigation (In re Pharmaceutical Average Wholesale Price Litigation, before Judge Patti Saris of the U.S. District Court for the District of Massachusetts). A number of PAL coalition organizations are plaintiffs in this massive case, against dozens of pharmaceutical defendants. In a nutshell, the case alleges that the defendants fraudulently and artificially inflated the “Average Wholesale Prices” (AWPs) of hundreds of physician-administered drugs. These AWPs are listed in commercial pricing publications and were used by Medicare and insurers to determine how much to pay doctors for drugs administered in doctors’ offices.

A trial of Medicare patients’ claims against BMS was originally slated to begin this coming Monday, July 23. Last month, Judge Saris issued a 183-page decision in another phase of the case, in which she found that BMS and two other defendants (Astra Zeneca and Warrick, a subsidiary of Schering-Plough) caused the publication of false and inflated Average Wholesale Prices for seven drugs. The BMS drugs were Taxol, Vepesid, Cytoxan, Blenoxane and Rubex.

The decision last month found BMS and the other defendants liabile for damages caused to classes of Massachusetts insurance companies and non-Medicare consumers in Massachusetts. The trial that was slated to begin next week concerned damages caused to a nationwide class of Medicare patients. The settlement is not surprising in the wake of Judge Saris’ decision last month. The claims of the nationwide Medicare class are based on the same facts as those that Judge Saris found in her recent decision, and the causes of action (primarily state consumer protection acts) pretty closely mirror those in that decision as well (which were based on the Massachusetts Consumer Protection Act, Chapter 93A). Thus, if the trial had gone forward, it’s likely that the facts that were established in the previous decision would have already been found to be true (known in legal parlance as “collateral estoppel”) — the only issues thus would have been whether BMS violated those other state consumer protection acts and the federal RICO statute, and the extent of damages that caused.

No settlement has been filed with the Court yet, but on July 18 Bloomberg News reported on the fact that a settlement was reached:

Bristol Avoids Trial Over Taxol Price With Settlement (Update2)

By Cary O’Reilly

July 18 (Bloomberg) — Bristol-Myers Squibb Co. agreed to settle a class-action lawsuit over prices the company charged for its Taxol cancer drug and other medicines, just before a trial was set to begin in Boston.

The company, which admitted no wrongdoing, agreed to pay $13 million to settle all claims in the nationwide suit, Bristol spokeswoman Laura Hortas said. The case, which was set for trial July 23, was filed on behalf of consumers in dozens of states who made copayments for company drugs based on prices that had been artificially inflated, according to the complaint.

U.S. District Judge Patti Saris in Boston last month ordered Bristol, AstraZeneca Plc and Schering-Plough Corp. to pay damages for overcharging on drugs through so-called average wholesale pricing, or AWP. The trial that was to begin next week concerned only copayments for Bristol drugs. Taxol generated $1.6 billion in sales in 2000 before Bristol lost patent protection for it.

“We’re quite pleased with the settlement,” plaintiffs attorney Steve Berman of Hagens Berman Sobol Shapiro in Seattle said in an interview. “Any time you get over 100 cents on the dollar in recovery for consumers, that’s pretty darn good.”

The company also agreed to pay as much as $1 million for the cost of notifying affected consumers.

Consumers made insurance plan copayments under Medicare Part B based on average wholesale prices for Bristol drugs, including Taxol, that were far higher than what the company was charging doctors and hospitals, according to the complaint.

Out of Pocket

Chemotherapy and other medicines administered in physician offices were covered under Medicare Part B, with patients in many instances paying 20 percent of those costs out of pocket. That meant any increase in the average wholesale price for Taxol could result in higher fees for patients on chemotherapy.

Saris will hold a hearing Aug. 9 to consider the Bristol settlement, according to a docket entry on her court’s Web site.

“Bristol-Myers Squibb is pleased to have reached a settlement of the Class 1 claims in the average wholesale price litigation,” Hortas said.

In an earlier case, Saris found that Bristol-Myers inflated AWP for five medications, including Taxol. The AWP price for the cancer drug was found to be as much as 500 percent higher than what was charged to doctors.

AWP, which is self-reported by drugmakers, was once used by government health programs such as Medicare to set reimbursement rates. Medicare has moved away from the system, though some private insurance plans, including Blue Cross, still use it.

Medicare Switch

Medicare, the federal health plan for the elderly, switched in 2004 from AWP to a system of paying 106 percent of the average reported sale price of a drug.

Consumers who say they were harmed by AWP pricing for more than 300 drugs sued in 2001, alleging an industrywide scheme to defraud the U.S. health-care system. The suit was carved up by Saris based on different drug types to make the litigation more manageable.

GlaxoSmithKline Plc, Europe’s biggest drugmaker, agreed in August to pay about $70 million to settle claims by state attorneys general and consumers that the company used AWP to overcharge government health programs for its medicines.

Bristol shares fell 7 cents to $32.07 as of 12:45 p.m. in New York Stock Exchange composite trading, giving the company a market value of $63.3 billion.

The case is In Re: Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, U.S. District Court, District of Massachusetts (Boston).

To contact the reporter on this story: Cary O’Reilly in Washington at caryoreilly@bloomberg.net

Consumers and third party payors in California who paid for Premarin, used to relieve the symptoms associated with menopause and to prevent osteoporosis in postmenopausal women, may be eligible to receive payments from a $5.2 million settlement fund. For more details, go to premarinclassaction.com

Claims must be filed by October 1, 2007. Objections to the settlement must be filed by August 15, 2007.

Trivia tidbit: Premarin is made from the urine of pregnant horses — Premarin = PREgnant MARes uRINe.

Excerpted from www.premarinclassaction.com/premarin/california.htm

A Proposed Settlement has been reached in a class action, Elizabeth Blevins, et al. v. Wyeth-Ayerst Laboratories, Inc., et al., Case No. 324380, filed in the Superior Court of California, County of San Francisco.

The Superior Court of the State of California for the County of San Francisco entered an Order Granting Preliminary Approval of Settlement, Directing Notice to the Class, and Scheduling Fairness Hearing. The Court has scheduled a Fairness Hearing on final settlement approval on September 10, 2007.

Description of the Lawsuit
Premarin® is a conjugated estrogens product prescribed by doctors to relieve the symptoms associated with menopause and to prevent osteoporosis in postmenopausal women. Plaintiff alleges that the manufactures Wyeth Pharmaceuticals (formerly Wyeth-Ayerst Laboratories, Inc.) and Wyeth (formerly American Home Products Corporation) violated California’s antitrust and unfair competition laws by engaging in anti-competitive and exclusionary conduct that blocked consumer access to Cenestin®, which was an alternative to Premarin®. Plaintiff does not challenge the safety or effectiveness of Premarin®.

The lawsuit claims that the Defendants violated California antitrust, unfair competition, unfair trade practices, and unjust enrichment laws by entering into exclusive rebate contracts with managed care organizations such as HMOs, insurance companies, and pharmacy benefit managers (“Third-Party Payors”). Defendants deny that they committed any violation of law or any wrongdoing or that they have any liability with respect to Plaintiff or the Class. However, the parties have agreed to this Proposed Settlement to avoid the risks and expense of continuing the case.

The Class includes all persons or entities who purchased or reimbursed others for the purchase of Premarin® from March 24, 1999 through April 3, 2007 in California for consumption by themselves, family members or covered individuals, and not for resale.

The Defendants have agreed to pay $5.2 million to settle this case. After deductions of Court-approved costs and expenses, the remaining amount will be divided between consumers and Third-Party Payors in the Class, subject to available funds based on the actual claims received.

“Class Member” Description
The proposed “Class” includes:

All persons or entities who, during the period from March 24, 1999 to April 3, 2007, purchased, paid for, or reimbursed for Premarin® purchased in the State of California for consumption by themselves, family members or covered individuals (including members, beneficiaries, employees and insureds) and who suffered economic loss thereby as a result of allegedly anticompetitive conduct by Defendants.

Excluded from the Class are Defendants and their respective subsidiaries and affiliates, all governmental entities, and all persons or entities that purchased Premarin®: (i) for purposes of resale, or (ii) directly from any of the Defendants. The Class also excludes those Class Members who have properly opted out of the Class.