Product Hopping, Big Pharma and the High Cost of Prescription Drugs

ATTORNEY: ADAM KURTZ
POMERANTZ MONITOR, March/April 2015

The Monitor has been reporting for years on so-called “pay for delay” schemes used by brand name drug manufacturers to stave off generic competition. Such schemes are subject to antitrust challenge as unlawful restraints of trade, and the Firm has been pursuing such cases vigorously.

Now there is a new scheme, called “product hopping.” In the classic version of this anticompetitive scheme, brand name manufacturers come out with a “new” version of their drug and stop production of the previous version altogether, forcing everyone taking that drug to switch to the new version, even if isn’t any better. The newly introduced drug likely has only minor changes from the existing one (e.g., from tablet to capsule; from immediate to extended release) and does not provide any improvement in its therapeutic benefits. But, since there are no generic competitors for the new version, the brand manufacturer can continue to reap monopoly profits for years to come. By the time a generic of the original formula enters the market, there is no longer a demand for the original brand formula, because it has been discontinued. State laws that require generic substitution do not apply because the new brand drug is slightly different that the original. As a result of a successful product hopping scheme, generic competition—which reduces brand drug prices by about 90%—will be eliminated.

The pushback is beginning against product hopping. Notably, a New York Federal District Court recently granted an injunction stopping a brand name pharmaceutical company, Actavis, from discontinuing sales of its popular Alzheimer drug Namenda IR. The court concluded that the move was an unlawful product hopping scheme intended to switch vulnerable Alzheimer’s patients from the existing Namenda formula, which will face generic competition in 2015, to a newer, slightly different formula, which will not have generic competition until 2029. By removing original Namenda from the market, Actavis would have forced Alzheimer’s patients to switch to the new drug, with all its attendant risks, and would eventually force them to pay billions of dollars more for the new brand name treatment.

New York Attorney General Eric T. Schneiderman successfully brought this antitrust case against Namenda’s manufacturer, Forrest Labs, (now owned by Actavis) alleging that the forced switch to a so-called new and improved version was nothing more than illegal attempt to maintain its $1.6 billion Namenda monopoly even after its patent expires. According to Schneiderman, “[a] drug company manipulating vulnerable patients and forcing physicians to alter treatment plans unnecessarily, simply to protect corporate profits, is unethical and illegal.” The federal district court agreed, although this decision is now on an expedited appeal before the United States Court of Appeals. Oral argument on the appeal is scheduled for April 13, 2015.

In the Namenda case, the brand drug company not only introduced a new once-a-day (extended release) capsule, but also announced that it intended to stop selling its original twice-a-day (instant release) tablet, which was soon to face generic competition. There is no therapeutic difference between the two formulations.

As another court defined the issue last year, “although the issue of product-hopping is relatively novel, what is clear from the case law is that simply introducing a new product on the market, whether it is a superior product or not, does not, by itself, constitute exclusionary [antitrust] conduct. The key question is whether the defendant combined the introduction of a new product with some other wrongful conduct, such that the comprehensive effect is likely to stymie competition, prevent consumer choice and reduce the market’s ambit.”

In particular, courts have increasingly found that where the brand drug company not only introduces a new drug version but also removes the original version of the drug from the market, it violates the antitrust laws. In cases involving the drugs Tricor and Doryx, the manufacturers introduced new versions of the drugs; stopped sales of the original versions; and removed unused inventory of the original formula from the market. In addition, in Tricor, the company changed the code for the original drug to ‘obsolete’ on an industry-wide database, which prevented pharmacies from filling Tricor prescriptions with a generic. In both cases, defendants’ exclusionary conduct restricted consumer choice. In the end, Tricor settled for in excess of $250 million, while Doryx is still pending.

More recently, In re Suboxone Antitrust Litig., allegations of another product hopping scheme were found sufficient to state an antitrust cause of action were the brand drug company not only introduced a new film version of the drug but made false safety claims about the original tablet version and threatened to remove the original version from the market. The court found that the “[t]he threatened removal of the tablets from the market in conjunction with the alleged fabricated safety concerns could plausibly coerce patients and doctors to switch from tablet to film.”

Pomerantz’s antitrust attorneys have been at the forefront of challenging anticompetitive conduct by pharmaceutical companies that seeks to block generic drugs, including product hopping schemes, pay-for-delay agreements and overall anticompetitive conspiracies that combine the two.

Is There Hope For Credit Rating Agencies?

ATTORNEY: Anna Karin F. Manalaysay
POMERANTZ MONITOR, MARCH/APRIL 2015

Anyone compiling a list of culprits in the U.S. subprime residential mortgage debacle of 2007-2008 would have to include the credit rating agencies at or near the top. Meant to provide investors with reliable information on the riskiness of various kinds of debt, the agencies have instead been accused of defrauding investors by giving triple-A ratings to mortgage-related securities so risky they were even considered doomed to fail by the banks that created them.

Why did this happen? Probably because the financial incentives for the ratings agencies have changed dramatically. In the past, credit rating agencies charged a subscription fee to subscribers to cover their rating activity. Then the practice changed, and the company or issuer being rated pays the fee. By switching to this business model, the ratings agencies assumed a crippling conflict of interest; for if they did not deliver high ratings regardless of the circumstances, issuers would shop around for a more compliant ratings agency the next time around.

The best-known credit rating agencies in the United States are Moody’s Investor Services, Standard and Poor’s, and Fitch. S&P issues nearly half of all credit ratings and together with Moody’s and Fitch, the so-called “Big Three” issue ninety-eight percent of the total ratings. On February 3, 2015, S&P agreed to pay $1.375 billion to settle lawsuits brought by the U.S. Department of Justice and 20 attorneys general concerning ratings S&P gave to certain mortgage securities just before the 2008 financial meltdown. So far, this has been the largest settlement involving a credit rating agency.

The press release issued by the Justice Department said the ratings at issue were given to residential mortgage-backed securities (RMBS) and collateralized debt obligations (CDOs) during the period 2004 to 2007. RMBS are created when a bank or other financial institution pools together mortgage loans. CDOs pool together cash flow-generating assets and repackages this asset pool into discrete tranches that can be sold to investors.

The lawsuit filed by the Justice Department in 2013 alleged that S&P had engaged in a scheme to defraud investors by knowingly inflating the credit ratings it gave to RMBS and CDOs which resulted in substantial losses to investors and ultimately contributed to the worst financial crisis since the Great Depression. The Justice Department claimed that S&P’s rating decisions were not independent and objective as they were required to be but, rather, based in part, on its business concerns.

As a part of the settlement, S&P agreed to a statement of facts that contained an admission that its ratings for CDOs were partially made based on the effect they would have on S&P’s business relationship with issuers. It also admitted that, despite knowledge within the S&P organization in 2007 that many loans in RMBS transactions it was rating were delinquent and losses were probable, it continued to issue and confirm positive ratings.

As credit rating agencies were being blamed for feeding a subprime mortgage frenzy, Congress passed the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank) in July 2010. Among its various provisions, Dodd-Frank outlined a series of broad reforms to the credit rating agencies market. Despite Dodd-Frank, however, some signs of trouble have re-emerged. In January 2015, for example, S&P paid nearly $80 million to settle accusations of the SEC that it orchestrated similar fraud in 2011, years after the financial crisis took place. S&P also agreed to take a one-year “timeout” from rating certain commercial mortgage investments at the heart of the case, an embarrassing blow to the rating agency. The pact is the SEC’s first-ever action against a major ratings firm.

The SEC has since issued new rules aimed to enhance governance, protect against conflicts of interest, and increase transparency. These rules, which went into effect January 1, 2015, require rating agencies such as S&P to: 

• provide records of their internal control policies and rating methodology;
•  prohibit their sales teams from participating in the rating process;
• review, and revise if needed, ratings for companies that later hire one of the agency’s employees; and
• file annual reports showing how the agencies monitor ratings, how ratings changed over time and whether evaluated companies eventually defaulted.

If a credit rating agency violates these rules, the SEC will suspend or revoke the agency’s registration — disciplinary action that may be effective in preventing further violations. However, while the regulations do attempt to keep rating activity under strict surveillance, they do not restructure the way rating agencies solicit business or receive payment. Thus, the inherent conflict of interest still exists since the agencies are paid by the same banks and companies they rate.

The SEC has thus far failed to maintain control and ensure rating agencies follow proper rating methodologies — the multiple accusations against S&P attest to these failures — but only the health of the future financial market will tell whether the recent regulations, coupled with the hefty consequences credit rating agencies such as S&P have had to face, will have a long-term stabilizing impact.

Pomerantz Wins Important Motion, Post-Halliburton

ATTORNEY: Joshua B. Silverman
POMERANTZ MONITOR, MARCH/APRIL 2015

When the Supreme Court issued its landmark decision in Halliburton v. Erica P. John Fund last summer, it did not give either side a total victory. Critically for investors, the Supreme Court reaffirmed the fraud-on-the-market presumption, which is necessary for class certification in most securities fraud actions. The presumption allows classwide proof of reliance, an element of Exchange Act claims, by demonstrating that the stock traded in an efficient market. In efficient markets, publicly-available information is incorporated into the stock price and traded on by all investors, so plaintiffs need not show that each class member actually heard or read the misrepresentations giving rise to the lawsuit. By reaffirming these principles, the Court ensured the continued viability of securities fraud class actions. However, at the same time, the decision offered defendants the ability to rebut the fraud-on-the-market presumption at the class certification stage by demonstrating that the alleged fraud did not affect the stock price.

Halliburton did not specify precisely how lower courts should determine market efficiency or lack of price impact. As lower courts begin to grapple with these issues, the early results are promising for investors. Thus far, district courts (and in one case, an intermediate court of appeals) have applied rational tests for both market efficiency and price impact, consistent with the principles set forth in Halliburton. 

The most important consequence of Halliburton may be to stabilize the law over what constitutes an efficient  market. In 1988, when the Supreme Court first recognized the fraud-on-the-market presumption, it declined to adopt any particular test for market efficiency. In the years that followed, most courts used the so-called “Cammer test,” which assessed, among other factors, trading volume, analyst coverage, and price movement following release
of important company-specific news. 

However, more recently defendants and their experts have urged courts to stack on top of the Cammer factors a litany of additional requirements lifted from the extreme end of academic debates about market efficiency. A significant minority of courts accepted these arguments, resulting in a patchwork of inconsistent standards. For example, some courts refused to certify cases involving stocks that moved in trends, theorizing that such trending—or serial correlation—was inconsistent with the belief of some academicians that efficient markets must be wholly unpredictable. Other courts looked to related options markets, holding that a lack of parity input and call options demonstrated constraints on arbitrage activity, and therefore showed market inefficiency. A few other courts suggested that impairments to arbitrage could also be found if the stock was difficult or expensive to sell short. 

Halliburton should put an end to these fringe academic tests. In its opinion, the Supreme Court emphasized that for purposes of the fraud-on-the-market presumption, market efficiency refers only to “the fairly modest premise that market professionals generally consider most publicly announced material statements about companies, thereby affecting stock market prices.” As one law professor explained, Halliburton demonstrates that “the efficiency question is not meant to be particularly rigorous.” District courts appear to get the message. Since Halliburton, no district court has cited serial correlation, lack of put-call parity, or short-lending costs as a basis for denying class certification in a securities fraud class action. 

Recently, Pomerantz won an important motion addressing the continued relevance of fringe academic market efficiency tests. In the Groupon securities litigation, where Pomerantz serves as lead counsel, defendants had argued that plaintiffs’ class certification expert was unreliable because he failed to conduct put-call parity and short lending fee analyses. After an extensive evidentiary hearing, the court sided with Pomerantz, holding that such tests were unnecessary because they addressed an extreme variation of market efficiency that “was squarely rejected by the Halliburton court.”

District courts have also applied reasonable, consistent tests when assessing the price impact defense recognized in Halliburton. They have thus far uniformly rejected defendants’ attempts to show lack of price impact by demonstrating that some or all of the misrepresentations did not move the stock at the time they were made. Instead, recognizing that misrepresentations are used to artificially maintain as well as boost share prices, courts in the Regions Financial, IntraLinks, and Best Buy litigations have all held that price impact can be found where the share price declines when the truth is revealed, even if the stock did not move at the time the false statements were issued. Best Buy has been appealed, so the Eighth Circuit will soon weigh in on the issue.

Defendants have been equally unsuccessful in attempts to persuade courts to disregard price movement, where it does occur, by claiming it was caused by something other than the alleged fraud. For example, in Catalyst Pharmaceuticals, the court rejected expert testimony that the truth was already known to the market. Such evidence, the court held, did not disprove price impact but instead addressed whether the omitted information was material, an issue reserved for the trier of fact. By strictly enforcing the Supreme Court’s requirement that defendants prove the absence of price impact instead of just proffering different explanations for price moves, lower courts have ensured that the exception to the fraud-on-the-market presumption did not swallow the rule.

Courts will continue to construe Halliburton in the coming months, particularly in the Best Buy appeal and Halliburton itself (where the issue of price impact was remanded to the district court). If they apply the measured reasoning seen in early cases, it will bring much-needed consistency and predictability to the class certification process.

Delaware Court Refuses to Apply Fee-Shifting Bylaw

ATTORNEY: Alla Zayenckik
POMERANTZ MONITOR, MARCH/APRIL 2015

Pomerantz achieved an important corporate governance victory for stockholders in March when Chancellor Bouchard of the Delaware Court of Chancery refused to apply a fee-shifting bylaw to plaintiff and the class in Strougo v. Hollander. Fee shifting bylaws impose on plaintiff shareholders and their counsel the defendants’ entire litigation costs, unless the action achieves a complete victory, including an award of the entire remedy sought in the action. Such bylaws, if widely adopted, would foreclose virtually all shareholder litigation, regardless of the merits. Last year, in a case called ATP, the Delaware Supreme Court held that such bylaws can be legally enforceable, at least in some circumstances.

In Strougo v. Hollander, a closely-watched test case, Chancellor Bouchard issued the first Delaware opinion to address fee-shifting bylaws since the Supreme Court’s ATP decision last year. The Chancellor found that defendants cannot bind plaintiff and the class to a fee-shifting bylaw adopted after plaintiff had been forcibly cashed out through a reverse stock split.

Accepting the arguments proffered by Pomerantz partner Gustavo F. Bruckner, head of Pomerantz’s corporate governance practice, the Court found the bylaw inapplicable as to plaintiff and the Class under both Delaware contract and corporate law. Chancellor Bouchard explained that the Bylaw does not apply for two related reasons: (i) the Board adopted the bylaw after plaintiff’s interest in the company was eliminated by the reverse stock split; and (ii) Delaware law does not authorize a bylaw that regulates the rights or powers of former stockholders who were no longer stockholders when the bylaw was adopted.

The Chancellor found that “[A] stockholder whose equity interest in the corporation is eliminated in a cash-out transaction is, after the effective time of that transaction, no longer a party to [the] flexible [corporate] contract. Instead, a stockholder whose equity is eliminated is equivalent to a non-party to the corporate contract, meaning that former stockholder is not subject to, or bound by, any bylaw amendments adopted after one’s interest in the corporation has been eliminated.”

The Chancellor also commented on the underlying merits of the case and the effect of fee-shifting bylaws. He wrote “the Bylaw in this case would have the effect of immunizing the Reverse Stock Split from judicial review because, in my view, no rational stockholder—and no rational plaintiff’s lawyer—would risk having to pay the Defendants’ uncapped attorneys’ fees to vindicate the rights of the Company’s minority stockholders, even though the Reverse Stock Split appears to be precisely the type of transaction that should be subject to Delaware’s most exacting standard of review to protect against fiduciary misconduct.”

Prior to the Chancellor’s ruling, on March 6, 2015, the Council of the Corporation Law Section of Delaware State Bar Association issued proposed amendments to the Delaware General Corporation Law that would ban fee-shifting provisions from a company’s bylaws or charter. If enacted, the amendments will become effective on August 1, 2015.

Pomerantz Appointed Lead Counsel in Historic Petrobras Securities Class Action

ATTORNEY: Francis P. McConville
POMERANTZ MONITOR, MARCH/APRIL 2015

Pomerantz will take the helm on a consolidated group of securities class actions over revelations of rampant corruption at Petroleo Brasileiro SA (“Petrobras”), according to an order issued March 4, 2015 by New York U.S. District Judge Jed S. Rakoff. We were selected as lead counsel by lead plaintiff Universities Superannuation Scheme Ltd. (“USS”).

USS was chosen over three other candidates for lead plaintiff: the SKAGEN-Danske group, made up of three European asset managers; a group of three State Retirement Systems; and an individual investor.

The class action against Petrobras, brought on behalf of all purchasers of common and preferred American Depositary Shares (“ADSs”) on the New York Stock Exchange, as well as purchasers of certain Petrobras debt, principally alleges that Petrobras and its senior executives engaged in a multi-year, multi-billion dollar money-laundering and bribery scheme, which was, of course, concealed from investors. Senior management has openly admitted its culpability. In testimony released by a Brazilian federal court, the executive in charge of Petrobras’ refining division confessed that Petrobras accepted bribes “from companies to whom Petrobras awarded inflated construction contracts” and “then used the money to bribe politicians through intermediaries to guarantee they would vote in line with the ruling party while enriching themselves.” These illegal acts caused the company to overstate assets on its balance sheet, because the overstated amounts paid on inflated third party contracts were carried as assets on the balance sheet.

As of November 2014, the Brazilian Federal Police had arrested at least 24 suspects in connection with Petrobras’ money laundering and bribery schemes; and Brazil’s president, who was a senior Petrobras executive during the relevant period, has also been engulfed in this scandal. As a result of the fraudulent scheme, Petrobras may be forced to book a $30 billion asset writedown in order to reduce the carrying value of some of its assets. That impairment would equal approximately 42% of the company’s market value.

USS was not the lead plaintiff applicant with the largest losses from the fraud. Indeed, the SKAGEN-Danske group, with purported losses exceeding $222 million, asserted by far the largest losses of all the competing lead plaintiff applicants. However, although the securities laws establish a rebuttable presumption in favor of the appointment as lead plaintiff of the movant with the “largest financial interest” in the litigation, that movant must also “otherwise sastisf[y] the requirements of Rule 23 of the Federal Rules of Civil Procedure” under the Private Securities Law Reform Act (“PSLRA”).

In particular, USS and Pomerantz argued that the SKAGENDanske and State Retirement Systems were artificial groupings put together by counsel trying to win the lead counsel position, and were plagued by numerous deficiencies rendering them inadequate to represent the Class. Although the PSLRA states that a lead plaintiff may be a “group of persons,” to allow an aggregation of unrelated plaintiffs (asset managers and pension funds, in this instance) to serve as lead plaintiffs defeats the purpose of preventing lawyer-driven litigation. In stark contrast, USS, the largest pension fund as measured by assets in London, opted to move for appointment as sole lead plaintiff, in order to allow it full and independent control of its counsel and the prosecution of the litigation. In fact, prior to engaging the Pomerantz firm, USS spent over 50 hours of in-house attorney time determining whether to step forward as lead plaintiff. To assist its decision making process, USS retained outside counsel at its own expense to assist it in deciding whether to enter the action.

Moreover, the record in this case demonstrated that the SKAGEN-Danske Group – with SKAGEN showing a net gain on Petrobras common ADSs – had interests that could be deemed antagonistic to purchasers of Petrobras common ADSs. In this case, the large losers in Petrobras preferred ADSs, such as the SKAGEN-Danske Group, potentially have interests antagonistic to common ADS purchasers because of the unique qualities of each security and the potential threats facing the capital structure of Petrobras. USS, with the single largest losses of PBR common ADSs among the various lead plaintiff movants, thus presented the court with an attractive and safe option for potential lead plaintiff.

At bottom, USS argued that it was the ideal plaintiff envisioned by Congress when it enacted the PSLRA. No other movant had demonstrated the willingness and ability to adequately oversee counsel and vigorously prosecute the claims against Petrobras on behalf of the Class. Critically, USS was the only movant not overwhelmed by various inadequacies and unique defenses. Nor did USS have any ties to potentially relevant political contributions or curious arrangements with counsel, which have heretofore afflicted the alternative lead plaintiff groupings.

Accordingly, the independence and diligence evidenced by USS and Pomerantz during the lead plaintiff process ultimately paid off. As articulated during the briefing process, USS’s conduct represented the “gold standard” for institutional oversight of proposed lead counsel, and represents the model for institutional investors seeking to file future applications for appointment as lead plaintiff in securities class actions.