Adderall manufacturer, Shire Pharmaceuticals, can’t seem to stay out of trouble with the FDA and consumers. In October 2014, the company settled claims of deceptive marketing for more than $56.8 million. The settlement was in response to allegations that Shire inappropriately promoted the sale of Adderall, a drug for ADHD and ADD, by advocating the drug for off-label use—despite lack of clinical data to support those claims.  Shire not only stated that competitor’s ADHD medications could not achieve similar results, but also that Adderall XR was “clinically superior to other similar drugs because it would normalize its recipients.” The lawsuit was brought by attorney generals in each U.S. state.

Shire’s Pay-For-Delay Deals

Unfortunately, this settlement may be only the tip of the iceberg as far as Shire’s history of padding profits at the expense of consumers. In 2012, Adderall topped the list of twenty drugs which adversely impacted consumers due to pay-for-delay deals. Pay-for-delay agreements are a form of patent dispute settlement agreements in which a generic manufacturer acknowledges the patent of the original pharmaceutical company. The generic manufacturer then agrees to refrain from marketing the generic for a specific length of time. In return for this agreement, the original pharmaceutical company pays the generic company an agreed-upon sum of money.

Pay-for-delay deals can delay generic drugs for three to five years on average, and, in some cases, as long as nine years. Brand name drugs cost as much as ten times their generic equivalent on average, and sometimes as much as thirty-three times more. The twenty companies listed as biggest offenders have made more than $98 billion in total sales of their drugs while the generic versions were being delayed. Shire inked their pay-for-delay deal in 2006, for a period of three years.

Shire Shifts Gears, Allowing “Authorized Generics”

Once the pay-for-delay deals ran out, Shire changed its tactics, reaching settlements with the same companies they had previously tried to squeeze out of the market. These settlements allowed the generic companies to introduce “authorized generics,” in return for royalty payments made to Shire. Even this, apparently, was not enough for Shire, as the company failed to provide the generic companies with enough product to meet demand, ensuring consumers could not purchase generic versions of Adderall XR. In any case, from 2006 to 2012, Shire maintained their hold on the Adderall market through one tactic or another. Finally, in 2012 and 2013, the first two unauthorized versions of Adderall generics were approved by the FDA.

The FTC has challenged pay-for-delay agreements in court, on the basis they violate United States antitrust laws, which protect consumers by allowing them to purchase cheaper generics of expensive drugs. The Senate has looked at prohibiting the pay-for-delay practices altogether.  Shire points to the Hatch Waxman Act of 1984 which, among other provisions, offers a thirty-month stay to drug companies that file suit against generic manufacturers who challenge their patent. The Hatch Waxman Act has become controversial because of companies like Shire who manipulate the system to prevent generics from taking a piece of “their” profits.

Shire Attempting to Introduce a New Version of Adderall XR

When Shire entered into the three-year pay-for-delay deals back in 2006, they wasted no time. The pharmaceutical company developed a new form of Adderall which would last 16 hours, requiring only one dose per day. This drug contained the same active ingredients as Adderall XR, however Shire has run into a few stumbling blocks in obtaining FDA approval of the drug. In April, 2014, it appeared as though Shire’s new ADHD drug would finally be approved, but very recently, the FDA demanded further studies on the drug, particularly as it relates to children. Anti-trust lawsuits have been filed against Shire in Florida, Pennsylvania, and California on behalf of consumers who were unable to purchase generic versions of Adderall XR due to Shire’s delaying tactics.

Contact National Consumer Protection Lawyers

Golomb & Honik is currently seeking individuals to serve as class action representatives in statewide and nationwide anti-trust class action lawsuits against Adderall XR manufacturer, Shire Pharmaceuticals. If you purchased Adderall XR and were forced to pay a higher price because a generic was not available, it is important to contact Golomb & Honik today. We are seeking individuals in Florida, Pennsylvania, and New Jersey who may have been affected. To learn more about your legal options or to schedule a free consultation call Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national consumer protection lawyers at Golomb & Honik have successfully represented individuals in Pennsylvania, New Jersey, and throughout the United States.

Four Connecticut power companies have been accused of over-charging consumers, and have recently had a class action lawsuit filed against them. The companies are Discount Power, Viridian Energy, North American Power and Direct Energy, and are being charged with deceptive practices. The lawsuit alleges that four power companies made claims in the contracts they entered into with consumers to the effect that the variable power rates will go up and down, depending on the wholesale cost of electricity. Instead, even when the wholesale prices dropped, the power companies continued to charge customers higher kilowatt hour rates—in some cases as much as five times the wholesale price.

Power Companies Offered “Teaser Rates”

Consumers in Connecticut are given a choice of power companies for their home, and many chose to stay with Connecticut Light and Power. Other consumers, who might be having trouble paying their power bills, were lured to other power suppliers who promised lower rates. The suppliers buy and re-sell energy for a profit, but it appears the profits received by the four power companies were much higher than they deserved—at a cost to their consumers.

The lawsuit claims the companies offered what is known as a “teaser rate,” which they put into effect for a few short months. When the teaser rate expired, it automatically shifted to a variable rate, causing the prices to skyrocket. Only one of the power companies involved in the class-action suit responded to requests for comment. A North American Power spokesman stated the lawsuit has no merit and that their company consistently provides written notice to consumers when the variable rate is about to go into effect.

Class-Action Lawsuits against Other Power Companies Filed Earlier

This lawsuit follows closely on the heels of another class action lawsuit filed against Connecticut-based electric company, Starion Energy in the amount of $50 million. The Starion lawsuit was filed in the U.S. District Court for the Southern District of New York on behalf of consumers who had been promised significant savings on their energy bills if they switched from the current energy supplier to Starion. After the customers switched companies, they found the rates they were being charged were two to three times the rates they had been quoted.

Starion Energy has a pattern of deceptive sales practices; in early 2014 the Maryland Public Service Commission determined the company had a pattern of misrepresentation toward potential customers. While Starion received a fine, they continued to perpetrate the fraud against consumers, particularly elderly consumers who were having trouble paying their power bills.

De-regulation of the Electric Energy Benefitted Suppliers

Many energy suppliers benefitted when the electric industry was deregulated, and Starion Energy was no exception. Starion has more than 30,000 customers in Connecticut alone, with thousands more in seven additional states, and is one of the fastest-growing energy suppliers in the United States.

The Starion lawsuit was filed in early November and has been given several weeks to respond to allegations. The Starion lawsuit asks for a jury trial, triple the amount of damages, compensatory damages, and an order to stop Starion from perpetrating further deception on consumers.

Hiko Energy, Palmco Power New Jersey, Keil & Sons, and Palmco Energy New Jersey all have similar lawsuits pending against them.  The Hiko Energy lawsuit filed by the lawyers at Golomb & Honik, P.C. in particular, claims that consumers were promised a ten percent reduction in monthly bills for the first six months—instead their bills immediately went up. Hiko customers were given no avenue for reaching the company with their complaints, and no way to terminate their contracts.

The recent class action suit against Discount Power, Viridian Energy, North American Power and Direct Energy has not been answered by the power companies, and many consumers are anxiously awaiting just how the companies will justify the increases in monthly bills.

Contact National Consumer Protection Lawyers

If your electricity rates have increased suddenly after switching to a different service provider, you may have cause to file a claim. The lawyers at Golomb & Honik are actively litigating consumer complaints of rate spikes by deceptive and fraudulent electric companies. For a free review of your case, call the Pennsylvania consumer protection lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The consumer protection lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

A proposed class action lawsuit was recently filed by the insured Medical Mutual of Ohio against Eli Lilly & Co, Actavis Pharma, Abbott Laboratories, and their subsidiaries. The 341-page lawsuit accuses the pharmaceutical companies of inventing the medical condition, known as low testosterone, and using deceptive marketing to build a billion dollar industry. The insurer alleges that the pharmaceutical companies violated civil racketeering laws, RICO statutes, and consumer protection laws in all 50 states. In addition, they allege that these drug makers engaged in fraud and negligent misrepresentation, which resulted in billions of dollars in unjustified claims for health insurers.

According to the complaint, the pharmaceutical companies deliberately convinced millions of men that they were suffering from a medical condition, known as low testosterone. In fact, the majority of these men were suffering from nothing more than the normal aging process. They then deliberately misrepresented the safety and effectiveness of their drugs and continued to promote off-label uses. The lawsuit claims that these pharmaceutical companies deliberately concealed the negative side effects of their drugs, including heart complications, and illegally paid physicians “kickbacks”.

Medical Mutual has claimed that these drug companies used deceptive marketing campaigns and direct to consumer marketing campaigns that generated annual sales of $2 billion in 2012, all while purposefully downplaying and ignoring health hazards and risks.

Sadly, both insurers and patients have suffered because of the off-label marketing of low testosterone drugs. Currently, low testosterone drugs are ONLY approved for men who have been diagnosed with hypogonadism.

Just How Risky are Low Testosterone Drugs?

The FDA is investigating recent connections between the use of popular low testosterone drugs, such as Androgel, Androderm, Testopel, and Testim. A recent study published in Plus One found that men under the age of 65 years old with a history of heart disease were 3x more likely to suffer a heart attack when taking low testosterone supplements. Men over the age of 65 were 2x more likely to suffer a heart attack—even if they never had a history of heart disease.

In light of these recent findings, the FDA advisory panel is recommending a more comprehensive study relating to heart attack and testosterone supplements. When asked about the risks of testosterone supplementation, FDA panel member John Teerlink replied, ” We have no evidence of any benefit for patients and we have questions about clinical safety.”

National Dangerous Drug Lawyers

You have a right to seek justice if you or someone you love has sustained a heart attack or cardiac complication after using a low testosterone drug. Drug companies who routinely put profits before people should pay for their negligence—and their unscrupulous behavior. To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.

The manufacturers of the blood-thinning drug Xarelto are seeking to expand the approved uses of the drug despite documented dangers. Bayer and Janssen—a subsidiary of Johnson & Johnson—were denied approval earlier in 2014 when they applied to expand the use of Xarelto to include patients with acute coronary syndrome and clogging of heart stents. This was the third rejection by the FDA for an expanded use of Xarelto. Xarelto is currently approved by the FDA only for use in preventing or treating deep vein thrombosis or pulmonary embolism. Patients undergoing a knee or hip replacement may also be prescribed Xarelto as a means of preventing blood clots.

Financial Greed Trumps Patient Safety

The aggressive push to expand the use of Xarelto despite the growing number of lawsuits being filed across the nation has to do with nothing more than financial greed.  While Xarelto has been on the market for a relatively short period of time (the drug was introduced in late 2011), it has closed in on blockbuster status. Sales of Xarelto are expected to top $1 billion by the end of 2014, and FDA approval for expanded uses of the drug could only boost sales further.

What’s the Problem with Xarelto?

Xarelto has been identified as the cause in a number of fatal and near-fatal bleeding incidents. Older blood thinning drugs like Warfarin and Coumadin have been prescribed since the mid- 1950’s, yet because the patients taking those drugs must be monitored regularly and because the drugs have certain food and drug interactions, many doctors are prescribing Xarelto and similar drugs (Pradaxa) as an alternative. Xarelto can be prescribed in a more standardized dose which is not dependent on the patient’s age or weight, requires no regular blood monitoring and has no known food or drug interactions.

While this all sounds great, Xarelto has one very serious side effect the older drugs do not. If a patient suffers an uncontrollable bleed while taking Warfarin, doctors can administer a shot of Vitamin K, which reverse the effects of the drug. Xarelto has no such reversing agent; when a patient suffers an uncontrollable bleed, doctors can do nothing other than transfusing blood to the patient and hoping the bleeding will stop on its own.

Black Box Warnings on Xarelto

The Xarelto labeling does include two black box warnings although neither are related to uncontrollable bleeding. In 2012, fifty-eight deaths were attributed to Xarelto use and in 2013, another 72. Current lawsuits claim Xarelto is unreasonably dangerous and that the manufacturers have failed to adequately warn patients of the potential risks of gastrointestinal bleeding, rectal bleeding, brain hemorrhage, and other uncontrollable bleeds. Further, the FDA has cited Xarelto manufacturers for distributing promotional materials which were misleading or completely false.

It is not clear just how many lawsuits have been filed against the manufacturers of Xarelto, although less than two weeks ago a group of 21 consumers petitioned the U.S. Judicial Panel on Multidistrict Litigation to combine their lawsuits into a single case. MDL status is often granted when the facts of the individual cases are very similar. Despite the last three FDA rejections, Bayer, Janssen and Johnson & Johnson intend to continue to push for expanded uses of Xarelto, and have announced three new clinical trials to prove the drug can be used to combat ACS and other problems. Those harmed by Xarelto could benefit from speaking to a knowledgeable product liability attorney.

National Dangerous Drug Lawyers

If you have suffered medical complications, pain, or excessive bleeding after using Xarelto, your injuries may be the result of a drug manufacturer’s negligence. To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb & Honik have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.