Andro Litigation Begins - Low T Marketing is the End of Met

AbbVie Testosterone Gel Faces Scrutiny as First Trial Begins
by
Jef Feeley
and
Margaret Cronin Fisk
June 5, 2017, 5:00 AM EDT June 5, 2017, 8:52 PM EDT

• Company has denied claims gel causes strokes and heart attacks
• Drug’s ‘Low-T’ marketing campaign criticized by patients

Brian DeMatteo said he hoped AbbVie Inc.’s AndroGel would give him more energy when he started taking the testosterone-replacement medicine in 2010. Instead, he claims, the drug put him in a wheelchair.

The 64-year-old Boston businessman blames AndroGel for a spinal stroke that left him a paraplegic suffering from chronic pain in 2012.

“I was the kind of guy who was always out playing tennis or surfing,” DeMatteo said in an interview. “You can’t do that kind of stuff in a wheelchair.”

DeMatteo and thousands of other men who used AndroGel are looking to hold AbbVie executives responsible for their strokes and heart attacks. DeMatteo can’t press his claims just yet but Tennessee resident Jeffrey Konrad is making his case to a jury in the first trial over the medicine that started Monday.

AbbVie has suffered as sales of AndroGel -- once a top-seller -- have slid after regulators called for tougher warning labels. The company faces more than 4,100 lawsuits by men like DeMatteo who claim AndroGel was responsible for their health problems, which range from blood clots to heart attacks. While DeMatteo’s trial date hasn’t been set, his case is among those consolidated in Chicago federal court.

Approved Uses
Lawyers for Konrad, a Tennessee traffic consultant, declined to make him available for comment. The 56-year-old had a heart attack after using AndroGel for two months in 2010. AbbVie, which has denied the allegations, said in court filings that Konrad recuperated and had returned to running long-distance races. The company called the attack “relatively mild” and blamed Konrad’s other ailments for his condition.

AbbVie, based in North Chicago, Illinois, was spun off in 2013 from Abbott Laboratories, and a spokesman for that drugmaker said liability for AndroGel suits lies with AbbVie.

“We believe our disease education and marketing of AndroGel have adhered strictly to FDA-approved uses and are in full compliance with applicable standards,” Toni Haubert, an AbbVie spokeswoman, said in an emailed statement.


Faced with lower AndroGel sales, AbbVie is also fighting to fend off patent challenges to its blockbuster arthritis drug Humira, which accounts for almost two-thirds of the company’s revenue.

The consolidated lawsuits accuse AbbVie and other makers of testosterone-replacement medicines, including Eli Lilly & Co., of hiding or downplaying their products’ risk for blood clots and violating federal law with aggressive marketing campaigns. AndroGel has been tied to fatal heart attacks in at least four cases.

Indianapolis-based Lilly is facing more than 500 suits over its Axiron product. Mark Taylor, a spokesman, didn’t respond to a request for comment about suits targeting the drugmaker’s testosterone gel.

AbbVie has been specifically targeted for allegedly launching an $80 million marketing campaign in 2012 to promote AndroGel for a condition known as “Low T” -- low testosterone. Television ads promised immediate benefits for men suffering from low energy and lack of sexual drive, according to court filings.

Safety Warnings
The FDA approved the drug only for men who suffer from hypogonadism, a severe loss of testosterone, rather than the natural decline of the hormone through aging. Regulators moved to strengthen safety warnings in 2015 after a study suggested testosterone-replacement medicines hiked risks of heart attacks and strokes by almost 30 percent.

Lawyers for Konrad said in court filings that had he and his doctors known the true risks of the drug, he would never have used AndroGel. Konrad is seeking unspecified damages for medical bills, and pain and suffering in addition to punitive damages to punish the company’s behavior.

Chris Seeger, told jurors in his opening statement Monday. “AndroGel was approved for one condition and marketed for another’’ even though the company knew it posed increased risk of heart attacks and strokes, he said.

Test Cases
The drugmaker contends in the filings that it “made no misrepresentations about the safety or effectiveness of AndroGel to Mr. Konrad or his doctor” and that the FDA signed off on the medicine’s warnings.

AbbVie properly developed and marketed AndroGel and didn’t engage in “corporate misconduct,’’ David Bernick, one of the drugmaker’s lawyers, told jurors in his opening statement Monday. “The FDA set the rules of the marketplace and we followed those rules,” he said.

Bernick also dismissed Konrad’s claims that it was the testosterone medicine that caused his heart attack, saying the patient’s own doctors never found a link between the product and the incident.

The initial trials are test cases for the company to gauge the reaction of juries to determine if and when to settle, said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.

“Once the folks at AbbVie gets a sense of its exposure to these claims, then they can start to figure out what it’s going to take to come up with a settlement to resolve them,” Tobias said.

DeMatteo said he’s angry that AbbVie continues to sell the testosterone gel even after receiving reports it can cause life-altering injuries. The businessman was forced to close his computer-security firm after his stroke because the wheelchair made traveling to client sites too difficult.

“I can’t believe there are still men out there using this stuff,” said DeMatteo. “Why would you take the chance of using something that could land you in a wheelchair for the rest of your life? It doesn’t make any sense to me.”

The consolidated case is In Re AndroGel Products Liability Litigation, MDL No. 2545, U.S. District Court, Northern District of Illinois (Chicago).

 

Here is the company's lawyer strategy: lie, lie,lie, deny, deny, deny. Anything for a buck.... Low T, bullshit.

 

We sold our soul a long time ago for big profits.

 

Heard our legal team has this beat !

 

Most of the humira force suffers from low T

 

Are you jealous that our low T was just marketing brilliance??

 

Well testosterone has been around for 60 years. Why have we never heard of any spinal strokes before. Androgel is a puff cake compared to where you your levels get on injections. There were no spinal strokes in the pivotals so how could Abbvie have been responsible for not warning this guy.

 

Guys had Low T, Low Drive in life, and a Low bank account. Ambulance chasing lawyer slugs ad catches his eye and POOF he chasing the lazy mans American dream.n

 

The end of Met....finally .

 

Hear Ye Hear Ye
Multidistrict litigation over testosterone gel FIRST Verdict Against Abbvie

The jury found that Abbvie was not liable for Heart Attack, BUT awarded the plaintiff $150M in punitive damages on the basis of fraudulent misrepresentation. No compensatory damages were awarded. AbbVie disagrees with the verdict saying the plaintiff was an obese smoker who suffered from high blood pressure and cholesterol with a family history of heart disease. AbbVie counsel David Bernick adds, "Together, these risk factors are completely sufficient to cause a heart attack."This is the first verdict in multidistrict litigation over testosterone gel products involving thousands of lawsuits concentrated in Illinois federal court
This verdict was enough to impact stock today $73.91 USD DOWN 0.72 (0.96%)

 

Absolutely, the levels in the injections are incrementally higher! I have not heard of any lawsuits or settlements regarding injectable T causing Spinal Strokes or any other Cardio events.

 

The Biggest Suckers back in the day were the Cardio folks who went to Met then were stupid enough to go to HCV then tank ........while Met coasts doing virtually nothing but sample drops.
How's Duffy and the Philly all stars ? Salanty, Sorg, Widman, and Stenhouse can all go Fk themselves.
I can't believe Sorg was dumb enough to leave lily for this shit show. Abbott suckered her knowing they'd spin off 8 months later into ABBVIE ( Abbott lite )

 

Its about time for the final message. Interim RMs are popping up, interim DMs are already there. I even heard interim POE and PAE. They don't work anyway.

Jim is retiring soon - maybe December. MC will follow after Elogolix is staffed. Quite a run, actually, pretty damn impressive. Let someone else take the reins...Jim will not replace Elaine when she becomes the new Jeff.

ACP is not long is the tooth either. MET continues to hold on until Lupron finishes its changes. Then poof. Maybe we will continue to have someone sell synthroid - but it will be contract at best with some light abbv marketing. we cannot pay $100k salary to sample drop. Does not make sense.

 

Haters hate us. I've been pulling in 100K for over 5 years of sample dropping. It's been quite a run, and it's still chugging along. We are like the Patriots, everybody is sooooo damn jealous of our winning ways. Like Brady we just keep going and going and ............2019!!!!!!

 

5 years ? Abbvies only 4 years old. Uh oh you done did it now.

 

Big celebration in Philly Duffy ? $150M andro verdict overturned.

 

That was the big talk at Einstein and Temple.

 

(Reuters) - A federal jury in Chicago on Friday found AbbVie Inc (ABBV.N) not liable in a lawsuit by an Arizona man who claimed he had suffered a pulmonary embolism due to using the company's testosterone replacement medication AndroGel.

The verdict in the lawsuit by Robert Nolte was the third to date in federal court in litigation over AndroGel, a drug approved for men whose bodies produce low or no testosterone that has become the subject of lawsuits by thousands of people.

"Our trial team did an excellent job with a very complicated case," Christopher Seeger, a lawyer for the plaintiffs in federal litigation, said on Friday. "We look forward to the next trial and holding AbbVie accountable for putting profits before safety."

Chicago-based AbbVie did not respond to a request for comment.

AbbVie says it faces 4,510 cases nationally over injuries blamed on AndroGel. The verdict came in one of a series of test trials in federal litigation over AndroGel aimed at helping both sides gauge the range of damages and define settlement options.

A federal jury in July awarded an Oregon man $150 million in punitive damages but awarded him no compensatory damages. A federal judge in December tossed the award and ordered a new trial.

A second jury in October ordered AbbVie to pay $140 million in punitive damages and $140,000 in compensatory damages in the case of a Tennessee man who claimed the drug caused him to suffer a heart attack. AbbVie is challenging that verdict.

The latest trial stemmed from a lawsuit filed in 2014 by Nolte, who suffered an embolism two months after he began using AndroGel, which he was prescribed for the off-label use of treating a drop in testosterone levels, according to court papers.

Nolte said AbbVie fraudulently misrepresented the drug's risk and misled patients by marketing AndroGel on television for off-label use.

AbbVie has said that its marketing of AndroGel adhered strictly to uses approved by the U.S. Food and Drug Administration and that it was in full compliance with applicable standards.

 

1.62% is hyped with the 4 pump marketing gimmick. ....I'd say primary care doctor will see 1.4 cases of Low T every week. ......A top endo has maybe 70 Rx through 13 weeks ( 1 a day) Primary care doc see 20 high blood pressure and cholesterol patients per day Hypogonadism is rare within a practice. When you look up Androgel in an ERX system there can be upto as many as 6 different choices and the 1.62 is listed differently depending on if its in as grams, milligrams, pump presses, or pumps. Then add in the 1% packets and you have an ERX disaster. If it was clearly called Androgel instead of the 1.62 marketing BS it would have been WAY better. JD in east knows this.