A U.S. judge on Thursday overturned a $140.1 million verdict against AbbVie Inc in a lawsuit by a man who claimed the company misrepresented the risks of its testosterone replacement drug AndroGel, causing him to suffer a heart attack.
U.S. District Judge Matthew Kennelly in Chicago ordered a retrial in the lawsuit brought by Tennessee resident Jeffrey Konrad, whose case is one of thousands AbbVie faces nationally over injuries blamed on AndroGel.
In October, jurors awarded Konrad $140,000 in compensatory damages and $140 million in punitive damages after finding that AbbVie was negligent and made misrepresentations related to AndroGel that helped cause his 2010 heart attack.
But Kennelly said the jury’s finding on the negligence claim was inconsistent with its decision to find AbbVie not liable on another claim as both involved determining if AndroGel was unreasonably dangerous and caused his heart attack.
“When this happens, the court cannot accept one of the two inconsistent verdicts while discarding the other; both of them have to go,” Kennelly wrote.
AbbVie did not immediately respond to a request for comment. A lawyer for Konrad also did not respond to a request for comment.
Chicago-based AbbVie has said it faces 4,500 cases nationally in which plaintiffs claim the company did not adequately warn about risks of heart attacks, strokes and blood clots that could result from using AndroGel.
The verdict in Konrad’s lawsuit came in one of a series of test trials in federal litigation consolidated before Kennelly over AndroGel aimed at helping both sides gauge the range of damages and define settlement options.
Konrad had alleged that he had been using AndroGel for two months in 2010 when he suffered a heart attack. He has since recovered from his injuries.
Thursday’s ruling marked the second time Kennelly has ordered a retrial in one of the test, or bellwether, cases.
In December, he overturned a verdict in which jurors awarded $150 million in punitive damages but no compensatory damages to Oregon resident Jesse Mitchell, who said he suffered a heart attack after using AndroGel.
Mitchell’s case was retried, and jurors in March ordered AbbVie to pay him $3.2 million.
The lawsuits by Konrad and Mitchell are among four to date that have gone to trial over AndroGel. The company won the other two cases that went to trial.
The case is In Re: Testosterone Replacement Therapy Products Liability Litigation, U.S. District Court, Northern District of Illinois, No. 14-cv-01748.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, announced that the company will present clinical and preclinical data for the company’s soluble guanylate cyclase (sGC) stimulator praliciguat (IW-1973) during the American Diabetes Association’s (ADA) 78th Scientific Sessions in Orlando, Fla., June 22 through June 26, 2018. Praliciguat is currently being studied in Phase II clinical trials in patients with diabetic nephropathy and in patients with heart failure with preserved ejection fraction (HFpEF) (see also Ironwood Pharmaceuticals Inc.).
Data from a Phase IIa 14-day study of praliciguat in patients with diabetes and hypertension will be featured as an oral presentation during the Emerging Targets for Diabetes Treatment session, presented by John P. Hanrahan, M.D., M.P.H., of Ironwood. In addition, a Phase IIa rapid dose escalation study of praliciguat in patients with diabetes and hypertension will be presented during a poster session. Finally, new data will be presented in a moderated poster discussion on praliciguat’s effect on glucose tolerance, insulin sensitivity and triglycerides in a preclinical diet-induced obesity model.
sGC plays an important role in regulating many critical physiological processes; therefore dysregulation of sGC may play a role in multiple serious diseases. Ironwood’s sGC stimulators, including praliciguat, are believed to harness the nitric oxide/sGC/cyclic guanosine monophosphate (NO/sGC/cGMP) pathway by working synergistically with NO to improve blood flow and metabolism and decrease inflammation and fibrosis. Praliciguat has the potential to address the underlying causes of devastating diseases such as diabetic nephropathy and HFpEF by improving NO signaling, which may improve vascular and metabolic function and decrease the inflammatory and fibrotic consequences associated with these diseases.
Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, recently reported preliminary interim data from ongoing H.P. Acthar® Gel (repository corticotropin injection) studies, including the company’s Phase 4 Rheumatoid Arthritis (RA) clinical trial and its prospective observational registry for Multiple Sclerosis (MS) relapse. Details on both the RA (available here) and MS (available here) data presentations were posted to Mallinckrodt’s website (see also Mallinckrodt Pharmaceuticals).
“We are pleased to see continued advancement of our evidence base to support the effectiveness of H.P. Acthar Gel and build on the decades of clinical experience for the product,” said Steven Romano, MD, Chief Scientific Officer and Executive Vice President of Mallinckrodt. “The progress of these studies may help prescribers and payers further understand how the drug may provide benefit to appropriate patients.”
Senseonics Holdings, Inc.(NYSE American: SENS) announced the U.S. Food and Drug Administration has approved its Premarket Approval (PMA) application to market the company’s Eversense® Continuous Glucose Monitoring (CGM) System to people with diabetes in the United States. The system is the first and only CGM system to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months (see also Senseonics).
“We’re very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets. With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way,” said Tim Goodnow, President and CEO of Senseonics. “More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides.”
With 70 percent of patients struggling to control blood glucose levels and with hypoglycemia prevalent among insulin users, healthcare professionals believe there are many U.S. patients who could benefit from CGM. Yet the technology is significantly underutilized among the millions of insulin-using patients who could be ideal CGM candidates.
“Research has repeatedly demonstrated the clinical benefits patients experience with regular CGM use, including improved glucose control and protection against severe hypoglycemia,” said Steven Edelman, MD, Professor of Medicine at University of California San Diego, Founder & Director of Taking Control of Your Diabetes, and Senseonics Board member. “Despite these benefits, a significant number of people with diabetes do not use, or have access to, continuous glucose monitoring. Furthermore, the data shows that many people who’ve tried traditional CGM in the past either don’t wear it as often as they should or don’t stick with it for a variety of reasons, including concerns surrounding sensor accuracy, sensor insertion, and sensor discomfort. So, it’s important that patients have choices and that medical device companies continue to advance the field of CGM with innovations that make it easier for the end user.”
The Eversense System addresses many of the barriers to CGM use. The system consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. The sensor, which is inserted subcutaneously in the upper arm by a physician via a brief in-office procedure, lasts up to three months, thereby eliminating the need for patients to self-administer the weekly or biweekly sensor insertions required by traditional CGM systems.
The system’s smart transmitter is light, discreet, and comfortable to wear. Interpreting glucose data from the sensor and sending it to the system’s mobile application via Bluetooth, the smart transmitter provides on-body vibratory alerts for discretion and added safety, and is the only CGM transmitter that can be removed and recharged without discarding the sensor.
The Eversense CGM System’s PMA application was based on the previously-reported results of the PRECISE II U.S. pivotal trial in which Eversense was studied in 90 adults with type 1 or type 2 diabetes at eight clinical centers in the United States. The study clearly demonstrated the system’s safety and effectiveness over 90 days of continuous glucose sensor wear. This March, the FDA’sClinical Chemistry and Clinical Toxicology Devices Panel of independent medical experts voted unanimously, 8 to 0, that the system not only was safe and effective, but also that its benefits outweighed the risks.
Webcast and Conference Call Information
Management will host a conference call today beginning at 4:30 p.m. ET to discuss the PMA approval and commercial activities to support the Eversense product launch in the U.S. Investors interested in listening to the conference call may do so by dialing (877) 883-0383 for domestic callers, or (412) 902-6506 for international callers, using Conference ID: 5389400. To listen to a live webcast, please visit the “Investor Relations” section of the Company’s website at: http://www.senseonics.com. Following the call, a replay will be available on the Investor Relations section of the Company’s website.
A California agency for occupational safety said on Thursday it opened a third investigation at Tesla Inc’s factory in Fremont, California, following a complaint.
The state’s Occupational Safety and Health Administration (Cal-OSHA) said it opened the latest case on June 21, but did not give details on the investigations beyond confirming that they are active and ongoing.
Online auto news website Jalopnic reported on Thursday that the latest investigation follows a complaint from one of the automaker’s employees at the plant.
Cal-OSHA spokeswoman Erika Monterroza the first investigation opened on April 12 following a serious injury to a millwright employed by Automatic Systems Inc.
The second investigation was launched on April 17, a day after news website Reveal said that Tesla’s omissions in legally mandated reports made its safety record appear better than it was.
Virtual care operator American Well is well on its way to raising $315 million, according to an SEC filing. As of June 28, the company had already fetched $291 million.
The securities being offered include equity and Series C convertible preferred and common stock.
A major backer is multinational technology powerhouse Philips, which partnered with American Well in January to embed telehealth services in a range of products.
Investors are also betting big on the modality. During the first half of 2018, telemedicine landed 21% of total digital health funding with 32 deals worth $714.6 million, a new Rock Health report shows. Behavioral health was also a big winner, with 16 deals across 15 companies valued at $273 million. More than half of those startups include virtual or on-demand services, the report notes.
Still, telehealth has struggled at times to show clear ROI, and adoption has been slowed by lack of consumer awareness and regulatory barriers that prevent doctors from providing virtual care across state lines in some areas.
Telehealth was vital to delivering care during last year’s Hurricanes Harvey and Irma and again during the last winter’s flu outbreak. But not everyone is convinced telehealth is headed for large-scale care delivery. “I remember when Segway came out and there were all these articles about how it was going to help people get around, and ultimately it found its niche in tourism and cities,” Jay Parkinson, founder and CEO of virtual primary care company Sherpaa, told Healthcare Dive earlier this year. “It feels like that’s what telehealth is … [I]t’s going to revolutionize a niche.”
Boston-based American Well continues to forge new partnerships and roll out products. In May, the company signed a definitive agreement to acquire acute care telehealth vendor Avizia for an undisclosed amount. The deal — set to close in the second quarter — would create a “single, end-to-end offering for telehealth customers,” American Well CEO Ido Schoenberg said at the time.
The hallways of Inova Health System’s newest inpatient mental health unit gleam white and new.
With all private patient rooms, they look very much the style of patient rooms popping up in brand new hospital towers around this region of the country. And despite safety design features—such as hidden sensors to help monitor patients at risk for self-harm and doors that are built to be barricade-proof—that is what Inova hopes patients will see in the newly renovated unit.
“Three years ago, we embarked on this journey to increase behavioral health beds with the knowledge that we really needed to find more specialized care for our patients outside of a general psychiatric population. We do that with any other type of illness,” said Michelle Mullany, Inova’s assistant vice president of behavioral health.
Later this month, the hospital will open that behavioral health inpatient unit with one floor dedicated to adolescents and another for adults.
They join a growing number of hospitals around the country that are adding or growing such units after years of efforts to deinstitutionalize mental health care led to shortages of inpatient behavioral health beds.
Children’s Hospital of Richmond at Virginia Commonwealth University recently redesigned its behavioral health center, boosting its inpatient bed count from 24 to 32 beds. San Francisco just opened a 54-bed inpatient facility, Mercy Medical Center recently announced plans to build a proposed 100-bed psychiatric hospital in Iowa and multiple psychiatric hospital projects have already been built or are underway in Massachusetts and New Jersey.
The creation of these specialized units makes sense because many of the patients with severe and persistent mental illness have co-occurring health conditions or present suicide risks that are landing them in inpatient units anyway, said Doug Tynan, the director for the American Psychological Association Center for Psychology and Health.
“I think some of the hospitals are finally realizing let’s just create the units that best suit these patients,” Tynan said. “They are looking at the patient population, more people have insurance now, there is now health parity and I think hospitals in a particular location look at their catchment and say, ‘What is our best setup for the patients we’re going to have coming in the front door?”
The creation of the Inova unit driven by a growth in needs with reports of increases in suicides and other “deaths of despair” related to drugs and alcohol, as well as poor outcomes for patients with mental health concerns, Mullany said.
“We get the meds wrong, we don’t necessarily give enough time to see how the trajectory of the improvement is on those medications, we discharge folks,” Mullany said about mental health care in general in the U.S. “Having an increase in beds will help us prevent the readmissions and really get that treatment right from the beginning.”
An inpatient room in the new behavioral health unit. (Inova Health System)
Inova’s unit, which will have all private patient rooms, will offer patients individual bathrooms, large windows that allow natural light and open areas such as shared dining space and group therapy rooms. In all, they will have 15 adolescent inpatient beds, 14 mood disorder unit beds, 12 medical and geriatric psychiatry unit beds and 12 acute care psychiatry beds. It will also have 25 Comprehensive Addiction Treatment Services beds. They are careful to point out this is part of a comprehensive suite of services that include outpatient services.
Inova said it will accept all appropriate patients regardless of which insurance they have. Mullany said she expects Medicaid expansion in Virginia will significantly help provide patients better access and improve Inova’s financial considerations when it comes to providing care to all comers.
But there are still significant reimbursement challenges Inova and other hospitals have to overcome to provide specialized inpatient behavioral health care as part of their overall mental health services continuum.
“Many hospitals will negotiate contracts with companies that provide higher reimbursement for high ticket items. Cancer. Transplant. Heart attacks. And they will take a lower rate for behavioral health in favor of bigger reimbursement for those other diagnoses,” Mullany said. “That’s not a criticism of the health system. That’s good fiduciary responsibility. But as a result, we sometimes see the rates of reimbursement are lagging behind.”
Further, to meet the demand among patients, she said health systems need to be able to make better use of midlevel providers such as social workers and counselors because the Centers for Medicare and Medicaid Services doesn’t reimburse for them in a hospital setting.
“If a patient comes into the hospital, the only person who can bill for services is a doctor and a psychologist,” Mullany said. “But 90% of mental health treatment is done by social workers and counselors who are billable and reimbursable—it’s just in the hospital they are not allowed to do that.
She ultimately wants to see a shift where mental health care is viewed—and paid for—the same as other health services.
“Essentially, what we’re saying to patients is ‘You’re different. This is a different diagnosis. It may or may not need the treatment that we think you need,'” Mullany said. “If you’re having a heart attack, no one is sitting around saying that. I think we have a lot of work to do there.”
Investments in inpatient units, such as Inova’s, are a step toward changing that, she said.
