A number of drug companies and medical device companies made the naughty list in 2013, with one company paying out more than $5 billion in settlements.
The U.S. Food and Drug Administration (FDA) also took on the regulation and taxing of medical devices.
Also, new cholesterol guidelines could change the way doctors treat patients.
Drugwatch unveiled a new podcast, Drugwatch Radio, and finished off 2013 by pumping up its social presence.
1. Johnson & Johnson Pays $5 Billion in Settlements
The pharmaceutical giant faced several multibillion-dollar settlements in 2013 related to plaintiffs who filed lawsuits against it for defective hip replacements, transvaginal mesh implants and federal charges of fraudulent marketing of its drugs.
In November, J&J proposed a $2.5 billion settlement, plus an additional $3 billion for medical expenses, to cover about 8,000 DePuy ASR hip implant claims filed by people injured by the metal-on-metal devices. A California jury in March ordered the company to pay $8.3 million to Loren Kransky who was injured by the ASR.
In addition to hip implants, the company’s Ethicon unit manufactured transvaginal mesh implants that led to thousands of lawsuits filed by women injured by the products. In February, a jury found that J&J failed to warn Linda Gross of the product’s risks and awarded her $11.1 million dollars. Gross had Ethicon’s Gynecare mesh implanted to treat pelvic organ prolapse, and needed 18 surgeries to repair damage caused by the implant.
The federal government also filed charges against J&J for fraudulent marketing of its blockbuster antipsychotic, Risperdal. In addition, the company was accused of paying doctors and nursing homes kickbacks to promote the drug for unapproved uses. In November, J&J paid $2.2 billion dollars to settle those charges.
Hundreds of lawsuits also were filed against J&J by the families of boys and young men who took Risperdal and developed gynecomastia (enlarged breasts), some needed to be surgically removed.
2. Hip Implant Lawsuit Numbers Continue to Climb
Problematic hip implants made news in 2013, specifically those manufactured by DePuy, Stryker and Biomet with more lawsuits filed against each company.
The design of implants where two metal pieces rub against one another like the DePuy ASR, Stryker Rejuvenate/ABG II and Biomet M2a-Magnum causes microscopic bits of metal to flake off and cause problems in surrounding tissue and bone.
While Johnson & Johnson negotiated a $2.5 billion settlement to settle DePuy ASR claims, Stryker settled the first Rejuvenate and ABG II hip implant lawsuits in December for an undisclosed amount.
Stryker faces hundreds more pending lawsuits, and analysts say the number could soar into the thousands.
Meanwhile, the number of lawsuits for Biomet’s Magnum M2a continued to rise in 2013, and the company now faces close to 1,000 federal cases and many more in states courts.
3. More Transvaginal Mesh Settlements on the Horizon?
In September, it was reported that five transvaginal mesh manufacturers – Endo Health Solutions (American Medical Systems), Coloplast, Cook Medical, Boston Scientific and C.R. Bard – had initiated settlement talks to try and resolved some of the more than 30,000 lawsuits filed against them.
A jury ordered C.R. Bard to pay $5.5 million to Christine Scott in 2012. Another jury in 2013 ordered it to pay an additional $2 million to Donna Cisson. Both women sued the company after its Avaulta Mesh caused them permanent injuries.
Drugwatch gained some great perspective on the litigation process in these cases when mesh lawyer Laura Yaeger became a contributor to the site.
4. Health Concerns About Diabetes Drugs Piling Up
Drugs for Type 2 diabetes called incretin mimetic therapies caused controversy when studies linked them to pancreatitis, pancreatic cancer and an increased heart failure risk.
In September, a jury found Takeda guilty of hiding increased bladder cancer risks linked to the company’s blockbuster Type 2 diabetes drug Actos. The company was ordered to pay $1.7 million to the plaintiff, but the verdict was later thrown out.
5. Safety Concerns over Birth Control
Bayer made birth control news this year with several of its products, including the birth control pill, Yaz and its two IUDs, Mirena and the brand new Skyla – the first IUD to be approved since 2000.
More than 10,000 women filed lawsuits against Bayer because of dangerous Yaz side effects like blood clots and stroke. Bayer paid $1.4 billion to settle about 7,000 claims. Bayer’s Mirena IUD is also embroiled in a number of lawsuits.
Another birth control device made national media when Vanity Fair Magazine featured NuvaRing in an article about the deadly blood clots linked to the device. There are hundreds of lawsuits filed against Merck’s NuvaRing stemming from the deadly side effects.
6. New Cholesterol Guidelines Affect Statin Prescriptions
New cholesterol guidelines were released this year that could double the number of people on statins.
Unfortunately, statins like Lipitor are controversial because while they lower cholesterol, they also have serious side effects such as development of Type 2 diabetes, muscle damage and liver damage. People injured by Lipitor filed lawsuits against Pfizer, the drug’s manufacturer.
7. Pradaxa Lawsuit Numbers Increase
Drug manufacturer Boehringer Ingelheim Pharmaceuticals was fined $1 million for failing to preserve more than 500,000 documents linked to Pradaxa bleeding lawsuits. This year the number of pending lawsuits climbed to nearly 2,000 lawsuits claiming Boehringer failed to warn of the bleeding risk.
8. Obamacare’s Medical Device Tax
The Affordable Care Act shined the spotlight on medical devices this year during the government shutdown. Medical device companies are bitterly fighting a medical device tax built into Obamacare.
9. FDA Released Mobile App Guidelines
The U.S. Food and Drug Administration (FDA) unveiled its long awaited guidelines for regulating mobile apps that function as medical devices. The FDA says they will not impede innovation and will regulate apps which may harm consumers if they malfunction.
10. Welcome to Drugwatch Radio
Drugwatch unveiled its new podcast series, Drugwatch Radio. The program’s host, Michelle Llamas, interviews medical experts as well as consumers affected by dangerous drugs and medical devices. Some notable guests this year include:
The show’s host also appeared as an expert on several shows. Drugwatch Radio’s Twitter feed keeps followers up to date on the latest health information as well as upcoming shows. Stay tuned for upcoming shows.