Category Archives: Drugs & Medical Devices

FDA Lets Avandia Up Off the Mat

Harsh sales restrictions on the once-popular diabetes medication Avandia have been lifted by the FDA. Use of the drug will no longer be limited to certain patients, and new labeling will be pretty much in-line with other prescription diabetes meds. Maybe you’re reading this and asking yourself, “Hey, isn’t the FDA sort of doing a complete 180 on Avandia?” Not a bad question.

The restrictions have been in place since 2010, when, on the heels of a study that linked Avandia use to an increase in heart problems, the FDA ordered that Avandia only be prescribed to certain diabetes patients whose condition could not be adequately controlled with any other medication.

The FDA wasn’t done with Avandia in 2010. The following year, the agency announced that the drug would no longer be available through retail pharmacies, and that only a very limited number of patients would still be able to receive it. Those patients needed to be enrolled in a special program before receiving Avandia via mail order, from specially-certified pharmacies.

So, why the regulatory change of heart now? A recent clinical trial suggested that Avandia use actually comes with no elevated risk of heart attack or death when compared with other diabetes drugs. Not that the new study was without controversy — check out this Wall Street Journal article featuring a few barbs from critics of the trial and the way it was carried out.

It sounds like Avandia’s new labeling will be pretty standard, according to the FDA announcement: “The FDA anticipates that the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus, an indication similar to other diabetes drugs currently available.”

Learn about Product Liability Claims Involving Pharmaceutical Drugs.

J&J Pays $2.2 Billion Fine to Feds Over Risperdal

Drug giant Johnson & Johnson, makers of the anti-psychotic medication Risperdal, have agreed to pay $2.2 billion in fines over allegations that the prescription drug was inappropriately marketed to older dementia patients and to children with behavioral disabilities.

The agreement was announced yesterday by the U.S. Department of Justice, which called it “one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.” In legalese, that is what is known as a “whopping” amount of money.

Risperdal is part of a class of “atypical antipsychotic” medications used to treat mental illnesses like schizophrenia, bipolar disorder, and irritability associated with autistic disorder.

Johnson & Johnson and other makers of atypical antipsychotics have come under regulatory scrutiny for for illegally touting these drugs for unapproved uses, and in spite of clear health risks. The New York Times calls yesterday’s settlement “part of a decade-long effort by the federal government to hold the health care giant — and other pharmaceutical companies — accountable.” Learn more about Lawsuits Over Risperdal and Other Antipsychotic Drugs.

J&J actually lost its patent protection for Risperdal a few years back, but the company is still paying a hefty price for a questionable-slash-illegal marketing strategy over the once-popular drug.

FDA Unveils New Medical Device Tracking System

From knee replacements to defibrillators and stents, all kinds of medical devices will be coded with a unique identifier and tracked electronically under a new system announced last week by the U.S. Food and Drug Administration.

The new FDA rules are intended to make it much easier for doctors and patients to understand which devices have been identified as problematic — even recalled — by manufacturers and federal health officials.

According to the FDA press release on the new “unique device identification” system, there are two key components:

    The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label. The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier.

Learn more about the FDA’s new Unique Device Identification System.

The past decade or so has seen an influx of new medical devices on the market, and an aging population is living longer and putting those devices to good use. A surge in medical device defects was almost inevitable.  Don’t take our word for it. Check out the FDA’s list of Recent Medical Device Recalls, and see how long it takes you to scroll all the way down.

Legal action over defective defibrillators, hip implants, and other medical devices has also made headlines in recent years, and cases like these raise some pretty unique legal issues. Learn more about Lawsuits Over Defective Medical Devices.

Defective Artificial Hip Verdict: Jury Awards $8M

Johnson & Johnson has been ordered to pay $8 million in damages to a retired prison guard who received a defective artificial hip that was manufactured (and later recalled) by the health care giant.

A Los Angeles jury sided with plaintiff Loren Kransky and placed Johnson & Johnson on the legal hook for marketing a defective product and failing to warn consumers about the health risks associated with the all-metal artificial hip device, 93,000 of which were recalled in 2010.

According to the Los Angeles Times, the financial hit that Johnson &  Johnson took today could have been a lot worse: the plaintiff’s attorney asked the jury to order the company to pay another $179 million in punitive damages. When the jury declined that request, you could probably hear the sigh of relief coming all the way from J&J headquarters in New Brunswick, New Jersey.

Learn more about Product Liability Claims Involving Medical Devices.

Sleeping Pill Safety: Study Sends a Wake-Up Call

It may be time to rethink what you’re willing to do for a good night’s sleep. According to a new study, taking prescription sleeping pills like Ambien, Lunesta, and Sonata — even once in a while — puts patients at a much higher risk of dying or developing cancer.

“It looks like sleeping pills could be as risky as smoking cigarettes. It looks much more dangerous to take these pills than to treat insomnia another way,” said Daniel F. Kripke, MD (who headed up the study) in an interview with WebMD.

And you don’t even need to take that many prescription sleeping pills over time before you’re exposed to the health risks. The BMJ (British Medical Journal) Open study found that even patients who were prescribed fewer than 18 hypnotic sleeping pills per year saw “greater than threefold increased hazards of death.” (Hypnotic sleeping pills are designed to induce sleep, not merely promote sleep through relaxation, according to WebMD.)

As this ABC News article points out, however, the study may not be telling the full health story of those who participated: “the study did not say why the patients were prescribed the sleeping medications, whether the patients were evaluated by a sleep specialist, or whether they were also undergoing other types of treatment for any underlying health conditions — all important factors when weighing an increased risk of death, said Dr. Steven Scharf, professor of medicine at the University of Maryland in Baltimore.”

The study will be published in the online-only medical journal BMJ Open (see an abstract here.)

More from Nolo: Drug Safety and the Law.

Avandia: FDA Puts End to a Drug Problem (Almost)

The rumors of Avandia’s total removal from the retail market became a reality this week, when the U.S. Food and Drug Administration (FDA) announced that starting in November, the once-popular type 2 diabetes drug will no longer be available to almost all patients.

Avandia (or rosiglitazone maleate), manufactured by GlaxoSmithKline, earned FDA approval in 1999. Since then, it’s been a popular prescription option for controlling blood sugar in adults with type 2 diabetes.

But Avandia has also been linked to an increased risk of heart attack since 2007, and the FDA hasn’t been shy about limiting sales of the drug since that time. Avandia’s complete removal from the market became a distinct possibility in September 2010, when the FDA ordered severe restrictions on the drug.

This week’s action doesn’t amount to a complete FDA recall of Avandia, but it’s about as close as it gets. According to the FDA’s announcement, after November 18, 2011 Avandia (and its companion rosiglitazone medicines Avandamet and Avandaryl) will no longer be available through retail pharmacies. Only a very limited number of patients will still be able to receive these drugs, and they must be enrolled in a special program before they’ll receive the medicine via mail order, from specially-certified pharmacies.

Vaccine Makers Immunized Against Many Suits, Top Court Says

Vaccine makers are shielded from certain kinds of personal injury lawsuits because of a 1986 law that set up a no-fault compensation system for injuries linked to childhood vaccines, the U.S. Supreme Court ruled today.

Today’s 6-2 decision (Bruesewitz v. Wyeth LLC) came about after a Pennsylvania family tried to step outside the confines of the National Vaccine Injury Compensation Program after their claim was rejected under that process. The Bruesewitz family sued drug maker Wyeth in state court, alleging that their daughter had become disabled after receiving a diphtheria, tetanus, and pertussis (DTP) vaccine manufactured by a company now owned by Wyeth.

The Supreme Court upheld two lower federal court decisions in ruling that the National Childhood Vaccine Injury Act of 1986 insulates vaccine manufacturers from any kind of personal injury lawsuit alleging a design defect — meaning all lawsuits that seek compensation for harm from a vaccine’s side effects based on a theory that the vaccine could have been make safer.

The 1986 law, which set up the no-fault National Vaccine Injury Compensation Program, was enacted for two key reasons. First, expensive lawsuits over injuries from childhood vaccines were acting as a deterrent that kept many companies from working to develop new vaccines, even when those vaccines could provide a clear benefit to kids and to society in general. Second, families and kids who had been injured by childhood vaccines spent large amounts of money and time trying to get compensation through increasingly complex court cases. The National Vaccine Injury Compensation Program eliminates manufacturer liability for a vaccine’s unavoidable, adverse side effects. Awards are paid out of a fund created by an excise tax on each vaccine dose.

Read the full text of today’s decision in Nolo’s Supreme Court Center: Bruesewitz v. Wyeth LLC. And to learn more about the National Vaccine Injury Compensation Program and how the claim process works, check out Nolo’s article Vaccine Injuries: The Federal Compensation Program.


Unnecessary Stents, Medical Fraud, and a Slow-Smoked Pig

A Baltimore cardiologist’s alleged pattern of unnecessarily inserting stents into patients is the subject of a recent U.S. Senate committee investigation and report. The story shines a spotlight on an emerging and disturbing trend in health care: doctors and hospitals churning out procedures that may or may not be necessary, and drug and medical device manufacturers rewarding those high-volume practices.

Articles in The New York Times and The Baltimore Sun can give you more details about the Senate report and all the garish attention paid to Dr. Mark Midei for inserting Abbott Laboratories stents into patients like he was going for some kind of record.

Those details include 585 stent procedures that weren’t medically necessary, and a celebratory $2,000-plus dinner featuring a slow-smoked pig, with the bill paid by Abbott Labs in order to honor Dr. Midei’s “achievements,” according to allegations. Meanwhile, every single procedure (necessary or not) brought lucrative profits, including Medicare reimbursements.

In non-emergency cases, stents are typically inserted only when an artery is completely or significantly blocked. That’s because the use of stents brings serious health risks — specifically, the increased chance that a patient will suffer blood clots, stroke, heart attack, and internal bleeding. And as the Times article points out, patients who have had stents inserted need to take blood-thinning drugs, and those medications come with their own unique risks.

So it’s not hard to see how inserting a stent when it’s not medically necessary to do so can rise to the level of medical malpractice. Cue the hundreds of lawsuits that have been filed against Dr. Midei and St. Joseph Medical Center, according to the Times.

Looking for more information on the legal issues behind this developing story? You’ll find dozens of articles and FAQs on medical malpractice cases and lawsuits involving medical devices in Nolo’s Medical Malpractice and Dangerous Products and Drugs sections.

Bitter Pill: GlaxoSmithKline Pays $750M Over Defective Drugs

Drug maker GlaxoSmithKline will pay a $750 fine to settle allegations that the company manufactured defective drugs — including the antidepressant Paxil — at a GSK facility in Puerto Rico.

Certain batches of drugs manufactured at the Puerto Rico plant were misidentified and were inconsistent in terms of their active ingredient levels and their purity — in some cases falling “materially below, the strength, purity or quality specified in the drugs’ FDA applications,” the U.S. Department of Justice says. It’s important to note that there were no reports of patients being harmed by the defective drugs; the penalty against GSK is for the company’s ongoing violation of laws meant to ensure the drugs’ quality and safety.

In addition to Paxil, other drugs that were allegedly manufactured with defects include Kytril (an anti-nausea drug), Bactroban (used to treat skin infections), and Avandamet (for treatment of Type II diabetes).

Under the deal, SB Pharmco Puerto Rico Inc. (a subsidiary of GSK) has agreed to plead guilty to charges related to the selling of the defective drugs. SB Pharmco will pay a criminal fine and forfeiture of $150 million, and another $600 million to settle allegations under the federal False Claims Act and related state claims.

Here’s some related news, and it should serve as incentive for corporate mischief-spotters everywhere to grab their whistles and blow like Dizzy Gillespie. Cheryl Eckard is the ex-quality assurance manager at GSK who filed the whistleblowersuit against the company in 2004, shining a spotlight on the questionable manufacturing practices at the Puerto Rico facility. Eckard will receive a lottery jackpot-like $96 million as compensation for coming forward and exposing GSK’s wrongdoing.

Learn more about defective drugs and the legal issues they raise in Nolo’sDangerous Products & Drugs section.


Meridia Recalled Over Heart Risks

Meridia manufacturer Abbott Laboratories has agreed to stop marketing the popular weight loss drug in the U.S., after a study raised serious concerns over a link between Meridia use and heart problems.

The announcement of the Meridia recall came on October 8, 2010. The main impetus for Abbott’s action (with a strong nudge from the FDA) was a recently concluded study that showed an increased risk of heart attack and stroke in patients that were taking Meridia, and minimal weight loss benefits in light of those health risks. The 60-month study (called the Sibutramine Cardiovascular Outcomes, or “SCOUT” trial) followed 10,000 men and women who were given Meridia or a placebo. Development of cardiovascular problems was closely monitored in these patients, while progress in their weight loss was also tracked.

According to the FDA, results of the study showed a 16 percent increase in the risk of serious (sometimes even fatal) heart events like heart attacks and strokes in patients who were given Meridia, compared with patients who took the placebo. At the same time, there was only a slight difference in weight loss progress when the Meridia group and the placebo group were compared.

A day after the Meridia recall announcement, this Washington Post article labeled the weight loss pill’s withdrawal “the latest setback in the long, frustrating quest for a pharmaceutical solution to the nation’s obesity epidemic.”

Meridia (sibutramine) was approved by the FDA in 1997, as a prescription weight loss medication intended for use by patients who were considered obese under the body mass index (BMI) measurement standard.

Related information from Nolo: