FDA Panel Advises Strict Limits on Testosterone Prescriptions

FDA Warning sign

Assuming the FDA adopts the advice of the panel, the drug companies will be forced to severely alter marketing strategies and the number of men prescribed these drugs will be significantly reduced. The recommendations might also impact insurance coverage of testosterone prescriptions.

On June 19, 2014 the FDA announced that labels for these drugs are now required to include warnings pertaining to the risk of blood clots.

Questions remain concerning the long-term risks of testosterone and prior studies have linked the medication to increased rates of heart disease. The same panel  voted 20 – 1 for the FDA  to require further studies be conducted related to cardiovascular risk and testosterone use. On Thursday, September 18th, the panel voted 18 – 3 against the approval of the oral testosterone drug Rextoro; the panel concluded that the risk-benefit ratio fails to support FDA approval.

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Recall of Children’s Tylenol, Motrin, Zyrtec & Benadryl

children's medications recalledMcNeil Consumer Healthcare, together with the U.S. Food & Drug Association, has implemented the voluntary recall of infant and children’s liquid  Tylenol, Motrin, Zyrtec and Benadryl due to concerns over manufacturing deficiencies. According to the announcement published on the FDA website, some of the products might a have higher concentration of the active ingredient than is specified on the label; others might contain inactive ingredients that have not satisfied testing requirements; and others possibly contain small particles that could be harmful to infants and children.

Although the likelihood of serious medical problems is believed to be remote, the FDA is advising consumers to discontinue using the above products. Consumers are being asked to report any adverse reactions to these products to: FDA’s MedWatch Program by fax 1-800-FDA-0178, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Supreme Court Considers the Liability of Generic Drug Companies

In 2008 a New Hampshire federal jury awarded Karen Bartlett $21 million for injuries she sustained after using a medication called sulindac. She was prescribed Clinoril for shoulder pain and received the generic version — sulindac. The drug was directly responsible for Bartlett developing Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), conditions that led to severe skin deterioration. Bartlett eventually suffered additional permanent injuries, including near-blindness, lung damage and burns in her esophagus.

The jury award relied on a New Hampshire products liability law allowing for damages based on defective design. The defendant in the case, Mutual Pharmaceutical Company, appealed to the U.S. Court of Appeals for the 1st Circuit arguing that the federal law regulating generic drugs preempts state design-defect laws. The 1st Circuit upheld the lower court decision and Mutual Pharmaceutical then appealed to the U.S. Supreme Court. The Supreme Court agreed to hear the case and oral arguments were held on March 19, 2013.

Mutual Pharmaceutical claims no liability since they are required, pursuant to the Food & Drug Cosmetic Act (FDCA) to use the same ingredients and warning labels as those used by the original manufacturer. In other words, they claim they are legally required to keep a generic drug identical to the brand name drug. Brand name manufactures maintain that they are not responsible for injuries caused by drugs that were not purchased from them.

Ultimately, this case well help clarify how federal law applies to generic pharmaceutical companies as well as determine the extent to which state product liability laws pertain to the generic drug industry.

For a thorough analysis of the legal issues involved in this case see  Cornell’s Legal Information Institute.

Judge’s Order Nullifies $6.5 Million Verdict in Diabetes Drug Trial

In a May 1, 2013 press release Takeda Pharmaceuticals announced that the trial court judge granted the defendant’s motion for non-suit. The ruling nullifies the April 26th jury verdict.

A Los Angeles Superior Court jury awarded $6.5 million to the plaintiff Jack Cooper in the first trial involving the diabetes drug Actos (Cooper v. Takeda Pharmaceuticals America, Inc., CGC-12-518535). The jury found Takeda Pharmaceuticals liable for the failure to warn patients that Actos could cause bladder cancer. The verdict awarded $5 million in compensatory damages to Jack Cooper and $1.5 million to his wife. As many as 3000 similar lawsuits are pending in the United States.

According to the attorney representing Cooper, the Japanese drug company was aware of possible links between Actos and bladder cancer as early as 2004. However, the company waited 7 years before reporting these findings to U.S. regulators. In 2011 Actos was removed from the market in both France and Germany after studies revealed that some patients using Actos have increased risk of developing heart problems and bladder cancer.

In 2012 the British Medical Journal reported that patients who use Actos for 2 years are twice as likely to develop bladder cancer. In the same year  the Canadian Medical Association Journal published the results of a study showing that users of Actos have a 20 percent increased risk of developing bladder cancer. Canada has since removed Actos from the list of approved medications.

A “black box” warning, the strongest of the FDA warnings, informing users that Actos is linked to congestive heart failure was added to the label in 2007. In 2011 an FDA Safety Announcement informed the public that the use of Actos for more than one year might result in “increased risk of bladder cancer”. The announcement required the drug manufacturer to add this warning to the drug label.

In response to FDA demands, Takeda launched a ten year study addressing the long term risk of bladder cancer associated with Actos. Data from the first five years of the study showed that patients taking the drug for over a year have a 40 percent higher risk of developing bladder cancer. The study was completed in 2012 and the full results should be available sometime in 2013.

Defensive Medicine and Rising Health Care Cost

surgeryDespite assertions that large medical malpractice payouts are largely responsible for the rising cost of health care, a new study by doctors from Johns Hopkins suggests that these claims are mistaken. The research revealed that malpractice payouts account for less than 1 percent of medical expenditures in the United States. The study, directed by Dr. Marty Makary, associate professor of surgery and health policy at Johns Hopkins University School of Medicine, reviewed nationwide medical malpractice settlements and judgments from 2004 to 2010.  According to Makary, the data shows that legal reform efforts should focus on curtailing defensive medicine rather than establishing caps on malpractice awards and settlements. “The real problem is that far too many tests and procedures are being performed in the name of defensive medicine, as physicians fear they could be sued if they don’t order them. That costs upwards of $60 billion a year. It is not the payouts that are bankrupting the system — it’s the fear of them.” Makary maintains that the findings support the need for more research to determine procedures to prevent catastrophic errors and improve patient safety. He also asserts the need to reduce unnecessary diagnostic tests and procedures as a means to lowering health care cost.

Click here for more details about the study.

Dozens of Lawsuits Allege Serious Risks Associated with Mirena IUD

Mirena birth control device Manufactured by Bayer Healthcare Pharmaceuticals, the Mirena IUD was approved by the FDA in 2000 as a contraceptive and later as treatment for heavy bleeding after childbirth. The device is used by more than 2 million women in the U.S. and 15 million women worldwide. Although considered a safe form of birth control, the FDA has received thousands of reports from women claiming they have suffered serious complications from the device. Recent lawsuits allege that women who use the contraceptive are susceptible to the following risks:

  • Perforation of the uterine or cervix wall
  • Embedment in vaginal tissue
  • Pelvic inflammatory disease
  • Ovarian Cysts
  • Migration out of the uterus which can result in infection or other injuries

Of the nearly 3 dozen lawsuits filed, the primary allegation is perforation of surrounding tissue.  According to the lawsuits, Bayer Healthcare Pharmaceuticals knew or should have known about the risks and neglected to provide adequate warnings to the medical community. Plaintiffs allege that the company withheld information about the risks and made false and deceptive representations concerning the safety  of the device. Although the FDA has not yet recommended a recall of the Mirena IUD, it appears likely that the manufacturer will be required to alter the warning label to include more comprehensive information about potential risks.

Click here to access the FDA’s description of the Mirena IUD, including side affects and risks.

Metal-on-Metal Hip Replacement Lawsuits

metal on metal hip replacement implantsJohnson & Johnson is facing up to 10,000 law suits due to the failure of the all metal DePuy ASR hip implants. The implants were recalled in 2010 following acknowledgement on the part of Johnson & Johnson that the devices had a higher than expected failure rate. Internal documentation revealed that the company’s own estimates predicted that 37% would fail within 4.6 years. As many as 93,000 ASR hip implants were sold prior to the 2010 recall.

The first of these cases is currently being tried in Los Angeles Superior Court. The Plaintiff alleges that the defective implants released toxic amounts of metal ions causing a form of metal poisoning.  Johnson & Johnson maintains that the levels were not high enough to cause health problems. Surgeons have predominantly stopped using metal on metal devices because of evidence that the components grind together and release metal debris, resulting in damage to tissue and bone.

Last month Johnson & Johnson recalled a  2nd type of metal hip implant that is sold outside the United States. The recent recall applies to the Adept metal-on-metal hip replacement device. Research shows that these devices need to be replaced after about 7 years in 12 % of the patients. Most hip implants are made with metal and plastic and often last up to 15 years.

For more information about problems associated with these devices and the recalls visit the FDA Metal-on-Metal Hip Implants page.

Hospital Safety Scores Updated

health care providers washing handsLeapfrog Group, an independent national nonprofit organization, recently concluded a study on Hospital Safety. With a focus on quality and affordable healthcare, the group launched the Hospital Safety Score project in June 2012. Hospitals were graded based on “preventable medical errors, injuries, accidents, and infections”. Of the 2618 hospitals studied, 790 received an A, 678 earned a B, 1004 earned a C, 121 earned a D, and 25 received a failing grade. Both Massachusetts and Maine demonstrated exceptional safety results with 83% of Massachusetts hospitals and 80% of Maine hospitals earning an A score.

Consumers are able to check the safety score of their local hospitals at Hospital Safety Score. For a summary of the Leapfrog Group study go to : http://www.leapfroggroup.org/policy_leadership/leapfrog_news/4971031

The Leapfrog Group encourages people who have been hurt by errors or accidents at a healthcare facility to share their stories with ProPublica, an independent organization that investigates patient safety concerns. People who wish to contact ProPublica may call the organizations hotline at (917)512-0241 or visit the online interactive web survey at: http://www.propublica.org/article/patient-harm-questionnaire.

Death Toll for Meningitis Outbreak Reaches 23

NECC injection bottlesOn Monday, October 22nd, the CDC announced that 3 more people have died from the national meningitis tragedy, bringing the total deaths to 23. There have now been 297 non-fatal cases, and of the approximately 14,000 people who received the contaminated steroid, 12,000 have been contacted.

The FDA is currently investing two additional drugs made by the New England Compounding Center (NECC) that appear to be linked to the fungal meningitis outbreak. They have received reports of two heart transplant patients who developed fungal infections after being given one of these drugs during surgery. The NECC has recalled all of the drugs produced at the facility and has surrendered its state license.

According to recent press reports, a 2006 investigation of the NECC revealed inadequate contamination controls along with other insufficiencies related to operation procedures. The House Committee on Energy and Commerce has requested up to 10 years of records from the drug company. Furthermore, two members of the House Oversight Committee appealed to the Government Accountability Office to investigate the pharmacy compounding industry with a goal to reforming state and federal rules so as to prevent this type of tragedy in the future.

On Tuesday, October 23rd, Massachusetts launched a criminal investigation into the specialty pharmacy. The Massachusetts Office of Health and Human Services started investigating the pharmacy on September 26 and the “Preliminary Investigation Report of NECC” is now available online.

Contaminated Steroid Linked to Fungal Meningitis Outbreak

aspergillus fumigatus fungasAs many as 119 patients who received epidural steroid injections have developed fungal meningitis. As of October 9, 2012, 11 people have died from the outbreak. According to the Food and Drug Administration, a vial of the steroid called methylprednisolone acetate was found to be contaminated with a fungus. In several of the patients, the meningitis was caused by the fungus aspergillus. New England Compounding Center (NECC) in Framingham, Massachusetts is believed to be the source of the contaminated steroid. NECC has recalled three lots of the drug and is no longer in operation.

The Centers for Disease Control & Prevention along with the Food and Drug Administration are conducting and a multi-state investigation focusing on cases of meningitis where the patient was given an epidural spinal injection. The injections are given to help relieve back pain. Up to 75 clinics in 23 states received the recalled lots of the steroid.The potentially contaminated injections were given staring May 21, 2012.

The States that received the NECC steroid include: California, Connecticut, Florida, Giorgia, Idaho, Illinois, Indiana, Maryland, Michigan, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia. A complete list of the Healthcare facilities which received lots of the recalled drug is available on the CDC website.

The CDC is advising patients to find out if they received a potentially contaminated medication by contacting the health care provider who performed the procedure.

“If you have received a potentially contaminated medication, seek medical attention if you have symptoms. It is important to note that infected patients have had very mild symptoms that are only slightly worse than usual. For example, many infected patients have had slight weakness, slightly worsened back pain, or even a mild headache. Patients have had symptoms generally starting from 1 to 4 weeks after their injection.”

People who received an epidural steroid injection since May 21, 2012 should seek medical attention should they have any of the symptoms listed below:
New or worsening headache
Fever
Sensitivity to light
Stiff neck
New weakness or numbness in any part of your body
Slurred speech
Increased pain, redness or swelling at your injection site”

Updates about the investigation as well as patient guidelines and answers to frequently asked questions are available at the CDC website.