Dangerous Product Alert: Defective Medical Device Recalls Nearly Doubled in the Last Decade

Just when you think that the inexorable march of progress will make us safer, you learn that medical device manufacturers have recalled almost twice as many defective products than they did ten years ago.  According to The Wall Street Journal the total number of recalls jumped from 604 in 2003 to 1,190 in 2012. The vast majority of these recalls were considered “Class II” recalls, which are serious concerns.  The FDA defines a Class II recall as a “situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

On the one hand, the increase of recalls may suggest that the FDA and the industry are now quicker to recall a product.  On the other hand,  the medical device industry is expected to reach $434.4 billion by 2017.  They make money when they sell their products. The increase in recalls may suggest an additional push to get products on the market—and into human guinea pigs—before adequate testing, with the notion that they can simply recall the product later if it proves unsafe. If that is the case, then the needs of the public will be best served with a robust combination of FDA oversight and a strong civil justice system to ensure that the manufactures who break the safety rules are held accountable, and victims of defective products are fairly and fully compensated.

Dangerous Drug Update: Jury Awards $3 Million in Topamax Birth Defect Case

A Philadelphia jury awarded $3 Million to a family of a five year-old girl who suffered a severe cleft lip and cleft palate birth injury due to the mother’s use of Topamax during pregnancy.  The jury found that the drug maker, Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson, failed to warn the public about the risks of Topamax during pregnancy.

Topamax is prescribed for severe migraines and as an anti-seizure medication. Annual sales of the drug were over $2 billion.  Evidence and arguments at trial suggested that Janssen ignored important red flags about risk of birth defect and only updated their warnings after the FDA forced them to do so.

Johnson and Johnson’s Janssen company was ordered to pay $4.02 million in an October, 2013 verdict and $11 million in a November, 2013 verdict in two other Topamax birth defect cases.

Dangerous Drug Alert: Acetaminophen-the key ingredient in Tylenol and other pain and fever drugs-used during pregnancy may be linked to ADHD in children

As an attorney that handles both product liability cases and birth injury medical malpractice cases, this story shocked me.  According to a new study published in JAMA Pediatrics, acetaminophen used during pregnancy—the key ingredient in Tylenol and other pain and fever drugs—may be linked to ADHD in children. Researchers found that children of mothers who used acetaminophen during pregnancy were 37% more likely to be diagnosed with hyperkinetic disorders, 29% more likely to use ADHD medications, and 13% more likely to exhibit ADHD-like behaviors at age 7 years. According to The LA Times “the risk increased the most – by 63% – when acetaminophen was taken during the second and third trimesters, and by 28% when used in the third trimester alone.” When taken just during the first trimester, however, “the added risk was 9%.” The study came out of Denmark where over 64,000 women participated and over half took the drug during pregnancy.  The drug is thought to interfere with hormone systems that ultimately alter brain development. Correlation does not necessarily mean causation.  As The USA Today reports, more study is needed to prove a cause and effect relationship, but pregnant women will no doubt think twice now about using acetaminophen.

Dangerous Drug Report: Makers of Pradaxa May Have Suppressed Health Study

Pradaxa has been linked to over 1,000 deaths and is the subject of thousands of lawsuits.   The lawsuits are overseen in federal court by a “Multi-District Litigation” (or “MDL”) in Illinois.  According to a recent New York Times article, e-mails and memos revealed by those lawsuits discussed whether an internal report on scientific research would undercut the manufacturer’s claim that using the drug does not require regular blood tests.  The manufacturer of Pradaxa, Boehringer Ingelheim, has been in a race to capture market share from warafin, which requires frequent blood testing, do Pradaxa’s “no blood testing” claim is a big selling point.  Pradaxa has garnered more than $2 billion in sales in the U.S. since 2010.  So it should come as little surprise that the manufacturers “were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents.”

Our system of justice may not be perfect, but here is one more example where trial lawyers standing up for the rights of consumers forced a company to reveal what was really going on.  Little did we know that the doctors in charge of drug safety have a vested financial interest in the outcome of their research and would consider suppressing their findings just to turn a buck… or a billion bucks.

Washington Consumers Beware of Big Pharm Marketing

Johnson and Johnson has agreed to pay $2.2 billion for its illegal marketing and kickback program.  At first blush, that seems like a tremendous blow.  But when you dig deeper, you see that this is a penalty that J & J will gladly pay. The drug at issue is Risperdal, a drug approved by regulators to treat schizophrenia in adults. But from 2003 to 2010 when J  & J was pitching off label uses of the drug for things ranging from dementia to anxiety, J & J sold $24.2 billion of  Risperdal alone. In August J & J proclaimed that the resolution with the federal government would not have a material adverse effect on J & J’s finances. They were right: as reported in Bloomberg Businessweek, the $2.2 billion agreement represents just 12.5 percent of J & J’s revenue in this quarter alone.  If there’s a lesson here for our Washington State readership, it’s to be very leery of Big Pharm marketing. From the time a drug is first marketed to the time it is prescribed, it’s a business process. Big Pharm is big business. We all know that. But even knowing this, sometimes we let our guard down when it comes to getting our prescription drugs.  You can never be too careful - you  can't ask your doctor too many questions (what alternatives are there? is this an off-label use?).  You need to keep your eyes wide open when it comes to the business of prescription medicine.