For diabetics, insulin pumps are critical for maintaining one’s health. These revolutionary devices are time-saving and life-saving solutions, helping diabetics electronically control their blood sugar levels without the constant need for insulin injections.

While insulin pumps can dramatically enhance the quality of life of a diabetic, any possible malfunction is hugely problematic.

I use an insulin pump manufactured by Medtronic. One day I suddenly fell extremely ill while shopping. I sat down, pulled out my trusty blood testing kit and found my blood sugar to be over 400 (normal is between 80-120). There was something wrong with my Medtronic insulin pump. As it turned out, I received a recalled batch of Medtronic insulin pump supplies. I immediately broke out my emergency insulin and managed the issue. But what if I didn’t have my emergency supplies? What if it happened when I was sleeping?

Needless-to-say the transcript of my call to Medtronic after that event is likely hanging somewhere as the world’s most hostile consumer complaint. All joking aside, what concerned me the most was that the issue that caused my high blood sugar could have been prevented with proper quality control. Now we have another insulin pump screw up by Animas, a division of Johnson & Johnson. But this time, unlike Medtronic, Johnson & Johnson allegedly continued to sell the product after it was notified it was defective.

The FDA recently notified Johnson & Johnson about the defects and quality control issues found in insulin pumps sold by Animas. Earlier in the year, defects in the pumps’ keypads were brought to light. These flaws, according to the FDA, could have a negative impact on the health of users, which could be potentially lethal. While the inquiry prompted Johnson & Johnson to change suppliers for future equipment needs, the company continued selling the defective pumps despite evidence that such products could compromise consumer health. This prompted the FDA’s notice, which was sent out to the company in late 2011.

Although Johnson & Johnson released a statement that it intends to cooperate with the FDA, the notice does bring into question the quality control measures in place at the company. If the company fails to make an adequate explanation or does not make necessary quality control improvements, the company may also be cut off from future government contracts. This latest run in with the FDA is not the company’s only trouble on this front. In fact, the FDA’s letter also mentioned a string of quality control issues over the last few years, involving investigations of J&J products ranging from over the counter medications and artificial hips.

The FDA gave Johnson & Johnson 15 days to respond appropriately to the concerns listed in the formal complaint. While the letter was sent late last year, the specifics were only made public this week, alerting all consumers to the growing concerns over the company’s products and processes.

The FDA’s comments were directed less toward the initial defect in the pumps and were more concerned with the company’s failure to remove all such pumps from stores. Without knowing all the details, this sounds like yet another example of putting profits over people.

For more information about this issue, please visit

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm285656.htm.

Doctors rely on drug company reps to keep them informed about the latest medicines and devices. But when doctors are paid to push certain products, a conflict occurs.

After ProPublica created a “Dollars for Docs” database, patients have been able to look up their own doctors to learn whether they accept money from drug companies. US newscasters began to report about the topic in local communities.

Since then, top medical schools disciplined professors for giving paid lectures promoting drug company products, and the drug companies themselves cut back on paying doctors to promote their products.

Stanford University took action in early 2011 against five professors who had accepted money for giving drug company speeches. In late 2011, ProPublica found that two drug companies, Cephalon and AstraZeneca, cut spending on “doctor speakers” by nearly half.

Following ProPublica’s disclosure that 12 University of Colorado professors were paid by drug companies to give promotional talks, the UC-Denver and affiliated teaching hospitals began to revise their conflict-of-interest policies.

Drug companies also fund medical societies. As a result, what doctors see at professional conferences and conventions can be largely influenced by sponsorship money provided by drug companies and medical device makers.

Patient advocacy groups are also affected. In fall of 2011, ProPublica reported on a significant relationship between the American Pain Foundation (APF) and companies that sell narcotic painkillers. In 2010, the APF received almost 90 percent of its funding from drug companies. However, it denied that drug companies influence its position. Yet, while overdose deaths from painkillers have risen sharply, the APF maintains that the danger of painkillers is overstated, and that these drugs are, in fact, underused.

Even more disturbing, ProPublica learned that none of the 75 doctors accused in federal lawsuits of taking money to push drugs and medical devices have been prosecuted or even disciplined.

On an encouraging note, ProPublica reported that its Dollars for Docs database, originally published in late 2010 and updated in late 2011, showed a decrease by drug companies in paying doctors to promote. Apparently, public exposure of for-profit connections between doctors and drug companies is a good beginning toward getting this conflict resolved.

Source: Drug Companies Reduce Payments to Doctors as Scrutiny Mounts via ProPublica

I was once contacted by a potential client who was hospitalized after he was hit by a truck. The potential client told me that he did not call anyone else and will wait for me to arrive at the hospital. When I got to the hospital, I learned that an orderly called another attorney and told him about this potential client’s situation. The orderly attempted to intimidate any visiting attorney by positioning himself at the injured person’s bedside. This practice is unethical and gives personal injury lawyers a bad name.

While this bill does not curb the unethical behavior above, it does help. Attorneys who attempt to follow the rules are at a loss when competing against those who will do anything to get a case. Now we finally can level the playing field at least a little bit.

What do you think?

Resources: Bill S2316

• Damages Cap Bites The Dust.  Finally a consumer victory out of Arkansas of all places.  What began as a case about negligent contamination of the domestic long-grain rice supply with genetically modified rice ended with the Arkansas Supreme Court striking down a blanket cap on punitive damages.

• Glaxo Fine For Vaccine Trials In Argentina.  Although vaccines can be effective in preventing illness and disease, they can also cause problems. GSK was fined for running a clinical trial in Argentina that resulted in the deaths of 14 infants.

• Safety Signal With Vaginal Mesh Implants Forces Additional Safety Studies.  Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women.  FYI my firm has been handling these cases since 2008! Ahead of the curve anyone? *crickets*

• Unreported Data From Clinical Drug Trials Risks Lives.  Unreported data from early trials of experimental medicines in humans can result in harm to future patients and needless costs for health systems, according to scientists writing in the British Medical Journal on Wednesday.

• What Novartis Did Wrong At Its Consumer Plant.  Novartis quietly suspended production at a plant in Lincoln, Nebraska, where various over-the-counter and animal health meds are made.

“What you need to know about metadata” was published in the January 2012 issue of Trial Magazine. Trial is the journal of the American Association for Justice and it is distributed to attorneys nationwide.

• Chemical Exposure Linked to Sperm Abnormalities.  The results of a recent study showed that exposure to certain organochloride chemicals are associated with chromosomal abnormalities in the sperm.

• Researchers Charge: Drug Trials Not Representative Of Patient Population.  Few major randomized, controlled clinical trials examine the effects of a drug in patients who have multiple chronic conditions, even though more than one-quarter of all Americans are living with at least two chronic health conditions, researchers reported.

• Toxic Groundwater Contaminants: An Overlooked Contributor to Urban Stream Syndrome? Researchers conclude that groundwater contaminants should be considered a genuine risk to urban stream aquatic ecosystems.

• Without Regulation, Companies Won’t Recall Products.  In India product recalls are rare because of a serious lack of regulations concerning product safety.  In this environment corporations are in full control on how and when to recall defective products.

• Yet Another Drug Used To Treat Type Two Diabetes Bites The Dust.  Actos, Avandia and now Rasilez.  The European Medicines Agency and Health Canada are reviewing the safety of the drug Rasilez when data showed that the drug was associated with an increased risk of non-fatal stroke, kidney complications, and other side-effects.

Product injury cases (product liability in legal terms) are complicated. Part one of this series focuses on the legal theories used to bring a lawsuit against a product manufacturer.

There are generally two types of legal theories used in product injury case:

1. We can either focus on the acts of the maker of the product (negligence); or
2. Focus on the product itself (strict liability).

Negligence Theory

The focus of negligence theory in product injury cases is on the acts of the maker of the product. When we focus on the acts of the manufacturer it become like a traditional personal injury case.

Five Things You Must Prove In A Negligence Case

1. Duty.  If you or someone you love is injured you can bring a lawsuit against the person who injured you. During that lawsuit you (and your lawyer) must prove that the person who injured you had a responsibility to not hurt you. This is called “duty” in legal terms.
2. Breach of Duty.  After you prove duty, you must next show that the person who injured you violated that duty. This is called “breach of duty” in legal terms.
3. Causation. The third item you must prove is that you were injured because of the breach of duty. This is called called “causation” in legal terms.
4. Damages. The final item you must prove is that you suffered some loss as a result of that injury. This is called “damages” in legal terms.

Want To Win On A Negligence Theory In A Product Injury Lawsuit? 

1. The injured person must show that the product was not “not made right” (called a manufacturing defect); or
2. The injured person must show that a reasonable maker of the product knew or should have known about the dangers of their product.

Attorney and public health advocate Mark Sadaka answers this question for you. Send your questions to SadakaAssociates@gmail.com.