Alaska Injury Law Blog

Eli Lilly and Co. has announced that it will now begin disclosing information about the money it pays to individual doctors for advice, speeches, and other services. The company is riding out ahead of legislators at the state and federal levels who have pushed disclosure bills that would impose a legal mandate upon drug manufacturers to make such payments public. Lilly will disclose payments above $500 made in 2009, but will not make disclosure about payments in past years.

A handful of states have legislated disclosure from drug manufacturers: Minnesota, Vermont, West Virginia, and Maine. No disclosure requirements have been imposed on medical device manufacturers, although the obvious ethical concerns apply there as well. ( See our previous posts here, and here.

Source:

AP Wire, September 24, 2008

The Federal Trade Commission announced today 11 law enforcement actions taken against firms deceptively advertising bogus cancer cures. The companies have been charged with making unsupported claims that their products have treated or cured various cancers, and some were charged with falsely stating that they had clinical or scientific proof of their products' efficacy. The FTC's Director of the Bureau of Consumer Protection stated that, "There is no credible scientific evidence that any of the products marketed by these companies can prevent, cure or treat cancer of any kind."

Of the 11 complaints, six were resolved by proposed settlements with the remainder to be litigated by the FTC. The companies will all be required to notify consumers that there is little to no scientific evidence demonstrating the efficacy of the products to treat or cure cancer. The complaints arose out of a year-long effort by the FTC, the FDA, and a corresponding Canadian agency in which 112 websites were targeted. Of those, over 30% responded to the governmental warnings and closed their websites or altered the fraudulent claims. Warning letters were then sent to 23 companies.

To identify the companies and products targeted, follow the links below.

The FTC also announced that it is offering a website to help the public identify bogus cancer cures--www.ftc.gov/curious

There can be little that is lower on the scale of human decency than taking advantage of a person struggling with cancer. The FTC and the FDA should be applauded for their efforts to rein in this industry.

Sources:

FTC Press Release

FDA Press Release

FDA Website Re: Fake Cancer Cures

Fake Cancer Cures FDA Warning Letters

Most readers know that PTSD can be caused by intense trauma from accidents and injuries, but the question whether medical intervention itself can cause PTSD has not been extensively studied. Dr. Dimitry Davydow of the University of Washington's School of Medicine reports in the Sept.-Oct. issue of General Hospital Psychiatry that as many as 22% of ICU patients will later suffer PTSD. This conclusion arose from the review of 15 medical studies and 1,745 ICU patients. The symptoms of PTSD include nightmares, sleep problems, flashbacks, irritability and anger, as well as emotional numbness. The risk of suffering PTSD increased if the patient had underlying mental illness, such as anxiety or depression, or was treated with certain sedatives that cause disorientation, confusion, or psychotic experiences.

Sources:

General Hospital Psychiatry, Vol. 30, at 421-34, Sept. Oct. 2008

Two studies in the New England Journal of Medicine have concluded that arthroscopic surgery doesn't improve patient outcome for those suffering from arthritis of the knee. In the first study, 200 patients with moderate to severe knee arthritis and no meniscal tears were placed randomly into surgical and nonsurgical groups. At two years, the complaints of pain, stiffness, and physical function did not differ between the two groups.

These findings comport with those of a 2002 study reported in the NEJM. There, 180 patients were studied using a placebo procedure, an arthroscopic lavage, and arthroscopic lavage with debridement. Again, at two years, there were no significant differences between the groups on scores for pain and physical functioning.

The conclusion is that arthroscopic surgery is ineffective for most patients with knee osteoarthritis.

Sources:
New England Journal of Medicine, July 11, 2002

New England Journal of Medicine, September 11, 2008

We have learned the lesson repeatedly, with drugs like Fen-Phen, Ephedra (see our litigation here), and similar magic pills, that there is no free lunch when it comes to weight loss. If drugs are being used to amp up the engine of the body's metabolism, something is eventually going to seize up. Yet, the pharmaceutical industry and the unregulated diet supplement industry keep trying.

Here's a case report concerning their latest victim, reported in the September 11, 2008, issue of Clinical Toxicology. A 37-year-old woman suffered a heart attack after using an herbal weight loss product for just 3 days. A urine screen, however, disclosed the presence of sibutramine. (The article doesn't disclose this fact, but one would assume that the herbal product was spiked with sibutramine, and the drug was not listed on the label as an ingredient.) Sibutramine is a serotonin-norephinephrine reuptake inhibitor that is structurally related to amphetamine, although its mechanism of action is distinct. Sibutramine is the active incredient in Abbott Labs' Meridia, a prescription weight loss product. The patient was not obese, did not smoke, and was not known to have hypertension or diabetes. No other stimulants were found in her blood stream. The author reports a similar case involving a young woman in their clinic who had also suffered myocardial infarction after using sibutramine for 30 days.

There have been 397 adverse events reported to the FDA concerning sibutramine between 1998 and 2001. There were 152 hospitalizations. Of the 29 patients who died, 19 suffered cardiac problems that led to their deaths. Sibutramine is one of drugs Dr. David Graham, the FDA whistleblower, and Public Citizen, have warned the public about.

Sources:

Clinical Toxicology, Sept. 11, 2008

Dr. David Graham

Public Citizen's Petition to the FDA to ban sibutramine (Meridia)

If the administration's preemption efforts continue to bear fruit,(see our concerns about this here and here), then any federal regulation will serve to prohibit someone who is injured from bringing a claim against a defendant who has maimed or killed someone they love. A case in point: if an auto manufacturer has met federal design minimums (remember, they can always design a product more safely than the minimum standards dictate), the manufacturer will say that the government has "approved" the design, and that it shouldn't be subject to litigation if the design proves faulty, regardless whether the design failure involves exploding gas tanks, failing seat belts ( see our litigation against GM about this Farnsworth v. General Motors), or vehicle rollovers.

The lesson for the class today involves roof crush. Follow the links below, and you will see video footage demonstrating that the federal roof strength standard will not protect vehicle occupants. Passengers who sustain these injuries often face the horrific consequences of brain injuries, spinal cord injuries, or death. Should the injured passenger's claim be preempted by federal regulation when it is patently clear that rollover accidents are foreseeable and that manfuacturers can design a vehicle to withstand them? (Remember that this legal sea change was brought to you by politicians pledging to keep the government out of your business and to maximize states rights against the overreaching urges of the federal government...)

Sources:

Multiple documents and video:
http://www.citizen.org/pressroom/release.cfm?ID=2728

http://www.newmediamill.com/webcasts/cas/20080909/

http://www.citizen.org/autosafety/rollover/crashwrth_/articles.cfm?ID=17995

Once a medical device is on the market, doctors can use them for other, unapproved purposes. Given this running room, Medtronic allegedly touted to doctors the use of its Infuse Bone Graft for use in cervical spine surgeries. Three whistleblower suits have been filed by former Medronic employees asserting that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic has paid $40 million to settle two of the suits, and the third remains pending. It alleges that the doctors working with Medtronic received inflated royalty payments and inappropriate consulting fees. (We have previously reported on other odious industry practices, here and here.)

In July, the FDA sent out a warning letter to doctors warning of life-threatening complications when the device is used in the cervical spine. The complications arose from use of recombinant morphogenic proteins, which caused swelling of the neck and throat tissue and led to compression of the airway and the neurological structures of the neck. Patients suffered difficulties swallowing, breathing, or speaking, and required emergency medical care including intubation and tracheotomies.

If a surgeon were going to operate on your neck, would you want to know if a medical device manufacturer was paying him to use the product on you, money paid in addition to the surgical fees you are already paying?

If you can't trust the folks wearing the white coats, who can you trust?

Sources:

FDA Warning Letter, July 1, 2008

Wall Street Journal, September 4, 2008

Whistleblower Complaint

Defendants' Answer

According to a recent study presented at the British Pharmaceutical Conference in Manchester, England, 60% of woman may be risking the health of their babies by taking herbal remedies while pregnant. The study was authored by Lone Holst, a researcher in Norway, who studied 578 women giving birth in the UK. In the study population, 49% knew nothing about the safety risks of the products they were taking, and had taken the products on the advice of their family or friends, rather than their healthcare providers. In pregnant women over 40, 72% of women had used herbal preparations during their pregnancy.

The reasons for caution are many. Unlike prescription drugs, herbal preparations are not tested for safety and efficacy. Moreover, the active ingredients often vary from the amounts stated on the label. Manufacturers also fail to test the products to be certain that toxic contaminants are not present, and intentionally "spike" their products with pharmaceuticals to make the concoctions are more potent, without disclosing this to the consumer.

Even in the best of circumstances, it is difficult to test a single active ingredient for safety and efficacy. Diet supplements and herbal preparations are manufactured with a "kitchen sink" approach using the dangerous notion that a combination of ingredients are better for you, than a single, active ingredient. In fact, the interactions between these ingredients, and between the ingredients and other medications that the consumer may be taking, is not known and can be a set up for disaster and cause fetal harm.

Inadvertent toxicities can also occur. For example, warnings have been recently published for women to make certain that no vitamin A toxicity occurs in the fetus from the mother taking excessive doses of vitamin A when using muliple supplements. Vitamin A is a known teratogen capable of causing birth defects.

Some thoughts for you:

Don't take diet supplements or herbal preparations during pregnancy unless you have discussed the product you are using with your health care provider.

If you do intend to take such products, investigate the company making the products by seeing if their products have any safety testing or the company uses "good manufacturing practices." Check the product and company out by googling them, or researching them on websites offered by Consumer Labs, the FDA, or the FTC.

Make certain that your health care provider knows what you are taking and how much. Be certain to have this discussion if you are otherwise already on medications to avoid dangerous interactions.

Don't assume that, because it is supposedly "all natural", that it is safe for your unborn child.

Sources:

Presentation to the British Pharmaceutical Conference, September 7, 2008

Toxic Metals in Ayurvedic Supplements

Spiked Supplements

Vitamin A Toxcity

The FDA has issued its first public disclosure of 20 drugs it is now investigating for safety concerns. The disclosure is the result of the 2007 Food and Drug Administration Amendments Act that mandated that the agency post on a quarterly basis information about drugs it is investigating based on adverse events reported by doctors. The information does not disclose the nature of the adverse events or the extent of the problem. The fact that a drug is listed is not intended to suggest that the agency has, in fact, concluded that the risk exists. The posting does not include all of the drugs currently being subjected to a further safety investigation.

The consumer now has more information at hand to make an informed decision about drugs a doctor prescribes. Hopefully, these disclosures will prevent unnecessary injury when the FDA and the manufacturer are aware of potential risks, and the unsuspecting patient is not. That is a gap that should, and must, be closed. Here is the list:

Arginine Hydrochloride Injection (R-Gene 10): Pediatric overdose due to labeling / packaging confusion
Desflurane (Suprane): Cardiac arrest
Duloxetine (Cymbalta): Urinary retention
Etravirine (Intelence): Hemarthrosis
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric): Adverse events due to name confusion
Heparin: Anaphylactic-type reactions
Icodextrin (Extraneal): Hypoglycemia
Insulin U-500 (Humulin R): Dosing confusion
Ivermectin (Stromectol) and Warfarin: Drug interaction
Lapatinib (Tykerb): Hepatotoxicity
Lenalidomide (Revlimid): Stevens Johnson Syndrome
Natalizumab (Tysabri): Skin melanomas
Nitroglycerin (Nitrostat) Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR): Ileus
Oxycodone Hydrochloride Controlled-Release (Oxycontin): Drug misuse, abuse and overdose
Perflutren Lipid Microsphere (Definity): Cardiopulmonary reactions
Phenytoin Injection (Dilantin): Purple Glove Syndrome
Quetiapine (Seroquel): Overdose due to sample pack labeling confusion
Telbivudine (Tyzeka): Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers: Cancers in children and young adults

Sources:

FDA FAQs

FDA's Report, January to March, 2008