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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…)

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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?

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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.

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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

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U.S. District Court Judge Arthur Spiegel sentenced the remaining employees of Berkeley Premium Nutraceuticals this week, each receiving prison sentences. The Berkeley executives, Greg Cossman (former President), Susan Cossman (Warshak’s sister), Shelly Kinmon (Sales Director), James Teegarden (Chief Operating Officer), Michael Wagner (Financial Officer), and Steven Pugh (Warehouse Manager) received sentences ranging from 12 to 13 months. Berkeley’s accountant, William Bertemes, and its bookkeeper, Sam Grote, cooperated with authorities and drew the lightest sentences of one month in prison.

Berkeley’s in-house counsel, Paul Kellogg, was the last of those convicted to be sentenced. He also received a sentence of a year and a day. Despite his professional training, Kellogg claimed that he was following the orders of Steve Warshak, Berkeley’s President, and did not realize what he was doing was wrong. (Surely he couldn’t have been clueless when he told a night manager to hide potentially damning evidence from FDA inspectors and had it returned to the warehouse when they left.)

All told, 11 Berkeley executives and employees were convicted on fraud, money laundering, and conspiracy charges.

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Steve Warshak, the founder of Berkeley Premium Nutraceuticals, has been sentenced to 25 years in prison and ordered to pay $93,000 in fines. He had been convicted in February on 93 counts of conspiracy, fraud and money laundering. His mother, Harriet Warshak, was sentenced to 2 years in prison arising from her conviction for conspiracy, bank fraud and money laundering. U.S. District Court Judge S. Arthur Spiegel, also ordered Warshak, his mother, and the company to forfeit more than $500 million in ill-gotten gains. Several other employees will be sentenced this week.

Most of the charges relate to the sale of Enzyte, a supplement supposedly capable of boosting male sexual performance. The company, however, falsified medical studies, used fraudulent bank documents, and ran up charges on the credit cards of customers, while refusing to give refunds or stop serial transactions on the cards.

The company’s logo included the Latin phrase suffragium asotas, which Warshak claimed translates to English as “enhanced sexuality”. He may have meant to use the phrase suffragor asotis, an awkward way of saying, “refuge for the dissipated”. Perhaps that is what the Big House will be for him.

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The Jounal of the American Medical Association reported today that the toxic metals lead, mercury, and arsenic have been detected in traditional Ayurvedic medicines being sold in the United States. Of the 230 products evaluated by x-ray spectroscopy, detectable levels of the toxic metals were found in 20.7% of the products. The contaminants were found in products manufactured in India and in the United States, but 95% of the contaminated products were being sold by US websites. Most troubling, 75% of the manufacturers claimed to be using Good Manufacturing Practices.

Source:

JAMA, August 27, 2008

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With increased attention being put on improper financial influences in medicine, by both the lay and professional press, you may be wondering how you can find out if your doctor is getting brown paper bags of cash from Big Pharma or a medical device manufacturer. The next time a doctor recommends a drug or a medical device, check with the Association for Medical Ethics to see if your doctor has improper financial ties with the manufacturer. As a result of a U.S. Department of Justice settlement with four medical device companies, Zimmer, Inc., DePuy Orthopaedics, Inc., Biomet, Inc., and Smith & Nephew, Inc., these back door consulting agreements must now be made public. (See our earlier post about this: Financial Ties) The Association for Medical Ethics maintains a searchable database that will tell you if your doctor is on the payroll of the company whose product he has just recommended: www.ethicaldoctor.org. Some of the information is shocking: two physicians listed made more than $8 million each from Dupuy Orthopaedics.

Now that’s a fact you would want to know before the doctor operated, isn’t it?

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Three executives of Hi-Tech Pharmaceuticals, Inc. of Norcross, Georgia have pleaded guilty to conspiracy and fraud charges for illegally selling prescription drugs. President and CEO, Jared Wheat, Vice President, Stephen D. Smith, and company co-founder Tomasz Holda admitted to conspiring to import and distribute adulterated, mislabeled and unapproved new drugs, and to commit mail and wire fraud. The company was selling via the internet generic forms of Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra and Cialis manufactured in their lab in Belize without requiring a prescription.

As a result of the plea bargain, the government dropped assertions that the company was spiking its diet supplements with ephedrine alkaloids after the FDA’s 2004 ban on the marketing of ephedra products. See Alaska Personal Injury Law Group’s litigation over this practice of illegal spiking of diet supplements, Talbert v. E’ola Products, Inc.. Also absent were the earlier assertions that the executives had conspired to murder an FDA agent and blackmail a former US attorney general. (Holda also pled guilty to ordering a silencer over the internet.) They face prison terms up to 5 years each, with fines of as much as $250,000, and the company itself faces fines as much $500,000. In June, a different federal court issued a preliminary order against the company for FTC violations for deceptive advertisements of weight loss and sexual performance products. Among the company’s diet supplement products is Lipodrene, a weight loss product, and Stamina-Rx, a sexual stimulant.

Wheat had previously been arrested for selling ecstasy, and Holda had been convicted of steroid possession with intent to distribute. The FTC had also previously accused the company of falsifying medical research regarding sexual impotent products.

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The Alaska Personal Injury Law Group recently obtained a favorable ruling on a matter of great importance for aviation law in Alaska. Apparently reversing a prior contrary decision, the Federal District Court ruled that aviation wrongful death and personal injury claims cannot normally be transferred (“removed”) from Alaska State Courts to the Federal District Court at the request of the defendant.

The Alaska Personal Injury Law Group (APILG) has extensive experience in the area of aviation accident litigation. APILG Attorney Neil O’Donnell, representing Port Heiden resident Ted Matson, filed a wrongful death action for the loss of Mr. Matson’s wife in the crash of a Peninsula Airways (“PenAir”) Piper Saratoga near Port Heiden. The wrongful death action was filed in the Alaska Superior Court in Naknek, the court closest to Port Heiden and closest to the aircraft crash site. PenAir, however, transferred (“removed”) the case to the Federal District Court in Anchorage arguing that a recent Ninth Circuit decision, Montalvo v. Spirit Airlines, 508 F.3d 464 (9th Cir. 2007), made all aviation-related wrongful death and personal injury claims removable to federal court. The Federal District Court in Alaska had previously agreed with this argument in another aviation personal injury case (not handled by the Alaska Personal Injury Law Group) that had been removed from the Alaska Superior Court in Bethel. Alexie v. Hageland Aviation, Case No. 4:07-cv-0031-RRB.

The effect of the Alexie case would have been to allow any defendant to transfer any aviation-related death or injury claim out of the Alaska State Courts and into the Federal District Court in Anchorage, Fairbanks or Juneau. Plaintiffs in rural Alaska often want their cases heard in local state courts for both practical and strategic reasons. For example, local rural jurors appreciate the importance of lost subsistence services, often a major portion of a rural plaintiff’s economic damages. Juries in federal court must also reach a unanimous verdict. Since the plaintiff has the burden of proof, one or two “holdout” jurors can derail what would otherwise have been a persuasive and successful claim. In contrast, juries in Alaska State Courts can return a verdict based on the vote of only 10 of the 12 jurors.

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