Bridgett Robb had a heart condition (arrhythmia). Five years ago, she had a defibrillator implanted to prevent her from dying. More than two months before her medical device fractured and repeatedly shocked her, the lead had been recalled by the manufacturer.
These fibrillators are not cheap, even with health insurance. Nor are they so prevelent that keeping track of the patients carrying one in their chest is a difficult task. Wouldn’t you think the severity of the condition and the amount of time, energy, money, and care needed to get one would entitle Bridgett to a little customer service? Two months is more than enough time when the case is this serious.
And then there is Nick Evola with another defibrillator. Nick is an Army veteran. The surgery to replace the lead was paid with coverage from Medicare and insurance, and not by the manufacturer, Medtronic.
So the maker of a faulty device is left unaccountable and taxpayers have to make up the difference. Mr. Evola deserves a working medical device, but does that right have to come at the public’s expense? The answer becomes even clearer when Mr. Evola’s attorney points out that Medtronic was aware the device was failing at “abnormally high rates but continued to market it…”.
It is not so surprising that a company like Medtronic would prioritize profits. They are a business. However, their business is unique in the amount of trust their customers must invest in their business practices. This makes medical devices a lucrative business. In 2008, Medtronic made $10 billion in profits, and is ranked first among medical products and equipment companies. As an industry leader, Medtronic sets an example, and this should mean more than the $6 million in lobbying for corporate immunity since 2008.
There is only one option to rectify this imbalance in American business and public safety. Congress must pass the Medical Device Safety Act. Over 14 thousand patients have been denied justice this year alone. Don’t take our word for it. Listen to U.S. District Court Judge Richard Kyle, who stated in his ruling, “The Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight. … Plaintiffs’ remedy, therefore, lies with Congress, and not with this Court.”
The investigation into the crash of flight 3407 has led to questions about the experience and training of the flight’s pilot.
With so many instructions and warnings on a bottle of prescription pills, one would think that the last person to disregard the intended use of a drug would be the doctor prescribing it. “Off-label” prescriptions are exactly that, and a number of legal cases are coming to trial because of the growing trend in pharmaceutical marketing of encouraging this practice.
Off-label presciptions exist in a gray area of medicine. Birth control is regularly prescribed for minimizing menstrual cramps and clearing up acne. Rogaine’s use for baldness was prescribed off-label for years before the FDA approved it. So that while the practice is not in keeping with FDA regulations, some advocates claim that the practice is not necessarily illegal either.
James Beck, a defense attorney and co-author of the Drug and Device Law blog, claims that most off-label use is beneficial and it is only the few disasters that get noticed. In fact, in 2008 the FDA rules for the promotion of off-label drug use became lax, but the Obama administration has yet to review these new regulations.
However the cases that have come to trial have not been about doctors finding creative ways to treat patients; they are about corporate marketing systems designed to create new outlets for sales.
For example, in March, Johnson & Johnson was ordered to pay the state of West Virginia $3.95 million for misleading doctors about the risks and benefits of Risperdal, an antipsychotic. The pharmaceutical giant is facing an even larger case in Texas. (http://industry.bnet.com/pharma/10001223/jj-fined-5000-per-sales-rep-visit-for-risperdal-mismarketing/).
Recent ad campaigns in Washington directed at “educating” lawmakers about the FDA approval process have cited that only 2% of medical devices fall under the category that is currently pre-empted by the Reigel v. Medatronic decision.
I recently contacted a representative for the American Association for Justice about this claim. He said that this argument is designed to obscure the main point behind the Medical Device Safety Act, which is to express in clear terms that no manufacturer is immune from accountability for their products. Product safety is a responsibility all industries must bear, no matter the number of products currently affected by the loophole made by Reigel v. Medatronic. What do you think?
…is currently being discussed by the House Energy and Commerce subcommittee of Health. The bill was introduced on behalf of the thousands of citizens who have been injured or killed by defective medical devices. When seeking restitution, they were denied their day in court by federal judges citing last year’s Supreme Court decision in Reigel v. Medatronic.
More about the bill can be found here, at stopcorporateimmunity.org http://www.kintera.org/site/c.juISL9MSJvE/b.4991999/k.B319/Facts.htm
According to AdvaMed President and CEO Stephen J. Ubl, legislation to “repeal the FDA’s pre-emptive authority” will stifle innovation and limit treatment options available to patients.
This statement is flawed, because pre-emption was never a case of federal authority granting invulnerability to companies with FDA approved products.
Counter to Ubl’s word choice, innovation comes from the natural checks and balances of a market that thrives on competition and the legal incentives to disclose risks promptly. It does not come from a profit-minded manipulation of a single Supreme Court decision.
How has the Supreme Court’s decision in favor of Diana Levine, a Vermont woman who lost her arm after being injected with an anti-nausea drug, changed the future of state-level tort suits?
Brian Wolfman, director of Public Citizen Litigation Group in Washington, says the ruling “reaffirms that preemption is the exception and not the rule”.
Justice John Paul Stevens of the US Supreme Court wrote for the majority when the Court upheld the state verdict in favor of Diana Levine. “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”
This affirmation is going to serve several tort litigation cases immediately, but it will also have an impact on laws and suits regarding medical devices. The day after the decision was handed down, The Medical Device Safety Act of 2009 (MDSA) was introduced to both houses of Congress.
Lawmakers have been encouraged by the Court’s ruling to think that medical device manufacturers could be held to the same determination, despite the Court’s previous ruling in Riegel v. Medtronic. In this case from 2008, the Court decided that state law tort claims regarding FDA pre-approved medical devices are preempted.
The Medical Device Safety Act of 2009 would allow for state-level tort suits. The purpose of the bill would be to give consumers recourse to remedy their injuries within the state court system without totally undermining the FDA’s authority.
As recently as January of this year, federal judges citing the Reigel decision dismissed 1,496 cases. Michael E. Seelie currently represents plaintiffs in pharmaceutical litigation in Jacksonville, Florida.
FDA laboratory tests have revealed the presence of sibutramine, fenproporex, fluoxetine, bumetanide, furosemide, phenytoin, rimonabant, cetilistat, and phenolphthalein in weight loss products being sold over-the-counter. The tainted products are listed below in alphabetical order along with the undeclared drug and/or chemical ingredient.
1. 2 Day Diet – sibutramine
2. 2 Day Diet Slim Advance – sibutramine
3. 2x Powerful Slimming – sibutramine
4. 3 Day Diet – sibutramine
5. 3 Days Fit – sibutramine
6. 3x Slimming Power – sibutramine, phenytoin
7. 5x Imelda Perfect Slimming – sibutramine
8. 7 Day Herbal Slim – sibutramine
9. 7 Days Diet – sibutramine
10. 7 Diet – sibutramine
11. 7 Diet Day/Night Formula – sibutramine
12. 8 Factor Diet – sibutramine, phenolphthalein
13. Eight Factor Diet – sibutramine
14. 21 Double Slim – sibutramine
15. 24 Hours Diet – sibutramine, phenolphthalein
16. 999 Fitness Essence – sibutramine
17. BioEmagrecim, sample 1 – fenproporex
BioEmagrecim, sample 2 – fluoxetine, furosemide
18. Body Creator – sibutramine
19. Body Shaping – sibutramine
20. Body Slimming – sibutramine
21. Cosmo Slim – sibutramine
22. Extrim Plus – sibutramine, phenytoin
23. Extrim Plus 24 Hour Reburn – sibutramine
24. Fasting Diet – sibutramine
25. Fatloss Slimming – sibutramine, phenolphthalein
26. GMP – sibutramine
27. Herbal Xenicol – cetilistat
28. Imelda Fat Reducer – sibutramine
29. Imelda Perfect Slim – sibutramine, phenolphthalein
30. JM Fat Reducer – sibutramine
31. Lida DaiDaihua – sibutramine
32. Meili – sibutramine
33. Meizitang – sibutramine
34. Miaozi MeiMiaoQianZiJiaoNang – sibutramine
35. Miaozi Slim Capsules – sibutramine
36. Natural Model – sibutramine
37. Perfect Slim – sibutramine
38. Perfect Slim 5x – sibutramine, phenolphthalein
39. Perfect Slim Up – sibutramine
40. Phyto Shape – rimonabant
41. Powerful Slim – sibutramine
42. ProSlim Plus – sibutramine
43. Reduce Weihgt – sibutramine
44. Royal Slimming Formula – sibutramine, phenolphthalein
45. Sana Plus – sibutramine
46. Slim 3 in 1 – sibutramine
47. Slim 3 in 1 Extra Slim Formula – sibutramine
48. Slim 3 in 1 Extra Slim Waist Formula – sibutramine
49. Slim 3 in 1 M18 Royal Diet – sibutramine
50. Slim 3 in 1 Slim Formula – sibutramine
51. Slim Burn – sibutramine
52. Slim Express 4 in 1 – sibutramine
53. Slim Express 360 – sibutramine
54. *Slim Fast – sibutramine
55. Slim Tech – sibutramine
56. Slim Up – sibutramine
57. Slim Waist Formula – sibutramine
58. Slim Waistline – sibutramine
59. Slimbionic- sibutramine
60. Sliminate – sibutramine
61. Slimming Formula – sibutramine
62. Somotrim – sibutramine
63. Starcaps – bumetanide
64. Super Fat Burner – sibutramine
65. Superslim – sibutramine, phenolphthalein
66. Super Slimming – sibutramine
67. Trim 2 Plus – sibutramine
68. Triple Slim – sibutramine
69. Venom Hyperdrive 3.0 – sibutramine
70. Waist Strength Formula – sibutramine
71. Xsvelten – sibutramine
72. Zhen de Shou – sibutramine, phenolphthalein
Excessive speed continues to be a risk factor in tractor-trailer crashes. In 2006 the American Trucking Association (ATA) called upon the National Highway Traffic Safety Administration (NHTSA) to limit the maximum speed of tractor-trailers to 68 mph in an effort to curtail the number of accidents involving tractor-trailers. These behemoths of the interstate have been a prime cause of traffic fatalities and property damage in all fifty states. By petitioning NHTSA, the ATA President and CEO Bill Graves said the trucking industry is trying to participate in the nation-wide movement to slow down traffic and reduce the rate of injury. “No vehicle should be capable of operating at excessive speeds on our nation’s highways”, Graves said.
Speed related traffic accidents are only one of the ATA’s concerns for the health, safety, and sustainability of the trucking industry in this country. In addition, the ATA has called for universal primary seatbelt laws in all 50 states, and for an increased awareness on the part of motorists to unsafe driving behavior near and around tractor-trailers. At this time, most federal efforts to reduce the rate of traffic accidents involving tractor-trailers have focused on equipment maintenance, driver fatigue, and the prevention of driver impairment. However, the ATA thinks the part played by excessive speed has gone overlooked. Although it is difficult to conceive of a way in which federal aid could be devoted to this problem, research indicates that speed plays a role in the majority of crashes.
Injuries that happen at the job site are not always limited to workers compensation claims. If the accident was as a result of an unsafe product, you may have a product liability claim.Often, when someone is injured by a product at work, the product lacks an important safety feature.
For example, settlement a man who underwent an L3-5 laminectomy and foraminatomy after he fell when the mobile interior scaffold on which he was standing collapsed. The man sued the manufacturer of the scaffold, alleging that it was defective in that it lacked a locking mechanism to secure the platform and prevent it from being inadvertently lifted out of position.
The Obama administration announced new rood crush rules. Auto makers will have to double the crush-resistance of passenger-vehicle roofs , but critics said the new standard was too weak to prevent many rollover deaths.
Transportation Secretary Ray LaHood unveiled the new rules, which dictate that roofs must be able to withstand a force equal to three times the weight of the vehicle for cars and light trucks weighing 6,000 pounds or less. Vehicles weighing more than 6,000 pounds must have a roof-crush resistance equal to 1.5 times their weight, the first time many trucks and heavy sport-utility vehicles will be subject to such a requirement. The rules will be phased in over five years, starting in 2012.
“Rollovers are the deadliest crashes on our highways and today’s rule will help occupants survive these horrific events,” Mr. LaHood said in a statement.
