5 Deadly diseases caused by smoking

Everyone knows that smoking cigarettes are dangerous. Most people have known someone or have seen someone they loved die slowly from some diseases that was caused by smoking. Tobacco contains more than 400 toxic substances on top of the super-addictive nicotine. Read along and find out about 5 of the many deadly diseases caused by tobacco and smoking.

Cancer- Cancer has almost become synonymous with tobacco. It's widely known that tobacco causes cancer, but most people fail to realize just how many types of cancer are involved. Lung cancer, cancer of the larynx and pharynx, bladder, kidney, cervical, colon, esophageal, and breast cancer are all related to smoking.

Cardiovascular Disease (Heart Disease)- Heart disease is the number one killer in the United States and most European countries. Smoking causes blood vessels to narrow, which leads to heart attacks, chronic chest pains, and strokes.

Erectile Dysfunction- Even though erectile viagra cialis online pharmacy pharmacy isn't going to cut your life short, most men will agree that impotence will certainly be deadly to an important part of their life. Studies have shown that the more a man smokes, the more likely he is to become impotent at even lower ages.

Acute Myeloid Leukemia (AML)- Acute Myeloid Leukemia damages developmental cells. It starts deep in bone marrow and quickly spreads into the blood stream and then to vital organs and into the central nervous system.

Abdominal Aortic Aneurysm- When smoking causes blood clots in the aorta, there becomes a bulge in the aortic artery. If not treated, there is great risk that this aneurysm can rupture and mean almost certain death.

Smoking cigarettes has many side effects. Above are just some of the serious ones. The nicotine in cigarettes is more addictive than most illegal drugs. With 443,000 smoking related deaths a year, smoking kills more people than alcohol, AIDS, car accidents, and all illegal drugs combined.

You can also order E-Cigarette from here

COUNTDOWN TO CHELSEA FLOWER SHOW (4)

COUNTDOWN TO CHELSEA FLOWER SHOW (4)

Glitz in the Garden. Consider man’s attempt to conquer nature within the landscape as a symbol for wealth and power. Specific oppulent civilizations  provide many examples throughout recorded history – as punctuated by Hadrian’s Villa, Versailles, and Hearst Castle.

Garrett Eckbo- “As social inequieties become more complex, those who have more than the average, and more than they need, tend to express or flaunt such surpluses…. For the common man, dish gardens, patios or suburban backyards may provide symbols of memories of the paradise of the rich.”

From the Telegraph, here is this morning’s article on this year's 20 million pound show garden, the most expensive in the history of “The Great Show”.  (Interestingly, this comes after complaints at last years show that Chelsea had scaled back, reflective of the global recession.)

“David Domoney's design is the most expensive in the event's 97 year history.

The Ace of Diamonds garden will be littered with jewels loaned by Bond Street store Leviev. The garden celebrates the links between plants and precious stones and its centrepiece will be diamond jewellery worth millions that will require unprecedented security.

It will boast a £1 million peony-shaped ring with pink and green diamonds and a daisy-shaped ring set with a rare, flawless blue diamond worth £3.2 million.

Domoney, who formerly appeared on ITV's This Morning, also hopes to include an even more valuable uncut diamond in his elaborate, outdoor display.

The garden will be worth more than all Chelsea's other collections put together when the Royal Horticulture Society's annual showpiece begins on May 25.

Many of the plants being used by Domoney have gemstones in their names such as euonymous emerald gaiety, potentilla gold finger and hosta diamond tiara.

A looping path of stepping stones leads to a central, diamond-shaped patio. When viewed from above, it is said to look like a pendant necklace.

The garden will boast Chiltern marble, Roman plinths and backlit walls with semi-precious stones such as quartz and amethyst.

The gems will be on display for the gardens launch and the duration of the judging.  Domoney, who has previously suggested using online pharmacy to perk up wilting plants, said: "I always endeavour to introduce something a little bit more entertaining and this garden is something really special.

"I am aiming to give the garden a real James Bond-style feel.

"There will be more bling on display than on Paris Hilton.

"But we will be asking the judges to think of Helen Mirren for a touch of class.

"It's high end and extreme but with a strong horticultural message. Its a jewellery box garden. "This garden will be the most expensive that Chelsea has ever had or is ever likely to have.”

"It will be more valuable than all the rest of Chelsea collections from this year and last year combined." RHS shows director Bob Sweet said: "We are all very excited that this very valuable diamond will be sat on a table in David's outdoor garden.  "We have tight security at Chelsea anyway but something like this will require special attention, which it will definitely get."

Chelsea's world-famous show gardens typically cost no more than £250,000.

The Ace of Diamonds is the second of four Domoney gardens designed for airline sponsor BMI's Diamond Club, following on from last year's Ace of Spades.

For that, a Harley Davidson motorbike took pride of place in a large pit shaped like a giant ace of spades and lined with recycled garden spades.”

 Last years Ace of Spades garden. 

How We Know What Isn't So by Thomas Gilovich

See also: cialis | 


A break from fiction this week, to consider Gilovich's important book, subtitled 'The Fallibility of Human Reason in Everyday Life'. As this suggests it is a study of why we tend to believe certain things (with lots of examples of popular misconceptions from everyday life), despite the lack of evidence for them or, in many cases, solid evidence that they are not true. A couple of points to clarify before anyone starts getting defensive: the book doesn't belittle people for what they believe, it just analyses the basis for such beliefs; and little is said about religion.

A common problem is the misunderstanding of statistics, especially probability theory, which can sometimes produce counter-intuitive results. A well-known example of this is the answer to the question "how many people do you need in a room in order to get a 50% chance that two of them will have the same birthday?" The answer is 23; and what's more, you only need 35 for the probability to rise to 85%. Most people find this amazing (I did too, despite some limited experience of probability theory). One reason for misunderstanding statistics is the clustering tendency of random events. If you toss a coin and it comes up heads five times in succession, you might think this is remarkable, but it is in fact inevitable if you keep tossing the coin long enough: the "50/50" rule only applies over a long series.

As a result of this lack of understanding, people experience coincidences which are well within normal probabilities and wrongly believe that something remarkable has happened, or even that they can't really be coincidences at all but must have some greater significance. This is exacerbated by the fact that humans have an inbuilt tendency to seek patterns in events, to the extent of seeing them where they don't exist.

A lack of contrary information can lead to unwarranted beliefs. For example, a selection board which interviews candidates for an academic or training scheme may believe that they are doing a good job, because the majority of their choices perform well. But they have no way of knowing how well the people they rejected would have performed, given the chance. In fact, research into the selection process has shown that "decisions based on objective criteria alone are at least as effective as those influenced by subjective impressions formed in an interview".

We are often misled by information we receive second hand, because of the tendency to "sharpen and level", as the author puts it. By this he means that in relaying a news item, for instance, we tend to emphasise the points which we consider to be important (or which we believe) and downplay or omit other aspects. So if a carefully-written report comes to a tentative conclusion which we agree with, but wraps this around with qualifications and caveats, we tend just to relay the conclusions, making the results appear far more definite than the report's authors intended. As people "sharpen" different aspects of information to suit their beliefs, so we get a rapid polarisation of opinions on controversial issues. Even worse, some organisations deliberately "sharpen and level" because they want to turn public opinion in their favour [popular news media and politicians are of course notorious for presenting such selectively slanted information, especially during election campaigns, but so do many organisations with agendas]. Most "urban legends" probably develop as a result of an extreme version of this, with the key points pulled out and exaggerated.

This sharpening effect is exacerbated by the fact that if we hold certain beliefs, we are likely to discuss them only with people who agree with us, and only to read supportive publications. Our beliefs are thereby rarely challenged but instead are constantly reinforced, so we tend to end up with the view that our beliefs are naturally and obviously right. Anyone who disagrees with them must therefore be entirely mistaken and possibly downright stupid if not malevolent. This polarisation is obvious today in politics and in debates about other controversial issues. In reality, of course, situations are rarely as polarised as this: we exaggerate differences.

A major reason for many misplaced beliefs is that notable events stick in our minds, whereas we are much less likely to remember when something did not happen. This can distort our understanding of the likelihood of particular events. For example, it is commonly believed that a previously infertile couple is much more likely to conceive after they have adopted a child. A careful analysis of a mass of birth and adoption statistics shows that there is no truth in this at all; there is no such effect. People believe that there is because if a couple does conceive after adoption it is a notable event likely to be commented on and remembered. Conversely, no-one remembers the couples who did not conceive after adoption, or those who eventually conceived without adoption (who may well not have publicised their fertility problems).

A related issue is that if we hold certain beliefs, we are much more likely to seize on and remember any events which appear to confirm those beliefs, while dismissing and quickly forgetting any contrary evidence. Even if we do spend time examining contrary evidence, it is usually only to attack it aggressively and try to find fault with it, while we accept at face value anything which appears to support our beliefs.

A major explanation for our beliefs is that we tend to believe what we would like to be true. An obvious example is life after death. It would be wonderful if our personalities and intelligence survived in some way after death, which accounts for some of the most powerfully-held human beliefs: most people really want to believe this. More generally, there is a yearning for order and purpose in life, a wish to believe that there is more to it than meets the eye. Many find the concept that we are here (individually and collectively) only by random chance in a vast and uncaring universe simply unacceptable. They feel that it makes them, and life itself, pointless and worthless, so they instinctively reject it, leading them to dismiss, for instance, the overwhelming evidence for evolution in favour of beliefs which have no evidential support at all.

A belief in extra-sensory perception is also widespread (and a very common theme of SFF) but, as the author points out, no evidence for it has ever survived any objective analysis. Some promoters of the idea claim that trying to measure it prevents it from working, which sceptics might regard as a self-serving way of avoiding the need to provide any proof. There are various reasons for a belief in ESP, including a long history of plausible fraudsters and a very biased coverage in relevant news media, books and magazines (the vast majority of which uncritically support the idea), but the basic reason is probably that it's something that we would love to be true – for us to have such impressive and useful powers. I suspect that a belief in an alien origin of UFOs falls into the same category.

A similar example concerns alternative medicine in general, and faith healing in particular. For people (especially if seriously ill) who have not been helped by conventional medicine, there is a powerful motivation to believe anyone who offers a potential cure. Examples of "cures" are seized upon as proof, ignoring the fact that the body has a potent self-repairing system and that many ailments clear up by themselves given time. Alternative medicine also often relies on plausible (but false) similarities. The classic case is the enthusiasm in some parts of the world for medicines incorporating ground-up rhino horn to use as a kind of alternative order cialis – simply because it's long and hard and stands up all the time. More controversially (because it concerns our culture's popular beliefs rather than another's) the author points out that homeopathy falls into the same category; there is no validated evidence that it works, and no logical reason why it should [it makes the rhino horn notion look relatively sensible].

We have a remarkable capacity for self-delusion when it suits us. A survey of one million US high school seniors showed that 70% believed that they were above average in leadership ability, and only 2% that they were below average [much the same results occur in surveys which invite people to rate their own driving ability].

A final point: the perception of human fallibility in understanding is not exactly new. The book includes a couple of quotes from Francis Bacon, the 16th/17th century philosopher:

"The human understanding supposes a greater degree of order and equality in things than it really finds; and although many things in nature be sui generis and most irregular, will yet invest parallels and conjugates and relatives where no such thing is." Which is to say in simpler modern language, that we tend to see patterns and relationships where none exist.

and:

"…all superstition is much the same whether it be that of astrology, dreams, omens, retributive judgment, or the like…[in that] the deluded believers observe events which are fulfilled, but neglect or pass over their failure, though it be much more common."

In this review I have only had space to provide a very superficial summary of a few highlights, but Gilovich's book is packed full of examples and detailed explanations, so if this kind of thing intrigues you, go and find a copy!

(New) Medical Device Preemption Scorecard

(New) Medical Device Preemption Scorecard

After Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), was decided, we decided it was time to retire our old device preemption scorecard. The big question, whether PMA device manufacturers are protected by preemption, was resoundingly answered “yes.”



But since then, we’ve said repeatedly that we don’t expect plaintiffs to just fold their tents and go away - and they haven't. Rather, we expect the other side to look for loopholes in Riegel – even if we don’t think there are any – especially in the area of so-called “parallel” claims.



Anyway, it’s been six months since Riegel was decided, and the decisions addressing such arguments are starting to pile up. So we’ve decided to resurrect and revamp our device preemption scorecard with special emphasis on what Riegel “loophole” arguments are made and how courts decide them. So here goes (drumroll, please), the new and updated druganddevicelaw device preemption scorecard:

1. Strini v. Edwards Lifesciences Corp., 2008 WL 820192 (Mag. N.D.N.Y. March 26, 2008). Preemption issues cannot be decided in context of a discovery motion. “Parallel” violation claims might escape preemption.
2. Stevens v. Pacesetter, Inc., 2008 WL 2637417 (D.S.C. April 1, 2008). No “parallel” violation claims pleaded; action preempted in its entirety.
3. Despain v. Bradburn, 282 S.W.3d 814 (Ark. April 10, 2008). Plaintiff’s claims preempted. No manufacturing defect claim pleaded.
4. O’Shea v. Cordis Corp., 2008 WL 3139428 (Fla. Cir. May 19, 2008), mandamus denied, 24 So.3d (Fla. App. 2009). Off-label use does not preclude preemption where the defect (in design claim) or risk (in warning claim) is common to both on- and off-label use. True “parallel” violation claims, including off-label promotion are not preempted. Express warranty claims are not preempted. Fraud claims amounting to fraud on the FDA are preempted under Buckman. Unfair trade practice claims are preempted.
5. Troutman v. Curtis, 185 P.3d 930 (Kan. June 20, 2008). Plaintiff barely pleaded, and entirely failed to prove, any unpreempted “parallel” violation claims.
6. Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008). A claim based on the activities of defendant’s on-site representative escapes preemption as not regulated by the FDA.
7. Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008). Taking judicial notice of FDA PMA. Plaintiff failed to plead any unpreempted “parallel” violation claims either before or after FDA approval. Express warranty claims are unpreempted but inadequately pleaded. Leave granted to amend.
8. Mattingly v. Hubbard, 2008 WL 3895381 (Ky. Cir. July 31, 2008). Plaintiff failed to prove any unpreempted “parallel” violation claims. Negligent failure to train claims are preempted as “in addition to” the FDA’s requirements imposed upon the device.
9. McCutcheon v. Zimmer Holdings, Inc., 586 F. Supp.2d 917 (N.D. Ill. Aug. 6, 2008). Violation claims involving information the defendant provided to the FDA are preempted by Buckman. No evidence supports post-approval claims, even if they could be unpreempted. Riegel overrules contrary anti-preemption precedent. Congressional legislation to overturn Riegel is of no significance until it is passed.
10. Purcel v. Advanced Bionics Corp., 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008). FDA filed suit against manufacturer for violating Good Manufacturing Practices requirements. Plaintiff's strict liability and implied warranty claims that manufacturer sold adulterated product not preempted under Riegel.  Renewed motion denied, Purcel v. Advanced Bionics Corp., slip op. (N.D. Tex. June 24, 2010).
11. Clark v. Medtronic, Inc., 572 F. Supp.2d 1090 (D. Minn. Aug. 18, 2008). Doctrine of res ipsa loquitur cannot be invoked to show that a device that failed had necessarily been manufactured improperly. Allegations about information withheld from FDA are preempted by Buckman, and would be an improper private right of action to enforce the FDCA. All claims, including consumer protection, and breach of unspecified warranties, are preempted.
12. Kavalir v. Medtronic, Inc., 2008 WL 4087950 (N.D. Ill. Aug. 27, 2008). Preemption motion to dismiss denied because available information did not conclusively establish that the products in question had PMA approval.
13. Walker v. Medtronic, Inc., 2008 WL 4186854 (S.D.W. Va. Sept. 9, 2008). Preemption motion denied without prejudice in infusion pump case. Plaintiff could amend complaint to allege "parallel" FDCA violations, but the issue would be rejoined after discovery concerning the defendant's evidence that it was in full compliance.
14. Carson v. Depuy Spine, Inc., 2008 WL 7258800, order (C.D. Cal. Sept. 17, 2008). Summary judgment on preemption grounds granted against all claims spinal disc implant case. Allegations of off-label promotion as "parallel" claim failed: (1) because mere sales rep presence during an off-label surgery isn't promotion, and (2) for lack of evidence of reliance or causation. An appeal is pending (08-56698) in the Ninth Circuit.
15. Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. Oct. 22, 2008). Motion to dismiss on preemption grounds granted. Plaintiff failed to plead any facts supporting "parallel" claims. Preemption cannot be avoided by reference to adulteration and misbranding because there is no private right of action under the FDCA. Express warranty claims involving product labeling are preempted.
16. Rollins v. St. Jude Medical, 583 F. Supp.2d 790 (W.D. La. Oct. 20, 2008). Motion to dismiss plaintiff's claim that defendants failed to abide by FDA reporting requirements granted in part and denied in part in Angio-Seal case. Plaintiff conceded that all claims were preempted except failure to manufacture/package in accordance with FDA specifications, failure to train, and failure to abide by reporting requirements. Noncompliance claims not preempted. Manufacturing defect claim based on product recall not preempted. Failure to train claim preempted to the extent of FDA compliance. Failure to report claim dismissed for lack of causation.
17. Link v. Zimmer Holdings, Inc., 604 F. Supp.2d 1174 (N.D. Ill. Nov. 26, 2008). Summary judgment granted against all claims concerning total knee replacement prosthesis. No factual dispute as to compliance with FDA requirements. Rejected loopholes: fraud on the FDA (preempted), post-approval defect (relies on dissent; no proof); congress might change the statute (hasn't).
18. Lake v. Kardjian, 22 Misc.3d 960, 874 N.Y.S.2d 751 (N.Y. Sup. Dec. 17, 2008). Summary judgment granted against all claims concerning Targis transurethral microwave therapy system. Plaintiff failed to identify any specific statement exceeding FDA-approved warnings that could qualify as an unpreempted express warranty. Post approval failure to report claims are preempted either as fraud on the FDA or prohibited private FDCA violation claims.
19. Huber v. Howmedica Osteonics Corp., 2008 WL 5451072 (D.N.J. Dec. 31, 2008). Motion to dismiss denied against complaint alleging solely a claim for express warranty in total hip replacement litigation. The court considered itself bound by pre-Riegel Third Circuit precedent. The question whether express warranty claims are preempted has been certified to the Third Circuit. Huber v. Howmedica Osteonics Corp., 2009 WL 2998160 (D.N.J. March 10, 2009).
20. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. Jan. 5, 2009), reconsideration denied, 2009 WL 294353 (D. Minn. Feb. 5, 2009), leave to amend complaint denied, 2009 WL 1361313 (D. Minn. May 12, 2009). Motion to dismiss granted against all claims in Sprint Fidelis MDL. Manufacturing defect claims not "parallel" because no specific violations alleged, or allegable given generality of FDA regulations. Parallel claims do not exist without a specific FDA regulation for state-law claims to parallel. Adulteration claims amount to prohibited private attempts to enforce the FDCA. Negligence per se only supplies a standard of care, and cannot resurrect an otherwise preempted claim. An express warranty of "safety" would require a jury to find a device unsafe, which is preempted. This is an appealable order, motion practice in the district court appears exhausted, and the matter is currently on appeal.
21. Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. Jan. 12, 2009). Motion to dismiss denied as to claims "based on theories that [defendant] failed to comply with federal requirements for manufacturing" a hip replacement prosthesis. Surviving claims include those for express and implied warranty and consumer fraud. All non-violation claims had been voluntarily dismissed.
22. Means v. Howmedica Osteonics Corp., 2009 WL 347407 (S.D. Ind. Feb. 11, 2009), minute order following Hofts in hip replacement prosthesis case.
23. Blunt v. Medtronic, Inc., 315 Wis.2d 612, 760 N.W.2d 396 (Wis. Feb. 17, 2009). Pre-Riegel ruling in favor of PMA preemption affirmed in implantable defibrillator case. Both PMA and supplemental PMA have equal preemptive effect. Supplemental approval does not diminish the preemptive effect of initial approval.
24. Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. Feb. 20, 2009). Motion to dismiss granted as to claims involving total hip prosthesis. All claims except manufacturing defect are preempted, including consumer fraud. Warning letters and recalls not involving the device in question do not create parallel claims. A plaintiff must plead how a particular violation caused injury. The manufacturing claim must be more specifically pleaded. Express warranty claims not based on the approved labeling would escape preemption.
25. Shertzer v. Howmedica Osteonics Corp., 2009 WL 535997 (S.D. Ind. March 3, 2009), minute order following Hofts in hip replacement prosthesis case.
26. Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. March 5, 2009). Motion to dismiss granted in part and denied in part as to claims involving hip prosthesis. Violation claims, even if not preempted under Lohr, are preempted as attempted private FDCA enforcement under Buckman. Express warranty claims are not preempted, but are insufficiently pleaded. Manufacturing defect claims are preempted without specific allegations of a deviation from FDA-approved specifications.
27. Dorsey v. Allergan, Inc., 2009 WL 703290, slip op. (M.D. Tenn. March 11, 2009). Summary judgment granted as to claims involving investigational breast implants. Riegel applies to Class III devices marketed pursuant to an IDE or its equivalent. FDA approval of both adjunct (equivalent to an IDE) and core studies (an actual IDE) has preemptive effect.
28. Mitaro v. Medtronic, Inc., 23 Misc. 3d 1122(A), 886 N.Y.S.2d 71, 2009 WL 1272398 (N.Y. Sup. April 9, 2009) (unreported). Motion to dismiss granted against almost all claims, including consumer fraud, in implantable cardiac defibrillator case. Manufacturing defect claim could be a parallel violation claim. Negligence per se claim is preempted both as restating other preempted claims and as attempted private FDCA enforcement. Express warranty claim preempted only to the extent it relies upon FDA-approved statements. Claims predicated on false statements to the FDA are preempted under Buckman. A product recall does not vitiate preemption.  The Appellate Division affirmed in a one-paragraph opinion, Mitaro v. Medtronic, Inc., 73 A.D.3d 1142, 900 N.Y.S.2d 899 (N.Y.A.D. May 25, 2010).
29. Heisner v. Genzyme Corp., 2009 WL 1210633 (N.D. Ill. April 30, 2009). Motion to dismiss granted as to all claims in anti-adhesive surgical barrier case. Negligence per se claims related to events that post-dated plaintiff's injuries and thus couldn't possibly be causal. All other claims are preempted. Express preemption claims based on FDA-approved language are preempted.
30. Miller v. DePuy Spine, Inc., 638 F. Supp.2d 1226 (D. Nev. May 1, 2009). Granting summary judgment against all claims in a spinal implant disc case, including express warranty because the claimed warranty concerned aspects of device safety and effectiveness. Plaintiff had no evidence to support allegations of violation of FDA manufacturing standards. Allegations of fraud on the FDA are preempted under Buckman and as they are a prohibited attempt at private FDCA enforcement, would not constitute negligence per se under Nevada law.
31. Mullin v. Guidant Corp., 114 Conn.App. 279, 970 A.2d 733 (Conn. App. May 12, 2009), affirming Mullin v. Guidant Corp., 2008 WL 2785498 (Conn. Super. April 8, 2008). All claims, including manufacturing defect and express and implied warranties, are preempted in action involving implantable defibrillator. Plaintiff did not plead anything that could be considered a “parallel” violation claim. Preemption does not deprive a court of subject matter jurisdiction.  The Connecticut Supreme Court declined to review the case.  292 Conn. 921, 974 A.2d 722 (Conn. 2009).
32. Riley v. Cordis Corp., 625 F. Supp.2d 769 (D. Minn. June 5, 2009). Judgment on the pleadings granted as to all claims in drug eluding stent case. A "parallel" claim involves conduct "forbidden" by the FDCA. Even a claim involving prohibited conduct may be impliedly preempted as an improper private FDCA action under Buckman. To escape Buckman, a claim must rely on traditional state tort theories. Preemption applies to off-label uses. A combination of a drug and a device will be treated as a device for preemption purposes where the FDA has regulated the product as a device. Allegations that the FDA is poorly run do not defeat preemption. Allegations of promoting off-label use escape preemption only if, in addition to violating the FDCA, the promotion failed to warn of risks in violation of the common law. All other warning related claims are preempted. Fraud claims must be specifically pleaded. Express warranty claims based upo the device's label are preempted. Manufacturing defect claims must allege a violation in the particular device at issue. Any claims not dismissed with prejudice must be repleaded. This case is currently on appeal in the Eighth Circuit at No. 09-2870.
33. Bencomo v. Guidant Corp., 2009 WL 1951821, slip op. (E.D. La. June 30, 2009). Summary judgment on preemption granted against express warranty claims involving embolis capture system. Alleged contradiction between patient material and product labeling could not support a claim where the language in both sets of material were FDA approved. A claim dependent upon the falsity of FDA approved language cannot be a parallel claim.
34. Colombini v. Westchester County Health Care Corp., 24 Misc.3d 1222(A), 899 N.Y.S.2d 58, 2009 WL 2170230 (N.Y. Sup. July 6, 2009). Summary judgment granted against all claims in action involving an MRI device. That the device had been downclassified to Class II did not eliminate preemption, as the device was initially PMA approved. Plaintiffs could not point to any FDA design requirement that defendant violated, therefore there was no viable parallel claim.
35. Prudhel v. Endologix Inc., 2009 WL 2045559 (E.D. Cal. July 9, 2009). Motion to dismiss granted in part in aortic stent case. Alleged express warranty of safety was preempted. Alleged parallel claims are preempted when they impose greater requirements on compliant manufacturers. Parallel claims that require "more than mere noncompliance" are not preempted. A manufacturing defect claim, involving product recalls, survives preemption. Strict liability, negligence, and implied warranty claims are preempted.
36. Weston v. Kim's Dollar Store, 385 S.C. 520, 684 S.E.2d 769 (S.C. App. July 15, 2009). All claims properly held preempted in litigation concerning colored contact lenses. The lenses were regulated by the FDA and were not purely cosmetic. Although a "misbranding" claim was alleged, it was not separately discussed.
37. Wolicki-Gables v. Arrow International, Inc., 641 F. Supp. 2d 1270 (M.D. Fla. July 22, 2009). Summary judgment granted against all claims against the manufacturer and distributor of a pain pump. No parallel claims were alleged.
38. Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009). Motion to dismiss granted against all claims in ceramic total hip replacement case. Finding broad preemption of state tort claims that "incidentally" regulate medical devices. Parallel violation allegations can escape express preemption, but are subject to implied preemption. Rejects argument that preemption may only be decided on summary judgment. Rather than vitiating the preemption defense, allegations of fraud on the FDA are themselves preempted. FDA warning letters issued after plaintiff's surgery, and thus not relating to the product implanted in plaintiff cannot support an unpreempted parallel claim. To plead an unpreempted parallel violation claim requires alleging a specific federal requirement, how it was violated, and how the violation caused this plaintiff's injury. Express warranty and consumer fraud claims are too vaguely pleaded to escape preemption.
39. In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 2600517, slip op. (M.D. Ga. Aug. 24, 2009). Motion to dismiss granted against punitive damages claim asserted under New Jersey law because fraud on the FDA exception to the statutory ban on punitive damages against FDA-approved products is barred by preemption under Buckman.  Cautionary note:  this opinion was vacated on state-law grounds (whether the product was covered by the statutory ban in the first place) in In re Mentor Corp. Obtape Transobturator Sling Products Liability Litigation, 2009 WL 4280829 (M.D. Ga. Nov 24, 2009).
40. William Beaumont Hospital v. Medtronic, Inc., 2009 WL 2849546 (E.D. Mich. Aug. 31, 2009). Motion to dismiss granted in part. All claims based on alleged inadequacy of warnings are preempted in case concerning pain pump refill kits. Contribution claims based upon the negligent distribution of an incorrect free sample that was not in fact the same device as represented are not preempted.
41. Williams v. Cyberonics, Inc., 654 F. Supp.2d 301 (E.D. Pa. Sept. 10, 2009). Summary judgment granted against all claims in two cases involving vagus nerve stimulation devices. Unknown manufacturing defects inferred from alleged device malfunction were preempted because proof of a failure to manufacture the device to comply with FDA design requirements was shown.  Affirmed memorandum, No. 09-3800, 2010 WL 2982839, slip op. (3d Cir. July 30, 2010).
42. Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009). Summary judgment granted against all claims in ruptured breast implant case involving IDE device. Claims of lack of valid consent are factually false. No pleaded facts support any violation claim. That PMA approval occurred only after the plaintiff's device was implanted does not prevent preemtion, since essentially the same device was approved. A non-waiver clause in an informed consent form does not override preemption.
43. In re Medtronic Sprint Fidelis Leads State Court Litigation, 2009 WL 3417867, slip op. (Minn. Dist. Hennepin Co. Oct. 20, 2009). Motion to dismiss granted against all claims in state court Sprint Fidelis litigation. Express warranty and consumer fraud claims preempted. Purported "parallel" claims dismissed because: (1) they are disguised private attempts to enforce the FDCA, which are impliedly preempted under Buckman; (2) there is no parallel state law claim for failure to follow the conditions of an FDA PMA; (3) there is no federal requirement to submit a CBE (it's strictly voluntary); (4) claims challenging the sufficiency of a defendant's submissions to the FDA are disguised fraud-on-the-FDA claims; (5) plaintiffs' design claims would impose rigid specificity that FDA regulations do not; (6) nothing in the FDA's regulations requires withdrawal of a device because an allegedly "safer" model was later approved; (7) there is no obligation to submit a PMA supplement immediately after learning of problems with an existing device; (8) certain alleged violations were not causally connected to any plaintiff's injuries; (9) adulteration claims are disguised private attempts to enforce the FDCA; negligence per se claims are disguised private attempts to enforce the FDCA; (10) a statute that does not authorize a private cause of action cannot be the basis of a negligence per se claim under state law; and (11) the regulations subject to plaintiff's negligence per se claims are only administrative requirements and do not prescribe standards of care owed to any individual.
44. Williams v. Endologix, Inc., slip op., 2009 WL 3554581 (Ky. Cir. Oct. 30, 2009). Summary judgment granted against all claims in some kind (aortic stent?) of PMA device litigation, except claims "premised upon" FDCA violations, which the court considered parallel claims.
45. McQuiston v. Boston Scientific Corp., 2009 WL 4016120, slip op. (W.D. La. Nov. 19, 2009). Summary judgment granted against all claims in a drug eluting stent case involving a combination device. Express warranty claim preempted. Plaintiff did not plead a "parallel violation" claim.
46. Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859 (D.N.J. Dec. 15, 2009) (bench opinion).  Motion to dismiss granted against all claims, including express warranty, in ceramic total hip prosthesis case.  No violation claims were properly pleaded.  A 2006 recall cannot be causally relevant to a device implanted in 2003.  Twiqbal bars speculative parallel violation claims.  Preemption extends to all components of a PMA device system, even those originally receiving §510(k) clearance.  The New Jersey punitive damages exception is preempted as based upon fraud on the FDA.  Rejecting Hofts.
47. Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. Dec. 28, 2009).  Motion to dismiss granted against plaintiff's sole "negligence per se" claim involving a cheap cialis pump.  The allegedly violated Good Manufacturing Practices were too "vague and open-ended" to constitute a non-preempted parallel violation claim because they "would necessarily result in the imposition of standards that are different from or in addition to those imposed by the FDCA."
48. Banner v. Cyberonics, Inc., 2010 WL 455286 (D.N.J. Feb. 4, 2010), summary judgment granted on all claims in action involving a vagus nerve stimulator.  A claimed that a device is a "lemon" because it malfunctioned in unspecified ways does not establish any FDA violation. There was no dispute that the device was manufactured according to FDA specifications.
49. McGuan v. Endovascular Technologies, Inc., 182 Cal. App.4th 974, 106 Cal. Rptr.3d 277 (Cal. App. Feb. 9, 2010), affirming Johnson v. Endovascular Technologies, Inc., 2008 WL 3139424 (Cal. Super. May 19, 2008), and McGuan v. Endovascular Technologies, Inc., 2008 WL 3139418 (Cal. Super. May 19, 2008).  Summary judgment affirmed against all claims in case involving an endograft device.  Claimed "parallel" violation claim was really a preempted fraud on the FDA claim.  The defendant's guilty plea did not establish the exception to Buckman because the FDA reapproved the device after the alleged fraud and the guilty plea did not require removal of the device from the market.
50. Rankin v. Boston Scientific Corp., 2010 WL 672135 (E.D. Ky. Feb. 19, 2010), summary judgment granted on all claims in action involving a balloon catheter.  An allegation that the product failed under normal use does not establish a violation of FDA regulations.
51. Heisner v. Genzyme Corp., 2010 WL 894054, slip op. (N.D. Ill. March 8, 2010).  Dismissing with prejudice a complaint that had been amended three times (see above for two earlier dismissals).  The device CBE requirements, being voluntary, could not be parallel to a post-sale duty to warn.  A failure to report adverse events to the FDA was not "defect" as required by strict liability.  Negligence per se claims involving post-injury events could not possibly be causal.
52. Wheeler v. Depuy Spine, Inc., 706 F. Supp.2d 1264 (S.D. Fla. March 9, 2010), summary judgment granted on almost all claims in action involving off-label use of an artificial spinal disc.  Non-violation-related product liability claims are preempted.  Claims seeking to enforce the FDCA, that defendant "permitted" off-label use, and that defendant withheld adverse reaction reports were all preempted under Buckman.  A hearing will be held on express warranty claims, which are vulnerable to both preemption and non-preemption defenses.
53. Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. March 15, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  Preemption of product liability claims was conceded.  Redhibition is equivalent to a breach of implied warranty and it preempted.
54. Yost v. Stryker Corp., 2010 WL 1141586 (M.D. Fla. March 23, 2010), motion to dismiss granted against all claims involving hip prosthesis.  Plaintiffs pleaded no violation claims, so all tort claims were preempted.  Express warranty were inadequately pleaded.
55. Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio March 31, 2010), motion to dismiss granted on all claims involving total hip prosthesis. Generalized manufacturing defect allegations that do not mention FDCA violations cannot be recast as parallel violation claims. No causal link pleaded between FDA warning letters and device implanted in plaintiff.
56. Adams v. I-Flow Corp., 2010 WL 1339948 (C.D. Cal. March 30, 2010), motion to strike claim that defendants failed to warn the FDA stricken as a fraud on the FDA claim preempted by Buckman.
57. Lewkut v. Stryker Corp., ___ F. Supp.2d ___, 2010 WL 1544275, slip op. (S.D. Tex. April 16, 2010), motion to dismiss granted on all claims involving total hip prosthesis.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  All claims, including manufacturing defect and consumer fraud, are preempted.  Plaintiff's claim that his device was "adulterated" because a component was recalled for GMP issues is preempted under 21 U.S.C. §337(a) because adulteration claims are improper private enforcement of the FDCA.  Reconsideration denied, Lewkut v. Stryker Corp., 2010 WL 2542215 (S.D. Tex. June 21, 2010).
58. Franklin v. Medtronic, Inc., 2010 WL 2543579 (Mag. D. Colo. May 12, 2010), adopted 2010 WL 2543570 (D. Colo. June 22, 2010), summary judgment granted on all claims involving implantable defibrillator.  Failure to recall claim was not a parallel claim because recall under the FDCA is a voluntary remedial action.  Express warranty claims are preempted.  FDA regulatory claim was conclusory under TwIqbal, and an improper attempted private FDCA cause of action.
59. Phillips v. Stryker Corp., 2010 WL 2270683 (E.D. Tenn. June 3, 2010), motion to dismiss denied as to "parallel" violation claims in total hip prosthesis case where a device recall applied to the plaintiff's device.   A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  The public FDA record is subject to judicial notice.  Manufacturing defect theories based upon a claimed FDCA violation that formed the basis for the recall of the plaintiff's device adequately states an unpreempted claim.  Reconsideration denied, 2010 WL 4238594 (E.D. Tenn. Oct. 21, 2010).
60. Kallal v. Ciba Vision Corp., 2010 WL 2330365 (N.D. Ill. June 9, 2010), motion to dismiss granted in part on claims involving Optix contact lens.  All design and testing claims are preempted.  A parallel violation claim was sufficiently pleaded.  Plaintiff's pleading that the violated standard was FDA-imposed was sufficient; defendant's argument that the standard was only internal will not be decided on motion to dismiss.  There is a reasonable inference that a product purchased shortly before a recall was covered by the recall; it was not necessary to plead product identification numbers.
61. Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436 (6th Cir. June 16, 2010) (unpublished), order preempting negligence per se claim in knee prosthesis case reversed.   While the FDA Good Manufacturing Practice plaintiff claims was violated could be read two different ways, other FDA materials suggest that a specific duty was imposed, therefore the regulation was enforceable.
62. Steen v. Medtronic, Inc., 2010 WL 2573455 (N.D. Tex. June 25, 2010), motion to dismiss granted on all claims, including express and implied warranty, involving an Adapta pacemaker.  No parallel violation claim alleged.
63. Cornett v. Johnson & Johnson, 414 N.J. Super. 365, 998 A.2d 543 (N.J. Super. A.D. July 23, 2010), order preempting all claims in drug eluting cardiac stent case affirmed in part and reversed in part.  Off-label use does not preclude preemption.  Design defect claim is preempted.  Manufacturing defect claims incorporating an FDA warning letter are not preempted.  Warning defect claims are preempted except for intentional nondisclosure and illegal off-label promotion.  Express warranty claims involving product labeling are preempted, but not those involving unapproved statements.
64. Poole v. Hologic, Inc., 2010 WL 3021528 (W.D. La. July 29, 2010), judgment on the pleadings granted on all claims, including express and implied warranty, involving a "controlled endometrial ablation aystem."  No parallel violation claim alleged.
65. Raleigh v. Alcon Laboratories, Inc., 403 Ill. App.3d 863, 934 N.E.2d 530 (Ill. App. Aug. 6, 2010), affirming summary judgment order preempting all claims in intraocular lens case.  No parallel violation claim alleged.
66. Bass v. Stryker Corp., 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010), motion to dismiss granted on all claims involving a total hip prosthesis.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  Unelaborated "parallel violation" allegations are insufficient to avoid preemption.  FDCA violation claims are preempted under Buckman.
67. Aaronson v. American Medical Systems, 2010 WL 3603618 (E.D.N.Y. Sept. 7, 2010), motion to dismiss denied in case involving penile implant.  It was unclear at the pleading claim whether the device was actually a PMA device. Limited discovery on the device's regulatory status is allowed and, if it is a PMA device, plaintiff has 14 days to file a more specific complaint.
68. Gelber v. Stryker Corp., ___ F. Supp.2d ___, 2010 WL 4740432 (S.D.N.Y. Sept. 14, 2010), motion to dismiss granted on all claims involving a total hip prosthesis.  Preemption extends to express warranty and consumer fraud claims.  Plaintiff fail to plead violation of FDA manufacturing requirements with any detail.  Rejecting "lax" pleading standard of Hofts.  Plaintiff must plead a "device-specific" violation and causation by the violation.
69. Sanders v. Advanced Neuromodulation Systems, Inc., 44 So.3d 960 (Miss. Sept. 30, 2010), summary judgment affirmed on all claims involving a spinal cord stimulator.  Preemption was not defeated by the manufacturer's unsuccessful attempt to have the device downclassified to Class II.  The FDA did not misinterpret its regulations in deciding that the device was Class III and requiring premarket approval.
70. Bagumyan v. Medtronic, Inc., 2010 WL 4009891 (Cal. App. Oct. 14, 2010) (unpublished), summary judgment affirmed on all claims involving a Sprint Fidelis pacemaker lead. Supplemental PMA approval is equally preemptive as initial approval. The PMA process cannot be re-examined to test the quality of the FDA's actual review.  Parallel requirements arguments fail for lack of any citation to anything allegedly violated.  Affirming 2008 WL 8071256 (Cal. Super. Dec. 29, 2008).
71. In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. Oct 15, 2010), summary judgment affirmed on all claims involving the Sprint Fidelis MDL.  With respect to parallel claims, express preemption under Riegel and implied preemption under Buckman create only a "narrow gap" for state-law claims.  Failure to warn claims not alleging any violation of FDA regulations are not "parellel" claims and are preempted.  Even if additional warnings were allowed they were not required; thus the claim is "different from or in addition to" and is preempted.  Levine, involving implied preemption, is inapposite.  There is no federal requirement that unmodified products be removed from the market when a modified device is approved.  Claims that the defendant provided the FDA with insufficient information or withheld adverse event reports are private enforcement barred by Buckman.  Absent "concrete" allegations of FDCA violations, design defect claims are preempted.  General allegations of failure to comply with FDA Good Manufacturing Practices are too vague to escape preemption, and are a "frontal assault" on the FDA's risk/benefit conclusion.  Express warranty claims based on "safety and effectiveness" would require a jury to find a device unsafe, creating a preempted conflict.
72. Cenac v. Hubble, 2010 WL 4174573, slip op. (E.D. La. Oct. 21, 2010), motion to dismiss granted on all claims in SynchroMed cialis pump case.  GMPs and certain other regulations are too vague to support a "parallel" violation claim.  Allegations of post-PMA adverse event reporting violations are preempted fraud on the FDA claims.  Express and implied warranty claims are preempted.
73. Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho Nov. 1, 2010), motion to dismiss granted on all claims in Trident total hip implant case.  A component of the system, which had originally received §510(k) clearance, was later included in the PMA and thus has PMA status for preemption purposes.  Plaintiff should have modified allegations concerning the applicability of a product recall once the facts were clear, but Rule 11 sanctions will not be imposed.  A product recall not involving the product at issue cannot form the basis of a "parallel" violation claim.  An adulteration claim is a prohibited private FDCA right of action.
74. Stengel v. Medtronic, Inc., 2010 WL 4483970, slip op. (N.D. Ariz. Nov. 9, 2010), motion to dismiss granted on all claims in Synchromed pain pump case.  Strict liability, negligence and warranty claims were all preempted.  Amendment to add parallel violation claims denied because they were prohibited private attempts to enforce the FDCA.  Judicially noticeable official FDA documents reflecting the PMA did not convert a motion to dismiss into a summary judgment motion.
75. Bishoff v. Medtronic, Inc., 2010 WL 4852650, slip op. (N.D.W. Va. Nov. 22, 2010), motion to dismiss granted on all claims in pacemaker lead case.  Manufacturing defect/negligence per se claims were improperly pleaded because they didn't identify "how or why" there was a regulatory violation.  Express warranty claims were improperly pleaded.  Implied warranty for a particular purpose claims were preempted.
76. Norks v. Endovascular Technologies, Inc., 2010 WL 4681417 (Cal. App. Nov. 19, 2010) (unpublished), summary judgment affirmed (2008 WL 5267875) against all claims in case involving an endograft device.  Riegel applies to investigational devices.  Plaintiff did not plead any parallel violation claims.  Fraud on the FDA claims were preempted, thus an amendment was properly denied as futile.
77. Robinson v. Endovascular Technologies, Inc., 190 Cal. App.4th 1490, 119 Cal.Rptr.3d 158 (Cal. App. Nov. 19, 2010), summary judgment affirmed (2008 WL 5267874) against all claims in case involving an endograft device.  Riegel applies to investigational devices.  Plaintiff did not plead any parallel violation claims.
78. Walker v. Medtronic, Inc., 2010 WL 4822135, slip op. (S.D.W. Va. Nov. 24, 2010), summary judgment granted on all claims in pain pump case.   Strict liability, negligence and warranty claims were all preempted.  That a device diverged from a performance standard does not, without more, establish any lack of FDCA compliance.
79. Burgos v. Satiety, Inc., 2010 WL 4907764 (E.D.N.Y. Nov. 30, 2010), summary judgment granted on all claims, including breach of warranty, in investigational gastric stapling system device case.  IDE devices are subject to FDA supervision that's identical to PMA for preemption purposes.  Blanket reference to violation of unspecified statutes and regulations cannot suffice to state a parallel violation claim.  Plaintiff can amend.
80. Warren v. Howmedica Osteonics Corp., 2010 WL 5093097 (E.D. Mo. Dec. 8, 2010), motion for reconsideration denied, 2011 U.S. Dist. Lexis 32643 (March 29, 2011), claims based solely on FDCA violations survive preemption in Trident total hip implant case.  The court follows Hofts with respect to pleading and allows violation claims without pleading causation.
81. Pardo v. Medtronic Inc., 2010 WL 5300847 (E.D. La. Dec. 15, 2010), summary judgment granted on all claims in case involving brain stimulation device.  Terse order is unclear which claims are barred as preempted and which are barred for other reasons.  Off-label use does not defeat preemption.
82. Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. Dec. 23, 2010), reversing Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008), manufacturing-related claims based solely on FDCA violations survive a motion to dismiss on the basis of preemption in Trident total hip implant case.  Violation claims related to FDA GMPs are sufficiently specific, at the pleading stage, to escape preemption.  The claims are not impliedly preempted because as pleaded there is no conflict with the federal regulations.   Before a plaintiff has discovery, it is not necessary to plead specifically what regulation was violated and how, as to do so may be impossible.
83. Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. Jan. 21, 2011), reversing Hughes v. Boston Scientific Corp., 669 F. Supp.2d 701 (S.D. Miss. Nov. 12, 2009).  All warning and design product liability claims were properly dismissed as preempted.  Violation claims that paralleled traditional state warning and negligence per se claims were not preempted under Riegel.  A formal FDA finding of violation is not required to avoid preemption.  Unexplained FDA silence is not equivalent to approval.  Because the plaintiff's violation claims paralleled existing state tort claims, there was no preemption under Buckman.
84. Funk v. Stryker Corp., 631 F.3d 777 (5th Cir.  2011), affirming Funk v. Stryker Corp., 673 F. Supp.2d 522 (S.D. Tex. Dec. 1, 2009), dismissal of all claims against hip implant as preempted is affirmed.  Dismissal of violation claims based upon res ipsa loquitur are implied preempted.  Plaintiff failed to plead any other violation claim with sufficient specificity.  It was proper to take judicial notice of FDA PMA documents.
85. Cafferty v. Cayuga Medical Center, 2011 U.S. Dist. Lexis 12245 (N.D.N.Y. Feb. 8, 2011), motion to dismiss granted against all claims against intraocular lens.  Without any positive allegation of a violation of FDA regulations, a manufacturing defect claim is preempted.  Res ipsa loquitur cannot establish a regulatory violation.
86. Cohen v. Guidant Corp., 2011 WL 637472, slip op. (C.D. Cal. Feb. 15, 2011), motion to dismiss granted against all claims involving pacemaker.  Plaintiff pleaded only boilerplate FDA regulations as a parallel claim with no attempt to plead that they caused him injury.
87. Timberlake v. Synthes Spine, Inc., 2011 WL 711075 (S.D. Texas Feb. 18, 2011), summary judgment granted against all claims, including express warranty, involving artificial intervertebral spinal disc.  Plaintiff's fraud on the FDA claim was impliedly preempted by Buckman.  Plaintiff had no evidence to establish a causal violation claim.
88. Wolicki-Gables v. Arrow International, Inc., 2011 WL 780684, slip op. (11th Cir. March 8, 2011), summary judgment affirmed against all claims against spinal pain pump system.  Plaintiff failed to plead the elements of a parallel claim with any specificity.  Plaintiff is not entitled to any inference of defect due to the loss of a critical component because a defect was not the most probable cause of injury with other causes not ruled out.  Claims against sales representative dismissed under same rationale.
89. Nimtz v. Cepin, 2011 WL 831182 (S.D. Cal. Mar. 3, 2011), motion to dismiss granted against all claims involving pacemaker.  Plaintiff did not allege a parallel violation claim.
90. White v. Stryker Corp., 2011 U.S. Dist. Lexis  32568 (W.D. Ky. March 25, 2011), motion to dismiss granted against all claims involving hip implant.  Plaintiff failed to plead the elements of a parallel claim with any specificity.  Plaintiff neither pleaded a violation of a device-specific FDA requirement, nor that any violation pertained to the implanted device.
91. Kinetic Co. v. Medtronic, Inc., No. 08-CV-6062, slip op. (D. Minn. April 19, 2011), motion for judgment on the pleadings granted against all but one claim brought by third-party payer concerning recalled implantable cardiac defibrillator.  Express warranty and consumer fraud claima are preempted.  Allegations of misrepresentations to the FDA are preempted private attempts to enforce the FDCA.  Having not pleaded any warning-related claims that come close to surviving preemption, plaintiff is not entitled to discovery "to fish for claims of which it is not aware."  Claim based on alleged promise to pay for certain expenses has nothing to do with the FDA and is not preempted.