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Tag Archives: Medtronic

2010 Canadian Healthcare Review: Success and Momentum Building

We had just finished the Q3 2010 report when I attended BioContact Québec in early October and the mood was discouraging. My co-author on these reports (James Smith, VP-Healthcare at Equicom) was in San Francisco in January for the annual JP Morgan conference and he described the overall mood as optimistic. What happened in those three months?

The subtitle for the 2010 Canadian Healthcare Review (pdf) is “Successes and Momentum Building.” The momentum building comes partially from the increased financing which occurred in Q4, and which appears to be continuing in 2011 – Bioniche’s Australian tranche and Paladin Labs’ bought deal.

The momentum also comes from the clinical and regulatory successes in 2010. Three novel products developed by Canadian companies were approved – Cardiome’s IV BRINAVESS (vernakalant), Theratechnologies’ EGRIFTA (tesamorelin), and one which we tend to forget because it was acquired by Medtronic in 2008 is CryoCath’s Arctic Front cryoablation system. Cipher and Labopharm also had specialty pharma products approved and many companies were successfully progressing products through Phase 2 and 3 clinical trials.

These successes are usually dwarfed by the failures but this was not the case in 2010. There were only two Phase 2 or 3 products for which development was terminated. There were three other products which had Phase 2 hiccups but for which product development is continuing. On balance, 2010 was a successful year for product development and regulatory approvals.

In any discussion of successes, we cannot forget the investors, who measure success by increases in share price. From a group of 105 companies we assessed, there were 17 companies with share price increases of 40% or more in 2010 (actually 18 as Nightingale Health Care should be added to the list). This is balanced by 32 companies which had share price decreases of 40% or more.

Success for the industry in 2011 will be defined by its clinical, regulatory and financing successes, and by share price performance of the companies. Some of the companies which made progress in 2010 with their Phase 2 and 3 clinical trials and regulatory filings will have data or decisions in 2011, while others will still be advancing their programs. If the industry is able to repeat the clinical and regulatory success rate of 2011, we expect that financing and share price performance will likely follow.

Corporate Liability Journal Article on Wyeth v. Levine, Reigel v. Medtronic and Medtronic v. Lohr

Check out Jeremy’s latest article, published in the current issue of Corporate Liability Journal.

In The Changing Landscape of U.S. State Tort Liability for FDA-Approved Drugs and Medical Devices (pdf), Jeremy and his co-author, Alison Varga, take a more detailed look at this year’s U.S. Supreme Court decisions in Wyeth v. Levine and Reigel v. Medtronic, which Jeremy has been following on the blog.

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Hearings on the Medical Device Safety Act of 2009

Reps. Waxman and Pallone introduced legislation in March, with a parallel effort by Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. Medtronic and reinstate (har) state tort liability for PMA-approved medical devices.

This week, they held a hearing on the bill – H.R. 1346, the Medical Device Safety Act of 2009. 

The witnesses were (click for their statements):

There is also video of the hearings available.

Opening Statements:

Panel Testimony:

Panel Questions:

More to come when I get a chance to dig in…

Canadian Life Sciences VCs Lead the Realization Parade

Liquidity Shrivels Up For VCs in First Quarter” was the banner screaming across the wire services earlier this week. While true, what was lost in the subtext were a few important observations for Canadian VCs, particularly those focused on life sciences:

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Preemption Update: Waxman and Pallone Hit the Ground Running

When we reported on the Supreme Court’s decision in Wyeth v. Levine, we wondered what the effect would be on legislation proposed by Reps. Waxman and PalloneWe did not have to wonder long — they introduced legislation yesterday, with a parallel effort from Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. Medtronic and reinstate (har) state tort liability for PMA-approved medical devices.

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Supreme Court Rules 6-3 Against Preemption in Wyeth v Levine

The Wyeth v. Levine opinion (pdf) was handed down this morning, holding that state tort law claims (in this case, inadequate warning) are not preempted by the FDCA.  Justice Thomas’ concurring opinion starts at page 30 of the pdf.  Alito and Scalia’s dissent starts at page 54 of the pdf.

Now we have different preemption rules for PMA-approved devices (Reigel v. Medtronic), where state tort law is preempted, than for 510(k) devices (Medtronic v. Lohr) and for drugs (Wyeth v. Levine) where state law claims are still available.

Let’s see where Waxman and Pallone head with this.

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More Waxman-Pallone Reporting on State Tort Liability, Preemption, Medical Devices and FDA Approval

The NY Times Business section (and the WSJ Health Blog) this morning picked up the story — that we noted last week – that Waxman and Pallone plan to reintroduce legislation essentially reversing the Supreme Court’s ruling in Reigel v. Medtronic.  Those stories also note a Senate version to be introduced by Sen. Kennedy and Sen. Leahy.

The basis for the Supreme Court’s decision in Reigel v. Medtronic is the interpretation of the Medical Devices Amendments of 1976, so by enacting changes that specifically disclaim preemption of state tort law, Congress could effectively moot the Supreme Court’s ruling. 

However, two state-level developments may change the debate:

  1. The Wisconsin Supreme Court’s decision this week in Blunt v. Medtronic, which was dictated by Reigel v. Medtronic, may create additional pressure in favor of federal action and maintaining state tort liability (although note that only two of seven justices signed on to the Wisconsin concurring opinion decrying the result); but on the other hand
  2. The Georgia Senate Economic Development Committee held its first hearing yesterday on legislation protecting Georgia-based businesses or companies with more than 200 employees headquartered out of state from liability for defects in any drug or medical device that has been approved by the FDA.  If this initiative is successful, and is replicated in other states, both the Supreme Court’s ruling(s) and the federal legislation would be moot, since there would be no underlying state tort liability.

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Device Liability Preemption: Blunt v. Medtronic

In a 7-0 ruling that it said was dictated by last year’s U.S. Supreme Court ruling in Reigel v. Medtronic, the Wisconsin Supreme Court dismissed a products liability claim against Medtronic relating to one of its defibrillator models. 

Two justices wrote a concurrence (agreeing with the result, but) criticizing the reliance it places on the FDA’s PMA process, citing criticism of that process from within the Agency itself:

It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices.

However, the concurring  justices are mistaken to rely on the cited concerns.  The GAO and “dissident” scientist concerns, as I understand them, were about devices approved through the 510(k) process, not the PMA process, but only PMA-approved devices are exempt from State tort liability under Reigel v. Medtronic.   Medtronic v. Lohr specifically denied preemption for 510(k)-approved devices.

That is not to say that as a matter of institutional competence, I believe the FDA is better suited than the courts to assess post-approval device safety.  I don’t think we have the data to make that assessment.  Certainly if the FDA is expected to competently act as the final arbiter of product safety, it would need more funds, and perhaps revisions to post-approval regulations.  Or maybe Waxman will succeed and legislate tort un-reform.

Read our other posts on this topic.

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Rep. Waxman, Reigel v Medtronic and Wyeth v Levine

Last Summer, the U.S. Supreme Court held in Reigel v. Medtronic that the premarket approval (PMA) process for medical devices pre-empts liability under State common law for claims challenging the safety or effectiveness of medical devices.  Wyeth v. Levine, which the U.S. Supreme Court heard last Fall, but has not decided, makes a parallel argument with respect to labelling of FDA-approved drugs. Together, these two cases could reshape liability for products under the FDA’s purview in a way that looks very much like tort reform, and therefore, have seemed ripe for a legislative response.  A story in yesterday’s Minneapolis-St.Paul Star Tribune includes a statement from Rep. Henry Waxman, D- Calif. that

Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would circumvent the Supreme Court ruling and “protect Americans from dangerous medical devices.”

and notes that Barack Obama was one of the cosponsors of the Senate bill introduced last year to address the issue. more analysis after the jump…

Wednesday Brain Dump: February 4, 2009

Some good news on the gene therapy front in adenosine deaminase-deficient SCID patients and in rheumatoid arthritis.

But mostly bad news on the job front at GSK, AstraZenecaAbbott,  GenVecPatheon, and others.

Other good news on the approvals front for Parusgel (despite process concerns), KapidexLamictalGelnique and Taxus Liberte.

Really small news: Nanomaterials may be heading for increased regulation in Canada, with a mandatory reporting program reportedly pending and a new guide from IRSST in Quebec (pdf) (although the IRSST guide doesn’t mention bio-materials).

Just NICE news: Comparative Effectiveness may be headed for some changes in the UK, where NICE is working on a review.

Positively Biblical news: The lion lies down with the lamb (or something equally unlikely)

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